chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Woke up with chills; Sweat through an undershirt; The arm that they gave the shot in at the injection site got red; Had arthritic stuff in fingers; Late reaction; This is a spontaneous report from a contactable consumer (patient). A male patient (age reported as 77) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 26Apr2021, patient blood drawn in general (results unknown). Last night, 28Apr2021 into 29Apr2021 (as reported), the arm that they gave the shot in at the injection site got red. Patient took Tylenol this morning and that subsided. He had arthritic stuff in fingers, but the Tylenol helped and woke up with chills, and his fellow golfers had the chills too, but he also sweat through an undershirt. Patient was scheduled for the second dose on 11May2021 and was just a little anxious of whether to delay it because of a late reaction. The case was non serious. Outcome for the event the arm that they gave the shot in at the injection site got red was recovered on 29Apr2021, had arthritic stuff in fingers was recovering, and for remaining was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Chills, Gait disturbance
Clinical narrative: muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; weakness; I can hardly walk right now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unspecified route  of administration on an unspecified date (4 weeks and 2 days after the first dose) (at the age of 78-year) as single dose for COVID-19 immunization. The patient medical history included lumber stenosis. The patient concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On an unspecified date, patient felt awful with muscle and joint aches, teeth and bones hurt, chills, weakness. She stated that she could hardly walk right now and could not get over to her primary care physician. The patient informed that she received a steroid injection of some kind on her back for lumbar stenosis 2 weeks and 2 days after the first dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Toothache
Clinical narrative: muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; weakness; I can hardly walk right now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unspecified route  of administration on an unspecified date (4 weeks and 2 days after the first dose) (at the age of 78-year) as single dose for COVID-19 immunization. The patient medical history included lumber stenosis. The patient concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On an unspecified date, patient felt awful with muscle and joint aches, teeth and bones hurt, chills, weakness. She stated that she could hardly walk right now and could not get over to her primary care physician. The patient informed that she received a steroid injection of some kind on her back for lumbar stenosis 2 weeks and 2 days after the first dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: started experiencing dizziness/vertigo; started experiencing dizziness/vertigo; This is a spontaneous report received from a contactable consumer. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 27Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received first dose last Tuesday (on 27Apr2021), starting Wednesday ( on 28Apr2021)afternoon started experiencing dizziness/vertigo. States reported yesterday via phone and ask if this a reported adverse event. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Feeling cold, Hypotension, Malaise
Clinical narrative: has not been feeling well; low blood pressure; feeling very cold; clammy; This is a spontaneous report from contactable consumer. This contactable female consumer (Patient) reported for herself. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol (METOPROLOL) taken for hypotension, start and stop date were not reported. On an unspecified date She received the first dose on Monday at 07:00PM and had not been feeling well. Patient had been experiencing low blood pressure and feeling very cold and clammy. Patient did not take her heart medication (Metoprolol) because of the low blood pressure. The patient went to the ER but she says they didn't know what to do.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: A female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Apr2021 (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 reported that "she still has bruising at the injection site" on Apr2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival abscess, Gingival blister
Clinical narrative: A  male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration 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, he noticed a blister on the inside of his mouth on his gums in the front part of his mouth, he states that he punctured it and it drained blood and pus in Apr2021. Patient reported that a few days ago (apprx 25Apr2021) he noticed a blister on the inside of his mouth on his gums in the front part of his mouth. Patient stated that he punctured it and it drained blood and pus and, as of today 29Apr2021, it has resolved and he has no pain. He is going to the Dentist today to have it checked out and states he does not have a current MD to help address his symptom. He reports wearing a bridge. He provided his dentist's contact information. He wanted to know if this side effect could be from the vaccine. There was no PQC. The outcome of event was recovered on 29Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Pain, Peripheral swelling, Swelling
Clinical narrative: her armpit got swollen,it is getting worse and is radiating to her back; breast; her armpit got swollen,it is getting worse and is radiating to her back; The caller took the first vaccine on 24Apr2021 and pain started that same day on the same side she was vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (consumer) of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), first vaccination dose via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Apr2021, the patient took first vaccine and pain started that same day on the same side she was vaccinated. After one day on 25Apr2021, her armpit got swollen and then yesterday it came to her breast and it is getting worse and is radiating to her back. 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: Visual impairment
Clinical narrative: her eyesight has deteriorated since 09 Jan 2021 from 20/80 to 20/200; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number unknown) as single dose, dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number unknown) as single dose for covid-19 immunisation. Medical history included (Uveitis) pre-existing condition with her left eye (Fuch's Heterochromic Iritis Cyclitis) for 20 years.  Concomitant medication(s) included Humira (The patient received 3 doses of Humira on 25Feb2021, 11Mar2021, and 25Mar2021). She went to the doctor to have surgery on her eye and her eyesight has deteriorated since 09Jan2021 from 20/80 to 20/200. She asked if her deterioration in her eye sight was related to the COVID vaccine. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Inflammation, Laboratory test, Scan
Clinical narrative: Joint pain; Inflammation; Redness in her knees; This is a spontaneous report from a contactable consumer (Husband to the Patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included interstitial cystitis, an autoimmune disorder that affects her bladder, she has had flair ups in her knees in the past. Concomitant medication(s) included pentosan polysulfate sodium (ELMIRON, 100mg) taken for cystitis interstitial; fluoxetine hydrochloride (PROZAC 20mg) taken for an unspecified indication, for 1-2 decades. The patient previously took first dose of vaccine. It was reported that the patient received the second dose of the Pfizer Covid 19 vaccine several weeks ago. Now, she has been having joint pain, inflammation, and redness in her knees. She saw a Rheumatologist yesterday (28Apr2021) who scanned her knee, which found "no water in the knee", and drew labs that were pending. She has had flair ups in her knees in the past. Stated that his wife took the booster shot of the Covid Vaccine several weeks ago. Stated his wife takes other prescription medications as well. They wanted to know if Elmiron was considered an immunosuppressant medication or not, whether her medications could interact with the vaccine and cause the symptoms she is experiencing. Referred caller to HCP for guidance. 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: Injury
Clinical narrative: She had an injury; This is a spontaneous report received from a contactable consumer (reporting on herself). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration on 21Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the first dose of the BNT162B2 vaccine on 21 April2021.  She had an injury and got a medically necessary tetanus shot last night.  She understands you are supposed to wait 14 days before and after. she was asking if she able to get the second dose in two weeks. 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: Feeling hot, Migraine
Clinical narrative: Bad migraine; Feels hot; This is a spontaneous report from a Pfizer sponsored program via a contactable reporter (patient) reported for herself. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 27Apr2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 06Apr2021 at a single dose for COVID-19 immunisation. No events were reported for the first dose. On 27Apr2021, the caller experienced bad migraine and felt hot after getting the 2nd dose. 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: Burning sensation, Pain in extremity, Vaccination site pain, Vaccination site rash
Clinical narrative: injection site feels sore and tender; had a rash on her arm; arm started to hurt; arm feels like fire; This is a spontaneous report from a contactable consumer (patient herself). A female consumer with unspecified age received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number/Expiration date) via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunisation. The patient medical history and Concomitant medications were not reported. On an unspecified date, Caller stated a week later after received the second dose her arm started to hurt, she had a rash on her arm and the injection site feels sore and tender. As she stated today the rash got bigger, her arm feels like fire. She would like to know if this has been reported and if she should speak to her doctor. 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, Vertigo
Clinical narrative: serious vertigo; exhausted everything I can do; This is a spontaneous report from contactable consumer. This contactable male consumer (Patient) reported that 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, as single dose for COVID-19 immunization.The patient experienced some serious vertigo as a side effect from the vaccine. He reports that he was exhausted everything which he can do and reports that he has seen his HCP who said she had no treatment or fix for him.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Her Legs swelled up again today and it has gotten worse; This is a spontaneous report from a contactable consumer (patient). This contactable female consumer (age not specified) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: unknown) through an unspecified route as a single dose on 24Apr2021 (age at vaccination: unknown) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot: unknown) and had legs swelled up this lasted for 3 or 4 days and then resolved. After getting her second dose on 24Apr2021 her legs swelled up again today and it had gotten worse. She could not put on shoes or slip-ons. The outcome of event was reported as not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a contactable consumer (Patient herself). A 25-year-old  female (non-pregnant )patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration on 14Apr2021 (at the age of 25-year-old) as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date the patient reports that's she waking up with a sore throat this morning. The patient did not receive any treatment for the event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Rash pruritic, Urticaria
Clinical narrative: I developed welts, very itchy and blotchy, there was one on my left arm, left side of neck and one big one below my neck or upper back; I developed welts, very itchy and blotchy, there was one on my left arm, left side of neck and one big one below my neck or upper back; I developed welts, very itchy and blotchy, there was one on my left arm, left side of neck and one big one below my neck or upper back; Itchy skin rash, on my right side; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient reported that the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: unknown) via an unspecified route in Left arm as a single dose on 13Apr2021, for covid-19 immunization (age at vaccination: 63). The patient medical history and concomitant medications was not reported. On 21Apr2021, the patient experienced itchy skin rash, on her right side, she had the shot in the left arm. It subsided, then 2 to 3 days later, this past Sunday 25Apr2021 the patient developed welts, very itchy and blotchy, there was one on her left arm, left side of neck and one big one below her neck or upper back. Occurred a week and day after. The clinical 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: Axillary pain, Pain in extremity
Clinical narrative: Her arm is hurting; The pain moved from the arm to arm pit; This is a spontaneous report from a contactable consumer (patient) reporting on herself. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced her arm was hurting on an unspecified date and the pain moved from the arm to arm pit on an unspecified. The outcome of both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache After vaccination. The patient asked she received the second dose of the Pfizer-BioNTech COVID-19 vaccine yesterday. she reported a headache to DSU agent, if she could take Aspirin for his symptoms after vaccination. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Stress
Clinical narrative: tiredness; Stress; This is a spontaneous report was received from a contactable consumer or other non hcp (patient).  A 86-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included cardiac fibrillation and first BNT162B2 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient received her 2nd dose of the Pfizer covid vaccine on 21Apr2021. She started to experience tiredness on the 27Apr2021 just over a week after the injection. A week after the injection can it cause extreme tiredness? Can it be that far out? The patient had afib (as reported) and had a call out to her cardiologist. Maybe it was stress. The patient did not have anything from the first one. The outcome of the events was unknown.  DSU e-transmitting potential duplicate AE. Response: Spoke from EUA PI (LAB-1457-7.0 Revised: 06Apr2021) under section 6 overall safety summary  and from attached document  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a contactable consumer (patient's husband). A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 15Apr2021 at 10:30, as single dose for COVID-19 immunisation. Patient's medical history included multiple sclerosis and he had triple bypass surgery three years ago. On 15Apr2021 at 12:00, the patient had soreness. They were sent home with a factsheet for side effects to look out for and to take Tylenol if needed. 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: Ageusia, Anosmia, Fatigue, Nasal congestion, Pain
Clinical narrative: she was loosing her taste and smell; she was loosing her taste and smell; nose constipation; feeling tiredness; generalized body pain; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 27Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of  BNT162B2 for COVID-19 immunization. Patient mentions that she got the second dose of the BNT162B2 on 27Apr2021 and that same night she started feeling tiredness and generalized body pain. Next day on 28Apr2021 she continue with the same symptoms but she also noted that she was loosing her taste and smell as well as having nose constipation. She wanted to know if this was normal. 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: COVID-19, Paraesthesia, SARS-CoV-2 test positive
Clinical narrative: Tingling in her left arm and leg; tested positive 2 weeks ago; This is a spontaneous report from contactable consumer (reported for herself) via Pfizer sponsored program COVAX US support.  The female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on 24Apr2021 Saturday, as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Two weeks ago, she was tested positive for Covid. On the day of this report, she started noticing more tingling in her left arm and leg. The outcome of the events of positive for Covid and more tingling in her left arm and leg was not reported.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nasopharyngitis, Pain
Clinical narrative: Body aches; Cough; Cold; He could resume his vitamin or supplements; scheduled to have his second dose on May 14; Chills; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via unspecified route of administration on 22Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient called in to ask if he could resume his vitamin or supplements. The patient received his first dose of the vaccine on 22Apr2021. The patient was scheduled to have his second dose on 14May2021 (which was more than 21 days). The patient specifically asked about vitamins E, C, B, and echinacea, which he states that takes as an immunity booster whenever he feels sick. It was reported that his 37 years old brother received his first dose of the Pfizer BioNTech COVID-19 vaccine and states he has started seeing symptoms of a cold including cough, chills, body aches that continued for 3 days. It was stated that his brother reached out to his doctor who told him it may not be related to the shot but may be because he has come in contact with COVID-19 since his first dose. Caller states that his brother is waiting on a COVID-19 test but caller was concerned because he state that his oxygen levels are going down. 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: Pain in extremity
Clinical narrative: arm starting hurting; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on Jan2021 (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration, administered in Arm 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. The patient experienced arm starting hurting (pain in extremity), on an unknown date in Apr2021. The patient asked how many people had to report and got response as Stated there have been reports of muscle pain, but it does not specific how long after there vaccination that they felt the pain. The outcome of the event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lethargy, Tenderness, Vaccination site pain, Vaccination site swelling
Clinical narrative: A female patient (unspecified age) received the first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number and expiry date: unknown), via unspecified route on 28Mar2021 at single dose for COVID-19 immunization. On an unspecified date, the patient noticed that when she getting dressed that she had tenderness in a small area that appeared bruised on the bra line to her back on the opposite side from where she got her vaccination. The patient stated that area is small and tender appears to be a "black and blue". The patient also had also had some lethargy, injection site pain and swelling to her arm at the injection site which she understands are normal, but she asks is the bruised area normal. Second dose of vaccination for the patient was scheduled on 19May2021 (21 days apart).  The patient did not receive any treatment for the events. Outcome of the events was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: pain from the shoulder to the fingertips; My whole shoulder; it's been bothering; pain in my arm I woke up with; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Apr2021 09:30 (Batch/Lot number was not reported) (at the age of -64-year-old) as single dose for covid-19 immunisation. Medical history included, that patient have carpal tunnel pain from an unknown date and was unrelated to getting the vaccine. The patient's concomitant medications were not reported. Patient called on 29Apr2021 and stated she woke up in the middle of the night took a Aleve, as her whole shoulder was been bothering for a week (pain from the shoulder to the fingertips) from pulling weeds/gardening. Patient felt she overdid it. She took 2 Aleve pm 18 hours after the injection and wanted to know if this would ruin the vaccine and whether she need another vaccine. Patient also wanted to know if there is an efficacy detriment. The patient received the 2nd dose of the pfizer covid vaccine yesterday at 9:30am and queried if that taking 2 Aleve tablets effect the vaccine. She also added that she might have taken some Motrin the day before (18 hours prior to getting the vaccine) but was not sure on that. Patient will just get an antibody test after 2 weeks. Patient also confirmed that the vaccine did not bother her at all. She tried to be so careful but because of the pain in my arm she woke up with. The patient was given a response that antibody testing is not recommended to assess for immunity to SARS CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. In addition, antibody tests currently authorized under an Emergency Use Authorization (EUA) are not authorized for the assessment of immune response in vaccinated people. The patient took treatment with Aleve (naproxen) as a result of the events. The outcome of the events were reported as unknown.   No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Joint injury
Clinical narrative: She "felt high, like on THC-high"; After her first dose of vaccine, she suffered an injury to her knee; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via unspecified route of administration at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Past drug includes a cortisone shot in her shoulder 6 days before her first dose of the PFIZER BIONTECH COVID-19 VACCINE. After her first dose of vaccine, she suffered an injury to her knee and presented to the orthopedic doctor who declined to give her a cortisone shot in her knee because she was in the middle of the vaccine series. She also mentioned that after her first dose she felt high, like on THC-high and went home and baked chocolate chip cookies- which was out of character for her. 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: Back pain, Muscle spasms
Clinical narrative: Back pain and Spasm; Back pain and spasm; This is a spontaneous report. A contactable male consumer (patient). A male patient of unspecified age received second dose of  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 26Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history included that the patient had received the fist dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection as a single dose for COVID-19 immunisation. The patient's concomitant medications was not reported. The patient experienced back pain and spasm. 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: Back pain, Herpes zoster, Rash
Clinical narrative: she had shingles; she started getting rashes on her back; excruciating pain in her back; This is a spontaneous report from a contactable consumer.   A 72-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for Injection, Lot number: Unknown, Expiration date: Unknown), at a single dose via unspecified route of administration on 17Apr2021 for COVID-19 immunization. Patient was expected to get the next dose on 08May2021. Medical history and concomitant medications were Unknown. On 19Apr2021 the patient experienced excruciating pain in her back and it lasted for the whole week after two days of vaccination. she visited her doctor, who gave her Celebrex, she started getting rashes on her back on the same day. She was told she had shingles and now she took an antiviral drug. Caller was not transferred due to long wait. She confirmed it was OK to contact her in the evening preferably. Response on the Shingles not found. Spoke per CONS documents below and Referred to her HCP. Outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: I ran a really high Fever yesterday 103.9 F it's back up to 103. F; chills; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 48-years-old female patient (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), second vaccination dose via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. On an unknown date, patient took first vaccination dose of BNT162B2 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Apr2021 after getting second shot on Tuesday, the patient had ran a really high Fever yesterday 103.9 F it's back up to 103. F and chills were observed with the first 1 to 2 days after vaccination. Patient took Acetaminophen 20 minutes ago and is still pretty high 103 F. On an unknown date, the events were resolved shortly. As per the Clinical Trials Experience Table, Fever which is greater than 38.9 degree C to 40.0 degree C, after second vaccination dose, 1.2 % of patient reported the same event. Outcome of events was resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site pruritus
Clinical narrative: I had some pain in my arm, not bad though; started itching 2 days after the dose; started itching 2 days after the dose ,"both arms and legs and chest sometimes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Patient received her 1st Pfizer vaccine dose and "had some pain in her arm, not bad though" and started itching 2 days after the dose, "both arms and legs and chest sometimes, it would go away and then it would come back." 2nd dose is scheduled on 06May2021. (3 weeks after 1st dose) She had a side effect after the first dose of the vaccine. She asked should she get the second dose. She got response you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. It was reported as PQC was not present. 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: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive for covid 19; female patient ( in late 70s or early 80s) got the Pfizer covid vaccine first dose in mid Jan and a  week later she was tested positive for covid. Caller stated its been 90 days can the patient get her second dose or they need to start all over again; This is a spontaneous report from a contactable pharmacist. An elderly female patient in her late 70s or early 80s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included neoplasm malignant. Patient was a cancer survivor. The patient's concomitant medications were not reported. On unspecified date two weeks later of the first dose she tested positive for covid 19, she was given an antibody injection in the beginning of February and is now wondering if she still needs the second dose or should she start the series over with the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. 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: Lymphadenopathy
Clinical narrative: I feel that the lymph node is swollen, but it's only in the left side, the side that I got the injection; This is a spontaneous report received from a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on left upper arm on 11Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, after vaccination the patient experienced that "it was her left side, right above her clavicle, where she felt that the lymph node was swollen, but it was only in the left side, the side that she got the injection". She stated that "I feel that the lymph node is swollen, but it's only in the left side, the side that I got the injection was coded as vaccination site lymphadenopathy". The patient stated that she was curious about 0.3% of participants experiencing swollen lymph nodes during the clinical study and asked how many participants were enrolled. 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: COVID-19, Disorientation, Dyspnoea, Headache, Nasal congestion
Clinical narrative: congestion; fever; headache; sore throat; disorientation; sometimes shortness of breath; had her first dose the 7th/ tested positive on the 13th; This is a Spontaneous report from Pfizer sponsored program. A contactable female consumer (patient) reported that a female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included autoimmune disease and concomitant medications were not reported. On 07Apr2021 she had first dose and scheduled tomorrow with 28Apr2021 for second dose. She tested positive on the 13th of April, tested negative on the 22nd of April and will have another test for Covid-19 by tomorrow. She also had symptoms like congestion, fever, headache, sore throat, disorientation and sometime shortness of breath since 14Apr2021 until now. She is also high-risk person and has autoimmune disease. She is asking if there will be a problem taking the second dose having these symptoms and if she can delay her second dose because her daughter tested positive and will be in quarantine for 10 days. The clinical outcome of the event COVID-19 was recovered, and other events are unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported Information: Amended  and deleted the event "she can delay her second dose because her daughter"/LLT Circumstance or information capable of leading to medication error" and removed "At Risk" classification
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: congestion; fever; headache; sore throat; disorientation; sometimes shortness of breath; had her first dose the 7th/ tested positive on the 13th; This is a Spontaneous report from Pfizer sponsored program. A contactable female consumer (patient) reported that a female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included autoimmune disease and concomitant medications were not reported. On 07Apr2021 she had first dose and scheduled tomorrow with 28Apr2021 for second dose. She tested positive on the 13th of April, tested negative on the 22nd of April and will have another test for Covid-19 by tomorrow. She also had symptoms like congestion, fever, headache, sore throat, disorientation and sometime shortness of breath since 14Apr2021 until now. She is also high-risk person and has autoimmune disease. She is asking if there will be a problem taking the second dose having these symptoms and if she can delay her second dose because her daughter tested positive and will be in quarantine for 10 days. The clinical outcome of the event COVID-19 was recovered, and other events are unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported Information: Amended  and deleted the event "she can delay her second dose because her daughter"/LLT Circumstance or information capable of leading to medication error" and removed "At Risk" classification
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: A  male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient had formed swollen nodes, a swollen kind of region above my left collar bone, patient can't really press into it, it was slightly sore when I press into it. Caller reported his experience after first dose. He recently had first dose on 16Apr2021 and since then well 3 days later he had formed swollen nodes, a swollen kind of region above his left collar bone? He can't really press into it was slightly sore when he pressed into it. Second dose was scheduled for 07May2021. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Movement disorder, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: her arm was sore near the injection site; then the soreness spread to her shoulder; she can barely move her arm and shoulder; She added she is in "excruciating pain";; it is "terrible" and "debilitating".; her arm pain; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. Patient medical history included spinal stenosis from an unknown date and unknown if ongoing. Patient concomitant medications were not reported. Patient persistently asked what to do to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She explained her doctor said he cannot help and has not seen this before.  She then threatened to call her lawyer if a doctor or scientist from the company could not assist her. It was stated that patient received the second dose of the Pfizer-BioNTech COVID-19 vaccine on 26Feb2021. She explained a few days after, her arm was sore near the injection site, then the soreness spread to her shoulder and she can barely move her arm and shoulder. She added she was in excruciating pain; it is terrible and debilitating. She took pain medicine for the arthritis in back and described it as spinal stenosis. She mentioned this medication was barely doing something to help with her arm pain. She then specified she also consulted her doctor who prescribed gabapentin and methyl prednisone tablets, which aren't relieving her arm pain. She expressed her concerns on the persistence and intensity of her pain. She asked if her symptoms were reported as side effects to the vaccine. Patient expressed her disappointment on the lack of information provided to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She said she was excited to get this vaccine among the other brand, and now that she is injured from it, she feels like Pfizer should be by her side and thus claims to have help from Pfizer. Outcome of the event her arm pain and her arm were sore near the injection site was not recovered. Outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained