chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in left shoulder and upper arm; severe pain in left shoulder and upper arm; Tingling sensation; Throbbing pain in left bicep/Flexing or extending arm increases the pain; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809) via an unspecified route of administration in Left arm on 08Feb2021 at 03:45 PM as single dose for COVID-19 immunisation. Medical history was not reported. No known allergies. Concomitant medications were none. No other vaccine received in four weeks. No other medication received in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration in left arm on 18Jan2021 at 03:45 PM (at the age of 68 years) as single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Feb2021 at 04:00 PM, the patient experienced severe pain in left shoulder and upper arm. Tingling sensation down lower left arm extending to tip of thumb. Throbbing pain in left bicep. Flexing or extending arm increases the pain. No visible redness or skin disruption at needle site. Events resulted in Doctor or other healthcare professional office/clinic visit. So far he received prednisone prescription as treatment. Patient had not tested with COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: shingles/had "too much pain"; felt "super bad"/mind is going crazy right now; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9261), via an unspecified route of administration on 05Feb2021 as 1 st dose, single for covid-19 immunisation. Medical history included psoriatic arthritis and osteoporosis. Concomitant medications included methotrexate for psoriatic arthritis and alendronate sodium (FOSAMAX) for osteoporosis and unspecified vitamins. On 09Feb2021, the patient developed shingles, she saw a doctor on Saturday because she had "too much pain", she was given a "very strong" treatment to fight the shingles with prednisone 20 mg, gabapentin 300 mg, acyclovir 800 mg. The patient did not know if this was a reaction from the vaccine or if what was happening to her, she never had shingles in her life. The rheumatologist recommended her to get the first COVID vaccine, but she didn't know about the second one. She was scheduled for the second vaccine on 26Feb, she didn't know what to do, if to get the second dose or not. The patient asked if the vaccine interfere with the meds she takes. Also asked if she could get the vaccine if she was on these meds. She felt "super bad" in Feb2021 and wondered if shingles were an allergic reaction to the vaccine or a disease. Patient stated, "My mind is going crazy right now". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster, Hiatus hernia
Clinical narrative: Herpes Zoster; has a hiatus hernia and mentioned that her condition is becoming severe; has a hiatus hernia and mentioned that her condition is becoming severe; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization. Medical history included ongoing hiatal hernia on her stomach from an unknown date. The patient's concomitant medications were not reported.  The patient has a hiatus hernia and mentioned that her condition is becoming severe on Feb2021, after receiving her first shot. She may undergo a surgery to remove the hiatal hernia on her stomach but at the moment she is not sure. It was also reported that the patient developed a Herpes Zoster infection on 23Feb2021. The patient stated that she got infected with herpes on her legs from her sister and asked if there are recommendations/information for this scenario. The outcome of the event has a hiatus hernia and mentioned that her condition is becoming severe was not recovered while the outcome of the event  Herpes Zoster as unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: outside of right nostril swelling at tip; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of BNT162B2 (solution for injection) via an unspecified route of administration on an unspecified date (at the age of 63) at single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date it was reported that outside of right nostril swelling at tip 11 hours after second injection. Prior to vaccination patient was not diagnosed with COVID-19. The patient has been not tested for COVID-19 since the vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose increased, Diabetes mellitus, Fall
Clinical narrative: diabetes/high glucose levels; Patient says he is feeling very weak; has fallen twice; This is a spontaneous report from a contactable consumer (patient's stepbrother). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Arm Right on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for covid-19 immunisation. The patient was feeling very weak and has fallen twice and no fever or flu like symptoms. He ended up going to the hospital where they did a blood test which came back showing he had very high glucose levels and he was now convinced that the vaccine has given him diabetes. The patient experienced Patient says he is feeling very weak and has fallen twice but no fever or flu like symptoms on 24Feb2021, high glucose levels and diabetes on an unspecified date. The patient underwent lab tests and procedures which included blood glucose increased: high glucose levels on an unspecified date.The patient was not tested for COVID-19 since the vaccination. Outcome of the events patient says he is feeling very weak and has fallen twice was not recovered and unknown for other events.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mastitis, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, mastitis in breast on the same side as injection
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Significant pain in knees, with some pain in hips and shoulder joints. Pain continues at this time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Injection site pain
Clinical narrative: Chills, body and joint pain, spontaneous dislocation of left hand pinky joint, severve nausea, weakness, insomnia, sinus pain, injection site pain, loss is appetite.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Joint dislocation, Nausea, Sinus pain
Clinical narrative: Chills, body and joint pain, spontaneous dislocation of left hand pinky joint, severve nausea, weakness, insomnia, sinus pain, injection site pain, loss is appetite.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Glossodynia, Pain in jaw, Sialoadenitis
Clinical narrative: Acute Sialoadenitis  Inflammation of salivary glands Swollen under jaw and tongue painful Increase pain with each day  Pain move up to parotida and ear
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Continued skin burning sensation/ she felt like she was on fire/ she felt like she has the worse sunburn but can't see it; This is a spontaneous report from a contactable consumer. A 71-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL9269; expiration date: 31May2021), via an unspecified route of administration on 17Feb2021 at 13:45 in left arm as single dose for covid-19 immunization. The patient's medical history included hypertension, elevated cholesterol and allergies to medications, food, or other products like sulfa, cipro and macrodantin. The patient did not received 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 had not been tested for COVID-19. The patient's historical drug included ciprofloxacin from Mar2018 to Mar2018 for which she had a similar experience (she had a fever and checked her temperature several times. She feels like she has the worse sunburn but can't see it. She does not have a rash). After she stopped taking it, the symptoms disappeared. Unless she takes Benadryl, she feels this way. Her doctor didn't want her to stay on Benadryl. In Mar2018, she took Cipro for 3 days straight before she noticed it. She called her doctor and was told to stop taking it immediately. The patient's concomitant medications included losartan, amlodipine and atorvastatin: all has been taking for several years and was ongoing. As per the context, it was reported that all was well until she woke Friday night. On 19Feb2021 at 02:00 AM the patient experienced continued skin burning sensation with no fever or rash for one week, only temporary relief with benadryl, she felt like she was on fire. She felt like she has the worse sunburn but can't see it. She thought she had a fever and checked her temperature several times. Her temperature was normal. She felt like she had the worse sunburn but can't see it. She does not have a rash. There was no emergency room or physician office visit. She was concerned about taking the second dose on of the Covid-19 vaccine which was due on 10Mar2021. She found in her research from a Dr with the Coronavirus Task Force where he talked about allergic reactions. This was listed as an allergic reaction versus a side effect. It mentioned that there was a higher risk for the same thing happening with the second dose. They don't think that it is related to the vaccine but instead to an additive to help stabilize the vaccine. The outcome for all the events was not recovered/not resolved.  Follow-up attempts are needed. Further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation, Eye irritation, Eye swelling
Clinical narrative: My right eye (white of the eye) became irritated and swollen; My right eye (white of the eye) became irritated and swollen; It continued to be swollen until about 7:00am. It is currently inflamed but no longer swollen; This is a spontaneous report from a contactable consumer. This 46-year-old male consumer (patient) reported for himself.  A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date unknown), via unspecified route on left arm on24Feb2021 at 10:15 (patient was 46-year-old at the time of vaccination) at a single dose for COVID-19 immunisation. The patient's medical history included allergies to bananas, walnuts. The patient's concomitant medications included atorvastatin, lisinopril, metformin, Farxyga. 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. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021, at 9:30 pm the patient experienced right eye (white of the eye) became irritated and swollen, It continued to be swollen until about 7:00am and currently inflamed but no longer swollen. The patient received treatment with Benadryl, ibuprofen. The outcome of the event eye irritation and eye inflammation were recovering while, eye swollen was recovered at 26Feb2021, at 07:00.  Follow up #1 (03Mar2021): This is a follow up-spontaneous report received from a contactable Other HCP. This Other HCP reported for himself that: This is not part of a study/SAE/AE form. This is personal experience, self-reporting of use of PFE product. I received the Pfizer vaccine on 24Feb. On 25Feb, I experienced the swollen eye issue, so yes that is the first moment an employee of Pfizer was aware.  Information about lot/batch number has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2 (Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 09:30 (Lot Number: EN6198) as SINGLE DOSE for COVID-19 immunization.  Medical history included hypertension from an unknown date and unknown if ongoing High Blood Pressure.  Concomitant medication included hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced starting off as a possible upset stomach but rapidly progressing into intense to possible severe abdominal pain and upset stomach but rapidly progressing on 26Feb2021 13:30 with outcome of recovered.  About four hours after initial injection, abdominal issue began to develop. Starting off as a possible upset stomach but rapidly progressing into intense to possible severe abdominal pain. At first I tried Pepto Bismol to no avail. Then I tried Mylanta. Again, to no avail. Went to bed that night hoping I could fall asleep and finally did. It was gone the next morning. I could have had to have called in sick. Was treatment received for the adverse event with Antacids Pepto Bismol and Mylanta. Therapeutic measures were taken as a result of starting off as a possible upset stomach but rapidly progressing into intense to possible severe abdominal pain and upset stomach but rapidly progressing. The outcome of the events was resolved on an unspecified date.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Skin irritation
Clinical narrative: shingles.; patch of skin irritation; pain in my right shoulder blade; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 51-years-old via an unspecified route of administration, administered in arm left on 04Feb2021 (Batch/Lot Number: el9265) as 1st dose, single for covid-19 immunisation.  Medical history included dermatomyositis, high blood pressure, depression and premenopausal from an unknown date and unknown if ongoing. Concomitant medications included folic acid; lisinopril; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); all taken for an unspecified indication, start and stop date were not reported. The patient reported having pain in her right shoulder blade on 19Feb2021 09:30, on 21Feb2021, noticed a patch of skin irritation under her right arm. It started to spread. She went to DR on 28Feb2021 and was told she had shingles. Therapeutic measures were taken as a result of the events which included 3 medicines (unspecified). The patient was recovering from pain in right shoulder blade, did not recover from patch of skin irritation and the outcome of shingles was unknown. The patient received the second dose on 25Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date (reported as eight days ago) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on her right arm on an unspecified date (reported as five days after vaccination). The outcome of the event was unknown. The patient was scheduled for second dose of the vaccine on 19 March 2021. The patient was querying if there was a contraindication if ever she will be using an anti-viral medication prior to her second dose of the vaccine. The patient was also querying if there was an information available on specific populations whether the patient should keep her scheduled second dose of vaccine or should wait for a few days as she had shingles on her right arm after getting the first dose of the vaccine. It was also reported that the patient was already in Pfizer's study and being monitored. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chillblains
Clinical narrative: perniosis; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A male patient of an unspecified age (reported as age of 51) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date on Feb2021, as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient wanted to know efficacy after one dose. Patient reported that 3 days in to it, he developed welts on his feet and hands. He then stated his HCP said it was COVID toe and diagnosed him with perniosis on an unspecified date on Feb2021. Patient stated he does not have COVID. He wanted to know if this could have been caused by the vaccine and if it is safe for him to get the second dose and how long before he has to get the second dose. The outcome of the event reported was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: mild shingles outbreak 6-7 days following vaccine; This is a spontaneous report from a non-contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9265) via an unspecified route of administration in the left arm on 05Feb2021 15:00 (03:00 PM) as the first dose, single for COVID-19 immunization at Workplace clinic. Medical history included Hashimotos disease, sulfa allergy and pineapple allergy; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given to the patient in four weeks. The patient has not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient was generally very healthy. The patient experienced mild shingles outbreak on an unspecified day on Feb2021 (reported to be six to seven days following vaccine). The patient have never had a shingles outbreak, nor have been sick in the last 4 years. The patient haven't needed any prescription medication in over 6 years until this shingles outbreak. The event resulted in physician or other healthcare professional office/clinic visit. Therapeutic measure, antiviral medication, was taken as a result of the event. The outcome was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: She developed shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non hcp (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 23Feb2021, as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed shingles on 01Mar2021. Patient was supposed to have her next dose on 16Mar2021. The outcome of event reported was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Herpes zoster
Clinical narrative: She developed shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non hcp (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 23Feb2021, as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed shingles on 01Mar2021. Patient was supposed to have her next dose on 16Mar2021. The outcome of event reported was unknown.  Information on the lot/ batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fatigue, Gastrooesophageal reflux disease, Insomnia
Clinical narrative: tired from loss of sleep; nose was dripping; acid reflux/ it was worse than before; pretty sick; throwing up; loss of sleep; lightheaded and dizzy; She experienced soreness on her arm after the first shot; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Mar2021 14:30 (Batch/Lot Number: EL9269) as 1st dose, single for covid-19 immunisation. Medical history included  ongoing shingles (but got the shot anyway), ongoing acid reflux (been years and years and years ago, way back in 1990s or so maybe later than that), high blood pressure from 2001 and ongoing, dry eye, macular degeneration, CPO because she was a smoker, 4 bypass surgery, allergic to a blood pressure medicine, blood thinner therapy, and bad sinuses. Concomitant medications included calcium carbonate, magnesium carbonate (TUMS) taken for gastrooesophageal reflux disease, start and stop date were not reported; amlodipine taken for hypertension from 2001 and ongoing; albuterol sulfate taken for ex-tobacco user, pulmonary oedema, start and stop date were not reported; krill oil taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; aspirin taken for anticoagulant therapy, start and stop date were not reported; ciclosporin (RESTASIS) taken for dry eye, start and stop date were not reported. She experienced soreness on her arm after the first shot. Patient have acid reflux anyway and it seemed like it come up and it was worse than before, she was pretty sick last night on 15Mar2021 throwing up and still feeling pretty bad today from loss of sleep. Her nose was dripping and her head was all lightheaded, was dizzy and she was sick to her stomach. She sat in her recliner until about 3AM. Patient did not know if this was from the shot or what, but it was terrible. These things were not really ongoing on 16Mar2021, but she feels tired on 16Mar2021 from the loss of sleep on 15Mar2021. She took her antihistamine and her blood pressure pills and she was alright now, just tired from no rest. She reported that she was scheduled for her second dose of the product on 31Mar2021 at 150PM. Patient had blood work done at her last physical on 20Jan2020, and she reports that was all good. Outcome of the events was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Rhinorrhoea, Vomiting
Clinical narrative: tired from loss of sleep; nose was dripping; acid reflux/ it was worse than before; pretty sick; throwing up; loss of sleep; lightheaded and dizzy; She experienced soreness on her arm after the first shot; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Mar2021 14:30 (Batch/Lot Number: EL9269) as 1st dose, single for covid-19 immunisation. Medical history included  ongoing shingles (but got the shot anyway), ongoing acid reflux (been years and years and years ago, way back in 1990s or so maybe later than that), high blood pressure from 2001 and ongoing, dry eye, macular degeneration, CPO because she was a smoker, 4 bypass surgery, allergic to a blood pressure medicine, blood thinner therapy, and bad sinuses. Concomitant medications included calcium carbonate, magnesium carbonate (TUMS) taken for gastrooesophageal reflux disease, start and stop date were not reported; amlodipine taken for hypertension from 2001 and ongoing; albuterol sulfate taken for ex-tobacco user, pulmonary oedema, start and stop date were not reported; krill oil taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; aspirin taken for anticoagulant therapy, start and stop date were not reported; ciclosporin (RESTASIS) taken for dry eye, start and stop date were not reported. She experienced soreness on her arm after the first shot. Patient have acid reflux anyway and it seemed like it come up and it was worse than before, she was pretty sick last night on 15Mar2021 throwing up and still feeling pretty bad today from loss of sleep. Her nose was dripping and her head was all lightheaded, was dizzy and she was sick to her stomach. She sat in her recliner until about 3AM. Patient did not know if this was from the shot or what, but it was terrible. These things were not really ongoing on 16Mar2021, but she feels tired on 16Mar2021 from the loss of sleep on 15Mar2021. She took her antihistamine and her blood pressure pills and she was alright now, just tired from no rest. She reported that she was scheduled for her second dose of the product on 31Mar2021 at 150PM. Patient had blood work done at her last physical on 20Jan2020, and she reports that was all good. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: developed a rash; shingles; This is a spontaneous report from a contactable physician. A 56-year-old female patient 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 first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporting physician reported that a friend (patient) received first Pfizer Covid vaccine. Few days later her friend developed a rash, sent pictures to doctor that appears by photos to possibly be shingles. The outcome of the events was unknown.   Follow-up attempts are not completed; information about lot/batch number cannot be obtained. 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). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Mar2021, patient had a case of shingles. Outcome of the event was unknown. Next second dose was scheduled on 24Mar2021.  Information on the lot/batch number has been requested.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: rash; shingles; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 95 years, on 03Mar2021 (Batch/Lot Number: EN6199) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included memory loss and dementia; both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient's daughter took the patient to get the first dose of the covid vaccine. The patient was in a nursing home. The nurse from the nursing home called the reporter and told her that the patient had shingles last Sunday 21Mar2021. The patient was due for her second dose of the covid vaccine tomorrow, 24Mar2021. The reporter was asking what the protocol for this was and what she should do about patients second dose of the vaccine. Currently, according to the nurse at the nursing home, the patient is taking medication for shingles. She was using a topical medication and taking a medication by mouth. The reporter stated that the nurse at the nursing home did not go into details about what kind of medications patient was using. Since the nursing home is a facility reporter did not ask. The reporter stated that honestly she spoke with patient yesterday and did not ask patient about the rash. The patient did not say anything about her rash. The reporter stated that patient was fine, and was in good spirits. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive; This is a spontaneous report from a contactable other health professional (patient). A 58-Year-old non pregnant female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration on 22Jan2021 at 12:00 PM in the left arm as 1st dose, single for COVID-19 immunisation. Facility where COVID-19 vaccine was administered was workplace clinic. The patient medical history and concomitant medication were not reported. Prior and post vaccination, the patient was diagnosed with COVID-19. The patient experienced nasal swab positive on 25Jan2021. The patient underwent lab tests and procedures which included nasal swab: positive on 25Jan2021. Outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report via a Pfizer-sponsored program, from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), via an unspecified route of administration on 24Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. About 7 hours after receiving the first dose of the vaccine (24Mar2021), he experienced back ache, rash on the back and was diagnosed with shingles as it was confirmed today. He was prescribed acyclovir and wanted to know if that will affect the efficacy of this vaccine. He wanted to know if it was okay to take the second dose since this was the only side effect he experienced. Then clarified that by 6-7 hours later, he started to have symptoms like shingles. He had a dull ache in his back and noticed a rash when he took off his shirt. Thought it might be an allergic reaction but went to the Urgent Care today and he was diagnosed with shingles and prescribed an antiviral. He said he was not in a lot of pain. He was prescribed the antiviral just because a small percentage of people actually have prolonged pain from the shingles and they just want to prevent that. His major concern is that he got the first dose of the vaccine and he does not want this to impact the vaccine itself. His second question is whether he should take the second shot, which he thinks he should since it is just shingles. Clarified that he has not started his prescribed antiviral. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for covid on 14Mar2021; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that patient already have first dose Pfizer vaccine since 05Mar2021 and tested positive for covid on 14Mar2021, patient second dose should be 26Mar2021. On 14Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: She was diagnosed with Shingles 2 days ago/ shingles are on the left side of her shoulder and neck; This is a spontaneous report from a contactable consumer (patient). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as 1ST DOSE, SINGLE for covid-19 immunisation, at 84 years old. Medical history included  arthritis, atrial fibrillation, blood cholesterol (abnormal), blood pressure (abnormal), insertable cardiac monitor; all from unspecified dates and ongoing. No vaccines administered on the same date with bnt162b2 and no other vaccines within 4 weeks. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation; pravastatin taken for cholesterol; diltiazem hydrochloride (DILTIAZEM) taken for blood pressure; acetaminophen taken for arthritis, all from an unspecified start date and ongoing. The patient experienced she was diagnosed with shingles on 27Mar2021. The shingles are on the left side of her shoulder and neck. Patient had no fever. Events did not require emergency room or physician office visit. Patient wanted to know if she can still get the 2nd dose. Outcome of the event was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache, Pain, SARS-CoV-2 test
Clinical narrative: exposed to COVID-19; she started with a headache; this pain feels similar to the pain when she had shingles in the eardrums; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization (Age at vaccination: 63 years). Medical history included ongoing high blood pressure, Ramsay-Hunt syndrome, Kidney Issues, exposed to COVID-19, nerve damage and facial paralysis. The patient's concomitant medications were not reported. The patient stated that she has had the first dose of the Pfizer covid 19 vaccine on 12Mar2021 and her second dose is on friday, 02Apr2021. The patient stated that a few days later she started with a headache that has not gone away on 16Mar2021. The patient stated that Excedrin, Tylenol and Advil does not help. The patient stated that the pain is everyday and comes and goes (occurred on Mar2021). The patient stated that this pain feels similar to the pain when she had shingles in the eardrum. Lastly, the patient stated that she was exposed to covid-19 on an unspecified date. The patient underwent lab tests and procedures which included Rapid/PCR: negative on 20Mar2021. Outcome of the event headache was not recovered while outcome of the remaining events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (parent). A 23-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication includes unspecified birth control and patient is on IUD. The patient previously received chickenpox vaccination and booster dose. In the afternoon of 24Mar2021, the patient came down with shingles/rash like shingles, even though she had her booster. The patient was not on any antiviral medications at the time of report. She was using a triple antibiotic cream. The shingles was on the right side only on her belly and painful. The outcome of the event was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles / couple of bumps on her back and front; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 55, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the covid vaccine on 18Mar2021. She was due on 08Apr2021 for her next dose. Right now, she had shingles and got it this past week. Her symptoms started on Tuesday, 23Mar2021. The severity of her shingles symptoms was very mild. Only a couple of bumps on her back and front. She started the antiviral already, last time. The doctor explained that some people developed shingles after the flu vaccine. The outcome of the event was unknown. Event was reported as non-serious.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes zoster
Clinical narrative: Shingles/ which showed up after she had the 2nd vaccine dose; Shingles/ which showed up after she had the 2nd vaccine dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 26Mar2021 as 2nd dose, single for COVID-19 immunisation. Medical history included shingles (has a history of shingles even before taking any vaccine). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 05Mar2021 for COVID-19 immunization. Patient called because she was asking whether it was safe to take Acyclovir 400mg once a day for her pre-existing condition (Shingles) which showed up after she had the 2nd vaccine dose last 26Mar2021. Outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 22Mar2021, 6 days after the Covid 19 vaccine, the patient developed shingles. Physician doesn't think it was related to the Covid 19 vaccine. Physician prescribed the patient with valaciclovir (VALTREX) and a cream as the shingles were extensive on the patient's abdominal wall. The patient's next dose was on 06Apr2021 and physician was asking if it's ok for the patient to proceed in getting the second Covid 19 vaccine on that day or does the vaccine need to be delayed and if it needs to be delayed how long can it be delayed. Physician doesn't think it's a reaction, she just wants to know how long she can delay the patient getting the second Covid 19 vaccine. The patient developed the shingles on 22Mar2021 but the patient didn't see the doctor until today so he's had the shingles about 10 days. Does the patient go ahead and get the second dose or delay. Physician would like to know how many days you can delay getting the second Covid 19 vaccine. Physician doesn't think the rash is from the Covid 19 vaccine she thinks it's just a coincidence. Patient was in the office exam room. Physician would just like the question answered as the patient in the office. No further information was provided or obtained. Outcome of the event was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to BNT162B2 .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Herpes zoster
Clinical narrative: Had a biopsy and it came back as shingles/ Rash, full breakout, nerve pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration (administered on the left upper arm) on 15Mar2021 08:30 (at the age of 72-year-old) as 1st dose, single for COVID-19 immunisation (reported as "so she wouldn't get covid"). Medical history included open heart surgery from an unknown date. Concomitant medications included spironolactone (ALDACTONE) from 2019 (reported as 2 years ago) and ongoing, taken for an unspecified indication; bisoprolol fumarate (ZEBETA), atorvastatin (LIPITOR) and apixaban (ELIQUIS) all taken for an unspecified indication, start and stop dates were not reported. It was also reported that the patient was taking unspecified blood thinners. The patient has no history of all previous immunization with the Pfizer vaccine. The patient has no reported adverse event prior to vaccination.The patient didn't take any vaccine within 4 weeks prior to the Covid vaccine. The patient has no family medical history relevant to the adverse events. On 17Mar2021 18:00, the patient experienced rash. The patient had full breakout on 18Mar2021. The patient also reported that she has quite a bit of residual nerve pain and was unsure if it started probably whether on 18Mar2021 or 19Mar2021. The patient had a biopsy and it came back as shingles. The patient experienced shingles on 17Mar2021 18:00. The patient underwent lab tests and procedures in a dermatology clinic at a University on 23Mar2021 which included biopsy: positive for shingles. The adverse events result in physician office visit on 18Ma2021 and 23Mar2021. Therapeutic measures were taken as a result of the event included steroid cream, lidocaine spray, ice, Tylenol and Tylenol with Norco for pain. The patient reported that the rash has been going away, not much left, about a quarter left, like 25% maybe left and the nerve pain changes. The outcome of the event was not recovered.   No follow-up attempts needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Burning sensation, Chest pain, Chills
Clinical narrative: Pain was stabbing and burning/Body ache; Shingles; Left lower shoulder blade pain; Stabbing pain that was radiating around her rib cage to her left breast; High fever/Fever was 102, fluctuated from 102-103; Nausea; Freezing/Chills; Shaking/Trembling; Burning up; Patient received 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021; Patient received 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL9262), dose 2, via an unspecified route of administration on 24Jan2021 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included chickenpox when she was a kid. The patient has no concomitant medications. The patient received the 1st dose of BNT162B2 (lot number: EK4176) on 07Jan2021 for COVID-19 immunization. The patient had no prior vaccinations within 4 weeks of the administration of BNT162B2. The patient received the 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021. The patient reported she was a healthy individual and hasn't gone to the doctor or anything. She hasn't call out of work or anything, but she called out for work after her 2nd vaccine dose, she was out for a week. On 25Jan2021, she had a high fever (fever was 102, fluctuated from 102-103) that would not break and nausea. The fever started 12-13 hours after the vaccine which stayed at 102-103 and made her feel nauseous. The patient felt she was freezing, shaking, and burning up. She believed the body aches and nausea aches came from trembling. The patient also had the chills. The patient drank lots of fluids, had soup, and Tylenol with the high fever. These symptoms all happened at the same time and she recovered completely. On 20Mar2021, a month and a half after the patient's 2nd dose, the patient started getting symptoms after her 43rd birthday. She started to develop pain in her lower left shoulder blade. She didn't know if she pulled or twisted it wrong. The pain increased by 21Mar2021. On 24Mar2021 at work, the patient's supervisor asked why she was using a heat pack. She told her supervisor that she was having stabbing pain that was radiating around her rib cage to her left breast. The supervisor asked if it was burning and she had a rash. The patient confirmed she had no rash. It was a deep excruciating pain like someone is hitting her with a bat or stabbing her. The patient added that the pain started medially, on the inner part of her shoulder blade. She was later diagnosed with shingles. No relevant tests were performed. Therapeutic measures were taken as a result of the events shoulder blade pain and chest pain (heat pack); and fever (Tylenol). The outcome of the events shoulder blade pain and shingles was not recovered while the outcome of the events fever, nausea, chills, tremor, and burning sensation was recovered on 29Jan2021. The outcome of the remaining events was unknown.