chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in rashes all over my chest, belly, and back so far; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No covid prior vaccination. The patient previously received first dose of bnt162b2 on 28Jan2021 for COVID-19 Immunization. The patient experienced broke out in rashes all over my chest, belly, and back so far on 25Feb2021 17:00. Treatment included Benadryl. Outcome of event was not recovered. No covid tested post vaccination.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Mild sore arm; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number EL9266, Batch number- DDM#32), intramuscular, in left arm on 23Feb2021 (at the age of 76-years-old) at a single dose for COVID-19 immunization. Medical history included covid-19 in Nov2020 (reported as also had the virus) with no taste or smell for 4 months and was very tired for 2 weeks and Stage 3 kidney disease from Feb2019 and ongoing. There were no concomitant medications. The patient was vaccinated at Pharmacy/drug store. No other vaccine was given in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318, Batch number- DDM#32), intramuscular, in left shoulder on 02Feb2021 at 5:00 PM at a single dose for COVID-19 immunization after which the patent experienced mild sore arm and chills. The patient experienced mild sore arm and chills on an unspecified date. The events lasted for about 4 hours. The outcome of the events was recovered.  Information about lot/ batch number has been requested.  Follow-up (23Apr2021): New information received from the same contactable consumer (patient) included: Patient medical history and details, Product batch number and lot number, Outcome and duration of the events.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from contactable consumer (patient) reported for herself. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 02Mar2021 08:00 am (age at vaccination was 47 years) as single dose for COVID-19 immunization. Medical history included acid reflux. The patient had a known allergy to penicillin. The patient previously took first dose of BNT162B2 (Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 09Feb2021 13:15 pm (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Concomitant medication patient received within 2 weeks of vaccination included omeprazole and famotidine, on unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 at 20:00 PM evening the patient had symptoms of chills, same day the patient received the vaccine. The facility where the most recent COVID-19 vaccine was administered was redacted. No treatment was received for the adverse event. The outcome of the event was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.   Follow-up (08Mar2021): New information received in response to mail trail sent regarding the confirmation of below mentioned query included: Updated the start date of symptoms (02Mar2021) and details regarding the follow-up attempts.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 14:30, at the age of 59-years-old, (Lot Number: EL9269) as SINGLE DOSE for covid-19 immunisation.  Medical history included Hodgkin Lymphoma diagnosed in Feb2017; had chemotherapy until a cell transfer on 15Oct2018. The patient did not have COVID-19 prior vaccination.  The patient was not pregnant at the time of vaccination. Concomitant medication included cyanocobalamin (B12-VITAMIIN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Benadryl and experienced allergies.  On 21Feb2021, the patient was diagnosed with shingles and received Acyclovir 800 mg, 4 times per day as a treatment. The event involved physician office visit. The patient has not been tested for COVID-19 post vaccination. The patient stated she still have some remaining signs of the shingles. The outcome of the event was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: 3247), via an unspecified route of administration on 02Mar2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was queried you have reported about an adverse regarding covid-19 vaccine, please help the first awareness date of this report. You filled PRD as 03Mar2021, however the adverse event start date 02Mar2021, it seemed that you know these on 02Mar2021, could you please help confirm the correct first awareness date for the events. In response, yes, I received my shot on 02Mar2021 at 08:00 PM when I began experiencing the sore arm at injection site (the day I received my vaccine) and reported it on 03Mar2021. No treatment was received for the adverse event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster
Clinical narrative: Shingles; Headache; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201), intramuscular, administered in Arm Left on 11Feb2021 09:30 as single dose for covid-19 immunization (Age at vaccination: 85 years). Medical history included blood pressure problems and gout. The patient's concomitant medications were not reported.  The patient stated that she had the first shot on 11Feb2021, then the night of the 14th, she had this terrible headache (14Feb2021) and the next day, she still had it. Her doctor couldn't see her at this point. Finally, about Feb 16th, she went to hospital and she was told it was shingles (16Feb2021). She was given treatment for the shingles and it gradually has gotten much better. Outcome of the event shingle was recovering while outcome of the remaining event was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm the next morning; Headache; Disorientation; general tiredness/fatigue; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old female (non pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (at the age of 47-years-old) (Batch/Lot number was not reported) as 1ST dose, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have any known allergies and no allergies to medications, food, or other products. Concomitant medication (within 2 weeks of vaccination) included doxepin (DOXEPIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 03Mar2021 at 02:00PM, the patient experienced sore arm the next morning; general tiredness, sore arm the next day, headache, fatigue and disorientation. There was no treatment received for the adverse event. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fall, Pain in extremity
Clinical narrative: his pain in his 3 left rotator cup, left hand/pain in left shoulder; feeling "dizzy"; sore arm after first dose; fell; This is a spontaneous report from a Pfizer-sponsored program,  from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to know if he should postpone second dose of covid-19 vaccine due to him receiving steroid shot on Tuesday, 23Feb for his pain in his 3 left rotator cup, left hand. Clarified he received first dose of covid-19 vaccine 3 weeks from today (unspecified date). His second dose is scheduled today. He fell after first dose of covid-19 vaccine due to him feeling "dizzy" which then caused pain in left shoulder, also stated "sore arm after first dose" of covid-19 vaccine. Therapeutic measures were taken as a result of his pain in his 3 left rotator cup, left hand/pain in left shoulder. The outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles developed, 1-2 days after the second dose; First dose 23Jan2021, second dose:06Feb2021; First dose 23Jan2021, second dose:06Feb2021; This is a spontaneous report from a contactable other healthcare professional.  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 06Feb2021 13:00 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient has no known allergies, did not have covid prior to vaccination. There were no concomitant medications. The patient experienced shingles developed, 1-2 days after the second dose on 07Feb2021 17:00. Treatment for the event included pill medication and cream for rash. The outcome of the event shingles was recovering. The patient was not tested post vaccination.  Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable female consumer. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on Feb2021. It was reported that Two weeks ago after she took the 1st dose of Covid-19 vaccine, she started to have shingles up until now. Outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm (upper portion); This is a spontaneous report received from a contactable consumer. The patient was 41-year-old female consumer. The patient received first dose of BNT162B2 (BNT162B2, Solution for injection, LOT: EL3248) through an unspecified route in left arm as a single dose on 03Mar2021, 09:45 for COVID-19 immunization (age at vaccination: 41-year-old). The patient was not pregnant at the time of vaccination. The medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient had not received any other medication within 2 weeks of vaccination. On 03Mar2021, the patient had Sore left arm (upper portion). The outcome of the event was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: My sister received the PFE vaccine today while approximately 36 weeks pregnant; This is a spontaneous report from a contactable consumer (patient's sister). A 32-year-old (pregnant) female received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (age at the time of vaccination was 32 years) solution for injection, lot number and expiration date were unknown), via an unspecified route of administration, on 08Mar2021at 14:00, as single dose for COVID-19 immunization. Medical history included factor V leiden. Concomitant mediations were not reported. The patient was allergic to stone fruits. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The delivery date provided as 22Mar2021 and the gestational period was 36 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Other medications in two weeks were unknown. On 08Mar2021, today at 14:00, the patient received the PFE vaccine, while approximately 36 weeks pregnant.She was likely to be induced on 22Mar. The (store) location also told her it was their policy at all locations to have the second shot after 4 weeks rather than 3 weeks. No treatment medications included. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Herpes zoster, Muscle strain, Neck pain
Clinical narrative: Shoulder pain; Neck pain; Pulled a muscle; Blisters appeared on the arm; Shingles; Some residual pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266; Expiration date was not reported) on the upper right arm on 13Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included acid reflux, anxiety, insomnia, and was stressed out. Concomitant medications included pantoprazole for acid reflux; and hydroxyzine HCl for insomnia and anxiety. On 21Feb2021, the patient had shoulder pain; neck pain; had pulled a muscle; blisters appeared on the arm; had shingles; and some residual pain. The patient had received prednisone and valacyclovir as treatment for shingles. The outcome of the evens was recovering for blisters; was recovered on an unspecified date in 2021 for shingles; and was unknown for all the other events. The patient wanted to make sure if it would be safe to receive the second dose of vaccination.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Shoulder pain; Neck pain; Pulled a muscle; Blisters appeared on the arm; Shingles; Some residual pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266; Expiration date was not reported) on the upper right arm on 13Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included acid reflux, anxiety, insomnia, and was stressed out. Concomitant medications included pantoprazole for acid reflux; and hydroxyzine HCl for insomnia and anxiety. On 21Feb2021, the patient had shoulder pain; neck pain; had pulled a muscle; blisters appeared on the arm; had shingles; and some residual pain. The patient had received prednisone and valacyclovir as treatment for shingles. The outcome of the evens was recovering for blisters; was recovered on an unspecified date in 2021 for shingles; and was unknown for all the other events. The patient wanted to make sure if it would be safe to receive the second dose of vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Diagnosed with Shingles; Rash; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ongoing valacyclovir. In Mar2021, the patient had rash; and was diagnosed with shingles. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 02Feb2021 (batch/lot number and expiration date not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 17Feb2021 (also reported as 18Feb2021; pending clarification), the patient developed shingles with blisters. His 2nd dose was supposed to be on 23Feb2021 and was moved to 10Mar2021. Now that all the blisters have dried up, he asked if he can go ahead with his 2nd dose tomorrow (10Mar2021). The patient recovered from the event on an unspecified date.   Information on the lot/batch number has been requested.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus
Clinical narrative: shingles; itching; This is a spontaneous report from a contactable consumer (reported for her aunt). A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 96years) as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included high blood pressure. Concomitant medications included pill for high blood pressure. It was reported that the patient was healthy as a horse and her mind is sharp as a tack; she is slow getting around and does not get around well. It was reported that the patient has received the first dose of Pfizer COVID-19 vaccine on 23Feb2021. Nine days later (04Mar2021), she has developed itching in her back and at the upper part of her arms. The reporter wanted to know if it would be from the Pfizer COVID-19 vaccine and if the patient should receive the second dose of the vaccine considering her adverse event. It was clarified that the patient did not develop rashes but only itching. The patient has been to a walk-in clinic but was only given Benadryl and Claritin for her condition. It was further reported that the patient was fine, and her arm was not even sore today. The patient developed some itching on her back and arms after 9 days. The reporter asked, since it is that far out would if that have to do with an allergic reaction and related to the vaccine; also asked if it was contraindicated for the patient to get her second dose. For the symptoms the patient went to a walk-in clinic and the doctor did not think it was related to the vaccine. The doctor stated that the patient does not have a rash, but they seemed to think it could be a mild case of shingles, but they don't know. The outcome of event itching was recovering; outcome of event shingles was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles, shingles pain, shingles blister; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm at age 57 years, on 24Feb2021 10:30 (Batch/Lot Number: EN6198) as 1st dose, single for COVID-19 immunisation. Medical history was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccination within 4 weeks. Patient reported that she got the first Pfizer COVID vaccine dose 24Feb2021, and a day after the vaccine (25Feb2021), she got shingles. Patient went to her doctor on Monday (01Mar2021) and was diagnosed with shingles. She clarified her shingles symptoms started on 25Feb2021. She said her doctor prescribed acyclovir 400mg, 1 tablet every 4 hours for 5 days. She said she had finished her acyclovir 400mg prescription that was dispensed in a pharmacy bottle. Patient was pretty much at the end of her shingles, but she still hurts once in a while. She said the shingles pain was so bad, the pain had woke her up at night. She said she did not have that many shingles blisters, and the shingles blisters were still there. She said her shingles pain and blisters are better now. Patient wanted to know if it was okay to get second dose and the doctor told her that is okay. Patient have heard a couple of people that have gotten the shingles after receiving the Pfizer and Moderna COVID-19 vaccines and was very worried about getting the second dose. She was scheduled to receive her second COVID-19 Vaccine on 17Mar2021. Vaccination facility type was other huge warehouse hospital, vaccine was not administered at military facility. The outcome of the event was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 18Feb2021 11:35, at the age of 75-years-old, (Lot Number: EN6201) as 1st dose, single for covid-19 immunisation.  Medical history included none.   The patient's concomitant medications was none. The patient was supposed to get her second vaccine but got shingles on 06Mar2021, after first dose and was told she can't get the second vaccine because of the shingles. The outcome of the event was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: She then went for a COVID test (rapid) and the results were positive; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient (non-pregnant) received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, (Batch/Lot number was not reported) dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced symptoms of covid 07Mar202 and the patient underwent lab tests and procedures which included sars-cov-2 test results positive on 09Mar2021. No treatment received for the adverse event. Outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (22Mar2021): This is a follow-up spontaneous report received from a contactable consumer (patient). The Pfizer Drug safety unit recently received the attached report submitted by patient and asked help to confirm the date that patient became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date was the date patient became aware of the occurrence of the reported events.  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: he had her first shot on 19Jan2021 and tested positive with Covid-19; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that, she had her first shot on 19Jan2021 and tested positive with Covid-19. Then she had medical Infusion on the 21Jan2021 and was advised to take her second shot after 90 days. The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test: positive. Therapeutic measures were taken for the events. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: not severe pain on her arms, shoulders and neck; not severe pain on her arms; not severe pain on her arms, shoulders; This is a spontaneous report from a contactable consumer (husband) 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 as single dose for COVID-19 immunization. Patient medical history included Parkinson's disease. The concomitant medications were not reported. On an unspecified date, the patient experienced not severe pain on her arms, shoulders and neck after receiving the first dose of Covid-19 vaccine.  The outcome for all the events was unknown.  No follow-up attempts are Possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 19Feb2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive on 20Feb2021. The patient underwent lab tests and procedures which included the test was positive on 20Feb2021. After tested positive, the following day for his pre-surgery, the surgery was also cancelled, and was informed to wait 90 days. His second dose was scheduled on 12Mar2021. The outcome of the event was unknown.   Information about Lot/Batch number is requested.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Migraine, Muscular weakness, SARS-CoV-2 test
Clinical narrative: migraine; muscle weakness; Brain fog; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 25Feb2021 13:00 (at the age of 65 years old) (Batch/Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included ongoing inflammatory bowel disease (IBD), ongoing anxiety. Concomitant medication(s) included metoprolol taken for skipping heart beats from an unspecified start date and ongoing; bupropion taken for anxiety from an unspecified start date and ongoing; estrogens esterified, methyltestosterone (ESTRATEST) taken for Hormones from an unspecified start date and ongoing; progesterone (PROGESTERONE) taken for Hormones from an unspecified start date and ongoing; butalbital, caffeine, paracetamol (BUTALBITAL APAP CAFFEINE) taken for headaches from an unspecified start date and ongoing. The patient previously received first dose of vaccine, Intramuscular in the right arm on 01Feb2021, 09:00 AM (Batch/Lot number: EN5318) and experienced Muscle weakness, Nausea, Brain fog. On 25Feb2021 13:00 PM, the patient experienced Muscle weakness, Brain fog, Headache. It was reported that after the second shot, the patient had immediate brain fog and slightly headache. On the second day (26Feb2021), the patient had Migraine which lasted 3 day. The patient received treatment for Migraine with Midrin. Still recovering from muscle weakness and headache. The patient underwent Covid-19 test on 11Jun2020, 19Aug2020 and 29Oct2020 and the result was negative. Outcome of the event migraine was recovered and other events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Nausea
Clinical narrative: About 2 hours after I received vaccine, I started experiencing some dizziness.  This has gotten more severe over the past 2 days. can't walk, drive, or sometimes even sit without the room seeming to start spinning.; About 2 hours after I received vaccine, I started experiencing some dizziness.  This has gotten more severe over the past 2 days.  I now can't walk, drive, or sometimes even sit without the room seemi; About 2 hours after I received vaccine, I started experiencing some dizziness.  This has gotten more severe over the past 2 days.  I now can't walk, drive, or sometimes even sit without the room seemi; nausea; This is a Spontaneous report from a contactable Other-HCP (Patient).  The 56-years-old (non-pregnant) female patient received dose 1 of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot Number: EN6208) on 24Mar2021 at 09:45 (at the age of 56-years-old) via an unspecified route of administration in right arm at single dose for COVID-19 immunisation. The patient medical history included type 2 diabetes, HTN, restless leg syndrome. The concomitant medication included Humalog insulin, Lexapro, Trulicity, Farxiga. Patient had allergies to Sulfa drugs, victoza, augmenten. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24-MAR-2021, about 2 hours after the vaccination the patient experienced some dizziness which had become more severe over next 2 days. It was reported that the patient could not walk, drive, or sometimes even sit without the room seeming to start spinning.  Patient had fallen in yard due to dizziness about 24 hours after the vaccine. Patient went to doctor or other healthcare professional office/clinic visit for further care. She felt like if the dizziness gets even a little bit more severe patient might go to the emergency room. Patient had nausea with severe dizziness. Patient was not diagnosed with COVID-19 Prior or since vaccination. The outcome of the event was Not recovered.  Information on the lot/batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dry mouth, Fall, Rotator cuff syndrome
Clinical narrative: the site is a little sore; pain in her left wrist/pain to right shoulder; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; dry mouth; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; This is a spontaneous report from a contactable consumer and other hcp received from. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 88-years-old via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   Medical history included bypass graft in 2016 (five years ago), pacemaker placed in 2021 (about a month and a half ago). The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number not reported) for covid-19 immunisation. The patient reported having pain in her left wrist, wears a band, and feels safe while performing activities. She further reported having pain to right shoulder and believes it is from either the fall, or torn rotator cuff. She had the vaccine on 01Apr2021 and reported that the site is a little sore. She further reported due to having dry mouth she was already drinking water all the time. The events occurred on an unspecified date in Apr2021. Patient reported placing ice pack to site, and taking tylenol. She also reported having various blood readings, and have shared readings with MD staff. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the site is a little sore; pain in her left wrist/pain to right shoulder; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; dry mouth; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; This is a spontaneous report from a contactable consumer and other hcp received from. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 88-years-old via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   Medical history included bypass graft in 2016 (five years ago), pacemaker placed in 2021 (about a month and a half ago). The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number not reported) for covid-19 immunisation. The patient reported having pain in her left wrist, wears a band, and feels safe while performing activities. She further reported having pain to right shoulder and believes it is from either the fall, or torn rotator cuff. She had the vaccine on 01Apr2021 and reported that the site is a little sore. She further reported due to having dry mouth she was already drinking water all the time. The events occurred on an unspecified date in Apr2021. Patient reported placing ice pack to site, and taking tylenol. She also reported having various blood readings, and have shared readings with MD staff. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as 1st dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the vaccine and 6 days later developed shingles. Patients doctor wants to put the patient on Acyclovir and the pharmacist was calling to make sure medication will not affect the efficacy of the vaccine. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. Outcome of the event was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of the two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Mar2021, the patient had shingles. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391125 same reporter/product/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood cholesterol, Blood test
Clinical narrative: anemia; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 23Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional. A 67-year-old female patient received the first and second doses of the bnt162b2 (BNT162B2), via unspecified routes of administration in Feb2021  at single doses for covid-19 immunisation. Medical history included rheumatoid arthritis from 12Feb2021 to an unknown date and anaemia from an unknown date and unknown if ongoing in her 20s. Concomitant medications included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 02Dec2020 to Feb2021; ascorbic acid, ferrous gluconate (IRON & VITAMIN C) taken for an unspecified indication, start and stop date were not reported. The patient experienced anemia on an unspecified date. The event was further described as: the patient had been off tofacitinib citrate since Feb2021. Per MD, tofacitinib citrate did not cause her anemia since she had been off the therapy for a while. The MD continued to hold the therapy due to anemia. The patient underwent lab tests and procedures which included cholesterol: great on an unknown date and blood test: showed anemia (low iron) and too much water in her body on 10Mar2021. Blood work showed improvement in Apr2021. However, MD was not comfortable for the patient to resume the therapy. Per patient, MD did not determine that the therapy caused "anemia" as she also received and completed her two doses of bnt162b2. The clinical outcome of the event, anemia, was unknown.    No follow up attempts are needed. Information on the lot/Batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of the two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, the patient had shingles. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391085 same reporter/product/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Gastrointestinal disorder
Clinical narrative: Loss of appetite; Now experiencing digestive issues; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the past Monday midmorning (05Apr2021) at single dose for COVID-19 immunization. The patient's medical history included that part of her intestine removed two and a half years ago. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. It was reported that, the patient was currently (Apr2021) experiencing digestive issues and a loss of appetite. The patient asked whether digestive issues had been seen as side effects and that how long the side effects usually last, whether up to second dose. The patient further enquired if she could take her probiotics. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes on her one arm; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, in left arm on 07Apr2021 15:00 (at 74-years age) last Wednesday as single dose for covid-19 immunisation and patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration, in left arm on 17Mar2021 15:15 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient was not allergic to medications, food, or other products. Concomitant medication(s) the patient received within 2 weeks of vaccination included gabapentin (GABAPENTIN); rosuvastatin (ROSUVASTATIN); diclofenac (DICLOFENAC); misoprostol (MISOPROSTOL). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 19:00 patient had experienced swollen lymph nodes on her one arm starting Thursday night up to today. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; muscles aches; back pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration, in Left Arm on 11Apr2021 at 11:00 (at the age of 29-years-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included Birth control received within 2 weeks of vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient had most recent COVID-19 vaccine at  Health Clinic/Administration facility. The patient experienced fever, muscles aches, back pain and nausea on 11Apr2021 at 16:00 after vaccination. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Headache; sore muscles; sore joints; chills; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was unknown), via an unspecified route of administration, in Left Arm on 11Apr2021 at 08:30 (at the age of 65 years old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration, in Left Arm on 14Mar2021 at 10:00 at single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at hospital. The patient experienced headache, sore muscles, sore joints and chills on 11Apr2021. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Glands had swollen; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), 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. On an unspecified date, the patient's glands had swollen. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.