chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 26Mar2021 14:30 (at 42-years-old) as single dose for COVID-19 immunization. Medical history included Ankylosing Spondylitis and Iritis. Patient had no known allergies. Patient had no covid prior vaccination. Patient was not tested with covid post vaccination. Vaccination facility type was School/Student Health Clinic. Concomitant medications included certolizumab pegol (CIMZIA); brimonidine tartrate.  The patient experienced bell's palsy on 06Apr2021 08:00 with outcome of not recovered. Event resulted in Emergency room/department or urgent care. Treatment given was Methylpred Na Succinate, Prednisone, and Acycolvir.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on my arm. It started at the top of the arm and went down all the way down/towards my elbow; Rash on arm it is itchy and red; Rash on arm it is itchy and red; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. Patient had second vaccine last Thursday 01Apr2021. On Monday the 05Apr2021 the patient started getting a rash on her arm, it was itchy and red and goes from the top of her arm down almost to her elbow, it did not stop itching. The patient put hydrocortisone and Benadryl on it and she went to the doctor and they didn't say much about it, just to keep doing what she is doing. Further reported It's itchy and red; and she trying not to itch it but it's hard because it's itchy. Every time she itch it get bigger and bigger. The outcome of the events was unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: shoulder was sore; on his right leg below his groin area on his thigh he states there is a place about 8 inches in diameter that aches if he puts pressure on it; his right thigh, not near the joint, but 4 inches down the right thigh area, he describes a big circle that is sore.; This is a spontaneous report via Pfizer- sponsored program Covax US support. A contactable consumer (patient) reported that a 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 21Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first single dose of bnt162b2 on 28Feb2021 single for Covid-19 immunization. Patient took second dose on 21Mar2021. his shoulder was sore for about a day after the second dose, however, on his right leg below his groin area on his thigh he states there was a place about 8 inches in diameter that aches if he puts pressure on it. He states that this was still bothering him and he wants to know if this is a common reaction. on 02Apr2021, when the vaccine had been in full effect for 10 to 14 days, he states his shoulder hurt, and then went away. his right thigh, not near the joint, but 4 inches down the right thigh area, he describes a big circle that is sore. when he walks he feels it on his thigh and he got it a few days after the second vaccine. starting 02Apr2021 top of right thigh was sore when he puts weight on it. The patient had recovered from the event shoulder pain in Apr2021 and rest of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease, Liver function test, Poor quality product administered, Product temperature excursion issue, Renal function test
Clinical narrative: chronic kidney disease; the vial from the first dose was improperly stored; the vial from the first dose was improperly stored; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration on 12Mar2021 (at the age of 66years) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient wanted to know, what percentage does the Pfizer COVID vaccine first shot cover and how accurate it is. On 12Mar2021, the patient got his first Pfizer COVID vaccine. He was going through kidney and liver testing right now. He was diagnosed with chronic kidney disease 17Mar2021. He was in the process of getting his liver examined. He was wondering what percentage of protection he got from the first shot. On 03Apr2021, he was informed by his vaccination site that he needed to receive another dose because the vial from the first dose was improperly stored. He was told that he would have to take it over again. It was not a manufacturer error it was the pharmacy error. The pharmacy didn't refrigerate the vaccine properly. He got his second "first" shot on 06Apr2021. The vaccine that day had lot number EN6202. Then he was scheduled to get another shot. He is scheduled for his second (third) dose 27Apr2021. On 27Apr2021, he will be getting his 3rd shot (as reported). He stated has no idea what that first shot did to him or it had any effect good or bad. The outcome of events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6198, expiry date unknown), via an unspecified route of administration, administered in the right arm on 27Feb2021 as a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. There were no concomitant medications. The patient did not receive any other vaccine in four weeks and did not have other medications in four weeks. The patient received the first dose of BNT162B2 (lot number: EN6198) on 06Feb2021 at 02:45 PM on the right arm for COVID-19 immunization. It was reported that within 5-7 days after the last vaccination, on 08Mar2021 at 13:00, the patient developed vertigo. The patient ended up in the hospital twice before anyone was able to diagnose what was wrong with him. The patient was hospitalized on an unspecified date for 5 days. The patient did not receive treatment for the event. The patient was still having issues to this day. The outcome of the event was not recovered. The patient had a nasal swab COVID test on 22Mar2021 with a negative result.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he tested positive for covid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included exposure to sars-cov-2 in Apr2021. The patient's concomitant medications were not reported. Patient received the first dose of the covid vaccine on Monday 05Apr2021, however he tested positive for covid on Wednesday, 07Apr2021, after an exposure 1-2 days before receiving the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Apr2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got COVID; The is a spontaneous report received from contactable consumer.  A 19-year-old female patient received first 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 20Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Mar2021, patient was diagnosed with Covid19 and reported he was fine. Outcome of event was reported as recovered on an unspecified date 2021.  No Follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: feeling nauseated; warm; This is an initial spontaneous report from a contactable consumer(patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) first dose via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. The patient medical history stated she had COVID-19 back in October. The patient concomitant medications were not reported. Patient wanted to know if the reaction happens right away when they ask us to wait for 15 mins. Patient wanted to know if vaccine have the virus in it. Patient wanted to know what if she does not take the second dose. On Apr 2021 patient stated that she received the Pfizer COVID vaccine on 07Apr and feeling nauseated, warm, patient has celiac sprue and wanted to know about the ingredient/ gluten in it. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, SARS-CoV-2 antibody test
Clinical narrative: Nausea; chills; headache; This is a spontaneous report received from a contactable pharmacist (patient) and contactable consumer (patient's husband) via medical information team. A female patient of an unspecified age, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an 14Feb2021, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 07Apr2021, patient underwent antibody test and it came back as negative. The husband reported that his wife had nausea chills and headache after getting the vaccine on an unknown date in 2021. Outcome of the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cerebrovascular accident, Headache
Clinical narrative: had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On 25Mar2021, she received the first COVID-19 vaccine and instantly had a pounding headache.  She went to her doctor who said her blood pressure was elevated and was going to do more testing. She and her sister went away thinking she just needed to relax but then had a stroke in the hotel that same day and was in the hospital for 3 days (until 28Mar2021). She has never had high blood pressure and no history of headaches.  The doctor in the hospital thought that this could be related to the vaccine since she had no high blood pressure or headaches before.  She asked the doctors if she should get the second one and they all said they don't know enough about the vaccine to give her guidance. Outcome of the events were unknown.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Fatigue, Headache, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). The consumer reported 2 reports, this is the second of two reports. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first dose of BNT162B2 on 28Jan2021 for COVID-19 immunization and she experienced these side effects to be untoward in that none of clinical /anecdotal reports. Patient reviewed before or after injection suggested that recipients could experience this range of effects after first dose included: Low grade headache(24hours), Arm site pain(48hour), Feeling of Un-wellness (48 hour), Muscle ache/joint pain(48 hours), Fatigue/Tiredness (strong for first 72 hours; moderate for up to 3 weeks), Anxiety/palpitation(3 weeks). All the same side effects occurred after the second dose but largely subsided after 48hours: with the addition of temporary rash near the injection site week after the second dose. The patient experienced low grade headache, arm site pain/limited range of motion, joint pain, feeling of unwellness, muscle aches, fatigue/tiredness, anxiety, palpitation, temporary rash near the injection site all on an unspecified date. The outcome of events was recovering.   No follow-up attempts possible. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194876 Same reporter, same patient, same product, different dose and similar events.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Vaccination site pain, Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). The consumer reported 2 reports, this is the second of two reports. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first dose of BNT162B2 on 28Jan2021 for COVID-19 immunization and she experienced these side effects to be untoward in that none of clinical /anecdotal reports. Patient reviewed before or after injection suggested that recipients could experience this range of effects after first dose included: Low grade headache(24hours), Arm site pain(48hour), Feeling of Un-wellness (48 hour), Muscle ache/joint pain(48 hours), Fatigue/Tiredness (strong for first 72 hours; moderate for up to 3 weeks), Anxiety/palpitation(3 weeks). All the same side effects occurred after the second dose but largely subsided after 48hours: with the addition of temporary rash near the injection site week after the second dose. The patient experienced low grade headache, arm site pain/limited range of motion, joint pain, feeling of unwellness, muscle aches, fatigue/tiredness, anxiety, palpitation, temporary rash near the injection site all on an unspecified date. The outcome of events was recovering.   No follow-up attempts possible. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194876 Same reporter, same patient, same product, different dose and similar events.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Pain, Pain in extremity
Clinical narrative: The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday; Right arm sore; Body was sore for a week; Tired for a week; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female consumer (reported herself). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular in right arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunization. The patient's familial medical history included that the patient's son passed away 10Jun2020, he had type 2 diabetes.  He went to hospital with Pneumonia and keep him for 3 weeks and released him and passed away the next day. The patient's medical history included soreness. The patient's concomitant medication included ibuprofen. On 18Mar2021, the patient experienced that in the morning when she woke up around 08:00the patient's body was sore for a week and she felt tired in the afternoon around 16:00-17:00. The patient's right arm was sore at 14:00, but not much. The patient went to work and used her arm and by the end of a day it was less sore and by the next day, it was almost normal. The patient's body was so sore, like doing exercise for a couple of days. On 18Apr2021, the patient was scheduled to receive her 2nd vaccine and patient tested COVID-19 vaccine and resulted positive so that the patient was sent to home. The patient would like to know when can get the second dose. Prior to the vaccination the patient received pills for high blood pressure. The patient did not received any vaccination 4 weeks prior to the COVID vaccine. The outcome of the events body was sore for a week, right arm sore and tired for a week was recovering and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday; Right arm sore; Body was sore for a week; Tired for a week; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female consumer (reported herself). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular in right arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunization. The patient's familial medical history included that the patient's son passed away 10Jun2020, he had type 2 diabetes.  He went to hospital with Pneumonia and keep him for 3 weeks and released him and passed away the next day. The patient's medical history included soreness. The patient's concomitant medication included ibuprofen. On 18Mar2021, the patient experienced that in the morning when she woke up around 08:00the patient's body was sore for a week and she felt tired in the afternoon around 16:00-17:00. The patient's right arm was sore at 14:00, but not much. The patient went to work and used her arm and by the end of a day it was less sore and by the next day, it was almost normal. The patient's body was so sore, like doing exercise for a couple of days. On 18Apr2021, the patient was scheduled to receive her 2nd vaccine and patient tested COVID-19 vaccine and resulted positive so that the patient was sent to home. The patient would like to know when can get the second dose. Prior to the vaccination the patient received pills for high blood pressure. The patient did not received any vaccination 4 weeks prior to the COVID vaccine. The outcome of the events body was sore for a week, right arm sore and tired for a week was recovering and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday; Right arm sore; Body was sore for a week; Tired for a week; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female consumer (reported herself). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular in right arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunization. The patient's familial medical history included that the patient's son passed away 10Jun2020, he had type 2 diabetes.  He went to hospital with Pneumonia and keep him for 3 weeks and released him and passed away the next day. The patient's medical history included soreness. The patient's concomitant medication included ibuprofen. On 18Mar2021, the patient experienced that in the morning when she woke up around 08:00the patient's body was sore for a week and she felt tired in the afternoon around 16:00-17:00. The patient's right arm was sore at 14:00, but not much. The patient went to work and used her arm and by the end of a day it was less sore and by the next day, it was almost normal. The patient's body was so sore, like doing exercise for a couple of days. On 18Apr2021, the patient was scheduled to receive her 2nd vaccine and patient tested COVID-19 vaccine and resulted positive so that the patient was sent to home. The patient would like to know when can get the second dose. Prior to the vaccination the patient received pills for high blood pressure. The patient did not received any vaccination 4 weeks prior to the COVID vaccine. The outcome of the events body was sore for a week, right arm sore and tired for a week was recovering and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza, Influenza like illness, Nasopharyngitis, Pain in extremity
Clinical narrative: she thought she just caught the flu; cough; flu like symptoms; cold; sore arm; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 12Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient said that after she received the first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 12Mar2021, she had a sore arm. The day of the present report (09Apr2021), she woke up with flu-like symptoms. She said she had the sniffles, cold, and sore throat. She said she had no temperature, her vital signs were normal, and everything was normal. She also said that this was not a reaction to the first dose, but she thought she just caught the flu. Patient wanted to know if she should still receive the second dose as scheduled. She said she was due to receive the second dose on 14Apr2021. It was also reported that she got a cold, sore throat and cough before her second dose of vaccine. Her second dose scheduled on 14Apr2021. She got her first dose last 12Mar2021 and it was more than 21 days timeframe. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, COVID-19, COVID-19 pneumonia, Computerised tomogram
Clinical narrative: did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad with symptoms; did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad with symptoms; did a blood test and they gave me an antibiotic for 7 days; did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in the left arm on 22Feb2021 10:30 (Lot Number: EL9266) as a single dose; and dose 1 via an unspecified route of administration in the left arm on 01Feb2021 13:30 (Lot Number: EL9266) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with Covid-19 prior to vaccination. There were no concomitant medications. The patient received the vaccine in a hospital. The patient did not have other vaccine in four weeks. The patient mentioned that the second shot on 22Feb2021. On 15Mar2021, he was coughing and feeling tired. He mentioned that he went to urgent care and did COVID test, but the result was negative. On 25Mar2021, he stated that he was worse and went to another urgent care. He did a blood test on an unspecified date in 2021 and they gave him an antibiotic for 7 days. On 03Apr2021, he was really bad and went to an ER emergency. They did a CT on an unspecified date in 2021 and the doctor said he had pneumonia by COVID, because his lungs were bad. The patient inquired if that was possible and they wanted to check if the vaccine wasn't efficient for him. The outcome of the events was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Vaccination failure
Clinical narrative: did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad with symptoms; did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad with symptoms; did a blood test and they gave me an antibiotic for 7 days; did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in the left arm on 22Feb2021 10:30 (Lot Number: EL9266) as a single dose; and dose 1 via an unspecified route of administration in the left arm on 01Feb2021 13:30 (Lot Number: EL9266) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with Covid-19 prior to vaccination. There were no concomitant medications. The patient received the vaccine in a hospital. The patient did not have other vaccine in four weeks. The patient mentioned that the second shot on 22Feb2021. On 15Mar2021, he was coughing and feeling tired. He mentioned that he went to urgent care and did COVID test, but the result was negative. On 25Mar2021, he stated that he was worse and went to another urgent care. He did a blood test on an unspecified date in 2021 and they gave him an antibiotic for 7 days. On 03Apr2021, he was really bad and went to an ER emergency. They did a CT on an unspecified date in 2021 and the doctor said he had pneumonia by COVID, because his lungs were bad. The patient inquired if that was possible and they wanted to check if the vaccine wasn't efficient for him. The outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea exertional, Electrocardiogram
Clinical narrative: chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer, Fibrin D dimer increased, Heart rate, Heart rate irregular
Clinical narrative: chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Laboratory test abnormal, Myalgia, Palpitations, Ventricular extrasystoles
Clinical narrative: chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dizziness, Headache
Clinical narrative: my lips and mouth were tingling then started tingling in my chest; my lips and mouth were tingling then started tingling in my chest; started having some tightness in my chest; dizziness / lightheadedness; blood pressure went up; Headache; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 23Mar2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient stated about minutes after vaccine shot on 23Mar2021, my lips and mouth were tingling then started tingling in my chest and started having some tightness in my chest, my blood pressure (BP) went up. The patient also had lightheadedness, headache, and dizziness along with the high BP with tightness in my chest on 23Mar2021. On Friday (26Mar2021) my BP in the ER (emergency room) was 182/102 and 168/112. The physician in the ER said this was a reaction to the second COVID shot received. The outcome of the events lips and mouth were tingling, tingling in my chest, tightness in my chest, blood pressure went up, headache, and dizziness was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: my lips and mouth were tingling then started tingling in my chest; my lips and mouth were tingling then started tingling in my chest; started having some tightness in my chest; dizziness / lightheadedness; blood pressure went up; Headache; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 23Mar2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient stated about minutes after vaccine shot on 23Mar2021, my lips and mouth were tingling then started tingling in my chest and started having some tightness in my chest, my blood pressure (BP) went up. The patient also had lightheadedness, headache, and dizziness along with the high BP with tightness in my chest on 23Mar2021. On Friday (26Mar2021) my BP in the ER (emergency room) was 182/102 and 168/112. The physician in the ER said this was a reaction to the second COVID shot received. The outcome of the events lips and mouth were tingling, tingling in my chest, tightness in my chest, blood pressure went up, headache, and dizziness was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: raging diarrhea; This is a spontaneous report from Pfizer-sponsored program Pfizer . A contactable consumer (patient) reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported) an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After receiving my first shot, the patient developed raging diarrhea. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: positive for covid; positive for covid; low grade fever; This is a spontaneous report from a non-contactable physician via a Pfizer-sponsored program. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 20Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Mar2021 the patient experienced low grade fever. On 03Apr2021 the patient experienced positive for covid, high grade fever. The patient was hospitalized for high grade fever (pyrexia) on 03Apr2021. The doctor was inquiring if patient should get the second dose tomorrow and the efficacy if the second dose was postponed.The reporter was going to cancel and reschedule in a week.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Apr2021. The outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective, COVID-19 and fever cannot be totally excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Peripheral swelling, Platelet count decreased, Vaccination site swelling
Clinical narrative: Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop in her platelet level; She was tired for 24 hours; This is a spontaneous report received from a contactable consumer (patient) and via a Pfizer-Sponsored program. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced a significant drop in her platelet level and on unspecified dates the patient experienced swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours. The patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 25Mar2021 and she then had routine blood work done on 27Mar2021 (also reported as 29Mar2021) which showed a significant drop in her platelet level. She stated that she normally had a platelet count on the lower side, but the platelets were quite a bit lower than the last bloodwork she had done. She stated that she had blood work last on 24Mar2021 which is why she knew. She stated that her platelets dropped after she got the first dose. She checked the internet for side effects of the vaccine and she did see that some people had reported that a lowered platelet count could happen. She stated that she was doing research to investigate if this was truly a side effect of the vaccine. She wanted to know if this had been reported before. She would like to know before she got the second vaccine. The patient also stated that she also had swelling at the injection site, her arm was the size of an egg and it was hard, and she was tired for 24 hours. The patient wanted to know if she would still need to wear a mask after having received both doses if she decided to go out in public or visit others and she wanted to know how effective the first dose was if she decided not to receive the second dose. The clinical outcomes of the events a significant drop in her platelet level, swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours were all unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Malaise, Pain, SARS-CoV-2 test positive
Clinical narrative: stayed home from school; Thursday she took him to get tested and he came out positive; feeling really tired and fatigue; didn't feel well; kind of body aches; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient's mother) A 18-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 02Apr2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. It was reported that the patient did not have any symptoms on that day, and he came at home. He started feeling tired. The next day, patient started feeling really tired, fatigue, and didn't feel well with kind of body aches. On Sunday, he still felt bad. Patient's mother thought this was still prolonged. Monday, he wasn't feeling better and stayed home from school. Thursday, patient's mother took him to get tested and he came out positive. It was unknown that when he contracted COVID, and he was asymptomatic when he got the vaccine. Patient's mother was wondering how the vaccine would affect him if he had COVID when he was vaccinated. It was reported that patient's second dose was scheduled on 25Apr2021. It was unknown if the symptoms that experienced by patient were because of COVID or the vaccine. Outcome of the events COVID-19 and stayed home from school was unknown while for remaining events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021398129 same reporter/drug, different patient/AE
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, SARS-CoV-2 test
Clinical narrative: Nose bleeds after each shot. After second shot nose bleeds would not stop and kept happening every 5 days or so where I had to go to ER and then I was hospitalized for 5 days.; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9264), via an unspecified route of administration, at the age of 83 years, administered on the left arm, on 29Jan2021 12:00 at a SINGLE DOSE, (Lot Number: EN6201) the second dose was received via an unspecified route of administration, administered on the left arm on 25Feb2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included heart issues and liver disease from an unknown date and unknown if ongoing. On 30Jan2021 02:30, the patient experienced nose bleeds after each shot. After second shot nose bleeds would not stop and kept happening every 5 days or so where the patient had to go to ER and then was hospitalized for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Mar2021. Therapeutic measures (Packing and observation while off blood thinners) were taken as a result of the event. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Somnolence
Clinical narrative: Very sleepy; red splotches all over and spots that raised up; This is a spontaneous report from a contactable other Health Care Professional (patient) via medical information team. A female patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an 29Mar2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient previously took Iodine and experienced anaphylactic allergic reaction to iodine, which means she cannot eat shellfish. The patient reported that immediately after receiving her first dose (29Mar2021), she became very sleepy and developed red splotches all over and spots that raised up. She stated that she still has spots on her arms now. Outcome of the event very sleepy was reported as unknow and for the event red splotches all over and spots that raised up it was reported as not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Retching
Clinical narrative: every time the patient tried to stand up, the patient will see yellow spots and felt as if the patient would pass out; retching; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left, at the age of 68-year-old, on 06Apr2021 08:15, as SINGLE DOSE for covid-19 immunisation.  Medical history included sulfonamide allergy. There were no concomitant medications. The patient did not receive any other vaccine in the last four weeks nor other medications in the last two weeks. The patient was not diagnosed with COVID before vaccination and was not tested after vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) single dose on 17Mar2021 08:30 at left arm at the age of 68-year-old, for covid-19 immunisation. On 06Apr2021 at 23:30, the patient began retching. After that for about an hour, every time the patient tried to stand up, the patient will see yellow spots and felt as if the patient would pass out. The patient was not dehydrated and had to lie down for a while and then it passed. The patient was still not on top of the world (3 days later) but much better. The patient did not receive any treatment in response to the events. Outcome of the events was recovered in Apr2021.