chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: called back to schedule her second appointment but is was past 42 days so they said she could not schedule; tested positive for Covid/Got COVID; tested positive for Covid/Got COVID; Tiredness; achiness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 68 years) (Batch/Lot Number: EN6200) as a single dose to prevent getting COVID (COVID-19 immunization). Ongoing medical history included high blood pressure (started about 10 years ago) and varicose vein (At least probably about 20 years). Family history includes both of her parents had heart problems, Mother had a stroke (she doesn't know when, she took medications for heart problems) and Father died of a heart attack. Concomitant medications included hydrochlorothiazide taken for hypertension. It was reported that the patient had the first dose on 19Feb2021 and was due to have second dose on 13Mar2021 and two days before that (11Mar2021) she ended up being sick having symptoms (cold) so she had to cancel the appointment and was tested for COVID. On 17Mar2021 the patient found out she got COVID. She called back to schedule her second appointment but is was past 42 days so they said she could not schedule. It was reported that she was not sure when she had COVID-19, it would have been in the evening when she started feeling like she had a cold. She's still having a little bit of tiredness since 11Mar2021 but no cough. Her tiredness is not as bad now. The patient also experienced achiness on an unspecified date in 2021. The patient received the following treatment for the events: Vitamin C, not sure if helped, Vitamin D, not sure if helped, and Advil, helped with achiness. The outcome of the event tiredness was not recovered, while unknown for the rest of the events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: called back to schedule her second appointment but is was past 42 days so they said she could not schedule; tested positive for Covid/Got COVID; tested positive for Covid/Got COVID; Tiredness; achiness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 68 years) (Batch/Lot Number: EN6200) as a single dose to prevent getting COVID (COVID-19 immunization). Ongoing medical history included high blood pressure (started about 10 years ago) and varicose vein (At least probably about 20 years). Family history includes both of her parents had heart problems, Mother had a stroke (she doesn't know when, she took medications for heart problems) and Father died of a heart attack. Concomitant medications included hydrochlorothiazide taken for hypertension. It was reported that the patient had the first dose on 19Feb2021 and was due to have second dose on 13Mar2021 and two days before that (11Mar2021) she ended up being sick having symptoms (cold) so she had to cancel the appointment and was tested for COVID. On 17Mar2021 the patient found out she got COVID. She called back to schedule her second appointment but is was past 42 days so they said she could not schedule. It was reported that she was not sure when she had COVID-19, it would have been in the evening when she started feeling like she had a cold. She's still having a little bit of tiredness since 11Mar2021 but no cough. Her tiredness is not as bad now. The patient also experienced achiness on an unspecified date in 2021. The patient received the following treatment for the events: Vitamin C, not sure if helped, Vitamin D, not sure if helped, and Advil, helped with achiness. The outcome of the event tiredness was not recovered, while unknown for the rest of the events.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Chills, Cough, Decreased appetite
Clinical narrative: double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pneumonia, Skin burning sensation
Clinical narrative: double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She found out on 09Jan2021 her results for Covid was positive; This is a spontaneous report from a contactable consumer via Medical Information Team. A female patient of an unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in an unspecified anatomical location on 08Jan2021 as single dose for covid-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was tested for covid on 04Jan2021 and 07Jan2021 with results unknown. The patient found out on 09Jan2021 positive for covid-19 after receiving the first dose on 08Jan2021. The patient was hospitalized on 16Jan2021 to 22Jan2021 for 6 days, during the time patient received the infusions for Covid. The events were considered serious due to hospitalization and medically significant. The outcome of the events covid-19 and drug ineffective was unknown. The patient was asking for 90 days to be okay or will she need to restart the vaccination series. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite
Clinical narrative: bit by a deer tick; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), 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. The patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that after the patient got her second vaccine, she was bit by a deer tick and stated that they carry Lyme disease. The patient was prescribed doxycycline and wanted to know if it was compatible with the vaccine that she received the day before. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Rash, Suspected COVID-19
Clinical narrative: in Jan2020 I suspect (not confirmed) I had covid; in Jan2020 I suspect (not confirmed) I had covid; illness; developed a rash on the trunk of my body; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Jan2020 patient suspect (not confirmed), had Covid. During patient illness developed a rash on the trunk of body. Now patient received second Covid vaccination on Wednesday afternoon and woke up this morning with a much milder version of the same rash (same location and pattern). Suspect patient had Covid in Jan2020 but that was before testing so not confirmed. No concomitant meds or underlying conditions. Event took place after use of product. The events "in Jan2020 I suspect (not confirmed) I had covid" were considered as medically significant. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Myalgia, Neck pain, Tremor, Vaccination site pain
Clinical narrative: pain in the left arm/Having pain in left arm; when I lift my arm up it's like; my arm is just trembling all the time; pain in the back of her neck; Nerve is jerking, it's so jittery; When I try to make a muscle it's like annoying to me; This is a spontaneous report received from a contactable 68-year-old female patient reported for himself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EN6201, expiration date: 02May2021), via an unspecified route of administration on 05Mar2021 at single dose for covid-19 immunization. The patient's relevant medial history included she had a surgery on 13nov2019 to thyroid nodules taken out. Historical vaccine included bnt162b2 for covid-19 immunization on 25Jan2021 (1st Dose of Covid-19 vaccine Taken, LOT#: EN5318). Concomitant medications included levothyroxine sodium for thyroid disorder. On an unknown date, the patient had pain in the left arm/having pain in left arm; when i lift my arm up it's like and her arm was just trembling and all the time pain in the back of her neck, nerve was jerking, it was so jittery, when she tried to make a muscle it was like annoying to the patient. The patient took Tylenol 500 mg Twice daily for the events. The patient stopped taking Tylenol as it was not working and it was really giving her pains in my stomach, so the patient tried to switch to Advil or Aleve. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a Pfizer sponsored program . A Contactable consumer (patient his wife) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2; Solution for injection), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) 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 03Mar2021 for Covid-19 immunization. It was reported he mentioned that his wife had a reaction with Pfizer vaccine like diarrhea in Mar2021, and he added that he experienced a pain in his arm where the vaccine injected. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349483 Different patient, same drug, different event
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Insomnia
Clinical narrative: Chills; fatigue; dehydration; trouble sleeping and staying asleep; trouble sleeping and staying asleep; headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EP7533), via an unspecified route of administration, in Left arm on 29Mar2021 at 12:15 PM (at the age of 21-years-old) at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient previously took Wellbutrin and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6206), via an unspecified route of administration, in Left arm on 08Mar2021 at 01:15 PM at a single dose for COVID-19 immunization. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced chills, fatigue, dehydration, trouble sleeping and staying asleep and headache from 30Mar2021 at 05:00 AM. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Middle insomnia
Clinical narrative: Chills; fatigue; dehydration; trouble sleeping and staying asleep; trouble sleeping and staying asleep; headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EP7533), via an unspecified route of administration, in Left arm on 29Mar2021 at 12:15 PM (at the age of 21-years-old) at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient previously took Wellbutrin and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6206), via an unspecified route of administration, in Left arm on 08Mar2021 at 01:15 PM at a single dose for COVID-19 immunization. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced chills, fatigue, dehydration, trouble sleeping and staying asleep and headache from 30Mar2021 at 05:00 AM. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Vomiting; Severe headache; This is a spontaneous report from a contactable consumer reported for self. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose in Left arm on 29Mar2021 12:00 AM (Lot number: ER8733) for COVID-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Prior to vaccination, the patient did not diagnose with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), both received within 2 weeks of vaccination. The patient experienced vomiting and Severe headache on 29Mar2021 07:00 PM, there was no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Fever; Chills; Sever headache; Nausea; diarrhea; Felt extremely tired; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 in Dec2020. The patient's concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced fever, chills, sever headache, nausea, diarrhea and felt extremely tired. The events were considered as non-serious. The patient underwent lab tests and procedures which included Covid-19 test in Dec2020 which shows positive results. The outcome of the event felt extremely tired was recovered after 24 hours, whereas outcome of rest all events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Sever headache; Nausea; diarrhea; Felt extremely tired; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 in Dec2020. The patient's concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced fever, chills, sever headache, nausea, diarrhea and felt extremely tired. The events were considered as non-serious. The patient underwent lab tests and procedures which included Covid-19 test in Dec2020 which shows positive results. The outcome of the event felt extremely tired was recovered after 24 hours, whereas outcome of rest all events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after receiving the first dose of the vaccine; Tested positive for Covid after receiving the first dose of the vaccine/she is very fatigued but that is from the Covid; This is a spontaneous report received from a contactable consumer (patient).   A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration on 26Feb2021 at single dose for covid-19 immunization. Medical history included high Blood Pressure and high cholesterol. Concomitant medications included losartan at a dose of 50mg per day; takes 25mg in morning and 25mg in evening for blood pressure, rosuvastatin calcium (CRESTOR) at a dose of 5mg once a day for cholesterol. Both the concomitant medications started a few years ago. The patient received her first covid vaccine dose on 26Feb2021 and she was supposed to get her second dose on 26Mar2021 but she got sick with COVID on 21MAR2021 and tested positive for COVID on 22MAR2021 but she thought her symptoms were there before a little bit. The patient asking that if she can have her second dose of the covid vaccine after 42 days if she had Covid following her first dose. It was reported that she was told to be at home for ten days, no repeat test. Patient was very fatigued but that was from the COVID, not her vaccine, that was over a month ago. Patient declines to complete the supplemental form at this time; she states that she is getting tired and would like to be transferred at this time. At the time of this report event outcome was unknown.   Follow-up attempts are needed. Further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Throat tightness
Clinical narrative: tightness in throat; "fuzzy" feeling in my head; This is a spontaneous report from a contactable consumer reported for self. A 33-year-old female patient (No pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 14:45 (Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included diagnosed with COVID-19 Prior to vaccination. Allergies to medications, food, or other products: Cephalexin. The patient's concomitant medications were not reported. The patient reported that she was experiencing tightness in throat and "fuzzy" feeling in head on 30Mar2021 15:00 with outcome of unknown. All events considered non-serious. No treatment received for the events. Since the vaccination, the patient did not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 101 degrees; Mild pain at injection site; Muscle pain (legs); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCCINE; Lot Number: EN6199), via an unspecified route of administration in left arm, on 24Mar2021 at 16:45 (04:45 PM), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cefalexin (CEPHALEXIN) as antibiotic and experienced allergies; and the first dose of BNT162B2 (Lot Number: EN6205) on 03Mar2021 at 05:00 PM in left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021 at 02:45 AM approximately 10 hours after shot, the patient experienced mild pain at injection site and muscle pain (legs) (also reported as on 24Mar2021 at 22:00) that were increasing until approximately 30 hours after shot. On 25Mar2021 at 10:45 PM approximately 18 hours after shot, the patient had fever of 101 degrees (also reported as on 24Mar2021 at 22:00). All reactions cleared by 36 hours after shot. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 26Mar2021 at 04:45 AM.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID on 30Mar2021 09:00; tested positive for COVID on 30Mar2021 09:00; This is a spontaneous report received from COVAES from a contactable nurse (patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 31Dec2020 09:15 (Lot Number: EK9231) as single dose, second dose via an unspecified route of administration, administered in left arm on 22Jan2021 09:00 (Lot Number: EL8982) as single dose for covid-19 immunisation. Medical history included allergies to sulfa. The patient received other medications within 2 weeks. Patient was no pregnant at the time of vaccination. The vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent rapid Covid test twice for COVID-19 on 22Mar2021 with result of negative. Reporter reported that tested positive for COVID on 30Mar2021 09:00.  The event outcome for events was recovering.; Sender's Comments: Based on the information currently available, vaccination failure with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis, Suspected COVID-19
Clinical narrative: she was positive with the corona virus; sinus infection; This is a spontaneous report received from Pfizer sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received vaccine first dose on 10Mar2021 and then when she thought she had sinus infection. They tested her and on 23Mar2021, she was positive with the corona virus. She is scheduled for the second dose of vaccine on 31Mar2021. She is asking if she can still get this. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fall, SARS-CoV-2 test
Clinical narrative: she fell when she came home; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient fell when she came home and had to go to the hospital when she was there she tested positive for COVID, the patient had the first dose of the vaccine then tested positive for COVID. Her next shot was due on 02Apr2021 (Friday). The outcome was unknown.  Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: She received her first Pfizer Covid vaccine dose on 11Mar2021 diagnosed with Covid-19 on 27Mar2021; She received her first Pfizer Covid vaccine dose on 11Mar2021 diagnosed with Covid-19 on 27Mar2021; This is a spontaneous report from a contactable consumer reporting on herself. A 39-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient was diagnosed with COVID-19 on 27Mar2021. She is due for her second dose on 01Apr2021. She wants to know if she can get her second dose of the vaccine or does she need to wait. The patient underwent lab test which included COVID-19: positive on 27Mar2021. Seriousness of the events was medically significant. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint lock
Clinical narrative: joint pain which started in the knee then shoulder and hands; left knee lock; This is a spontaneous report from a Pfizer Sponsored Program . A contactable female consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received Pfizer Covid-19 vaccine first dose last 20Mar2021 and she experienced joint pain which started in the knee then shoulder and hands on an unknown date in Mar2021. The next morning, she experienced left knee lock. Her 2nd dose will be on 10Apr2021 and she wanted to know if she needed to delay the appointment for the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: got the 1st dose of COVID-19 vaccine on 09Jan2021 and her 2nd dose was supposedly scheduled on 30Jan2021/advised by the facility that she needs to wait 90 days to get the 2nd dose; got the 1st dose of COVID-19 vaccine on 09Jan2021 and her 2nd dose was supposedly scheduled on 30Jan2021/advised by the facility that she needs to wait 90 days to get the 2nd dose; positive with Covid-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program,. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 09Jan2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the 1st dose of COVID-19 vaccine on 09Jan2021 and her 2nd dose was supposedly scheduled on 30Jan2021; however, on 18Jan2021 (9 days after getting the 1st dose), she got positive with COVID-19. The patient's concern was to reschedule her 2nd dose because she was advised by the facility that she needs to wait 90 days to get the 2nd dose due to being positive with COVID-19. The outcome of the event COVID-19 was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient son) reported for a female (mother) patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were unknown), via subcutaneous route of administration, on 10Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It reported that, the consumers mom (patient) received first dose of the COVID-19 vaccine on 10Mar2021. The patient tested positive for COVID-19 after COVID-19 vaccine. She was scheduled to take the second dose of the vaccine on 31Mar2021. However, her doctor recommends to postpone the second dose of the vaccine since she has COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The outcome of the patient event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unknown date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date, the patient was tested positive for Covid. She received a BAM fusion after testing positive and was not sure if she can get 2nd dose after receiving BAM fusion. The outcome of the events was unknown. The patient underwent lab tests and procedures which included SARS-CoV-1 test which was positive on an unknown date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unknown date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date, the patient was tested positive for Covid. She received a BAM fusion after testing positive and was not sure if she can get 2nd dose after receiving BAM fusion. The outcome of the events was unknown. The patient underwent lab tests and procedures which included SARS-CoV-1 test which was positive on an unknown date.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid after first shot; Tested positive for covid after first shot; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got first dose of vaccine. Tested positive for covid after first shot. The patient was advised by his HCP to quarantine for 10 days, ending on 31Mar2021, and proceed to get second shot on 01Apr2021. Wanted to know if he should wait another week before getting second shot or if getting it on 01Apr2021 was okay. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach pain; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had her first shot on 05Mar2021 and was due to get her second dose tomorrow. She mentioned that she currently had stomach pain and diarrhea. The patient would like to know if it is okay for her to take the second dose. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with Covid; tested positive with Covid; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) 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. The patient got her first dose of the vaccine but she got tested positive with COVID on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Disseminated intravascular coagulation, Haemoglobin, Haemoglobin decreased, Haemolytic anaemia, Investigation
Clinical narrative: acute hemolytic anemia; she developed DIC; Hbg was 6.0; This is a spontaneous report from a contactable physician.  A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. Medical history included ongoing Wilson's disease, copper overload syndrome (taken Penicillamine for decades). Concomitant medication included ongoing penicillamine taken for Wilson's disease and copper overload syndrome. The patient was admitted to the hospital last week with a life-threatening illness. After multiple tests the physician believed it was related to patient's 1st dose of the vaccine. She had acute hemolytic anemia and her HBG was 6.0. The physician also stated patient developed DIC (disseminated intravascular coagulation). She was transfused with 3 units of blood due to adverse reactions and improved. She then received 2 more units of blood and was steadily improving. The patient has a history of Wilson's disease, copper overload syndrome, and has taken Penicillamene for decades, which can cause hemolysis. The patient was still taking this medication and was still getting better. This patient was due for her 2nd dose soon. The physician will defer to a later date. The physician would like to request if there was any information/data regarding hemolysis, DIC associated with the vaccine. The events were reported as life-threatening. Patient was admitted to hospital in Mar2021 due to the events. Multiple tests done in Mar2021 with unknown result. Outcome of the events was recovering.  Information on lot/batch number has been requested.; Sender's Comments: Due to a plausible drug-events temporal association, the company cannot completely exclude a contributory role of vaccine BNT162b2 administration in the development of the reported, serious events: "hemolytic anemia and disseminated intravascular coagulation, with HBG 6.0, as consequence of anemia.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive of COVID-19; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for himself that. A male patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: Formulation and Lot number: unknown), via an unspecified route of  administration on 12Mar2021 at a single dose for COVID 19 Immunization. Medical history and concomitant medications were not reported. since the vaccination  patient had tested positive of COVID-19. He is asking if he can still get the 2nd dose of the vaccine which is scheduled on 02APR21. He refused to be transfer due to a long queue and created manual AE form.   Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information? No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Fatigue; Weakness; Dizziness; Diarrhea; Dehydration; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 14:00 as  single dose for covid-19 immunisation. Medical history included parkinson's disease from an unknown date and unknown if ongoing. Concomitant medications included carbidopa, levodopa (SINEMET); opicapone (ONGENTYS); rasagiline mesylate (AZILECT); clonaazepam (KLONOPIN); docusate sodium (COLACE) and Dulco. The patient experienced fatigue, weakness, dizziness, diarrhea, dehydration, headache, and she stated her medications didn't work well, could not get herself up to do anything on 25Mar2021 05:00 (as reported, specified time pending confirmation). There is no treatment for the events. The patient did not have covid prior vaccination, she did not test covid test post vaccination, she did not have known allergies. The outcome of the events was resolving.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Fatigue; Weakness; Dizziness; Diarrhea; Dehydration; Headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 14:00 as  single dose for covid-19 immunisation. Medical history included parkinson's disease from an unknown date and unknown if ongoing. Concomitant medications included carbidopa, levodopa (SINEMET); opicapone (ONGENTYS); rasagiline mesylate (AZILECT); clonaazepam (KLONOPIN); docusate sodium (COLACE) and Dulco. The patient experienced fatigue, weakness, dizziness, diarrhea, dehydration, headache, and she stated her medications didn't work well, could not get herself up to do anything on 25Mar2021 05:00 (as reported, specified time pending confirmation). There is no treatment for the events. The patient did not have covid prior vaccination, she did not test covid test post vaccination, she did not have known allergies. The outcome of the events was resolving.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Caller received 1st shot and went in for a routine physical. they ran blood work and found no antibodies.; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced caller received 1st shot and went in for a routine physical, they ran blood work and found no antibodies. Caller received 1st shot and went in for a routine physical. they ran blood work and found no antibodies. she wants to know what is going on. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative. The patient did not receive any treatment for the event. The clinical outcome of the caller received 1st shot and went in for a routine physical, they ran blood work and found no antibodies was unknown. Information about lot number has been requested.