VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 0984397
Sex: U
Age:
State: CA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 59-year-old, White, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms. The patient's medical history was not reported. No concomitant product use was reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, after vaccine administration, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 59 year old subject with unknown medical history, who experienced a serious unexpected event of Anaphylactoid reaction. The event occurred after first dose of the study medication administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0984398
Sex: F
Age: 44
State: TX

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/29/2021
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Symptoms: Angioedema of arm, face, and tongue; Difficulty swallowing; A spontaneous report was received from a physician concerning a 46-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed angioedema arm, face, and tongue and difficulty swallowing probably due to swelling. The patient's medical history, as provided by the reporter, included penicillin allergy, seasonal allergies, dermatological fillers and collagen fillers. Concomitant medications included Redopx and Aloim. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, after receiving the vaccine, the patient had swelling, angioedema of the arm, face and tongue. She also had difficulty swallowing, probably due to the swelling per the reporter. Treatment for the event included prednisone and diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed angioedema arm, face, and tongue and difficulty swallowing probably due to swelling, were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 46-year-old female patient with relevant medical history of penicillin allergy, seasonal allergies, dermatological fillers and collagen fillers who received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced the serious unlisted event of angioedema of the arm, face, and tongue and serious unlisted event of difficulty swallowing probably due to swelling. Treatment for the events included prednisone and diphenhydramine which resolved the events. Based on the temporal association between the use of the product and the events occurring after receiving the vaccine, a causal relationship cannot be excluded and the events of angioedema of the arm, face, and tongue and difficulty swallowing are possibly related to the product.

Other Meds:

Current Illness: Penicillin allergy; Seasonal allergy

ID: 0984399
Sex: F
Age: 65
State: OR

Vax Date: 12/28/2020
Onset Date: 12/30/2020
Rec V Date: 01/29/2021
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Symptoms: Horner's syndrome; A spontaneous report was received from a 66-year-old female physician who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Horner's syndrome. The patient's medical history was not provided. Concomitant product use was not provided. On 28 Dec 2020, approximately two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported after receiving the vaccine, she developed Horner's syndrome on 30 Dec 2020. She reported having a droopy eye on the left side and her left eye having a small pupil. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, Horner's syndrome, was unknown.; Reporter's Comments: This case concerns a 66-year old female patient. The medical history is not provided. The patient experienced an expected medically significant event of Horner's syndrome approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot 011J20A). Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 0984400
Sex: U
Age:
State:

Vax Date: 12/14/2020
Onset Date: 12/14/2020
Rec V Date: 01/29/2021
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Symptoms: arm soreness; headache; fatigue; mild body aches; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 17Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) and another contactable consumer. A 39-year-old patient of an unspecified gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 14Dec2020 at single dose for covid vaccine. The patient's medical history and concomitant medications were not reported. The patient was almost 72hrs in and feel normal. The patient had arm soreness the first day (14Dec2020) followed by headache, fatigue, and mild body aches lasting about 36hrs. The patient was vaccinated in the middle of six emergency room shifts in 7 days so the patient suspected that contributed to some of the fatigue. The patient was able to go for a run yesterday (unspecified date) before night shift and felt fine during shift. So all in all, the side effects for the patient had been mild without needing any Motrin or Tylenol. The outcome of events was recovering.

Other Meds:

Current Illness:

ID: 0984401
Sex: M
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: when he pushes on the injection site, he does feel a little pain; feel a little tightness in his breathing/ tightness/shortness of breath; on his finger (pulse ox) showing he had 95% oxygen uptake, looked like 91% and then it went up to 93%; feel a little bit of heat on his forehead; nose dripping/nose was running; seems like it isn't working; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1283, via an unspecified route of administration on 13Jan2021 09:55 at a single dose on the Upper Left Arm, probably on muscle near the top for COVID-19 immunization. Medical history included shellfish allergy, asthma, hay fever, reaction/allergy to oleander plant (rash on his legs) and had surgery on his hip. There were no concomitant medications. The caller received Pfizer's COVID-19 vaccine early yesterday morning, 13Jan2021 and his second dose has been scheduled for more than 3 weeks. He also mentioned that his vaccine "seems like it isn't working". The patient stated it doesn't look like he had much of a response. All of his neighbor's arms are so sore and 'blah blah' and they have other side effects. He feels like everybody else had a much bigger reaction. He read there was a whole bunch of people that was given the COVID-19 vaccine with a short needle and all of their vaccinations had to be re-done. He really didn't feel nothing when he was being injection. He explained that when he pushes on the injection site, he does feel a little pain on 14Jan2021. However, he was heavily muscled in that area, and also based on his recent surgery on his hip and other experiences, he noticed on the surgeons files on his case, it says he has a high tolerance for pain which he believes to be true. He believes he may have been injected with a short needle. He was just wondering what size of needle is supposed to be used for the Pfizer vaccine and asked how he can find out what needle was used on him. He doesn't know if this was an intramuscular injection, but he assumes they were trying to get into the muscle. The patient stated he does have allergies, particularly to shellfish, but they haven't been really acting up a lot or that much. He told them about his allergies when he was receiving the COVID-19 vaccine, and they kept him for half an hour after receiving it on 13Jan2021. He did feel a little tightness in his breathing. He does have a little bit of asthma and he does have hay fever and all of that stuff. They put the little thing on his finger (pulse ox) showing he had 95% oxygen uptake, which is little low for him. The next time that checked it first looked like 91% and then it went up to 93%, but the way one holds their finger has something to do with that. He waited a few more minutes and assumed it was probably just allergies. He felt how it feels when he gets into pollen. He took a couple of puffs of his inhaler (Pro air HFA (albuterol sulfate) and the tightness very quickly went back to normal. The last reading when they put the pulse ox on his finger was 96.5. It should be 98 but at that point he talked to them and was feeling much better. He also mentioned he did feel a little bit of heat on his forehead last night (13Jan2021), he might have noticed it. However, the breathing stuff (Tightness/shortness of breath) started again. He used his inhaler again which would have been about 9 hours later, and he also took a Claritin as well. He doesn't normally take Claritin but he does take it every day up north and the last few weeks he did have his Condo wide open. The patient confirmed the tightness/shortness of breath wasn't immediately after receiving the COVID-19 vaccine, it was about 15-20 minutes after. The feeling felt no different than when he starts having a reaction to cigar smoke or something like that. The tightness/ shortness of breath improved immediately after using his inhaler. He used the inhaler which cleared up the tightness instantly as it always does but his nose was running kind of like when one has the flu. He clarifies he noticed late afternoon/evening; his nose was dripping. The dripping went on for 2-3 hours. He knew the inhaler wouldn't necessarily stop the dripping, so he figured he better take a Claritin. He stated not too longer after taking the Claritin, maybe 15-20 minutes afterwards when the Claritin started taking effect, the dripping stopped, and it hasn't been back since. He believes he took one Claritin a day before. The outcome of the event nose dripping was recovered, tightness/shortness of breath and 'on his finger (pulse ox) showing he had 95% oxygen uptake, looked like 91% and then it went up to 93%' was recovering, 'when he pushes on the injection site, he does feel a little pain' was not recovered while for other events was unknown.

Other Meds:

Current Illness:

ID: 0984402
Sex: U
Age:
State: AK

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/29/2021
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Symptoms: pulse 128, heart is still beating too fast; took my blood pressure and it was high for me. 167/102/high blood pressure; patient was very tired; I was lightheaded and saw spots before my eyes; My heart pounded in my chest; my pulse erratic; low potassium; high sugar; high thyroid; low sodium; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 04Jan2021 at 12:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies to latex from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient previously took tetracycline and experienced allergies to tetracycline. It was reported that the evening of the vaccine, the patient was very tired. Patient stated, "I took my blood pressure and it was high for me. 167/102, pulse 128, I was lightheaded and saw spots before my eyes". The patient called the nurse hotline and was sent to the ER. The ER just said that the patient had high blood pressure which patient stated, "I don't, I take it regularly". The patient also stated, I was off work for a week, too tired to get off the couch. My heart pounded in my chest, my pulse erratic. I went to the doctor 2 days later. She said it was from the vaccine. My labs from the ER showed low sodium, low potassium, high sugar and high thyroid. I had no health issues before the vaccine. I am back at work, but my heart is still beating too fast. This morning while doing nothing it was 102". No treatment was provided for the events. Covid test post vaccination (test type: nasal swab) on 07Jan2021 was negative. Outcome of the events was reported as recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0984404
Sex: F
Age:
State: IL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0984405
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
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Rec V Date: 01/29/2021
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Symptoms: tested positive for Covid-19; asymptomatic; tested positive for Covid-19; asymptomatic; Back pain; Cold; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient informed that she received the first dose of the Covid-19 vaccine on 29Dec2020 and her second dose was scheduled on 19Jan2021, but she was tested positive for Covid-19 on unspecified date. The patient informed that she was asymptomatic and only has back pain and cold. The patient wanted to know if she can receive the second dose of the vaccine. The outcome of the events tested positive for Covid-19; asymptomatic, back pain, cold was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on the time association, the lack of efficacy cannot be excluded for vaccine BNT162B2.

Other Meds:

Current Illness:

ID: 0984406
Sex: M
Age:
State: AR

Vax Date: 12/22/2020
Onset Date: 12/30/2020
Rec V Date: 01/29/2021
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Symptoms: test for COVID-19/Positive; test for COVID-19/Positive; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration in left arm on 22Dec2020 17:00 at single dose for covid-19 immunization. Medical history included High Cholesterol. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. The patient received the Rapid throat swab test for COVID-19 on 30Dec2020, the result was positive. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 0984408
Sex: F
Age:
State:

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/29/2021
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Symptoms: Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 05Jan2021 at 05:00 at a single dose for COVID-19 immunization. Medical history included skin auto-immune disease and auto-immune hypothyroidism. The patient's concomitant medications were not reported. The patient received the vaccine on 05Jan2021 at 05:00. The next day at 6:30 AM (06Jan2021), the patient started having vaginal bleeding that has not subsided yet and still going strong. The patient had seen a lot of specialist. She went to the ER twice and had CT scan, 3 biopsies taken, internal sonogram, had blood tests and urinalysis done, all with unknown results. The doctor told her if it doesn't stop in a couple of weeks, the patient will undergo a general anesthesia to further analyze the situation. The physician did not have information on vaccination for people with auto-immune issue. The patient had not yet recovered from the event vaginal bleeding. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0984409
Sex: F
Age:
State: IL

Vax Date: 12/30/2020
Onset Date: 01/10/2021
Rec V Date: 01/29/2021
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Symptoms: She has abdominal cramping now; Chills; she develops joint pain /They were sore and stiff; she develops joint pain /They were sore and stiff; This is a spontaneous report from a contactable consumer patient via a Pfizer-sponsored program. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685, Lot Expire Date: unknown), intramuscular injection in left deltoid on 30Dec2020 07:15 AM at single dose for COVID-19 immunization (reported as "Why was the patient taking COVID19 Vaccine (Verbatim): healthcare worker "). Medical history included ongoing allergy to sulfa antibiotics since 1998 (diagnosed within her first year of life) and allergic to the cold from 2011 and ongoing. She has an allergy to the cold and people sometimes confuse it with Raynaud's. It is not Raynaud's. Concomitant medication included etonogestrel (NEXPLANON) from May2019 and ongoing for birth control. The patient received the vaccine on 30Dec2020 and developed symptoms 4 days ago (10Jan2021), she was experiencing joint pain and chills, also reported as "just over the last 2 days she develops joint pain and chills". Patient experienced chills on 13Jan2021. Patient just called about possible side effects and she was wondering if she should get the second dose. Her side effects were minor. They were joint pain and chills. Joint Pain started in the hips and felt like something was wrong. They were sore and stiff. She has abdominal cramping now and she was not sure if that is from the joint pain or regular period. She just finished her menstrual cycle and normally she has cramps afterwards. She does not have a fever. Patient has checked her temperature three times. 30Dec2020 was when she received her first dose. Vaccination Facility Type was health center . The events did not require a visit to emergency room and physician office. No prior vaccination within 4 weeks but patient reported that events following prior vaccinations was "the worst was swelling and tenderness with HPV vaccine. HPV vaccine manufacturer: unknown". Outcome of the event chills was not recovered (ongoing) while for other events was unknown.

Other Meds: NEXPLANON

Current Illness: Environmental allergy; Sulfonamide allergy (diagnosed within her first year of life)

ID: 0984410
Sex: F
Age:
State: CT

Vax Date: 12/22/2020
Onset Date: 01/01/2021
Rec V Date: 01/29/2021
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Symptoms: she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.

Other Meds:

Current Illness:

ID: 0984411
Sex: U
Age:
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Rec V Date: 01/29/2021
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Symptoms: significant leakage from the site of injection; This is a spontaneous report from contactable pharmacist. This pharmacist reported similar events for two (2) patients. This is the first of the two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After administration of the vaccine, two of the doctors had significant leakage from the site of injection. This was a clear fluid leaking out of the site of injection. The pharmacist stated this type of leaking fluid is a common occurrence with the flu vaccine and asked if there is any particular guidance on what should be done in the case of this vaccine. Should the doctors get titers drawn up to determine if they need to get a 3rd dose? Should they go ahead and get the 3rd dose anyways? Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042161 same drug/event, different patients

Other Meds:

Current Illness:

ID: 0984412
Sex: F
Age:
State: NY

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 01/29/2021
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Symptoms: numbness to my left leg (from my ankle to my hip/waist)/ right side also became slightly numb/numbness to her left arm; My left knee was buckling, making walking very difficult; My left knee was buckling, making walking very difficult; my right side also became slightly numb, and was also tingling; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO140, expiration date unknown), via an unspecified route of administration in the left arm on 10Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included neuropathy and migraine. The patient did not have COVID prior to vaccination. Patient is not pregnant. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S) on unspecified dates for unspecified indications. The patient has not had other vaccines in four weeks. On 10Jan2021, three hours after being vaccinated (at approximately 3:00 PM), the patient experienced complete numbness to her left leg (from her ankle to her hip/waist). Hours later, the patient noted numbness to her left arm. Her left knee was buckling, making walking very difficult. The patient reported to the ER, and after several hours of waiting to be seen by a doctor, her right side also became slightly numb, and was also tingling. 18 hours after symptom onset (at approximately 9:30am, the day following injection), the numbness on her right side resolved. It was also reported that the numbness on her left side did not completely resolve for more than 24 hours. The patient underwent lab tests and procedures which included nasal swab test which was negative on 13Jan2021 . Therapeutic measures were taken as a result of the events which included anti-anxiety medication for calming. The outcome of the events left knee was buckling, making walking very difficult and tingling was recovered on unspecified date, while the rest of the events was recovering at the time of report.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported complete numbness to her left leg (from her ankle to her hip/waist)/numbness to her left arm, left knee was buckling, walking very difficult, right side also became slightly numb and tingling, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.

Other Meds: VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]; ONE-A-DAY WOMEN'S

Current Illness:

ID: 0984413
Sex: F
Age:
State: CA

Vax Date: 12/20/2020
Onset Date: 12/20/2020
Rec V Date: 01/29/2021
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Symptoms: BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15. On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg. Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course. However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors. The case will be reassessed should additional information become available. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DOXYCYCLINE; PREDNISONE; BENADRYL

Current Illness:

ID: 0984414
Sex: F
Age:
State: OK

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/29/2021
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Symptoms: Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on the right arm on 08Jan2021 at 07:15 at a single dose for COVID-19 immunization. Medical history included anemia, Vitamin D deficiency, and known allergies to dairy and kiwi. Concomitant medication included iron (IRON), colecalciferol (VITAMIN D [COLECALCIFEROL]), zinc (ZINC), linum usitatissimum oil (FLAXSEED OIL [LINUM USITATISSIMUM OIL]), and cetirizine (CETIRIZINE). The patient had no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, on the right arm on 19Dec2020 at 0745AM for COVID-19 immunization. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The patient experienced facial numbness and tingling on 08Jan2021 at 08:15. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.

Other Meds: IRON; VITAMIN D [COLECALCIFEROL]; ZINC; FLAXSEED OIL [LINUM USITATISSIMUM OIL]; CETIRIZINE

Current Illness:

ID: 0984415
Sex: F
Age:
State: HI

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 01/29/2021
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Symptoms: on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous report from a non-contactable Other-HCP reporting for herself. A 40-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on arm left from 14Jan2021 07:00 to 14Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Prolonged QT syndrome. The patient's concomitant medications were not reported. The patient had her first dose of BNT162B2 on 23Dec2020 to 23Dec2020. On 15Jan2021 at 07:00, on left arm, almost immediately after left had became increasingly cold. Right had was ok and did not change in temperature. Area around the shot was not cold, only hand. Coldness lasted for about 15 minutes before slowly getting back to normal temperature. The patient had not received any treatment for the event. The patient was not pregnant at the time of the report. Outcome of the event was recovered on an unspecified date. No follow up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0984416
Sex: F
Age:
State:

Vax Date: 01/10/2021
Onset Date: 01/12/2021
Rec V Date: 01/29/2021
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Symptoms: Severe generalized pruritus, likely delayed hypersensitivity; Severe generalized pruritus, likely delayed hypersensitivity; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 10Jan2021 at 08:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included seasonal allergies. Patient has no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021, the patient experienced severe generalized pruritus, likely delayed hypersensitivity. Patient was given antihistamines and topical agents for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information about lot/batch number has been requested.

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Current Illness:

ID: 0984417
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 01/29/2021
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Symptoms: Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 13:15 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient had no known allergies and patient was not pregnant. Concomitant medication included gabapentin, diltiazem hydrochloride (DILT-XR), losartan and ezetimibe (ZETIA). On 14Jan2021 at 22:00, the patient experienced very painful stiff neck and rapid heartbeat. The patient had no therapy for the events. The patient had no other vaccine in 4 weeks, and did not have Covid prior vaccination. The patient was no Covid tested post vaccination. Outcome of events was not recovered. Information on Lot/Batch has been requested.

Other Meds: GABAPENTIN; DILT-XR; LOSARTAN; ZETIA

Current Illness:

ID: 0984418
Sex: M
Age:
State: NC

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/29/2021
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Symptoms: Muscle tightness; soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 13:15 at single dose for Covid-19 immunization. The patient's medical history included Penicillin allergy (reported "known allergies: Penicillin". Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (20:00), the patient experienced muscle tightness and soreness at the injection site up to 24 hours post injection. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 0984419
Sex: F
Age:
State: ME

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/29/2021
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Symptoms: red circle around the injecting site; injecting site, itchy; injecting site; a hard ball underneath; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El3246 and expiry date unknown) via unspecified route of administration at the left arm on 13Jan2021 09:15 at single dose for Covid-19 immunization in a hospital. Medical history included liver tumors, and allergies to "sulfer", thyroid (disorder), anxiety and blood pressure (abnormal). Concomitant medications included thyroid, anxiety and blood pressure medications. The patient has no other vaccine in four weeks. On 14Jan2021, the patient experienced red circle around the injecting site, itchy and a hard ball underneath. The patient did not receive treatment due to the events. The outcome of the events red circle around the injecting site, itchy and a hard ball underneath was not recovered.

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Current Illness:

ID: 0984420
Sex: F
Age:
State: LA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), intramuscular in right arm on 13Jan2021 at 07:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included diabetes and high cholesterol. The patient's concomitant medication included unspecified vitamins. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, unknown expiration) via intramuscular in left arm on 23Dec2020 at 07:15 AM in a hospital. The patient also had known allergies to codeine. The patient experienced fever and body aches on 13Jan2021 at 13:00. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The patient had not yet recovered from the events.

Other Meds:

Current Illness:

ID: 0984421
Sex: M
Age:
State: CT

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/29/2021
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Symptoms: coughed up what looked like blood in his spit; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on 14Jan2021 for COVID-19 immunization, and apixaban (ELIQUIS) via an unspecified route of administration at an unspecified dose from an unspecified date as blood thinner. The patient's medical history and concomitant medications were not reported. The patient received his first shot of vaccine in the morning 14Jan2021 while on apixaban. After going to sleep at night, he woke up a couple hours later and coughed up some spit that looked like it had blood. It was 6 or 7 times. He stated he was "ok now" and it was just last night that one time. The action taken for apixaban was unknown. The outcome of the event was resolved on a unspecified date in Jan2021. He will have his second shot in 4 weeks and he is asking if he should get the second shot and if he should stop taking apixaban before his second shot. Information on the lot/batch number has been requested.

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Current Illness:

ID: 0984422
Sex: M
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/29/2021
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Symptoms: 101.8F fever; chills; nausea; headache; sinus pain; This is a spontaneous report from a contactable healthcare professional. A 32-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on his left arm, via an unspecified route of administration on 14Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history included allergies to sulfa drugs. Concomitant medication included loratadine (CLARITINE) and crisaborole (EUCRISA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (first dose). The patient experienced 101.8F fever, chills, nausea, headache, sinus pain; all on 14Jan2021 11:00pm. No treatment was received for the events. The outcome of the events was recovering.

Other Meds: CLARITINE; EUCRISA

Current Illness:

ID: 0984423
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/01/2021
Rec V Date: 01/29/2021
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Symptoms: experiencing diarrhea that is a little bit on the loose side; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also known as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 13Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea that she was a little bit on the loose side on an unspecified date in Jan2021. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 0984424
Sex: M
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 01/29/2021
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Symptoms: Really dizzy; This is a spontaneous report from a contactable consumer (wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 15Jan2021 the patient experienced the event really dizzy. The reporter called to ask if dizziness was a side effect of the vaccine. The clinical outcome of the event, really dizzy, was unknown. The lot number for vaccine BNT162B2, was not provided and will be requested during follow-up.

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Current Illness:

ID: 0984425
Sex: F
Age:
State: PA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/29/2021
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Symptoms: both cheeks were very rosy red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) via an unspecified route of administration on 14Jan2021 (in the morning) at a single dose as COVID-vaccine, she got it as a protection to her because she's elderly with underlying conditions. Medical history was not reported. Concomitant medications included unspecified five prescriptions which she has been taking for a long time (nothing new). She has had no reaction to medications. Her diet was her normal diet. The patient experienced both cheeks were very rosy red on 14Jan2021 21:30. She wanted to know if experiencing very rosy red cheeks, on both sides, after receiving the Covid vaccine was a normal side effect. She received the first dose of the COVID Pfizer vaccine yesterday morning on 14Jan2021, everything was fine (good) at 7:30 p.m. Then at 9:30 p.m., while she was brushing her teeth, she noticed that both cheeks were very rosy red (her cheeks were rosy red). This morning, her cheeks appeared to be skin tone (skin looked normal). It was gone now; both cheeks were her normal skin tone and everything looked normal now. She didn't eat anything unusual the day of the vaccine. She was wondering if she should go back on 15Feb2021. She was going to ask her doctor and was going to notify her primary care doctor as well if she experiences any redness today or tomorrow. Investigation assessment was noted as no. The outcome of the event was recovered on 15Jan2021.

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Current Illness:

ID: 0984426
Sex: M
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/29/2021
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Symptoms: bronchitis; Arm soreness; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: A3246/H3246, via an unspecified route of administration from 12Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included asthma and ongoing cough. There were no concomitant medications. The patient had a minor cough and was spitting up phlegm but had no temperature before he got the vaccine. The patient had bronchitis but no virus currently. He still has a bit of cough. He wanted to know if it gets worse was, he allowed to take an antibiotic and if taking antibiotics or prednisone will interfere with the vaccine as he already received the first dose. He was asking if it got worse, should he wait five more days and then go to the doctor. He wanted to know if prednisone affects the vaccine. The only side effect of COVID-19 Vaccine was his arm was hurting for about four to five hours on 12Jan2021, but that was it. The patient took two Tylenol. Arm soreness went away maybe five to seven hours later. The outcome of the event arm soreness was recovered while bronchitis was unknown. Information on the lot/ batch number has been requested.

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Current Illness: Productive cough (minor cough and was spitting up phlegm)

ID: 0984427
Sex: F
Age:
State: TX

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.

Other Meds: ATORVASTATIN; AMLODIPINE; LOSARTAN; TERAZOSIN

Current Illness:

ID: 0984428
Sex: M
Age:
State: FL

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Rec V Date: 01/29/2021
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Symptoms: The caller and his wife are to receive the second dose 28 days after the first; This case has been considered invalid since there is no indication that the consumer experienced an event under Product BNT162B2, just medical inquiry. This is a spontaneous report from a contactable consumer (patient). The reporter reported similar event for two patient (reporter and his wife). This is the first case of 2 reports, for consumer himself. A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1283, on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient explained that yesterday he and his wife were scheduled to get the Modera vaccine in (address). They drove down there only to find out they ran out of the Moderna vaccine so they gave them the Pfizer one, which was fine, it was good actually. Now his second dose was based on the Moderna one and was scheduled at 28 days out. He was reading and found out we recommend it being given at 21 days. The patient explained the site said it was fine but he wanted to know if there's a problem with getting it at 28 days instead of 21 days or should he raise a fuss with the Health Department to make them give it to them at 21 days. He and his wife both got the shot that day with the same lot number: EL1283.

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Current Illness:

ID: 0984429
Sex: F
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.

Other Meds: XARELTO

Current Illness:

ID: 0984430
Sex: M
Age:
State:

Vax Date: 01/10/2021
Onset Date: 01/01/2021
Rec V Date: 01/29/2021
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Symptoms: a little soreness in the arm; nauseated/cannot throw up anything, he was just continually nauseated; his stomach hurt; headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 10Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife stated that the patient received the Covid vaccine on 10Jan2021 with a little soreness in the arm on 10Jan2021 when he first received the shot. However, in a couple days in Jan2021, he got nauseated and his stomach hurt, but cannot throw up anything, he was just continually nauseated. He also had a headache for a while on Jan2021 but that's gone now. The patient's wife asked if there was something to help the patient with the nausea after receiving the vaccine and also asked if the patient should receive the second dose if he was experiencing nausea. The outcome of the event headache was recovered on Jan2021; nausea was not recovered; while the outcome of the other remaining events was unknown. Information about the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0984431
Sex: F
Age:
State:

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 01/29/2021
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Symptoms: her blood sugar is 260's; This is a spontaneous report from a Non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter indicated that she received her first dose of vaccine yesterday (14Jan2021) and her blood sugar is 260's on an unspecified date. She ate a slice of toast and exercised, asking if steroids are in vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 0984432
Sex: M
Age:
State: MA

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 01/29/2021
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Symptoms: losing night time sleep; welts on his body; rashes on delicate parts of belly, buttocks, scalp which were itchy/The rash gradually developed an itch; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: 31Mar2021), via intramuscular route of administration on 30Dec2020 at 11:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, a week after the injection, the patient experienced rashes on delicate parts of belly, buttocks, scalp which were itchy. The rash gradually developed an itch and he is now losing night time sleep. Patient stated that there were welts on his body on an unspecified date. He tried everything to stop the itch. He later stated there were objects across the counter that he tried, not prescription. One was alcohol and the other one was peroxide and a third one is Jergen's hand lotion and none worked. The outcome of the event itchy rash was not recovered, while unknown for the other events.

Other Meds:

Current Illness:

ID: 0984433
Sex: M
Age:
State: SC

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/29/2021
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Symptoms: Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0984434
Sex: F
Age:
State:

Vax Date:
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Rec V Date: 01/29/2021
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Symptoms: Not feeling well; Really bad headache; This is a spontaneous report from a non-contactable consumer via the Medical Information Team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she was not feeling well and have a really bad headache. The outcome of the events was unknown. No follow-up attempts are possible: information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0984435
Sex: F
Age:
State: CA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/29/2021
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Symptoms: in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a "large mass hard and stiff", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby

Other Meds:

Current Illness:

ID: 0984436
Sex: M
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks; dizzy; vertigo; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: not reported), via an unspecified route of administration on 12Jan2021 (around 11:00 or 11:30 AM) on left shoulder (arm left) for COVID-19 immunization. Vaccine was not administered at a military facility. There were no additional vaccines administered on same date of bnt162b2. He did not receive other vaccines 4 weeks prior to COVID-19 vaccination. Medical history and concomitant medications were none. The patient had his 1st dose on 12Jan2021. He was fine that day, but on the 13Jan2021, he woke up and was dizzy. He stated that he had no problem after having the shot, 15 minutes later, he had no problems; but, the next day he began having vertigo and dizziness. Vertigo and dizziness began 13Jan2021 at about 8:00 AM. This has continued the past 3 days. It is getting better, but he is wondering if that is a big problem. At the time of report, it's getting better but still have it. He asked if he should be concerned. It is quite a bit improved but it's still there. If he had to drive a car for an emergency, he thinks he could do it, but he wouldn't volunteer for that right now. He looked up all that stuff and it says that 20% of the people who take it have that. But when they list the side effects, they don't list dizziness until they list severe that is the only thing that has concerned him. He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks. Outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 0984437
Sex: F
Age:
State: CA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: Local skin allergic reaction at the injection site; Swelling (about the size of a quarter) at the injection site; Red dots (about the size of a pencil eraser) that appeared around the injection site; some spots around the area approximately the size of pencil erasers; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), intramuscular in the left upper deltoid muscle, on 13Jan2021 at 10:30, at a single dose, for COVID-19 vaccination. The patient had no medical history and concomitant medications. On 13Jan2021, the patient received first dose of vaccine and immediately (about 5 minutes after she received the vaccine at 10:35) developed non-severe local skin allergic reaction and swelling at the injection site, and some spots around the area approximately the size of pencil erasers. The patient had swelling (about the size of a quarter) at the injection site, along with red dots (about the size of a pencil eraser) that appeared around the injection site. The patient's vital signs were normal, her breathing was fine, and she had no swelling in her throat or lips. The patient took diphenhydramine hydrochloride (BENADRYL) 25 mg tablet, and a minute or two after taking the diphenhydramine hydrochloride tablet, all the symptoms went away. The patient was calling to see if she should receive the second dose of the vaccine. The patient asked if she should get the second COVID-19 vaccine dose, based on her adverse reactions after receiving the first dose. The patient recovered from the events on 13Jan2021.

Other Meds:

Current Illness:

ID: 0984438
Sex: F
Age:
State: AZ

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 01/29/2021
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Symptoms: Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.

Other Meds: METFORMIN; ROSUVASTATIN; LEVOTHYROXINE; LIOTHYRONINE

Current Illness:

ID: 0984439
Sex: F
Age:
State: MA

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 01/29/2021
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Symptoms: chills; tiredness; temperature was 100.8; sore arm with redness; sore arm with redness; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included covid-19 in Apr2020. There were no concomitant medications. On 13Jan2021, the patient experienced chills and tiredness and at the end of the day, her temperature was 100.8. The patient also experienced sore arm with redness in Jan2021. The patient stated that every once in a while, she get a shot and get a sore arm. She added that she noticed that her arm was more sore with redness that morning of reporting. The outcome of events chills, tiredness and temperature was 100.8 recovered on 14Jan2021, event sore arm with redness was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0984440
Sex: M
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 01/29/2021
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Symptoms: vomiting; does not feel good; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received a 1st shot of Pfizer vaccine yesterday (14Jan2021) and has been vomiting since this am (morning) (15Jan2021) and does not feel good (exact date unspecified; Jan2021). The outcome of events was unknown. This case is non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0984441
Sex: F
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/29/2021
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Symptoms: pain; headache; shiver; a fever which is currently 99.7 F; This is a spontaneous report received from a non-contactable consumer (patient's husband). A female patient of an unspecified age (reported as 62, unit not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration, on 14Jan2021 10:00, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the vaccine yesterday (14Jan2021) around 10:00 and around 20:00, the patient experienced pain, headache, shiver and a fever which is currently 99.7 F. The reporter asked if the patient can use antipyretics before or after vaccination with the BNT162B2 vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0984442
Sex: M
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/15/2021
Rec V Date: 01/29/2021
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Symptoms: large swelling around his right leg; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 13Jan2021, at a single dose for COVID-19 immunization. The patient also received insulin (manufacturer unknown), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history and concomitant medications were not reported. The patient got the COVID vaccine shot on Wednesday, 13Jan2021. At the morning of the report, 15Jan2021, he noticed a large swelling around his right leg. When he takes insulin through his right leg, he sees a few spots, but it usually goes away. This morning, when he woke up, a large area around the right site was swollen and it's not going away. He had been injected insulin around the same site a few times. He called to know if this was normal. The action taken in response to the event for insulin was unknown. Outcome of the event was not recovered. Information on the lot/batch number has been requested.

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Current Illness:

ID: 0984443
Sex: F
Age:
State: LA

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/29/2021
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Symptoms: pain on left side of head that extends from left temple to above and behind my left ear and down the back of her neck; chills; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 04Jan2021 at 13:30 at a single dose in the workplace clinic for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not have COVID prior to vaccination. The patient is not pregnant. The patient experienced sharp pain on left side of head that extends from left temple to above and behind my left ear and down the back of her neck on 05Jan2021 at 15:00. Sudden onset and fades over 10-60 minutes and reoccurs off and on throughout the day. Also have noticed chills at the same time, on 05Jan2021 at 15:00. The patient did not receive treatment for the events. Outcome of event chills was not recovered while recovered on 05Jan2021 for the other event. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0984444
Sex: M
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 01/29/2021
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Symptoms: light headiness; feel tightness around my chest; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 15Jan2021 11:15 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated "I already reported the side effects to Pfizer before calling you. I received the vaccine today (15Jan2021) at 11:15 am. I felt light headiness for 5 to 19 minutes. I attributed this to the fact that I was fasting. I felt better after drinking water and a little walk. When I got home I started to feel tightness around my chest, no difficult breathing, no high pulse and no fever." The patient wasnted to know if this was considered a severe allergic reaction that may require hospitalization. The outcome of the event light headiness was recovering, while feel tightness around my chest was unknown. Follow-up activities are possible, information on the batch number has been requested.

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Current Illness:

ID: 0984445
Sex: F
Age:
State: AR

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 01/29/2021
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Symptoms: Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date not reported), intramuscular on 14Jan2021 10:15 at single dose on the right arm for COVID-19 immunization. Medical history included chronic pain and known allergies to sulfa. The patient's concomitant medications were not reported. The patient experienced shortness of breath, chest heavy, lightheaded on 15Jan2021 at 10:00. The patient has not recovered from the events at the time of the report. The patient was not pregnant, has no prior COVID vaccination and was not tested for COVID post vaccination.

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Current Illness:

ID: 0984446
Sex: F
Age:
State: WV

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/29/2021
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Symptoms: A rash that was located on the neck,chest and back area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 08Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced a rash that was located on the neck,chest and back area on 08Jan2021 14:00. No treatment was given for the event. The patient has not been tested for COVID post vaccination. The patient recovered from the event on Jan2021.

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Current Illness:

ID: 0984447
Sex: M
Age:
State: MS

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 01/29/2021
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Symptoms: Transient numbness inside mouth buccal mucosa for about 3-5 minutes; Slight swelling upper left lip; 2cm petechia on border of left upper lip stopping at the midline; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), Intramuscular at left arm on 15Jan2021 11:00 at SINGLE DOSE for covid-19 vaccination. Medical history was reported as none. The patient's concomitant medications were not reported. On 15Jan2021 11:15, the patient experienced transient numbness inside mouth buccal mucosa for about 3-5 minutes, slight swelling upper left lip, 2cm petechia on border of left upper lip. Stopping at the midline. No treatment received for the events. No covid-prior-vaccination, no covid-tested-post-vaccination, no known allergies. The outcome of the events was recovering.

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Current Illness:

ID: 0984448
Sex: F
Age:
State: CO

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/29/2021
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Symptoms: Myalgias; She was nursing her infant; She was nursing her infant; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported for herself and her infant. This is mother report. A 37-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 11Jan2021 at 18:15 at single dose in left arm for covid-19 immunization. Medical history included hypothyroid, and known allergies: penicillin. Concomitant medication included levothyroxine, biotin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ergocalciferol (VIT D), lactobacillus acidophilus (PROBIO). The patient previously received the first dose bnt162b2 (lot number: EK5730) on 22Dec2020 at 06:15 pm in right arm for covid-19 immunization. The patient experienced myalgias on 12Jan2021 at 11:00. Event details: The patient experienced myalgias 16 hours after receiving the 2nd vaccine. She was nursing her infant and the infant developed fever for 3 days without any other symptoms following her vaccination. The patient did not received treatment for event myalgias. The patient did not have COVID prior vaccination, and have not been tested for COVID post vaccination. The outcome of the event myalgias was resolved in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051876 infant case

Other Meds: LEVOTHYROXINE; BIOTIN; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; VIT D; PROBIO

Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm