chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Mobility decreased, Pharyngeal disorder, Renal failure
Clinical narrative: Guillain-Barre Syndrome; urinary incontinence; confusion; lethargy; dehydration; expired; This is a spontaneous report from a contactable physician. A 76-year-old male patient received second 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 received first dose of bnt162b2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received his second Pfizer vaccine dose and 2 weeks after receiving the vaccine he presented to her office with urinary incontinence, confusion and lethargy. He was admitted to the hospital and within a few days later, day 5, he was diagnosed with Guillain-Barre Syndrome. Following tests and a lumbar puncture. He was hospitalized x2 weeks, received IVIG x 5days. He was then transferred to a Nursing Home. He was readmitted to the hospital with dehydration and expired 2 days later (last night). The physician asked, "have you seen this type of thing before, with GBS?" The physician considered the case as non-serious. The outcome of the events was unknown except for expired. The patient died on 06Apr2021 as he expired. There was no autopsy done.  Information on the lot/batch number has been requested.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case.  Based on the current available information, a possible contributory role of the suspect product to the development of events cannot be totally excluded. Additional information including relevant medical history, detailed clinical course, and specified concomitant medications is required to better assess the case.  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.; Reported Cause(s) of Death: expired
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills and muscle aches 12 hours following second shot of Pfizer covid-19; chills and muscle aches 12 hours following second shot of Pfizer covid-19; This is a spontaneous report received from a non-contactable physician. A patient with unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient experienced chills and muscle aches 12 hours following second shot of Pfizer covid-19 vaccine. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain
Clinical narrative: develops ache; experiencing diarrhea; This is a spontaneous report received from a Pfizer sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on 01Apr2021. On an unknown date, the patient developed ache and diarrhea. The patient took Tylenol for aches and wants to know if she can take over-the-counter medicine like Imodium for the diarrhea. The clinical outcome for the events were captured as Unknown. It was unknown if the reporter a Healthcare Professional. It was unknown if the reporter is the prescribing HCP. It was unknown if the reporter's contact information available to you or a sub-contracted party.  The patient attempted to provide #, caller says that she will just wait on queue.  There was no medical Information: Customer and/or medical inquiry was NOT forwarded or referred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: an allergic reaction.; This is a spontaneous report from a  non-contactable consumer (for her mother) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA 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 immunisation. The patient's medical history and concomitant medications was not reported. Patient was in an ICU. Trying to figure out if it was due to the covid vaccine and an allergic reaction. Serious criteria was hospitalization. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified),  via an unspecified route of administration, administered in left arm on 05Dec2020 11:00 as single dose for COVID-19 immunisation; and amoxicillin, clavulanic acid (AUGMENTIN), via an unspecified route of administration from 18Mar2021 at unspecified dose for an unspecified indication. Medical history included myocardial infarction (MI), coronary artery bypass grafting (CABG), AV Nodal block, and pacemaker. The patient's concomitant medications were not reported. On 18Mar2021 20:00, the patient experienced anaphylaxis. The patient was hospitalized for 2 days on an unspecified date due to the event. The patient reported that he was on augmentin on and off for years and when he got his first vaccine. And on 18Mar2021, he began augmentin again and had anaphylaxis requiring hospitalization. The patient was asking if this was related to the vaccine, but seems to be a possibility. The event resulted in resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The event was treated with epinephrine, steroids, benadryl, and fluids. There was no other vaccine in 4 weeks and patient had not had Covid prior vaccination and was not Covid tested post vaccination. The action taken in response to the event for amoxicillin, clavulanic acid was unknown. Outcome of event was recovered in 2021.  Information on batch/lot number was requested.; Sender's Comments: Based on available information, the event anaphylaxis is assessed as unrelated to BNT162B2. The event occurred more than 3 months after the administration of vaccine and can be attributed to augmentin based on provided information, including close temporal relationship and positive rechallenge.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had his 1st dose of BNT162b2 on 14Mar2021 and on 24Mar2021 he was not feeling well and then tested positive for Covid. He had been quarantined after that. His 2nd dose would be on 04Apr2021 and he wanted to know if what would be going to happen next. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Right Sided Bell's Palsy; This is a spontaneous report from a contactable Other-HCP reporting for a patient. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Stargardt's Disease, Prediabetes, Low Testosterone, Chronic neck pain, and covid-19. Concomitant medication included testosterone (AXIRON). No other vaccine received in four weeks. The patient experienced right sided bell's palsy on 07Apr2021 06:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of right sided bell's palsy included Prednisone. Outcome of the event was not recovered. No Covid tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported Bell's palsy cannot be excluded based on a temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulties in breathing; This is a spontaneous report received from a contactable consumer (patient) through Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COIVD-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced difficulties in breathing on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support via a contactable consumer on behalf of his wife(patient). A female patient of an unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Apr2021 (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 previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 for covid-19 immunisation. The patient experienced diarrhea on 2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female 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 25Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she had the first dose of the vaccine on 25Mar2021 and is scheduled for the second dose on 15Apr2021. She has tested positive for COVID-19 since the first dose and asked if she can get the second dose? She asked if it is safe for someone to get the second dose if they have had Covid recently (she asked this multiple times). She stated she is almost symptom free now but the second dose is just a week after she recovers. She stated she doesn't think she should not get it just because she has antibodies. She also asked if she could get the second dose late because she isn't sure if it is too soon to get it after recovering. The reporter classified the event as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Paralysis, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6207), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 08:30 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient started throwing up, fever, complete body went paralyzed and lost vision all it the ER on 05Apr2021 13:00. The events were resulted in emergency room /department or urgent care. There is some treatment (saline and ondansetron) for the events. The patient did not have covid prior vaccination, did not test covid post vaccination. The patient received Covid test post vaccination via Nasal Swab on 05Apr2021, covid test result was negative. There is no known allergies, no other medical history, no other vaccine in four week, no other medications in two weeks. The outcome of the events was resloving.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: severe rash in trunk area, lower back, thighs; This is a spontaneous report received from a contactable other HCP (patient). A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 17:30 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunization.  Medical history included obesity, gout, kidney stones and gastric sleeve bariatric surgery. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced severe rash in trunk area, lower back, thighs on 14Mar2021. The adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot ER2613) on 31Mar2021 at Arm Left as single dose for covid-19 immunisation. Since the vaccination, the patient has not been tested for COVID-19. The outcome was not recovered.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: headache; dizziness; photophobia; Fatigue; nausea; Right arm pain; This is a spontaneous report from a non-contactable consumer.  The reporter reported two reports, This is the 1st of 2 reports, for the 1st dose.  A 67-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm Right on 16Feb2021 12:15 (Lot Number: EL9267) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Headache, Dizziness, photophobia, fatigue and nausea on 16Feb2021 12:58, Pertinent details: patient felt to ill to work whole day migraine type HA/fatigue/nausea. Patient also experienced right arm pain on 16Feb2021. Patient recovered from Headache, Dizziness, photophobia and fatigue on 20Feb2021, recovered from nausea on unknown date, outcome for event Right arm pain was unknown.  Tylenol/acetaminophen received as treatment for Right arm pain and headache orally from 16Feb2021 to 19Feb2021, also reported as ongoing as of the report.    No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021234032 same drug/reporter/patient, different dose
Sex: U
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: headache; dizziness; photophobia; Fatigue; nausea; Right arm pain; This is a spontaneous report from a non-contactable consumer.  The reporter reported two reports, This is the 1st of 2 reports, for the 1st dose.  A 67-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm Right on 16Feb2021 12:15 (Lot Number: EL9267) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Headache, Dizziness, photophobia, fatigue and nausea on 16Feb2021 12:58, Pertinent details: patient felt to ill to work whole day migraine type HA/fatigue/nausea. Patient also experienced right arm pain on 16Feb2021. Patient recovered from Headache, Dizziness, photophobia and fatigue on 20Feb2021, recovered from nausea on unknown date, outcome for event Right arm pain was unknown.  Tylenol/acetaminophen received as treatment for Right arm pain and headache orally from 16Feb2021 to 19Feb2021, also reported as ongoing as of the report.    No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021234032 same drug/reporter/patient, different dose
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Dizziness, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: brachycardia; Fatigue; rush through back of head that turned into headache; dizzy/lightheaded/feeling faint; This is a spontaneous report from a contactable consumer (reported for herself). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection), via an unspecified route of administration on 02Apr2021 12:15 (Batch/Lot Number: EP7533) as SINGLE DOSE, for covid-19 immunisation. Medical history included Asthma, factor v Leiden, heart pfo/ stroke 2003 surgically closed 2004 and known allergies was due to Penicillin. Concomitant medications included mometasone furoate (ASMANEX HFA); azelastine; triamcinolone acetonide (NASACORT); acetylsalicylic acid (ECOTRIN); calcium citrate, colecalciferol (CALCIUM CITRATE + D3) all were taken for an unspecified indication. The patient previously took Bactrim and, nystatin suspension and experienced allergies. It was reported that on 02Apr2021 12:15, within minutes of the injection patient got a it rush through back of head that turned into headache that lasted 5 days, immediately got dizzy and lightheaded, which lasted 3 days and ended up in ER (Emergency room) with brachycardia and feeling faint fit 2 days. Fatigue still ongoing, day 6. Patient was hospitalized from an unknown date in APR2021 for 2 days. Patient received treatment for AE as IV fluids, heart monitoring. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Apr2021. Outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: abdominal pain and cramping; This is a spontaneous report from a contactable pharmacist received from a Pfizer- sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced abdominal pain and cramping on an unspecified date and they are wondering if this is a side effect. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had this vaccine and had a sore arm but the flu vaccine was worse.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received flu shot and stated it hurt worse. It was reported that the patient had this vaccine and had a sore arm but the flu vaccine was worse. Reporter states that he had both vaccines and he had nothing but a sore arm. States the flu shot hurt worse than that one. Event was assessed as non serious. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer (patient) via the Pfizer- sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, patient wanted to reschedule second dose of COVID Vaccine due to diarrhea. 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: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from Pfizer - General Company Information received from contactable consumer reporting for himself (patient). A male patient (Age: 49; Unit: Unknown) received bnt162b2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included DVT (deep vein thrombosis). Concomitant medication included ongoing rivaroxaban (XARELTO) taken for DVT. The patient developed Bell's Palsy after receiving vaccination shot on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Diarrhoea, Pyrexia
Clinical narrative: Bell's palsy; fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 reported as Covid Vaccine), via an unspecified route of administration on an unspecified date (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 reporter stated that "after I got the Covid vaccine after two day I mean after the same day like I got it I came home and I had fever for two days actually and then I have the next day diarrhea, two days and then again I experienced some fever after I experienced some Bell's palsy so my question is if I am going to take the Covid vaccine again should I take it or if I would not take it do I have the protection? So, I have this concern because I experienced Bell's palsy." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Underdose, Vaccination site extravasation
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During administration, there was some general leakage from the administration site. It was clear and patient was concerned that the vaccine has seeped out. Patient was wondering if it's sufficient dosage. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This is spontaneous report from a contactable consumer (patient). A 66-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9267, expiration date unknown) via unspecified route of administration at left upper arm  on 10Feb2021 at age of 66-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had some symptoms and he was fine. He had really no symptoms after the first vaccine just there was sore arm for couple of days and for a few days a little bit tired more than he normally would be. Outcome of the events was unknown.  No follow up attempts are needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: he actually developed ITP immune thrombocytopenia as a result of taking the shot; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (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. It was reported that the patient was perfectly healthy when he took the shot, then he actually developed ITP (immune thrombocytopenia) as a result of taking the shot on an unspecified date. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included diabetes mellitus and hypertension. The patient took the first dose of BNT162B2 (Batch/Lot Number: ER8733) on 08Mar2021 for COVID-19 immunization and experienced achy in arm. Concomitant medications included ongoing metformin (strength: 1000 mg) taken for diabetes mellitus; ongoing sitagliptin phosphate (JANUVIA, strength: 100 mg) taken for diabetes mellitus; indapamide (strength: 1.25 mg) taken for hypertension; lisinopril (strength: 40 mg) taken for hypertension. The patient experienced fatigue on 30Mar2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hair growth abnormal, Therapeutic response unexpected
Clinical narrative: got hair growing; got hair growing; This is a spontaneous report received from a contactable consumer (patient). This 89-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization. Medical history included the top head of the patient was bald. The concomitant medications were not reported. Patient called about good side effect of Pfizer Covid vaccine. The top head of the patient was bald and getting hair on there since patient got the shot. Patient got hair growing. The patient was going to be 90 and this was best side effect for patient's birthday. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: facing bit cold; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECHCOVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration on 11Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was facing bit cold for the past 5 days (Mar2021), and was going to have his second dose on the day of reporting. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Echocardiogram, Headache, Influenza like illness
Clinical narrative: Lightheadedness/almost fainted; Nauseous; Headache; fluish sick; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included artificial heart valve from Jun2018 and ongoing, transient ischemic attack (TIA), high cholesterol, blood pressure (abnormal), all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS) tablet taken for transient ischemic attack from Oct2019 and ongoing; rosuvastatin tablet taken for high cholesterol from an unspecified start date and ongoing; metoprolol caplet taken for blood pressure from Nov2020 and ongoing. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 22Jan2021 13:00 (Lot Number: EL9263) for COVID-19 immunization. Patient was reporting reaction to Pfizer COVID vaccine. Patient stated he read some articles to call and reported if you have a type of reaction or something after having the COVID vaccine. Patient had second COVID vaccine on 14Feb2021. Three or four days later (as reported), he began feeling lightheaded, nauseous and headaches beginning around 18Mar2021 or 19Mar2021. Patient reported he almost fainted a few times and it had gotten progressively worse. The patient reported having headaches not every day, but pretty much close to every day, 4 out of 5 days a week. Patient reported sometimes the headaches were bad and sometimes constant. Patient was hospitalized and had every test known to mankind. The patient reports actually being kind of fluish sick for 2 days after having vaccine, the normal feeling that every one says they have. He completely recovered; started night of the 14Feb2021, lasted next two days and then totally gone on 16Feb2021. Blood thinner stopped a couple of days before the shot per his doctor. Patient stated that every test he had was negative, nothing that would cause the symptoms.  He had a Computerized axial tomogram (CAT) scan with dye; CAT scan without dye; carotid artery tested; echocardiogram; left the hospital said they didn't find anything to cause it. After talking to people and reading, he decided to call Pfizer. All results came back negative. Vaccination Facility Type was community center - other. Vaccine was not administered at Military Facility. No additional vaccine was administered on same date of Pfizer COVID vaccine. No additional vaccine was administered. Adverse events lightheadedness, nauseous, headache required a visit to Emergency Room. The patient was hospitalized for 2 days from 29March2021 to 31March2021 due to lightheadedness, nauseous, headache. The outcome of event fluish sick was recovered on 16Feb2021, of other events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Nausea, Vascular test
Clinical narrative: Lightheadedness/almost fainted; Nauseous; Headache; fluish sick; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included artificial heart valve from Jun2018 and ongoing, transient ischemic attack (TIA), high cholesterol, blood pressure (abnormal), all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS) tablet taken for transient ischemic attack from Oct2019 and ongoing; rosuvastatin tablet taken for high cholesterol from an unspecified start date and ongoing; metoprolol caplet taken for blood pressure from Nov2020 and ongoing. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 22Jan2021 13:00 (Lot Number: EL9263) for COVID-19 immunization. Patient was reporting reaction to Pfizer COVID vaccine. Patient stated he read some articles to call and reported if you have a type of reaction or something after having the COVID vaccine. Patient had second COVID vaccine on 14Feb2021. Three or four days later (as reported), he began feeling lightheaded, nauseous and headaches beginning around 18Mar2021 or 19Mar2021. Patient reported he almost fainted a few times and it had gotten progressively worse. The patient reported having headaches not every day, but pretty much close to every day, 4 out of 5 days a week. Patient reported sometimes the headaches were bad and sometimes constant. Patient was hospitalized and had every test known to mankind. The patient reports actually being kind of fluish sick for 2 days after having vaccine, the normal feeling that every one says they have. He completely recovered; started night of the 14Feb2021, lasted next two days and then totally gone on 16Feb2021. Blood thinner stopped a couple of days before the shot per his doctor. Patient stated that every test he had was negative, nothing that would cause the symptoms.  He had a Computerized axial tomogram (CAT) scan with dye; CAT scan without dye; carotid artery tested; echocardiogram; left the hospital said they didn't find anything to cause it. After talking to people and reading, he decided to call Pfizer. All results came back negative. Vaccination Facility Type was community center - other. Vaccine was not administered at Military Facility. No additional vaccine was administered on same date of Pfizer COVID vaccine. No additional vaccine was administered. Adverse events lightheadedness, nauseous, headache required a visit to Emergency Room. The patient was hospitalized for 2 days from 29March2021 to 31March2021 due to lightheadedness, nauseous, headache. The outcome of event fluish sick was recovered on 16Feb2021, of other events was not recovered.  Follow-up attempts were completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site mass
Clinical narrative: Developed a bubble under the skin; Mild kind of soreness; Mild muscle soreness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (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 wanted to know if she can take Tylenol after getting her vaccination. She said after it she developed a bubble under the skin. The patient also experienced mild kind of soreness, just mild muscle soreness. The patient was just wondering if it is okay to take Tylenol for it. The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Myocardial infarction
Clinical narrative: heart attack; back pain; felt very bad; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient thought like he was having a heart attack in the first day or two after having the back pain. He stated 12 hours after getting the back pain. He woke up in the middle of the night he felt very bad. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: swollen lymph nodes; swelling under my arm; This is a spontaneous report from a contactable consumer(patient).  A 23-year-old male patient received the second dose of bnt162b2 (BNT162B2, Lot Number unknown), via an unspecified route of administration on left arm on 28Mar2021 at single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. Patient stated, "I have like Pfizer vaccine on Sunday my second dose and I don't know if this is the right place to ask but it says the side effects is swollen lymph nodes. Should I be concern if it goes pass like its day 4 and still have like swelling under my arm, I saw that it's a side effect I am just wondering, it's been like 4 days so (incomplete sentence)." The patient stated the onset date of the events was the day after so it was 24 hour later on 29Mar2021. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Hepatic pain, Lethargy
Clinical narrative: liver ache/believed it could have been due to ginseng; liver ache/believed it could have been due to ginseng; Fatigue; lethargic; Felt a little achy; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), intramuscularly in left arm on 23Feb2021 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient also took ginseng, via an unspecified route of administration from an unspecified date to 04Mar2021 at one pill, twice a day for an unspecified indication. Medical history included hepatitis A from 1975, moderate drinking and liver ache. Concomitant medications included L-arginine taken to "keep the veins permeable"; aspartate zinc, magnesium aspartate, pyridoxine hydrochloride (ZMA) taken to help after exercise, help rebuild muscle tissue, keep up the blood flow; and lepidium meyenii (MACA). The patient reported he was slightly dizzy on 25Feb2021, just a little bit, couple of days after. Then on Saturday, 27Feb2021, he was the most fatigued he was. He really was lethargic to sit there. He did not have a temperature but felt a little achy. He felt it was just minor, not serious at all, nothing to be debilitated. He was not debilitated at all. The patient further stated that he maybe experienced a very strange side effect. He mentioned that he had hepatitis A in 1975 and did not drink for a couple of years to get his system better and to keep his liver from becoming scarred. This happened when he was 25-26 years old; though he enjoyed life of a moderate drinking with eating. Earlier on, maybe a few years after he had hepatitis, he would feel his liver ache a little. After the first shot, on 28Feb2021, he felt an ache in his liver and did not know what it was. It lasted 3-4 days on and off. He used Ginseng and changed the kind of what he used to take. He had to take it twice a day, each pill with 7% of ginsenosides so he got 14% in a day. He researched to see if there was any effect that his liver would have because he noticed that it happened a couple of hours after the ginseng. He had read about it on the internet, there were insights of ginseng interacting with medication and can possibly cause some form of liver damage. He stopped using ginseng and felt fine. The liver ache stopped after 4 days on 04Mar2021. That was when he stopped using the ginseng. It was only an ache nothing really a damage at all. It was an unusual may be a coincidental happening. He had the hepatitis A in 1975 then felt the liver ache most recently. He believed it could have been due to ginseng as COVID-19 vaccine was flowing through his body. The action taken in response to ginseng was permanently withdrawn in 04Mar2021. Outcome of the event liver ache was recovered on 04Mar2021, and of the remaining events was unknown.
Age: 69.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain
Clinical narrative: liver ache/believed it could have been due to ginseng; liver ache/believed it could have been due to ginseng; Fatigue; lethargic; Felt a little achy; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), intramuscularly in left arm on 23Feb2021 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient also took ginseng, via an unspecified route of administration from an unspecified date to 04Mar2021 at one pill, twice a day for an unspecified indication. Medical history included hepatitis A from 1975, moderate drinking and liver ache. Concomitant medications included L-arginine taken to "keep the veins permeable"; aspartate zinc, magnesium aspartate, pyridoxine hydrochloride (ZMA) taken to help after exercise, help rebuild muscle tissue, keep up the blood flow; and lepidium meyenii (MACA). The patient reported he was slightly dizzy on 25Feb2021, just a little bit, couple of days after. Then on Saturday, 27Feb2021, he was the most fatigued he was. He really was lethargic to sit there. He did not have a temperature but felt a little achy. He felt it was just minor, not serious at all, nothing to be debilitated. He was not debilitated at all. The patient further stated that he maybe experienced a very strange side effect. He mentioned that he had hepatitis A in 1975 and did not drink for a couple of years to get his system better and to keep his liver from becoming scarred. This happened when he was 25-26 years old; though he enjoyed life of a moderate drinking with eating. Earlier on, maybe a few years after he had hepatitis, he would feel his liver ache a little. After the first shot, on 28Feb2021, he felt an ache in his liver and did not know what it was. It lasted 3-4 days on and off. He used Ginseng and changed the kind of what he used to take. He had to take it twice a day, each pill with 7% of ginsenosides so he got 14% in a day. He researched to see if there was any effect that his liver would have because he noticed that it happened a couple of hours after the ginseng. He had read about it on the internet, there were insights of ginseng interacting with medication and can possibly cause some form of liver damage. He stopped using ginseng and felt fine. The liver ache stopped after 4 days on 04Mar2021. That was when he stopped using the ginseng. It was only an ache nothing really a damage at all. It was an unusual may be a coincidental happening. He had the hepatitis A in 1975 then felt the liver ache most recently. He believed it could have been due to ginseng as COVID-19 vaccine was flowing through his body. The action taken in response to ginseng was permanently withdrawn in 04Mar2021. Outcome of the event liver ache was recovered on 04Mar2021, and of the remaining events was unknown.
Age: 69.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Dyspnoea, Therapeutic response unexpected
Clinical narrative: liver ache/believed it could have been due to ginseng; liver ache/believed it could have been due to ginseng; Fatigue; lethargic; Felt a little achy; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), intramuscularly in left arm on 23Feb2021 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient also took ginseng, via an unspecified route of administration from an unspecified date to 04Mar2021 at one pill, twice a day for an unspecified indication. Medical history included hepatitis A from 1975, moderate drinking and liver ache. Concomitant medications included L-arginine taken to "keep the veins permeable"; aspartate zinc, magnesium aspartate, pyridoxine hydrochloride (ZMA) taken to help after exercise, help rebuild muscle tissue, keep up the blood flow; and lepidium meyenii (MACA). The patient reported he was slightly dizzy on 25Feb2021, just a little bit, couple of days after. Then on Saturday, 27Feb2021, he was the most fatigued he was. He really was lethargic to sit there. He did not have a temperature but felt a little achy. He felt it was just minor, not serious at all, nothing to be debilitated. He was not debilitated at all. The patient further stated that he maybe experienced a very strange side effect. He mentioned that he had hepatitis A in 1975 and did not drink for a couple of years to get his system better and to keep his liver from becoming scarred. This happened when he was 25-26 years old; though he enjoyed life of a moderate drinking with eating. Earlier on, maybe a few years after he had hepatitis, he would feel his liver ache a little. After the first shot, on 28Feb2021, he felt an ache in his liver and did not know what it was. It lasted 3-4 days on and off. He used Ginseng and changed the kind of what he used to take. He had to take it twice a day, each pill with 7% of ginsenosides so he got 14% in a day. He researched to see if there was any effect that his liver would have because he noticed that it happened a couple of hours after the ginseng. He had read about it on the internet, there were insights of ginseng interacting with medication and can possibly cause some form of liver damage. He stopped using ginseng and felt fine. The liver ache stopped after 4 days on 04Mar2021. That was when he stopped using the ginseng. It was only an ache nothing really a damage at all. It was an unusual may be a coincidental happening. He had the hepatitis A in 1975 then felt the liver ache most recently. He believed it could have been due to ginseng as COVID-19 vaccine was flowing through his body. The action taken in response to ginseng was permanently withdrawn in 04Mar2021. Outcome of the event liver ache was recovered on 04Mar2021, and of the remaining events was unknown.