chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Her arm was swollen all the way down to her wrist; part under her arm pit was very sore and swollen; extremely painful and relaxing by her side was uncomfortable; extremely painful and relaxing by her side was uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 52-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Batch/Lot Number was ER8731; Expiration date: Unknown), via an unspecified route of administration in Arm Right on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant was not reported.   On an unspecified date, The patient stated she is calling regarding the Pfizer COVID19 vaccine and has some questions about that. Got the shot about 3 weeks ago and her arm was swollen. The part under her arm pit was very sore and swollen. It did not turn red. She had swelling in her armpit area, for 3-4 days it was very swollen, her arm was swollen all the way down to her wrist and really painful right underneath her arm, The part under her arm pit was very sore and swollen. It did not turn red. Even to put deodorant on was extremely painful and relaxing her arm by her side was uncomfortable.    The patient would like to know whether she should get the next dose of the Pfizer COVID vaccine after the side effects she had from the 1st dose. She had called the doctor and they said that it happens sometimes. Does not know if she should get the second shot. Confirmed that the shot was the first dose of the COVID vaccine. Is signed up for the second shot 05May2021. She had COVID and does not want to get it again. Do not want to spread to others.  On an unspecified date the patient underwent lab tests and procedures which included antibody test: positive for antibodies, sars-cov-2 test was negative. Had tested negative when she thought she had it and got an antibody test a few weeks later that was positive for antibodies. There is no product complaint to report. Yes, there is a medical information request.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: a bad rash with hives, all on her left side.; a bad rash with hives, all on her left side.; 'allergic to everything'; This is a spontaneous report from a contactable consumer.  A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, on unspecified date at a single dose for COVID-19 immunisation. The patient's medical and concomitant medication was not reported. it was reported that the patient got allergic reaction after she got her shot, she broke out in a bad rash with hives, all on her left side. she is 'allergic to everything. hcp advised not to take the second shot. The outcome of events were not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: had a red mark on her arm the size of a quarter; This is a spontaneous report from a contactable consumer. This female consumer (patient) of an unspecified age reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing neoplasm malignant. Concomitant medication included palbociclib (IBRANCE) taken for neoplasm malignant and letrozole (LETROZOLE) taken for neoplasm malignant, start and stop date were not reported. The patient experienced had a red mark on her arm the size of a quarter on an unspecified date. Caller, is a cancer patient is on Ibrance and Letrozole. Received first vaccine and has red mark on arm that is size of a quarter. Wanted to know if she should have second vaccine or not. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Fatigue, Hepatic enzyme increased, Laboratory test
Clinical narrative: Fatigue; Cut on finger became infected; elevated liver lab values; Alanine aminotransferase 100; This is a spontaneous report from a contactable pharmacist.  A 27-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced fatigue, cut on finger became infected, elevated liver lab values and Alanine aminotransferase 100 on an unspecified date. The patient stated that he got his  first dose 3 weeks ago and went to the doctor after he  had cut in his finger and it got infected. the patient stated that he had also become quite fatigued which was unusual for him. They did labs and his ALT come back elevated. They informed him if he had any reports of altered liver values from the vaccine. The patient stated that he had no information on elevated liver lab values after vaccination. The physician ordered lab work because the patient had not had blood work done in a while as well as a Covid test. The patient's Covid-19 test was negative and patient's blood work came back normal except for his ALT which was 100. The patient stated that he was due for his second dose tomorrow. He enquired if it is contraindicated for him to get the second dose?. The patient was prescribed Keflex for the infected cut on his finger. Caller stated that he doesn't think that there is any interaction between Keflex and the Covid-19 vaccine and inquired if that was true. Caller stated that he can't imagine why Keflex would be contraindi-cated with the Covid-19 vaccine for one thing. Caller inquired if there were any reports of any al-tered liver values from the Covid-19 vaccine in original studies. Caller reported that he couldn't find anything online and stated that he would imagine that it had looked at liver studies. The patient underwent lab tests and procedures which included alanine aminotransferase increased: 100 on unspecified date Elevated , covid-19: negative  on unspecified date, blood work: normal on un-specified date.  Therapeutic measures were taken as a result of cut on finger became infected (lo-calised infection). The patient was given Kelflex.
Sex: M
Vaccine: COVID19
Symptoms: Localised infection, SARS-CoV-2 test
Clinical narrative: Fatigue; Cut on finger became infected; elevated liver lab values; Alanine aminotransferase 100; This is a spontaneous report from a contactable pharmacist.  A 27-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced fatigue, cut on finger became infected, elevated liver lab values and Alanine aminotransferase 100 on an unspecified date. The patient stated that he got his  first dose 3 weeks ago and went to the doctor after he  had cut in his finger and it got infected. the patient stated that he had also become quite fatigued which was unusual for him. They did labs and his ALT come back elevated. They informed him if he had any reports of altered liver values from the vaccine. The patient stated that he had no information on elevated liver lab values after vaccination. The physician ordered lab work because the patient had not had blood work done in a while as well as a Covid test. The patient's Covid-19 test was negative and patient's blood work came back normal except for his ALT which was 100. The patient stated that he was due for his second dose tomorrow. He enquired if it is contraindicated for him to get the second dose?. The patient was prescribed Keflex for the infected cut on his finger. Caller stated that he doesn't think that there is any interaction between Keflex and the Covid-19 vaccine and inquired if that was true. Caller stated that he can't imagine why Keflex would be contraindi-cated with the Covid-19 vaccine for one thing. Caller inquired if there were any reports of any al-tered liver values from the Covid-19 vaccine in original studies. Caller reported that he couldn't find anything online and stated that he would imagine that it had looked at liver studies. The patient underwent lab tests and procedures which included alanine aminotransferase increased: 100 on unspecified date Elevated , covid-19: negative  on unspecified date, blood work: normal on un-specified date.  Therapeutic measures were taken as a result of cut on finger became infected (lo-calised infection). The patient was given Kelflex.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody nose; This is a spontaneous report from a contactable consumer (the patient). A 35-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Apr2021, the patient experienced bloody nose and would like to know if this was anything to worry about. Outcome of the event was unknown.   Response: Spoke from the FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION PFIZER-BIONTECH COVID-19 VACCINE Prescribing Information Section 6.1 (LAB-1457-7.0. Revised: 06 April 2021) to let caller know that while there were no reports of bloody nose with the clinical trial participants, the data only speaks to commonly reported side effects and does not include all possible side effects of the vaccine. Referred caller to HCP for further guidance.  Follow-up1 (28Apr2021): This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer female patient reported information related to the same event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling, Pruritus, Rash
Clinical narrative: broke out from her ankle on up to her hip; her being sickly; leg started itching real bad, swelled up and had a rash; leg started itching real bad, swelled up and had a rash; leg started itching real bad, swelled up and had a rash; This is a spontaneous report from a contactable consumer. This 76-years-old consumer (Patient) reported for herself that she received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 15Apr2021 at single dose for cvid-19 immunization. Patient's medical history included She is allergic to latex and had X amount of surgeries (dates unspecified). Historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 VACCINE). Concomitant medications included diphenhydramine hydrochloride (BENADRYL) with unspecified dosage, indication. Consumer stated that she had the first dose of the Pfizer covid 19 vaccine and came home and did excellent. She got the second dose of the Pfizer covid 19 vaccine on 15Apr2021. She started breaking out the same day. She broke out from her ankle on up to her hip. She stated she is allergic to latex. She stated someone at the vaccination facility confirmed that she was ok to get the Pfizer covid 19 vaccine. Her primary doctor was informed of her allergies but wanted the patient to get the vaccine because of her being sickly and had 'x" amount or surgeries. A doctor insisted that she get the pneumonia shot and consumer stated she had a bad effect after getting the pneumonia shot. Consumer stated after the pneumonia shot her leg started itching real bad, swelled up and had a rash. She was given medication for the pneumonia reaction. Her leg had to be cleaned and wrapped. She came home from the second shot of the covid vaccine and the identical same thing happened. She is 2000 percent sure the reaction came from the vaccine. She has been taking Benadryl and has itch medicine and cleaning with alcohol. She stated she will have to go to the doctor. She asked about the payment for this. She also stated that she appreciated the agent's patience and listening to her. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: A contactable female consumer (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 10Apr2021 at a single dose for covid-19 immunization. The patient relevant medical history and concomitant medications were not reported. On an unknown date, the patient got her period, but her flow was heavier than normal. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, SARS-CoV-2 test
Clinical narrative: She got her first dose of the Covid 19 vaccine on 14Apr2021/She was tested for the Covid 19 virus by the nurse at her school on 19Apr2021.; she had a headache, cough, and shortness of breath; she had a headache, cough, and shortness of breath; she had a headache, cough, and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot# EW0162), via unspecified route of administration in right arm on 14Apr2021 09:00 at single dose for COVID-19 immunization. The patient was not administered with prior vaccine within four weeks. The Patient medical history and concomitant medications were not reported. There was no AE prior vaccination and no history of previous immunization with the Pfizer vaccine considered as suspect. She got her first dose of the Covid 19 vaccine on 14Apr2021 then she got the Covid 19 virus. She did her quarantine and all her symptoms have been gone for a while and she is all better now. Her second Covid 19 vaccine is scheduled for 05May2021. She enquired if she should get her second vaccine on 05May2021 or if she needs to reschedule it. She was tested for the Covid 19 virus by the nurse at her school on 19Apr2021. Her results came back positive for the Covid 19 virus on either the 21Apr2021 or 22Apr2021. She got tested for the Covid 19 virus because after she received the Covid 19 vaccine she had a headache, cough, and shortness of breath. Her symptoms started on the 15Apr2021. She started feeling better around the 18Apr2021. The patient did not require any Emergency Room/ Emergency Room due to adverse events. The patient was recovering from the event. NO PQC involved.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: her arm is hurting; This is a spontaneous report from a contactable consumer (patient reported herself) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration to her arm on 27Apr2021 2:00 PM as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "caller was a 77-year-old female who received her first dose of the Pfizer BioNTech COVID-19 vaccine yesterday 27Apr2021 at 2:00PM and stated that her arm was hurting. She stated that she could slowly lift it up and that when she keeps lifting it, the pain subsides. She stated that the pain was "not as bad" as when she got up and could barely lift up her arm and reported that it was slowly going away. Caller would like to know if there is anything she could take for it". E-transmitting potential duplicate AE. Caller states she just spoke to someone to report her side effects, however call was not a warm transfer. Spoke from the attached document regarding CDC's guidance for taking medications such as Tylenol and NSAIDs after vaccination to treat symptoms. Referred caller to HCP for further guidance. No PQC present. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: loss of smell; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. A customer got the first dose of the Pfizer covid vaccine on Monday. She experienced a loss of smell after receiving the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizzy; vertigo; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 12Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. A couple days later after vaccination patient was really dizzy like vertigo that lasted a couple of days. Is that a normal side effect,  should patient get her second dose, Is dizziness considered a very bad reaction. The outcome of the events was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait inability, Muscular weakness
Clinical narrative: weakness to her left leg; unable to walk; left leg is reportedly without strength; This is a spontaneous report. A contactable Consumer reported that a 71-year-old female patient received (solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced weakness to her left leg, unable to walk, left leg is reportedly without strength. Callers wife reportedly with weakness to her left leg. Her left leg is reportedly without strength and she is unable to walk on it following her vaccination on April 6th. The action taken in response to the event was not applicable. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Diarrhoea, Dizziness
Clinical narrative: very dizzy; headache; joint pain; "burning" in her stomach when she ate or drank anything,; diarrhea; fever that went from 99 to 100; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that:   A 74 years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Apr2021 as SINGLE DOSE for covid-19 immunisation The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced very dizzy headache ,joint pain ,burning in her stomach when she ate or drank anything, diarrhoea,fever that went from 99 to 100 on 26Apr2021.The patient underwent lab tests and procedures which included body temperature: 99-100 on 26Mar2021 that went from 99 to 100.Question: E-transmit Potential Duplicate AE report to DSU: caller states she just spoke to DSU and gave them "all my information." No reportum number given.Caller states she received her 2nd Pfizer vaccine dose on 24Apr21. She states she had "a little red spot on Sunday. My friend told me to get online and I put ice on it for 10 min 2x/day."On Monday, 26Apr21, the red area started to "spread like rash around where the injection was, it was not hurting and using my left arm was no problem." Tuesday, 27Apr21, "the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up." Are these normal side effects and what should I do Response: Referenced the PI: section 6.1 table #1 and  section 6.2: LAB-1457-7.0 Revised: 06Apr2021 The events were assessed as Non serious by health authority and outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: very dizzy; headache; joint pain; "burning" in her stomach when she ate or drank anything,; diarrhea; fever that went from 99 to 100; This is a spontaneous report received from a contactable consumer. This consumer reported for herself (patient) that:   A 74 years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Apr2021 as SINGLE DOSE for covid-19 immunisation The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced very dizzy headache ,joint pain ,burning in her stomach when she ate or drank anything, diarrhoea,fever that went from 99 to 100 on 26Apr2021.The patient underwent lab tests and procedures which included body temperature: 99-100 on 26Mar2021 that went from 99 to 100.Question: E-transmit Potential Duplicate AE report to DSU: caller states she just spoke to DSU and gave them "all my information." No reportum number given.Caller states she received her 2nd Pfizer vaccine dose on 24Apr21. She states she had "a little red spot on Sunday. My friend told me to get online and I put ice on it for 10 min 2x/day."On Monday, 26Apr21, the red area started to "spread like rash around where the injection was, it was not hurting and using my left arm was no problem." Tuesday, 27Apr21, "the area was getting bigger and becoming itchy and then last night it was hurting when I lifted my arm up." Are these normal side effects and what should I do Response: Referenced the PI: section 6.1 table #1 and  section 6.2: LAB-1457-7.0 Revised: 06Apr2021 The events were assessed as Non serious by health authority and outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection
Clinical narrative: bacterial infection; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included lymph nodes surgery under her left arm  in 2004 and concomitant medication was not reported. The patient experienced bacterial infection and was prescribed with Metronidazole. Caller stated that the pamphlet of the medication states that you should not get a vaccine and she wanted to know when to take second dose of vaccine. the outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccines that expired on Saturday; This is a spontaneous report from a contactable consumer. This case is linked with AER #2021466018. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization on unspecified date on Saturday at 5:00PM. The patient's medical history and concomitant medications were not reported.  The caller is an assistant/manger of an urgent care and stated that one of her staff members administered two of the Pfizer BioNTech COVID-19 vaccines that expired on Saturday at 5:00PM to two different patients. Clarified with caller that this expiration date was contingent upon the undiluted vaccines being in the fridge at 2C to 8C, so this meant that the 5 days labeled time ended on Saturday at 5:00PM. She stated that the vaccines were in the fridge up until that morning which is when they were administered. Caller would like to know if there is any guidance on how to proceed.   E-transmitting AE due to long hold times.Response: Spoke from the attached document to let caller know about the 48 hours excursion time for undiluted vaccines at 2C to 8C in addition to the 120 hours labeled time. According to the caller, the vaccines were in the fridge at this temperature for less than the additional 48 hours excursion time. Sent document via email for caller's review. Of note, the attached "Revaccination after Administration of Invalid Dose" was also reviewed for further guidance, but not sent via email. The outcome of event was unknown.  No follow up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466018 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination, Visual impairment
Clinical narrative: see a small point when i move my eye; This is spontaneous report from a contactable consumer. This consumer (patient) of an unspecified age reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced see a small point when i move my eye on an unspecified date. Since i got the 1st dose there is something going on with my left eye. I see a small point when i move my eye, I had an eye exam on 8FEB2021 and it was not there. Has this been reported and what should i do? The patient underwent lab tests and procedures which included ophthalmological examination: unknown on 08Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was reported as unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Swelling face
Clinical narrative: I got really hot; my face swelled; This is a spontaneous report from a contactable consumer. A 35-years-old Female (patient her-self) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an un-specified date (on 3Apr or 4) (Batch/Lot number was not reported) as single dose for covid-19 im-munization. The patient's medical history and concomitant medications were not reported.  The patient experienced I got really hot; my face swelled on an unspecified date. The patient stated that she got the first dose on 3Apr or 4 and about 4-5 hours later her face swelled and got really hot. he enquired if she could get the 2nd dose or get Johnson and Johnson instead? The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Pyrexia
Clinical narrative: a slight fever; stomach was bothering; appetite wasn't there; This is a spontaneous report from a contactable consumer. This consumer (Patient's Husband) reported for a patient (his Wife) that a female patient with unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient's medical history and concomitant medications were not reported. Consumer mentioned in passing his wife has side effects after vaccine but were less severe than his. Did not notice AE during call, so did not offer transfer back to DSU, unsure if she was included in the AE report. Consumer questioned that if one can wait six weeks to get second dose. Information was provided as per CONS attached and referred back to HCP. Patient's husband (reporter) received first dose of the Pfizer BioNTech Covid 19 vaccine approximately 3 weeks ago from his place of employment. In Feb2021 he tested positive for Covid and was hospitalized for three days due to a pulmonary embolism. Two days after receiving his first dose of the vaccine, he started developing symptoms, he felt like he was getting Covid again. He experienced a slight fever, stomach was bothering him, appetite wasn't there and it took two weeks to recover. The consumer questioned 'Why do the side effects of the vaccine feel so much like Covid. ' He stated that his wife had same side effects but less severe. (recognized this potential AE after call, did not obtain her age, not sure if this was transmitted to DSU when he initially reported side effects. He further questioned 'Is there any study going on about the efficacy after one dose? Didn't "another country" talk about doing a study on one dose on the variants but ended up not doing it. Did did one hospital say that the Pfizer vaccine was 80% effective in people who have already had covid?'' Information as per CONS attached and referred back to HCP. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: she woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them.; she woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them.; her right thumb "was off" feeling numb and with pain; This is a spontaneous report from a contactable consumer (patient reported herself). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration in her left arm on 26Mar2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Mar2021, the patient experienced woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them and right thumb "was off" feeling numb and with pain. Caller reported that "she received her first Covid shot on Friday, March 26th in her left arm and on Saturday she woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them. Caller reported that she went to her chiropractor for an adjustment, and it appeared to feel a little better, but she reported that her right thumb "was off" feeling numb and with pain. She reported that she missed her second dose because her son tested positive for Covid and so she got her second dose, again in her left arm, this Monday, April 26th. Caller reports that she was fine but then on Tuesday her right arm started feeling heavy with sharp pains in it and today she reported that her right thumb was "killing" and her right arm has a tingling sensation and numbness to it. She asked, is that normal or a side effect being reported from the vaccine". Confirmed Pfizer Covid vaccine. Spoke from attached documentation. Referred to HCP for evaluation and guidance. Caller reported that she already spoke with safety - reference r9mvdoqc. Survey offered. Therapeutic measures were taken in response to the events. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: pain in the arm; fatigue; muscle pain, calf and arms; Cramping/burning in calves; Cramping/burning in calves; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unknown date, at single dose, for covid-19 immunisation. The patient medical history included hypothyroid. Concomitant medication was not reported. On an unknown date, next day after vaccination patient experienced pain in the arm, two days after on friday afternoon patient had fatigue muscle pain in calf and arms which came and went off and on and had cramping/burning in calves. Treating with Motrin. Reached out to health care professinal, asked if need to get the second dose. The outcome of all the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Illness, Oropharyngeal pain, Pyrexia
Clinical narrative: sick; fever; sore throat; mucous and coughing; This is a spontaneous report received from a non- contactable consumer (patient).   A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced sick, fever, sore throat, mucous and coughing all on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Had a severe joint pain due to the covid vaccine from Pfizer; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Pharmacist mentions that he has a patient that had a bad reaction to the Pfizer-BioNtech covid vaccine and to other vaccine and he was looking to know if it was safe for him to get Prevnar 13. He mentions that the patient a couple of days ago had a severe joint pain due to the covid vaccine from Pfizer and he was trying to look about the information of the cultures from where the Prevnar 13 is prepared. On an unspecified date, The patient experienced had a severe joint pain due to the covid vaccine from Pfizer. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: a little bit of a headache; "real tiny" body aches; tired; sore arm; This is spontaneous report from a contactable nurse. A 28 1/2-years old male patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, batch/lot not reported) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was mentioned that with the first dose, patient experienced a little bit of headache (that was mild and lingering), real tiny body aches, tired-ness and a sore arm. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Paraesthesia
Clinical narrative: on the back part on my back/shoulder pain/My pain was pertaining to my back and spine; tingling; This is a spontaneous report received from a contactable consumer or other non hcp. A 37-year-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 Left on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on unspecified date on her left side, "started having problems like on the back part on my back/shoulder pain there and thought maybe it will go away but it ended up going across my top of my back and tingling." It was reported that pain was pertaining to my back and spine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypotension, Pain, Rash macular
Clinical narrative: red round spot on his arm the size of a band aid; sore and achy; tired; blood pressure is low; This is a spontaneous report from non-contactable consumer (Patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date. the patient reported that, a month after second dose, still had a red round spot on arm the size of a band aid, and still feels sore, achy, and blood pressure is low. The outcome of the events red round spot on arm, pain, fatigue was not recovered, and blood pressure is low was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Contusion, Pruritus, Rash, Urticaria
Clinical narrative: her legs have broken out in hives that are "very, very itchy; her legs have broken out in hives that are "very, very itchy/ as soon as she touches her skin, it starts itching; "bruised up" from scratching; pimples on her legs are "very, very small" and "very itchy."; as if the rash is underneath her skin; This is a spontaneous report from a contactable consumer (patient) reported that. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration was not reported) via an unspecified route of administration on 16Apr2021 as a single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. Patient experience side effects that she calls very odd. Caller reports that her legs have broken out in hives that are very, very itchy. She states that this started about 5 hours after her first dose and has been ongoing for 9 days in total. She reports that she was bruised up from scratching. Caller states that the pimples on her legs are very, very small and very itchy. She states that it looks as if the rash was underneath her skin and states she cannot feel it but can see it, and states that as soon as she touches her skin, it starts itching. Caller would like to know if it was safe for her to get her second dose of the vaccine because of these side effects. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Myalgia, Pain
Clinical narrative: weakness; fatigue; shortness of breathe a little not bad; muscles ache; body ache; This is a spontaneous report from a consumer or other non-healthcare professional. A 55-years-old female patient received second dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) on 23Apr2021 as single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. Patient previously took bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Patient didn't have anything after the first dose. On 24Apr2021, patient experienced fatigue, weakness and shortness of breathe a little not bad, Patient mentioned that even standing was making patient exhausted. On an unspecified date, patient experienced muscles aches and body aches. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: Cough; Not feeling well; This is a spontaneous report from a contactable consumer. A 64-years-old female patient 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 28Feb2021 at a single dose for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced cough and not feeling well, when she coughs it does not stop. Reporter wanted to know what tests they should do to see if his wife has covid or not. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Vaccination site pain
Clinical narrative: Dizziness; Tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) via Pfizer Support. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date in Apr2021 (reported as yesterday) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated, he went to work, everything was good, but towards the end of the night (as per report) he started experiencing tenderness at the injection site. In morning he woke up and was dizzy, in which he was still experiencing dizziness, but it was manageable. Patient pulse was good, and he has not checked his blood pressure. The outcome of the event dizziness was not recovered and for tenderness at the injection site was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pyrexia
Clinical narrative: felt bad; fever; pain in his shoulder; This is a spontaneous report from a non-contactable consumer (patient parent) via medical information team. A 17-Year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Unknown) as a single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Unknown) as a single dose for COVID-19 immunization. On an unspecified date, the patient felt bad and had a fever. The patient had 800mg Tylenol which helped. That night, the patient had fever again and had 500 mg of Tylenol, which helped once again. The patient experienced pain in shoulder. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Light rash.Chest more, little bit on my face/serious rash on my arms/It itches.  It's reddish. It's a rash.; Light rash.Chest more, little bit on my face/serious rash on my arms/It itches.  It's reddish. It's a rash; This is a spontaneous report from a contactable consumer. A 74-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 10Apr2021 a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Mar2021 a single dose for COVID-19 immunization. Clinical course reported as Caller received first dose 20Mar2021, second dose 10Apr2021. Caller reports light rash. Chest more, little bit on my face. "Don't you have a team? It's their vaccine.  Hospital. Escalate. I'm gonna live with it. I have a serious rash on my arms. I won't ask for legal. It itches. It's reddish. It's a rash. I hope to God. I'll take it out a month. I am going to give it a month. I am going to wait on legal." Caller states she is using cream perrigo. triamcinolone acetonide cream usp. She's concerned that it doesn't go away. "You guys are saving lives" Use it for two weeks the pharmacist said take a break. Caller repeated asked for a team for a treatment recommendation. Potential Duplicate AE. On an unspecified date, Patient experienced Rash erythematous and rash pruritic. Therapeutic measures were taken for the events. The outcome of the events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Light rash.Chest more, little bit on my face/serious rash on my arms/It itches.  It's reddish. It's a rash.; Light rash.Chest more, little bit on my face/serious rash on my arms/It itches.  It's reddish. It's a rash; This is a spontaneous report from a contactable consumer. A 74-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 10Apr2021 a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Mar2021 a single dose for COVID-19 immunization. Clinical course reported as Caller received first dose 20Mar2021, second dose 10Apr2021. Caller reports light rash. Chest more, little bit on my face. "Don't you have a team? It's their vaccine.  Hospital. Escalate. I'm gonna live with it. I have a serious rash on my arms. I won't ask for legal. It itches. It's reddish. It's a rash. I hope to God. I'll take it out a month. I am going to give it a month. I am going to wait on legal." Caller states she is using cream perrigo. triamcinolone acetonide cream usp. She's concerned that it doesn't go away. "You guys are saving lives" Use it for two weeks the pharmacist said take a break. Caller repeated asked for a team for a treatment recommendation. Potential Duplicate AE. On an unspecified date, Patient experienced Rash erythematous and rash pruritic. Therapeutic measures were taken for the events. The outcome of the events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.