VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
66,833
AK1,573
AL5,032
AR3,172
AS44
AZ12,907
CA55,820
CO10,603
CT7,472
DC1,591
DE1,593
FL34,354
FM3
GA12,742
GU74
HI2,105
IA4,166
ID2,385
IL18,540
IN22,179
KS4,109
KY6,416
LA4,489
MA13,356
MD11,478
ME2,896
MH8
MI17,043
MN10,845
MO8,482
MP30
MS2,528
MT2,055
NC14,687
ND1,190
NE2,596
NH2,760
NJ16,433
NM3,577
NV3,887
NY31,462
OH17,316
OK5,741
OR7,625
PA21,538
PR1,997
QM2
RI1,848
SC5,719
SD1,097
TN8,205
TX32,584
UT3,861
VA13,379
VI49
VT1,618
WA13,251
WI9,996
WV2,144
WY763
XB5
XL1
XV2

ID: 1521977
Sex: F
Age:
State: TN

Vax Date: 04/05/2021
Onset Date: 04/15/2021
Rec V Date: 08/03/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: psychosis; cognitive decline; could not go out in heat; hives almost all my body/bad rash all over your body; bad rash all over your body; Vaginal pain; skin feels tingling all over her body; throat had pain and was dry and hot; waves of heat and hot spots/it was worse on her legs; she would be so cold she couldn't get warm again; butt was stinging and burning; butt was stinging and burning/burning in the back of her knees; couldn't sleep; Confusion; Constipation; Weight loss; throat had pain and was dry and hot; throat had pain and was dry and hot; noticed round raised bumps on same arm as the shot; This is a spontaneous report from a Contactable consumer. This 68-year-old female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered in left arm (on the arm but not the shoulder) on 05Apr2021 at 10:30 (at the age of 68 years) as dose 2, single for covid-19 immunization. Patient received prednisone on 15apr2021 at unknown dose, via an unspecified route of administration, on 16apr2021, 10 mg, tablet and orally, 18apr2021 at unknown dose, Intravenous, 19apr2021, 40 mg and on 26Apr2021, UNK, it was a 30,20,10 taper, via an unspecified route of administration for unknown indication. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID) 88 mcg daily. It was reported that the patient took Synthroid but she did not have a thyroid. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 68 years) as dose 1, single for covid-19 immunization. The vaccination facility was health department type and not military facility. The patient wanted to report her adverse event and severe reaction that she had after the second dose. The event happened 10 days after the second dose. On 15Apr2021, the patient noticed round raised bumps on the same arm as the shot, not pimples because they did not have a head. The patient applied calamine lotion but the bumps kept coming up more and more. The patient ended up being covered in hives on her whole body except her face, she was bright red and looked like a lobster. The patient was given a prednisone shot (unknown lot, NDC and expiration date) at the emergency room and the hives were better for about 12 hours, this was on 15Apr2021, but they came back. It was reported that she had this rash that would come up and go away. She went to an urgent care the following day and they gave her Prednisone (unknown lot, NDC and expiration date) 10 mg tablet and the next day she felt normal but then it rebounded. The patient went back to urgent care on the 17Apr2021 because the hives rebounded. Then on 18Apr2021, the patient went back to the emergency room and they gave her IV prednisone. The patient did not have any problems breathing. On 18Apr2021, the dermatologist took two biopsies and determined the rash was not lupus and it was from a drug but none of her normal medications. The doctor thought that this was from the covid shot. On 19Apr2021, the patient went into her dermatologist and got 40mg of Prednisone and was on that for a long period of time. The step down of that medicine started on 26Apr2021 and it was a 30,20,10 taper. The patient was scared that the hives would come back. She could not go out in the heat, her skin felt tingling all over her body. That had been going on since the hives was ongoing. If it was above 74 degrees outside, the patient could not go out because it got uncomfortable, it was really severe but had gotten less. On 05May2021, she was at the gynecologist with vaginal pain and they took her to the emergency room and was sent to the psych ward for a week because of psychosis from the Prednisone. She was admitted to the psychiatric hospital from 05May2021 to 12May2021. She had throat pain and was dry and hot. Cold water caused extreme pain if she drank it so she gurgled with lukewarm water. All of the patients symptoms were happening at the same time, starting with the hives, but varying intensities. She had waves of heat and hot spots that lasted 15-45 minutes then moved to another place, from her arms to her legs. Her butt was stinging and burning. This came back on the 04Jul2021 it was worse on her legs. She could not sleep, the bed would get really hot and would get pressure points lines from the sheets or if she crossed her legs it would leave a mark. She had cognitive decline, the doctor said that this was from the Prednisone and would take 4 months to get out of her system. She had confusion and constipation. She had weight loss, she had not tried to gain it back because if she ate too much she got an upset stomach. On 18Apr2021, her reaction was full blown. If she kept cold water on her skin it was okay, she would stand in front of fans but she would be so cold she could not get warm again. She did not remember all of this because of the steroids. On 04Jul2021, she had burning in the back of her knees until 08Jul2021. She was disappointed that all of this happened after the vaccine. The patient underwent lab tests and procedures which included biopsy skin: the reaction was from a drug and not lupus on 18Apr2021. The outcome of events hives, rash, skin feels tingling all over her body, waves of heat and hot spots, butt was stinging and burning, could not sleep, cognitive decline, confusion, constipation, she would be so cold she could not get warm again was not recovered while outcome of rest of events were unknown.

Other Meds: SYNTHROID

Current Illness:

ID: 1521978
Sex: M
Age:
State: NH

Vax Date: 05/20/2021
Onset Date: 05/01/2021
Rec V Date: 08/03/2021
Hospital:

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Symptoms: discomfort and soreness in his arm; soreness in his arm; he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; discomfort and soreness in his arm/he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; see if there was a lump; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0176, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 20May2021 in the morning (at the age of 71-years-old) as single dose for covid-19 immunization (So that he would have resistance to the Covid-19 virus). Medical history included ongoing High blood pressure. Reporter reported that he was diagnosed with high blood pressure about 3 years ago Stop, hip arthroplasty in Sep2019. Reporter reported that he has had 2 hip replacements, one in Sep2019 and one in Sep2020, hip arthroplasty in Sep2020. Reporter reported that he has had 2 hip replacements, one in Sep2019 and one in Sep2020. Concomitant medication included lisinopril taken for hypertension from an unspecified start date and ongoing. Lisinopril, Reporter reported that he began taking Lisinopril a couple of years ago. Reporter reported that he was diagnosed with high blood pressure probably 3 years ago. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in Arm Left on 29Apr2021 (at the age of 71-years-old) as a dose 1, single for covid-19 immunization. After first dose patient had Little bit of discomfort in arm, Fatigued on 29Apr2021. And Little bit of discomfort in arm was resolved on 2021 and Fatigued was resolved on 30Apr2021. Had a little bit of hydraulic pressure from injecting fluid into tissue and he did consider general muscle pain in his shoulders as a source for the discomfort in his arm. Additional Vaccines Administered on Same Date of the Pfizer Suspect were None. Vaccinations (within 4 weeks) were None. following prior vaccinations were also None. Family Medical History Relevant to AEs and Relevant Tests were None. The patient experienced discomfort and soreness in his arm on 20May2021, he did consider general muscle pain in his shoulders as a source for the discomfort in his arm and he did consider general muscle pain in his shoulders as a source for the discomfort in his arm on May2021 and see if there was a lump in 2021. Reporter stated he received his first dose on 29Apr2021 and had some discomfort in his arm that went away, but then he had his second dose on 20May2021 and had discomfort and soreness in his arm that took 5 weeks to go away. Reporter stated he went online and looked at SIRVA. Reporter asks if the practitioner that gave him the second dose injected it incorrectly, and injected it into the bursa sac, would the vaccine come out of the bursa sac and back into his system to be effective or should he get another vaccination. Reporter asks if there is a way of knowing if it came out of the bursa. Reporter stated the vaccine was injected by a pharmacist and if MI has no information for him, why would they. Reporter asked what we tell people with SIRVA or what information do we have on SIRVA because it seems to him that if someone had the wrong angle, they could hit the subdeltoid bursa. Reporter reported that he had both Covid-19 shots, one on 29Apr2021 and the second on 20Jun2021. Reporter reported that the first one was a piece of cake. Reporter stated that he is 71 and has had a few shots in the past. Reporter reported that following the first dose of the Covid-19 vaccine, he experienced a little bit of discomfort and after a few days it was gone. Reporter reported that following the second dose of the Covid-19 vaccine, the discomfort continued to grow in the same location where the vaccine was injected in his arm. Reporter reported that his arm got sorer and sorer and sorer, and it took about 5 weeks to go away. Reporter reported that there are still some telltale signs and he went online and looked at SIRVA, Shoulder Injury Related to Vaccine Administration, and it brought on questions. Reporter inquired if hypothetically, the practitioner administered the Covid-19 vaccine incorrectly and injected the vaccine into his bursa sac, does it eventually get out of the bursa and back into the system so that you have an appropriate amount of vaccine. Reporter reported that he has not gotten an answer from anyone, even doctors. Reporter reported that it does seem remote, but nevertheless, its plausible. Reporter stated if it in fact did get injected into the bursa, one person, a friend of his that's an anesthesiologist, said that had like to get another shot. Reporter inquired if the Covid-19 vaccine gets out of the bursa sac if it was administered incorrectly. Reporter inquired if there's interference with the Covid- 19 vaccine getting into your system, what is the outcome of getting a third shot and was it recommended. Reporter reported that he has not been to see his primary care physician yet, but he did set up an appointment. Reporter reported that he ended up going to urgent care because it was part of a large hospital versus a small family practice. Reporter reported that he figured with the size, there was a greater probability that they may have run into this. Reporter reported that the practitioner at the urgent care asked why the reporter went to the clinic versus his primary care physician. Reporter reported that he told the practitioner his reasons, and the practitioner suggested that the reporter make an appointment with a doctor the next town over who is a virologist and has more experience with virology than your average doctor. Reporter reported that he went to his pharmacy, and the pharmacist there said that what they would do is call Pfizer and they have a hotline. After first dose patient had Little bit of discomfort in arm, Reporter reported that he sees the discomfort in his arm like a little bit of hydraulic pressure from injecting fluid into tissue. Reporter reported that the discomfort in his arm was gone in a day or two. After second dose he had Discomfort in arm Reporter reported that his arm got more and more and more painful. Reporter reported that it lasted for about 4 weeks until it settled down into the 5th week. Reporter reported that the discomfort in his arm is still present and is just kind of there, but it's mostly gone away. Reporter reported that he doesn't think there as anything to see if he went to the doctor anymore. Reporter reported that when he went to urgent care, they checked to see if there was a lump. Reporter reported that the discomfort in his arm was mostly gone and he doesn't think they'd find anything. Reporter originally reported that he received his second dose of the Covid-19 vaccine on 20Jun2021. Reporter confirmed date of second dose of Covid-19 vaccine as 20May2021. Reporter unable to provide the NDC number or expiry date for the Covid-19 vaccines he received. Reporter reported that he did a lot of reading and read about how the research on mRNA vaccines started in 1990 and the evolution of it. Reporter reported that he found it fascinating and chose Pfizer because he thought they were ahead of the pack. Reporter reported that he periodically takes ibuprofen or naproxen for aches and pains. Reporter reported that sometimes he has to take them more regularly, like lately they've had incredible weather that's been very rainy. Reporter reported that has had 2 hip replacements, and it's not the hip itself because its synthetic, but the muscles around them every once in a while, get a little sore. Reporter reported that he did consider general muscle pain in his shoulders as a source for the discomfort in his arm. Reporter reported that he is still pretty active, very active for 71 years old, and working. Reporter reported that it's a different kind of pain that originated with and continued with

Other Meds: LISINOPRIL

Current Illness: Hypertension (High blood pressure; he was diagnosed with high blood pressure about 3 years ago Stop)

ID: 1521979
Sex: F
Age:
State: OH

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 08/03/2021
Hospital:

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Symptoms: autoimmune disease; doctor did a lab test and tested her SED rate. It resulted at 60 and is supposed to be 5; legs were hurting again; anemic; pain in her lower back; extremely tired /After receiving her second Covid 19 vaccine she reports her symptoms and side effects stayed about the same.; had trouble walking/After receiving her second Covid 19 vaccine she reports her symptoms and side effects stayed about the same.; having trouble doing activities of daily living; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old female patient reported for herself that: A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EN6205 and Expiration date: 30Jun2021) via an intramuscular route of administration on 06Mar2021 8:30AM, as a dose 2, single for Covid-19 immunization. The patient medical history included Asthma Had maybe 15 years and was ongoing. The patient concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EL9267, Expiration date: 31May2021) via an unspecified route of administration on 13Feb2021 8:30AM, as a dose 1, single for covid-19 immunization. After her first dose, she experienced that same day, extreme tiredness (evening after receiving her first Covid 19 vaccine), trouble walking, and leg soreness in her inner thigh area (legs were sore but not related to muscle or bone), things like bending over, putting her shoes and socks on and going up steps are hard for her to do (all were not recovered). The patient experienced cellulitis, arm swelled up and fever on past medication: pneumonia vaccine (Vaccination Date: 2018). Her doctor told her it was not related to her muscle or bones. After her second dose, the doctor did a lab test and tested her SED rate. It resulted at 60 and was supposed to be 5. Her inflammatory response was very high. She saw a rheumatologist and that doctor repeated the SED rate and it resulted an even higher number. The rheumatologist believed she has autoimmune disease. As of date of this report (reported as of today), no one medically knew what to do with her. Reporter wanted to know of any physicians that are dealing with symptoms of Covid-19 for example, has lower back pain and unable to do daily activities been reported after receiving the Pfizer Covid-19 Vaccine. It was stated that she was still having trouble puting shoes on going up steps. Sedimentation rate was 60, inflammatory numbers were really high, sedimentation rate kept going up higher, autoimmune disease, she was anemic, pain in her lower back. Results of tests and procedures for investigation of the patient: Test MRI of her spine, more information available: NO, Results of tests and procedures for investigation of the patient: Test Chest X-ray, More information available: NO, Results of tests and procedures for investigation of the patient: Test Hip X-ray More information available: NO, Test Knee X-ray More information available: NO, Test Blood work More information available: NO, Test Sedimentation rate: Result 60 More information available : NO, She received the first dose on 13Feb2021, and that same day, later in the evening she was extremely tired and had trouble walking. Her legs are sore but not related to muscle or bone. Her legs are sore in her inner thigh area. Things like bending over, putting her shoes and socks on and going up steps are hard for her to do. She went to her doctor in Mar2021 and her sedimentation rate was 60 and it's normally supposed to be 5 so her inflammatory numbers were really high. Her doctor prescribed a steroid and referred her to a rheumatologist. The rheumatologist repeated the blood work and her sedimentation rate kept going up higher. The rheumatologist believes the caller has an autoimmune disease. The rheumatologist prescribed another steroid because the caller's legs were hurting again. The caller was signed up for Otezla but that medication takes a long time for approval from insurance so she was finally approved and took the Otezla. It's supposed to be in her system for 40 days to know if it's going to work. The Otezla did not work. She was prescribed another round of steroids and is now trying to get Humira. Her blood work now shows she is anemic. She has pain in her lower back. She doesn't think that her doctor's know what to do with her. She has a full time job working with special education kids and she's very concerned over how can she go back to work. Her doctor wanted to prescribe an opioid but she doesn't want to take that and to become addicted to something like that. She's asking for some kind of direction or guidance. She is hoping to find a doctor that deals with adverse events from the Covid 19 vaccine. She's called the withheld, and the CDC but no one can help her. She reports she used to work in at Hospital . She had to quit because of the Covid 19 pandemic because she's immune compromised. She quit prior to receiving her Covid 19 vaccines. She received her second Covid 19 vaccine on 06Mar2021 in the right arm but isn't 100 percent certain. First Covid 19 vaccine information is in the suspect product field. When probing anatomical location of her first Covid 19 vaccine she wants to say she received it in the left arm but isn't 100% sure. She received the second vaccine in the other arm thinking maybe that would cure her. After receiving her second Covid 19 vaccine she reports her symptoms and side effects stayed about the same. When probing for medical history and concomitant medications she reports she does not think her medications are relevant, she's been on her medications for years. She reports the rheumatologist did an X-ray of her hips and her knees and her chest. She had an MRI done of her spine. The MRI was about 2 weeks ago. The chest X-ray was sometime last week. Her hips and knees were X-rayed on 10May2021. When probing for adverse events following other vaccines she reports she had an allergic reaction to the pneumonia vaccine. She states one doctor called it an allergic reaction but the emergency room doctor called it cellulitis. She reports her arm swelled up and she had a fever of 103 degrees Fahrenheit. That happened in 2018. When probing for information regarding the Otezla, she reports she tried it maybe in Mar2021. She had to take it for 40 days before she could see results. She's been off of it for maybe 2 or 3 weeks now. Did not have history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The event Did not require a visit to: Emergency Room, but required visit to physician Office. Did not receive Prior Vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. She was signed up for Otezla but that medication takes a long time for approval from insurance so she was finally approved and took the Otezla. It's supposed to be in her system for 40 days to know if it's going to work. The Otezla did not work. When probing for information regarding the Otezla, she reports she tried it maybe in Mar2021. She had to take it for 40 days before she could see results. She's been off of it for maybe 2 or 3 weeks now. She does not have the dosage. She states they are thinking that her pain that she is having is being cause by her "blood being out of wack". States her SED rate should be 0-25 and hers is in the 50s now, CRP extended range is now 77 and keeps going up. Her leg issues are the main concern at the moment. RBC is low at 3.91, HGB is 11.5, HCT 35.9, percentage Sat 16, platelets 500. She states the blood work and leg pain is all from the Pfizer Vaccine. Also states she is having trouble doing activities of daily living and having leg and back pain, she could not remember if she said that before. Potential AE duplicate. Outcome of the events was reported as not resolved. No further information was provided.

Other Meds:

Current Illness:

ID: 1521980
Sex: F
Age:
State: CA

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 08/03/2021
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Symptoms: vision being off; blurred vision; slight headache; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm left on 20Jul2021 at 12:20 PM (Lot Number: EW0186) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure (abnormal). Concomitant medications included atenolol with five years for blood pressure (abnormal), amlodipine besilate with five years for blood pressure (abnormal). On 20Jul2021, patient had vision was kind of off, slight headache. Patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 20Jul2021 at around 12:20pm. She started having blurred vision and slight headache at around 1:15-1:30. She would like to know if anyone else has reported these side effects. Patient stated that she will not get her second dose of the vaccine. Patient never got shots, never got the flu shot. Patient was fine in there but when she started looking at her phone, reading the email, her vision was kind of off. It was blurry a little bit. She had a slight headache. She didn't see that as a side effect. She didn't know if anyone else has had this reaction to the shot or not. Patient got the vaccine about 12:20PM. She had to wait 15 minutes so she got out of there about 12:50. She looked at her phone so maybe her vision being off and the headache started about 1:15PM or 1:30PM. It affected her when she looks at something she needs to read. Sees far fine. She had a headache and can tell when reading the article they gave her or her phone. She can't see that clear. Patient did not feel like she was having a medical emergency where she would need to call or go to the emergency room. Events did not require a visit to emergency room or physician office. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). Outcome of the event blurred vision was unknown, while of the other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ATENOLOL; AMLODIPINE BESILATE

Current Illness:

ID: 1521981
Sex: M
Age:
State: FL

Vax Date: 03/23/2021
Onset Date: 04/01/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus. He has been diabetic a long time. Concomitant medication(s) included metformin (MANUFACTURER UNKNOWN) taken for diabetes mellitus. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any vaccines four weeks prior vaccination. It was reported that the patient received Pfizer covid vaccine on 23Mar2021. They made him sit for half an hour. He was supposed to get his second shot on 13Apr2021, but he was diagnosed with Covid-19 on the fourth or fifth of April. He went to the emergency Room during the night because he was not feeling that good. He waited for 3 hours and saw the doctor at 4 AM. Blood work has been good. Patient was hospitalized for the event. When he went to the hospital the doctor said the first shot was working and that was why his symptoms weren't so bad. Then they gave him the antibodies. He spent 3 days in the hospital. He did not have to have oxygen. Upon discharge the doctor said he had to wait 90 days to get the second shot. His primary care provider told him that he needs to start the series over. When the Patient went to receive the second dose, he was told that Pfizer told them that he should not get vaccinated. Patient clarified that his first dose was given by a man at the vaccine at a clinic at County College. The lady said to start over and he was willing to start over. When he went to Pharmacy he was told that he could not start over and he couldn't get the shot. He doesn't see Pfizer on the vaccination card, but they told him it was Pfizer. Patient asked if he could take the second dose of the vaccine or do have start over, since he had Covid and was treated with antibodies. Patient was asking if he could get the second dose, or will he be starting all over again. The patient underwent lab test in which blood test: good, and SARS-COV-2 test: Positive on an unspecified date. The patient received treatment for event. The outcome of the event was unknown. Upon follow-up received from a Product Quality Complaint Group on 21Jul2021, the following was included: This report included Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further information is expected.

Other Meds: METFORMIN

Current Illness:

ID: 1521982
Sex: F
Age:
State: NJ

Vax Date: 01/11/2021
Onset Date: 02/04/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: Developed shortness of breathe; Right leg edema; Hospitalized with heavy burden bilateral PE; 3 blood clots in right leg; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 16:00 (58-years-old at the time of vaccination), (Batch/Lot Number: EK9231) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension (HTN) hyperlipidaemia (HLD), gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. Patient had known allergies to Penicillin (PCN), Sulfa, honey dew, Boniva. Concomitant medication included rosuvastatin calcium (CRESTOR), loratadine (CLARITINE) omeprazole (PRILOSEC [OMEPRAZOLE]), hctz (HCTZ), docusate sodium (COLACE) and calcium taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Dec2020 16:15 (Batch/Lot Number: EL0140) as DOSE 1, SINGLE for covid-19 immunization. On 04Feb2021 14:00, the patient experienced developed shortness of breath and right leg edema. 3 weeks after 2nd vaccine. Hospitalized with heavy burden bilateral PE and 3 blood clots in right leg. The events was serious (medically significant). The patient was hospitalized for 5days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021. Patient received treatment for the events as Eliquis many tests. The clinical outcome of the events was recovering at the time of reporting.

Other Meds: CRESTOR; CLARITINE; PRILOSEC [OMEPRAZOLE]; HCTZ; COLACE; CALCIUM

Current Illness:

ID: 1521983
Sex: F
Age:
State: NC

Vax Date: 03/17/2021
Onset Date: 03/20/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: Dizziness/Vertigo; Insomnia; Dull aching within the legs; Difficulty walking; weakness within the legs; Severe brain fog; Short term memory loss; Intense vision/brightness; Pain behind the eyes.; Cheeks aching/Tingling; Migraine with no pain; Anxiety; Lack of sensation throughout the body, especially the legs; Feeling out of body; Random bouts of heat/burning sensation in tiny areas of the body (lip, foot); Internal vibration; Tremor in right hand; Tinnitus in left ear; Toes twitching; Back beginning to feel numb and cold; Back beginning to feel numb and cold; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 30-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 as DOSE 1, SINGLE for covid-19 immunisation patient didn't received other vaccines within 4 weeks prior to vaccination patient received other medication levothyroxine within 2 weeks prior to vaccination. Medical history included autoimmune thyroiditis hash moto's thyroiditis from an unknown date and unknown if ongoing, allergy & hay fever relief from an unknown date and unknown if ongoing Gluten allergy patient didn't had Covid prior to vaccination patient was not tested to covid to post vaccination. The patient's concomitant medications were not reported. It was reported that, on 20Mar2021 the patient experienced dizziness/vertigo, insomnia, dull aching within the legs, difficulty walking, weakness within the legs, severe brain fog, short term memory loss, intense vision/brightness, pain behind the eyes, cheeks aching/tingling, migraine with no pain, anxiety, lack of sensation throughout the body, especially the legs, feeling out of body, random bouts of heat/burning sensation in tiny areas of the body, burning sensation, internal vibration, tremor in right hand, tinnitus in left ear, toes twitching, back beginning to feel numb and cold. The patient was hospitalised (1day) for the events at Medical Center and patient had Emergency room and physician office visits for the events and patient had disability for the events patient didn't had any treatment for the events. The outcome of the events vertigo, insomnia, pain in extremity, gait disturbance, asthenia, feeling abnormal, amnesia, visual impairment, paraesthesia, migraine, anxiety, sensory loss, lip, foot, burning sensation, nervousness, tremor, tinnitus, muscle twitching, hypoaesthesia, feeling cold was not recovered. Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.

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Current Illness:

ID: 1521984
Sex: M
Age:
State: WA

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 08/03/2021
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Symptoms: I was screaming, feeling horrible.; low count of white cell; scared; I started feeling pain below my belly button and the pain was start not in my stomach, it was right below my belly button; I just got below my belly button I got bloated and even like a sharp pain, like a pain that didn't got away. A pain didn't not fluctuate, a pain that was not going up and down at all. It was steady.; My face got numb, a little bit but for the short time.; I just got below my belly button I got bloated and even like a sharp pain, like a pain that didn't got away. A pain didn't not fluctuate, a pain that was not going up and down at all. It was steady.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Jun2021 (at the age of 30-years-old) (Batch/Lot Number: EW0178) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included abstains from alcohol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot number EW0182), via an unspecified route of administration, administered in Arm right on 17May2021 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation and not experienced any adverse event. Patient previously had tramadol and experienced drug ineffective. Reporter stated that he had some weird side effect so, he wants to know, he take his second shot of Covid Vaccine on June and it was horrible at night. First thing, Patient had numb face for 5 minutes after taking the vaccine and it went away. It was for a short period. He was fine but when, he got numb lets say, he took the vaccine around 10:30-11:00 AM and at 11:00 PM in the night, Patient started feeling pain below his belly button and the pain was start not in his stomach it was right below his belly button, thought it was side effect at some point and let me tell you, I don't have insurance. The patient also had a bad reaction. He don't have insurance. He was a healthy person. Patient meant to fitness. He don't drink, he don't do anything weird so. He basically take care of himself. I Patient was pretty healthy, he had never been to ER or stuff like that, than hold up pain to 11pm to 7am, which there he ended up going to the hospital for ER specifically because, He thought something was going to up there and pop up in there you know, he was there with the pain, they gave him Morphine, then gave him Tramadol because the pain didn't go away and then at some point they gave him another round of Morphine (intent treatment) and there pain in the little bit not near so, they did X-ray (not further clarified hence not captured in tab). They did blood test and they took urine sample and the same got everything negative with the blood test. Patient just got some white cells low count but it feels good overall. Secondly, he had the urine sample with which, he don't have the kidney stone or whatever. So, the third one was the X-ray. So, gladly, patient did not had any appendicitis or whatever. Everything was fine. It was scary because the doctor don't knew what was happened to me and he was disable in pain. You can go to doctor to find it scary, if you go to the doctor and they don't know what was going on with you to stop and now he had the couple of bill they are very expensive bills here over 7000. The patient underwent lab tests and procedures which included blood test: your blood is okay, urine analysis: you don't have kidney stone, white blood cell count: low, x-ray: unknown results on an unspecified date. Therapeutic measures were taken as a result of i just got below my belly button i got bloated and even like a sharp pain, like a pain that didn't got away. a pain didn't not fluctuate, a pain that was not going up and down at all. it was steady, i started feeling pain below my belly button and the pain was start not in my stomach, it was right below my belly button. The outcome of event ''I started feeling pain below my belly button and the pain was start not in my stomach, it was right below my belly button and I just got below my belly button I got bloated and even like a sharp pain, like a pain that didn't got away. A pain didn't not fluctuate, a pain that was not going up and down at all. It was steady'' was recovered on 08Jun2021, My face got numb, a little bit but for the short time was recovered on 07Jun2021. The outcome of event scared, low count of white cell, I was screaming, feeling horrible was unknown. And outcome of other event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924381 Same reporter/ drug, different AE/ patient

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ID: 1521985
Sex: U
Age:
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Rec V Date: 08/03/2021
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Symptoms: CLL lymphoma; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she was vaccinated with the Pfizer (COVID) vaccine, had the 2 vaccines, had CLL lymphoma, had been tested twice by Oncologist and had negative antibodies. And Oncologist would like patient to take a third vaccine. Patient asked if there was any way patient can get that vaccine. No other additional information was provided. The patient underwent lab tests and procedures which included antibody test: negative on unspecified date. Clinical outcome of event was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1521986
Sex: F
Age:
State: CA

Vax Date: 06/25/2021
Onset Date: 06/01/2021
Rec V Date: 08/03/2021
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Symptoms: when she lays down to go to sleep and her heart starts going boom boom boom; not able to fall asleep very easily because her heart is beating like that, it energizes her and keeps her awake; the heart palpitations are worse when she lays down; chest pains; have a blister/boil on their leg; have a blister/boil on their leg; myocarditis; pericarditis; felt kind of tired, just lethargic; felt kind of tired, just lethargic; arm pain; arrhythmias/ constant arrhythmia; would feel a little bit dizzy; couldn't quite catch a full breath/ not quite breathing deeply enough or getting enough oxygen; felt a heaviness in her chest; feels lightheaded; crabby; brain fog; This is a spontaneous report from a Pfizer-sponsored program, received from contactable consumer or other non-hcp (Patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via intramuscular route of administration in Left Arm on 25Jun2021 as dose 1, single for COVID-19 immunization.Medical history included foot operation (surgery once on her foot) from an unknown date and unknown if ongoing.Concomitant medication included ibuprofen (ADVILGEL).In Jun2021, the patient experienced arrhythmias/ constant arrhythmia, would feel a little bit dizzy, couldn't quite catch a full breath/ not quite breathing deeply enough or getting enough oxygen, felt a heaviness in her chest, feels lightheaded, crabby, brain fog. On an unspecified date, patient experienced myocarditis, pericarditis, when she lays down to go to sleep and her heart starts going boom boom boom, not able to fall asleep very easily because her heart is beating like that, it energizes her and keeps her awake, the heart palpitations are worse when she lays down, chest pains, have a blister/boil on their leg.On 25Jun2021, patient had arm pain.On 26Jun2021, the patient felt kind of tired, just lethargic. The event arrhythmia lead to visit Physician Office. She had a surgery once on her foot where they had to cut her open and the expected time later, they went to take the stitches out and her skin hadn't even started to mend so they made a mistake. Caller stated this is a big shock to everybody even as she was saying that they need to make sure they look at her and not what they expect to happen to her, and they never listen to her until that happened one day and of course she's not in a proper place to have her skin opened up left open. Family history None, caller stated there's no heart arrhythmia issues in her family. Caller stated she didn't even know what it was until now. Caller stated literally until yesterday when she looked it up. Caller stated her doctor said it sounds like an arrhythmia so she looked it up and every single symptom was like check, check, all of them and what was really interesting to her was that this article specified as WEBMD, specified that its worse, the heart palpitations are worse when she lays down and it was very specific about where she feels the pressure and pain and it said in the middle of the chest, up where the heart is and right below it where the solar plexus is and she's thinking oh that makes sense, if it's her heart muscle that's swollen or the lining that's swollen and its sitting on her sternum then that makes sense, that area of the sternum has to do with her breast, her lungs too, taking an actual breath. Caller stated it doesn't feel like her lungs, it's her heart/chest area, that was interesting to her that its worse when she lays down and that's when she's trying to sleep, that' the nightmare of it. Caller stated she talked to her doctor and a couple of people and they suggested that she call Pfizer to ask these questions because Pfizer knows. Caller stated she knows it's a work in progress, but the doctors aren't on top of everything. Caller stated initially, the day after the vaccine, she felt arm pain, felt kind of tired and maybe not even sick just lethargic. Caller stated she wanted to nap a lot, which she did because she kind of didn't have a choice. Caller stated on 25Jun2021, caller stated her arm started hurting on that same day. Caller stated her being tired started the next day 26Jun2021 and is ongoing and persisting. Caller stated and she has more symptoms and now with the symptoms that have progressed to the arrhythmia. Caller stated along with tiredness, she would feel a little bit dizzy, there was one day she felt like she was going to faint, but she didn't. Caller stated she felt like she couldn't quite catch a full breath and then it was a week later. Caller stated it kept going, symptoms got worse, then she felt a heaviness in her chest, she felt like, she's still feeling it now, like she can't quite get enough breaths, her lungs don't bother her, just feels more like chest and solar plexus that area, just feels really heavy and so during the day she feels tired, like she's not quite breathing deeply enough or getting enough oxygen or something. Caller stated then at night when she lays down to go to sleep and she's tired, her heart starts going boom, boom and she goes what is that and that's been going on pretty much every night, what is it a couple of weeks now. Caller stated it happened last night, so she's not able to fall asleep very easily because her heart is beating like that, it energizes her and keeps her awake and that's where they are today. Caller stated it all started right after the vaccine. Call confirms all symptoms began in Jun2021. Caller stated for the vaccine, she has never had an arrhythmia in her life. Caller stated this is happening and so because she doesn't fit into the standard population that's getting these symptoms, she feels like her doctor just dismissed it because oh it must not be happening to her. Caller stated as she's talking, she feels lightheaded, dizzy, her chest is heavy, she's tired and she's a healthy person otherwise as far as exercise and diet and how she takes care of herself and so this is hard. Caller stated the only antidote she would add is that she does have a history since childhood to present of not being able to process medications very quickly and also, she has a very slow, her ability to heal things is very slow, but she heals, but she's kind of like the antidotal patient that people don't understand, they look at her and appear healthy. Caller stated so this is her, this is her life, and she was actually kind of nervous about getting the vaccine because she's like she wants to protect herself and it took her a really long time to decide if she should get it or not, she thought long and hard and she is the person in the 1 or 2%. Caller stated when everybody was trying to convince her to get the vaccine, they said most people don't have this, that and the other side effects and she is usually not in the most people category. Caller stated so now she's in a position where she is having a situation and she doesn't know what to do. Caller stated she doesn't know. Caller stated her common sense tells her first she needs to deal with what's happening and heal and then is it a good idea for her to get vaccine number two when she is still having these problems? Caller stated her common sense says no but she hasn't been able to get anything concrete, the nurse that just transferred her over didn't know she had to look it up. Caller stated she wants to talk to somebody that she can talk to. Caller stated she feels like she's falling through the cracks and that's not necessary. Caller stated she thought, alright, this is going to pass at some point then a week after that she started feeling more. Caller stated it's not a good loop, if the call handler doesn't know and Medical doesn't know then obviously nobody knows. Caller stated she has to figure out who then does she talk to? Caller stated pharmacists are going to go off what Pfizer knows, so it's all really stemming from what she doesn't know and that this is a work in progress and as Pfizer gets new information then Pfizer puts out new information. Caller stated her situation is registered with the CDC and with Pfizer as

Other Meds: ADVILGEL

Current Illness:

ID: 1521987
Sex: F
Age:
State: MI

Vax Date: 06/10/2021
Onset Date: 06/11/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: pain in stomach after the second dose; Her hemoglobin was 7. Normal for women is 12-13./ One result for her hemoglobin was 7.1 then it was up to 7.9.; She had Xrays and an Ultrasound. Those indicated she had a hiatal hernia.; She still is having blood problems.; She also had an upper GI; The pain was higher up and went from side to side and would go around to the back.; The pain was higher up and went from side to side and would go around to the back.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; She continued to feel sluggish and dizzy after te second dose and had stomach pain.; slept the whole day after getting the second dose; This is a spontaneous report from a contactable consumer. This 68-Year-Old female consumer reported for herself that received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on Left arm anatomical location on 10Jun2021. (at the age 68-year-old) as a dose 2, single for covid-19 immunisation. Patient historical vaccine included received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0158 and expiration date: unknown), via an unspecified route of administration on left arm anatomical location on 20May2021 as a dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included PAROXETINE HYDROCHLORIDE (Paxil) 20mg daily at night start from Sep2012 which was ongoing. After second dose of Pfizer vaccine patient experienced slept the whole day after getting the second dose on 11Jun2021 and pain in stomach on 13Jun2021 patient hospitalized due to pain in stomach from 23Jun2021 to 25Jun2021. Patients' hemoglobin range was decreased from unknown date which was 7 Normal for women is 12-13. / One result for her hemoglobin was 7.1 then it was up to 7.9. Patient was very close to having a transfusion. She had Xray's and an Ultrasound those indicated she had a hiatal hernia. She still was having blood problems. Patient continued to feel sluggish and dizzy after te second dose and had stomach pain. The pain was higher up and went from side to side and would go around to the back. Patient had an upper GI gastrointestinal disorder start from unspecified date. On 23Jun2021 patient underwent lab test hemoglobin which result was 7 and 7.1 and in JUL2021 again tested hemoglobin result was 7.9 range normal for women is 12-13. Patient done second test which was ultrasound and Xray which result was hiatal hernia. The outcome of the events pain in stomach was recovered in june2021, slept whole days was recovered on 12JUN2021. And outcome for another events was unknown.

Other Meds: PAXIL

Current Illness:

ID: 1521988
Sex: F
Age:
State:

Vax Date: 05/27/2021
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Rec V Date: 08/03/2021
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Symptoms: Entire torso and knees consumed with an intense rash; Little bump under my breast; Not progressing as i hoped/doctor expected that my skin should have cleared by now; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 2021, as dose 1, single for COVID-19 immunisation; and received dupilumab (DUPIXENT, Solution for injection, Lot Number: Unknown), via subcutaneous route of administration from 27May2021 to an unspecified date, as dose 1, single for atopic dermatitis. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, following the first intake of BNT162b2 and dupilumab, the patient's entire torso and knees consumed with an intense rash, little bump under my breast. The rashes were not progressing as she had hoped. The doctor expected that her skin should have cleared by now. Dupilumab was continued. The event rash assessed as serious. It was not reported if the patient received a corrective treatment for the events. The clinical outcome of the events entire torso and knees consumed with an intense rash and little bump under my breast was not resolved. The clinical outcome of the event not progressing as i hoped/doctor expected that my skin should have cleared by now, was unknown. Information on Lot/Batch number has been requested.

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Current Illness:

ID: 1521989
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/03/2021
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Symptoms: Vaccinated with BioNTech, with doses 4 weeks apart, and then a third time with Moderna 8; After all doses: slight dent in the injection site; This is a spontaneous report from a Non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose and received second dose via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient also received third dose of covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via intramuscular route from Jun2021 (Batch/Lot number was not reported), as single dose for COVID-19 immunisation. Medical history included hypochondriac and thrombosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient states that he was vaccinated two times with BioNTech, with doses 4 weeks apart, and then a third time with Moderna, 8 weeks later. The patient is now being offered a fourth dose 6 weeks after. The patient states they (the vaccination centres) don't know that he has previously been vaccinated. After all doses on an unknown date in 2021, patient had slight dent in the injection site. The event was considered as non-serious. Patient reports hearing discussions in the media about getting a third vaccination to boost the vaccination. The patient would make the effort to receive the fourth vaccination if advised to do so. The patient heard that the antibody count could be increased by 5 or 10 times if a third dose is received. The patient has also just read that BioNTech is more efficient with a larger time between doses. The patient says they want to be vaccinated again because they are a bit of a hypochondriac and have a medical history of a risk of thrombosis and want to avoid even having a slight case of Covid. The patient has the following questions: Are there studies for receiving multiple doses of vaccines? Is it worth it to receive the fourth vaccination dose from Moderna? Would It make sense to test the antibody numbers let this decide whether a fourth vaccination is necessary? It would be interesting to see the antibody levels in a young person that has been vaccinated so many times. When the patient was directed to contact their HCP, they stated that they were trying to avoid this as they knew their HCP would not be happy with them being vaccinated so many times. The outcome of the event slight dent in the injection site was recovered after 2-3 days on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

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ID: 1521990
Sex: M
Age:
State: PA

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 08/03/2021
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Symptoms: 100.3 fever; body aches; nausea; cold sweats, woke up in middle of night completely soaking wet; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; Administration date: 19Jul2021/Dose number: 2/Administration date: 05Jul2021/Dose number: 1; This is a spontaneous report from a contactable consumer (patient). This 40-year-old male consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 19Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 05Jul2021 at 18:30 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included covid-19 prior vaccination. No known allergies. There were no concomitant medications. Facility type for vaccine was pharmacy or drug store. No other vaccine administered in four weeks. No other medications in two weeks was provided. Patient was not tested Covid post vaccination. On 20Jul2021 at 14:00, patient experienced 100.3 fever, body aches, nausea, cold sweats, woke up in middle of night completely soaking wet. No treatment received for AE. The outcome of all events were recovering. Information about batch/lot number has been requested.

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ID: 1521991
Sex: M
Age:
State: GA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/03/2021
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Symptoms: body ache; I got very high fever; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 15Apr2021 07:30 (lot number: EP6955; expiry date: unknown) at the age of 40-years-old, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955; expiry date: unknown) in the right arm, as dose 1 single, at 12:30 PM, for COVID-19 immunisation. Patient is a vegan. The patient was not diagnosed with COVID prior vaccination. Facility type vaccine was reported as "Other". The patient did not receive other vaccines in four weeks; and did not receive other medications in two weeks. On 15Apr2021, after getting second dose of Pfizer, immediately after 15 minutes (07:45), patient experienced headache. After 12 hours of vaccine (at 19:30), the patient got a very high fever and body ache which remained for 4-5 days. After that, fever and body pain were gone but headache remained after 3 months. The patient did not receive treatment for the events. Outcome of the events body ache and fever was recovered on unspecified date in Apr2021. Outcome of the event headache was not recovered. The patient has not been tested for COVID-19 since vaccination.

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ID: 1521992
Sex: M
Age:
State: FL

Vax Date: 04/11/2021
Onset Date: 04/28/2021
Rec V Date: 08/03/2021
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Symptoms: Hearing loss; Unilateral tinnitus; This is a spontaneous report from a contactable consumer (reporting for himself). A 22-year-old male patient received bnt162b2 (Lot Number: EP 7533), via an unspecified route of administration, administered in left arm on 11Apr2021 13:30 (at the age of 22-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Apr2021 12:00, the patient experienced unilateral tinnitus and hearing loss. The events resulted in disability or permanent damage. Therapeutic measures were taken as a result of the events included prednisone 60mg 2-week taper. No covid prior vaccination nor covid tested post vaccination. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

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Current Illness:

ID: 1521993
Sex: F
Age:
State: LA

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Rec V Date: 08/03/2021
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Symptoms: Started with a headache; pulsatile tinnitus; arm and legs would suddenly twitch; This is a spontaneous report from a contactable consumer reported for a female patient who experienced same symptoms as her daughter. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced symptoms started with a headache, pulsatile tinnitus (as which also her daughter as experienced) which in your ear you could hear your heartbeat constantly for 2-3 weeks and when subsided went down to her face, her sinus to her neck and her left arm that then tingle. Which is now down to her legs, just her touching her legs would hurt and that her arm and legs would suddenly twitch. The clinical outcome of the events was unknown. Information on batch/lot number has been requested.

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Current Illness:

ID: 1521994
Sex: U
Age:
State: NY

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Rec V Date: 08/03/2021
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Symptoms: one of her coworkers had a very red face that benadryl helped; This is a spontaneous report from a contactable consumer. A patient (co-worker) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reported one of her co-workers had a very red face that Benadryl helped on an unspecified date. Therapeutic measures were taken as a result of one of her co-workers had a very red face that Benadryl helped. The outcome of event was unknown. Information about batch/ lot number has been requested.

Other Meds:

Current Illness:

ID: 1521995
Sex: M
Age:
State:

Vax Date: 07/20/2021
Onset Date: 07/22/2021
Rec V Date: 08/03/2021
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Symptoms: Problems with his throwing shoulder on the right arm, moderate pain in the right shoulder; His son is having pain on his throwing arm or the right arm; Problems with his throwing shoulder on the right arm; This is a spontaneous report from a contactable consumer (patient's father). A 16-year-old male patient (reporter's son) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: was not reported, Expiry Date: was not reported) via an unspecified route of administration in left shoulder on an unspecified date on 11:30 as Dose 2 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date (Batch/Lot Number: was not reported, Expiration Date: was not reported) for covid-19 immunization. Reporter stated after 2 days of vaccination, patient having pain on his throwing arm or the right arm. He did mention that his son plays baseball. He wasn't feeling 100%, but nothing like that. He has pain in the shoulder when trying to throw and it's still bothering him. Reporter stated that he wanted to see if there are any reports; his son who is 16, nearly 17 years old received the Pfizer COVID 19 vaccine in his left shoulder. Reports the next morning, his son is having problems with his throwing shoulder on the right arm and moderate pain in the right shoulder. The outcome of all events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1521996
Sex: F
Age:
State:

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Rec V Date: 08/03/2021
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Symptoms: Caller is asking if she can apply topical rubbing alcohol to injection site. She states with injections it can "minimize swelling and pain". Received first dose today.; Caller is asking if she can apply topical rubbing alcohol to injection site. She states with injections it can "minimize swelling and pain". Received first dose today.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she could apply topical rubbing alcohol to injection site. She stated with injections it could minimize swelling and pain. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1521997
Sex: F
Age:
State: IL

Vax Date: 07/15/2021
Onset Date: 06/24/2021
Rec V Date: 08/03/2021
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Symptoms: persistent cough. The cough got worse after getting the second dose.; fever; weakness; aching; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 23Jun2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EW0196, Expiration date: Unknown), via an unspecified route in the left arm on 15Jul2021 (age at vaccination: 65-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Jun2021, patient experienced persistent cough, fever, weakness and aching after getting both doses. The cough got worse after getting the second dose. She wanted to know how long will this last and was asking for treatment recommendations. Patient said she already called up her doctor and they gave him cough medicine which was only masking the problem. She said that this has nothing to do with her health as this is vaccine related. The clinical outcome of the persistent cough got worsened, fever and achiness lasted for about 3 days and weakness lasted for a week. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1521998
Sex: F
Age:
State: CA

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: Gained weight; This is a spontaneous report from a contactable consumer reporting for herself. This report was not related to a study. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6201; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00 (at the age of 78-years-old) as DOSE 2, SINGLE for COVID-19 immunisation at Health Dept., Mass vaccination site. Medical history included emphysema, pernicious anaemia and non-tobacco user. It was reported that she never smoked a day in her life and still got emphysema. The patient previously took first dose BNT162B2 (Lot Number: EL9263) in left arm on 25Jan2021 11:00 (at the age of 78-years-old) for COVID-19 Immunisation. The patient was taking COVID 19 vaccine to prevent COVID 19 virus. NDC or Expiry not known for both the doses. Concomitant medications included vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]) taken for pernicious anaemia; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for emphysema, start and stop date were not reported. Caller reported she takes very little medicine including Vitamin B12 shots once every 4 weeks for pernicious anemia. She had an albuterol inhaler that she uses sometimes because she was having emphysema. At the time she received her COVID 19 vaccines she was not getting her Vitamin B12 shots because she was keeping herself shut in. The patient did not received additional vaccines administered on same date of the Pfizer Suspect and Prior Vaccinations (within 4 weeks). The patient did not had any AE following prior vaccinations. On unspecified date in 2021, the patient gained weight. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 17Jul2021, sars-cov-2 antibody test: negative on 19Jul2021. Caller was asking how she can participate in a clinical study if possible, for the Pfizer COVID Booster Vaccine. The patient received her first Pfizer COVID 19 Vaccine on 25Jan2021. She received the second Pfizer COVID 19 Vaccine on 15Feb2021 at a mass vaccination site in (withheld) and she had no symptoms with either vaccine and she knew that not everyone would have symptoms, and some will. When probing current weight, she reported she had gained weight. Caller voiced that her son was a Nurse Practitioner, all of his patients who received the vaccine have tested positive on the antibody test. Caller was asked if Pfizer has any information on why she may test negative on the antibody testing after being fully vaccinated. A number of people that she knew including friends and family had a COVID 19 antibody test after getting the COVID 19 vaccine and these friends and family members all have positive COVID 19 antibodies except her. She was concerned that the effectiveness of the vaccine has worn off because she was old and was way to 80 years old. Even though she was 79 years old she was still working and teaches on Zoom. She went on 17Jul2021, last Saturday. After she received the negative results, her son suggested she go to (withheld) for a COVID 19 quantitative test and that was also negative. She went to (withheld) on Monday, 19Jul2021. She told her primary healthcare provider that her COVID 19 antibody test was negative, and her doctor said the test was not testing vaccinated people, it was a test only for people who actually had the COVID 19 virus. It was her son who recommended she get the COVID 19 antibody tests. Her daughter-in-law was concerned because the caller received her vaccine at a mass vaccination site and the vaccine had to be kept cold, but she told her daughter-in-law that she did receive both doses. When probing lot number for the first COVID 19 vaccine the caller reports it could be EL9263 or EC9263. She thinks it was EL9263. When probing lot number for the second COVID 19 vaccine she reported it could be EN6201 or EM6201. She received her second COVID 19 vaccine on 15Feb2021 in the left arm. She stated she does not know why everyone was not getting the COVID 19 vaccine because the COVID 19 virus looks like a horrible death. She was concerned over her negative COVID 19 antibodies and would like information on that. Caller was asking if there was a trial for a booster vaccine and how can she be a candidate. AE did not required a visit to Emergency Room or Physician Office. Clinical outcome of the event was unknown.

Other Meds: VITAMIN B12 [VITAMIN B12 NOS]; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1521999
Sex: M
Age:
State: HI

Vax Date: 06/30/2021
Onset Date: 06/01/2021
Rec V Date: 08/03/2021
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Symptoms: Couldn't sleep for one night.; restless legs syndrome; Sore arm; This is a spontaneous report from a contactable consumer(patient). A 15-year-old male patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0198), via an Intramuscular route of administration on 30Jun2021 at 18:00(at the age of 15-year-old male) into left arm as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Jun 2021, the patient Couldn't sleep for one-night, restless legs syndrome, Sore arm. It was reported that Pfizer COVID 19 vaccine- mother is calling on behalf of her 15-year-old son who received the second dose of the vaccine yesterday. She states he has had no reaction or side effects from the second dose, and he says, "he feels fine like he never got the vaccine. After the first dose, she says he had a sore arm and restless legs syndrome overnight but that has resolved. For me I do have a reaction because I get an arm soreness after the first dose and a headache and a higher temperature than normal after the second dose. Caller is a 51-year-old female. Caller received the Pfizer COVID 19 vaccine as well. First dose: 22Feb2021 LOT #EN6200, second dose: 15March2021 Lot #EN6205.she has additional questions about her own side effects however she is at work and doesn't feel comfortable talking about it at this time. She stated she would call back later. Stated it is possible for people to have no side effects after either dose of the vaccine. Stated to caller we would be unable to determine if he received the vaccine or if it was prepared appropriately. Referred caller back to the vaccination provider. Reports her son just took the second dose yesterday and then he felt fine and did not even have a arm sore. She is asking did he really get the vaccine? Caller adds the first one he had kind of like an arm sore for one day but otherwise he was fine. Then four days later at night-time, he got like restless leg syndrome; he had to keep moving his leg to get comfortable and couldn't sleep for one night. That was the first time he had that. She did take him to the doctor, but the doctor said it might be low iron but the blood test for iron was fine. They still don't know what caused the problem. He is completely recovered from that now. (name) she expected with a young boy that there might be more problems; and she kept him home just in case; but he felt totally fine like he never had the vaccine. he can move his arm all around everywhere without difficulty. The patient was not visited to Emergency Room for the event. The patient was visited to Physician Office for restless leg. The patient did not receive any vaccine four weeks Prior Vaccinations. The patient underwent lab tests and procedures which included blood iron with normal result on an unspecified date 2021.The outcome of the events was recovered In Jun2021.

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Current Illness:

ID: 1522000
Sex: U
Age:
State: MN

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: Headache; Tiredness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 38-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167), via an intramuscular route of administration (at the age of 38-years), administered in arm right on 28Apr2021 19:20 as dose 2, single for COVID-19 immunization. The patient medical history included family history as Mother and Maternal Mother with Diabetes type 2 and none from an unknown date and unknown if ongoing. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731), via an intramuscular route of administration (at the age of 38-years), administered in arm right on 07Apr2021 20:00 as dose 1, single for COVID-19 immunization and experienced headache and tiredness. The concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache and tiredness. Patient stated that it felt more intense in the second dose in both I felt both I felt good after the second day of the vaccination. The treatment was not received for the event. The clinical outcome of the event was reported as recovered on an unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1522001
Sex: U
Age:
State: GA

Vax Date:
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Rec V Date: 08/03/2021
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Symptoms: Patient took 2nd covid shot thursday running fever and has a headache; Patient took 2nd covid shot thursday running fever and has a headache; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient that: A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of Covid Shot on an unspecified date, as single dose for COVID-19 immunization. The pharmacist reported that the patient took 2nd COVID shot and on an unspecified date (on Thursday) running fever and has a headache, so MD advised to hold off on shot until fever goes down. Potentially next day. Pharmacist advised that they have not heard of any known DDI'S or adverse events associated with Dupixent and COVID vaccines. No additional information was provided and stated that If require additional information, please contact the reporter directly. The outcome of the events was unknown. Follow-up attempts are needed; Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1522002
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: small flare up of hives; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. On an unspecified date, after second dose of vaccine, patient had a small flare up of hives. This was not confirmed if it was caused by vaccine or not. The outcome of the event was unknown. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1522003
Sex: M
Age:
State:

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Rec V Date: 08/03/2021
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Symptoms: Numbness in the hands and legs; High heart rate; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself. A male patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE NUMBER UNKOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced numbness in the hands and legs and High heart rate. The events assessed as non-serious. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1522004
Sex: F
Age:
State: CA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/03/2021
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Symptoms: Aching arm for 2 hours; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in arm on 27Jan2021 at 08:00 (at the age of 79 years old) as single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from 35+ years, gluten sensitivity from 35+ years, chronic fatigue came down on 24Nov2019 and no treatment for chronic fatigue syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, patient experienced aching arm for 2 hours in evening then ok. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Sep2020. The outcome of events was recovered on 27Jan2021. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1522005
Sex: F
Age:
State:

Vax Date: 04/25/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: had a flare up of Diverticulitis; This is a spontaneous report from a contactable consumer or other non-health care professional. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications of the patient were not reported. It was reported that the patient received Pfizer covid vaccine on 25Apr2021 and had a flare up of Diverticulitis, her HCP told her to postpone getting the second dose. It had been 3 months since postponed second dose of Pfizer covid vaccine. Reporter wants to know was it ok to receive second dose of Pfizer covid vaccine then due to the time and asked if she could receive HPV vaccine and the Pfizer covid vaccine or would she had to wait. The outcome of event was Unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1522006
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date: 05/03/2021
Rec V Date: 08/03/2021
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Symptoms: I had moderate vaginal bleedings each and every morning; This abnormal spotting was going on, non stop, for 3 months.; fully sick for a week; fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Apr2021 as dose 2, single for covid-19 immunization (Vaccinated at 32-years age). Medical history included known allergies: Strawberry. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ep7534), via an unspecified route of administration in arm left on 16Mar2021 as dose 1, single for covid-19 immunization (Vaccinated at 32-years age). Facility where the most recent Covid-19 vaccine was administered was Workplace clinic. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with Covid-19. Patient did not received any other vaccines within 4 weeks prior to the Covid vaccine. On 03May2021, the patient had moderate vaginal bleedings each and every morning, this abnormal spotting was going on, non stop, for 3 months, fully sick for a week, fever, chills. It was reported that after the periods following her second shot (09Apr2021) she had moderate vaginal bleedings each and every morning. This abnormal spotting was going on, non stop, for 3 months. She saw an obgyn who tested her for about anything without finding anything. No progesterone amount would stop it. never had hormonal issues before, so this was concerning. The bleeding stopped after three months. She was fully sick for a week following the second shot (done having about all the side effects advertised, chills, fever, etc). Since the vaccination, patient has been tested for Covid-19. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: unknown result, Nasal Swab: negative on 15Jul2021, scan: unknown result, x-ray: unknown result. Events were assessed as medically significant by the reporter. Therapeutic measures were taken as a result of all events. Treatment received for the adverse event included testing, biopsy, xray, scan, progesterone. Outcome of all the events was unknown. Information on the Batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1522007
Sex: F
Age:
State:

Vax Date: 07/20/2021
Onset Date: 07/21/2021
Rec V Date: 08/03/2021
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Symptoms: severe skin rashes; This is a spontaneous report. A Contactable Consumer reported for a female patient (reporter's sister). An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown), via unspecified rout of administration on 20Jul2021 (at the age of 85-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection on an unspecified date for COVID-19 immunisation. On 21Jul2021, the patient experienced severe skin rashes all over her body. On 22Jun2021 it was subsiding, the rashes are only under her arms now. Caller wanted to know if it is a reaction from the Pfizer COVID 19 vaccine. Outcome of the events was recovering. Information about lot/batch number can be requested.

Other Meds:

Current Illness:

ID: 1522008
Sex: F
Age:
State: LA

Vax Date: 03/26/2021
Onset Date: 07/19/2021
Rec V Date: 08/03/2021
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Symptoms: her getting covid even though she received both doses of the vaccine; her getting covid even though she received both doses of the vaccine; This is a spontaneous report from a contactable consumer(patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 26Mar2021(age at vaccination:66 years) (Batch/Lot Number: EN6199) as DOSE 2, SINGLE for covid-19 immunization and BNT162b2 dose 1 via an unspecified route of administration in left arm on 05Mar2021(Age at vaccination:65 years) (Batch/Lot Number: EN6204) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Caller received both doses of Pfizer Covid 19, vaccine first dose on 05Mar2021 and 2nd dose on 26Mar2021. On 24Jun2021, The patient experienced cough, congestion, scratchy throat, watery eyes. It wasn't until 28Jun2021 she had cough and congestion with lots of mucus. She had watery eyes that lasted for 5-6 days and scratchy throat that lasted for 4-6 days. She had a rapid Covid test. She did it twice to confirm that she was getting the right information. Patient has completed both doses of the vaccine. On 18Jul2021 she tested rapid test twice in a row and was positive. She had a PCR on the 20Jul2021 which was negative, and an antibody test was positive. She went to the doctor and asked for a steroid shot. The doctor did not want to give her a shot. She gave her a prescription for Prednisone 20mg twice daily for 5 days. She started it on 28Jun2021. After three days she was not getting any better. She called and asked for something else. The doctor ordered an antibiotic for 7 days and an inhaler. The doctor didn't think it was anything an antibiotic would take care. The doctor thought it was viral. Her doctor didn't think she needed to be tested because she was vaccinated. Caller was concerned because she was getting a hefty cough and a lot of mucous. It didn't go away with the antibiotic or steroid. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1522009
Sex: M
Age:
State:

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Onset Date:
Rec V Date: 08/03/2021
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Symptoms: his co-worker tested positive for COVID-19 after returning from a trip to country. He had received the full 2 dose of the Pfizer COVIS-19 Vaccine prior to going to country; his co-worker tested positive for COVID-19 after returning from a trip to country. He had received the full 2 dose of the Pfizer COVIS-19 Vaccine prior to going to country; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on an unknown date, as dose 1 and dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient tested positive for COVID-19 after returning from a trip a (Withheld). He had received the full 2 doses of the Pfizer COVID-19 Vaccine prior to going to (Withheld). It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19, Since the vaccination, the patient been tested for positive COVID-19. Treatment for adverse event was unknown. The outcome of the event was unknown. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1522010
Sex: M
Age:
State: NC

Vax Date: 07/19/2021
Onset Date: 07/22/2021
Rec V Date: 08/03/2021
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Symptoms: Fast heart beat; slowed breathing; intense headache; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; cant sleep; violently jerk; my face eyes nose itch bad for about 10 minutes and then go away; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration, administered in right arm on 19Jul2021 10:00, (at age of 54 year old), as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date. No known allergies. Concomitant medications included methadone, roflumilast (DALIRESP), Breztri all taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within 4 weeks prior to the COVID. On 22Jul2021, 06.00, patient experienced fast heartbeat, slowed breathing, intense headache, every muscle in his body hurts especially his lower Back. He could not sleep, but 2 hours before, he woke up with muscles and lower back throbbing. Also, at the time of reporting, patient reported as he was sitting and watching tv, holding remote and out of nowhere he would violently jerk and his face, eyes, and nose itch bad for about 10 minutes and then went away. No treatment was given for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event face, eyes, and nose itch bad was recovered, where of all other events was not recovered. Lot number/Batch has been requested.

Other Meds: METHADONE; DALIRESP; BREZTRI

Current Illness:

ID: 1522011
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: couldn't move my arms; couldn't move my arms; This is a spontaneous report from a Regulatory Authority received from a contactable Healthcare Professional. A 53-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date, at 53 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from Mar2021 and ongoing (Batch/Lot number was not reported), at 125 mg, cyclic daily for 21 days on and 7 days off for breast cancer. Medical history included breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications included exemestane daily in conjunction with palbociclib. The patient reported that the first vaccine dose was really bad and she couldn't move her arms since an unknown date. The patient reported that the most recent blood work (date unknown) "looked okay". In response to the events palbociclib dose was not changed. At the time of the report the events outcome was unknown. Information about batch/ lot number has been requested.

Other Meds: EXEMESTANE; IBRANCE

Current Illness:

ID: 1522012
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: stroke; She had blood clots in her heart up until her brain; hand went numb and tingling; hand went numb and tingling; she has not had energy/she feels weak/dizzy; she has not had energy/she feels weak; Dizzy; This is a spontaneous report from a contactable consumer. This consumer reported for a 91-Year-old female patient that patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from unknown date in Mar2021(at the age of 91-Years) on unknown location for COVID-19 immunization. No prior Vaccinations (within 4 weeks). No AEs following prior vaccinations. Patient's Medical History (including any illness at time of vaccination) was reported as None. Patient's family medical history was not reported. Concomitant medications were not reported. It was reported that patient experienced stroke (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), she had blood clots in her heart up until her brain (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days.), hand went numb and tingling (required emergency Room, and physician office visit and patient was hospitalized, for two nights and three days). Her mother's first shot was in March, her second shot was in April. She has been perfectly healthy up until this point. Ever since she got the shot in April, she has not had energy, she feels weak, and she has been dizzy worsened, no treatment received, and the same doctor tells her to rest. She has not had energy, no treatment received, and she has went to doctor she has been resting more. A week ago, yesterday she was standing at the pantry and her right hand went numb and tingling so she rushed over and took her to the urgent care and the doctor said he thinks she is having a stroke and she took her to hospital, and they found out on the second day they did an MRI and cat scan and an ultrasound of the heart. The MRI showed she had two strokes. So, they kept her in the hospital she had blood clots in her heart up until her brain. She got the covid vaccine and now she has two blood clots. The outcome of the events for stroke, she had blood clots in her heart up until her brain, hand went numb and tingling was unknown, and for she has not had energy/she feels weak, Dizzy was not recovered. Information on the lot/ batch number has been requested.

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Current Illness:

ID: 1522013
Sex: M
Age:
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Rec V Date: 08/03/2021
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Symptoms: Nervous; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 2 single for COVID-19 immunization. Medical history included rheumatoid arthritis, erectile dysfunction and immunocompromised. Concomitant medication included tofacitinib citrate (XELJANZ), aspirin [acetylsalicylic acid] (ASPIRIN 81), sildenafil citrate (VIAGRA) for erectile dysfunction. Patient stated that he had been tested for antibodies three times after receiving the two doses of the Pfizer COVID-19 vaccine. He stated that he took the antibody test, and two spike antibody tests and both came back with no antibodies. He stated that on an unspecified date, he was nervous because of the delta variant and he does not think he was protected. He stated that his doctor does not have information for him. He called the head of the immunization department, and they told him that it was up to him to make the choice on whether or not he wants to get another vaccine or not. He called a doctor and he was told to take the third shot. He stated that he was at a loss especially because he was immunocompromised because of his rheumatoid arthritis. He stated that he does not know if the booster shot is going to have the same ingredients as the two dose series, and he wanted to know what possible side effects are going to come from getting the third dose of the vaccine. He stated that if it is the same ingredients he will go an take another dose of the vaccine. He just wanted some sort of response because his doctor does not know what ingredients are going to be in the booster. He stated that the Problem is, look they know what is in the drug, not asking them to guarantee anything, what ever is in there is it the same. He stated his doctor suggests double masking. He stated that the precautions did not work if someone who was not taking precautions and get the variant and then they give it to him. He stated is there any information on getting a third shot of the dose that is already released (normal dose). In response as part of Pfizer's and BioNTech's continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. Caller was informed that in review of the EUA prescribing information for the COVID-19 vaccine no information was found about the side effects and dosage of the booster vaccine. Caller was referred to his doctor. Caller wanted to know if he can be a part of the clinical trials. In response caller was given the clinical trials phone number. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: XELJANZ; ASPIRIN 81; VIAGRA

Current Illness:

ID: 1522014
Sex: F
Age:
State: GA

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 08/03/2021
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Symptoms: And then "immediately" developed Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: AM9810, Expiration date: Jun2021) via an unspecified route of administration in left arm on 8Mar2021 10:00 (at the of 64-years-old) as first dose single for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had no other vaccinations the same day as her Pfizer COVID-19 vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced Bell's palsy symptoms a day or two after getting her first dose of the vaccine. Patient was treated with Prednisone and it did clear up, she didn't have it anymore because she took all of it. Patient did not undergo any lab test. The outcome of Event was recovered on an unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1522015
Sex: F
Age:
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Rec V Date: 08/03/2021
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Symptoms: blood clots; She's been bedridden now for 3 days; she's in bed she can't even standup long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot; she's in bed she can't even standup long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot; had to quit her jobs its awful; she's really depressed; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a female patient of an unknown age received second dose of BNT162B2 (Solution for injection, batch/ lot number: unspecified), via an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Solution for injection, batch/ lot number: unspecified), via an unspecified date as historical vaccine as single dose for COVID-19 immunisation. Caller stated "It is in regard to my older sister and she had some it's been 3 months since she got her 2nd vaccination. She's been bedridden now for 3 days, 3 days after she got her second Pfizer shot. Like I said after 3 months she's in bed she can't even stand up long enough to brush her teeth cause she got nerve pain in her legs that she got a blood clot from like I said it happened 3 days after she got her second shot. I am only trying to give the doctors something to go on because the pain she's in I can't even believe her doctors are letting her go for 3 months without being able to move. Her and her husband had to quit her jobs its awful and I'm worried about her both physically and mentally she's really depressed." The outcome of the adverse events was unknown. The lot number for the vaccine, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1522016
Sex: F
Age:
State: NJ

Vax Date: 05/01/2021
Onset Date: 05/30/2021
Rec V Date: 08/03/2021
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Symptoms: Bell's Palsy; This is a spontaneous report from a contactable consumer (husband) via Pfizer sponsored program Pfizer regulatory authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30May2021, the patient was affected by Bell's Palsy. This was exactly after 2 weeks after her 2nd Pfizer COVID shot. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and no reaction were reported. The reporter wrote to you previously as well, but reporter did not receive any reply from your side. Yesterday, reporter contacted the Neurologist and he suggested reporter to write to you again informing about the situation. It seems to be an acute Bell's Palsy and reporter requested to take this matter on an urgent basis. The outcome of the event was unknown at the time of reporting. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100953159 Same reporter/ drug/ event for different patients

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Current Illness:

ID: 1522017
Sex: F
Age:
State:

Vax Date: 07/11/2021
Onset Date: 07/12/2021
Rec V Date: 08/03/2021
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Symptoms: The next morning experienced "weird" muscular and neurological reactions; The next morning experienced "weird" muscular and neurological reactions; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot/Batch number, not reported), via on an unspecified route of administration on 11Jul2021 (age at vaccination was 53-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 12Jul2021, the next morning of vaccination, the patient experienced weird muscular and neurological reactions. These side effects lasted 36 hours. Reporter stated that she sought medical care from her PCP yesterday and they could not recommend whether she should get the second dose of the vaccination series on Saturday or not, therefore patient seeking this information from Pfizer. At the time of this report event outcome was recovered on an unknown date in Jul2021. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1522018
Sex: F
Age:
State:

Vax Date: 07/24/2021
Onset Date: 07/01/2021
Rec V Date: 08/03/2021
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Symptoms: having burning pain in lymph nodes under her left arm; having burning pain in lymph nodes under her left arm that is getting worse; pain that radiated into her left leg / having burning pain in lymph nodes under her left arm; pain is so bad; This is a spontaneous report from a contactable consumer or other non hcp (parent) reported for her daughter (patient). A 30-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 24Jul2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported the patient had left side pain that radiated into her left leg on Sunday but it subsided. Previous day she began having burning pain in lymph nodes under her left arm that is getting worse. She got the vaccine in her left arm. She fought getting the vaccine because she heard it causes fertility issues but finally decided to get it. She had to leave work because the pain was so bad. The reporter asked was this normal. Had it been reported before and how long would it last. The outcome of the events was reported as not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

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Current Illness:

ID: 1522019
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: contracted COVID-19; contracted COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Mar2021 (end of March) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient contracted COVID-19. It had already been 4 months past her first dose, and she wanted to know if she can still take the second dose of the vaccine with this situation. Patient was concerned since one doctor told her that she should start the vaccination series all over again and the other doctor told her that it was okay to go ahead with the second dose. The outcome of both the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1522020
Sex: F
Age:
State:

Vax Date: 07/08/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: have both now been diagnosed with COVID; have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: was not reported; Expiration Date: was not reported), dose 1 via an unspecified route of administration on 08Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced have both now been diagnosed with COVID-19 and feeling sick on an unspecified date. Caller stated both her and her son received their first dose of the Pfizer COVID-19 vaccine on 08Jul2021 and have both now been diagnosed with COVID-19. Caller was looking for information about when her and she son can get the second dose. She was still feeling sick so would like to know when she can receive her second dose and it's going to be after the three-week mark is that going to be a problem. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unspecified date. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient

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Current Illness:

ID: 1522021
Sex: M
Age:
State: LA

Vax Date: 07/08/2021
Onset Date: 07/15/2021
Rec V Date: 08/03/2021
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Symptoms: have both now been diagnosed with COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-year-old male patient (Reporter's son) received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/ lot number was not reported), via unspecified route on 08Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced Covid-19, Caller is looking for information about when her and son could get the second dose, patient was feeling better now and their Primary care physician said he could go ahead and proceed and get his scheduled second dose on 29Jul2021, the patient had COVID-19 Test on15Jul2021 and result was positive. The outcome of event was recovered in Jul2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100958348 same reporter/drug, different event/ patient

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Current Illness:

ID: 1522022
Sex: M
Age:
State: NY

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: After second dose caller had COVID; After second dose caller had COVID; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in January2021 as dose 1, single; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in February 2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient after second dose the patient had covid. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date in 2021.Patient treated with monoclonal antibodies. The reporter states that he really wants to know if the booster is going to be the same as the other two doses because he had no effects from them whatsoever. COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. For HCPs with general inquiries about booster doses, please refer to the SRD titled "Administration of More Than a 2-Dose Series (Booster Dose)". Non-HCPs should be referred to their HCP for further discussion. The outcome of the events was unknown. There was no product quality complaint (PQC) present. The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957896 Pfizer

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Current Illness:

ID: 1522023
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: bell's Palsy; she experienced swelling of her left underarm where she got her shot.; Lymphadenopathy; experienced facial swelling (left side of her face); This is a spontaneous report from a non-contactable physician via Medical Information Team. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in the left arm on an unspecified date in Jan 2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid 19 vaccine back in Jan and after her first dose On an unspecified date patient experienced swelling of her left underarm where she got her shot. Stated it was lymphadenopathy. patient also experienced facial swelling (left side of her face) and bell's Palsy. she went to her doctor and she was given Prednisone 50mg for 5 days as she was diagnosed of bells Palsy. patient wanted more information specific to Bells Palsy and patient was asking if she could get the second dose of the vaccine. The clinical outcome for the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected. ; Sender's Comments: based on the strong temporal relationship the events bells palsy , lymphadenopathy,facial swelling and the suspect vaccine BNT162B2 cannot be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

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Current Illness:

ID: 1522024
Sex: M
Age:
State:

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Rec V Date: 08/03/2021
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Symptoms: thyroiditis subacute; Blood thyroid stimulating hormone decreased; Iodine uptake decreased; Lymphocyte count decreased; Monocyte count increased; Red blood cell sedimentation rate increased; Serum ferritin increased; Thyroxine free increased; Tri-iodothyronine free increased; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 44-years-old) for COVID-19 immunization. Medical history included Gilbert's syndrome; Ragweed allergy; COVID-19, showed as past COVID-19 infection (acute infection excluded via antigen test). Concomitant medication included ascorbic acid, colecalciferol, potassium, selenium; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single was taken for covid-19 immunization. The patient experienced thyroiditis subacute, Blood thyroid stimulating hormone decreased, Iodine uptake decreased, Lymphocyte count decreased, Monocyte count increased, Pyrexia or Fever of 40 centigrade for 36 hours, Red blood cell sedimentation rate increased, Serum ferritin increased, Thyroxine free increased, Tri-iodothyronine free increased. The patient underwent lab tests and procedures which included antibody test: covid on showed past COVID-19 infection (acute infection excluded via antigen test), blood thyroid stimulating hormone: decreased, body temperature: 40 centigrade for 36 hours, iodine uptake: decreased, lymphocyte count: decreased, monocyte count: increased, red blood cell sedimentation rate: increased, serum ferritin: increased on, thyroxine free: increased, tri-iodothyronine free: increased, radioactive iodine uptake test (RAIU): almost zero TC99 uptake in the thyroid; all on unspecified date. Outcome of the events was not recovered. No follow up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds: ASCORBIC ACID; COLECALCIFEROL; POTASSIUM; SELENIUM

Current Illness:

ID: 1522025
Sex: M
Age:
State: NV

Vax Date: 02/22/2021
Onset Date: 07/25/2021
Rec V Date: 08/03/2021
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Symptoms: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 at 10:00 (at the age of 68-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included lisinopril 20 mg and atorvastatin 10 mg both were taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Had no known allergies. Facility type vaccine: Doctor's office/urgent care. Other vaccine same date product: Pfizer COVID 19 vaccine, on 22Feb2021, dose number: 2 administered in Left arm. On 25Jul2021 21:00, patient experienced bells palsy. Patient visited Emergency room/department or urgent care for event. The patient underwent lab tests and procedures which included blood work, Ct scan and x-rays with unknown results on unspecified date. Therapeutic measures were taken as a result of bells palsy. The outcome of event was recovering.

Other Meds: LISINOPRIL; ATORVASTATIN

Current Illness:

ID: 1522026
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: My left arm went on full out shaking all over the place; but I can't eat anything.; nausea; fever; diarrhea; I was tired; This is a spontaneous report from a contactable consumer. An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid 19 immunization. The patient medical history included diabetic, heart failure. The patient concomitant medications were not reported. It was reported that, After the first dose of the vaccine, on an unspecified date, the patient had experienced nausea, fever, diarrhea that lasted all night and day. She did not eat all day until 6:30 tonight. She supposed to eat breakfast lunch and dinner, but she can't eat anything. She was tired. The patient had a bad tremor in the left leg which was the side she got her vaccine. Her left arm went on full out shaking all over the place. She was diabetic and on blood thinners. I am oxygen. She wanted to know she can get the second shot. They cannot tell her if she should receive the second dose of the vaccine or not. The patient wanted to know she can get the vaccine if she has a medical conditions. The outcome of events was unknown. Information on the lot/batch number has been requested.

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Total 2021 VAERS Injuries: 572,316

Page last modified: 03 October 2021 5:28pm