chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Headache, Myalgia
Clinical narrative: Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; weakness; feverish; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN- reported as misplace/discarded), dose 1 via an unspecified route of administration, administered in left arm (at the age of 40 years) on 21Dec2020 at 12:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There was no patient medical history. The patient had no known allergies to medications, food, or other products. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 21Dec2020 at 14:30, 2.5 hours after the vaccine, the patient had steadily increasing headache, muscle ache, weakness and feverish. He took 250mg Tylenol. At 5.5 hours after the vaccine, his headache was so severe that he went to the Emergency Department of the facility he works in. Treatment for the adverse event included 1gram Tylenol, IV with saline and another drug (unspecified). The patient did not have COVID-19 prior to vaccination. On 24Mar2021, post vaccination, he was tested for COVID-19 via nasal swab with a positive result. The outcome of headache, muscle ache, weakness and feverish was recovered. The outcome of COVID-19 was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; weakness; feverish; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN- reported as misplace/discarded), dose 1 via an unspecified route of administration, administered in left arm (at the age of 40 years) on 21Dec2020 at 12:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There was no patient medical history. The patient had no known allergies to medications, food, or other products. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 21Dec2020 at 14:30, 2.5 hours after the vaccine, the patient had steadily increasing headache, muscle ache, weakness and feverish. He took 250mg Tylenol. At 5.5 hours after the vaccine, his headache was so severe that he went to the Emergency Department of the facility he works in. Treatment for the adverse event included 1gram Tylenol, IV with saline and another drug (unspecified). The patient did not have COVID-19 prior to vaccination. On 24Mar2021, post vaccination, he was tested for COVID-19 via nasal swab with a positive result. The outcome of headache, muscle ache, weakness and feverish was recovered. The outcome of COVID-19 was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Influenza
Clinical narrative: hallucinations; strong flu symptoms; This is a spontaneous report received from a contactable other HCP (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), second dose via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 (at the age of 40 years old, not pregnant), single dose for covid-19 immunisation. Medical history included chronic migraines secondary to an old neck injury. The patient previously took tetracycline, minocycline, experienced allergies. The patient had her first dose of bnt162b2 (lot_number=EM9809)for covid-19 immunisation on 13Feb2021 11:00, left arm. On 07Mar2021 0100, patient woke up at 1 am with strong flu symptoms and hallucinations. She saw a gigantic bunny standing next to her, and three clowns who were talking to her. The clowns and bunny were not concerning to her, but very real, and she vividly remembers having a conversation with them for hours. Later, she found it funny, but they were just so real. Again, it wasn't a problem since she was lying in bed anyway, so was interesting and so real. The bunny and clown stayed with her until 5am when she fell back asleep and were gone when she awoke at 9am. The outcome of the events was recovered on 07Mar2021 0900. No treatment received for the events.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument to suggest a causal relationship for BNT162B2 in development of serious Hallucination and non-serious Influenza. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I was diagnosed with covid on 24Mar; I was diagnosed with covid on 24Mar; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and the patient's concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The patient received her first vaccine dose on 08Mar2021. After that she got symptoms on 16Mar2021 and was diagnosed with COVID-19 on 24Mar2021. She was over her symptoms and was feeling better. The outcome of COVID19 was recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cellulitis, Fall
Clinical narrative: cellulitis; fallen; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 27Feb2021 (Lot:EN6198, expiry:30Jun2021) as a single dose for covid-19 immunisation; and potassium, via an unspecified route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included ongoing non-ischemic cardiomyopathy. Concomitant medications included atenolol taken for cardiomyopathy, magnesium (MAGNESIUM) taken for an unspecified indication, and furosemide, potassium chloride (LASIX + K) taken for an unspecified indication. The patient was diagnosed cellulitis and was prescribed with cortisone and antibiotics, she was taking 2 antibiotics, named one as Bactrim and unable to name second one, possibly Cefaxin. She was prescribed with prednisone now. She was wondering if the prednisone would interact with the vaccine. Patient had blood work and everything was normal, including new blood tests yesterday. Went off a particular medication, had been on a high dose of Magnesium because she was taking Lasix and Potassium so this test was checking all of that. She hasn't heard back regarding the test yet but is not anticipating any problems. Patient wanted to know if she should take an antibody test to determine if she already gained immunity then she could take her prednisone. It was also reported that about 5 or 6 days before her second shot, which was this past Saturday, she went to her orthopedic doctor and got 2 shots of Cortisone, 1 in each shoulder. Patient had fallen a week before her doctor thought there was a hairline fracture not picked up on the first X-ray. Stated she was supposed to start prednisone and was reading the pamphlet. Patient wanted to know if this would interfere and if taking steroids after the vaccine will interfere with the efficacy of the vaccine. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Illness, SARS-CoV-2 test
Clinical narrative: He contracted Sars-CoV-2 in-between doses/ her husband tested positive with Covid a week after his first dose on 03/11/2021; Still has symptoms of illness; extremely dizzy; was tired before this, but is still tired all the time; This is a spontaneous report from a contactable consumer (patient's wife). A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date a week after taking the first dose, the patient experienced he contracted Sars-CoV-2 in-between doses/ her husband tested positive with COVID a week after his first dose on 11Mar2021 and still has symptoms of illness. The reporter stated that her husband was extremely dizzy and was tired. The reporter stated that the patient was tired even before this, but was still tired all the time. The reporter wanted to know whether dizziness be a symptom of vaccination. The reporter is due to receive his second dose on 01Apr2021. The patient still has symptoms of illness. The reporter wanted to clarify whether the patient should go for his second dose as scheduled. On an unspecified date, the patient underwent SARS-CoV-2 test: positive. The reporter classified the event as non-serious. The outcome of the event extremely dizzy was unknown and was not recovered for the rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Speech disorder, Trismus
Clinical narrative: aphasia; difficulty speaking; Jaw: Trismus; This is a spontaneous report from a non-contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 24Mar2021 (batch/lot number: ER8727) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Mar2021 during her 15 minute waiting period after the injection, the patient began to experience difficulty speaking. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Jaw: trismus present. Treatment included: no therapy. Follow up response to treatment: no change. Patient transported to ED by ambulance. Differential diagnosis: systemic reaction (hypoglycemia, hypotension, generalized rash) and red flag symptoms (CP, SOB, NVD, visual/neuro concerns). Patient with no other neuro deficits but aphasia was clearly present. AMR called to have patient brought to ED for further evaluation. Husband, will meet her there. The report was assessed as non-serious. The outcome of the events "difficulty speaking" and "trismus" was not recovered; and unknown for aphasia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The company cannot completely rule out a reasonable possibility that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) caused the aphasia (speech disorder) and trismus due to a reportedly close drug event chronological association. Information on further evaluation would be necessary for a more meaningful medical assessment.  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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive in Covid-19; tested positive in Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband reported that the patient got already the first dose of the vaccine and have a second dose scheduled tomorrow. He wanted to reschedule the second dose because his wife (patient) was tested positive in Covid-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Internal haemorrhage
Clinical narrative: internal bleeding; had shingles before getting the vaccine /recovered but after getting the vaccine "I've broken out again"/breakout again of Shingles; This is a spontaneous report received from a contactable consumer reporting for herself   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 15Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Shingles. Concomitant medications were not reported. On 15Mar202 after the vaccination the patient was hospitalized for internal bleeding. It was informed patient  has been out of the hospital for a week and a half. The patient also reported she had shingles on an unspecified date before getting the vaccine that was recovered,  but after vaccination she had broken out again"/breakout again of Shingles. At the time of the reporting events outcome was unknown. The patient was scheduled for second dose of vaccine on 05Apr2021.    Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had COVID symptoms on 20Mar2021 and diagnosed with COVID on 22Mar2021; had COVID symptoms on 20Mar2021 and diagnosed with COVID on 22Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162B2 (Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 05Mar2021 at 10:30 AM at age of 45-year-old at single dose for covid-19 immunisation. Medical history included hypertension. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine received. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Concomitant medication included amlodipine besilate/ benazepril (5-40mg). The patient had COVID symptoms on 20Mar2021 and diagnosed with COVID on 22Mar2021. Lab tests and procedures included Lumiradx sars cov2 ag test (nasal swab) on 22Mar2021 showed positive. No treatment was received for the adverse event. The outcome of event was unknown.  Follow up are needed. Information of lot/batch number available.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Oral discomfort
Clinical narrative: upper lip starting to swell; discomfort of lip; Numbness of lip; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 29Mar2021 at 15:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure and cholesterol medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced upper lip starting to swell, discomfort of lip, and numbness of lip on 31Mar2021 at 07:30. It was reported that the upper lip swelling was noticed during breakfast and throughout the day, it got increasingly worse. There was no pain, just discomfort and numbness. The patient did not receive any treatment as a result of the events. The clinical outcome of upper lip starting to swell, discomfort of lip, and numbness of lip was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash under left arm; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (Batch/Lot number was not reported), via an unspecified route of administration at the age of 51-year-old at arm left on 26Mar2021 09:00 at single dose for COVID-19 immunization. Medical history was not reported. The patient wasn't allergies to medications, food, or other products. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced rash under left arm and swollen lymph node on 28Mar2021. The patient hasn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient hasn't received other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There was no treatment for events. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This is a spontaneous report from a contactable consumer (patient's mother). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had seizures. The patient's mother was worried that patient might develop fever; and was asking how soon after the vaccination could she give paracetamol (TYLENOL). The outcome of the event, seizures, was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Retinal haemorrhage, Vitreous detachment
Clinical narrative: vitreous detachment; 5 hemorrhages in her eye/hemorrhage on the eye (retina); This is a spontaneous report from a Pfizer Sponsored Program  received from a contactable pharmacist (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She mentioned that she got her first dose vaccine on 05Mar2021 at pharmacy. The patient reported that two weeks and two days after (21Mar2021), she experienced vitreous detachment, her vitreous detached from the retina and she already had had 5 hemorrhages in her eye. She mentioned that her second dose is due on Friday, 02Apr2021 and she requested information on this specific side effect to make an informed clinical decision on whether or not to get her second dose of the vaccine this Friday. She mentioned that she does not know if this happened because of the vaccine or not. She added that she had a hemorrhage on the eye (retina). The outcome of the events was unknown.   Information on lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported vitreous detachment and retinal haemorrhage.  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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID19 pneumonia, bilateral infiltrates, hypoxia/COVID-19 confirmed by positive COVID-19 test; COVID19 pneumonia, bilateral infiltrates, hypoxia/COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician.   A 67 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration on 04Feb2021(at age of 66 years old) (Lot Number: EN5318), the first dose via Intramuscular route on 14Jan2021 (at age of 66 years old) (Lot Number: EL3249), both  at single dose for covid-19 immunisation .  Medical history included closed head injury, migraine headaches, nephrolithiasis, seizure disorder, HTN (as reported). No Known allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient was exposed to COVID by contact with a friend developed COVID symptoms around 24Mar2021,  and had to be hospitalized with COVID19 pneumonia, bilateral infiltrates, hypoxia.  Events resulted in Hospitalization. Still hospitalized as of the time of this writing. Remdesivir, steroids, supplemental oxygen received as treatment for the adverse events. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient been tested for COVID-19, Covid test type was Nasal Swab and tested with positive result. Outcome for events was unknown.   No follow-up attempts possible. No further information expected.; Sender's Comments: Based on known drug safety profile, the events of vaccination failure and COVID-19 pneumonia are assessed as related to the suspect vaccine BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she got COVID-19; she got COVID-19; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got covid-19 on an unspecified date with outcome of unknown. It was reported that the patient got first dose of the vaccine last 15MAR2021. She mentioned that she got COVID-19, and was asking how long in between can she take the second dose. She asked what would happen if she took the vaccine at the recommended interval.   No follow-up attempts are needed. No further information is expected, batch/lot number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Hyperhidrosis, Loss of consciousness, Paraesthesia
Clinical narrative: passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very hot and sweating; This is a spontaneous report received from a contactable consumer (patient) . A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EP7533) as single dose (at the age of 45 years old) for covid-19 immunisation.  The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included magnesium citrate taken for an unspecified indication, start and stop date were not reported.  It was reported that about five minutes after the shot, the patient passed out in the observation area. When he awoke, his fingers were tingling on both hands, a was very hot and sweating, and his breathing was labored. Events onset date was 27Mar2021. The patient received lactated ringers as treatment. The outcome of the reported events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Pain
Clinical narrative: After normal fatigue and general aches the day of the vaccine, today I developed a random nosebleed which took approximately 15 minutes to stop with pressure.; After normal fatigue and general aches the day of the vaccine, today I developed a random nosebleed which took approximately 15 minutes to stop with pressure.; After normal fatigue and general aches the day of the vaccine, today I developed a random nosebleed which took approximately 15 minutes to stop with pressure.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 30Mar2021 02:15 PM (Lot Number: EP6955) at single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient's medical history and concomitant medications were none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine or other medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (lot number: EN6206), on 13Mar2021, 02:30 PM in right arm for covid-19 immunization. After normal fatigue and general aches the day of the vaccine, today patient developed a random nosebleed which took approximately 15 minutes to stop with pressure. Adverse events started from 31Mar2021 01:00 PM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The patient had recovered from the events. Seriousness criteria was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Illness, Rash pruritic
Clinical narrative: I broke out in a very itchy rash with blisters on my right forearm then in my left forearm.; I broke out in a very itchy rash with blisters on my right forearm then in my left forearm.; I was very sick for 8 days; This is a spontaneous report received from a contactable consumer (patient). A 55-years-old-female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiration date: Not reported) via an unspecified route of administration in right arm on 01Mar2021 at 15:15 at single dose for COVID-19 immunisation. The patient Medical history included allergic to sulfa drugs, chocolate and peanuts. The concomitant medications were not reported. It was reported that she have several medications she take daily. The patient was very sick for 8 days and a few days after that she broke out in a very itchy rash with blisters on her right forearm then in my left forearm. She is still dealing with the rash and itching on her left forearm on 01Mar2021 at 8:00 PM. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient visited emergency room. It was reported that she was given a shot please medicine. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: Dizziness; body chills; body aches (arm); headache; tired; sleepy; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in left arm on 22Mar2021 12:30 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included high blood pressure, prostate cancer, COVID-19. Concomitant medications included amlodipine besylate, tamsulosin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced dizziness, body chills, body aches (arm), headache, sleepy, tired on 22Mar2021 23:00 with outcome of recovering. No treatment was received. Patient would like to know if the second dose of the vaccine will give me the same reaction. Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, has the patient been tested for COVID-19 was no.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Dizziness; body chills; body aches (arm); headache; tired; sleepy; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in left arm on 22Mar2021 12:30 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included high blood pressure, prostate cancer, COVID-19. Concomitant medications included amlodipine besylate, tamsulosin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced dizziness, body chills, body aches (arm), headache, sleepy, tired on 22Mar2021 23:00 with outcome of recovering. No treatment was received. Patient would like to know if the second dose of the vaccine will give me the same reaction. Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, has the patient been tested for COVID-19 was no.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 16:30 (at the age of 54-years old) (Batch/Lot Number: EP7534) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced positive COVID-19 test with symptoms on 27Mar2021 with symptoms of fever and chills on 29Mar2021. The patient underwent lab tests and procedures which included Sars-Cov-2 test: positive on 27Mar2021.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Total lost of vision in the left eye for about one minute; This spontaneous report from a contactable consumer reporting for herself   An 83-year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 30Mar2021 at 09:00 at single dose via an unspecified route of administration  on left arm for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included unspecified antidepressants and levothytoxine. On 30Mar2021 on 15:30 the patient experienced total lost of vision in the left eye for about one minute. The patient recovered from the event on 30Mar2021.    Information on the lot/batch number has been requested. Follow up attempts are needed.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Localised oedema, Pharyngeal oedema, Vaccination site pain
Clinical narrative: chills; fatigue; injection site pain; swelling of neck; swelling throat; This is a spontaneous report form a contactable consumer(patient). A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 at 15:30 at single dose for COVID-19 immunisation at the age of 30-year-old. Medical history was none. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D 12 HOUR), ergocalciferol, retinol palmitate (VITAMINS A & B), paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient experienced chills, fatigue, injection site pain, swelling of neck and throat on unknown date. The patient was not treated due to the events. The patient recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19, UNK
Symptoms: Petechiae
Clinical narrative: Blue spots on chest and legs skin; This is a spontaneous report from a contactable consumer reporting for the father. A 91-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Mar2021, as single dose, for COVID-19 immunisation and apixaban (ELIQUIS), via an unspecified route of administration, from an unspecified date and ongoing, at unspecified posology, as anticoagulant therapy. The patient's medical history and concomitant medications were not reported. The patient experienced blue spots on chest and legs skin (non-serious) on 18Mar2021 with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: red rashes on left foot, left pan and finger joints; itching; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- ER8727 ), via an unspecified route of administration, in left arm on 20Mar2021 at 12:30 (at the age of 43-years-old) at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food or other products. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced red rashes on left foot, left pan and finger joints and itching from 27Mar2021 at 04:15 PM. It was unknown if treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: I am having fatigue; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was ER2613),via an unspecified route of administration, administered in Left arm on 27Mar2021 at 13:30 (at the age of 48-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 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 and since the vaccination has not been tested for COVID-19. The patient experienced fatigue and muscle soreness on 30Mar2021. The events were reported as non-serious. No treatment was given for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Pain in extremity
Clinical narrative: Arm pain; Tired; Abdominal swelling; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730), via an unspecified route of administration, in left arm on 27Mar2021 at 12:00 (at the age of 60-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced arm pain, tired and abdominal swelling on 29Mar2021. The events were reported as non serious. The patient didn't receive any treatment for the events. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever of 102; Chills; Body ache; Headache; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration in left arm on 29Mar2021 at 15:00 (at the age of 20-years-old) at a single dose for COVID-19 immunization. The patient was diagnosed with COVID-19 on an unspecified date prior to vaccination. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient was not pregnant. No other vaccine was given in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever of 102, chills, body ache, headache and tiredness on 29Mar2021. The patient did not receive any treatment for the events. The outcome of the events was recovered in Mar2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102; Chills; Body ache; Headache; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration in left arm on 29Mar2021 at 15:00 (at the age of 20-years-old) at a single dose for COVID-19 immunization. The patient was diagnosed with COVID-19 on an unspecified date prior to vaccination. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient was not pregnant. No other vaccine was given in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever of 102, chills, body ache, headache and tiredness on 29Mar2021. The patient did not receive any treatment for the events. The outcome of the events was recovered in Mar2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dysarthria, Facial paralysis, Scan brain, Vision blurred
Clinical narrative: Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared 20-30 approx; Inability to see or focus and many more serious conditions sppeared 20-30 approx; slurred speech; confusion; This is a spontaneous report from a contactable consumer reporting for himself. A 55-years-old male patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at School or Student Health Clinic, via an unspecified route of administration, administered in right arm on 29Mar2021, at 55 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergy to penicillin and sulfa since an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. On 29Mar2021 at 12:00 the patient experienced facial paralysis on right side, inability to see or focus and "many more serious conditions appeared 20-30 approximately after injection", slurred speech and confusion, all assessed serious for disability. The patient visited his doctor and was prescribed with unspecified medications and a brain scan. The brain scan was performed on an unknown date and no result were provided. At the time of the report the reported events had not resolved yet.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared 20-30 approx; Inability to see or focus and many more serious conditions sppeared 20-30 approx; slurred speech; confusion; This is a spontaneous report from a contactable consumer reporting for himself. A 55-years-old male patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at School or Student Health Clinic, via an unspecified route of administration, administered in right arm on 29Mar2021, at 55 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergy to penicillin and sulfa since an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. On 29Mar2021 at 12:00 the patient experienced facial paralysis on right side, inability to see or focus and "many more serious conditions appeared 20-30 approximately after injection", slurred speech and confusion, all assessed serious for disability. The patient visited his doctor and was prescribed with unspecified medications and a brain scan. The brain scan was performed on an unknown date and no result were provided. At the time of the report the reported events had not resolved yet.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood bilirubin increased, Jaundice, Liver function test, Liver function test increased
Clinical narrative: has symptoms of an autoimmune liver injury; elevated liver function tests; elevated liver function tests and bilirubin; jaundice; This is a spontaneous report from a non-contactable pharmacist. A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient has symptoms of an autoimmune liver injury with elevated liver function tests and bilirubin and the patient had jaundice. Caller stated that this is not viral and nothing else has changed with the patient. Caller would like to know if the patient's symptoms are capable of being linked to the Pfizer COVID vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be fully excluded based on temporal relationship and due to the lack of alternate explanation at this time. The information provided is limited and does not allow for a complete medical assessment. 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.
Sex: M
Vaccine: COVID19
Symptoms: Liver injury
Clinical narrative: has symptoms of an autoimmune liver injury; elevated liver function tests; elevated liver function tests and bilirubin; jaundice; This is a spontaneous report from a non-contactable pharmacist. A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient has symptoms of an autoimmune liver injury with elevated liver function tests and bilirubin and the patient had jaundice. Caller stated that this is not viral and nothing else has changed with the patient. Caller would like to know if the patient's symptoms are capable of being linked to the Pfizer COVID vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be fully excluded based on temporal relationship and due to the lack of alternate explanation at this time. The information provided is limited and does not allow for a complete medical assessment. 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea haemorrhagic, Oropharyngeal pain, Viral infection, Vomiting
Clinical narrative: bloody (moderate amount of blood) diarrhea; vomiting; she developed a virus but her medical team could not determine what type of virus it was; sore throat; feels weak; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 25Mar2021, she developed a virus but her medical team could not determine what type of virus it was. She experienced bloody (moderate amount of blood) diarrhea, vomiting and was in the hospital from Mar2021 for treatment. She also states that she has a sore throat and feels weak on an unspecified date in Mar2021. She is due for her second Pfizer Covid vaccine dose 01Apr2021 and wants to know if it is safe to do so. The reporter feels that her symptoms are not related to the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.