chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Septicemia; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program (Patient's wife reported).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single; patient also received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient's wife reported that her husband was in the hospital with septicemia on an unspecified date before the booster. Patient was over it now. Two weeks after he recovered on antibiotics and fluids. He was fine, the reporter stated. Seriousness was reported as hospitalization and medically significant. Outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101400475 Same patient and drug, different event separated in time
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood pressure measurement, Cough, Fall, Hypertension
Clinical narrative: Blood pressure, it was 182/115, in her doctor's office, after second vaccine.; Pain from her injection site shooting down her arm in a single line for a day/ Severe pain in both of her forearms and then it went away; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; Wheezing and coughing and then it stopped, after second vaccine.; Wheezing and coughing and then it stopped, after second vaccine.; She had intense pain in the left side of her abdomen, and by the next day it was gone.; pain from her injection site; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) (at the age of 64 year-old), via an unspecified route of administration on 26Sep2021 as Dose 2, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on  on an unspecified date for covid-19 immunization. The patient reported, after taking second shot, she had been having side effects. The patient had pain from her injection site shooting down her arm in a single line for a day. She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided. She had wheezing and coughing and then it stopped. The patient had intense pain in the left side of her abdomen, and by the next morning it was gone. She had severe pain in both of her forearms and had to take two Tylenol, and the pain went away. The patient went to her doctor and when they took her blood pressure, it was 182/115. She has never had any previous problems and this is not normal. The patient underwent lab tests and procedures which included blood pressure measurement: 182/115 on an unspecified date. The outcome of events was resolved on an unspecified date while the outcome of the events  blood pressure, it was 182/115, in her doctor's office; kidney pain, and dropped to her knees, causing her to throw up water and then it subsided was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Renal pain, Vaccination site pain, Vomiting, Wheezing
Clinical narrative: Blood pressure, it was 182/115, in her doctor's office, after second vaccine.; Pain from her injection site shooting down her arm in a single line for a day/ Severe pain in both of her forearms and then it went away; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; Wheezing and coughing and then it stopped, after second vaccine.; Wheezing and coughing and then it stopped, after second vaccine.; She had intense pain in the left side of her abdomen, and by the next day it was gone.; pain from her injection site; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) (at the age of 64 year-old), via an unspecified route of administration on 26Sep2021 as Dose 2, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on  on an unspecified date for covid-19 immunization. The patient reported, after taking second shot, she had been having side effects. The patient had pain from her injection site shooting down her arm in a single line for a day. She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided. She had wheezing and coughing and then it stopped. The patient had intense pain in the left side of her abdomen, and by the next morning it was gone. She had severe pain in both of her forearms and had to take two Tylenol, and the pain went away. The patient went to her doctor and when they took her blood pressure, it was 182/115. She has never had any previous problems and this is not normal. The patient underwent lab tests and procedures which included blood pressure measurement: 182/115 on an unspecified date. The outcome of events was resolved on an unspecified date while the outcome of the events  blood pressure, it was 182/115, in her doctor's office; kidney pain, and dropped to her knees, causing her to throw up water and then it subsided was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Adverse reaction, Blood pressure increased, Muscle twitching, Pain in extremity
Clinical narrative: Blood pressure, it was 182/115, in her doctor's office, after second vaccine.; Pain from her injection site shooting down her arm in a single line for a day/ Severe pain in both of her forearms and then it went away; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; Wheezing and coughing and then it stopped, after second vaccine.; Wheezing and coughing and then it stopped, after second vaccine.; She had intense pain in the left side of her abdomen, and by the next day it was gone.; pain from her injection site; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) (at the age of 64 year-old), via an unspecified route of administration on 26Sep2021 as Dose 2, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on  on an unspecified date for covid-19 immunization. The patient reported, after taking second shot, she had been having side effects. The patient had pain from her injection site shooting down her arm in a single line for a day. She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided. She had wheezing and coughing and then it stopped. The patient had intense pain in the left side of her abdomen, and by the next morning it was gone. She had severe pain in both of her forearms and had to take two Tylenol, and the pain went away. The patient went to her doctor and when they took her blood pressure, it was 182/115. She has never had any previous problems and this is not normal. The patient underwent lab tests and procedures which included blood pressure measurement: 182/115 on an unspecified date. The outcome of events was resolved on an unspecified date while the outcome of the events  blood pressure, it was 182/115, in her doctor's office; kidney pain, and dropped to her knees, causing her to throw up water and then it subsided was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal pain, Vomiting, Wheezing
Clinical narrative: Blood pressure, it was 182/115, in her doctor's office, after second vaccine.; Pain from her injection site shooting down her arm in a single line for a day/ Severe pain in both of her forearms and then it went away; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; Wheezing and coughing and then it stopped, after second vaccine.; Wheezing and coughing and then it stopped, after second vaccine.; She had intense pain in the left side of her abdomen, and by the next day it was gone.; pain from her injection site; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) (at the age of 64 year-old), via an unspecified route of administration on 26Sep2021 as Dose 2, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on  on an unspecified date for covid-19 immunization. The patient reported, after taking second shot, she had been having side effects. The patient had pain from her injection site shooting down her arm in a single line for a day. She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided. She had wheezing and coughing and then it stopped. The patient had intense pain in the left side of her abdomen, and by the next morning it was gone. She had severe pain in both of her forearms and had to take two Tylenol, and the pain went away. The patient went to her doctor and when they took her blood pressure, it was 182/115. She has never had any previous problems and this is not normal. The patient underwent lab tests and procedures which included blood pressure measurement: 182/115 on an unspecified date. The outcome of events was resolved on an unspecified date while the outcome of the events  blood pressure, it was 182/115, in her doctor's office; kidney pain, and dropped to her knees, causing her to throw up water and then it subsided was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient tested positive for COVID following completion of the 2 dose series.; Patient tested positive for COVID following completion of the 2 dose series.; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration on 19Feb2021 as dose 1, single for COVID-19 immunization administered at Workplace clinic. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID following completion of the 2 dose series. The patient had vaccination failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date. The outcome of the events was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient experienced headaches, cough and fever and tested positive for COVID on 18Oct2021; patient experienced headaches, cough and fever and tested positive for COVID; This is a spontaneous report from a contactable Other Health Professional. A 34-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, Expiry Date was not provided), via an intramuscular route of administration, on 28Jan2021 (age at vaccination was 34 Years) as DOSE 1, SIN-GLE, second dose via an intramuscular route of administration on 18Feb2021 (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history and Concomitant medication(s) were not reported. It was unknown if patient received any other vaccines in four weeks prior to the COVID vaccine and diagnosed with COVID-19 prior vaccination. Patient has been tested positive for COVID-19 since the vaccination on 18Oct2021. On 17Oct2021, patient experienced headaches, cough and fever and on 18Oct2021, patient experienced tested positive for event COVID on 10/18/2021. The patient underwent lab test and procedure included COVID test (nasal swab) with positive result on 18Oct2021. Patient did not receive treatment for events. The outcome of events was not recovered for Headaches, fever and Cough while for tested positive for event COVID on 10/18/2021 under PT 'Vaccination failure' was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Covid-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Rash, Throat tightness
Clinical narrative: dizzy; felt like her throat was closing; rash on her neck; slight headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (COMIRNATY), (at the age of 61years old) via an unspecified route of administration, administered in Arm Left on 15Oct2021 (probably around 10:00 O'clock in the morning, 10:30) (Batch/Lot Number: FE3590) as dose 3 (booster), single for covid-19 immunisation. Medical history included allergic to shrimp. The patient stated, "sometimes I am sensitive to take properly you know I wanna knew antibiotics and some I might be sensitive but that I not know". There were no concomitant medications. The patient has no prior vaccination within 4 weeks. The patient had BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 09Jan2021 (at the age of 60 years old) (Batch/Lot Number: EK5730) and dose 2 on 30Jan2021 (at the age of 60 years old) (Batch/Lot Number: EN5318) for COVID-19 immunization, both were administered at a pharmacy. The patient called and stated that she had the booster vaccine on Friday at work and on Saturday (16Oct2021) had a slight headache, on Sunday (17Oct2021) woke up with a rash on her neck and on Monday (18Oct2021) felt like her throat was closing and went to the doctor on Monday. The patient stated that It felt like her throat was closing and she had a headache and dizzy and they gave her a shot of cortisone in her arm and she was put on a steroid pack. The patient wanted to know how long it takes to get better. She does feel better since having cortisone and being on the steroid, but she gets lightheaded and dizzy and wanted to know how long that would last. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Atrial flutter, Blood test, Pain in extremity
Clinical narrative: Atrial flutter; arm pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262), intramuscular, administered in arm right on 17Jan2021 16:00 as dose 1, single for covid-19 immunisation. The patient medical history included hypothyroidism from 05Jan1976 and ongoing, occasional atrial flutter from 02Jul2020 and ongoing 0x or 1x or 2x/ month and none on Apr2021, endometriosis from 1963 to 1990, caesarean section from 06Jan1976 to 06Jan1976, hip fracture from 02Jul2018 to 03Jul2018, and had surgery - 3 titanium screws inserted. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1976 and ongoing; metoprolol taken for atrial flutter from Jul2020 and ongoing; apixaban (ELIQUIS) taken for atrial flutter from Jul2020 and ongoing. The patient previously took DANAZOL for endometriosis from 1975 to 1990. On 28Jan2021, the patient experienced atrial flutter and arm pain. The patient underwent lab tests and procedures which included too many blood test: unknown results on an unspecified date. No covid-19 testing. The events were considered as important medical event by the reporter. No treatment was received for the events. The outcome of the events was recovered on 28Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm, felt heavy, and when she lifted it, "super sore; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Left Arm on 24Feb2021 13:45 (Batch/Lot Number: EL9262, expiry date: unknown) (at 41-years age) as dose 1, single for COVID-19 immunisation at the hospital. Medical history included thyroid cancer, and covid-19. Concomitant medication(s) that within 2 weeks prior to the vaccination includes included levothyroxine sodium (SYNTHROID); topiramate (TOPAMAX); rizatriptan (RIZATRIPTAN) taken for migraine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 24Feb2021 09:00PM the patient experienced sore left arm, felt heavy, and when she lifted it, super sore. Sore left arm started around 9pm (after 1:40pm vaccination that day) felt heavy, and when she lifted it, super sore. She said milder as of following morning. The patient had not received treatment for all the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm/soreness and swelling for a day; Sore arm/soreness and swelling for a day; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team.   A female patient of unspecified age (Age: 66; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm/soreness and swelling for a day on an unspecified date. The  Caller says had that before with a shot. Soreness and swelling for a day.  The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills
Clinical narrative: Experienced chills and a temperature; Experienced chills and a temperature; This is a spontaneous report from a contactable consumer.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that on an unspecified date, she took the second dose of the Pfizer BioNTech COVID-19 vaccine yesterday and last night experienced chills and a temperature. She inquired and would like to know if there are any other people who took the second dose of the Pfizer BioNTech COVID-19 vaccine and reported a fever afterwards. Therapeutic measures were taken as a result of events and patient already took two Tylenol. The outcome of events was unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Magnetic resonance imaging
Clinical narrative: Headache; Tiredness; sharp excruciating pain in her lower back when she stood up and walked; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN(6)200), via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose and first dose via an unspecified route of administration, administered in left arm on 31Jan2021 (Lot Number: EN5318) (at the age of 78-year-old) as single dose for COVID-19 immunization. The patient's medical history included pleurisy and bacterial pneumonia, had abdominal surgery and liver hemangioma (maybe 8-10 years ago). The patient's concomitant medication included vitamins NOS. No prior vaccinations within 4 weeks. The patient previously took morphine and experienced severe facial itch, codeine and experienced rapid heart beat and legs very weak. On an unspecified date in Feb2021, the patient experienced sharp excruciating pain in her lower back when she stood up and walked. The patient stated that the patient had the exact same pain when she was treated for bacterial pneumonia a year ago. She suspects it has something to do with the nerve. She wanted to know if this adverse event was reported as an adverse event associated with the vaccine. On 22Feb2021, The patient experienced headache and tiredness. No visits of emergency room and physician office. On 03Feb2021, the patient underwent lab tests and procedures which included MRI: unknown results. On 22Feb2021, the patient recovered from all the events.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingle and numb in left arm where I got shot.; Tingle and numb in left arm where I got shot.; This is a spontaneous case received from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 14:30 (age at vaccination 37-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks were reported as none. On 25Feb2021, the patient experienced tingle and numb in left arm. The patient did not receive any treatment for the event. The patient did not had any vaccination prior to COVID vaccination and had not tested positive  after vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: temp chills; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar event for 2 patients. This is 1st of 2 reports. This consumer reported for himself.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced temp chills on an unspecified. Patient stated that, yesterday (name) and got shot number 2 of the Pfizer COVID-19 injection. We have had a temp chills etc. Not getting COVID-19 is worth it. The outcome of the event unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225707 same drug/reporter/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hurt to raise his arm the day after getting vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the day after getting vaccine, patient hurt to raise his arm. 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: Influenza
Clinical narrative: flu; This is a spontaneous report from a  Support, from a contactable consumer (Patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Feb2021, the patient experienced flu. Caller asked if it is still okay to get the vaccine tomorrow as scheduled appointment for a second dose. The outcome of the event was unknown.   Information of batch/lot number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Sore arm; slightly lightheaded; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 66-year-old non-pregnant female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: En6199), via an unspecified route of administration on 03Mar2021 at 13:00 (at the age of 66-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation administered in facility. Medical history included known allergies from an unknown date and unknown if ongoing. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) inhaler taken for an unspecified indication, start and stop date were not reported, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) taken for an unspecified indication, start and stop date were not reported. It was reported that patient was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 17:30 patient experienced sore arm, slightly lightheaded. No treatment was received for events. The outcome events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: node on the back side of her shoulder; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, 4 hours ago, the patient experienced node on the back side of her shoulder. caller wants to know if it is normal. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: I got place in my arm like a 'kicked' placed; lumps under my arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EN6208, Expiry date was not reported) via an unspecified route of administration, administered on 12Mar2021 (at the age of 66-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the reporter reported that, I got my shot Pfizer shot next day I got place in my arm like a 'kicked' placed, lumps under my arm. Patient received no treatment for the event. The outcome for the event was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Neuritis, Pyrexia
Clinical narrative: Headache; fever; Chills; inflamed nerve 2-3 days; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6203) via an unspecified route of administration in the left arm on 13Mar2021(at the age of 68-years-old) at 12:00 as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had a history of allergy to sulfa, lanolin, latex, thimerosal and nickel. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), Fluvastatin (MANUFACTURER UNKNOWN) and vitamins B, C and D (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN); all for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 14Mar2021 at 02:00, the patient experienced headache for 1 day, fever/chills for 2 days, fatigue for 3 days and had inflamed nerve for 2 to 3 days. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache was resolved on 15Mar2021, fever and chills was resolved on 16Mar2021, however the outcome of the event fatigue was resolved on 17Mar2021, and inflamed nerve was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated Relevant Med History verbatim (from 'Sulfonamide allergy' to 'known_allergies: sulfa', 'Nickel sensitivity' to 'known_allergies: Nickel') and added 'known_allergies: Latex'. Updated concomitant medications VITAMIN C and VITAMIN D.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Swollen injection site; chills; Slight fever; Muscle ache all over the body; This is a spontaneous report received from a non-contactable pharmacist, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248) via the unspecified route of administration on 23Mar2021 at 10:45 hours (at the age of 33-years-old) as a single dose, for COVID-19 immunisation. Medical history included seasonal allergy from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. On 23Mar2021 at 23:00, about 12 hours after the vaccination the patient experienced injection site pain, swollen injection site, chills, slight fever, and muscle ache all over the body. The symptoms lasted for about a day and resolved. The event did not result in a doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care visits. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, swollen injection site, chills, slight fever, and muscle ache all over the body was recovered on 24Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated lead sentence to reflect "non-contactable pharmacist"; narrative verbatim updated as "Since the vaccination, the patient had not been tested for COVID-19".
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Thirst, Vaccination site pain
Clinical narrative: dulled taste buds; dizziness; thirst; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 9:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Patient was allergic to sulfa. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 14:00, the patient experienced dulled taste buds, dizziness, thirst, and pain at injection site. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dulled taste buds, dizziness, thirst and pain at injection site was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated Relevant medical history verbatim to known_allergies sulfa. Vaccine Facility Information updated.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Fever; chills; sweating; Light-headed; Unwell for 24 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er8737) via an unspecified route of administration in the left arm on 31Mar2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 02:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced fever, chills, sweating, light-headed, and unwell for 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event fever, chills, sweating, and light-headedness was recovering. The clinical outcome of the event unwell for 24 hours was recovered on 02Apr2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated Patient Country, updated administration time of first dose of BNT162b2 from 12Mar2021 at 14:45 to 12Mar2021 at 02:45 in narrative.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th October 2021, 3 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a vaccine representative calling on behalf of the customer. The reporter reported that the patient received dose of Bexsero vaccine Friday (15th October 2021) in left arm and today (day of reporting) came back to HCP office and was diagnosed with cellulitis at injection site. The vaccine was given by an experienced MA, spoke per content. The reporter consented to follow up. This is one of the 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215513:Same reporter. Pt 1 of 2
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 month-old was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th September 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 10th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse reported that that a 9 month-old male was administered the Kinrix vaccine inadvertently, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Chest pain
Clinical narrative: Mild chest pain; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 308444, expiry date 25th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, less than a week after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced chest pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chest pain was not recovered/not resolved.   It was unknown if the reporter considered the chest pain to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows; This case was reported by the patient for herself. The age at vaccination was not reported. The provided lot number and expiry date, but SF shows no result for the lot number given.  The patient received FLUARIX QUAD and experienced mild chest pain, for which, she went to emergency room. She had been discharged from the emergency room and had been prescribed steroid medication. The reporter was in rush, therefore, was unable to gather the date of birth, email address, and if the vaccine administered in left/right arm. The patient did not consented to follow-up.  Therefore, Health care professional contact information was not collected.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose was still not given,; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable. Pharmacist reported that till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.  The reporter did not consented to follow-up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT SICK; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211048011.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: DIARRHEA; FEVER; This spontaneous report received from a consumer concerned a 6 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced diarrhea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944337, 20210627859 and 20210651237.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: USE OF EXPIRED PRODUCT (VACCINE OPENED ON 19-OCT-2021 AND ADMINISTERED TO PATIENT ON 21-OCT-2021); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 21-OCT-2021, the patient experienced use of expired product (vaccine opened on 19-oct-2021 and administered to patient on 21-oct-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of use of expired product (vaccine opened on 19-oct-2021 and administered to patient on 21-oct-2021) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for covid-19; A spontaneous report  was received from a Reporter concerning about a female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  The patient's medical history was not provided. No relevant concomitant medications were reported.  Consumer received the first dose of the Moderna Covid-19 vaccine and tested positive for covid. She is a student and wants to know how this will affect anything. No treatment details were provided  Action taken with mRNA-1273 in response to the events was not reported.