chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Syncope
Clinical narrative: he fainted for 1-2 seconds; palpitation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (he fainted for 1-2 seconds) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neutropenia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SYNCOPE (he fainted for 1-2 seconds) (seriousness criterion medically significant) and PALPITATIONS (palpitation). On 05-Mar-2021, SYNCOPE (he fainted for 1-2 seconds) and PALPITATIONS (palpitation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information reported.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Head discomfort, Headache, Lymphadenopathy
Clinical narrative: tinnitus; head is still cloggy; woke up with plugged ear; ringing in left ear; Swollen glands with whole neck side; 50% hear loss; sore arm; tender to touch; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (50% hear loss) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), TENDERNESS (tender to touch,) and HEADACHE (headache). On 13-Mar-2021, the patient experienced TINNITUS (tinnitus), LYMPHADENOPATHY (Swollen glands with whole neck side), DEAFNESS (50% hear loss) (seriousness criterion medically significant), HEAD DISCOMFORT (head is still cloggy), EAR DISCOMFORT (woke up with plugged ear) and TINNITUS (ringing in left ear). At the time of the report, PAIN IN EXTREMITY (sore arm), TENDERNESS (tender to touch,), HEADACHE (headache), TINNITUS (tinnitus), LYMPHADENOPATHY (Swollen glands with whole neck side), DEAFNESS (50% hear loss), HEAD DISCOMFORT (head is still cloggy) and TINNITUS (ringing in left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender'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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Tinnitus
Clinical narrative: tinnitus; head is still cloggy; woke up with plugged ear; ringing in left ear; Swollen glands with whole neck side; 50% hear loss; sore arm; tender to touch; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (50% hear loss) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), TENDERNESS (tender to touch,) and HEADACHE (headache). On 13-Mar-2021, the patient experienced TINNITUS (tinnitus), LYMPHADENOPATHY (Swollen glands with whole neck side), DEAFNESS (50% hear loss) (seriousness criterion medically significant), HEAD DISCOMFORT (head is still cloggy), EAR DISCOMFORT (woke up with plugged ear) and TINNITUS (ringing in left ear). At the time of the report, PAIN IN EXTREMITY (sore arm), TENDERNESS (tender to touch,), HEADACHE (headache), TINNITUS (tinnitus), LYMPHADENOPATHY (Swollen glands with whole neck side), DEAFNESS (50% hear loss), HEAD DISCOMFORT (head is still cloggy) and TINNITUS (ringing in left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender'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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .4 ml. On 08-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake). On 08-Feb-2021, ACCIDENTAL UNDERDOSE (Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was given. No concomitant medications were reported.  This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-013253 (E2B Linked Report).; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Visual impairment
Clinical narrative: Blood pressure over 200; Could not see very clearly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure over 200) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HYPERTENSION (Blood pressure over 200) (seriousness criterion hospitalization) and VISUAL IMPAIRMENT (Could not see very clearly). In March 2021, VISUAL IMPAIRMENT (Could not see very clearly) had resolved. At the time of the report, HYPERTENSION (Blood pressure over 200) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender'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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Nausea
Clinical narrative: nausea; dizziness; no appetite; This is a spontaneous report from a contactable consumer (Patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration on 02Feb2021 at 10:00 (at the age of 86 years-of-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. Concomitant medication(s) included atenolol, pravastatin and Aspirin. On 07Feb2021 at 07:00, patient experienced nausea, dizziness and no appetite. The patient had no other vaccinations within 4 weeks prior COVID-19 vaccination and was not tested for COVID-19 since vaccination. The outcome of all the events was recovered on an unspecified date Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose of Pfizer-Biontech Covid19 vaccine 10 days ago.  She has since gone for a PCR test for Sars-Cov-2 infection which came back positive.  Could the vaccine have caused a false positive?; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (Daughter) who received 1st dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection) on 01Feb2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date, Caller's daughter underwent PCR test for SARS-COV-2 infection which results positive, after her first dose of Pfizer-Biontech Covid-19 vaccine 10 days ago. Caller questioned could the vaccine had caused a false positive result. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back started aching; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809, expiry date: 30Jun2021), via an unspecified route of administration in the deltoid left on 08Feb2021 at 13:30 (at the age of 73-years-old) as 0.3 ml for try to avoid getting COVID. Medical history reported was his main artery is plugged up, High cholesterol, Type II diabetes and Blood thinner, all ongoing. It was reported that patient was not vaccinated with any other vaccinations prior (within 4 weeks). Concomitant medications reported was metformin at 500 mg daily for type II diabetes been on it two years, simvastatin at 20 mg daily for high cholesterol been on it approximately 3 years, aspirin [ACETYLSALICYLIC ACID] at low dose daily taken it for three years, cilostazol for blood thinner at 100 mg twice a day been on it two years, all ongoing. It was reported that patient got the Pfizer COVID19 vaccine on Monday, 08Feb2021. On Tuesday, 09Feb2021, in the afternoon his back started aching. By 8 o'clock Tuesday night it was hard to stand up without excruciating pain. He was having to use a heating pad because the back pain has not gotten better. Caller was calling for the symptom he had yesterday (10Feb2021). He wanted to know if there had been reports of lower back pain with the Pfizer COVID-19 vaccine. It was reported that patient did not required visit to emergency Room or physician Office. There was no family medical history relevant to adverse event. No additional vaccines were administered on same date of the Pfizer Suspect. There is no history of previous immunization with the Pfizer vaccine considered as suspect. Outcome of the event was not recovered.  No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large swollen bump at injection site, red, giving off heat, itchy; Large swollen bump at injection site, red, giving off heat, itchy; Large swollen bump at injection site, red, giving off heat, itchy; Large swollen bump at injection site, red, giving off heat, itchy; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EM9809) dose 1 via an unspecified route of administration in Arm Left on 08Feb2021 14:15 as single dose for COVID-19 immunization. Medical history included Arthritis, obesity, medicated for high glucose, medications for inflammation, pain and nerve pain. The patient's concomitant medications were not reported. The patient experienced Large swollen bump at injection site, red, giving off heat, itchy on 09Feb2021 13:00. Seriousness was reported as non-serious. Patient did not receive any treatment. Outcome of events was not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Pain in arm; She was slightly dizzy; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 11Feb2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer. A 81-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL8982), via an unspecified route of administration in the left arm on 10Feb2021 18:30 (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included (caller mentions she dyslexia but this was prior to the COVID vaccine). Concomitant medication included apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date (taking for 6-7 years) at unknown dose and frequency for an unknown indication. On an unspecified date the patient experienced pain in extremity and dizziness. Caller, reporting that she took the COVID shot and was told that if she is on a blood thinner she shouldn't have gotten the vaccine, is that true. She asks if we make Eliquis. The only small issue she had after the vaccine was some pain in her arm. She worked the pharmacy at one time. She got the shot on 10Feb2021 at 6:30pm. Treatment: Hot compress to the area. Caller remarks that just now when she stood up, she noticed she was slightly dizzy. Could that be caused by the vaccine. Therapeutic measures were taken as a result of pain in arm (pain in extremity). The clinical outcomes of the pain in extremity and dizziness were unknown. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021 patient experienced headache and chills. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 11Feb2021, as single dose for COVID-19 immunisation, at Workplace clinic. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. On 12Feb2021, the patient experienced arm pain and malaise. No treatment was received for the events. Patient was not diagnosed with COVID prior vaccination. Patient has not been tested for COVID post vaccination. Outcome of the events was reported as not recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: some of the vaccine leaked out of the injection site; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on an unknown date. On an unknown date, the patient experienced some of the vaccine leaked out of the injection site during the administration. She was following with the CDC recommendations and wanted to see if we have recommendations on our side with regards to revaccination or getting more than the intended dose of the vaccine. The outcome of the event was unknown.  Information on Lot /Batch Number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: first dose of the Pfizer-Biontech COVID-19 vaccine on Monday (08Feb2021) and tested positive for COVID yesterday (11Feb2021); This is a spontaneous report from a contactable consumer. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date were UNKNOWN), via an unspecified route of administration on 08Feb2021 as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Patient stated that she was vaccinated with the first dose of the Pfizer-Biontech COVID-19 vaccine on Monday 08Feb2021 and tested positive for COVID yesterday (11Feb2021). She is scheduled for her second dose on 01Mar2021. The outcome of the event was unknown. No PQC present.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Crying, Hyperexplexia, Self-injurious ideation
Clinical narrative: uncontrolled weeping; thoughts of self harm; extreme startle response; Emotional liability; This is a spontaneous report from a contactable other Healthcare Professional reported for herself. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Feb2021 12:00 at age of 44-year-old (Lot Number: EU9809) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included PMDD (premenstrual dysphoric disorder) but controlled by chemical menopause over 3 months, known allergies to shellfish. Concomitant medications included naproxen and elagolix sodium (ORILISSA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose bnt162b2 (Lot number: EL8982) administered in arm left on 21Jan2021 at 11:45 (at age of 44-year-old) at single dose for COVID-19 immunization.  The patient experienced emotional liability, uncontrolled weeping, extreme startle response, thoughts of self harm on 12Feb2021 16:00. The events was reported as non-serious and did not result in emergency room visit or physician office visit. Patient received treatment  for the adverse events which included clonazepam. 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 the events was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle discomfort
Clinical narrative: On day 12 muscle discomfort in quadriceps; discomfort in lower back; This is a spontaneous report received from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 first dose (BNT162B2, Solution for injection, lot Number: EN5318) via an unspecified route of administration, on left arm on 30Jan2021 13:00 at single dose for an unspecified indication. Relevant medical history and concomitant medications were not provided. Since the vaccination, the patient had not tested positive for COVID-19. Patient has not had symptoms associated with COVID-19. The patient previously received sulfa [sulfadiazine] and experienced drug hypersensitivity. On 10Feb2021 12:15, the patient experienced on day 12 muscle discomfort in quadriceps and discomfort in lower back gradually worsening each day. The outcome of the events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Malaise
Clinical narrative: tiredness; muscle pain; chills; joint pain; fever 100 degree; feeling unwell; This is a spontaneous report from a contactable consumer (self-reported). A 34-years-old non pregnant female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 10Feb2021 at 18:30 (Batch/Lot Number: EL0140) as single dose for covid-19 immunisation. Medical history included anxiety, depression, mild asthma and environmental allergies. Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received list of any other medications the patient received within 2 weeks of vaccination. On 12Feb2021 at 19:30, the patient had experienced tiredness, muscle pain, chills, joint pain, fever 100 degree, feeling unwell. The patient was not diagnosed with COVID Prior to vaccination and the patient was not tested for COVID Since the vaccination. The outcome of the event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: tiredness; muscle pain; chills; joint pain; fever 100 degree; feeling unwell; This is a spontaneous report from a contactable consumer (self-reported). A 34-years-old non pregnant female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 10Feb2021 at 18:30 (Batch/Lot Number: EL0140) as single dose for covid-19 immunisation. Medical history included anxiety, depression, mild asthma and environmental allergies. Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received list of any other medications the patient received within 2 weeks of vaccination. On 12Feb2021 at 19:30, the patient had experienced tiredness, muscle pain, chills, joint pain, fever 100 degree, feeling unwell. The patient was not diagnosed with COVID Prior to vaccination and the patient was not tested for COVID Since the vaccination. The outcome of the event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dry mouth, Fatigue
Clinical narrative: tiredness; muscle pain; chills; joint pain; fever 100 degree; feeling unwell; This is a spontaneous report from a contactable consumer (self-reported). A 34-years-old non pregnant female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 10Feb2021 at 18:30 (Batch/Lot Number: EL0140) as single dose for covid-19 immunisation. Medical history included anxiety, depression, mild asthma and environmental allergies. Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received list of any other medications the patient received within 2 weeks of vaccination. On 12Feb2021 at 19:30, the patient had experienced tiredness, muscle pain, chills, joint pain, fever 100 degree, feeling unwell. The patient was not diagnosed with COVID Prior to vaccination and the patient was not tested for COVID Since the vaccination. The outcome of the event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea
Clinical narrative: tiredness; muscle pain; chills; joint pain; fever 100 degree; feeling unwell; This is a spontaneous report from a contactable consumer (self-reported). A 34-years-old non pregnant female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 10Feb2021 at 18:30 (Batch/Lot Number: EL0140) as single dose for covid-19 immunisation. Medical history included anxiety, depression, mild asthma and environmental allergies. Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received list of any other medications the patient received within 2 weeks of vaccination. On 12Feb2021 at 19:30, the patient had experienced tiredness, muscle pain, chills, joint pain, fever 100 degree, feeling unwell. The patient was not diagnosed with COVID Prior to vaccination and the patient was not tested for COVID Since the vaccination. The outcome of the event was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Investigation
Clinical narrative: fever up to 101 degrees; weakness; Body aches; headache; exhaustion; Chills for 3 hours; This is a spontaneous report received from a contactable (reporting on herself). A 78-years-old Non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6201 and Expiry date not reported), via an unspecified route of administration in Arm Left on 11Feb2021 16:45 as single dose for COVID-19 immunization. Medical history included penicillin allergy. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283 in Arm Right on 22Jan2021 17:15 for COVID-19 immunization. Concomitant medication(s) included Liothyronine/Levothyroxine T3/T4, and usual vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on 12Feb2021 at 13:00 symptoms started (at 20 hours after the injection) Chills for 3 hours, fever up to 101 degrees, weakness, body aches, headaches, exhaustion. Patient did not received any treatment for adverse event. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever up to 101 degrees; weakness; Body aches; headache; exhaustion; Chills for 3 hours; This is a spontaneous report received from a contactable (reporting on herself). A 78-years-old Non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6201 and Expiry date not reported), via an unspecified route of administration in Arm Left on 11Feb2021 16:45 as single dose for COVID-19 immunization. Medical history included penicillin allergy. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283 in Arm Right on 22Jan2021 17:15 for COVID-19 immunization. Concomitant medication(s) included Liothyronine/Levothyroxine T3/T4, and usual vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on 12Feb2021 at 13:00 symptoms started (at 20 hours after the injection) Chills for 3 hours, fever up to 101 degrees, weakness, body aches, headaches, exhaustion. Patient did not received any treatment for adverse event. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Recently was with her daughter/family, which now have tested positive; This is a spontaneous report from a Pfizer-sponsored program form a contactable female consumer (Patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant was not reported. Patient stated that recently she was with her daughter/family, which now have tested positive. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Illness, Lymphadenopathy
Clinical narrative: Nausea; My hand was purple-ish and tingling; My hand was purple-ish and tingling; lymph's were so swollen; hand was basically unusable; Sick; Weak; Extremely sore arm; Chills; Cold sweat; This is a spontaneous report received from a contactable consumer (Reporting for herself). A 33-years-old non-pregnant female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date not reported), via an unspecified route of administration in Arm Right on 25Jan2021 15:00 (at age of 33-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported and no allergies to medications, food, or other products. The patients concomitant medications were not reported. It was reported that patient was not pregnant at the time of vaccination. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient diagnosed with COVID-19. It was reported that on 25Jan2021 at 15:00 extremely sore arm, unable to use for 5-7 days. The first 24 hours patient had chills even with 3 blankets on. She shivered and started to cold sweat into the next day. Nau-sea came and went for 72 hours. The weirdest part was her arm and hand. Her hand was purpleish and tingling for 6 days. Patient was told to try to move it and maybe her lymph's were so swollen they were pressing on a nerve. However her hand was basically unusable the entire week. Patient was so sick and weak for the entire week. Patient did not received any treatment for ad-verse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered with sequelae.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain in extremity, Paraesthesia, Skin discolouration
Clinical narrative: Nausea; My hand was purple-ish and tingling; My hand was purple-ish and tingling; lymph's were so swollen; hand was basically unusable; Sick; Weak; Extremely sore arm; Chills; Cold sweat; This is a spontaneous report received from a contactable consumer (Reporting for herself). A 33-years-old non-pregnant female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date not reported), via an unspecified route of administration in Arm Right on 25Jan2021 15:00 (at age of 33-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported and no allergies to medications, food, or other products. The patients concomitant medications were not reported. It was reported that patient was not pregnant at the time of vaccination. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient diagnosed with COVID-19. It was reported that on 25Jan2021 at 15:00 extremely sore arm, unable to use for 5-7 days. The first 24 hours patient had chills even with 3 blankets on. She shivered and started to cold sweat into the next day. Nau-sea came and went for 72 hours. The weirdest part was her arm and hand. Her hand was purpleish and tingling for 6 days. Patient was told to try to move it and maybe her lymph's were so swollen they were pressing on a nerve. However her hand was basically unusable the entire week. Patient was so sick and weak for the entire week. Patient did not received any treatment for ad-verse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered with sequelae.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: right hand started to feel like it was going to sleep; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer it has been in remission for 3 years , milk allergy, ongoing high blood Pressure, ongoing cholesterol, ongoing Diabetic. The patient historical vaccine included flu shot for immunization. Concomitant medication included lovastatin at 40 mg, twice a day taken for cholesterol, Ongoing metformin at 500 mg, twice a day taken for diabetic,amlodipine besylate;benazepril at once a day (10-40mg once a day) for high blood pressure from an unspecified start date and ongoing, vitamin d (Lot number: 507530-01 and expiration date: Oct2023) at 800 iU (takes two 400IU); ascorbic acid (VITAMIN C Lot number: 526680-01 and expiration date Sep2024) taken 1000 mg (takes two 500mg to make 1000mg) for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12-VITAMIN Lot number: 505721-03 and expiration date: MAR-2023) taken 500 mg, daily for an unspecified indication, and multivitamin. He noticed one hour after receiving the first dose of the vaccine his right hand started falling asleep. It occur only in the arm where he got the vaccine. It got better and five minutes later it happened again. Caller wants to if this side effect is associated with the vaccine. The outcome of the event was unknown
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Illness
Clinical narrative: he came down with covid,virus; low O2 sats; getting sick; no taste/ loss of sense of taste; no smell/ loss of smell; muscle aches; low grade fever; Sore throat; Cough; This is a spontaneous report from a contactable consumer (patient wife). A 70-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261) via an unspecified route of administration in arm left on 26Jan2021 at 01:00 as single dose for covid-19 immunisation. Medical history included diabetes mellitus and asthma and concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus. On an unspecified date, the patient came down with covid virus and was quarantined. On 05Feb2021 he was getting sick, no taste/ loss of sense of taste, no smell/ loss of smell, muscle aches, low grade fever, sore throat, 15Feb2021 with low o2 sats, on an unspecified date in Feb2021 cough. The patient underwent lab tests which included oxygen saturation: 88 percent on 15Feb2021 low, on room air. Prior to this they were 92 percent and was not tested for covid. Seriousness of all the events were resported as non-serious. The outcome of the events he came down with covid virus and getting sick was unknown. The outcome of the events low grade fever was recovered on 15Feb2021. The outcome of the events no taste/ loss of sense of taste, no smell/ loss of smell, muscle aches, low O2 sats was not recovered. The outcome of the events sore throat, cough was recovering.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: he came down with covid,virus; low O2 sats; getting sick; no taste/ loss of sense of taste; no smell/ loss of smell; muscle aches; low grade fever; Sore throat; Cough; This is a spontaneous report from a contactable consumer (patient wife). A 70-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261) via an unspecified route of administration in arm left on 26Jan2021 at 01:00 as single dose for covid-19 immunisation. Medical history included diabetes mellitus and asthma and concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus. On an unspecified date, the patient came down with covid virus and was quarantined. On 05Feb2021 he was getting sick, no taste/ loss of sense of taste, no smell/ loss of smell, muscle aches, low grade fever, sore throat, 15Feb2021 with low o2 sats, on an unspecified date in Feb2021 cough. The patient underwent lab tests which included oxygen saturation: 88 percent on 15Feb2021 low, on room air. Prior to this they were 92 percent and was not tested for covid. Seriousness of all the events were resported as non-serious. The outcome of the events he came down with covid virus and getting sick was unknown. The outcome of the events low grade fever was recovered on 15Feb2021. The outcome of the events no taste/ loss of sense of taste, no smell/ loss of smell, muscle aches, low O2 sats was not recovered. The outcome of the events sore throat, cough was recovering.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Magnetic resonance imaging
Clinical narrative: sore at injection site; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 (at the age of 72-year-old) as single dose for covid-19 immunisation. Medical history included surgery on 2016 (The pain is what was felt prior to having surgery in 2016). The patient's concomitant medications were not reported. The patient experienced sore at injection site (injection site pain) on an unspecified date. Caller, reported on the Pfizer vaccine and who was calling to report and ask some questions. It was explained that with her first vaccine that was on 20Jan2021 about 1pm and though this doesn't have anything to do with it, the nurse that gave it, her masking kept coming down. She gave the injection and the caller felt it was weird where she gave even though her friend said it can be given in different areas. It was administered up high and toward the mid line, more toward the middle of her body. That night 21Jan2021 22Jan2021 and half the day of 23Jan2021 she was very sore at the injection site and a few days later, in fact she was still having pain. She reports that it was a similar pain that she experienced prior to having surgery in 2016 between C5 and C6; she had a fusion. The pain was from her scapula down throughout the elbow to the forearm and to her fingers on that side. She was calling because she was concerned it from vaccine though she was told it probably wasn't by her friend that was a nurse. The patient underwent lab tests included magnetic resonance imaging (for a fusion surgery on C5 and C6, a pinched nerve from bending her neck) on 12Feb2021. The action taken in response to the event for bnt162b2 was not applicable. Outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Low fever 100.5; Severe body aches; Strong headache; Some off and on very sharp pains in wrist area of injection arm; This is a spontaneous report from a contactable consumer (patient).A 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no: EL9269) via an unspecified route of administration on left arm on 13Feb2021 at 16:30 at single dose for COVID-19 Immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 04:30 PM, anatomical location was left arm. The patient's medical history included allergies (Dairy). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 05Feb2021 and tested negative. The concomitant medication included Tetanus and Synthroid. It was reported that on 14Feb2021, 11:00 AM the patient experienced Low fever 100.5, Severe body aches, Strong headache and Some off and on Very Sharp pains in wrist area of injection arm. Patient did not felt better until full 24 hours later and still experienced some lingering symptoms. The patient did not received any treatment. The outcome for the event was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Low fever 100.5; Severe body aches; Strong headache; Some off and on very sharp pains in wrist area of injection arm; This is a spontaneous report from a contactable consumer (patient).A 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no: EL9269) via an unspecified route of administration on left arm on 13Feb2021 at 16:30 at single dose for COVID-19 Immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 04:30 PM, anatomical location was left arm. The patient's medical history included allergies (Dairy). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 05Feb2021 and tested negative. The concomitant medication included Tetanus and Synthroid. It was reported that on 14Feb2021, 11:00 AM the patient experienced Low fever 100.5, Severe body aches, Strong headache and Some off and on Very Sharp pains in wrist area of injection arm. Patient did not felt better until full 24 hours later and still experienced some lingering symptoms. The patient did not received any treatment. The outcome for the event was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 to 15Feb2021 (Lot Number: EL3247, at the age of 28-years-old) as single dose for covid-19 immunization. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Lot Number: EL3247) as single dose for COVID-19 immunization. The patient did not have known allergies. There were no concomitant medications. The patient experienced shortness of breath, nausea, vomiting, dizziness when going from a sitting to standing on 15Feb2021. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: On Wednesday I got the shot, but Sunday I was diagnosed with covid; This is a spontaneous report received from a contactable consumer (patient, pharmacy technician). Follow-up information received on 03Mar2021 was processed together with initial information.   A 22 (unit not specified) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date around after 4 days of vaccination, the patient was diagnosed with COVID-19. She wanted to know if she could continue with her second dose or had to take the first dose again to start over. And she stated that her HCP thought that was fine if she enquiry manufacturer. Outcome of event was unknown.  Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: injection site pain; tiredness; headache; joint pain; chills; muscle pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male consumer reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on15Feb2021at single dose for COVID-19 Immunization. Medical history was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date. Concomitant medication included lisinopril. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines (10Feb2021) in right arm within 4 weeks prior to the COVID vaccine. The patient was tested for COVID-19 since the vaccination after the nasal swab test. On16Feb2021 02:00 AM, patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. On16Feb2021 02:00 AM, patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The patient did not receive any treatment for events. Reporter assessed the events as non-serious. The outcome for the events was recovering  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: injection site pain; tiredness; headache; joint pain; chills; muscle pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male consumer reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on15Feb2021at single dose for COVID-19 Immunization. Medical history was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date. Concomitant medication included lisinopril. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines (10Feb2021) in right arm within 4 weeks prior to the COVID vaccine. The patient was tested for COVID-19 since the vaccination after the nasal swab test. On16Feb2021 02:00 AM, patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. On16Feb2021 02:00 AM, patient experienced Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The patient did not receive any treatment for events. Reporter assessed the events as non-serious. The outcome for the events was recovering  Information on the lot/batch number has been requested.