chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia, X-ray limb abnormal
Clinical narrative: approx 12 hours woke up to left knee swelling/stiffness/ could barely bend knee/great difficulty walking. Also fever to 100.4 for about 24 hours.  Knee pain/swelling persisted  Seen by urgent care physician on 2/5 am regarding knee who prescribed prednisone; x ray of knee showed small to moderate knee effusion. Prescribed Prednisone 50mg daily for 4 days.  I took 50mg on Friday evening, 25mg on Saturday and Sunday.  Swelling reduced after first dose of prednisone.  Physician at Urgent care did not believe that swelling to knee was related to vaccine.  Saw orthopedic doctor by Tuesday and received steroid injection to knee.  I have a history of left knee issues with some swelling but never to that extent and have had no issues since.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Pyrexia, Tachycardia
Clinical narrative: Myocarditis.  1d after vaccine with fever, tachycardia, chest pain.  Abnormal ekg, elevated troponin.  Admitted
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis.  1d after vaccine with fever, tachycardia, chest pain.  Abnormal ekg, elevated troponin.  Admitted
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 20Apr2021 at 09:15 (at the age of 30-years-old) as a single dose indicated for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose indicated for COVID-19 immunisation. The patients medical history was not reported. The patient's concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19.  The patient did not receive any other medications/ vaccines within two weeks prior to the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 20Apr2021, the patient experienced sore arm and fatigue. The patient did not receive any treatment for events. The clinical outcomes of both the events were recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got Covid-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 07Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated that she had the first dose of the Pfizer Covid-19 vaccine on 07Apr2021 and she got Covid-19 on 11Apr2021. She got out of quarantine on past Friday and she would like to consult if she could take the second dose tomorrow or if she needs to reschedule. The patient underwent lab tests and procedures which included Covid-19: positive on 11Apr2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 48-years-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0175), via an unspecified route of administration administered at Arm left on 27Apr2021 16:15 at the age of 48 years as single dose for COVID-19 immunisation. The patient medical history and concurrent condition included Fibroids, PVCs (Premature ventricular contractions) and gerd (Gastrooesophageal reflux disease). The patient received Metoprolol tartrate, medroxyprogesterone 10 mg medications within 2 weeks of vaccination. Patient's past drug history included Latex, cipro and flagyl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021, the patient had experienced tachycardia. The patient previously had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ew0150), via an unspecified route of administration administered at Arm left on 06Apr2021 04:15 PM, at single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the event. Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: he got slight fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) via an unspecified route of administration on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Apr2021 as dose 1, single for covid-19 immunisation. The patient stated that he got the second dose yesterday 26Apr2021 and mentioned that he got slight fever on an unspecified date in Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash all over the body after the 1st dose; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: penmanship is not that great on vaccine card, so unable to tell if LOT number is 6W0153 or GW0153, Expiry date: unknown, age at vaccination: 50-year-old), via an unspecified route of administration in Arm Right on 13Apr2021 17:30 as dose 1, single for covid-19 immunisation administered at Pharmacy. Medical history included ongoing allergic to penicillin (Mother is also allergic to penicillin). The patient does not even take vitamins or over the counter pills or any other medications. The concomitant medications within 4 weeks were not reported. The patient reported, after 2 weeks since getting the shot, has been getting a rash all over her body on 25Apr2021. It is not just the Covid arm, it is all over, the rash. Is asking if she should have the second shot tomorrow since she still has the rash. The patient was treated with Benadryl and was prescribed Prednisone for the rash. The outcome of the event was not recovered.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dyspepsia, Fatigue, Feeling abnormal
Clinical narrative: arm soreness, arm that received the shot; fatigue; swollen lymph nodes; burning sensation in the left side of the body; chest pain; sever indigestion/severe heartburn; left side of the body just has a weird odd feeling; whole left side of the body is hot; arm started getting hot and sore again; This is a spontaneous report from a contactable consumer (patient).   A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153), dose 1 via an unspecified route of administration, administered in arm on 24Apr2021 as single for COVID-19 immunisation. The patient medical history included autoimmune illness. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness, arm that received the shot, fatigue, swollen lymph nodes, burning sensation in the left side of the body, chest pain, sever indigestion/severe heartburn, left side of the body just has a weird odd feeling, whole left side of the body is hot, and getting hot and sore again. The patient reported that she had the typical side effects like the sore arm and a little bit of fatigue. About the fifth day after she had severe heartburn and chest pain. She further reported that since the heartburn episode she felt like there was burning down her left side of the body. The arm that received the shot stopped being sore but then about 2 days ago it started getting hot and sore again but there were no bumps or swelling. On the left side of her body, she felt like it was on fire and her lymph nodes were swollen under her arm and her left side of the body just had a weird, odd feeling. She has an autoimmune disease, and she was wondering if that could be why she was having a reaction to the vaccine. The outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Lymphadenopathy, Vaccination site pain, Vaccination site warmth
Clinical narrative: arm soreness, arm that received the shot; fatigue; swollen lymph nodes; burning sensation in the left side of the body; chest pain; sever indigestion/severe heartburn; left side of the body just has a weird odd feeling; whole left side of the body is hot; arm started getting hot and sore again; This is a spontaneous report from a contactable consumer (patient).   A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153), dose 1 via an unspecified route of administration, administered in arm on 24Apr2021 as single for COVID-19 immunisation. The patient medical history included autoimmune illness. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness, arm that received the shot, fatigue, swollen lymph nodes, burning sensation in the left side of the body, chest pain, sever indigestion/severe heartburn, left side of the body just has a weird odd feeling, whole left side of the body is hot, and getting hot and sore again. The patient reported that she had the typical side effects like the sore arm and a little bit of fatigue. About the fifth day after she had severe heartburn and chest pain. She further reported that since the heartburn episode she felt like there was burning down her left side of the body. The arm that received the shot stopped being sore but then about 2 days ago it started getting hot and sore again but there were no bumps or swelling. On the left side of her body, she felt like it was on fire and her lymph nodes were swollen under her arm and her left side of the body just had a weird, odd feeling. She has an autoimmune disease, and she was wondering if that could be why she was having a reaction to the vaccine. The outcome of all the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Myalgia, Pain, Pain in extremity
Clinical narrative: cough; chronic diarrhea/Uncontrollable Diarrhea; Itching on back of my head and in front of my arms; hands and muscles aching; swelling; pain; hands and muscles aching; This is a spontaneous report from a contactable reported for unknown patient. A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Apr2021, as dose 2, single for COVID-19 immunization. The patient's medical history included hearing impairment and smoker, unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after the second dose of vaccine, the patient experienced cough; but attributed it to smoking, chronic diarrhoea/uncontrollable diarrhoea, itching on back of her head and in front of her arms, hands and muscles aching, swelling, and pain. Patient experienced chronic uncontrollable diarrhoea and every time when she ate or drink something, she had diarrhea afterwards. The patient took Pepto-Bismol for diarrhoea and it did not stop. She tried to eat fruits and everything but became miserable. The clinical outcome of the event diarrhoea was not resolved and clinical outcome of all other events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: cough; chronic diarrhea/Uncontrollable Diarrhea; Itching on back of my head and in front of my arms; hands and muscles aching; swelling; pain; hands and muscles aching; This is a spontaneous report from a contactable reported for unknown patient. A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Apr2021, as dose 2, single for COVID-19 immunization. The patient's medical history included hearing impairment and smoker, unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after the second dose of vaccine, the patient experienced cough; but attributed it to smoking, chronic diarrhoea/uncontrollable diarrhoea, itching on back of her head and in front of her arms, hands and muscles aching, swelling, and pain. Patient experienced chronic uncontrollable diarrhoea and every time when she ate or drink something, she had diarrhea afterwards. The patient took Pepto-Bismol for diarrhoea and it did not stop. She tried to eat fruits and everything but became miserable. The clinical outcome of the event diarrhoea was not resolved and clinical outcome of all other events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Several rashes have developed on the arm of the injection site of the second dose; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in left arm on 31Mar2021 at 15 hours as a single dose, for COVID-19 immunisation. Medical history included pre-diabetic. The concomitant medications included metformin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) both for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19. The patient previously received single dose of Pfizer vaccine in arm Left on 03Mar2021 at 12:45 hours. On 25Apr2021, the patient experienced several rashes that had developed on the arm of the injection site (vaccination site rash) following the second dose. The first sign of the rash had occurred during the week of 25Apr2021 and was still present at the time of this report. The rash had begun with a circular patch around where the shot was given and had spread down the arm which formed a circle around the middle of the forearm. The event had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported event was not recovered at the time of this report.   No follow-up attempts are possible. Information about lot number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Eating disorder, Fatigue, Malaise
Clinical narrative: fairly debilitating; can hardly eat; generally feeling unwell; really weak; feels shakey; diarrhea; stomach churning; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 02May2021 at 10:30 or 11:00 am, (at the time of vaccination 64-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 11Apr2021 (at the time of vaccination 64-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06May2021, the patient experienced diarrhea, stomach churning; on 07May2021, really weak, feels shakey; on an unspecified date, fairly debilitating, can hardly eat and generally feeling unwell. Caller has been taking anti-diarrheal Loperamide, 2mg, every day since 06May2021. Patient neither visited to emergency room nor physician office. Patient did not take any vaccine within 4 weeks prior vaccination. The outcome of the events diarrhea, really weak, feels shakey and stomach churning was not recovered and events fairly debilitating, can hardly eat and generally feeling unwell was unknown. No Follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness
Clinical narrative: fairly debilitating; can hardly eat; generally feeling unwell; really weak; feels shakey; diarrhea; stomach churning; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 02May2021 at 10:30 or 11:00 am, (at the time of vaccination 64-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 11Apr2021 (at the time of vaccination 64-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06May2021, the patient experienced diarrhea, stomach churning; on 07May2021, really weak, feels shakey; on an unspecified date, fairly debilitating, can hardly eat and generally feeling unwell. Caller has been taking anti-diarrheal Loperamide, 2mg, every day since 06May2021. Patient neither visited to emergency room nor physician office. Patient did not take any vaccine within 4 weeks prior vaccination. The outcome of the events diarrhea, really weak, feels shakey and stomach churning was not recovered and events fairly debilitating, can hardly eat and generally feeling unwell was unknown. No Follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a contactable consumer (patient's friend) via Medical Information Team. A patient of an unspecified age and gender received an unknown dose number of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route, on an unknown date (Batch/Lot Number: unknown) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter reported that the patient actually had a blood clot after receiving a COVID Vaccine but did not verify manufacturer of friend's vaccine. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oxygen consumption
Clinical narrative: she was set back and was sick as a dog for 3-4 days; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID on an unspecified date in Jan2021, to which she had terrible indigestion and was hospitalized to the hospital for 8 days. Patient's oxygen levels were 91-92, in which she would occasionally get some oxygen to help her breathe. She had tests done for 4 days in the hospital, after which she was discharged upon recovery. Concomitant medications were not reported. The patient's doctor advised to get vaccinated within 3 weeks after recovering from COVID, to which the patient opted for 4 weeks after because she felt it was too soon. Patient was healthy after her recovery. On an unspecified date in Feb2021, after the administration of first dose of vaccine, the patient was set back and was sick as a dog for 3-4 days. Patient recovered from it, but has yet to receive her 2nd dose. Patient was not sure how she could receive it and she believes she has enough antibodies and asked about any test to determine how many antibodies she took and what was the value she was looking for. The patient underwent lab tests and procedures which included oxygen consumption: 91-92 during COVID infection, on Feb2021. The clinical outcome of the event was resolved, on an unspecified date in Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore left arm; tiredness; This is a spontaneous report from a contactable consumer (Parent). A 12-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in Left Arm on 12May2021 (at the age of 12-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. The Concomitant medications included  fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) loratadine (CLARITINE) vaccine in two weeks. No other vaccine administered in four weeks. No Known allergies were reported. The patient did not test for covid post vaccination. The patient did not suffer from covid prior vaccination. On 12May2021, the patient experienced sore left arm and tiredness. Patient did not received ant treatment. Query included Drug safety unit recently received the attached report submitted via a web site. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response received I first became aware of this event on 12May2021. Please let me know if you need anything else. The outcome for the events was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dysgeusia, Parosmia, Taste disorder
Clinical narrative: metallic taste and smell; metallic taste and smell/diesel taste and smell; diesel taste and smell; This is a spontaneous report from a contactable consumer (patient himself) via Pfizer. A 68-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 02Mar2021 at around 13:00 (as reported) as dose 2, single (at the age of 68-years-old) for COVID-19 immunization. Patient medical history was not reported. The concomitant medications included amitriptyline had been on for 20 years, patient takes as needed because he was in a bad car accident at a dose of 10 mg, butalbital, caffeine, paracetamol (FIORICET), cyclobenzaprine, had been on for 20 years at a dose of 10 mg taken for headache. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 09Feb2021 at around 14:00 (as reported) as dose 1, single for COVID-19 immunization. Patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (First dose last 09Feb2021 & Second dose on 02Mar2021). He reported to have had a metallic taste and smell, like a diesel engine. Patient mentioned he was unsure when this started but it had been 3 months already. He also stated that he saw a physician, but he still wanted to know if it had been reported. He had an awful taste and smells the same odor. It had been a few months with the metallic taste in his mouth. Patient added that diesel taste and smell started about the time that they got the shots. Patient stated that he did say it was metallic earlier but he would not say it was metallic, he thought that people who do not have experience say it was metallic. He stated it was more like diesel fumes and a bitter taste that he tastes and smells. He did not know when this started but stated that it just stays the same. Patient was asked when symptoms started and he stated he could not really say that. He never thought about it until the last months or so he noticed he had it for a while. He smelled the same odor and taste if that makes any sense because taste and smell are related. Patient added he had never been sick or had any childhood diseases. He wanted to know if it was something because the doctor wants to test his kidney and liver. He had no health problems. He had bloodwork a month before the vaccines and everything was fine and they want to use him as a lab rat right now. Description of Product Complaint included patient was discussing the treatment for his diesel-like taste and smell that he was experiencing for a while. The doctor gave him a pantoprazole 40 mg for acid reflux. The adverse events resulted in physician office visit but not the emergency room visit. Patient received pantoprazole at a dose of 40 mg for acid reflux. The outcome of the events was not resolved.   Additional information about batch/lot has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Frustration tolerance decreased
Clinical narrative: hair has been falling out by the hand full; It is quite frustrating; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 17Mar2021 (age at vaccination: 69 year), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Pfizer vaccine with the 2nd shot completed on 17Mar2021. Not long after receiving the vaccine, her hair has been falling out by the hand full on an unspecified date in 2021. She has found that she was not alone in this as several neighbor's family members and read elsewhere other folks who received the Pfizer vaccine have the same issue: hair falling out and asked did the Pfizer vaccine have any chemo drugs. Now she didn't know how to stop the hair loss. It was quite frustrating. She was a 69-year-old female and do not take any type of chemotherapy now or ever. The patient asked about to advise on why this was happening right after the second vaccine that she received and there were a people in our community that were interested in an answer on this subject. Outcome of the events was unknown.  Information on batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Blood count, Gastrooesophageal reflux disease, Loss of consciousness, Scan
Clinical narrative: Loss of consciousness with hospitalization for six days; This is a spontaneous report from a contactable Other HCP (Nurse) and a contactable consumer (patient).  An 85-year-old patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Not reported), via an unspecified route of administration on 09Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included high blood pressure, for which she takes "critical blood pressure medications- that are compounded by a special pharmacy", lot of allergies including cannot tolerate artificial sugars as they cause headaches, sensitive to many things for which she responds with flu and can only tolerate brand medications as generic" have too many fillers" for which she also developed a headache and "feels awful". She had been independent and living alone (her husband has dementia and lives in a care centre), She was able to drive and able to walk independent of assistive deceives. A history of a loss of consciousness in the past was denied. Concomitant medications included Doxazosin Mesilate (CARDURA) for high blood pressure, Vitamin D3 as dietary supplement, Alprazolam (XANAX), Metoprolol tartrate (LOPRESSOR), Cipcal Vitamin D3 Gummies and Nature's Bounty D3 Gummies, Strawberry, Orange & Lemon Flavored Gummies (Lot number:5164590, Expiry Date: 31Jan2022). The patient previously received first dose of BNT162B2 (Lot number and Expiry date: Not reported), via an unspecified route of administration, administered on 19Mar2021 as dose 1, single for COVID-19 immunisation. On 13Apr2021 the patient experienced loss of consciousness with hospitalization for six days and inpatient rehabilitation for ten days. In Apr2021, the patient had a head scan, urinalysis, throat test, unspecified blood tests and heart tests (all heart tests they could do). Outcome of the event was unknown.   No Follow-up attempts are needed, information about lot/batch number can not be obtained.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported event of loss of consciousness and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Loss of consciousness with hospitalization for six days; This is a spontaneous report from a contactable Other HCP (Nurse) and a contactable consumer (patient).  An 85-year-old patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Not reported), via an unspecified route of administration on 09Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included high blood pressure, for which she takes "critical blood pressure medications- that are compounded by a special pharmacy", lot of allergies including cannot tolerate artificial sugars as they cause headaches, sensitive to many things for which she responds with flu and can only tolerate brand medications as generic" have too many fillers" for which she also developed a headache and "feels awful". She had been independent and living alone (her husband has dementia and lives in a care centre), She was able to drive and able to walk independent of assistive deceives. A history of a loss of consciousness in the past was denied. Concomitant medications included Doxazosin Mesilate (CARDURA) for high blood pressure, Vitamin D3 as dietary supplement, Alprazolam (XANAX), Metoprolol tartrate (LOPRESSOR), Cipcal Vitamin D3 Gummies and Nature's Bounty D3 Gummies, Strawberry, Orange & Lemon Flavored Gummies (Lot number:5164590, Expiry Date: 31Jan2022). The patient previously received first dose of BNT162B2 (Lot number and Expiry date: Not reported), via an unspecified route of administration, administered on 19Mar2021 as dose 1, single for COVID-19 immunisation. On 13Apr2021 the patient experienced loss of consciousness with hospitalization for six days and inpatient rehabilitation for ten days. In Apr2021, the patient had a head scan, urinalysis, throat test, unspecified blood tests and heart tests (all heart tests they could do). Outcome of the event was unknown.   No Follow-up attempts are needed, information about lot/batch number can not be obtained.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported event of loss of consciousness and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Asthenia, Inflammation
Clinical narrative: pt. is having inflammation and  pain in left ankle; pt. is having inflammation and  pain in left ankle; feels that bones are very weak; This is a spontaneous report from a Caremark Xeljanz C&P Program (Program ID: CEP 141003). A contactable CVS/Caremark Specialty Pharmacy reported for female patient. This is a spontaneous report from a contactable other Healthcare professional.  A 36-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15May2021 (at the age of 36 years old) as a dose 2, single, for covid-19 immunization; tofacitinib citrate (XELJANZ XR), oral from 2019 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis (From 2019 to 8May2021). Patient's medical history included, rheumatoid arthritis from 2019 and ongoing. The patient's concomitant medications were not reported. Patient took first dose of bnt162b2 on 28Apr2021 dose 1, single, for covid-19 immunization. Patient reported that, her xeljanz was on therapy hold as per md instruction to discontinue 1 week before each of the covid-19/corona virus vaccine doses, so patient stopped it a week before her Pfizer corona vaccine on 28Apr2021 and then a week before 15May2021, due to missed doses patient was having inflammation and pain in left ankle (she stepped wrong and hurt her left ankle as previously reported), felt that bones are very weak, md was aware and ordered patient to resume xeljianz on monday, 24May2021. On an unspecified date, the patient experienced pt. is having inflammation and pain in left ankle and feels that bones are very weak. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: reaction: allergic to product/the covid-19 had a serious side effects; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 15Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This consumer reported events for different vaccine doses. This is the second of two reports. This 82-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWOI75), via an unspecified route of administration on 18May2021 (at the age of 82-year-old) as single dose for COVID-19 immunization. The patient's medical history included contusion from brain damage from 1987 and ongoing (she was hit by a drunk 30 years ago) and allergic to sulfa (Sulfonamide allergy). Concomitant medication included alprazolam (manufacturer unknown) taken for brain injury and contusion from 1987 and ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscularly on 27Apr2021 13:45 (at the age of 82-year-old) as single dose for COVID-19 immunization and experienced adverse reactions of can barely think on 27Apr2021 13:45, she is a mess and can barely walk. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, the patient experienced reaction: allergic to product which was serious due to medically significant. The patient stated, "I did not choose to be vaccinated it was my family, my son would not see me until I had vaccinated. If I had acknowledged my allergy to sulfa they would have refused the vaccination. Because I am allergic to sulfa the covid-19 had a serious side effects." No treatment was received for the adverse event. The clinical outcome of the "reaction: allergic to product/the covid-19 had a serious side effects" was resolving.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515270 same patient and drug, different dose and event.
Sex: M
Vaccine: COVID19
Symptoms: Product leakage, Underdose
Clinical narrative: a small amount of the vaccine leaked out; a small amount of the vaccine leaked out; This is a spontaneous report from a contactable other hcp (Nurse). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a small amount of the vaccine leaked out. The reporter stated that they had a patient who while he was receiving the second dose of his Pfizer COVID 19 vaccination a small amount of the vaccine leaked out. She states that they followed the agency recommendations on if it was estimated to be less then half of the vaccine dose, not to revaccinate. This patient is concerned that he is not fully protected since some of the vaccination leaked out.   Information on the batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product preparation error, Product temperature excursion issue
Clinical narrative: Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Sore arm; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. This report has similar events for 3 patients. This is 2 of 3 reports  A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 2nd dose. Formulation: solution for injection, Lot number EW0217) via an unspecified route of administration, on 09Jun2021, single dose (at the age of 13-years-old) for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 09Jun2021, the patient experienced product temperature excursion issue, poor quality vaccine administered, product preparation error and in Jun2021 the patient experienced pain in arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of the events was unknown. Information on Lot/Batch number has been requested.  Follow up (14Jun2021): This is a follow up spontaneous report from a contactable pharmacist. This pharmacist reported for a 13-year-old male patient that: Duplicate AE E-transmitted for report of inadvertent dosing of the vaccine past 6 hour storage in syringe. Caller would like written document sent to email address. Caller states she has not received previous email request.  Response: Disclaimer Provided Pfizer has conducted physical and chemical stability studies which have shown that the vaccine maintains all its measured quality attributes when diluted vaccine is stored in polycarbonate or polypropylene syringes for 6 hours at 2 degree C to 30 degree C. Microbiological risk must be considered. Degradation of RNA in the vaccine has been observed when stored for longer than 6 hours in syringes.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021683146 same reporter, AE and product, different patient;US-PFIZER INC-2021684836 same reporter, AE and product, different patient
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Inflammation, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: The patient was less than 12 years old; he had a lymphoma inflammation; he started complaining that his armpit  hurts more than where he took his shot,; he started to feel too much pain on his arm; he also had headache; This is a spontaneous report received from a contactable consumer (parent). A 9 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 13:30 (Batch/Lot Number: twc/71), vaccinated at the age of 9 years old, as single dose for covid-19 immunisation. Patient received the first dose on 17May2021 16:00 in Arm Left. Medical history included attention deficit hyperactivity disorder.  The patient's concomitant medications were not reported.  Relevant past drug history included "Mold, ash three". Patient took his second dose on Monday at 1:30PM on his left arm, at 5 pm he went to his regular ninja class (the doctor said he could exercises normally) He did one exercise then he started to feel too much pain on his arm then he stopped. Next day, on 08Jun2021 he started complaining that his armpit hurts more than where he took his shot, he also had headache. Reporter took him to the doctor and he told me he had a lymphoma inflammation. Reporter not sure if it was from the exercise or for the vaccine, Reporter just want to report to help on the research. He is under antibiotics now and still with a lot of pain when you touch it. The doctor said if not get better in 1 week he is going to take an ultrasound. Outcome of reported events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: She has had diarrhea for 14 days and it is worsening.; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EW0176, expiration date 01Aug2021) via unspecified route in the right arm, on 27May2021 (at the age of 64-years-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that after the first dose of the Pfizer COVID shot on May2021, she has had 14 days of diarrhea real bad. Patient received her first dose of the Pfizer Covid-19 Vaccine and has a question about the side effect Diarrhea. She has had diarrhea for 14 days and it is worsening. She is asking how long the diarrhea will last. She stated that she talked to her Pharmacist and he recommended a medicine for her to take and she is still having diarrhea. She was wondering if there was anything she could take to help with the diarrhea because that was embarrassing and her rectum was raw and when it hits, she does not know if she had time to make it to bathroom. Pharmacist recommended her to take for the diarrhea Loperamide Hydrochloride Lot number 977532, Expiry Oct2022. Patient had no other vaccines on the same day as the suspect product. There was no emergency room or physician office visit required for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Description of complaint included patient who experienced an adverse event to the suspect product COVID shot and while completing a safety report on that suspect product, caller mentioned that her Pharmacist recommended that she takes Loperamide Hydrochloride for diarrhea, and she states that her diarrhea is not getting better. query mentioned Start date for 1st dose was given as 27Apr2021 and 27May2021. Kindly, confirm the start date of 1st dose. Response After reviewing the call recording it was confirmed the first dose was given on 27May2021. This was populated incorrectly by the call handler in the designated field. The clinical outcome for the event was not recovered.  No new information received. No follow-up attempts are needed. No further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in one of her legs/ I have numbness in one my leg; This is a spontaneous report from a contactable consumer (patient) through Medical Information.  A 46-year-old female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she received her 1st dose of the Pfizer COVID 19 vaccine "3 weeks ago." She is scheduled to have her 2nd dose administered today, however states that she is unsure if the symptoms she is experiencing could be a side effect from the 1st dose. She states that the symptoms of numbness in one of her legs began shortly after the time she got her 1st vaccine. She is not sure if the two are related to one another or not but wanted to follow up and ask and see if numbness in the legs a potential side effect is and should she follow through with 2nd dose of COVID vaccination or be seen by HCP. She stated I got the first dose of the vaccine on 22May2021, this was Saturday. So, it's going to be 3 weeks in 2 days. So anyways I have this side effect and I am stepped in to see if this is a side effect of a vaccine because it started around the same time. The outcome of the event was reported as unknown.   Follow up attempts are needed; information about lot/batch number has been requested.