chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Syncope
Clinical narrative: faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received bnt162b2 dose 1 intramuscular in right arm on 13Feb2021 16:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient had known allergies to penicillin and shellfish. Other medical history was not provided. The patient's concomitant medications included atorvastatin, vitamin, fish oil, probiotic. 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. The patient became faint, tired and had chills which caused mild diarrhea from 13Feb2021 05:00 PM. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient received the bnt162b2 dose 2 intramuscular in Right arm on 06Mar2021 01:15 AM (Lot number unknown) at single dose for COVID-19 immunization. The outcome of the event events was recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fungal peritonitis
Clinical narrative: 2 weeks after taking the vaccine and had developed a Peritonitis which is fungal in nature; This is a spontaneous report from a contactable consumer who reported for his father that an 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. Medical history included peritoneal dialysis. The patient's concomitant medications were not reported.  Patient's son asking in behalf of his father seeking information if these is any reported data on patient undergoing peritoneal dialysis experiencing peritonitis (fungal in nature) as a side effect after taking the PFIZER BIONTECH COVID19 vaccine. Also, he was asking if there were any reported serious adverse events as well with other patients with co-morbidities after taking the Pfizer Biontech Covid19 Vaccine. Patient had the first dose of the vaccine 25Feb2021, he is a peritoneal dialysis patient and has been hospitalized since 10Mar2021, 2 weeks after taking the vaccine and had developed a Peritonitis which is fungal in nature (Mar2021). He also mentioned that he and his family has been sanitary and careful in caring for their father given the underlying condition. He also mentioned that 25% of the people he knew with underlying condition such as heart disease, Hashimoto's, Raynaud syndrome and Chron's disease had experience side effects after taking the vaccine. Outcome of the event was unknown.   Information about lot/batch has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Gait disturbance, Investigation
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported that her 56 years-old male son (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on 24Mar2021. Relevant history and concomitant drugs were unknown. The reporter stated that her 56 year old son received his first dose of the Pfizer BioNTech COVID-19 vaccine a day earlier than she received hers (which was on 25Mar2021) and while waiting after getting his vaccination, her son became "very, very dizzy." He told the nurse working at the vaccination site that the dizziness was getting worse and "getting very bad." He was asked how his breathing was and he told the nurse it was okay, but an ambulance was called for him anyways and he was sent to the hospital. Her son reported feeling better when he laid down but still reported feeling dizzy. At the hospital, her son was told that all the test came back okay. When her son got up to use the restroom with the assistance of the doctor, the doctor told him that he was dehydrated and gave him IV fluids. Caller stated that her son reported feeling "a lot better" after the IV fluids but "couldn't hardly walk" and had to have someone else drive him. Her son reported feeling "alright" the next day. Caller stated that she was reading in the information pamphlet on the Pfizer vaccine that a severe reaction could include dizziness. Caller was worried about her son getting his second dose and think she should speak with his physician before receiving his next dose, and would like to know if this was okay. She was concerned because she states that she had heard that people have gotten sick from the second dose of the vaccine. Outcome of the events was resolving. Information about the Lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node above left collar bone; This is a spontaneous report from a non-contactable consumer. A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation.  Medical history were none. No pregnant. No any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Allergies to medications, food, or other products. Historical vaccination included BNT162B2 on 10Mar2021 08:45, in left arm, dose 1, lot number:EN6206 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced swollen lymph node above left collar bone on 01apr202110:00 with outcome of unknown. Appeared approximately 17 hours after the second Pfizer shot. I had not had any reactions after the first Pfizer shot. No treatment.  Follow-up attempts have been completed and no further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dysgeusia, Erythema, Gingival discomfort
Clinical narrative: Very red hands; chemical taste in mouth within 5 minutes of shot; Burning tongue and lower front gums within 10 minutes of shot; Burning tongue and lower front gums within 10 minutes of shot; Throat started to burn and swell within 20 minutes of shot; Throat started to burn and swell within 20 minutes of shot; Blood Pressure shot up to 190 over 90 and don't have high blood pressure; Heart rate increased from resting of 65 to 80's and 90's; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 15:15 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation in hospital. Medical history included asthma, allergies, intolerance to some narcotics and Opioids. Not pregnant at the time of vaccination. No patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccination included BNT162B2 on 3Mar2021 02:45 PM, lot number:EN6205,in right arm, dose 1 for covid-19 immunisation. Concomitant medication(s) included Cortisone shot left shoulder, Rhinocort, Flovent. The patient experienced very red hands and chemical taste in mouth within 5 minutes of shot, burning tongue and lower front gums within 10 minutes of shot, throat started to burn and swell within 20 minutes of shot, blood pressure shot up to 190 over 90 and don't have high blood pressure, heart rate increased from resting of 65 to 80's and 90's on 24Mar2021 15:15 with outcome of not recovered.  Therapeutic measures were taken as 3 tablets of predniSONE 20 mg, Allerest. Events are non serious.  Follow-up attempts have been completed and no further information is expected
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pharyngeal swelling, Throat irritation, Tongue discomfort
Clinical narrative: Very red hands; chemical taste in mouth within 5 minutes of shot; Burning tongue and lower front gums within 10 minutes of shot; Burning tongue and lower front gums within 10 minutes of shot; Throat started to burn and swell within 20 minutes of shot; Throat started to burn and swell within 20 minutes of shot; Blood Pressure shot up to 190 over 90 and don't have high blood pressure; Heart rate increased from resting of 65 to 80's and 90's; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 15:15 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation in hospital. Medical history included asthma, allergies, intolerance to some narcotics and Opioids. Not pregnant at the time of vaccination. No patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccination included BNT162B2 on 3Mar2021 02:45 PM, lot number:EN6205,in right arm, dose 1 for covid-19 immunisation. Concomitant medication(s) included Cortisone shot left shoulder, Rhinocort, Flovent. The patient experienced very red hands and chemical taste in mouth within 5 minutes of shot, burning tongue and lower front gums within 10 minutes of shot, throat started to burn and swell within 20 minutes of shot, blood pressure shot up to 190 over 90 and don't have high blood pressure, heart rate increased from resting of 65 to 80's and 90's on 24Mar2021 15:15 with outcome of not recovered.  Therapeutic measures were taken as 3 tablets of predniSONE 20 mg, Allerest. Events are non serious.  Follow-up attempts have been completed and no further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Irregular breathing, Neck pain, Pain in extremity, Pruritus, Swelling face
Clinical narrative: received her first dose last Friday and 45 mins after the caller said that her face is swollen and she was having itchiness in her whole; received her first dose last Friday and 45 mins after the caller said that her face is swollen and she was having itchiness in her whole body; pain at the back of her neck; her legs started to hurt on the side; breathing issues; This spontaneous report was received from a Pfizer-sponsored program. A Contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (COVID-19 Vaccine) via an unspecified route of administration (Batch/lot number: unknown) as a single dose on 26Mar2021 Friday, for COVID-19 immunization. Medical history and concomitant medications were not reported. On the same day, 45 minutes later, she felt that her face was swollen and she was having itchiness in her whole body. On an unspecified date in Mar2021, her legs started to hurt on the side, had pain at the back of her neck and she also experienced breathing issues. She took Benadryl. Action taken with the suspect was not reported. The outcome of the events of face swollen and itchiness in whole body, legs started to hurt on the side, had pain at the back of her neck and breathing issues was not reported.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid 19 positive on 28Mar2021; This is a spontaneous report received from a Pfizer- sponsored program Covax US Support. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for covid 19 on 28Mar2021. The second dose is scheduled on 13Apr2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360084
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Malaise, Myalgia
Clinical narrative: fever; chills; muscle aches; nausea; fatigue; cough; very sick; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Mar2021 04:00 as single dose for covid-19 immunisation. Within 30 minutes of receiving the vaccine, on 19Mar2021 16:30, patient got very sick: fever, chills, muscle aches, nausea, fatigue, cough. The fever broke early the next morning but the other symptoms remained for 2 more days. At that point, he continued having fatigue, cough, nausea and chills for a further 5-6 days. At that point, and continuing now, he still have low level nausea, fatigue and a cough. It's very slowly getting better but it has take 2 weeks to not feel completely sick. The patient underwent lab tests and procedures which included viral test (Nasal Swab, Aegis PCR): negative on 01Mar2021. No treatment. Outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Polymerase chain reaction, Pyrexia, Viral test
Clinical narrative: fever; chills; muscle aches; nausea; fatigue; cough; very sick; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Mar2021 04:00 as single dose for covid-19 immunisation. Within 30 minutes of receiving the vaccine, on 19Mar2021 16:30, patient got very sick: fever, chills, muscle aches, nausea, fatigue, cough. The fever broke early the next morning but the other symptoms remained for 2 more days. At that point, he continued having fatigue, cough, nausea and chills for a further 5-6 days. At that point, and continuing now, he still have low level nausea, fatigue and a cough. It's very slowly getting better but it has take 2 weeks to not feel completely sick. The patient underwent lab tests and procedures which included viral test (Nasal Swab, Aegis PCR): negative on 01Mar2021. No treatment. Outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: sick and went to the hospital and had Covid pneumonia; sick and went to the hospital and had Covid pneumonia; This is a spontaneous report from a non-contactable consumer (patient).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient stated he took his 1st Pfizer vaccine dose on 14Jan2021 and then on 02Feb2021 he was sick and went to the hospital and had Covid pneumonia. He was in hospital until 09Feb2021, when he was discharged they said he should isolate for 7 days (until 16Feb2021). The patient stated that (Pharmacy name) came  on 24Feb2021 to give the 2nd vaccine dose and he was told by (Pharmacy name) that he had to wait 30 days to get his next shot. The patient asked when can he safely get the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021364193 similar report from same reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: small reaction; This is a spontaneous report from a contactable HCP . This HCP reported for a 67-years-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Patient's medical history included age related osteoporosis. Type of historical vaccine was reported as vaccination adverse reaction (unspecified). Concomitant medications included abaloparatide (TYMLOS) via a subcutaneous route from 10Aug2019 to ongoing at 80 mcg 1x/day for Age related osteoporosis without therapy. It was reported that the patient took the covid vaccine and had small reaction. Case description: This potential case reported by pharmacy from a consumer is considered invalid with the initial information provided. the case report is missing one or more of the following ICSR minimum elements as defined by the regulations: Adverse event. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Drug ineffective
Clinical narrative: Does this mean the first dose doesn't work; had an allergic reaction; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Feb2021 as a SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medication were not reported. On 24Feb2021 got first dose and had an allergic reaction to vaccine. The patient enquired about getting the second dose and does that mean vaccine does not work. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Mild Sore throat; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 10:30 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation.  The patient medical history was not reported. No pregnant. 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 or been tested for COVID-19. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC ALLERGY); paracetamol (TYLENOL); ibuprofen. The patient previously took amoxicillin and experienced hypersensitivity, septra and experienced hypersensitivity.  The patient experienced mild sore throat on 01Apr2021 04:00 with outcome of unknown. No treatment.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Blood cholesterol, SARS-CoV-2 test positive, Thyroid function test
Clinical narrative: Caller got her first dose of the vaccine on 26MAR2021/Caller tested positive on 29MAR2021; This is a spontaneous report from a contactable consumer or other non hcp (patinet).  A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:15 (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Medical history included neck surgery from 2007 to an unknown date, neck surgery from 2010 to an unknown date, migraine, cluster headache, rash on his upper back, feels a little bit itchy on his upper back on 16Mar2021. The patient's concomitant medications were not reported. The patient experienced caller got her first dose of the vaccine on 26Mar2021/caller tested positive on 29Mar2021, she had no symptoms but did not feel 100%, she's wondering if it's dangerous to get vaccinated while having covid, caller believes she might have had covid while she got the vaccine.  She's been doing a lot of gardening and working like a maniac" yet no coughing or sneezing. She would like to know if she would notify somebody or if it is safe for her to take the 2nd dose. She also mentioned that she didn't have any symptoms and she didn't know what she was exposed to. Caller stated there were no medical conditions for herself that she feels is related to the reported events but states she is on disability and had two neck surgeries and one was in 2007 and the other was in 2010, stating she had chronic migraines and cluster headaches that she sees a neurologist for and was diagnosed around 2010. Also stated that she had blood drawn the day before on 25Mar2021 just to test her cholesterol and for her thyroid as a routine thing.  She did not have results for that testing yet. The HCP only tested the cholesterol, thyroid and stuff so she could refill medications for that.  No vaccines administered on same date of the pfizer suspect. The patient underwent lab tests and procedures which included blood cholesterol and thyroid function test on 25Mar2021 whereas sars-cov-2 test was positive on 29Mar2021. The outcome of events was unknown.  Follow-up information requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain
Clinical narrative: headache; chills; joint pain; body ache; This is a spontaneous report received from Pfizer-sponsored program. A male contactable consumer (patient) reported for himself that, a male patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 1 intramuscular on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient called to report that on the 27Mar2021 he experienced headache, chills, body ache and joint pain three days after he received his 1st dose on 24Mar2021, his 2nd dose schedule was on 17Apr2021. The patient experienced headache, chills, joint pain, and body ache on 27Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have Covid; I have Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN6204) as a SINGLE DOSE for COVID-19 immunisation. The patient's medical and concomitant medications were not reported. The patient experienced "I have covid" on an unspecified date prior to the second dose of bnt162b2 (next dose was due 30Mar2021). The clinical outcome of the event drug ineffective and COVID-19 was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Came down with Bell's palsy symptoms 5 days after injection on the Right side of my face.; This is a spontaneous report from a contactable consumer reported for himself. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 27Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on 06Mar2021 for covid-19 immunization. The patient medical history included allergies to penicillin.   The patient's concomitant medications were not reported.  The patient came down with bell's palsy symptoms 5 days after injection on the right side of face on 01Apr2021 06:00. Facial paralysis resulted in emergency room visit. Therapeutic measures were taken as a result of facial paralysis included Steroid and Viral scripts. The outcome of event was unknown. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Head discomfort, Headache, Hypoaesthesia, Multiple sclerosis relapse
Clinical narrative: Flared up Multiple sclerosis; flared up optic Neuritis; numbness; pressure at the base of her neck; head pressure; headache; muscle problems in mouth; problems in mouth with speech; problems in mouth with speech and swallowing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation; hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indictaion. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine and when the shot was given had a wave of numbness and pressure at the base of her neck and intense head pressure that flared up optic neuritis. Extreme headache and still has it since getting the vaccine on Friday. It caused muscle problems in mouth with speech and swallowing, flared up multiple sclerosis. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder, Musculoskeletal discomfort, Optic neuritis, Speech disorder
Clinical narrative: Flared up Multiple sclerosis; flared up optic Neuritis; numbness; pressure at the base of her neck; head pressure; headache; muscle problems in mouth; problems in mouth with speech; problems in mouth with speech and swallowing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation; hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indictaion. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine and when the shot was given had a wave of numbness and pressure at the base of her neck and intense head pressure that flared up optic neuritis. Extreme headache and still has it since getting the vaccine on Friday. It caused muscle problems in mouth with speech and swallowing, flared up multiple sclerosis. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthenia, Heart rate irregular, Loss of consciousness, Nasopharyngitis
Clinical narrative: passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Rash
Clinical narrative: passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19/ he has recovered from the infection and he has no symptoms already; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (manufacturer: Pfizer) on 12Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included tetanus vaccine toxoid (TETANUS ADS IMPFSTOFF) on 20Mar2021, measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN) on 20Mar2021. Patient is due for the second dose of the vaccine tomorrow, 02Apr2021. However, on 22Mar2021, he has tested positive for COVID-19. He said that more or less he has recovered from the infection and he has no symptoms already. He wanted to know if he should be taking it tomorrow or not. Patient also mentioned that on 20Mar2021 he had 2 other vaccines, tetanus and MMR vaccines. Patient asked if they would interfere with bnt162b2. The outcome of the event was recovered. Event was considered serious as medically significant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the temporal relationship, the association between the event COVID-19 with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got symptoms of Covid and tested positive; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number) via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient had got first Pfizer shot on March 13th, Saturday and 1 week Later on March 20th I got symptoms of Covid and tested positive, two days later got an antibody infusion. My doctor says get the second shot 2 weeks after I feel 100% or close. The CDC guidelines say "If I got the shot and the antibodies, I should wait 90 Days". The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was reported as unknown  Follow-up activities has been raised. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test and tested positive/feeling a little sick with headache, runny nose and a sore throat; Covid test and tested positive/feeling a little sick with headache, runny nose and a sore throat; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 11Mar2021, the following Saturday (13Mar2021), the patient started feeling a little sick with headache, runny nose and a sore throat. The patient got a covid test and tested positive and then went again on Thursday (15Mar2021) and it came back negative. The patient wanted to know if it has shown positive covid test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received vaccine 19 days ago and now tested positive for COVID-19; Received vaccine 19 days ago and now tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 10Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine 19 days ago and now (29Mar2021) tested positive for COVID-19. The patient wanted to know if it was ok to get the second shot. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Optic neuritis, Sudden visual loss
Clinical narrative: Left retrobulbar optic neurtis of the left eye post vaccination 10 days -2 weeks; Vision loss is reported as sudden in onsent and constant in the left eye per patient; This is a spontaneous report from a contactable physician. A 22 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL1284) at the age of 21 years via intramuscular, administered in arm left on 18Jan2021 08:45 as single dose for covid-19 immunisation. Medical history included heart murmur, history of COVID-19 in Oct2020. Patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  Patient previously received first dose of BNT162B2 (Lot number: ek5730) at the age of 21 years via intramuscular, administered in arm left on 28Dec2020 as single dose for covid-19 immunisation. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine, nor received any medications within 2 weeks of vaccination. Left retrobulbar optic neuritis of the left eye post vaccination 10 days -2 weeks since 31Jan2021 08:00 AM. Patient had IV steroid infusions for 5 days, oral steroids to follow. Tapered down from 75mg prednisone. Patient had to have MRI. Vision loss was reported as sudden in onset and constant in the left eye per patient. Patient visited doctor office/clinic or emergency room and requiring urgent care. Treatment included infusions, prednisone, MRI. Patient has not tested COVID post vaccination. Outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: psychiatric issue; This is a spontaneous report from a contactable consumer reported for his son. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was unable to receive the second dose as of today 01Apr2021.  He was currently inpatient in the behavior health unit for an unrelated psychiatric issue.  Father and psychiatrist wanted him to receive the second dose of the vaccine, but the hospital was unwilling to administer the vaccine.   He was going to be transferred to hospital in another state and the hospital there said they wanted him to get vaccinated before he arrived. Father stated psychiatric issue was unrelated. The outcome of the event was unknown.  Information of Lot /batch number are requested.; Sender's Comments: The event of psychiatric issue was considered as an intercurrent condition and unrelated to the use of BNT162B2.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Face injury, Fall, Fatigue, Loss of consciousness, Pain
Clinical narrative: fainted/blacked out; fainted/blacked out; Fell on floor; Tired; achey all day; Face hurt and swelling from fall; Face hurt and swelling from fall; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (age at vaccination: 20 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: EP7533) in left arm on 31Mar2021 12:15 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Clinic. Medical history was none. Known allergies was no. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are no other medications the patient received within 2 weeks of vaccination. Patient experienced fainted/blacked out, fell on floor, tired and achey all day (Face hurt and swelling from fall), all on 01Apr2021 06:30 AM with outcome of recovering. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Syncope
Clinical narrative: fainted/blacked out; fainted/blacked out; Fell on floor; Tired; achey all day; Face hurt and swelling from fall; Face hurt and swelling from fall; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (age at vaccination: 20 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: EP7533) in left arm on 31Mar2021 12:15 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Clinic. Medical history was none. Known allergies was no. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are no other medications the patient received within 2 weeks of vaccination. Patient experienced fainted/blacked out, fell on floor, tired and achey all day (Face hurt and swelling from fall), all on 01Apr2021 06:30 AM with outcome of recovering. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chromium, Blood chromium increased
Clinical narrative: elevated levels of chromium; This is a spontaneous report from a contactable other HCP (patient).  A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC: 59267-1000-02), dose 2 intramuscular, administered in arm right at the age of 39-year-old on 07Jan2021 (Lot Number: EJ1685) as single dose for COVID-19 immunisation, tocopherol (VITAMIN E), route of administration, start and stop date and dose were not reported for an unspecified indication. Medical history included NASH (non-alcoholic steatohepatitis) from 2015 and ongoing. There were no concomitant medications. The patient previously took first dose of bnt162b2 (lot number: EJ1685) in left arm at the age of 39-year-old on 18Dec2020 for COVID-19 immunisation. Had elevated levels of chromium on 31Mar2021 and only took the vaccine and vitamin E during this period of time. It was asked if it was something related to the vaccine. Caller states she had two rounds of Pfizer COVID-19 vaccine on 18Dec2020 at 10Am and 07Jan2021 sometime in the afternoon. Caller states that all of a sudden come up with an extremely abnormal amount of chromium in her body. Caller states she just found out yesterday (31Mar2021) and the test was performed on 02Mar2021. Causality: Unknown. Caller states she has not taken anything else in the previous 90 days prior to the vaccine. No medications or supplements or anything, which is why they are concerned this is from the vaccine. Reporter seriousness for abnormal amount of chromium in her body was Medically significant. The patient underwent lab tests and procedures which included blood chromium: 2979 ug/kg on 02Mar2021, blood chromium: elevated/abnormal amount on 31Mar2021. The action taken in response to the event for tocopherol was unknown. The outcome of the event was unknown.; Sender's Comments: Based on known drug profile it is unlikely that the reported blood chromium: elevated was causally  related to bnt162b2.  This is probably an intercurrent  medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: its been 70 days since from the first dose and wanted to know should they give him his second dose now or do they need to start over the series; tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable pharmacist. A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number, expiration date were not reported ), dose 1 via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunisation. Medical history included disable. Concomitant medications were not reported. On an unspecified date in Feb2021, the patient tested positive for COVID. The pharmacist stated its been 70 days since from the first dose and wanted to know should they give him his second dose now or do they need to start over the series. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Feb2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event cov id 19 ____ and the suspect drug _BNT162B2___.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; This is a spontaneous report from a non-Contactable consumer. This consumer (patient's husband) reported for a female patient (wife) of unspecified age that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The medical history and concomitant medications were not reported. Consumer said his wife was scheduled to receive the 2nd dose next week. He said his wife had rheumatoid arthritis with outcome of unknown, and was currently taking methotrexate and abatacept (ORENCIA) infusion.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test positive, Vaccination failure
Clinical narrative: already got the 2 doses of the vaccine; result came on 26th March positive; This is a spontaneous report from a contactable consumer reported a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: unknown), via unspecified route of administration in left arm on 11Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received historical vaccine of BNT162B2 in Jan2021 for COVID-19 immunisation (1st dose was 3 weeks before the 2nd dose). It was reported patient was tested on Wednesday 24Mar2021 and the result came on 26Mar2021 positive, already got the 2 doses of the vaccine, the second dose was on 11Feb2021 and the 1st dose was 3 weeks before the 2nd dose. The outcome of the event COVID-19 positive was unknown.  Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspepsia, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous report received from a contactable consumer(patient).  A 75-years-old female received second dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot no: EL9267), via an unspecified route of administration in Arm Right as SINGLE DOSE for covid-19 immunisation on 12-FEB-2021. Medical history included Diabetes mellitus from an unknown date in 2002 and unknown if ongoing, gastroesophageal reflux disease from 2010 and unknown if ongoing, Gall bladder reflux surgery and blood cholesterol from 2014. Concomitant medication included farxiga (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10mg from 2018, esomeprazole sodium (ESOMEPRAZOLE SODIUM) 40 mg, Januvia (SITAGLIPTIN) 100 mg, montelukast (MONTELUKAST)-10 mg, atorvastatin calcium (ATORVASTATIN CALCIUM) 80 mg, hydrochlorothiazide(HYDROCHLOROTHIAZIDE) 12.5 mg. All the drugs are ongoing.On 13Feb2021, patient experienced body aches, fever, nasty taste, dark urine, backache, heartburn, fatigue. There was no treatment due to events. The  outcome of events were recovered.  No follow-up attempts are needed. No further information is expected.