chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: WORST HEADACHE, FELT LIKE SHE WAS BEING HIT REPEATEDLY WITH A HAMMER; MUSCLE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced worst headache, felt like she was being hit repeatedly with a hammer. On 16-MAY-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from worst headache, felt like she was being hit repeatedly with a hammer, and muscle soreness. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Influenza like illness
Clinical narrative: PAIN IN UPPER BACK AND ACROSS  SHOULDER; FLU LIKE SYMPTOMS; JOINT PAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic hip pain, sepsis-staph infections collected in right hip, seasonal allergies, nerve pain, alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with promethazine for nausea, drug allergy when treated with azithromycin, and doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included gabapentin for chronic hip pain, and nerve pain. On 11-MAY-2021, the subject experienced pain in upper back and across shoulder. On 11-MAY-2021, the subject experienced flu like symptoms. On 11-MAY-2021, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 101.8 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and joint pain on 12-MAY-2021, and had not recovered from pain in upper back and across shoulder. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE GIVEN NEXT DAY AFTER TEMPERATURE EXCURSION FROM 46.2-46.7F FOR ABOUT 31 MINUTES; This spontaneous report received from a health care professional concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine given next day after temperature excursion from 46.2-46.7f for about 31 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given next day after temperature excursion from 46.2-46.7f for about 31 minutes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: ARM FELT IRRITATED LIKE SUNBURN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced arm felt irritated like sunburn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt irritated like sunburn on MAY-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: RUNNING NOSE; DISCOMFORT IN THROAT; SORE THROAT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced discomfort in throat. On 13-MAY-2021, the subject experienced running nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, running nose and discomfort in throat was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: VACCINATION ERROR; This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vaccination error. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccination error was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain of skin, Pulmonary congestion, Pyrexia
Clinical narrative: Chest Congestion; Skin pain on his back; Low grade fever of 100; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Chest Congestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-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 PULMONARY CONGESTION (Chest Congestion) (seriousness criterion medically significant), PAIN OF SKIN (Skin pain on his back) and PYREXIA (Low grade fever of 100). At the time of the report, PULMONARY CONGESTION (Chest Congestion), PAIN OF SKIN (Skin pain on his back) and PYREXIA (Low grade fever of 100) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 100 low grade fever.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. The patient had seen his doctor who told him to call Moderna for answers. 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (sensitive to a lot of medications).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The next day after the injection, the patient developed a read patch that grew over time from injection site to elbow, to inside of arm, then up toward armpit. It did feel a little warm, then really hot. The patient's family doctor gave her an antibiotic and it was only slight pink at the time of reporting.  No relevant concomitant medications were reported.   Treatment information included, antibiotic unspecified.  This case concerns a 78-year-old female with a serious unexpected event of cellulitis. Latency 2 days after first mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information was provided.; Sender's Comments: This case concerns a 78-year-old female with a serious unexpected event of cellulitis. Latency 2 days after first mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial paralysis, Headache, Swelling face
Clinical narrative: Headache; chills; Right sided facial drooping; Right sided facial drooping and swelling; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Right sided facial drooping) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HR002B021) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FACIAL PARALYSIS (Right sided facial drooping) (seriousness criterion medically significant) and SWELLING FACE (Right sided facial drooping and swelling). On 11-Apr-2021, the patient experienced HEADACHE (Headache) and CHILLS (chills). At the time of the report, FACIAL PARALYSIS (Right sided facial drooping), SWELLING FACE (Right sided facial drooping and swelling), HEADACHE (Headache) and CHILLS (chills) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FACIAL PARALYSIS (Right sided facial drooping) and SWELLING FACE (Right sided facial drooping and swelling) to be possibly related. No further causality assessments were provided for HEADACHE (Headache) and CHILLS (chills).    Description: On 07 Apr 2021, the patient experienced right sided facial drooping (medically significant) and swelling. The patient also experienced chills and headaches on 11 Apr 2021. The symptoms (chills and headaches) went away and resurfaced on 14 April 2021.  No concomitant medications were reported.   The patient took extra strength acetaminophen with good effect for headache and chills. The patient was also prescribed valacyclovir (Valtrix, 1 grams, TID for 7 days) and prednisone (60 milligrams, QD) for ight sided facial drooping and swelling.  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.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Case upgraded to serious. Serious event Facial droop and non-serious event of Facial swelling added. Dosing details and action taken with suspect product updated.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Heart injury, Troponin
Clinical narrative: She feels that vaccine had done permanent damage to her heart; constantly dizzy; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (She feels that vaccine had done permanent damage to her heart) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE/SALMETEROL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On an unknown date, the patient experienced HEART INJURY (She feels that vaccine had done permanent damage to her heart) (seriousness criterion medically significant) and DIZZINESS (constantly dizzy). At the time of the report, HEART INJURY (She feels that vaccine had done permanent damage to her heart), DYSPNOEA (shortness of breath) and DIZZINESS (constantly dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Blood pressure measurement: 177/107 mmhg (abnormal) blood pressure increased. On 08-May-2021, Troponin: increased (abnormal) troponin level raised.     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.   Treatment given with Prednisone tablets for 5 days and Doxycycline.  Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: added with new event information and reporter details; Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Worsened peripheral neuropathy; Nerve Pain; Tingling; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Worsened peripheral neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Peripheral neuropathy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Worsened peripheral neuropathy) (seriousness criterion medically significant), NEURALGIA (Nerve Pain), PARAESTHESIA (Tingling) and MYALGIA (Myalgia). At the time of the report, NEUROPATHY PERIPHERAL (Worsened peripheral neuropathy), NEURALGIA (Nerve Pain), PARAESTHESIA (Tingling) and MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - 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.; 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Positive Covid-19 diagnosis; low grade fever; muscle aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive Covid-19 diagnosis), PYREXIA (low grade fever) and MYALGIA (muscle aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015-M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (low grade fever) and MYALGIA (muscle aches). On 07-Feb-2021, the patient experienced COVID-19 (Positive Covid-19 diagnosis) (seriousness criterion hospitalization). The patient was hospitalized on 07-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Positive Covid-19 diagnosis), PYREXIA (low grade fever) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Patient was treated with the antibody. Concomitant medications were not provided.  Company Comment : Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. 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.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium, Laboratory test, Laboratory test abnormal
Clinical narrative: showed things were messed up/hardly any output; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of PROTEIN TOTAL INCREASED (protein really high), BLOOD SODIUM ABNORMAL (sodium abnormal) and LABORATORY TEST ABNORMAL (showed things were messed up/hardly any output) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Indwelling catheter management (due to urinary retention). Concurrent medical conditions included Urinary retention, Diabetes and COPD. Concomitant products included METFORMIN for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced protein really high, sodium abnormal and LABORATORY TEST ABNORMAL (showed things were messed up/hardly any output) (seriousness criterion hospitalization). The patient was hospitalized from sometime in April 2021 to 24-Apr-2021 due to  LABORATORY TEST ABNORMAL. On 24-Apr-2021, LABORATORY TEST ABNORMAL (showed things were messed up/hardly any output) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood sodium: abnormal abnormal. On 20-Apr-2021, Laboratory test: hardly any output abnormal. On 20-Apr-2021, Protein total: really high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes medication for blood sugar.  The patient was transported by ambulance to the hospital, admitted, and remained hospitalized for four days. He was released from the hospital on 24-Apr-2021. As per the patient wife, the patient is now on hospice. The wife believes this is due to the vaccine.  The patient wife states that neither she nor her husband will be getting their second dose of the vaccine, which is scheduled for 13-May-2021.   This case was linked to MOD21-088053 (E2B Linked Report).; 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. MOD21-088053:case for caller
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: stated that her mother in law died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (stated that her mother in law died) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 07-May-2021 The patient died on 07-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant medications and treatment information was not provided.  A 61-year-old female patient who received mRNA-1273 died 2 days after the first dose of vaccine. No medical condition or conmeds were provided.  The cause of death was not reported. Very limited information has been reported at this time. Further information is being followed up.; Sender's Comments: A 61-year-old female patient who received mRNA-1273 died 2 days after the first dose of vaccine. No medical condition or conmeds were provided.  The cause of death was not reported. Very limited information has been reported at this time. Further information is being followed up.; Reported Cause(s) of Death: Unknown cause of death
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: Headache; All over body pain(joint and Muscular); All over body pain(joint and Muscular); All over body pain(joint and Muscular); Fever; GI issues; Fatigue; This is a spontaneous report from a contactable consumer other hcp. A 48-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL0142 intramuscular), administered in Arm Left on 18Jan2021 09:00 as SINGLE DOSE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, was the patient diagnosed with COVID-19. Historical vaccination was that the patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL1284 intramuscular), administered in Arm Left on 31Dec2020 08:30 AM as sing for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient has not been tested for Covid-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID-19 vaccine was administered at Hospital. Vaccine Facility, Ethnicity and Race information was available. There were no seriousness criteria for Results in death, Life threatening Seriousness criteria, Caused/prolonged hospitalization, Congenital anomaly/birth defect. Concomitant medications included zolmitriptan (ZOMIG) taken for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient experienced drug hypersensitivity, zofran [ondansetron hydrochloride] and codeine. On 18Jan2021 at 15:30, the patient experienced headache, all over body pain, fever, gastrointestinal issues and fatigue. Therapeutic measures were taken, patient was treated with OTC motrin, Aleve. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Headache; All over body pain(joint and Muscular); All over body pain(joint and Muscular); All over body pain(joint and Muscular); Fever; GI issues; Fatigue; This is a spontaneous report from a contactable consumer other hcp. A 48-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL0142 intramuscular), administered in Arm Left on 18Jan2021 09:00 as SINGLE DOSE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, was the patient diagnosed with COVID-19. Historical vaccination was that the patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL1284 intramuscular), administered in Arm Left on 31Dec2020 08:30 AM as sing for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient has not been tested for Covid-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID-19 vaccine was administered at Hospital. Vaccine Facility, Ethnicity and Race information was available. There were no seriousness criteria for Results in death, Life threatening Seriousness criteria, Caused/prolonged hospitalization, Congenital anomaly/birth defect. Concomitant medications included zolmitriptan (ZOMIG) taken for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient experienced drug hypersensitivity, zofran [ondansetron hydrochloride] and codeine. On 18Jan2021 at 15:30, the patient experienced headache, all over body pain, fever, gastrointestinal issues and fatigue. Therapeutic measures were taken, patient was treated with OTC motrin, Aleve. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Today, on the 28th, I woke up with redness and heat at the injection site; Today, on the 28th, I woke up with redness and heat at the injection site; redness; my arm was sore; This is a spontaneous report from a contactable Other HCP (patient)  A 31-year-old non-pregnant female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection; lot number EL1283), via an unspecified route of administration at Left arm on 13Jan2021 11:00 AM at single dose for Covid-19 immunization. Medical history included to ceclor allergy. The patient was not diagnosed with Covid-19 prior to vaccination and the patient has not been tested for Covid-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gabapentin. On 14Jan2021 next day of vaccination, the patient had a mild reaction of redness and arm was sore but that went away within 24 hours. She did not have any problems until 28Jan2021 05.00am. On 28Jan2021, the patient woke up with redness and heat at the injection site. She further stated that her event did not get any worse however she was concerned about the delayed reaction. She was due to receive second dose on 03Feb2021. No treatment was received for the adverse events. The Outcome of redness and arm was sore was recovered and outcome of the patient woke up with redness and heat at the injection site was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: My head gets headaches off and on; My R arm is very sore to the touch and when moving my arm it is very sore; This is a spontaneous report from a contactable consumer. A 68-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Right on 27Jan2021 13:30 (the day of vaccination) (at the age of 68 years) as SINGLE DOSE for covid-19 immunisation. Medical history included gluten sensitivity, food allergy, dairy intolerance, hypothyroidism, dyspnoea, balance disorder, osteoarthritis, sjogren-larsson syndrome. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 post vaccination and not had COVID prior to vaccination. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXIN), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 27Jan2021 16:00, the patient experienced my head gets headaches off and on, my r arm is very sore to the touch and when moving my arm it is very sore. The  outcome of events were not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Tinnitus
Clinical narrative: pain at injection site; nauseated/Nausea; not feeling up to par; headache; ringing in the ears/Ringing in ears; I had like sore arm; This is a spontaneous report from a contactable consumer (patient). This is the first case out of three cases. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 73-year age at the time of vaccination, Batch/Lot number was not reported), via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID-19 vaccine. She reports side effects of "pain at injection site, nauseated and not feeling up to par, ringing in the ears and slight headache. had like sore arm and I feel nausea and little bit ringing in the ear in Jan2021". The outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; nauseated/Nausea; not feeling up to par; headache; ringing in the ears/Ringing in ears; I had like sore arm; This is a spontaneous report from a contactable consumer (patient). This is the first case out of three cases. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 73-year age at the time of vaccination, Batch/Lot number was not reported), via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID-19 vaccine. She reports side effects of "pain at injection site, nauseated and not feeling up to par, ringing in the ears and slight headache. had like sore arm and I feel nausea and little bit ringing in the ear in Jan2021". The outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Pain
Clinical narrative: Having trouble moving arm in any position and trouble turning neck; Intense aches and pains from left shoulder to left scapula to left side of neck.; This is a spontaneous report from a non-contactable consumer. A 22-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 at 13:15 as first dose single for COVID-19 immunization. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. On 27Jan2021 at 16:00, the patient experienced having trouble moving arm in any position and trouble turning neck and intense aches and pains from left shoulder to left scapula to left side of neck. The patient received treatment for events with Tylenol 2 tablets. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is first of 2 reports. A female patient of an unspecified age (Age: 79; Unit: unknown) received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 27Jan2021 as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021 patient received vaccine and have only developed a sore arm on an unknown date in Jan2021. The 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106968 Same reporter/drug/event, different patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; chills; fatigue; This is a spontaneous report from a non-contactable consumer. A 73-year-old non-pregnant female patient received BNT162B2 (COVID 19, brand: Pfizer; Solution for injection, Lot number: EL3249), via an unspecified route of administration on 21Jan2021 as single for COVID-19 immunization. The patient medical history includes iron deficiency. The patient did not have any allergies to medications, food, or other products. Concomitant medication included iron supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 22Jan2021, the patient experienced headache, chills, and fatigue. The patient did not received treatment due to the events. No seriousness criteria reported. The outcome of events was recovered on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: experiencing increasing muscles pains from the waist down to his leg on the right side; his right arm was sore for the first two days but that has went away; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route administration at arm right on Jan2021 at first dose single for COVID-19 immunization. Medical history and patient's concomitant medications were not reported. The patient experienced increasing muscles pains from the waist down to his leg on the right side, his right arm was sore for the first two days but that has went away on an unspecified date. It was reported that, caller stated he received the first dose of the Pfizer COVID vaccine last Wednesday and as the days have gone on he has been experiencing increasing muscles pains from the waist down to his leg on the right side. Caller stated he received the vaccine on the right arm. Caller stated he has not worked out in many years and the muscle pain feel similar to what it feels like after you have worked out. Caller stated after receiving the injection his right arm was sore for the first two days but that has went away and he only has muscle pain from his butt and trunk area down to his leg. Caller would like to know if his symptoms are normal and what he should do regarding his second dose that is scheduled a week from next Wednesday. The outcome of event experiencing increasing muscles pains from the waist down to his leg on the right side was unknown, while the other event was recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Insomnia, Pyrexia
Clinical narrative: upset stomach; insomnia; chills; headache; mild fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 76-year-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced upset stomach, insomnia, chills, headache and mild fever. The outcome for events were unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Diarrhoea, Fatigue, Nausea
Clinical narrative: Blood sugars in the 400 to 500 range. Administered 94 units of insulin. Blood sugars still in the 300 range.; Nausea; diarrhea; Extreme fatigue; This is a spontaneous report from a contactable other HCP (patient). A 58-years-old non- pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262, via unspecified route, in right arm on 27Jan2021 at 14:00 (at 58-years age) as single dose for covid-19 immunization. The patient's medical history included diabetes, hypertension, hypercholesterolemia, previous heart attack, heartburn. The patient had no allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 18:00 the patient had experienced blood sugars in the 400 to 500 range. Administered 94 units of insulin. Blood sugars still in the 300 range and the patient experienced nausea, diarrhea and extreme fatigue. The patient had undergone the lab test which included blood sugars (blood glucose) 400 to 500 range on 27Jan2021 and 300 range on an unspecified date in Jan2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event blood glucose abnormal and the suspect vaccine BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Patient broke out in a red rash all over her body; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration, administered in left arm on 26Jan2021 as single dose for covid-19 immunization. Medical history included Allergies to Mushrooms. On 06Jan2021, patient had first dose of COVID 19 vaccination. Concomitant medication included naproxen sodium (ALEVE). Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Aleve within 2 weeks of vaccination. On 27Jan2021 18:00, the patient broke out in a red rash all over her body. The patient received Benadryl as a treatment for the adverse event. The outcome of the event was recovered.    Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Nausea, Somnolence
Clinical narrative: bad stomach; Fall asleep during the day; Had nausea after sleeping/nauseous; Very tired/tiredness; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 20Jan2021 10:15 as unknown single dose (at the age of 65-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included acid reflux and IBS along with allergies to medications, food, or other products that included raw fruits and veg tree nuts. The concomitant medications included Omeprazole, Famotidine and Cranberry supplement and Cult. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID- 19 since the vaccination. Patient stated that she received her Pfizer covid vaccine on the 20Jan2021 and from 21Jan2021 14:00 she has been having tiredness and nausea while sleeping in the day also. Patient wanted to know about the symptoms and how long they lasts. Patient says she has a bad stomach anyway, but not like this normally. The patient was not treated for the adverse events nausea while sleeping in the day also. The outcome of the event feeling tired and bad stomach was unknown while for others was not recovered.   Upon follow-up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported that: Patient says that she filled out the reporting form online while she was on hold. She clarifies this was on the website. Patient reported about the adverse event she experienced as updated in the initial narrative and is tells this happened everyday and asks whether any else complained about being very tired and having nausea after sleeping which constitutes the medical information request.  NDC and Expiration Date were not provided on her handwritten vaccine card. Patient says that lot number is either E13247, or El3247 as it is handwritten and she cannot tell.  Upon follow-up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported that included relevant medical history, age and pregnancy status at the time of vaccination, drug start date and time and anatomical location, event description with onset date and outcome, batch number updated as unknown from previously reported as E13247, concomitant medication details, treatment details as updated in the initial narrative.   Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepiness; This is a spontaneous report from a contactable Consumer. This male Consumer reported that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 22JAN2021 as single dose for covid-19 immunisation. The patients relevant medical history included knee pain. The patients past drug included aleve and tylen. Patient's concomitant medications were not reported. The patient stated he did not have any side effects from the vaccine except a little sleepiness, and that was all. He reports concern and asks I saw on TV that said Do not take Ibuprofen and tylenol, it makes vaccines ineffective. I took at midnight the night before his shot Aleve and Tylenol before getting the vaccine. Inquiring if the vaccine is ineffective now. The outcome of the event is unknown.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle fatigue, Muscular weakness, Vaccination site pain
Clinical narrative: pain at injection site; chills; muscle fatigue; decreased strenght in bilaterl arms esp right; This is a spontaneous report from a contactable Nurse. A 51-year-old non-pregnant female Nurse received the second dose of BNT162B2 (PFIZER COVID-19 Vaccine; Lot Number: EL3246), via unspecified route in the left arm on 28Jan2021 (Age at the time of vaccination: 51-year-old) as a single dose for COVID-19 immunization. Medical history included TRIPLE NEG BREAST CANCER, GERD, allergy to NOTREL and BACTRIM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included SYNTHROID, PROTONIX and PEPCID (manufacturer unknown). Historical Vaccine included first dose of BNT162B2 (PFIZER COVID-19 Vaccine; Lot number: EK9231) via intramuscular route in left arm on 08Jan2021 at 07:30 as a single dose for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021 at 16:45, patient experienced pain at injection site, chills, muscle fatigue and decreased strength in bilateral arms esp. right. It was unknown if the patient received any treatment for the events. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.