chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: patient died of complications of pneumonia related to COVID-19; patient died of complications of pneumonia related to COVID-19; This is a spontaneous report from a contactable consumer.  A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Jan2021 at 13:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization.  Medical history included melanoma, chronic obstructive pulmonary disease, diabetes mellitus, and diminished kidney function; all from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was vaccinated on 06Jan2021 during an existing hospitalization. On 22Jan2021, the patient developed pneumonia related to COVID-19. The patient did not receive any treatment. On 03Feb2021, the patient died of complications of pneumonia related to COVID-19. It was not reported if an autopsy was performed. The events were serious for hospitalization prolongation, being life-threatening and death.       The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: patient died of complications of pneumonia related to COVID-19
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Urinary tract infection
Clinical narrative: UTI; Blood in urine; This is a spontaneous report from a contactable Pharmacist. This reporter reported 2 reports for similar event; this is the second of 2 reports. A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced urinary tract infection (UTI) and blood in urine on an unspecified date. Seriousness for events was hospitalization. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the known properties and safety profile of suspect product, there is no evidence or argument to suggest a causal relationship between the events 'urinary tract infection' and 'blood in urine' and the vaccine bnt162b2.  Events most likely represent intercurrent medical conditions. This case will be re-assessed 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.,Linked Report(s) : US-PFIZER INC-2021130811 same reporter/drug, different patient;US-PFIZER INC-2021130811 same reporter/drug, different patient, similar event
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: fainting; Fatigue; dizziness/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); nausea/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); hot flashes/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); chills; loss of appetite; unable to focus; sleep disturbance (wake up with hot, dizzy, nauseous every few hours); This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#EL9269), via an unspecified route of administration in left arm from 02Feb2021 14:00 at first single dose for Covid vaccine. Medical history included known allergies: Oak trees, kiwi. Concomitant medication in two weeks included hydroxyzine hydrochloride (ATARAX), sertraline hydrochloride (ZOLOFT). No other vaccine was received in four weeks. The patient experienced fatigue, dizziness, nausea, hot flashes, chills, fainting, loss of appetite, unable to focus, sleep disturbance (wake up with hot, dizzy, nauseous every few hours). Adverse event start date: 03Feb2021 02:00 AM. AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received for the events. No covid prior vaccination. Covid was tested post vaccination: nasal swab on 05Feb2021: negative. Symptoms lasting 6 days and counting. Outcome of the events was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, SARS-CoV-2 test, Sleep disorder, Syncope
Clinical narrative: fainting; Fatigue; dizziness/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); nausea/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); hot flashes/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); chills; loss of appetite; unable to focus; sleep disturbance (wake up with hot, dizzy, nauseous every few hours); This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#EL9269), via an unspecified route of administration in left arm from 02Feb2021 14:00 at first single dose for Covid vaccine. Medical history included known allergies: Oak trees, kiwi. Concomitant medication in two weeks included hydroxyzine hydrochloride (ATARAX), sertraline hydrochloride (ZOLOFT). No other vaccine was received in four weeks. The patient experienced fatigue, dizziness, nausea, hot flashes, chills, fainting, loss of appetite, unable to focus, sleep disturbance (wake up with hot, dizzy, nauseous every few hours). Adverse event start date: 03Feb2021 02:00 AM. AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received for the events. No covid prior vaccination. Covid was tested post vaccination: nasal swab on 05Feb2021: negative. Symptoms lasting 6 days and counting. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Syncope
Clinical narrative: Vasovagal syncopal event; This is a spontaneous report from a non-contactable consumer reporting for a patient. A 31-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. Medical history included anxiety, breast feeding, from an unknown date and unknown if ongoing. No current illness; no known allergies. Concomitant medication included norethindrone (NORETHINDRONE), sertraline (SERTRALINE), ascorbic acid/betacarotene/calcium carbonate/colecalciferol/docosahexaenoic acid/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine mononitrate/tocopheryl acetate/vitamin b12 nos/zinc oxide (PRENATAL MULTIVITAMIN + DHA). The patient experienced vasovagal syncopal event on 23Dec2020. The event was considered non-serious by the reporter, and visit to emergency room and physician office was required. Her blood pressure was 79/54 on 23Dec2020 after the event.  The vasovagal syncopal event was resolved on an unspecified date.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Loss of consciousness, Pruritus, SARS-CoV-2 test, Visual impairment
Clinical narrative: suspect anaphylaxis; passed out while driving.; entire body itching; vision issue; This is a spontaneous report from a contactable physician. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular Right arm on 22Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included diabetes mellitus (DM), hypertension (HTN), hypercholesterolaemia. No other vaccine in four weeks. There were other medications in two weeks. No covid prior vaccination. Clinical course reported as: Patient got vaccine with no issues. 36 hours later he developed entire body itching. He then developed vision issues and passed out while driving. He was hospitalized and no cardiac or neurologic issues were found. The reporting physician suspected anaphylaxis since patient had severe itching with the event. There were no other likely triggers found during history other than the vaccine. Events onset date reported as 23Jan2021. Events resulted in Emergency Room Visit and Physician Office Visit. Covid test type post vaccination: Nasal Swab on 06Feb2021 result: Negative. Treatment received for the events. Outcome of events was Recovered/Resolved with Sequel.   Information on the lot/batch number has been requested.; Sender's Comments: A causal relationship between the events suspect anaphylaxis, passed out while driving, entire body itching, and vision issue and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 71-year-old male patient. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Erythema, Feeling hot, Red ear syndrome
Clinical narrative: Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red face and ears all day; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at single dose in right arm for covid-19 immunisation at the age of 44-year-old. Lot number was Ez9264. Medical history included asthma, interstitial cystitis, allergy to peanuts. The patient experienced anaphylactic reaction with GADAVIST. Concomitant medications were unknown. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 04:30 in right arm at the age of 44-year-old for Covid-19 immunisation (lot number was Gl3249). The patient was not pregnant. On 03Feb2021 at 07:15, the patient experienced extreme heat in face that lasted 2 minutes. Red face and ears all day but no more extreme heat. On 06Feb2021, Bell's palsy on right hand side of face occurred. The patient was not treated for the events. The patient did not recover from the events. Patient was not covid tested post vaccination; patient did not have covid prior vaccination.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Weight
Clinical narrative: Congestive heart failure; This is a spontaneous report from a contactable consumer or other non hcp.  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 18Jan2021 for covid-19 immunisation. Age at vaccination was 72-year-old. Medical history included ongoing cardiac disorder (for years). The patient's concomitant medications were not reported. He was having trouble breathing and his face and stomach just kept getting bigger, so they admitted him for congestive heart failure, onset date 06Feb2021. The patient was hospitalized from 06Feb2021. He lost 13 pounds since they removed fluid from him in the hospital. The event outcome was unknown.  Information on the lot/batch number has been requested
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral 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.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, SARS-CoV-2 test, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: I was positive for the virus; UTI; This is a spontaneous report from a Pfizer-sponsored program, . A contactable consumer (patient) reported that a 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL8982; expiry: May2021), intramuscular on the left arm on 26Jan2021 (at the age of 70years) at single dose for covid-19 immunization. Medical history included high blood pressure and diabetic. Concomitant medications were unspecified. The patient was hospitalized on 04Feb2021 for a UTI and when she got into the hospital and they did the testing and they found that she was positive for the virus (in Feb2021). The patient was released on 06Feb2021 and she haven't had anything wrong, nothing and doctors were really surprised. When she was in the hospital, it was done on 04Feb2021 to the 06Feb2021, and every day, they took blood work for two days. The patient had her first vaccine on 26Jan2021 and due for her second vaccine tomorrow. She was wondering if she should go and get her next vaccine because she really wanted to, and her quarantine was up to Thursday. The patient was out of quarantine on 16Feb2021. The outcome of the events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: I was positive for the virus; UTI; This is a spontaneous report from a Pfizer-sponsored program, . A contactable consumer (patient) reported that a 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL8982; expiry: May2021), intramuscular on the left arm on 26Jan2021 (at the age of 70years) at single dose for covid-19 immunization. Medical history included high blood pressure and diabetic. Concomitant medications were unspecified. The patient was hospitalized on 04Feb2021 for a UTI and when she got into the hospital and they did the testing and they found that she was positive for the virus (in Feb2021). The patient was released on 06Feb2021 and she haven't had anything wrong, nothing and doctors were really surprised. When she was in the hospital, it was done on 04Feb2021 to the 06Feb2021, and every day, they took blood work for two days. The patient had her first vaccine on 26Jan2021 and due for her second vaccine tomorrow. She was wondering if she should go and get her next vaccine because she really wanted to, and her quarantine was up to Thursday. The patient was out of quarantine on 16Feb2021. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Balance disorder, Dizziness, Ear discomfort
Clinical narrative: extreme weakness; constantly feeling that she was going to pass out; constant ringing in ears; balance issues; massive dizzy spells; can't function normally; anxiety; fullness in inner ear; A spontaneous report was received from a consumer concerning a 52-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally.  The patient's medical history, as provided by the reporter, includes low Vitamin D levels Sarcoidosis.  Concomitant medication use includes Vitamin D supplements.  On 29-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A ) in the left arm for prophylaxis of COVID-19 infection.  Patient reported that after receiving the shot, she began having balance issues, dizzy spells and was extremely weak.  She stated that she constantly felt like she was going to pass out.  Additionally, she endorsed a constant ringing in her ears as well as a feeling of fullness in her inner ear.  She reported that she was unable to function normally.  Patient stated that she was hospitalized from 08-Feb-2021 through 11-Feb-2021.  She reported multiple tests were performed including an MRI (with and without contrast) that was negative. Patient complained of new onset anxiety following all of these events.   Treatment included discharge prescriptions for promethazine and alprazolam.    Action taken with mRNA-1273 in response to the events, balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally, was not reported.    The outcome of events, balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally, were unknown .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Magnetic resonance imaging, Presyncope, Tinnitus
Clinical narrative: extreme weakness; constantly feeling that she was going to pass out; constant ringing in ears; balance issues; massive dizzy spells; can't function normally; anxiety; fullness in inner ear; A spontaneous report was received from a consumer concerning a 52-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally.  The patient's medical history, as provided by the reporter, includes low Vitamin D levels Sarcoidosis.  Concomitant medication use includes Vitamin D supplements.  On 29-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A ) in the left arm for prophylaxis of COVID-19 infection.  Patient reported that after receiving the shot, she began having balance issues, dizzy spells and was extremely weak.  She stated that she constantly felt like she was going to pass out.  Additionally, she endorsed a constant ringing in her ears as well as a feeling of fullness in her inner ear.  She reported that she was unable to function normally.  Patient stated that she was hospitalized from 08-Feb-2021 through 11-Feb-2021.  She reported multiple tests were performed including an MRI (with and without contrast) that was negative. Patient complained of new onset anxiety following all of these events.   Treatment included discharge prescriptions for promethazine and alprazolam.    Action taken with mRNA-1273 in response to the events, balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally, was not reported.    The outcome of events, balance issues, massive dizzy spells, extreme weakness, constantly feeling that she was going to pass out, constant ringing in her ears, a feeling of fullness in her inner ear and cannot function normally, were unknown .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaccination site pain
Clinical narrative: Developed a Urinary Tract Infection; little soreness at the injection site; A spontaneous report  was received from a consumer, a 64-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed urinary tract infection and little soreness at the injection site/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed urinary tract infection after the vaccine and she was prone to get urinary tract infection. The patient went to the doctor and received antibiotics. The patient also had little soreness at the injection site on an unknown date.  Treatment for the event of urinary tract infection included cefuroxime axetil.  The action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, developed urinary tract infection and little soreness at the injection site were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Patient being prone to develop urinary tract infection was considered a confounder for the event of urinary tract infection.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Blackout and Had to go to Bed; Red From Shoulder to elbow; Intense itching From Shoulder to elbow; Mild Chills; Hard to the Touch; Swollen Injection Site.; Injection Site was Very Red (Golf Ball Size); Intense Itching 2-4" across on injection site; Muscle pain; A spontaneous report was received from a consumer concerning a 72-year-old female patients, who received Moderna's Covid 19 vaccine(mRNA1273) experienced muscle pain, itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site, mild chills, started blackout, itching and redness from shoulder to elbow.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 17 Feb 2021, prior to the onset of the symptom, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, approximately 2 hours prior to the onset of symptoms, the patient received second of two planned doses of mRNA-1273 (Batch Number: 41L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced muscle pain. On 19 Feb 2021, after two hours of vaccination, the patient experienced intense itching 2-4" across on injection site. Eight hours post second shot patient's injection site was very red (Golf Ball Size), hard to the touch and swollen. 25 hours after the injection patient developed mild chills followed by blackout and had to go bed, intense itching and redness from shoulder to elbow.   Treatment for the event included Hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events mild chills, started blackout, intense itching and was reported recovering. The outcome of the events itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site was reported recovered. The outcome of the events muscle pain, itching and redness from shoulder to elbow was not reported.; Reporter's Comments: Based on the information provided which includes a strong temporal association, and the known safety profile of the  mRNA-1273  vaccine, a causal association between the reported events and the administration of vaccine cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Loss of consciousness, Myalgia, Pruritus
Clinical narrative: Blackout and Had to go to Bed; Red From Shoulder to elbow; Intense itching From Shoulder to elbow; Mild Chills; Hard to the Touch; Swollen Injection Site.; Injection Site was Very Red (Golf Ball Size); Intense Itching 2-4" across on injection site; Muscle pain; A spontaneous report was received from a consumer concerning a 72-year-old female patients, who received Moderna's Covid 19 vaccine(mRNA1273) experienced muscle pain, itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site, mild chills, started blackout, itching and redness from shoulder to elbow.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 17 Feb 2021, prior to the onset of the symptom, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, approximately 2 hours prior to the onset of symptoms, the patient received second of two planned doses of mRNA-1273 (Batch Number: 41L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced muscle pain. On 19 Feb 2021, after two hours of vaccination, the patient experienced intense itching 2-4" across on injection site. Eight hours post second shot patient's injection site was very red (Golf Ball Size), hard to the touch and swollen. 25 hours after the injection patient developed mild chills followed by blackout and had to go bed, intense itching and redness from shoulder to elbow.   Treatment for the event included Hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events mild chills, started blackout, intense itching and was reported recovering. The outcome of the events itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site was reported recovered. The outcome of the events muscle pain, itching and redness from shoulder to elbow was not reported.; Reporter's Comments: Based on the information provided which includes a strong temporal association, and the known safety profile of the  mRNA-1273  vaccine, a causal association between the reported events and the administration of vaccine cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: sore arm; neck pain; difficulty moving his head side to side; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction to the Pfizer covid vaccine and wanted to know if it is normal or not. He received the vaccine on Friday afternoon (unspecified date) and experienced sore arm lasting 2 days which he expected, but by the end of this time experienced neck pain and difficulty moving his head side to side. "Can I take Tylenol for this reaction?" Outcome of all the events was unknown.   Information about lot/batch number has been requested.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hyperhidrosis, Neuralgia, Pyrexia, Sciatica
Clinical narrative: sciatic nerve pain; fever; every nerve in my body, fingers, buttocks was in pain; sweating; Dry cough; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 18Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took gabapentin and felt burning in her feet and couldn't sleep at night. Historical vaccine includes flu vaccine. One time when she had the flu shot 64, she had a reaction to it. She said had the same reaction with COVID-19 vaccine. On 29Jan2021, every nerve in her body, fingers, buttocks was in pain, in the middle of the night woke up and she was sweating. It all lasted for a day and a half, by the next day it has diminished. She was also coughing, dry cough. It happened all at one. All at once, she could hardly get out of bed. She couldn't touch her body the night of the 29Jan2021. She also has sciatic nerve pain. It hurt so bad she couldn't handle it. The nerves in her hands, fingers, buttocks, and legs just hurt. That lasted the night until noon. Sunday morning it was gone.  She clarified the hurting and not being able to get out of bed started the 30Jan2021, but was gone by Sunday. The pain in her buttocks and hands started to slowly go away. She thinks when she woke up soaking wet that she had had a fever that broke (29Jan2021). She woke up Saturday morning with the nerves and the pain. By Sunday late evening, it was starting to diminish. Her next vaccine was next Monday. Her legs aren't moving as fast at 90 years old. The outcome of the events sweating and fever was recovered on 30Jan2021; cough recovered on 31Jan2021; nerve pain and sciatic nerve pain recovered on Jan2021.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea; stomach pain/pains in her stomach; loss of appetite; generally feeling unwell; Tiredness/been tired; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 30Jan2021 15:00 at single dose (right arm) for COVID-19 immunization. Medical history included ulcerative colitis diagnosed 14 years ago. Concomitant medication included budesonide (UCERIS) for ulcerative colitis from Jan2021. On 01Feb2021, the patient experienced stomach pain/pains in her stomach, loss of appetite, been tired, and had a headache. She was generally feeling unwell and was asking if these were common side effects of the vaccine. On an unspecified date, she started having diarrhea. She says she doesn't know if these could be side effects, she also has ulcerative colitis. She has already checked out a website and she would like more information about whether this was something she should ride out, or how long it might last. She does not currently have her vaccine card with her to provide lot information for this product. She says she has had no other recent vaccination in the last 6-8 weeks, though she started a new medication in Jan2021 for her ulcerative colitis. She reported that she has not treated her headache, stomach pains, or diarrhea yet. She says that the possible side effects started yesterday (as reported), she would say that they have gotten worse as she was really tired, and it has gotten more noticeable. She says she had nothing on Saturday or Sunday, these things started yesterday afternoon (01Feb2021). Outcome of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: diarrhea; stomach pain/pains in her stomach; loss of appetite; generally feeling unwell; Tiredness/been tired; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 30Jan2021 15:00 at single dose (right arm) for COVID-19 immunization. Medical history included ulcerative colitis diagnosed 14 years ago. Concomitant medication included budesonide (UCERIS) for ulcerative colitis from Jan2021. On 01Feb2021, the patient experienced stomach pain/pains in her stomach, loss of appetite, been tired, and had a headache. She was generally feeling unwell and was asking if these were common side effects of the vaccine. On an unspecified date, she started having diarrhea. She says she doesn't know if these could be side effects, she also has ulcerative colitis. She has already checked out a website and she would like more information about whether this was something she should ride out, or how long it might last. She does not currently have her vaccine card with her to provide lot information for this product. She says she has had no other recent vaccination in the last 6-8 weeks, though she started a new medication in Jan2021 for her ulcerative colitis. She reported that she has not treated her headache, stomach pains, or diarrhea yet. She says that the possible side effects started yesterday (as reported), she would say that they have gotten worse as she was really tired, and it has gotten more noticeable. She says she had nothing on Saturday or Sunday, these things started yesterday afternoon (01Feb2021). Outcome of events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Muscular weakness, Oropharyngeal pain
Clinical narrative: a significant headache this morning with pain focused at the front of her head; Weak feeling; feelings of weakness in her legs when walking; sore throat; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, intramuscular on left deltoid on 26Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication was reported as none. The patient received the first dose of COVID vaccine on 26Jan2021 and reported a significant headache this morning with pain focused at the front of her head after she was up for a while, she also had a weak feeling, feelings of weakness in her legs when walking and a sore throat, all on 02Feb2021. Her headache was very bad, but after treating with 2 tablets of extra strength paracetamol (TYLENOL) 500 mg, her headache was not as bad as it was. This happened suddenly. Her sore throat started the same time as the headache which was currently gone. She wanted to know if these events could be from the vaccine, a week later; if she should get a COVID test; and how long will the headache last if it came back. The outcome of the headache was recovering and recovered on 02Feb2021 for all other events.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the 1st of two reports.  A male patient (Age: 75, Units: unknown) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 30Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he and his wife received the first dose of the pfizer covid 19 vaccine on Saturday 30Jan2021. The patient wanted to report that he and his wife experienced vertigo type symptoms. The outcome of the event was unknown.  Information about lot/batch number has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: achy arm on the injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EN9810 and expiry date unknown), via an unspecified route of administration on 02Feb2021 (at 70 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included blood pressure, blood thinner, and heart rate; all from an unknown date. Concomitant medications included atenolol, oral at 50mg, once daily for blood pressure; baby aspirin (acetylsalicylic acid) oral at 81mg, once daily as blood thinner; fish oil oral at 1000mg, once daily; hydrochlorothiazide, oral at 12.5mg, once daily for blood pressure; and levothyroxine, oral at 88mcg, once daily for heart rate; all the products were taken from an unspecified date for a long time and ongoing. It was also reported that patient takes blood thinners and other heart medications. The patient received the first dose of the vaccine today and noticed the information on the fact sheet after the shot. She is on baby aspirin and asked if she should still take it. Patient also asked what pain medication can she take; can she take Tylenol for her achy arm on the injection site? The patient further reported that when she got her shot, she didn't read the paper, but it says, "if you are on blood thinners" and does that affect this? She takes blood thinners and other heart medications. She asked if any of her medications affect her shot, she has not taken any today and she wanted to ask about that. Her only concern is the possible blood thinner interaction with the vaccine. With regards to the second dose, patient mentioned they didn't schedule her yet because she had to check and see where to get the second dose. She wanted to be more educated for the second dose. The outcome of "achy arm on the injection site" was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Erythema, Lethargy, Pyrexia
Clinical narrative: Redness; temperature of 102.7 F/fever; loss of appetite/no appetite; Lethargic; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number, expiry date unknown), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, temperature of 102.7 F/fever, loss of appetite/no appetite and felt lethargic in Feb2021. It was reported that while the patient didn't have much redness, he has had a temperature of 102.7 F. They wanted to know if this is normal and how long should they anticipate him having a fever or is it something he should expect over the course of one or multiple days. He also had loss of appetite and felt lethargic. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; itching; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included prednisone (PREDNISONE), mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) and belimumab (BENLYSTA). On an unspecified date, the patient stated, "I have a question regarding the Pfizer covid vaccine as it relates to someone allergic to contrast dye, if it would be a problem. I was pre-medicated when I received it. After that I had a breakthrough of rash and itching that lasted a few days. No respiratory throat closing or any thing like that. There are several medications that I am taking and want to knowif they need to be stopped: prednisone, cellcept and benlysta infusion. Along with Long term opioids." The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/Batch could not be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had the Pfizer Covid vaccine first dose on 14Jan2021. On 21Jan2021 she tested positive for Covid virus and on 22Jan2021 had the antibody infusion. She had completed her quarantine and was back at work and to get the second dose which was scheduled for next Thursday, 04Feb2021. She wanted to know if she should get the second did or not. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This is a spontaneous report from a contactable consumer. This consumer reported 2 reports for different patients (herself and her husband). This report is for herself. A 70-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fatigue the day after vaccination when she woke up for a few hours.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a slight headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a slight headache on an unspecified date. The patient reportedly took 2 tabs of paracetamol (TYLENOL) as treatment. Outcome of event was unknown.  Information regarding lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Jan2021 at 14:15 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccine, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not take any concomitant medications. The patient did not have any allergies to medications, food, or other products. On 31Jan2021 at 15:00 the patient experienced diarrhea going on 3 days. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of diarrhea was not recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.