chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash, Urticaria
Clinical narrative: Extreme rash/welts over entire body from head to feet; Extreme rash/welts over entire body from head to feet; This is a spontaneous report from two contactable consumers (patient and patient husband). A 75-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW6200), via an unspecified route of ad-ministration on 24Feb2021 at 10:00 AM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 75 Years. Facility where COVID-19 vaccine was administered was at the other. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Epstein barr viraemia. Concomitant medications included olmesartan medoxomil (BENICAR) taken for blood pressure measurement and levothyroxine sodium (SYNTHROID) taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (Lot Number: EL9263), on 03Feb2021 at 09:00 AM in the left arm at single dose for COVID-19 immunisation. On 04Mar2021, the patient experienced extreme rash/welts over entire body from head to feet. Reporter stated, she went to her internist on Friday as a result of the rash that she developed, it's a very serious rash basically from her head to her toes and he put her on Benadryl which did not help and then he gave her Medrol pack which she started yesterday and getting two days worth of the Medrol pack which does not seem to be helping yet. Reporter added, we would like to know, going online we could see this is somewhat not rare side effect any other medication or treatment she should be receiving or what is the experience with respect to the side effect how long does it last. Multiple blood work, they were all within normal limits. Date of Lab work was approximately 3 weeks ago. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. The patient underwent lab tests and procedures which included blood test: normal on an unknown date 2021 (all within normal limits). Therapeutic measures were taken as a result of extreme rash/welts over entire body from head to feet with Benadryl & Medrol Pak. Outcome of the events was not recovered. Health authority comment: none.  More follow-up information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysphagia, Hypertension, Throat tightness, Vaccination site discomfort
Clinical narrative: Throat constriction could not swallow; Throat constriction could not swallow; Blood pressure high 225/170; It wasn't right on site; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration in right arm on 01Mar2021 09:15 as first dose single for covid-19 immunisation. Medical history included migraines, fibromyalgia, arthritis, Known allergies to tetracycline, Iodine, Ecklonia Kurome, degenerative joint and Osteoarthritis. Concomitant medications included sumatriptan, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET), rosuvastatin calcium (CRESTOR) all are taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfacetamide and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced throat constriction could not swallow/blood pressure high 225/170 on 08Mar2021 02:00. Patient received the 1st dose of the Pfizer vaccine on 08Mar2021. She had adverse events after the 1st dose and was rushed to the ER, but they were able to stabilize her. She is wondering if she would be a candidate for the 2nd dose which is scheduled on 12Apr2021. She also mentioned that she had a check-up, and she was told that she can get the 2nd dose. She was asked to bring her EpiPen with her and take some antihistamine prior to getting the 2nd dose. She was asking maybe Pfizer has some advice for her as well. Patient ended up being taken in the ambulance to ER with an adverse reaction. It was a delayed reaction. It was not right on site on an unspecified date in Mar2021, right after I had the shot that it was a delayed reaction and I ended up in emergency in the ER. As per the reporter seriousness criteria reported as medically significant. Patient received treatment of IV drip methylprednisolone sod succ (Solution-MEDRO) for adverse events. The patient underwent lab tests and procedures which included blood pressure: 225/170 on 08Mar2021. The outcome of the event vaccination site discomfort was unknown and not recovered for other events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Loss of consciousness, Nausea, Vision blurred
Clinical narrative: blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a spontaneous report received from a contactable consumer (reporting on herself). A 67-years-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 09Mar2021 10:15 as single dose for COVID-19 immunization. Medical history included hypertension, blood cholesterol increased, obesity , goitre , sciatica , arthritis, fibromyalgia, all from an unknown date and un-known if ongoing. Concomitant medication(s) included meloxicam (MELOXICAM); gabapentin (GABAPENTIN); levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen, sulfa and synthroid and experienced drug hypersensitivity, First dose of BNT162B2 on 16Feb2021 09:15 for covid-19 immunisation 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. It was reported that patient was up at 5:30 am and started seeing gray splotches and then she got nauseous and started blacking out. It happened again about 10 minutes later and she barely made it back to bed be-fore the whole thing stopped. When she woke up later she was still a little light headed. The out-come of the events was recovered on an unspecified date.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Joint stiffness, Muscle spasms, Musculoskeletal stiffness, Overdose
Clinical narrative: red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin.; feel something under skin; looked like red rash broke out on his thighs and seemed like the shingles; looked like red rash broke out on his thighs and seemed like the shingles; muscle spasms on the left side of his back; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; 2nd dose, 3 mg single; This is a spontaneous report from a contactable consumer (who is also the patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm, on 01Mar2021 (also reported as 02Mar2021) a little before 10:00 close to an hour after arriving at 09:00, as 2nd dose, 3 mg single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), administered in the left arm shoulder, at 0.3 mg, for COVID-19 immunization. On 02Mar2021, the patient started having muscle spasms in the lower part of his back. The patient clarified that the muscle spasm was on the left side of his back which was the same side as the vaccination. On the same day, 02Mar2021, the patient experienced stiffness and it was hard to straighten up, it was catching in his left hip and lower part of his back and it was pretty severe. On 05Mar2021, the patient could feel something under his skin that looked like red rash broke out on his thighs and seemed like the shingles or something and he didn't know what that was. He stated that he saw red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin. The patient was recovering from muscle spasms, stiffness, and joint stiffness. The outcome of the remaining events was not recovered.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash erythematous, Rash macular
Clinical narrative: red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin.; feel something under skin; looked like red rash broke out on his thighs and seemed like the shingles; looked like red rash broke out on his thighs and seemed like the shingles; muscle spasms on the left side of his back; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; 2nd dose, 3 mg single; This is a spontaneous report from a contactable consumer (who is also the patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm, on 01Mar2021 (also reported as 02Mar2021) a little before 10:00 close to an hour after arriving at 09:00, as 2nd dose, 3 mg single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), administered in the left arm shoulder, at 0.3 mg, for COVID-19 immunization. On 02Mar2021, the patient started having muscle spasms in the lower part of his back. The patient clarified that the muscle spasm was on the left side of his back which was the same side as the vaccination. On the same day, 02Mar2021, the patient experienced stiffness and it was hard to straighten up, it was catching in his left hip and lower part of his back and it was pretty severe. On 05Mar2021, the patient could feel something under his skin that looked like red rash broke out on his thighs and seemed like the shingles or something and he didn't know what that was. He stated that he saw red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin. The patient was recovering from muscle spasms, stiffness, and joint stiffness. The outcome of the remaining events was not recovered.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue; tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue; This is a spontaneous report from a contactable consumer or other non-HCP.  A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in Right Arm on 03Mar2021 as single dose, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in Right Arm Right on 10Feb2021 as single dose for covid-19 immunization. Medical history included rheumatoid arthritis, increased blood cholesterol, hypothyroidism, raynaud's phenomenon. Concomitant medications included hydroxychloroquine (HYDROXYCHLOROQUINE); atorvastatin calcium (ATORVASTATIN CALCIUM); pantoprazole (PANTOPRAZOLE); levothyroxine sodium (LEVOXYL); ergocalciferol (VIT D). The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. On 10Mar2021 the patient experienced tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue. No treatment was received for the events. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 10Mar2021. The outcome of event was recovering.   Follow-up (15Mar2021): New Information received from the contactable consumer included event onset date and was updated.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 03Mar2021, first dose on 10Feb2021 for covid-19 immunization.  On 10Mar2021 the patient experienced tested positive for COVID-19 with fever, chills, runny nose, sneezing, coughing and fatigue.  Based on information available, vaccination failure in the patient cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dermatitis allergic, Herpes zoster, Pain, Scratch
Clinical narrative: pain was horrible; bumps on the back of her neck and they were small, raised sharp bumps and has jabs of sharp pain back there; reports the area is now still sensitive with a little bit of roughness.; she thinks the vaccine has irritated the shingles; she thinks the vaccine has irritated the shingles; Scratching at her neck; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from Nov2020, tenderness from 2020, ongoing arthralgia, ongoing neck pain, ongoing pain in extremity, pigmentation disorder. Caller reported that she had shoulder was tender with bumps at the end of last year and still has pain in her shoulder up to her neck and still has light red spots and pain in the bicep of her arm. The patient's concomitant medications were not reported. Caller reported that 4-5 days after the covid vaccine she had bumps on the back of her neck and they were small, raised sharp bumps and has jabs of sharp pain back there. Caller reports the area is now still sensitive with a little bit of roughness. When the caller got shingles back in November, it didn't immediately go away, you could see the marks on her left arm but the pain started in her shoulder. The caller didn't relate the pain to shingles because she has had issues in that shoulder in the past. The caller didn't have any scars or pimples, her doctor didn't know what was going on so the caller went to her sports medicine doctor. From that Friday to Monday, all the redness was down the caller's arm so the caller went back on Tuesday to her primary care provider. The original pain from the shingles was from the shoulders to the neck, the red marks and scabs were on her left arm and none on the shoulder and neck had the red marks and scabs but the pain was there. The pain was horrible and it went away. The marks on the caller's arms are still there, discomfort pain not screaming pain in her left arm, bicep. Several days after the covid shot the caller was scratching at her neck then realized that the whole area of the neck to the same shoulder was tender, it has remained sensitive since and has as few bumps, so she doesn't know but she thinks the vaccine has irritated the shingles. The caller's skin right now is sensitive. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: pain was horrible; bumps on the back of her neck and they were small, raised sharp bumps and has jabs of sharp pain back there; reports the area is now still sensitive with a little bit of roughness.; she thinks the vaccine has irritated the shingles; she thinks the vaccine has irritated the shingles; Scratching at her neck; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from Nov2020, tenderness from 2020, ongoing arthralgia, ongoing neck pain, ongoing pain in extremity, pigmentation disorder. Caller reported that she had shoulder was tender with bumps at the end of last year and still has pain in her shoulder up to her neck and still has light red spots and pain in the bicep of her arm. The patient's concomitant medications were not reported. Caller reported that 4-5 days after the covid vaccine she had bumps on the back of her neck and they were small, raised sharp bumps and has jabs of sharp pain back there. Caller reports the area is now still sensitive with a little bit of roughness. When the caller got shingles back in November, it didn't immediately go away, you could see the marks on her left arm but the pain started in her shoulder. The caller didn't relate the pain to shingles because she has had issues in that shoulder in the past. The caller didn't have any scars or pimples, her doctor didn't know what was going on so the caller went to her sports medicine doctor. From that Friday to Monday, all the redness was down the caller's arm so the caller went back on Tuesday to her primary care provider. The original pain from the shingles was from the shoulders to the neck, the red marks and scabs were on her left arm and none on the shoulder and neck had the red marks and scabs but the pain was there. The pain was horrible and it went away. The marks on the caller's arms are still there, discomfort pain not screaming pain in her left arm, bicep. Several days after the covid shot the caller was scratching at her neck then realized that the whole area of the neck to the same shoulder was tender, it has remained sensitive since and has as few bumps, so she doesn't know but she thinks the vaccine has irritated the shingles. The caller's skin right now is sensitive. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: horrible pains in both shoulders; Pain spreaded to other joints; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 74-years-old female patient (who was not pregnant at the time of vaccination), received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in arm left on 18Feb2021 as 2nd dose, single; dose 1 (Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Arm Right on 21Jan2021 10:00AM, as 1st dose, single for COVID-19 immunization. Medical history included arthritis, high blood pressure and chronic boreliosis. The patient had known allergies to NSAIDs, Levaquin and latex. Concomitant medications included Oxycodone (OXYCODONE)7.5 mg; carvedidol (CARVEDILOL) 20 mg; gabapentin (GABAPENTIN) 300. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient stated that, No adverse effects first 4 days. Then a horrible pain in both shoulders, samnitska m up dcery houf. Could not lift a cup od water, pull my pants up or shirt on. Because I heard from a friend in a state that hers lasted a month I was waiting. After three weeks, Eben Pain spreaded to other joints I visited my family doctor. He prescribed Medrol- steroid pack.and to stop Simvastatin. Pains subsided after 24 hours. On 23Feb2021 06:00AM, the patient experienced horrible pains in both shoulders and pain spreaded to other joints. Therapeutic measures (Medrol) were taken as a result of horrible pains in both shoulders and pain spreaded to other joints. Outcome of the events was recovered.  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 Covid 19 positive; This is a spontaneous report from a contactable consumer (reported for himself).  The male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot number and Expiration Date: UNKNOWN), via an unspecified route of administration on 28Jan2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. After a week Patient tested COVID-19 positive. Patient inquired what was the recommended date for the second dose. The outcome of the event of tested COVID-19 positive was unknown.   No follow-up attempts were Possible. No further information was expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Positive covid test; Headache; Nauseousness; a little bit of a fever; Chills; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on 25Feb2021 the age of 58-year-old year, as first dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications was not reported. the patient was taking Pfizer COVID-19 vaccine works at a school, around her mom who is an elderly lady and they offered it so she took it. The patient did not receive other product prior to vaccine. The patient experienced, headache, nauseousness, a little bit of a fever on 05Mar2021, positive COVID test on 07Mar2021. Patient stated she received her first dose of the Pfizer Covid-19 vaccine on 25Feb2021. She was supposed to go back 18 Mar 2021 for her second dose, but she was not feeling well so she took a COVID test and it came out positive. She clarifies her symptoms began on 05 Mar 2021 and then she went and got tested for COVID and tested positive on 07Mar 2021. Caller states she had chills Friday evening and Saturday, but her temperature was like 98.6 or 98.9, but then she got the fever. Caller reports the chills stopped yesterday (Tuesday) or Monday. Treatment-she has been taking 500 mg Ibuprofen. She stated she has not given the fever a chance to get up there. She wanted to know what the next step is; should she go to her appointment or reschedule. She really just wants to find out what she has to do. Does she have to wait 14 days or 2 weeks or 3 weeks or what. Seriousness of the event was reported as non-serious. The outcome of events headache, nauseousness, not recovered, fever was recovering, Positive COVID test was unknown and chills was recovered.  There was a Product Complaint, description of Product Complaint: Caller stated she received her first dose of the Pfizer Covid-19 vaccine on 25 Feb 2021. She is supposed to go back 18 Mar 2021 for her second dose, but she wasn't feeling well so she took a COVID test and it came out positive. She clarifies her symptoms began on 05 Mar 2021 and then she went and got tested for COVID and tested positive on 07Mar2021. Caller does not have her vaccine record card at the time of the call. No further details were provided or obtained.  No follow up attempts are possible: No Further information is excepted.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Positive covid test; Headache; Nauseousness; a little bit of a fever; Chills; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on 25Feb2021 the age of 58-year-old year, as first dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications was not reported. the patient was taking Pfizer COVID-19 vaccine works at a school, around her mom who is an elderly lady and they offered it so she took it. The patient did not receive other product prior to vaccine. The patient experienced, headache, nauseousness, a little bit of a fever on 05Mar2021, positive COVID test on 07Mar2021. Patient stated she received her first dose of the Pfizer Covid-19 vaccine on 25Feb2021. She was supposed to go back 18 Mar 2021 for her second dose, but she was not feeling well so she took a COVID test and it came out positive. She clarifies her symptoms began on 05 Mar 2021 and then she went and got tested for COVID and tested positive on 07Mar 2021. Caller states she had chills Friday evening and Saturday, but her temperature was like 98.6 or 98.9, but then she got the fever. Caller reports the chills stopped yesterday (Tuesday) or Monday. Treatment-she has been taking 500 mg Ibuprofen. She stated she has not given the fever a chance to get up there. She wanted to know what the next step is; should she go to her appointment or reschedule. She really just wants to find out what she has to do. Does she have to wait 14 days or 2 weeks or 3 weeks or what. Seriousness of the event was reported as non-serious. The outcome of events headache, nauseousness, not recovered, fever was recovering, Positive COVID test was unknown and chills was recovered.  There was a Product Complaint, description of Product Complaint: Caller stated she received her first dose of the Pfizer Covid-19 vaccine on 25 Feb 2021. She is supposed to go back 18 Mar 2021 for her second dose, but she wasn't feeling well so she took a COVID test and it came out positive. She clarifies her symptoms began on 05 Mar 2021 and then she went and got tested for COVID and tested positive on 07Mar2021. Caller does not have her vaccine record card at the time of the call. No further details were provided or obtained.  No follow up attempts are possible: No Further information is excepted.
Sex: M
Vaccine: COVID19
Symptoms: Groin pain, Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: herpes zoster on upper right chest; groin, thigh, thoracic nerve pain; groin, thigh, thoracic nerve pain; groin, thigh, thoracic nerve pain; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: FL3247) as UNKNOWN, SINGLE for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient developed groin, thigh, thoracic nerve pain on an unspecified date after the COVID vaccine. He later on developed herpes zoster on upper right chest with months of pain. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Herpes zoster, Laboratory test
Clinical narrative: lost hearing in her right ear; mouth sores diagnosed as oral shingles; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 22Sep2020 (had lab work on Sep2020 because of surgery) and blood pressure. The patient had shingle's vaccine. Concomitant medication(s) included irbesartan (IRBESARTAN) taken for blood pressure, start and stop date were not reported. Five days after the first vaccine the patient got severe sores in her mouth and then she went to the doctor, they call it she could possibly have shingles or shingles in her mouth it appeared to be canker sore (later reported mouth sores diagnosed as oral shingles). Then five days later she woke up in the night and could not hear. She lost hearing in her right ear. Actually loss of hearing 2 days before the got her second vaccine and she talked to her doctor and doctor thought the patient still went ahead and had the second vaccine but she didn't want to put the patient on the Prednisone because that will weaken her immunity but then it didn't get better and she sent the patient to Ear, Nose and throat he told the patient if she has any hope to getting her hearing back she had to start this medicine but that's what the patient was concerned about. The patient took Prednisone on 12Mar2021 for the ear treatment. For the first 2 week she was taking 60 mg and then after 3 weeks, she took 2 tablets 40 mg and then the next week she took 10 mg for 2 days. The outcome of event mouth sores diagnosed as oral shingles was recovering, others was unknown.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Pruritus, Rash, Swelling face
Clinical narrative: her chin looks puffier; In between doses she developed itching; rashes; later turned out to be shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation.  Medical history included Allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for Allergies and metformin for unknown indication. On an unspecified date, the patient experienced her chin looks puffier, in between doses she developed itching, rashes and later turned out to be shingles. The patient said that her chin looks puffier and she's asking if it is part of the side effects. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE 16Mar2021 - In between doses she developed itching, rashes, and later turned out to be shingles - She went to ENT and dermatologist and diagnosed with shingles - Medications given: Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021, second dose schedule will be on 13Apr2021 and asking if she can safely have it. She had the first dose on 16Mar2021 and developed Shingles. The patient was currently on Prednisone and Antibiotics. Caller would like to know if she can get her second dose scheduled on 13Apr2021. Therapeutic measures were taken as a result of in between doses she developed itching, rashes, later turned out to be shingles with Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Eczema, Rash, Swelling, Upper-airway cough syndrome
Clinical narrative: her chin looks puffier; In between doses she developed itching; rashes; later turned out to be shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation.  Medical history included Allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for Allergies and metformin for unknown indication. On an unspecified date, the patient experienced her chin looks puffier, in between doses she developed itching, rashes and later turned out to be shingles. The patient said that her chin looks puffier and she's asking if it is part of the side effects. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE 16Mar2021 - In between doses she developed itching, rashes, and later turned out to be shingles - She went to ENT and dermatologist and diagnosed with shingles - Medications given: Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021, second dose schedule will be on 13Apr2021 and asking if she can safely have it. She had the first dose on 16Mar2021 and developed Shingles. The patient was currently on Prednisone and Antibiotics. Caller would like to know if she can get her second dose scheduled on 13Apr2021. Therapeutic measures were taken as a result of in between doses she developed itching, rashes, later turned out to be shingles with Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear disorder, Eczema, Eustachian tube obstruction, Hypersensitivity, Rash macular
Clinical narrative: her chin looks puffier; In between doses she developed itching; rashes; later turned out to be shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation.  Medical history included Allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for Allergies and metformin for unknown indication. On an unspecified date, the patient experienced her chin looks puffier, in between doses she developed itching, rashes and later turned out to be shingles. The patient said that her chin looks puffier and she's asking if it is part of the side effects. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE 16Mar2021 - In between doses she developed itching, rashes, and later turned out to be shingles - She went to ENT and dermatologist and diagnosed with shingles - Medications given: Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021, second dose schedule will be on 13Apr2021 and asking if she can safely have it. She had the first dose on 16Mar2021 and developed Shingles. The patient was currently on Prednisone and Antibiotics. Caller would like to know if she can get her second dose scheduled on 13Apr2021. Therapeutic measures were taken as a result of in between doses she developed itching, rashes, later turned out to be shingles with Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular, Upper-airway cough syndrome
Clinical narrative: her chin looks puffier; In between doses she developed itching; rashes; later turned out to be shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation.  Medical history included Allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for Allergies and metformin for unknown indication. On an unspecified date, the patient experienced her chin looks puffier, in between doses she developed itching, rashes and later turned out to be shingles. The patient said that her chin looks puffier and she's asking if it is part of the side effects. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE 16Mar2021 - In between doses she developed itching, rashes, and later turned out to be shingles - She went to ENT and dermatologist and diagnosed with shingles - Medications given: Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021, second dose schedule will be on 13Apr2021 and asking if she can safely have it. She had the first dose on 16Mar2021 and developed Shingles. The patient was currently on Prednisone and Antibiotics. Caller would like to know if she can get her second dose scheduled on 13Apr2021. Therapeutic measures were taken as a result of in between doses she developed itching, rashes, later turned out to be shingles with Acyclovir taken for 7 days at two times a day, Antibiotics taken for 7 days at two times a day, Prednisone last day was 03Apr2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: was exposed to someone who was positive for COVID-19; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a female patient (wife) that of an unspecified age received first dose of BNT162B2 (PPFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration, on 02Mar2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medication were not reported. The reporter stated that he and her wife both got their first dose of the Pfizer COVID vaccine on 02Mar2021. The reporter tested himself and was positive for COVID-19. Then his wife (patient) exposed to who was positive for COVID-19. Now, both he and his wife were quarantined. They both due for their next shot on 22Mar2021, but caller stated they might have to miss that appointment due to their quarantine, and was wondering how long they could go before getting their second dose, without having to start the series over. The outcome of event was unknown.  Information on lot/ batch has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 24Feb2021 (Lot Number: EN6201) as single for COVID-19 immunization. Medical history included hypertension and known allergies: sulpha from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide taken for hypertension; lisinopril; calcium carbonate, colecalciferol (VITAMIN D); calcium; cyanocobalamin (B12) and unspecified multivitamin; start and stop date of all medications were not reported. The patient has not received other vaccine in four weeks. The patient experienced shingles on 18Mar2021 with outcome of recovering. Therapeutic measures include gabapentin. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of covid prior vaccination. The patient has not been tested for covid post vaccination.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test; This is a spontaneous report from a contactable other health care professional via medical information team. This other HCP reported similar events for 4 patients. This report is for 3rd of 4 patients. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Stated that "it was affecting 4 patients currently. They were totally asymptomatic. They had their first Pfizer vaccine 2 weeks ago and now have a positive PCR test" on an unspecified date in 2021. The patient underwent lab tests and procedures which included sars-cov-2 PCR test: positive. The clinical outcome of the events was unknown.  Information about lot/batch has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-2021304208 Different paitent, same drug, same event (split)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After I had my first vaccine I got COVID; I got COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE), Dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, after she had her first vaccine, she got COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. Outcome of the events was Unknown.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: Covid test result positive; patient tested positive for COVID-19; Aches; Back ache; All joints hurt; This is a spontaneous report from a contactable consumer. A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207), via an unspecified route of administration on 12Mar2021 at 13:15 in left arm as a single dose for covid-19 immunization. Medical history included atrial fibrillation. The patient did not received any other vaccines in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies were reported as none. Concomitant medications included amoxicillin trihydrate, clavulanate potassium 875 mg, lisinopril, apixaban and diltiazem: all start and stop date was not provided and used for unspecified indication. On 13Mar2021 at 12:00, the patient experienced back ache, all joints hurt, aches, fever, sore throat and cough. The patient took tyneol. The adverse events resulted in emergency room/department visit or urgent care. The patient was quarantined for 10 days and Dexamethasone was prescribed. On 19Mar2021, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test as positive on 19Mar2021 via nasal swab. The outcome of all events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid test result positive; patient tested positive for COVID-19; Aches; Back ache; All joints hurt; This is a spontaneous report from a contactable consumer. A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207), via an unspecified route of administration on 12Mar2021 at 13:15 in left arm as a single dose for covid-19 immunization. Medical history included atrial fibrillation. The patient did not received any other vaccines in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies were reported as none. Concomitant medications included amoxicillin trihydrate, clavulanate potassium 875 mg, lisinopril, apixaban and diltiazem: all start and stop date was not provided and used for unspecified indication. On 13Mar2021 at 12:00, the patient experienced back ache, all joints hurt, aches, fever, sore throat and cough. The patient took tyneol. The adverse events resulted in emergency room/department visit or urgent care. The patient was quarantined for 10 days and Dexamethasone was prescribed. On 19Mar2021, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test as positive on 19Mar2021 via nasal swab. The outcome of all events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Malaise, SARS-CoV-2 test
Clinical narrative: Covid test result positive; patient tested positive for COVID-19; Aches; Back ache; All joints hurt; This is a spontaneous report from a contactable consumer. A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207), via an unspecified route of administration on 12Mar2021 at 13:15 in left arm as a single dose for covid-19 immunization. Medical history included atrial fibrillation. The patient did not received any other vaccines in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies were reported as none. Concomitant medications included amoxicillin trihydrate, clavulanate potassium 875 mg, lisinopril, apixaban and diltiazem: all start and stop date was not provided and used for unspecified indication. On 13Mar2021 at 12:00, the patient experienced back ache, all joints hurt, aches, fever, sore throat and cough. The patient took tyneol. The adverse events resulted in emergency room/department visit or urgent care. The patient was quarantined for 10 days and Dexamethasone was prescribed. On 19Mar2021, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test as positive on 19Mar2021 via nasal swab. The outcome of all events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.