chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature abnormal, Headache, Pain
Clinical narrative: had temperature; Body ache; Headache; Loss of taste; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 23Dec2020 16:45 at a single dose for COVID-19 immunization. The patient has no medical history and concomitant medications. The patient got her vaccine on Wednesday and had some side effects. She would like to make sure that it was normal, but she was pretty sure it would be going to go away. How long will it take for the side effects to go away. The patient had temperature, body ache, headache and loss of taste as well on 24Dec2020. She said it's going to be 3 weeks from the date she got the first one but she didn't know exactly what date. The patient received Aleve liquid gel as treatment and threw that bottle away. The outcome of the events was unknown. The reporter believed that the adverse events was caused due to Pfizer BioNTech COVID 19 Vaccine.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Influenza like illness, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: flu; tachycardia; headache; heart rate was 120; This is a spontaneous report from a contactable other healthcare professional (patient himself: family nurse practitioner). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tachycardia on 24Dec2020, and he felt like he had the flu and he checked his temperature and it was fine on 26Dec2020. His heart rate was 120 and he had a headache. Caller states he had a COVID test done and he is not positive. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Malaise
Clinical narrative: fatigue; Headache; Intermittent facial flushing; Nausea; Lightheadedness; Malaise; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 19:00 in right arm at single dose for COVID-19 immunization. Medical history included HTN (hypertension), ADD (attention deficit hyperactivity disorder) and latex allergy from an unknown date and unknown if ongoing. Concomitant medication included losartan, bisoprolol, duloxetine hydrochloride (CYMBALTA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and paracetamol (TYLENOL). The patient experienced moderate fatigue, headache, intermittent facial flushing, nausea, lightheadedness and malaise on 24Dec2020. The facility where the most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: fatigue; Headache; Intermittent facial flushing; Nausea; Lightheadedness; Malaise; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 19:00 in right arm at single dose for COVID-19 immunization. Medical history included HTN (hypertension), ADD (attention deficit hyperactivity disorder) and latex allergy from an unknown date and unknown if ongoing. Concomitant medication included losartan, bisoprolol, duloxetine hydrochloride (CYMBALTA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and paracetamol (TYLENOL). The patient experienced moderate fatigue, headache, intermittent facial flushing, nausea, lightheadedness and malaise on 24Dec2020. The facility where the most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Vomiting
Clinical narrative: muscle aches; chills; diarrhea; nausea; vomiting; This is a spontaneous report from a contactable physician. A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 at single dose for COVID-19 immunization in hospital. Medical history was reported as none, no known allergies.  The patient's concomitant medications within 2 weeks of vaccination was reported as none.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced diarrhea started from day after vaccine (24Dec2020) then nausea vomiting. Patient's diarrhea has resolved but 2 days after vaccine (25Dec2020) patient continues to have vomiting, muscle aches and chills. No treatment received for the adverse events. The outcome of diarrhea was recovered in Dec2020, of the other events was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  The information on the batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site for 24 hours; This is a spontaneous report from a non-contactable physician (patient).  A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in Right arm on 23Dec2020 at 15:30 at single dose for COVID-19 immunisation.  Medical history was none. No known allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient experienced soreness at injection site for 24 hours (non-serious) on 24Dec2020. No treatment given and patient recovered from the event on an unknown date in Dec2020. No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: minimal pain at the injection site; This is a spontaneous report from a Pfizer-sponsored Program. A non-contactable physician (patient) reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included many allergies including allergy to shellfish. The patient's concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient got COVID vaccine and before she took the vaccine she had Benadryl as she has many allergies including allergy to shellfish. She experienced minimal pain at the injection site on an unknown date. Reporter wanted to know if Benadryl affect the efficacy of the vaccine and if Benadryl would decrease the efficacy of COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: he can no longer smell or taste food; he can no longer smell or taste food; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday on 21Dec2020, and 6 days later he noticed that he can no longer smell or taste food. He wanted to know if that was still part of the side effects of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Rhinorrhoea
Clinical narrative: chest tightness; nasal drainage; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot, expiry unspecified), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he received the vaccine on 23Dec2020 and in Dec2020, the patient experienced chest tightness and nasal drainage. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable nurse.  A 6-decade (reported as around late 50s or early 60s) female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced fever on unspecified date with outcome of the event was unknown. Information on the Lot/Batch Number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: Cough; Scratchy throat; This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the first of two reports.   A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiration date were not reported), via an unspecified route of administration on 18Dec2020 at single dose for the frontline healthcare workers/COVID-19 immunisation.  Medical history included arthritis.  Concomitant medication included ibuprofen. The patient stated, "I got the COVID vaccine on Friday the 18th from my work and I started having like a scratchy throat on Sunday (20Dec2020) and then yesterday, the 23rd I developed cough and my employee helped and said I should report to you guys and then the CDC. That I have the side effects, even though it's common to get after the vaccine." Patient received treatment: of MUCINEX, zinc and Vitamin C. The outcome of scratchy throat was unknown and other event was not recovered.   Information on the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513781 same reporter, same drug, same event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore in the arm where he received the vaccination; This is a spontaneous report from a non-contactable consumer (patient's wife). A 63-year-old (reported as 60 to 65 years age) male patient received BNT162b2 (Solution for injection, lot number and expiration date not provided), via an unspecified route of administration at arm on unspecified date in 2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The day after patient received the vaccination, he had sore in the arm where he received the vaccination in 2020. Problem resolved within 24 hours. He had it one day after the immunization and then it was off. The outcome of the event was recovered in 2020.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; fatigue; chills; headache; This is a spontaneous report from a contactable Other HCP. This 26-year-old male Other HCP (patient) reported that a 26-years-old male patient started to receive bnt162b2 (BNT162B2; brand=Pfizer, lot number=EH9899,dose number=1), via an unspecified route of administration from 25Dec2020 17:15 to 25Dec2020 17:15 at SINGLE DOSE at vaccine location of Left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Prior to vaccination, the patient was diagnosed with COVID-19). Patient had no known allergies. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient experienced fever, fatigue, chills and headache, all on 26Dec2020 09:00 AM with outcome of recovering.  No treatment received for events. Event reported as non-serious.  Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 was not tested post vaccination
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site vesicles, Pain, Pain in extremity
Clinical narrative: On the arm I got the shot, down and to the side of my body , I had arm pain and the following day got a blister at that site; On the arm I got the shot, down and to the side of my body , I had arm pain and the following day got a blister at that site; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received first dose bnt162b2 (BNT162B2), intramuscular on Right arm on 22Dec2020 06:15 at SINGLE DOSE for covid-19 immunisation. Medical history included patient diagnosed with COVID-19. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), ergocalciferol (Vzinc (ZINCIT D), ) and multivitamin. The patient reported "on the arm i got the shot, down and to the side of my body, i had arm pain and the following day got a blister at that site" on 22Dec2020 12:00. No treatment received. The event outcome was recovered in Dec2020. The event was non-serious.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, SARS-CoV-2 test negative
Clinical narrative: Temp 100.7 degrees Fahrenheit and chills lasting for less than 7 hours; Temp 100.7 degrees Fahrenheit and chills lasting for less than 7 hours; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable Nurse(patient). The 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:el0140), intramuscular at Left arm on 18Dec2020 11:15 AM at single dose(dose number was 1) for COVID-19 immunization in hospital.  Medical history included ongoing allergy to treenuts. She was not pregnant. The patient's concomitant medications were not reported. There was no other vaccine in four weeks nor other medications in two weeks. There was no covid prior vaccination. The patient experienced temp 100.7 degrees fahrenheit and chills lasting for less than 7 hours on 19Dec2020 12:00 AM. There was no treatment. Lab data included body temperature: 100.7 fahrenheit on 19Dec2020, Covid-19 PCR (Covid test type post vaccination=Nasal Swab): negative on 22Dec2020.  Outcome of events was recovered in Dec2020. Case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Pyrexia, Vision blurred
Clinical narrative: I still was not feeling well; Joint pain; I thought I was having fever; the highest temperature I got was 101.3; my vision was really blurred; This is a spontaneous report from a contactable consumer. This consumer of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for Covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer got the shot on the 23Dec2020 probably around little bit after 6 PM and the consumer was working that night.  The consumer thought he/she was having fever and checked temperature and think the highest temperature got was 101.3 on 23Dec2020. After his/her shift when the consumer came home and took ibuprofen (MOTRIN) and the fever was controlled. The consumer went home and developed joint pain and still have fever when the consumer woke up so that was the 24Dec2020. On 24Dec2020 when the consumer woke up because worked night. When the consumer woke up late in the evening and woke finally at 4:30 in afternoon the consumer still was not feeling well on 25Dec2020. So the only think he/she felt differently the previous night my vision was really blurred. The consumer had difficulty in reading stuff that he/she read before in Dec2020. The consumer do use reading glasses but this time when he/she say blurry even when was focusing alone, it was hard for him/her. The outcome of fever and not feeling well was not recovered. The outcome of other events was unknown.  Information on the batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Oropharyngeal pain, Pain
Clinical narrative: Severe Headache; Migraine; Body aches; Fever; Chills; Extreme Fatigue; Sore Throat; Congestion; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm, on 23Dec2020 08:30 at single dose for COVID-19 immunization. There was no medical history, no known allergies. The patient was not allergic to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, migraine, body aches, fever, chills, extreme fatigue, sore throat, congestion on 24Dec2020 04:00. AEs resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Events outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Severe Headache; Migraine; Body aches; Fever; Chills; Extreme Fatigue; Sore Throat; Congestion; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm, on 23Dec2020 08:30 at single dose for COVID-19 immunization. There was no medical history, no known allergies. The patient was not allergic to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, migraine, body aches, fever, chills, extreme fatigue, sore throat, congestion on 24Dec2020 04:00. AEs resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Events outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Breast feeding, Chills, Pain
Clinical narrative: chills; body ache; breast Feeding; breast Feeding; This is a spontaneous report from a contactable Nurse(patient). This nurse reported information for herself and the baby. This is a maternal report. This 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, first dose), intramuscular on 21Dec2020 at single dose for COVID-19 immunization.  Medical history included none.  Concomitant medication included ascorbic acid/betacarotene/calcium sulfate/ colecalciferol/ cyanocobalamin/ ferrous fumarate/ folic acid/ nicotinamide/ pyridoxine hydrochloride/ retinol acetate/ riboflavin/ thiamine mononitrate/ tocopheryl acetate/zinc oxide (PRENATAL VITAMINS).  The patient(healthcare worker) wanted to report a possible side effect that she had chills and body ache on 5th day after she got her first dose on 26Dec2020, there was no treatment received and she was also breast Feeding. It didn't say they did not write the expiration. When probed for the causality, patient stated she thought so.  Lab data included blood work was normal. Outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020514624 same drug/reporter different patient(baby case)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling abnormal, Feeling jittery, Pain in extremity, Palpitations
Clinical narrative: Localize arm pain; My whole arm is kind of aching and my armpit on that side; My heart is racing a little fast; I just kind of thought like it is different than it looks; Its just a little strange; feel like a little jittery; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration on 17Dec2020 at single dose for Covid-19 immunisation. There was no medical history nor concomitant medications. The patient had COVID-19 vaccination on 17Dec2020. She did have some like localize arm pain and then it resolved. It is like a week later her whole arm was kind of aching and her armpit on that side. It was just that side effect with this, her arm and the other thing, its just like she was starting to feel like little a bit like my heart was racing a little fast, like I just feel like a little jittery. The arm pain was like two days before and it started and she just kind of thought like it was different than it looks. The patient just noticing that like feeling like little bit her heart was racing, its just a little strange. All event was in Dec2020 with outcome of unknown. The patient did not received any treatment, it was mild but she just notice it.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: It hurt less than the flu shot and so far my arm is just a little sore; This is a spontaneous report from a Pfizer Sponsored Program Corporate (Pfizer) Social Media Platforms. Two contactable consumers (one is the patient) reported that a female patient of an unspecified age started to receive BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration from an unspecified date at single dose  for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID-19 vaccine this morning and sated that it hurt less than the flu shot and so far her arm is just a little sore on an unspecified date. Stated, "Once I get my second dose I'll feel much safer at work and in public". The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart rate has been over a hundred; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive BNT162B2 (lot number and expiry date unknown), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I got the COVID vaccine yesterday. I am just a little concerned because my heart rate has been over a hundred for an hour now". It has been over 24 hours since the vaccine was administered. The patient was requested to visit nearest emergency room or contact a health care provider. The outcome of the event was unknown.  The following information on the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Sore arm; This is a spontaneous report from a contactable physician (patient) via Pfizer Sales Representative (pending clarification). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown. Event took place after use of product.  Information on the batch/lot number has been requested.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on my leg; itching; This is a spontaneous report from a contactable nurse (patient). A 63-year-old patient of an unspecified gender started to receive BNT162B2 (lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. There were no medical history and concomitant medications. The patient received the COVID vaccine on Monday (21Dec2020) and two and half hours later, the patient had a rash on leg and it stopped, it was itching a little but not bad and it stopped at like my knees and it has increased instead of going away and now it's been basically 4 days and the patient has shown it to one of the doctors she/he worked with, stated "he was just not alarmed, I mean I said it's not itching but I am concerned that it was increasing and not decreasing". Therapeutic measures were taken as a result of rash on my leg and itching which included Benadryl. The outcome of the events was not recovered. The reporter assessed as causality as related, reported as "It happened 2 and half an hour after I got the vaccine so yes, I know it due to the COVID".
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Have an allergic reaction all over her body; a rash all over her body; she thought it was eczema that she had had before; she thought it was eczema that she had had before; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. Medical history included a rash on her body in college before and eczema. Concomitant medications were not reported. On 18Dec2020, patient had an allergic reaction all over her body like a rash all over her body, and she thought it was eczema that she had had before. She thought that maybe that could be from the vaccine. Regarding treatment, she took diphenhydramine (BENADRYL, non-Pfizer drug) and it didn't work. Outcome of events was not recovered.  Information on the Batch/Lot number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; Immediately after receiving the vaccine and around 48 hours after, I experienced dizziness/nausea, headache and severe injection site pain; This is a spontaneous report from a contactable nurse (patient herself).  This 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 23Dec2020 at single dose for COVID-19 immunisation.  Vaccine location was left arm. The patient was not pregnant. Relevant medical history included diabetes and hypertension. No known allergies. Relevant concomitant medications included metformin and losartan. The patient was vaccinated at hospital, age at vaccination was 62-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. Immediately after receiving the vaccine and around 48 hours after, she experienced dizziness/nausea, headache and severe injection site pain. No therapeutic measures were taken as result of the events. The patient had recovered from the events in Dec2020.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: I just do not feel myself; Tired/Fatigue; Joint pain; A little nauseous; Muscle pain; This is a spontaneous report from a contactable Nurse.  This 57-year-old female Nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 at single dose for COVID-19 immunisation at the age of 57-year-old. Lot number was EK5730. The patient had not medical history. Concomitant medications were none. Patient received suspect vaccine on 26Dec2020, and she was feeling like really tired, fatigue, joint pain, a little nauseous on 27Dec2020. She did not think she had a fever, but she just did not feel herself. She had like muscle pain on 27Dec2020. She knew that all these are side effects, but she should go and have herself tested (as reported). Maybe the patient was becoming sick and she did not know. The outcome of the events was unknown. Nurse stated about causality that she did think so; she was not feeling sick before; she meant that she was not feeling like this before.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Muscle spasms, Myalgia
Clinical narrative: stuffed up nose; sore throat; fatigue/more exhausted and tired; sore muscles and legs; sore muscles and legs; stomach is hurting; she woke up with a really bad cramp on her side.; headache/headaches had been pretty bad; felt a little sick; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EL1284), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history reported none. There were no concomitant medications. After vaccination, the patient felt sick, the patient experienced headache on 26Dec2020; fatigue on 27Dec2020; sore muscles and legs (really sore) in night on 27Dec2020; stomach is hurting on 27Dec2020; she woke up with a really bad cramp on her side on 27Dec2020, it was unbearable to the point where she had to sit down, she woke up really bad; woke up with a stuffed up nose on 28Dec2020; sore throat on 28Dec2020 (really started this morning). She was more exhausted and tired. Her headaches had been pretty bad. The patient underwent lab tests and procedures which included COVID test with unknown results on 28Dec2020. She was taking medicine for the headaches on 28Dec2020. The outcome of events was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: stuffed up nose; sore throat; fatigue/more exhausted and tired; sore muscles and legs; sore muscles and legs; stomach is hurting; she woke up with a really bad cramp on her side.; headache/headaches had been pretty bad; felt a little sick; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EL1284), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history reported none. There were no concomitant medications. After vaccination, the patient felt sick, the patient experienced headache on 26Dec2020; fatigue on 27Dec2020; sore muscles and legs (really sore) in night on 27Dec2020; stomach is hurting on 27Dec2020; she woke up with a really bad cramp on her side on 27Dec2020, it was unbearable to the point where she had to sit down, she woke up really bad; woke up with a stuffed up nose on 28Dec2020; sore throat on 28Dec2020 (really started this morning). She was more exhausted and tired. Her headaches had been pretty bad. The patient underwent lab tests and procedures which included COVID test with unknown results on 28Dec2020. She was taking medicine for the headaches on 28Dec2020. The outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Within the hour I had quite a bit of pain at the injection site.; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient stated that, "I received my first dose of your COVID-19 vaccine on 23Dec2020. Within the hour I had quite a bit of pain at the injection site. Not even thinking, I applied heat. Now I am worried I may have messed up the vaccine. The heat was not applied for very long but could I have messed up this very important privilege." Therapeutic measures were taken as a result of event. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Body aches; Feeling unwell; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is the 1st of 2 reports. A 63-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, feeling unwell and fever all on an unspecified date with outcome of unknown.    The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518044 Same reporter/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: Headache; Nausea; I had Vertigo real bad; Its almost irritating; my life is terrible with Vertigo; This is a spontaneous report from a contactable consumer (patient herself).  This patient (demographics unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Dec2020 (last Tuesday, as reported) at single dose for COVID-19 immunisation.  No relevant medical history and concomitant medications were provided. The day after vaccination, the patient had headache and that was on Wednesday all day and then on Thursday she had vertigo really bad and nausea.  She stated that had vertigo and nausea since then even today and it's not going away. Prior to that she never had any problem like vertigo and now it's almost irritating. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid after the first dose of the vaccine; Tested positive for covid after the first dose of the vaccine; This is a spontaneous report from a contactable Pharmacist.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on 18Dec2020 at single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Tested positive for covid after the 1st dose of the vaccine on an unspecified date. The outcome of unknown. Reporter wanted to know if the patient should receive the 2nd dose.   Information on the lot/batch number has been requested.; Sender's Comments: 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: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: was sick; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involves a patient (unknown demography) who was sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) non-serious (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported as was forced for 25 years at work and became sick every year. Patient did not take any vaccine for 4 years and had no sickness.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient was administered expired Pentacel , no AE; Initial information regarding an unsolicited valid non-serious case was received from an other healthcare professional.  The case is linked to 2020SA348576 (same reporter).  This case involves a 14-months-old male patient who was administered with 0.5 mL dose of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ021AAA and expiry date: 21-Oct-2020 (also reported as 30-Nov-2020)) once via an unknown route in the left thigh for prophylactic vaccination in error (expired product administered) on 27-Nov-2020.  Medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), INFLUENZA VACCINE (FLU), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  The reporter would like to know if the patient must be revaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received expired dose of ACTHIB/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional.  This case involves a 16-months-old female patient who received expired 0.5 mL fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, lot number: UJ063AA and expiry date: 31-Oct-2020 via an intramuscular route in the right thigh) (expired product administered) on 02-Dec-2020 for prophylactic vaccination.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  Reporter stated that the product was not used for first time in the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: patient was given expired vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician.  This case involves a 21-years-old male patient who received fourth dose of the suspect RABIES (HDC) VACCINE [IMOVAX RABIES] vial  (frequency: once, strength: standard, lot number: P1E52 and expiry date: 30-Oct-2020 via an intramuscular route in the right shoulder) (expired product administered) on 07-Dec-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  No other vaccines were received.  It was an actual medication error case due to expired product administered (latency: same day).  Reporter asks about asks what is appropriate follow-up after expired vaccine given. Reporter stated that product was not used for the first time and safety test was not successful.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired Ipol was administered to the patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse.  This case is linked to case 2020SA357294 (same reporter).  This case involves a female patient of unknown age who received a 0.5ml standard dose of an expired IPV (VERO) [IPOL] (lot number: P1F491M and expiry date: 30-Nov-2020) once via intramuscular route in the right deltoid for prophylactic vaccination on 03-Dec-2020 (Expired product administered).  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination .  This was an actual medication error case due to expired vaccine used (latency: unknown).  At the time of reporting, no adverse event was reported.  Reporter asked for any recommendations regarding dosing and administration of expired product.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired doses of IPOL was administered to the patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional.  This case was linked with case 2020SA360209 (same reporter)  This case involves a 10 years old male patient who received a 0.5 ml dose of expired IPV (VERO) [IPOL] (lot number: P1F54, expiry date: 07-Dec-2020, dose 1) via intramuscular route in the right arm on 14-Dec-2020 for prophylactic vaccination (expired product administered).  Medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination   It was an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  Reported asked whether the vaccine should be repeated or was viable until the end of the month if label reads Dec7 2020.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Expired product administered
Clinical narrative: that the Ipol vaccine had expired with no AE; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old female patient who received an 0.5 ml expired dose of IPV (VERO) [IPOL] (lot number: P1F49, expiry date: 30-Nov-2020) via intramuscular route in unknown administration site on 09-Dec-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) And Hepatitis B Vaccine (Hepatitis B Vaccin)  It was an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.