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
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1320123
Sex: F
Age:
State: CA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Paralysis; Sore for four days\Arm was very sore; Mild headache; Mild nausea; throbbing pain temple; tongue swells; lips felt numb/her tongue went numb; Heaviness to her tongue; flu like symptoms; her face a has a feeling of numbness on her right side; asthma; allergies/Food allergy/completed for initial report (PRD 30Apr2021, SRD 01May2021) and FU#1 (PRD 29Apr2021, SRD 01May2021); the second shot hurts; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 25Mar2021 at the age of 71 years old (Batch/Lot number: ER8732, expiration date: 31Jul2021) as 2nd dose, single for covid-19 immunisation. Medical history included asthma, some allergy, seasonal allergies, allergy to mold, high blood pressure, high cholesterol. Concomitant medications were not reported. The patient previous received the first dose of bnt162b2 on 04Mar2021 (Lot Number: En6199, Expiration Date:30Jun2021) at the age of 71 years old for covid-19 immunisation and what happened was just this injection site was hurting for about 4 days and she just had some fever and nausea. The patient asked if Pfizer had provided a statement on the need for a booster dose (3rd dose), if Pfizer was investigating the need for a booster dose, if she would receive a Pfizer dose. The patient reported that usual her arm did not even swell. Sore for four days. She did not take anything. Mild headache. She could not stand the smell of chicken for instance. Mild nausea. Second dose, throbbing pain temple. She had asthma, allergies. Took Tylenol. Five and half hours later she craved salad. She had had Haig tabbouleh. Fresh lemon. She did react to walnuts, tomatoes. Her tongue swells. She took one taste of the tabbouleh. Her lips felt numb. Heaviness to her tongue. She called the nurse. On-call Dr Food allergy. Suggested she went to bed. Arm was very sore. She took a Ibuprofen. By that night, flu like symptoms. Just went to bed. Her own doctor. That was the vaccine. Immune system was working. Paralysis. eggplant. Do you think it could cause food allergies? The patient hesitant to take a booster dose. As of 29Apr2021, patient reported she got her first shot on 04Mar2021 and her 2nd shot on 25Mar2021. She was surprised at herself that was not sacred. She had been sheltering at home for a year as she came under the critical category. Patient further stated she had reaction she thought to the vaccine from second shot so she wanted to report it and she needed some clarification on that she did reported this last week about it (further clarification unknown). She just wanted some reassurance and because what happened was, from the first shot she was fine she had been tested there for 30minutes of 15 for her allergies and asthma was fier. So, what happened was just this injection site was hurting for about 4 days and she just had some fever and nausea but the second shot hurts and hours after the second shot she wanted to eat something and so she ate some salad. For Weight, Consumer stated was about 165 pounds, she had not weighed herself lately. For Treatment: Consumer stated she came back she did take Tylenol for the pain and for the headache. Consumer further stated she had been waiting to talk to you not for the headache but because she had reaction when she ate something. She ate salad and she had eaten the salad before and it had some lemon juice, olive oil and it was cracked with tomatoes and cucumber and parsley and she had eaten the one my whole life and these particular take out that, she took from grocery for the salad. So, when she ate it, it bothered her tongue just a little bit because her tongue reacted when she eat citrus fruits like tomatoes and spicy things. So, what happened was as soon as she took a taste of this salad, her tongue went numb like she had a Novocaine shot (further clarification unknown), her lips went numb, her face a has a feeling of numbness on her right side and it lasted for 8 hours and she talked to her doctor and he said, it was food allergy or it may due to be a vaccine. Investigation Assessment was no. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1320124
Sex: F
Age:
State: SC

Vax Date: 04/01/2021
Onset Date: 04/07/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Developed Deep Vein Thrombosis. Diagnosed 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 14:30 (Batch/lot number: EN8207) as 2nd dose, single for COVID-19 immunisation. Medical history included Diabetes, High Blood Pressure and High Cholesterol, all from an unknown date. There no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Arm Left on 11Mar2021 11:45 AM (Batch/lot number: EP7533) at the age of 59-year-old for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient developed deep vein thrombosis since 07Apr2021, which was diagnosed on 30Apr2021. Therapeutic measures were taken as a result of deep vein thrombosis which included Prescribed Xarelto. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1320125
Sex: F
Age:
State: IN

Vax Date: 04/22/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), dose 2 via an unspecified route of administration, administered in arm left on 22Apr2021 12:30 as 2nd dose, single for covid-19 immunisation. Medical history included fibromyalgia, ongoing diabetes type2, non-Alcoholic Cirrhosis, ongoing Chronic fatigue syndrome (CFS), spinal degeneration, hypo thyroid, gallbladder removal, hernia repair, hysterectomy, restless leg syndrome, sleep apnea, Known allergies with Wellbutrin, Naltrexone, tape. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) administered in arm left on 23Mar2021 12:30 for COVID-19 Immunization. The patient reported to ER with severe swelling of lips and tongue, severe itching and rash on 30Apr2021 09:15. The adverse event result in emergency room/department or urgent care. The patient received treatment (IV of Solumedrol and Benedryl) for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination with Nasal swab and result was negative. The outcome of the events was resolved with sequelae.

Other Meds:

Current Illness: Chronic fatigue syndrome; Type 2 diabetes mellitus

ID: 1320126
Sex: F
Age:
State:

Vax Date: 04/22/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: passed out; Astronomical Headache; I got very dizzy and had dots; She got very dizzy and had dots; I just started spinning and broke out; Iave a bump on her head; scrape on her knee; chills; Nausea; Vomiting; Diarrhea; I was severely cold; I was very sluggish; My chest feels congested; her head feels like it weighs 30 lbs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as first dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that this past Wednesday (30Apr2021), she was getting severe chills, nausea, vomiting, and diarrhea. She took Dayquil because she still had the chills and she was severely cold. Yesterday (30Apr2021), she was very sluggish. She mentioned that her head feels like it weighs 30 lbs. on 30Apr2021. She added that her chest feels congested on 30Apr2021. This morning (01May2021), she was lightheaded and had an astronomical headache. She got very dizzy and had dots. She got up again to turn the tea kettle off and she just started spinning and broke out and went to the bathroom. When she went to the bathroom and went to squat on the toilet, she passed out. She doesn't know how long she was out. She has a bump on her head and a scrape on her knee. When she woke up, she was so cold, so she put on flannel pajamas. She also mentioned that she was scheduled for second one on next Tuesday (11May2021). She inquired if she can still get Covid after getting the vaccine. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320127
Sex: F
Age:
State: NJ

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Stomach pains; She came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose; She came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose; This is a spontaneous report from a contactable consumer and from Pfizer sponsored program from a contactable consumer (patient's husband). A 90-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included neck pain from an unspecified date and clostridium difficile infection from 2020 (C-diff issue started a year ago in which it was the consequence of taking 5 different antibiotics). The patient's concomitant medications were not reported. The patient experienced she came down with a possible c.dif (clostridium difficile) issue or possible UTI after her 1st dose on Apr2021 and stomach pains on an unspecified date. Consumer was reporting for his 90 year old wife who received her 1st dose of the Pfizer COVID vaccine with him in the beginning of April. He mentioned that she came down with a possible C.dif (Clostridium difficile) issue or possible UTI after her 1st dose. She is supposed to get her 2nd dose tomorrow but was advised by her doctor not to get it yet in order for them to wait for the results of her urine sample. He is asking if there have been reports of these issues after getting vaccinated. He mentioned that the C-diff issue started a year ago in which it was the consequence of taking 5 different antibiotics due to a possible meningitis diagnosis because of very serious pains on her neck. The meningitis was later ruled out. He mentioned that she is taking vancomycin and ventil for her stomach pains. The patient underwent lab tests and procedures which included Urine sample: unknown results on an unspecified date. Therapeutic measures were taken as a result of stomach pains. Outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1320128
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Suddenly developed AFib; difficulty breathing; large buildup of fluid in my lungs; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot number: UNKNOWN) as single dose for COVID-19 immunisation; metoprolol tartrate, via an unspecified route of administration from an unspecified date to an unspecified date, at 50 mg, 2x/day for an unspecified indication; apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date, 2x/day for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced suddenly developed afib, difficulty breathing, large buildup of fluid in my lungs. The patient reported the course of the events as follows: Within 6 weeks after receiving the 2nd Pfizer C19 shot I suddenly developed AFib. I've never had heart problems and all of a sudden I had difficulty breathing. Dr prescribed large doses of Furosemide because of large buildup of fluid in my lungs. I am still on Eliquis 2x a day and 50 mg of Metoprolol 2 x a day. The patient inquired Have there been other patients develop AFib after receiving 2nd shot of Pfizer C19.The action taken in response to the events for metoprolol tartrate and apixaban was unknown. Therapeutic measures were taken as a result of large buildup of fluid in my lungs. The clinical outcome of the events was unknown. Pfizer is a marketing authorization holder of [Metoprolol Tartrate] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Metoprolol Tartrate] has submitted the same report to the regulatory authorities. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320129
Sex: F
Age:
State: LA

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: preeclampsia level migraines; soreness at shot site; joint pain; chills; 104.0 fever/103 fever; I was itchy all over for a few nights; weird lump in my armpit by my breast; 3rd time CMV has reactivated; 3rd time CMV has reactivated; Anafalactic shock; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0158), via an unspecified route of administration in left arm on 26Apr2021 14:45 (at the age of 36-years-old) as 2 nd dose, single for covid-19 immunisation. The vaccination facility type was a hospital. The patient received first dose of bnt162b2 (Lot no: ER8729) on 05Apr2021 at 14:45 in left arm for COVID-19 immunisation and experienced cytomegalovirus (CMV). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included CMV; HELLP syndrome and preeclampsia, all when she delivered her son 3 weeks early and pregnant. Concomitant medications included ferrous sulfate; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and unspecified prenatal vitamins. The patient reported 3 rd time CMV has reactivated in 2021. After 2nd vaccine dose (on 26Apr2021), soreness at shot site and joint pain. Late that night, chills, 104.0 fever. Next day (on 27Apr2021), 103 fever took paracetamol (TYLENOL) 4-6 hrs. Third day after (on 29Apr2021), 103 fever, still joint pain, & preeclampsia level migraines. Still had Rx migraine meds but couldn't mix with fever reducer. So took leftover oxycodone from having a baby at midnight and 05:00. Next day/4th post shot day (30Apr2021), severe migraine, fever staying around 100.something. So the patient took migraine medicine, melatonin (3 mg a few times that night). The melatonin was kinda helpful. In 2021, the patient was itchy all over for a few nights (been in anafalactic shock 3x prior so the patient knew it wasn't that) joint pain, now she have a weird lump in her armpit by her breast that hasn't gone away. Almost woke her husband to go to hospital because of migraine. The case was considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event axillary mass was not recovered while for the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case

Other Meds: FERROUS SULFATE; ADDERALL

Current Illness:

ID: 1320130
Sex: F
Age:
State: AZ

Vax Date: 02/17/2021
Onset Date: 02/19/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: felt very ill (flu like symptoms); Blood Sugars have ranged from 40-440 for no reason, with no change in diet or exercise; Neuropathy in her feet/legs; Severe fatigue and weakness in my legs, have intensified to the point of not being able to walk, or put my feet to the ground.; Severe fatigue and weakness in my legs, have intensified to the point of not being able to walk, or put my feet to the ground.; Memory loss; confusion; stomach had become paralyzed (Gastroparesis); Severe fatigue and weakness in my legs, have intensified to the point of not being able to walk, or put my feet to the ground.; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN5318, on 17Feb2021 15:30 at single dose in left arm for COVID-19 immunization. Medical history included depression, Anxiety, Fibromyalgia, Neuropathy, Type II Diabetic. The patient was not diagnosed with COVID-19 Prior to vaccination. Concomitant medication was not reported. The patient did not have other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2, Lot/Batch: EL1283 on 27Jan2021 15:15 on left arm. The patient previously received droperidol (INAPSINE) and had allergy. On 19Feb2021, the patient felt very ill (flu like symptoms) for 10 days. Her Blood Sugars have ranged from 40-440 for no reason, with no change in diet or exercise. She was not on insulin prior to the vaccine. The Neuropathy in her feet/legs and severe fatigue and weakness in her legs, have intensified to the point of not being able to walk, or put her feet to the ground. She had also had memory loss and confusion. Also, her stomach had become paralyzed (Gastroparesis). Her employer stated, that they will place her on inactive status until her Doctors and her figure out what was going on. Lab data included Nasal swab (Rapid test) negative on 06Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for all events. The outcome of all events was not resolved. All events are serious with disability.; Sender's Comments: Based on the available information, the company considers that a causal relationship between felt very ill (flu like symptoms), severe fatigue and weakness in her legs, have intensified to the point of not being able to walk, or put her feet to the ground and BNT162B2 vaccination cannot be excluded due to plausible temporal association. The Company considers the reported events Blood Sugars have ranged from 40-440, Neuropathy in her feet/legs, memory loss and confusion, stomach had become paralyzed (Gastroparesis) are unrelated to BNT162B2 vaccination, but more likely due to underlying or inter-current medical conditions. 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:

Current Illness:

ID: 1320131
Sex: M
Age:
State: TX

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 12:45 PM at the age of 65-years-old (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Herniated discs L4,L5,S1,C4,C5C6C7, type 2 diabetes from an unknown date. Concomitant medications included apixaban (ELIQUIS); dipyridamole (METROPOLYN) and bupropion, all taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 01:15 PM, the patient experienced Fainting, pain, itching, fatigue, headache, nausea, Lost of smell, short term memory off and on. It was unknown if treatment received. The outcome of the events was resolving. Information on the lot/batch number has been requested.

Other Meds: ELIQUIS; METROPOLYN; BUPROPION

Current Illness:

ID: 1320132
Sex: F
Age:
State: NC

Vax Date: 04/08/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Bell's palsy; metallic, numb sensation on end of tongue; metallic, numb sensation on end of tongue; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 at 09:45 AM (at the age of 50 years old) (Lot Number: ew0162, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included chronic atopic dermatitis, mild asthma, sulfa allergies, latex allergies, allergies of peanuts and almond, banana peel allergies, allergy to tomatoes, sesame allergy, and shrimp allergy. Concomitant medications included dupilumab (DUPIXENT); hydroxyzine hcl; and ibuprofen. The patient experienced metallic, numb sensation on end of tongue and Bell's palsy on 23Apr2021. The events resulted in emergency room/department or urgent care visit. The patient received prednisone and valacyclovir as treatment for the events. No other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.

Other Meds: DUPIXENT; HYDROXYZINE HCL; IBUPROFEN

Current Illness:

ID: 1320133
Sex: M
Age:
State: AZ

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: really really big allergy attack; Impairing his breathing; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 08Apr2021, as 1st dose, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he received the first dose of BNT162B2 on 08Apr2021 and was scheduled to receive his second dose on 03May2021. However, on an unspecified date, he experienced a "really really big allergy attack" which was impairing his breathing. He stated that the events were not related to the vaccine. He wanted to reschedule his second dose appointment and wanted to know if it was okay to take the second dose more than 21 days after the first dose. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: The events are hypersensitivity and dyspnea are likely intercurrent and are unrelated to suspect product BNT162B2.

Other Meds:

Current Illness:

ID: 1320134
Sex: M
Age:
State: MS

Vax Date: 03/29/2021
Onset Date: 04/05/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 10:00 (Batch/Lot number was not reported) at the age of 51 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline hydrochloride (DOXYCYCLIN) and experienced allergy. The patient previously received first dose of bnt162b2 on 09Mar2021 09:00 AM at the age of 51 years old for COVID-19 immunization (vaccine location: right arm). No other vaccines received within 4 weeks prior to COVID vaccine. On 05Apr2021 07:00, the patient experienced Palsy (palsey) on left side, watering of left eye and numbness on left side around mouth and cheek. No treatment was received for the adverse events. The patient recovered from all the events on unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.

Other Meds: WARFARIN

Current Illness:

ID: 1320135
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: nasopharyngeal congestion; ear popping; feverish feeling; night sweats; sob sensation; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; temperature instability 97-100F; joint pain; achy spine; heel cellulitis; paresthesias; This is a spontaneous report received from contactable physician ((patient) reported for herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Ek9231, expiry date not reported), intramuscular, administered in left arm on 29Dec2020 12:00 (age at vaccination as 47 years old) as first dose, single for COVID-19 immunization. The patient had no medical history and no known allergies. The patient was not pregnant at the time of vaccination and of the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN BAMBINI), zinc chloride, vitamin c (ascorbic acid), vitamin D, and zinc; all taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 08:00 AM, day 1, heel cellulitis and paresthesias started. On day 4, 02Jan2021, nasopharyngeal congestion, ear popping, feverish feeling, night sweats, sob sensation, "throbbing in face, nose, throat, chest, and head", temperature instability 97-100F. On an unknown date in 2021, patient had joint pain, headaches, achy spine for 4 months. Currently, patient was on treatment for heel cellulitis, and have been out of work since vaccine. Patient's symptoms have waxed and waned and still present. The reported events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events reported, which included antibiotics for several times. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, has the patient been tested for COVID-19 which included PCR (nasal swab) on 12Jan2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: The event cellulitis is likely intercurrent and is unrelated to suspect product BNT162B2.

Other Meds: AUGMENTIN BAMBINI; ZINC CHLORIDE; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; ZINC

Current Illness:

ID: 1320136
Sex: M
Age:
State:

Vax Date: 04/22/2021
Onset Date: 04/25/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: blood in my feces; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included asthma, hay fever, and allergies. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient stated that he had his second shot on Tuesday, 22Apr. The patient was okay on Wednesday, Thursday and Friday. On 25Apr2021, the patient had a bowel movement and had a quite a bit of blood in his feces. The patient stated that he has not had blood coming out of his rectum ever. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320137
Sex: M
Age:
State: IA

Vax Date: 03/29/2021
Onset Date: 04/07/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Then a sudden spike in my blood sugar. It was almost 600; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:00 (Batch/Lot Number: Er8727) (at 48 years old) as unknown, single for covid-19 immunisation. Medical history included Type 2 diabetes for about 10 years. But always well maintained. Concomitant medication included metformin. No problem the first 5-7 days. Then a sudden spike in patient's blood sugar. It was almost 600 on 07Apr2021 12:00. Treatment Received was IV and insulin. Patient visited Doctor and was brought to Emergency room/department or urgent care. Patient was hospitalized for 1 day. The outcome of the event was unknown. Prior to vaccination,the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: METFORMIN

Current Illness:

ID: 1320138
Sex: F
Age:
State: TX

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: fainting; Extreme fatigue; chills; headache; insomnia; elevated resting heart rate; nausea; brain fog; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, administered in right arm on 23Apr2021 08:15 as 2nd dose, single for COVID-19 immunization. The patient's medical history included allergic to chocolate. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), in the right arm on 02Apr2021 08:15 AM for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 was administered was clinic (Public Health Clinic/Veterans Administration facility). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme fatigue, chills, headache, insomnia, elevated resting heart rate, nausea, fainting, brain fog, all on 23Apr2021 at 13:00. These started about 5 hours after injection, worsened for about 35 hours, then improved over the next 48 hours. No treatment was received for the events. The outcome of the events were recovered on an unspecified date. Follow-up attempts are needed. Information about lot/batch number is available.

Other Meds:

Current Illness:

ID: 1320139
Sex: F
Age:
State: FL

Vax Date: 03/22/2021
Onset Date: 04/08/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Radial nerve damage to left arm and hand; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration in left arm, on an unspecified date, as second dose, single, for COVID-19 immunization. The patient's medical history included diabetes, irritable bowel syndrome (IBS), high cholesterol, and allergies to sulfur or sulfa. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EN6208) in Mar2021 (reported as 22Mar2021; pending clarification) at the age of 48 years for COVID-19 immunization (left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a public health clinic or Veterans administration facility. On 08Apr2021, the patient experienced radial nerve damage to left arm and hand and was hospitalized in 2021 for 3 days; event caused disability. The adverse event resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.; Sender's Comments: Based on limited information and temporal association a contributory role of BNT162B2 to the reported radial nerve damage cannot be totally excluded. Case will be reassessed if additional information is received. 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:

Current Illness:

ID: 1320140
Sex: M
Age:
State: OH

Vax Date: 04/20/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1320141
Sex: F
Age:
State: CA

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Fainting 14 hours after shot; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 29Apr2021 at 08:30 (batch/lot number: EW0173) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to penicillin. The patient was not pregnant. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 1st dose on 08Apr2021 at 09:30 (lot number: EW0158) administered in the right arm for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. No other vaccine in four weeks and no other medications in two weeks. The patient experienced fainting 14 hours after shot on 29Apr2021 at 23:15. No treatment was received for the adverse event. No Covid prior to vaccination. The patient was Covid tested post vaccination which included Covid test type nasal swab with unknown result on an unspecified date. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been received. Further information has been requested.

Other Meds:

Current Illness:

ID: 1320142
Sex: M
Age:
State: FL

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: had reactions to things I'm not allergic to; Vomit; issues with breathing; high fever; Chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Apr2021 10:00 (Batch/Lot Number: Ep7534) as 2nd dose, single for COVID-19 immunization. Medical history included egg allergy and anaphylactic reactions from an unknown date and unknown if ongoing. The patient previously took dose 1 of BNT162B2 in the left arm lot number: Er8732 on 09Apr2021 10:00 AM for COVID-19 immunization. Concomitant medications included amoxicillin taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021, at 2AM, the patient had high fever and chills lasted most of night. The patient stated that on 30Apr2021 12:00, "I have an egg allergy and occasionally have anaphylactic reactions when I have it. Strangely anytime I ate or drank anything for the day after my shot I had reactions to things I'm not allergic to. This manifested itself in needing to vomit then later it triggered issues with breathing and was quite concerning." The events resulted in doctor or healthcare professional office/clinic visit. The patient was treated with Prednisone. The outcome of the event was recovered on unspecified date. The events were serious per hospitalization on 30Apr2021 reported from health authority. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: AMOXICILLIN

Current Illness:

ID: 1320143
Sex: F
Age:
State: MI

Vax Date: 03/25/2021
Onset Date: 04/28/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Heavy bleeding including passing a blood clot with my first cycle after my second dose.; Heavy bleeding including passing a blood clot with my first cycle after my second dose.; This is a spontaneous report from a contactable consumer (reporting for herself). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 13:00 (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included etonogestrel (NEXPLANON); levothyroxine sodium (LEVOTHYROXIN); cetirizine hydrochloride (ZYRTEC ALLERGY); fluticasone propionate (FLONASE ALLERGY RELIEF), all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Left Arm on 04Mar2021 at 13:00 (Batch/Lot number: EN6206) for COVID-19 immunization. On 28Apr2021 at 14:30, the patient experienced heavy bleeding including passing a blood clot with her first cycle after my second dose. The have NEVER bleed like this except for when she was having a miscarriage or postpartum after giving birth to her daughters. She usually can go all day with the same pad and soaked through a pad and her underwear was completely bloody in 3 hours (it was so bad I discarded the underwear). When she got on the toilet it kept gushing out and that was when she passed a clot. After that the bleeding slowed down. The outcome of the events was unknown. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.

Other Meds: NEXPLANON; LEVOTHYROXIN; ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF

Current Illness:

ID: 1320144
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: I know someone that just had a miscarriage from it (Covid Vaccine); This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said: " I know someone that just had a miscarriage from it (Covid Vaccine)". The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320145
Sex: M
Age:
State: UT

Vax Date: 04/03/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Three weeks after my second shot, I developed Bells palsy, and virus attacked right side of my face; virus attacked right side of my face; This is a spontaneous report received from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 15:15 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included meniere's disease from Oct2020 to an unknown date. There was no known allergy. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on 13Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization and experienced vertigo. Three weeks after his second shot, the patient developed Bells palsy, and virus attacked right side of his face at 27Apr2021 07:30 AM. These events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. This event did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. Treatment for the events included Zaltrex - antivirus, Prednisone. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320146
Sex: F
Age:
State:

Vax Date: 04/27/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Posterior vitreous detachment; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in right arm on 27Apr2021 09:45 (Lot Number: ER2613) as single for COVID-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. The patient experienced posterior vitreous detachment on 30Apr2021 09:45 with outcome of not recovered. Event reported as non-serious. Therapeutic measures were taken as a result of event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient had doctor visit with many exams (unknown results). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1320147
Sex: F
Age:
State: FL

Vax Date: 03/27/2021
Onset Date: 04/13/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: She got admitted to the hospital for stroke like symptoms. The doctors diagnosed her with Bells Palsy. The doctors told her that the Bells Palsy was probably from the covid vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 34-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 between 9:00-10:00 (Lot Number: EP7534) as single dose for covid-19 immunisation at the age of 34-year-old. No additional vaccines administered on the same date. There is no medical history of patient and family and no concomitant medications. The patient got admitted to the hospital for stroke like symptoms. The doctors diagnosed her with bells palsy. The doctors told her that the bells palsy was probably from the covid vaccine. The event started on 13Apr2021 with outcome of recovering. The patient went to the emergency room and physician office for the event and was hospitalized for the event from 13Apr2021 to 15Apr2021. Everyone in the hospital did not know if she should get the second dose of the covid vaccine. She sucked it up and got the second dose of the covid vaccine on 17Apr2021(Lot number: ER8737) at about 10:30 in left arm.. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1320149
Sex: M
Age:
State: CT

Vax Date: 03/23/2021
Onset Date: 04/03/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Diagnosed with a blood clot; Diagnosed with stroke; not feeling well; wakes up at night; Numbness of left hand and mouth; Numbness of left hand and mouth; Constipation; severe headache, described as he felt his eyes were exploding out of his head.; Temperature of 100.2; Could not sleep; This is a spontaneous report from a contactable consumer (spouse reporting on behalf of husband). A 63-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing rheumatoid arthritis started few years ago, ongoing back pain (for many years), ongoing pain (for many years) (patient is a farmer 'seeing another doctor' for back pain/pain, testis cancer from 1986 and ongoing. Concomitant medication(s) included adalimumab (HUMIRA) taken for rheumatoid arthritis from an unspecified start date ' a few years ago.' and ongoing; tramadol (TRAMADOL) taken for back pain from an unspecified start date ' for years' and ongoing. Vaccine was not Administered at Military Facility. No other vaccines were given within 4 weeks. No additional vaccines were administered on the same date of the Pfizer suspect product. The patient experienced diagnosed with a blood clot, diagnosed with stroke, numbness of left hand and mouth on 12Apr2021, severe headache, described as he felt his eyes were exploding out of his head, temperature of 100.2 (in the evening.) , could not sleep on 03Apr2021, constipation on 05Apr2021, not feeling well and wakes up at night on an unspecified date. The patient was hospitalized for stroke and blood clot from 12Apr2021 to 14Apr2021. The patient underwent lab tests and procedures which included body temperature increased: 100.2 on 03Apr2021; computerized tomogram: first cat scan, a blood clot was diagnosed on unspecified date., computerised tomogram head: unknown result on an unspecified date, electrocardiogram: unknown results (husband was not having a heart attack) on 12Apr2021 , laboratory test: unknown results an unknown date , sars-cov-2 test: negative on 12Apr2021, computerised tomogram: negative on an unspecified date. Treatment was given thrombosis, Stroke, Headache, Insomnia. On an unspecified date patient contacted his primary care doctor and was told to take some extra Motrin, twice a day but Motrin was not effective for his headache. The patient was not feeling well he went to his primary care doctor. Caller states her husband was at his doctor on 07Apr2021, and he went to radiology for a Cat Scan on an unspecified date and the results was negative. He had lab work drawn and a CT of the head. Her husband was given a medication to help him sleep, medication not specified. Caller mentioned she rescheduled her husband's second vaccine. On 12Apr2021, in the evening when he was getting out of the shower, he developed numbness in his left hand, and added later in the report, numbness of his mouth. Patient went to the emergency room, where they performed several tests, Multiple Cat Scans. Results of the first Cat Scan, a blood clot was diagnosed, and an EKG because they thought he may be having a heart attack but it was confirmed he was not having a heart attack.. When her husband was in the emergency room, they did a Covid test and it was negative. The patient was diagnosed with a blood clot and got Tissue plasminogen activator. At 7:33 pm, when he was given tissue plasminogen activator. After the treatment, the headache went away, but she is not sure if he has lasting effects. He was admitted to the Intensive Care Unit and was in the hospital for two days and diagnosed with a stroke, but he was able to walk out of the hospital. The patient still gets an ache in his head, and it comes and goes. Caller states it seems that these events were not coincidental, as they all happened after he got the vaccine. Since her husband has been home from the hospital, he is sleeping better but normally does not get a full night of sleep, and he usually wakes up at night and husband gets constipated when he takes Motrin. Caller mentioned that her husband is not fully constipated anymore, but he feels that his system is not back to normal. Caller assumed the stroke has cleared up, but is not sure. Caller rescheduled her husband's second vaccine, and she is not sure her husband should get the second vaccine. Caller states if these events were caused from the Covid vaccine, what will happen in the future? The clinical outcome of the events Clot blood, Stroke, malaise and wakes up at night was unknown; Numbness of left hand and mouth was recovered on 12Apr2021, Fever was recovered on 04Apr2021, while headache and Constipation was recovering. Follow up attempts are needed. Further information has been requested.

Other Meds: HUMIRA; TRAMADOL

Current Illness: Back pain (back pain and other pain for many years., as he is a farmer seeing another doctor); Pain (back pain and other pain for many years., as he is a farmer seeing another doctor); Rheumatoid arthritis; Testicular cancer

ID: 1320150
Sex: F
Age:
State: NJ

Vax Date: 04/06/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; This is a spontaneous report from a contactable consumer (patient daughter). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after. The patient was due for their second doses, tomorrow (on 30Apr2021), but her quarantine will not be over by her. Event outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320151
Sex: F
Age:
State: MS

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Pain in heart area; Can't walk or get out of bed; Headache; Fingers hurt; Occasional tight band around chest; Severe muscle pain throughout the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 29Apr2021 (at the age of 74 years old) (Lot Number: EN727, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included penicillin allergy and diagnosed with COVID-19 (prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient's concomitant medications were not reported. The patient previously took codeine and experienced codeine allergy. The patient experienced can't walk or get out of bed, headache, fingers hurt, severe muscle pain throughout the body, occasional tight band around chest, and sometimes pain in heart area on 30Apr2021. The patient did not received treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient had not yet recovered from the events. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1320152
Sex: F
Age:
State: TX

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1320153
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Transverse Myelitis; had no feeling in his feet or left leg; Severe back pain; This is a spontaneous report from contactable consumers. A 33-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously healthy and athletic. Three days after receiving the vaccine the patient reported severe back pain, and 2 days after the back pain started he had no feeling in his feet or left leg. The staff at the hospital believe his condition is transverse myelitis, and told the family there are no reported cases of this being caused by the Pfizer covid vaccine, but the family would like more information from Pfizer. The patient was hospitalized for the event transverse myelitis on unspecified date. The outcome of the events was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320154
Sex: M
Age:
State: CA

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: transient heart arrhythmia usually lasting 5-15 seconds.; pronounced exhaustion; occasional mild headaches; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 26Apr2021 17:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient medical history included insomnia. The patient had no known allergies. Concomitant medication included mirtazapine taken as sleep aid. The patient previously received the first dose of BNT162B2 (Lot Number: ER8734) administered in left arm on 05Apr2021 18:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 19:00, the patient experienced pronounced exhaustion, occasional mild headaches, and a transient heart arrhythmia usually lasting 5-15 seconds. These symptoms have not subsided, and the arrhythmia became persistent enough last night that it required a trip to the local ER. The consistent heart palpitations which ultimately brought him into the ER. The patient was referred to a local cardiologist and was told not to worry about the arrhythmia, that it would clear up in a few days. The reported events resulted in Emergency room/department or urgent care. There was no treatment received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Other Meds: MIRTAZAPINE

Current Illness:

ID: 1320155
Sex: F
Age:
State: CA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: passed out; sweating; turned blue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0173, expiry date not reported) via an unspecified route of administration, administered in left arm on 01May2021 18:00 (at the age of 24 years old) as first dose, single for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. On 01May2021 18:00, patient immediately started sweating after getting the shot then passed out within a couple minutes. Pharmacist told the patient that she turned blue and they injected her with Epipen. Patient woke up after and felt fine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious medically significant. Since the vaccination, the patient was not tested for COVID-19. The patient recovered from the events reported on an unspecified date in May2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events loss of consciousness, hyperhidrosis and skin discolouration cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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:

Current Illness:

ID: 1320156
Sex: F
Age:
State: TX

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: extreme dizziness to passing out stage when standing; numbness in arms; sweats; chills; fever; severe headache; extreme dizziness to passing out stage when standing; loose stools; joint pain in the arm where she received the shot; Mild fatigue for 2 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 16Apr2021 10:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation. Medical history included cortical basal degeneration and allergies. Patient was not pregnant. No other vaccines were received in four weeks. Unspecified concomitant medications were received in two weeks. 15 days after injection on 01May2021 08:00, patient had numbness in arms, sweats, chills, fever, severe headache, body pain, extreme dizziness to passing out stage when standing and loose stools. The eve of injection on 16Apr2021, patient had joint pain in the arm where she received the shot, but no other issues other than mild fatigue for 2 days. No treatment was received for the events. Outcome of the event of fatigue was recovered on 18Apr2021 while for the remaining events was not recovered. Patient was diagnosed with covid prior to vaccination and had not been tested post-vaccination. The reporter considered the events non-serious. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1320157
Sex: M
Age:
State: NY

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 30Apr2021 15:00 as 1st dose, single for COVID-19 immunization. Medical history included amoxicillin allergy. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced difficulty breathing, feverish on 01May2021 23:00. The events resulted in emergency room/department or urgent care visit. The patient was hospitalized due to the events. Therapeutic measures were taken as a result of the events and included treatment with prednisone 20 mg for 5 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Seriousness of the events was reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1320158
Sex: F
Age:
State: CA

Vax Date: 02/14/2021
Onset Date: 02/16/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: terrible muscle/joint pain; terrible muscle/joint pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: 9266), via an unspecified route of administration, administered in the left arm on 14Feb2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included ongoing lung cancer and known allergy to lobster and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 25Jan2021 on the left arm for COVID-19 immunization. On 16Feb2021 at 03:00 the patient had terrible muscle/joint pain since the second dose of the vaccine. It gets worse everyday. The event caused a doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. The events were reported with a seriousness of disability.

Other Meds:

Current Illness: Lung cancer (lung cancer)

ID: 1320159
Sex: F
Age:
State: MI

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: fainted; low blood pressure; fever; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01May2021 (Batch/Lot Number: Unknown) as 2nd dose, single dose (at the age of 28-years-old) for COVID-19 immunization. Medical history was not reported. The patient did not have concomitant medications: the patient did not have any other medications the patient received within 2 weeks of vaccination. The patient received the first dose of 12Apr2021 BNT162B2 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. On 02May2021, around 24 hours after receiving the second shot of COVID vaccine the patient fainted due to fever and low blood pressure. The patient required emergency room/department or urgent care. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. 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: 1320160
Sex: M
Age:
State: FL

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Sore joints; his butt is still a little sore from falling; dizziness/ light headed; fainting; pain in upper abdomen area; Sweating; Nausea; falling; This is spontaneous report from a contactable consumer (patient). A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Apr2021 at 1 pm (around 12:20ish as reported) (Lot Number: FN6206) (at 23-year-old) at single dose in arm right for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations within 4 weeks, no family medical history relevant to AEs. The patient stated he is a pretty healthy guy. All day after getting the vaccine he was fine. He got the shot at like 1 came home took a nap, ate some dinner, and was playing XBOX with the boys when this happened. At around 10:30 pm on 29Apr2021 he went to rub, his stomach just above his belly button and it hurt. He said that he read on line that that area is called the pancreas or liver, it has a lot of names for that area when looking online. He stated it's the left upper abdomen area he felt pain when he pressed on it. It radiated really fast across his abdomen while he was on the phone with mother. The more he pressed the more the pain got sharper, and it radiated right across the abdomen, mainly above belly button not too much in lower abdomen, not much in upper abdomen. It was very sensitive. He didn't have to press hard to trigger the pain. It was almost like the area was inflamed. It happened really fast and that it was his upper stomach not so much the lower part of his abdomen. He felt dizziness and nauseous and like a silly boy he tried to run to the bathroom. He stated that he fell and fainted. His butt was still a little sore from falling. He said when he woke up, he was sweating like he had been out side all day. He did not recall sweating any time he fainted in the past. The side effects were gone after about ten minutes. He was really light headed and had the crazy sharp pain in abdomen for about ten minutes and then it was gone. He had never had that kind of pain. He was laying on the floor for a couple minutes. He went to get his phone, and then sat back down and was sweating. He still had pain at that time but it only lasted about 10 minutes at most. He was still a little bit sore in some joints which was not unexpected. He confirmed that he had a little bit of sweating, and he fainted a little bit. Since the episode he hasn't felt any symptoms like that before, he has not had any pain like gastritis but he has had some random gastrointestinal things before. It's also reported nausea on 29Apr2021. No required to emergency room and physician office. He was on the verge of going to the ER while the pain was there. He was going to go until it stopped and to get checked out. No relevant test. The outcome of the events sore joints, dizziness and butt sore was unknown; for other events was resolved on 29Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1320161
Sex: U
Age:
State: IA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Diarrhea; first dose on 17Feb2021/second dose on 03Mar2021; first dose on 17Feb2021/second dose on 03Mar2021; This is a spontaneous report from a contactable consumer (patient). A 69-year-old patient of unspecified gender received 2 nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at right arm at the age of 69 years old on 03Mar2021 as single dose for COVID-19 immunization. The patient medical history included headache. Concomitant medications included ibuprofen taken for headache, start date reported as'20 years, 30 years before, not confirmed, actually 40 year before when Ibuprofen 1st came out' and Multivitamins took it regularly one tablet per day from many years, all life (as reported). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 (at 69 years old) in right forearm near the shoulder for covid-19 immunization with no adverse event. The patient experienced a little small amount of diarrhea on 04Mar2021 on the following day of the 2nd dose but otherwise was pretty good. No investigation assessment. No treatment received. Diarrhea was gone in couple of days. The outcome of the event diarrhea was recovered on unknown date in 2021. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds: IBUPROFEN

Current Illness:

ID: 1320162
Sex: F
Age:
State: TX

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 26Apr2021 11:30 at age of 21 years old as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on 26Apr2021. The patient underwent lab tests and procedures which included test for COVID-19: negative (nasal swab) on 26Apr2021. The outcome of the event was resolving. The report was reported as non-serious. The event had not being prolonged hospitalization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1320163
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date: 04/18/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: abducens nerve palsy right eye and fever; fever; This is a spontaneous report from a non-contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient experienced abducens nerve palsy right eye and fever on 18Apr2021. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event abducens nerve palsy right eye cannot be totally excluded. 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:

Current Illness:

ID: 1320165
Sex: M
Age:
State: NY

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: ENALAPRIL

Current Illness:

ID: 1320166
Sex: F
Age:
State: IN

Vax Date: 04/26/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Have some kind of bleeding issue I am on warfarin; Hard of hearing; leg started swelling a week; Eye pain, they hurt; Low grade fever with a 100; chills; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: EW0161) as 2nd dose, single for COVID-19 immunization; warfarin, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose for bleeding issue. Concomitant medication included simvastatin; and furosemide (LASIX) taken for an unspecified indication from 26Apr2021 to an unspecified stop date. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose on 25Mar2021 (lot number: EN6199) for COVID-19 immunization and experienced leg swelling and hard of hearing. The patient mentioned she was hard of hearing. The patient had a reaction to both of the Pfizer shots. Her second one was on the 26Apr2021, her first one was on 25Mar2021. Her leg started swelling a week after and on 26Apr2021, she had her second and the same evening she started having eye pain, it's just they hurt, there was no redness, no swelling, no visual problems, they just hurt and they still hurt. And that night, she had low grade fever with a 100, chills and that lasted about, the fever and chills lasted about 10 hours but the eye pain was still there, it's just eye pain, no vision changes, no redness nothing it's just eye pain. She mentioned she was not tired or stressed, it was just there. The patient also reported that she had some kind of bleeding issue and she was on warfarin. The outcome of the event eye pain was not recovered, fever and chills was recovered while other events was unknown. The event bleeding issue was assessed as serious- medically significant.

Other Meds: SIMVASTATIN; LASIX [FUROSEMIDE]

Current Illness:

ID: 1320167
Sex: F
Age:
State: MA

Vax Date: 04/24/2021
Onset Date: 04/28/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Arm was very sore; Muscle ache throughout my body; Headache; Sore throat; Swelling mouth; ulcer on tongue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 09:30 (at 39 years old, not pregnant) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient used nickel on an unspecified date. First dose received Saturday 24Apr2021 on left arm, next day (all events also reported started 28Apr2021) arm was very sore and muscle ache throughout my body and headache. Couple days later sore throat and swelling mouth and ulcer on tongue. Adverse events result in Emergency room/department or urgent care. Treatment received for the adverse event wasUrgent care and Rx. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, nasal swab on 29Apr2021, negative results, nasal swab on 01May2021, unknown results. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320168
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: His arm hurt; A little tired; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had zero issues, his arm hurt. The patient was fine, nothing happened to him, he had nothing, he was a little tired and his arm hurt. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320169
Sex: M
Age:
State:

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Had 2 episodes of syncope; Shortness of breath; weakness; Fatigue; 80% O2 saturation on RA; Heart rate up to 180; Rash on his abdomen appeared; This is a spontaneous report received from a non-contactable pharmacist. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscularly administered in left arm on 29Apr2021 08:45 (Batch/Lot Number: EW0172) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. On an unspecified date, prior to vaccination, the patient was diagnosed with COVID-19, unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. He had previously received the first dose of BNT162b2 on 08Apr2021 08:00 (Batch/lot number: EWP0158) (age at vaccination: 39 years old) as single dose for COVID-19 immunisation. Concomitant medication(s) included albuterol (ALBUTEROL) inhaler, naproxen (NAPROXEN) and calcium carbonate (CALCIUM CARBONATE), taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, the patient developed shortness of breath, weakness, fatigue hours after administration of the vaccine. He had 2 episodes of syncope, 80% O2 saturation on room air (RA), heart rate up to 180. Rash on his abdomen appeared. The adverse events resulted in emergency room/department or urgent care. The patient was admitted to the hospital on an unspecified date in Apr2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 cannot be excluded. 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: ALBUTEROL [SALBUTAMOL]; NAPROXEN; CALCIUM CARBONATE

Current Illness:

ID: 1320170
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: seizure like movements; passed out; dizzy; nausea; This is a spontaneous report from a non-contactable healthcare professional (HCP). A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (age at vaccination: 19 years old) (Batch/Lot Number: ew0167) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient experienced dizzy, nausea, passed out, seizure like movements on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1320171
Sex: F
Age:
State: NJ

Vax Date: 03/12/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Bell's palsy; After second shot, 102 fever for 76 hours; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) via an unspecified route of administration on 12Mar2021 (36-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history was reported as the patient did not test positive for COVID, but did have a respiratory illness preceding the bell's palsy. Known allergies: sulfa and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination was reported as none. The patient was not pregnant at time of vaccination. The patient experienced adverse events after second shot, was reported as 102 fever for 76 hours, vomiting and diarrhea; all with onset date in 2021. On 30Apr2021, the patient was diagnosed with bell's palsy in emergency room. She was not sure that they were related, just reporting for your tracking purposes. The adverse event result in emergency room/department or urgent care. Treatment received for the adverse event included steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1320172
Sex: F
Age:
State: SC

Vax Date: 04/14/2021
Onset Date: 04/24/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Blood clot; Random bruise on knuckle; Joint pain; Rash; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 14Apr2021 at 04:00 PM at age of 57-year-old at single dose, unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and at time of events onset. Medical history included known allergies (unspecified). Compound heft (pending clarification) was reported as other medical history. Prior to vaccination, it was unknown if patient was diagnosed with COVID-19. Since the vaccination, the patient wasn't tested for COVID-19. Concomitant medications included supplements in two weeks. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had rash on day 10 on 24Apr2021 at 03:00 PM, joint pain on day 11 (25Apr2021), day 12 (26Apr2021), day 13 (27Apr2021) and a blood clot and random bruise on knuckle on day 14 (28Apr2021). Events didn't result in emergency room visit or physician office visit. No treatment received for the events. Outcome of events was recovering. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1320173
Sex: F
Age:
State: NY

Vax Date: 04/22/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: her chest didn't feel normal/ she had shooting "things" in her chest, and she felt weird; really bad chest pain; when the chest pain first started, she couldn't move or breath; when the chest pain first started, she couldn't move or breath; she had shooting pains in her left breast area. She said after an hour, the shooting pains moved from her left breast area to the center of her chest; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0169, expiration date unknown) via an unspecified route of administration at arm left on 22Apr2021 between 07:00-07:30 at age of 37-year-old at single dose for COVID-19 immunization. Medical history was reported as none. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The events required a visit to emergency room. Physician Office visit was not required. There was no prior vaccinations (within 4 weeks). Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), paracetamol (TYLENOL 8 HOUR). Patient had her first COVID-19 Vaccine dose one week and one day ago on 22Apr2021. She said she was rushed to the hospital last night on 29Apr2021 (at around 11:00 PM) because she thought she was having a heart attack. She said she had really bad chest pain that lasted about 30 minutes. She clarified when the chest pain first started, she couldn't move or breath. She said she took an aspirin before she went to the hospital. She said she still had a shooting pain in her chest, today on 30Apr2021. She said she wanted to know what was going on. She said while she was at the hospital (Emergency Room), she had blood work done on 29Apr2021, and she had no blood clots. She said she had a (chest) x-ray done on 29Apr2021, and the (chest) x-ray was fine. She said her heart was monitored, and her heart was fine, but her left chest still had pain. She said she was a healthy 37 year old, who had no types of problems. She said the only thing she had recently was the COVID-19 Vaccine. She said she wanted to know if she should get the second COVID-19 Vaccine, or if the second COVID-19 Vaccine would kill her. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. Patient reported she liked to Google, and was not sure if anybody had called Pfizer to go and report if they experienced chest pain after getting the COVID-19 Vaccine. She said she was not sure if the hospital was going to report what happened to her. She said she asked the (emergency room) doctor last night about people experiencing chest pain after getting the COVID-19 Vaccine. She said the doctor told her people with COVID complain about chest pain. She said what the doctor said didn't mean anything because he was talking about the COVID-19 Virus, and not the COVID-19 Vaccine. She stated she took 1 Bayer brand Aspirin 81mg (Lot Number: N8A94D0 or O, Expiration Date: Sep2022) before she went to the hospital for chest pain. She stated the hospital gave her Ketorolac to treat her chest pain. She said the Ketorolac was given to her in an IV form through an IV access in her arm. She said she did not have the Ketorolac dose, NDC, Lot, and Expiration Date. She reported that on 29Apr2021, the hospital took some urine and blood tests, a chest x-ray, and an EKG which was normal. She said beside the Ketorolac that was all the hospital (emergency room) did. Patient reported she took Tylenol 500mg caplet (Lot Number: AAA103, Expiration Date: Sep2024) if she had a headache, but usually didn't take medication. Reported while waiting for the doctor to see her at the hospital (emergency room) on 29Apr2021, she had chest pain for about 5-10 minutes. She said the chest pain calmed down, but she had shooting pains in her left breast area. She said after an hour, the shooting pain moved from her left breast area to the center of her chest. She said the chest pain was not as bad today (30Apr2021), as it was last night. She said her chest didn't feel normal on 30Apr2021, and she still had the shooting pains. She said after she had been talking with the Pfizer agent, she had shooting "things" in her chest, and she felt weird. No further details provided. Events were serious as hospitalized. Outcome of chest pain was recovering, of the other events was unknown. Communication: The caller was provided with phone number of option 3, and hours of operation of Monday through Friday, 8AM to 8PM ET & Saturday and Sunday 9AM-3PM, prior to warm transfer Follow-up attempts are needed. Further information is expected.

Other Meds: ASPIRIN (E.C.); TYLENOL 8 HOUR

Current Illness:

ID: 1320174
Sex: M
Age:
State: NE

Vax Date: 01/11/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Bells Palsy; Facial numbness and drooping left side. Eye, cheek, lips.; This is a spontaneous report from a contactable nurse. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 15:00 (Batch/Lot Number: EK4176) as 2nd dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 15:30 in the left arm (lot number: EH9899). The patient did not receive any other vaccines within 4 weeks prior the COVID vaccine. The patient experienced Facial numbness and drooping left side. Eye, cheek, lips; had Bells Palsy on 30Apr2021 11:00 which resulted a visit in the emergency room or urgent care. Steroids and acyclovir were taken as treatment for the events. The patient was not diagnosed with COVID prior vaccination and has not been tested after vaccination. The outcome of the event was unknown. The event Bells Palsy was assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 the Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm