chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: With the first vaccine I had a slight headache for about 2 1/2 days.; This is a spontaneous report from a contactable other HCP. This 67-year-old female other HCP reported. A 67-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ELO140), via an unspecified route of administration, in right arm on 04Jan2021 11:30 (at 67-years age) as single dose for covid-19 immunisation. Medical history included hypothyroidism and patient reported that she never was diagnosed with Covid, but she thought that she had on Feb2020. Patient had no known allergies. Concomitant medication(s) included thyroid (THYROID); vitamin b complex (VITAMIN B); zinc (ZINC); ergocalciferol (VIT D). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. With the first vaccine patient had a slight headache for about 2 1/2 days. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Have like hives or rash or something from my elbow down to my hand not solid but there are several spots; This is a spontaneous report received from a contactable consumer (patient). A 66-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EN6201, Expiry Date: 30Jun2021) via an unspecified route of administration on 23Feb2021 (at the age of 66-year-old) as a single dose for Covid-19 immunization in hospital. The patient medical history and concomitant medications were not reported. On 24Feb2021, patient reported that she had like hives or rash or something from elbow down to hand not solid but there are several spots. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 27Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced nausea on 28Feb2021 (this morning). Patient wanted to know what medication she can take for nausea. The outcome of the event was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test, Sinus disorder
Clinical narrative: exposure made it first two weeks; Sinus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced exposure made it first two weeks (exposure to sars-cov-2) and sinus. First dose 05Mar2021. Miscalculated quarantine period exposure made it first two weeks. Second weeks no symptoms, testing negative. Sinus. I am wondering. Two times I was exposed. They had a mask on. Where would that leave me? Miscalculated. If I am fighting it, and I am adding? Potential AE. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria
Clinical narrative: Slurred speech; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 12:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing, polycystic ovaries from an unknown date and unknown if ongoing, dairy intolerance (allergy to dairy) from an unknown date and unknown if ongoing, drug hypersensitivity (hydrocodone and Darviset allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications included levotyroxine (levothyroxine), liothionine (liothyronine) and estrogen patch (estrogen). The patient's historical vaccine included the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Feb2021 at 12:45PM on right arm. The patient had not taken any other vaccine in four weeks prior to the first dose of COVID-19 vaccine. The patient did not have COVID prior to COVID vaccination. On 08Mar2021 at 07:00 PM, the patient experienced slurred speech. The patient was not tested for COVID post vaccination. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date 2021.  No follow-up attempts are possible.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Condition aggravated, Herpes zoster, Pruritus
Clinical narrative: itching; bug bite on her left lower rib cage; itching/bug bite on her left lower rib cage/When she got the second shot, the itching got worse; shingles; This is a spontaneous report from a contactable consumer patient. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on an unspecified date (lot number and expiration date were not reported) as single dose (at the age of 74-years-old) for COVID-19 immunisation. Medical history included allergies to mussels, clams and oysters. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient took the first BNT162B2 on 05Feb2021, 10:30 (lot number: EL9269) administered in the right arm for Covid-19 immunisation (at the age of 74-years-old) and experienced "I had a small breakout of vaginal herpes which I haven't had for two years". The patient did not have other vaccine in four weeks. The patient did not have covid prior to vaccination and was not tested post vaccination. The week of the second shot she started itching. She thought it was a bug bite on her left lower rib cage. When she got the second shot, the itching got worse. She went to a walk-in clinic and it was diagnosed as shingles which was still lingering. The patient received an unspecified treatment for the event. At the time of the report, the patient was recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: positive for COVID; patient experienced COVID on 20FEB2021 after the first dose of vaccination; This is a spontaneous report received from a contactable consumer. A Female patient of unspecified age received first dose bnt162b2 (COMIRNATY, Solution for injection Lot No. Unknown, Expiration date-unknown) via unspecified route of administration on unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were unknown. Family History was unknown. The patient experienced COVID on 20FEB2021 after the first dose of vaccination, now she feels well and asked her doctor what she needs to do because her second dose is scheduled by 13Mar and her doctor replied as don't know.   No follow-up attempts are possible; No information about lot/batch cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event COVID-19, Drug ineffective and the suspect drug BNT162B2.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Developed shingles (herpes zoster); typical rash; nerve pain; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 02:30 (Batch/Lot Number: EN6206) (at the age of 71 years old) as single dose for COVID-19 immunization. Medical history included asthma and known allergies: penicillin and multiple foods. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 09Mar2021, the patient experienced developed shingles (herpes zoster), typical rash and nerve pain. The condition shingles was diagnosed at an urgent care center. The patient had a typical rash and nerve pain. The event resulted in emergency room/department or urgent care. Treatment for the event included Acyclorvir. No COVID prior vaccination. The patient was not COVID tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neuralgia, Oral herpes, Pyrexia
Clinical narrative: severe right sided facial nerve pain and sensitivity; developed herpes simplex sore on right side of mouth/ cold sore; low grade fever; fatigue; This is a spontaneous report received from a contactable nurse (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 03Mar2021 09:00 (Lot Number: EJ1685) as single dose for covid-19 immunisation; lidocaine hcl and bupivacaine hydrochloride (BUCAINE), both via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at unknown dosage for numbing the right upper molar area. Patient is not pregnant. Medical history included known allergies to Latex and hypertension. Concomitant medications in two weeks including vitamins. No other vaccine in four weeks. Patient had dental procedure on 06Mar2021 on including Lidocaine/Bucaine injection to numb the right upper molar area. On 08Mar2021 patient developed severe right sided facial nerve pain and sensitivity. On 08Mar2021 patient developed herpes simplex sore on right side of mouth, low grade fever, fatigue. Evaluated by HCP on 10Mar2021 who was going to prescribe steroids but did not due to receiving the Covid vaccine on 03Mar2021. HCP unsure if the herpes simplex, low grade fever, fatigue are due to dental procedure or Covid vaccine. Have been taking Ibuprofen & Acetaminophen. Facility type vaccine at Workplace clinic. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. On 16Mar2021, patient stated cold sore symptoms began on 08Mar2021. patient became aware that the facial pain symptoms may or may not be related to the Covid vaccine and/or the cold sore on 10Mar2021 when seeing a physician. The action taken for lidocaine hcl and bupivacaine hydrochloride was unknown. The event outcome for all events was recovering.  Pfizer is a marketing authorization holder of lidocaine hcl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of lidocaine hcl has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A patient of a pharmacist in a certain pharmacy chain needed the second dose next week but was diagnosed with shingles yesterday (10Mar2021). They wanted to make sure if it was still okay for the patient to receive the second dose. The outcome of the event was unknown.  Follow-up attempts are completed; information about batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dizziness, Fatigue
Clinical narrative: I was hospitalized with Covid.I took the antibody test and it was +. I feel as if I have Covid all over again. COVID-19-like symptoms; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; chills; nausea; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep7534, Expiry date: Unknown), dose 1 via an unspecified route of administration in Arm Left on 18Mar2021 08:30 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included patient was COVID positive on 22Nov2020 and was hospitalized 3 days later. This was prior to the vaccine. Then she did an antibody test and was positive and was oozing antibodies. This was prior to the vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient have not tested for COVID-19. Patient did not have allergies to medications, food or other products. The patient's concomitant medications were not reported. On 18Mar2021 13:00, the patient reported that she was hospitalized with COVID she took the antibody test and it was positive, she felt as if she had COVID all over again, COVID-19 like symptoms dizziness, fatigue, wicked headache, body aches, coughing overall horrible, chills and nausea. Received call from consumer regarding the Pfizer COVID vaccine.  She thinks she had a bad reaction. Then she did an antibody test and was positive and was oozing antibodies. She wanted to travel and needed the vaccine.  Last night felt like the very night she had COVID.  It was horrible. She had a wicked headache and all the symptoms again. She wanted to know if she still needs to get the second shot and was this a normal experience. Therapeutic measures were not taken as a result of adverse events. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: I was hospitalized with Covid.I took the antibody test and it was +. I feel as if I have Covid all over again. COVID-19-like symptoms; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; chills; nausea; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep7534, Expiry date: Unknown), dose 1 via an unspecified route of administration in Arm Left on 18Mar2021 08:30 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included patient was COVID positive on 22Nov2020 and was hospitalized 3 days later. This was prior to the vaccine. Then she did an antibody test and was positive and was oozing antibodies. This was prior to the vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient have not tested for COVID-19. Patient did not have allergies to medications, food or other products. The patient's concomitant medications were not reported. On 18Mar2021 13:00, the patient reported that she was hospitalized with COVID she took the antibody test and it was positive, she felt as if she had COVID all over again, COVID-19 like symptoms dizziness, fatigue, wicked headache, body aches, coughing overall horrible, chills and nausea. Received call from consumer regarding the Pfizer COVID vaccine.  She thinks she had a bad reaction. Then she did an antibody test and was positive and was oozing antibodies. She wanted to travel and needed the vaccine.  Last night felt like the very night she had COVID.  It was horrible. She had a wicked headache and all the symptoms again. She wanted to know if she still needs to get the second shot and was this a normal experience. Therapeutic measures were not taken as a result of adverse events. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles/ started as a rash/itching for a few days then the area became sore; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6202), via an unspecified route of administration, administered in left arm on 08Mar2021 (at the age of 65-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has family history of colon cancer (mother). There were no concomitant medications. Patient reported she received the first dose on 08Mar2021. One week later, she developed a rash and it persisted. It started as a rash; she went to her doctor who said it was definitely shingles. Patient's doctor told her to wait 2 months before she got her second shot. She was not due to recover from her shingles until the first week of May2021. Patient asked if she needed to start over then. Patient's biggest concern was if she had to start all over again and how to schedule her appointment. While reporting case of shingles that she got after getting the Pfizer COVID vaccine, she stated that she had an older version of the shingles shot 6 years ago. Patient said she felt that the shingles shot must have helped as the shingles never broke out to blisters so she thinks whatever part of the shingles shot that was still in her when the COVID hit, along with the scripts that the doctor gave her, it never got severe. Patient did not provide a specific trade/brand name when speaking of the "shingles shot". Patient stated that she was itching for a few days (started on 09Mar2021) then the area became sore. When she looked on 16Mar2021, she noticed the rash. It was under her arm and on her thigh. Patient saw her doctor on 19Mar2021, that is when she was diagnosed with shingles and he started her on medication. Patient stated that the itching is gone and the rash is very faint and has improved. Patient stated she has no medical conditions and takes no prescriptions. She is as healthy as a horse. Patient denied any labs or testing relevant to this event. Patient was given medications prescribed and both started on 19Mar2021: valacyclovir HCl 1g tablet, take one tablet every 8 hours; dispensed 21 tablets; finished on 26Mar2021 and gabapentin: 100mg, 1 capsule every 8 hours for 90 days which patient is still taking at this time. Patient visited physician office due to the event. Patient had no prior vaccinations within the 4 weeks. Outcome of shingles was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular
Clinical narrative: Generalized maculopapular rash within 2-3 days; This is a spontaneous report from a contactable physician via Medical Information Team. A 61-year-old female patient received first dose of 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 medical history included hepatitis C viremic, cirrhotic. Concomitant medications were not reported. The patient was on hepatic transplant list. The patient developed generalized maculopapular rash within 2-3 days of receiving COVID-19 vaccine. The patient did not experience liver enzyme worsening and was fine at the time of report. The patient asked whether she should get the second vaccine dose. The event resolved with corticosteroid treatment. The outcome of the event was reported as resolved on an unspecified date.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She has "restless leg syndrome"(RLS). After taking the Pfizer-BioNTech COVID-19 Vaccine, Caller reported that there was no more RLS; 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 expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included restless legs syndrome. The patient's concomitant medications were not reported. Patient mentioned that she had "restless leg syndrome". After taking the Pfizer-BioNTech COVID-19 Vaccine, she reported that there was no more Restless leg syndrome.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Spinal pain
Clinical narrative: having a problem with his lower back/ sharp pain in his back; if he coughs the pain goes right to the spine in lower back; if he coughs the pain goes right to the spine in lower back; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, on 06Apr2021 at 10:45 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number not reported) in Mar2021 (3 weeks ago), as SINGLE DOSE for COVID-19 immunization. On 06Apr2021, the patient was having a problem with his lower back. An hour and 15 minutes or an hour and 20 minutes later of the second dose, on the same day of 06Apr2021, he had a sharp pain in his back and as he coughed the pain went right to the spine in lower back.  The patient wanted to know what he could do to relieve this. The patient had been taking Tylenol every 4 hours and took 8 on 06Apr2021 and it was not working on it. The patient never had back problems before. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Sweating real bad, gotten 10 times worse since she got the shot; 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 01Apr2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing menopause and ongoing sweating. Concomitant medications were not reported. The patient experienced real bad sweating in Apr2021, the patient was in menopause, but it seemed it was gotten 10 times worse since she got the shot. The patient asked whether the vaccine would have run its course and how long it would last. The patient mentioned that she did not think she was running a fever, but just sweating. The patient asked whether the vaccine would cause fever. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable other healthcare professional (patient).  This other healthcare professional reported same events for two patients (patient himself and his mom). This is the first of two reports.  A 47-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 01Apr2021 09:30, at the age of 47-years-old, (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation.  Medical history included testicular cancer - currently in remission, and penicillin allergy.     The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2, lot number: EN6202, on 11Mar2021 08:30 AM on Left arm. Prior vaccination, the patient was not diagnosed with COVID-19. On 04Apr2021 02:00 AM, the patient experienced extremely painful headache (just on the left side) and congested ear ache on the left side, red bumpy rash on scalp and forehead extremely sensitive to touch and painful on scalp. Then on a follow-up call, the patient reported he was calling because he had to go to the ER. He was diagnosed with shingles after his COVID dose which was whole a new adverse events and his mother also went in for her second dose on Tuesday she also got shingles. Patient also added, Is there anything in regards to compensating for ER visits or kind of stuff or no and he has to go to the ER due to being diagnosed with shingles, is there anything monetarily Pfizer can do to compensate for having go to the ER. Is there any way applying for the reimbursing of money to put out that he has to go to the ER? Since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not recovered. Treatment includes acyclovir.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443896 same reporter/drugs/events; different patients
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a non-contactable consumer (the patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second Pfizer COVID vaccine shot and had a fever since. He took ibuprofen for it when it went up to 101. He asked if he could continue to take it. The outcome of fever was not recovered.   No follow up attempts are possible; information about lot number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Urticaria
Clinical narrative: started feeling a sensation in her skin; she felt itching; she had a few spots she could see ...by the next morning she had a lot of them/hives; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received dose 1 of BN162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration on 01Apr2021 at 10:00 (at the age of 73-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included hormone replacement from an unspecified date for an unspecified indication. On 04Apr2021 the patient experienced feeling a sensation in her skin, itching, and hives. She had not taken any new medications, gone anywhere, or done anything different. She felt itching and thought she must have gotten into bugs. It was her arms and legs. That night she had a few spots she could see and thought they were mosquito bites. By the next morning (05Apr2021) she had a lot of them. She was itching a lot and it kept her up all night. The itching was in her hands. The breakout on her body didn't itch so much and her hands didn't have anything on them. The itching was horrible "yesterday" (06Apr2021) especially during the night; she didn't sleep. On 05Apr2021, the patient visited an urgent care for the events and was diagnosed with hives. The patient was treated with cetirizine (lot number OKE2392A; expiration date Jul2022; strength: 10 mg; tablets) from 05Apr2021 to an unspecified date and a steroid pack for 6 days from 07Apr2021. When the patient took the steroid, the itching went away but the hives were still there. They were everywhere, on her thighs, some on her arms, chest, back, and feet. There were no hives on her face and neck. Her breasts and upper chest were real bad and they were red and coming together to be big areas. On 07Apr2021 the rest of the hives were pink and some had gone away. The itching was gone. The outcome of strange sensation on her skin was unknown. The outcome of itchy was recovered on 07Apr2021. The outcome of hives was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Erythema, Hypoaesthesia, Throat tightness
Clinical narrative: numbness in chin; jaw tightness in throat; redness on hands and upper back; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 12:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing; and allergy to intravenous (IV) contrast red dye from an unknown date and unknown if ongoing. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had not been diagnosed with COVID-19 prior to vaccination. Concomitant medications included propranolol hydrochloride (INDERAL), irbesartan, and atorvastatin all from unknown dates for unknown indications. On 06Apr2021 the patient experienced numbness in chin, jaw tightness in throat, and redness on hands and upper back. The events required an emergency room/department or urgent care visit. The patient was treated with diphenhydramine hydrochloride (BENADRYL) and received an electrocardiogram (EKG) and a computerized tomography (CT Scan), the results of which were not reported. The outcome of numbness in chin, jaw tightness in throat, and redness on hands and upper back were recovered in Apr2021. It was also reported the patient had not been tested for COVID-19 since vaccination.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-10 VACCINE, solution for injection), via an unspecified route of administration on 28Feb2021 (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's wife reported that the patient received the first dose on 28Feb2021 and developed shingles on the same day. The patient was told by a doctor to wait 2 weeks before receiving the second dose. However, it was reported that it has been 8 weeks and the wife wanted to know if the patient can still get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Significant fatigue; This is a spontaneous report from a contactable consumer (patient), and another contactable consumer. A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EP6955) in Left Arm on 07Apr2021 at 11:45 (at the age of 65-years-old) via an unspecified route of administration, at single dose for COVID-19 immunization. Medical history included diabetes type 2. Concomitant medication included metformin and daily insulin 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. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was not known if patient has been tested for COVID-19. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EP6955) in left arm on 17MAR2021 at 11:30 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at Workplace clinic. The patient experienced significant fatigue on 08Apr2021 at 06:00 after the second dose. No treatment was received for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Headache, Malaise
Clinical narrative: has not been feeling good; fatigue; headache/ head still hurting; when he inhales his throat feels weird and he starts coughing; when he inhales his throat feels weird and he starts coughing; he is still feeling weak; This is a spontaneous report from a Pfizer- sponsored program received from a contactable consumer (patient). A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (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 reported that he had not been feeling good, and experienced fatigue, headache/ head still hurting and reported when he inhaled his throat felt weird and he started coughing and he was still feeling weak. The outcome was reported as not recovered for asthenia and headache and unknown for rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: has not been feeling good; fatigue; headache/ head still hurting; when he inhales his throat feels weird and he starts coughing; when he inhales his throat feels weird and he starts coughing; he is still feeling weak; This is a spontaneous report from a Pfizer- sponsored program received from a contactable consumer (patient). A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (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 reported that he had not been feeling good, and experienced fatigue, headache/ head still hurting and reported when he inhaled his throat felt weird and he started coughing and he was still feeling weak. The outcome was reported as not recovered for asthenia and headache and unknown for rest of the events.  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 Pfizer-sponsored program . A non-contactable consumer (patient herself) reported that a female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date (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. Patient wanted to know if she should take her second COVID vaccine since she broke out with shingles. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was ER8732), via an unspecified route of administration, in Left Arm on 01Mar2021 (at the age of 52-years-old) at single dose for COVID-19 immunization. The patient's medical history includes penicillin and sulfa allergy. Concomitant medications included thyroid (ARMOUR THYROID) 15mg daily, received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient experienced tinnitus on 04Mar2021 after first dose of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included audiology test with unknown results. The outcome of the event was not recovered. Therapeutic measure has been given in response to the event.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Felt very stuffy and my chest felt tight.; Felt very stuffy and my chest felt tight.; Extremely sore; This is a spontaneous report from two contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration administered in arm left on 06Mar2021 13:30 as single dose for covid-19 immunization. Medical history included allergy to penicillin and keflex. Concomitant medications included benzylpenicillin sodium, procaine benzylpenicillin (PANCILLIN [BENZYLPENICILLIN SODIUM;PROCAINE BENZYLPENICILLIN]) taken as an antidepressant therapy. cefalexin monohydrate (KEFLEX [CEFALEXIN MONOHYDRATE]) taken for anxiety. Patient took her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in arm left on 07Apr2021 13:30 for covid-19 immunization, The patient experienced felt very stuffy and her chest felt tight also experienced extremely sore on 17Mar2021. It was asked to patient to confirm event onset date as if case late delay comment required. Outcome of the events was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: extremely sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 31Mar2021 at a single dose for COVID-19 immunization. Medical history included ongoing Systemic lupus and ongoing Rheumatoid disease. The patient's concomitant medications were not reported. After her first dose the patient got extremely sick on an unspecified date and is scared to get second dose. The patient wanted to know if the vaccine is safe for people with autoimmune disease. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Rash papular, Swelling
Clinical narrative: Allergic reaction; Starting with a rash on your neck. , Large mosquito bite now on the right side of my neck; I am still slightly itchy; Over the night swelling started and became worse just in the localized area on the back of my neck; Bumps and rash; This is a spontaneous report received from a non-contactable consumer (patient). A 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at the age of 28-years-old) as a single dose on the left side for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 as a single dose for COVID-19 immunization. On an unspecified date the patient experienced allergic reaction, rash on her neck, bumps and rash, itchy, and swelling. The events were reported as non-serious. The patient had an allergic reaction starting with a rash on her neck, "large mosquito bite" now on the right side of her neck. Today she was still slightly itchy but not as severe as yesterday. Over the night swelling started and became worse just in the localized area on the back of her neck. She was not sure if it was a lymph node. The patient received treatment with diphenhydramine (BENADRYL) one hour after the vaccine. The outcomes of allergic reaction and itchy were unknown. The outcome of bumps and rash was recovered. The outcome of swelling was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Thrombophlebitis superficial, Ultrasound scan
Clinical narrative: long vertical bruise on inner thigh along the saphenous vein; ultrasound confirmed that patient had superficial thrombosis; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 13:15 (lot number: EW0150) as SINGLE DOSE for COVID-19 immunization. Medical history included polycystic ovaries and penicillin allergy. Concomitant medications included metformin; loratadine, pseudoephedrine sulfate (CLARITIN-D); acetylsalicylic acid, caffeine, paracetamol (EXCEDRINIL); calcium carbonate, colecalciferol (VITAMIN D 2000); zinc. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 11Mar2021 at 08:30 in the left arm for COVID-19 immunization. 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. On 05Apr2021, the patient developed a long vertical bruise on inner thigh along the saphenous vein. The event resulted in  emergency room/department or urgent care as this can be a sign of clotting. Upon arrival at the ER, the doctor checked the patient's platelets and palpated the area and determined that an ultrasound is needed to rule out deep vein thrombosis. The ultrasound confirmed that patient had superficial thrombosis. Therapeutic measures were taken as a result of the events which included treatment with Baby aspirin for two weeks. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Headache, Hypoacusis, Musculoskeletal stiffness, Rash
Clinical narrative: stiffness; rash in left arm pit/under the left arm; Hearing was dull; disoriented for week; headache/pain in head, felt as if someone was hitting with a stick of wood and experiencing sore at the top of head; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EP7534), via an unspecified route of administration, in Left Arm on 23Mar2021 at 16:00 (at the age of 72-years-old) at single dose for COVID-19 immunization.  Medical history included asthma. Concomitant medications included Tamsulosin received within 2 weeks of vaccination. Patient had no allergies to medications, food or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EN6202) in Left Arm on 02Mar2021 at 16:00 (at the age of 72-years-old) at single dose for COVID-19 immunization. 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. The patient experienced stiffness, rash in left arm pit/under the left arm and hearing was dull, experienced ringing in the left ear on 24Mar2021 at 12:00. Patient was disoriented on 24Mar2021 at 12:00 for a week. It was reported that patient experienced headache/pain in head, felt as if someone was hitting with a stick of wood and experiencing sore at the top of head from 24Mar2021 for two weeks. No treatment was given for the events. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.