chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Fatigue, Pain in extremity
Clinical narrative: Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vertigo
Clinical narrative: Very slight vertigo; Very slight nausea; Maybe a little bit of muscle ache but no fever; This is a spontaneous report from a contactable consumer. This male consumer reported for himself that he on an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included sulfasalazine taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced very slight vertigo, very slight nausea and maybe a little bit of muscle ache but no fever. It was reported that patient had his first PFIZER COVID-19 Vaccination shot yesterday (at this point of report) at noon and that would be about 20hours ago. And then, patient went to sleep and then when he woke up a couple of hours ago, patient had mild symptoms, like on a 10 scale. Patient had like a 1 or 2. Very slight vertigo, very slight nausea and maybe a little bit of muscle ache but no fever. This the things that PFIZER was seeing in some of its population. Name of the vaccine: Pfizer COVID-19 vaccine. When paraphrased the concern, patient confirmed the same. Patient was informed about the role of PFIZER Drug Safety and PFIZER Medical Information. Patient was provided with the contact for PFIZER Medical Information. Patient further stated, he have if it was possible for him to get the second shot of PFIZER or whether it would be advisable for him to switch to a different vaccine. Reason for no lot number: of COVID-19 Vaccine was reported as other. Patient stated, he did not know if he have that immediately available there. patient can't get my hands on that. Patient stated, there was one medication that he had taken that might be related, it was Sulfasalazine, that was his regular. That was his routine medication (hence captured as Medical History). Patient stated he did not received any treatment. The outcome of events were unknown.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 24 hours; This is a spontaneous report from a contactable Consumer (patient, reported for herself)  A 43-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UNKNOWN) via an unspecified route of administration in Arm Left on 25Feb2021 17:15 as SINGLE DOSE for covid-19 immunization at pharmacy or drug store. Lot unknown reason other, not given info by pharmacist. Patient Medical history, known allergies included Drug allergy to Codeine and morphine. Other medical history included congenital heart Defect from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (Other medications in two weeks) included: digoxin (LANOXIN), lisinopril, furosemide (LASIX [FUROSEMIDE]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and multivitamin all taken for unspecified indications, doses, unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination.   On 25Feb2021 at 22:30 patient experienced sore arm for 24 hours. Patient did not received treatment for the adverse events. The patient was not tested for COVID post vaccination. Event Sore arm for 24 hours was non-serious. Outcome of the event was reported as recovered on an unspecified date.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: At 10 days, broke out with shingles.; This is a spontaneous report from a contactable consumer (patient himself). This consumer reported similar events for 2 patients. This is 1st of 2 reports.   A 70 years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3248; Expiration Date: unknown) via an unspecified route of administration, administered in Left arm on 13Jan2021 at 11:45 as single dose for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patients known allergies was reported as none. Concomitant medication(s) included metformin (METFORMIN), lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN) and pantoprazole (PANTOPRAZOLE) taken for an unspecified indication. The patient was not diagnosed prior and since the vaccination with COVID-19. It was reported that, at 10 days, after the first dose on 23Jan2021 the patient was broke out with shingles and still was suffering. The adverse event started hurting 5days after first shot. Patient said there was delay in reporting this event because everything he had read, said there was no connection between the Civic shot and Shingles. He also started feeling bad 5 days after first shot and broke out with Shingles at 10 days. It was reported that the adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient had not received any treatment for adverse event. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021265135 same reporter/product/event, different patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient, self-reported). A 66-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on 05Mar2021 at 13:00 (at the age of 66-years-old), as second dose, single for COVID-19 immunisation. Medical history included arthritis, known allergies to Sulfa. Concomitant medications included lisinopril; valacyclovir [valaciclovir]. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration, in Arm Left on 12Feb2021 at 12:45 as first dose, single for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 05Mar2021 at 18:00, the patient experienced explosive diarrhea, lethargy and site soreness. Patient did not received treatment for adverse events. Facility type vaccine: Doctor's office/urgent care. The patients adverse event does not required treatment. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: rash; It is blistered slightly and it is a little itchy but it is not overwhelming; It is blistered slightly and it is a little itchy but it is not overwhelming; This is a spontaneous report from a contactable consumer (Patient). An 84-year-old female patient received second dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot number was not reported, NDC number: 59267-1000-01), via an unspecified route of administration on 27Feb2021 as (dose reported as 0.3) single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first dose of BNT162B2 on 06Feb2021 and patient experienced slight rash. On an unspecified date, patient experienced rash and at the time of report she still had some of that a little bit more and it was blistered slightly, and it was a little itchy, but it was not overwhelming. Patient thought it should be passed and reported. Patient wanted to know if an Epsom salt bath was okay to take. Patient would like to take an Epsom salt bath. It was not medication. The doctor gave her some Cortisone. It was neither here nor there, it was not that severe. Patient had not done any lab work. The outcome of the events was reported as unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Paraesthesia, Rash
Clinical narrative: severe headache; major rash with prickle feeling on face, chest, both arms; major rash with prickle feeling on face, chest, both arms; lethargic; This is a spontaneous report from a contactable other-healthcare professional (patient) reported for herself. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6202, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 03Mar2021 11:45 AM (at the age of 60-year-old) as 2 ND DOSE, SINGLE for COVID-19 immunisation at public health clinic. The patient medical history included tachy-Brady syndrome, thyroid, gout and umbilical hernis. The patient had no known allergies. The patient previously received her first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN9810, Expiration date: Unknown) via an unspecified route of administration, in the left arm on 10Feb2021 (at the age of 60-year-old) as 1 ST DOSE, SINGLE for COVID-19 immunisation and had severe chills, severe soreness in shot area, lethargic. The patient received the medication within 2 weeks included Synthroid, Allupurinol and Digitex. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 03Mar2021 at around 15:00, the patient had experienced severe headache, major rash with prickle feeling on face, chest, both arms and lethargic. The patient did not received treatment for adverse events. The outcome of all events was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: Patient is pregnant- received COVID 19 vaccine; slightly sore arm; This is a spontaneous report received from a contactable consumer, the patient.    A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration in Mar 2021 as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was pregnant and received COVID 19 vaccine in Early March, due in June. She had slightly sore arm. Patient had 3 children. Event took place after use of product. The outcome was unknown.  Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; fever; chills; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: not reported), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient got her 1st dose of the vaccine on 04Mar2021 and she took TYLENOL before she got the vaccine and wanted to know if that was okay. On 05Mar2021 (last night), the patient also had a fever, chills, and runny nose. The outcome for all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain
Clinical narrative: slight pain; felt warm; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient, reported for self).  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced slight pain and felt warm. Patient asked if she could take any medication for fever and pain killer. The events slight pain and felt warm were non-serious. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that, A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that the patient had her second shot last Wednesday (03Mar), on 06Mar2021 (reported as today), she started feeling achy, her joints were aching, and she felt very tired. She wanted to know how long this will last. The outcome of events was unknown. There were not any unaddressed medical questions referred or forwarded to Medical Information. No Follow-up attempts are possible; information about batch/lot number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Felt chilly all night; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient felt chilly all night after receiving second dose of the COVID vaccine on an unspecified date. The outcome of the event was reported unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; This is a spontaneous report via Pfizer  from a contactable consumer or other non-HCP (patient, self-reporting).   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced tingling. The patient experiencing adverse reactions after receiving the 1st dose of vaccine including tingling wanted to know what to expect with the 2nd dose. The outcome of event was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 26Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications was not reported. After 10 days of vaccination, on 07Mar2021, she broke out with the shingles. She wanted to know what to do about taking second dose. No treatment was given for the adverse event. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 05Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient asked for pain pill, she was experiencing headache after first shot 05Mar2021. No unaddressed medical questions referred or forwarded to Medical Information. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder, Eye irritation, Rash pruritic
Clinical narrative: My eyes turned light red one more darker than the other. It is now day 3 and it has gotten darker to a dark purple; Where the rash is it is very sensitive and itchy; My eyes burn from time to time; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 (age at vaccination unspecified) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. As per the verbatim, the patient got Pfizer covid vaccine on Thursday 04Mar2021. On an unspecified date in Mar2021, the patient woke up the day after and under my eyes turned light red one more darker than the other. It was now day 3 and it has gotten darker to a dark purple. Patient never had a reaction to any medicine before. Where the rash is it is very sensitive and itchy and eyes burn from time to time. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: had symptoms of cold; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (Patient, self-reported).   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: were not reported), via an unspecified route of administration on 03Feb2021 as single for COVID-19 immunisation.   The patient medical history and concomitant medications were not reported.  Reportedly, (on an unspecified date) patient had symptoms of cold before getting the 2nd dose and he said that this is the reason why the health facility did not provide him the 2nd dose of the vaccine scheduled last 24Feb2021. Patient was asking if the 1st shot would be enough to be protected from COVID-19 virus. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received bnt162b2 (BNT162B2) via an unspecified routes of administration, administered in left arm (at the age of 42 years old); on 10Mar2021 at 13:30 (Batch/Lot Number: EL3247) as 1st dose, single dose, then on 31Mar2021 at 13:45 (Batch/Lot Number: EP6955) as 2nd dose, single dose; both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and he was not tested for COVID post-vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 14:00, it was reported that the patient experienced sore arm. The patient also experienced sore arm on 31Mar2021 at 13:45. The patient did not receive a treatment for the adverse event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Feeling hot, Rash macular, Vomiting
Clinical narrative: she had pain in the stomach and threw up; she had pain in the stomach and threw up; had a red spot like a tennis ball in size and it felt warm; had a red spot like a tennis ball in size and it felt warm; chills; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Covax US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 04Mar2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient experienced chills on 05Mar2021, on 06Mar2021 she had pain in the stomach and threw up and had a red spot like a tennis ball in size and it felt warm. She was asking if this was okay. 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: Asthenia, Body temperature, Fatigue, Nervousness, Pyrexia
Clinical narrative: feeling tired, weak and shaky; feeling tired, weak and shaky; feeling tired, weak and shaky; temperature of 100.4 F; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Mar2021, the patient experienced tired, shaky, weak and temperature of 100.4 F. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation mucosal, Hypoaesthesia
Clinical narrative: burning sensation of her mouth, tongue; numbness in her face; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 04Mar2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Any unaddressed medical questions were not referred or forwarded to Medical Information. Patient got the second dose of the vaccine on 04Mar2021. On an unspecified date in Mar2021, she was experiencing the burning sensation of her mouth, tongue, and numbness in her face, wants to know if these are side effects of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles one week after shot; This is a spontaneous report received from a Contactable Consumer. A 59-Year-old male (Adult 18-64 Years) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in left arm, on 19Feb2021 at 18:45 (at the age of 59 years), as a single dose for COVID-19 immunisation. The patient medical history included Hypertension, herpes. Concomitant medications was not reported. The patient had no known allergies. Prior vaccination, the patient had no covid. Post vaccination, the patient had not tested for covid. The patient didn't receive other vaccine in four weeks. The patient received other medications in two weeks. On 24Feb2021, the patient had experienced Shingles one week after shot. Not sure if related but thought should report. AE resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the AE. Outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. .
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Drug hypersensitivity, Fatigue, Gastric disorder, Pain
Clinical narrative: developed a "severe reaction"; body aches; constant rash; burning sensation on the back; fever; she feels uncomfortable; has stomach issues; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number was not reported expiry date was not reported) dose 1 via an unspecified route of administration on 04Mar2021, as FIRST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient developed a severe reaction, with body aches, constant rash, burning sensation on the back, fever, she feels uncomfortable, tired, and has stomach issues. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin burning sensation
Clinical narrative: developed a "severe reaction"; body aches; constant rash; burning sensation on the back; fever; she feels uncomfortable; has stomach issues; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number was not reported expiry date was not reported) dose 1 via an unspecified route of administration on 04Mar2021, as FIRST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient developed a severe reaction, with body aches, constant rash, burning sensation on the back, fever, she feels uncomfortable, tired, and has stomach issues. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I contracted Shingles; This is a spontaneous report from a contactable other health professional (patient). A 71-year-old non-pregnant female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 24Feb2021 at 12:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included diabetes mellitus (Diabetes), hypertension (High Blood Pressure), and known allergies: penicillin (known allergies: penicillin). concomitant medication included losartan, atorvastatin, colecalciferol (VITAMIN D (COLECALCIFEROL)), vitamin c (ascorbic acid), ascorbic acid, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (VITAMIN B COMPLEX [ASCORBIC ACID; CALCIUM PANTOTHENATE; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]). The patient experienced contracted shingles on 26Feb2021 at 10:00. The patient did not take any other vaccine in 4 weeks. The patient did not take any vaccination prior to Covid vaccination. The patient did not test Covid post vaccination. The patient has an appointment for second dose on 24Mar2021. The patient took Valtrex and gabapentin as treatment for the event. The outcome of the event was recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Malaise; Tiredness; This is a spontaneous report from a contactable Pharmacist (Patient). A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: unknown; Expiration date: unknown), via an unspecified route of administration on 25Jan2021 (at the age of 59-years-old) as a single dose for Covid-19 immunization in hospital. The medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2, Covid-19 immunization and experienced injection site pain, tiredness, headache, chills and nausea. On an unspecified date, the patient experienced malaise and tiredness. The patient relevant tests were none. The treatment was included Acetaminophen 1gm (oral) on 04Jan2021 prior and after the vaccination. The outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness at injection site; fatigue; This is a spontaneous report from a contactable consumer received via Pfizer Sales Representative.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced soreness at injection site and fatigue on an unspecified. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: stomach pains; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 10Mar2021 13:00 (Lot Number: EL 3247) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included anxiety and herniated disc in neck. Concomitant medications included gabapentin; escitalopram oxalate (LEXAPRO); and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 13:30, the patient experienced stomach pains and nausea with outcome of recovered. The patient did not receive any treatment for the reported events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Mar2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date, for COVID-19 immunization and experienced feeling achy, flu like, had some arm pain. The patient experienced stomach issues on an unspecified date. The patient took some "imodium" (as reported) and was wondering if it will affect the vaccine at all. She also wanted to know if she can start taking antibiotics on 19Mar2021 and if it would interact with the vaccine. The outcome of the event was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Lymphadenopathy
Clinical narrative: Shingles; swollen lymph nodes; This is a spontaneous report from a non-contactable consumer (Patient). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Feb2021 (Lot Number: EN6201), (age at vaccination 35-year-old) as first dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for covid post vaccination. On 23Feb2021, the patient experienced shingles, swollen lymph nodes. Therapeutic measures were taken as a result of shingles, swollen lymph nodes as antiviral (Valtrex). Patient did not experienced covid prior to vaccination. The outcome of events were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: rash and redness at injection site; rash and redness at injection site; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05Mar2021 (at the age of 67years) as 2ND DOSE, SINGLE for Covid-19 immunization. The patient received the first dose of BNT162B2 in Feb2021 (at the age of 67years) for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the 2nd dose of vaccine on Friday, 05Mar2021, and developed rash and redness at injection site about one day later (06Mar2021), which was treated with antibiotic (oral). The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable Consumer. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9809), via unspecified route of administration in the left arm, on 25Feb2021 (at the age of 47-year-old), as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination and no COVID tested post vaccination. The patient's concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D), multivitamin, calcium, ergocalciferol (VIT D) and calcium carbonate (ANTACID). The patient's known allergies: penicillin, sulfas, seasonal and dander. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9810), via unspecified route of administration in the left arm, on 03Feb2021, as single dose for COVID-19 immunisation. On 05Mar2021, the patient experienced shingles. The patient received antiviral treatment for the event. The outcome of the event was reported as resolving.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Scab
Clinical narrative: Scabbed over; Broke out in shingles/shingles rash; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 26Feb2021 (Batch/Lot Number: EL9267; Expiration Date: May2021) as single dose for COVID-19 immunization. The patient's medical history included low thyroid from an unknown date, diagnosed 20 years ago. There were no concomitant medications. On 08Mar2021, 10 days after the vaccination the patient had broken out in shingles/shingles rash, patient said she had two of her shingles shots three years ago. Patient said she was scheduled for her second dose in 11 days, she enquired that was she eligible to get the second dose of the vaccine as her Shingles rash was scab over. Patient received treatment for shingles, she was prescribes to take Valtrex three times a day for a week, 1gm tablet. The outcome of the event shingles/shingles rash was not recovered, and scab over was unknown.  No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Pt had shingles outbreak within 2 weeks of 2nd Pfizer COVID vaccine.; This is a spontaneous report from a contactable Nurse. A 65-years-old non pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EJ1685, expiration date unspecified), intramuscularly on 08Feb2021 as 2nd DOSE, SINGLE DOSE for covid-19 immunization. Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3246, expiration date unspecified), intramuscularly on 18Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. No other vaccine in four weeks. Medical history included DM Type 2, Hypertension. The patient's concomitant medications were not reported. The patient had allergies NSAIDS - causes lips tingling and swelling, prednisone causes hives. On 22Feb2021, Patient had shingles outbreak within 2 weeks of 2nd Pfizer COVID vaccine. The patient had to visit Doctor or other healthcare professional office/clinic visit. The patient was not tested for COVID-19 post vaccination. No covid prior vaccination. The patient was treated with Acyclovir for the event. The outcome of the event was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Restlessness
Clinical narrative: Fatigue; Inner restlessness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN8203; Expiration date was not reported) on the left arm on 10Mar2021 (11:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration date was not reported) on 17Feb2021 (at the age of 58 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 10Mar2021 (15:15), the patient had fatigue and inner restlessness. The patient had not received treatment for the reported events. The outcome of the events was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: A little light headed; very tired; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 at 60-years-old (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included High blood pressure. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. Patient had no known allergies. Facility type vaccine: Other. Concomitant medications included amlodipine besilate (NORVASC). The patient experienced a little light headed and very tired on 10Mar2021 14:00 with outcome of recovered in Mar2021. No treatment received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: I had this morning the vaccine first shot at at 9:30. Now I am on the phone (not cleared) I was getting allergies; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 09:30 at a 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that he was getting allergies. Reporter question is it okay to take any allergy medicines or it is to get bad to go to the emergency or whatever. Outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal disorder
Clinical narrative: sore throat; spots on the back of her throat; This is a spontaneous report from a contactable consumer (patient's husband) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first shot last 25Feb2021 her second dose will be on 18Mar2021. The reporting consumer asked if the patient can take the vaccine (2nd dose) even after having a sore throat or white spots on the back of her throat yesterday, 09Mar2021. It was queried if it can become an infected throat or if she's sick. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in left arm on first day; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non- pregnant female patient received first dose of BNT162B2(PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6208), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to Codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 16Mar2021 at 18:00, the patient experienced pain in left arm. The patient made sure to drink a lot of water and workout but her arm was still really sore. No therapeutic measures were taken for the reported event. The clinical outcome of the event vaccination site pain was not recovered/ not resolved.    No follow-up attempts are needed. No further information is expected.