chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccine could have contributed to the positive test; her father who received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27MAR2021 the following week he tested positive for Covid-19.; This is a spontaneous report received from a contactable consumer (patient father) via a medical information team. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration, on 27Mar2021 at single dose for covid-19 Immunization. Medical history and concomitant medication were not reported. It was reported, on behalf of her father who received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021 the following week, on an unspecified date in 2021, he tested positive for Covid-19. They would like to know if there was a time frame when he was able to receive the second dose of the vaccine, he was scheduled 3 weeks after the first dose however they would like to know the "regulation" for this cases and if the vaccine could have contributed to the positive test. The outcome of events was unknown.  Information on batch/lot number requested. Additional information required.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site mass, Vaccination site pain
Clinical narrative: vaccination provider administered the vaccine by her shoulder and "not in the muscle at all"; injection site has formed a lump and a little pain; injection site has formed a lump and a little pain; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on unspecified date on arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller received the first vaccine three weeks ago and is scheduled to receive the second dose this weekend. Caller reports that the vaccination provider administered the vaccine by her shoulder and "not in the muscle at all."  Caller states that the injection site has formed a lump and a little pain. Patient wanted to know if it would affect efficacy. Caller states that she is really anxious and this is very stressful for her. She has consulted with her HCP. 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, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; rash; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of bnt162b2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated she received the 1st dose of the Pfizer Covid vaccine on 18Mar2021, and had been complaining of itching and rash. She has contacted her HCP who has advised her to take Tylenol for itching. Patient wanted to reschedule her 2nd dose of the vaccine until the itching is resolved. The outcome of the events was not reported.  No follow-up information needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: itching; rash; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of bnt162b2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated she received the 1st dose of the Pfizer Covid vaccine on 18Mar2021, and had been complaining of itching and rash. She has contacted her HCP who has advised her to take Tylenol for itching. Patient wanted to reschedule her 2nd dose of the vaccine until the itching is resolved. The outcome of the events was not reported.  No follow-up information needed. Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Feeling abnormal, Loss of consciousness, Pain in extremity
Clinical narrative: Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a light; Sore right arm; goofy; This is a spontaneous report from a contactable consumer.  A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 58-years-old intramuscular, administered in Arm Right on 04Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation and prophylaxis. Medical history included high cholesterol, allergy (When pollen is heavy, it is worse) from an unknown date and unknown if ongoing, fractured his shoulder in 05Feb2021, sinus jacked up from an unknown date and unknown if ongoing, covid-19 from Nov2020 to an unknown date, anemic from Dec2020 to an unknown date, nasal surgery on an unknown date, fever blisters from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing. Concomitant medications included zolpidem tartrate (AMBIEN) taken to help sleep; atorvastatin (LIPITOR) taken for high cholesterol; loratadine taken for allergy; cetirizine hydrochloride (ZYRTEC) taken for allergy; mometasone furoate (FLONASE) taken for allergy; start and stop date were not reported for all; fish oil (OMEGA 3) and selenium (SELENIUM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3 1000) taken for immune system disorder; iron (IRON) taken for anaemia; lysine taken for fever blisters ; zinc taken for immune system disorder, start and stop date were not reported for all and multivitamin. It was reported that four hours after getting vaccine on 04Mar2021, he was on the floor and out like a light. This is the first one he received and his doctor said not to get second one.  He had the first one and about 4 hours later, he was on the kitchen floor and out like a light. He doesn't know if it was connected to shot or not.  He never had problems before. He got the vaccine around 09:30 and around 13:30, his friend came in for lunch and found him on the floor. She freaked out. She said she liked to never got him awake and said he was goofy for a good half hour. He does not know how long he was on the floor. His arm was sore on 04Mar2021 09:30 for about 4 days. The patient underwent lab tests and procedures which included blood iron: so low on an unspecified date. The patient was recovering from passed out and sore arm while recovered from goofy on 04Mar2021.
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Seizure, Tremor
Clinical narrative: Started shaking uncontrollably like a seizure; He felt energized; Shaking uncontrollably like a seizure/shaking (jerking side to side) on a very strong tremor; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included clonazepam and gabapentin taken as mood medications (as reported). It was reported that after the patient was administered with the first dose of the Pfizer COVID vaccine on 18Mar2021 or 11Mar2021 (he said that he does not remember it very well since he has bad memory), the next two hours (in Mar2021), he felt energized and then started shaking uncontrollably like a seizure although he takes a variety of medications that could cause that. He mentioned that it was like shaking (jerking side to side) on a very strong tremor. He wanted to know if someone has reported seizures as a side effect of the vaccine. He also mentioned that he is scheduled to get the second dose on 15Apr2021. He stated he has never had tremors like the one he is reporting. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electric shock sensation, Fatigue, Feeling abnormal, Headache
Clinical narrative: electric shocks on the neck and skull and above the ear and then where the bone was below the ear; having pain shooting in her head down her right arm; having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) at the age of 70-years, via an unspecified route of administration in arm right on 15Mar2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 infection from Nov2020 to an unspecified date; seasonal bronchitis which comes with laryngitis almost every time. Concomitant medications included methylprednisolone from 05Apr2021 and ongoing; tramadol. Patient received her first injection of the vaccine and then 10 days later, she started experiencing electric shocks on the neck and skull and above the ear and then where the bone was below the ear, was on her right side, which was the same side where she received the vaccine. On unspecified date, the patient also experienced having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand. The patient underwent lab tests and procedures, which included on 02Apr2021, flu test was negative, COVID-19 virus test was negative. Outcome of the event electric shocks on the neck and skull and above the ear and then where the bone was below the ear was recovering/resolving while of remain was unknown.   No follow up attempts are needed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza virus test, Memory impairment, Muscle twitching, Pain
Clinical narrative: electric shocks on the neck and skull and above the ear and then where the bone was below the ear; having pain shooting in her head down her right arm; having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) at the age of 70-years, via an unspecified route of administration in arm right on 15Mar2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 infection from Nov2020 to an unspecified date; seasonal bronchitis which comes with laryngitis almost every time. Concomitant medications included methylprednisolone from 05Apr2021 and ongoing; tramadol. Patient received her first injection of the vaccine and then 10 days later, she started experiencing electric shocks on the neck and skull and above the ear and then where the bone was below the ear, was on her right side, which was the same side where she received the vaccine. On unspecified date, the patient also experienced having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand. The patient underwent lab tests and procedures, which included on 02Apr2021, flu test was negative, COVID-19 virus test was negative. Outcome of the event electric shocks on the neck and skull and above the ear and then where the bone was below the ear was recovering/resolving while of remain was unknown.   No follow up attempts are needed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, SARS-CoV-2 test
Clinical narrative: electric shocks on the neck and skull and above the ear and then where the bone was below the ear; having pain shooting in her head down her right arm; having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) at the age of 70-years, via an unspecified route of administration in arm right on 15Mar2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 infection from Nov2020 to an unspecified date; seasonal bronchitis which comes with laryngitis almost every time. Concomitant medications included methylprednisolone from 05Apr2021 and ongoing; tramadol. Patient received her first injection of the vaccine and then 10 days later, she started experiencing electric shocks on the neck and skull and above the ear and then where the bone was below the ear, was on her right side, which was the same side where she received the vaccine. On unspecified date, the patient also experienced having pain shooting in her head down her right arm; brain fog; hardly remember something; body aches; fatigue; rash on her arms; shingles; twitches and shooting pain from her right shoulder all the way down to the thumb of her right hand. The patient underwent lab tests and procedures, which included on 02Apr2021, flu test was negative, COVID-19 virus test was negative. Outcome of the event electric shocks on the neck and skull and above the ear and then where the bone was below the ear was recovering/resolving while of remain was unknown.   No follow up attempts are needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety disorder, Chest discomfort, Chills, Decreased appetite, Disease recurrence
Clinical narrative: anxiety disorder; anxiety disorder; Fatigue (extreme)/ worn down; chills (shaking); nausea; tightness in his chest; lightheaded; no appetite; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The relevant medical history included anxiety disorder from an unspecified date. Concomitant medications were not reported. The patient wanted to know if he could delay the second dose, due to his anxiety around receiving it. He was calling to report an adverse reaction to the first vaccine and he was nervous about getting the second one. How much coverage after the first one, necessary to get the second dose. After the first one he was worn down for about 5 days, had an anxiety disorder as well. Fatigue (extreme) and chills (shaking) some nausea. Right away he felt some tightness in his chest and felt really lightheaded, they gave him gatorade and it helped. No appetite, tested for Covid, etc. He thought he might have corona-virus was tested and was negative. He also reported a history of anxiety disorder which may be contributing to his hesitancy around the second dose. The patient got a negative antibody test after being vaccinated. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: anxiety disorder; anxiety disorder; Fatigue (extreme)/ worn down; chills (shaking); nausea; tightness in his chest; lightheaded; no appetite; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The relevant medical history included anxiety disorder from an unspecified date. Concomitant medications were not reported. The patient wanted to know if he could delay the second dose, due to his anxiety around receiving it. He was calling to report an adverse reaction to the first vaccine and he was nervous about getting the second one. How much coverage after the first one, necessary to get the second dose. After the first one he was worn down for about 5 days, had an anxiety disorder as well. Fatigue (extreme) and chills (shaking) some nausea. Right away he felt some tightness in his chest and felt really lightheaded, they gave him gatorade and it helped. No appetite, tested for Covid, etc. He thought he might have corona-virus was tested and was negative. He also reported a history of anxiety disorder which may be contributing to his hesitancy around the second dose. The patient got a negative antibody test after being vaccinated. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphonia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Brain fog; Anxiety; Worst headache of my life/back of head felt like a brick was in it/Headache was migraine wrong entire head; Worst headache of my life/back of head felt like a brick was in it/Headache was migraine wrong entire head; Extreme nausea; Fatigued and worn out from nothing/horrible waves of exhaustion; Change in voice/Raspy voice; Sore arm; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided via an unspecified route of administration, administered in left arm on 02Apr2021 16:00 as single dose for Covid-19 immunisation. Medical history included bacterial allergy, cystitis interstitial, irritable bowel syndrome, depression and anxiety. Concomitant medications included clonazepam (KLONOPIN) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. On 02Apr2021, the patient experienced worst headache of her life (back of head felt like a brick was in it and headache was migraine wrong entire head), extreme nausea (even after 8 mg of Zofran), fatigued and worn out from nothing, change in voice on second day (raspy voice), sore arm, brain fog and anxiety. On 09Apr2021, the patient still experiencing brain fog, anxiety, and horrible waves of exhaustion. The outcome of the events was not recovered.  Information on batch/lot number was requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain in extremity
Clinical narrative: Brain fog; Anxiety; Worst headache of my life/back of head felt like a brick was in it/Headache was migraine wrong entire head; Worst headache of my life/back of head felt like a brick was in it/Headache was migraine wrong entire head; Extreme nausea; Fatigued and worn out from nothing/horrible waves of exhaustion; Change in voice/Raspy voice; Sore arm; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided via an unspecified route of administration, administered in left arm on 02Apr2021 16:00 as single dose for Covid-19 immunisation. Medical history included bacterial allergy, cystitis interstitial, irritable bowel syndrome, depression and anxiety. Concomitant medications included clonazepam (KLONOPIN) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. On 02Apr2021, the patient experienced worst headache of her life (back of head felt like a brick was in it and headache was migraine wrong entire head), extreme nausea (even after 8 mg of Zofran), fatigued and worn out from nothing, change in voice on second day (raspy voice), sore arm, brain fog and anxiety. On 09Apr2021, the patient still experiencing brain fog, anxiety, and horrible waves of exhaustion. The outcome of the events was not recovered.  Information on batch/lot number was requested.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Nausea
Clinical narrative: second dose of Covid vaccine and only had nausea; This is a spontaneous report from the non-Pfizer sponsored program received from a consumer (patient) via specialty pharmacy based on information received by Pfizer (manufacturer control number: UNT-2021-005877). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml) via an unspecified route of administration from 10Mar2020 Inhalation at 0.6 mg/ml and currently at 60-120 ug (10-2- breaths) four times a day (Batch/Lot Number: 2101898; Expiration Date: 31Oct2021) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included tadalafil (ADCIRCA). The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced blood pressure went up. The patient had nausea on an unspecified date. The outcome of event was unknown.    Pfizer is a marketing authorization holder of bnt162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of bnt162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Aphasia, Blood pressure decreased, Dehydration, Disturbance in attention, Drug interaction
Clinical narrative: second dose of Covid vaccine and only had nausea; This is a spontaneous report from the non-Pfizer sponsored program received from a consumer (patient) via specialty pharmacy based on information received by Pfizer (manufacturer control number: UNT-2021-005877). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml) via an unspecified route of administration from 10Mar2020 Inhalation at 0.6 mg/ml and currently at 60-120 ug (10-2- breaths) four times a day (Batch/Lot Number: 2101898; Expiration Date: 31Oct2021) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included tadalafil (ADCIRCA). The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced blood pressure went up. The patient had nausea on an unspecified date. The outcome of event was unknown.    Pfizer is a marketing authorization holder of bnt162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of bnt162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Fatigue, Feeling abnormal, Hypotension, Loss of consciousness, Movement disorder
Clinical narrative: second dose of Covid vaccine and only had nausea; This is a spontaneous report from the non-Pfizer sponsored program received from a consumer (patient) via specialty pharmacy based on information received by Pfizer (manufacturer control number: UNT-2021-005877). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml) via an unspecified route of administration from 10Mar2020 Inhalation at 0.6 mg/ml and currently at 60-120 ug (10-2- breaths) four times a day (Batch/Lot Number: 2101898; Expiration Date: 31Oct2021) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included tadalafil (ADCIRCA). The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced blood pressure went up. The patient had nausea on an unspecified date. The outcome of event was unknown.    Pfizer is a marketing authorization holder of bnt162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of bnt162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Renal impairment, Therapy change
Clinical narrative: second dose of Covid vaccine and only had nausea; This is a spontaneous report from the non-Pfizer sponsored program received from a consumer (patient) via specialty pharmacy based on information received by Pfizer (manufacturer control number: UNT-2021-005877). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml) via an unspecified route of administration from 10Mar2020 Inhalation at 0.6 mg/ml and currently at 60-120 ug (10-2- breaths) four times a day (Batch/Lot Number: 2101898; Expiration Date: 31Oct2021) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included tadalafil (ADCIRCA). The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced blood pressure went up. The patient had nausea on an unspecified date. The outcome of event was unknown.    Pfizer is a marketing authorization holder of bnt162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of bnt162b2 has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Developed Covid; This is a spontaneous report from a contactable consumer (patient). A female 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 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received first dose of Covid Vaccine last week, Developed Covid, contacted HCP and was advised that she had to wait 3 months to get second vaccination. Wanted to know what Pfizers stance on this was. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood count abnormal, Blood test, Granulocyte count, Granulocytes abnormal, Laboratory test
Clinical narrative: White, red and GR cells are all abnormal; White, red and GR cells are all abnormal; White, red and GR cells are all abnormal; Blood work and the numbers are all out of my norm; This is a spontaneous report from a contactable consumer (who is also the patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), 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. On an unspecified date the patient experienced "blood work and the numbers are all out of my norm." and "white, red and GR cells are all abnormal". The patient stated, "I donated some blood. It was shown that I was COVID reactive but not positive. I did some blood work and the numbers are all out of my norm. My white, red and GR cells are all abnormal. Normally these numbers indicate anemia or cancer of the blood. I have none of that. I have these side effects, which potentially is reported in limited amount of people. I also read an article of 254 people in (place name) which developed bleeding disorder or blood clot after getting the vaccine. They didn't identify which vaccine it was." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, Red blood cell count abnormal, White blood cell count, White blood cell count abnormal
Clinical narrative: White, red and GR cells are all abnormal; White, red and GR cells are all abnormal; White, red and GR cells are all abnormal; Blood work and the numbers are all out of my norm; This is a spontaneous report from a contactable consumer (who is also the patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), 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. On an unspecified date the patient experienced "blood work and the numbers are all out of my norm." and "white, red and GR cells are all abnormal". The patient stated, "I donated some blood. It was shown that I was COVID reactive but not positive. I did some blood work and the numbers are all out of my norm. My white, red and GR cells are all abnormal. Normally these numbers indicate anemia or cancer of the blood. I have none of that. I have these side effects, which potentially is reported in limited amount of people. I also read an article of 254 people in (place name) which developed bleeding disorder or blood clot after getting the vaccine. They didn't identify which vaccine it was." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Vaccination site discolouration, Vaccination site mass
Clinical narrative: she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; lump at site of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at the age of 77-year-old) as single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208; Expiration Date: Jun2021)via an unspecified route of administration on 19Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had already completed her 2 dose series of the vaccine. After her first dose, she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm. After her second dose, the lump on her left arm had develop some rash, swelling and itching and just went away after a week. On 08Apr2021, the lump looks like a teenager skin blemish that looks close to a large pimple. She also noticed that on the exterior of the skin, there was still minute reddish purplish discoloration and that the little lump was still there. She mentioned that she did not feel alerted and concerned because initially when she asked a nurse in the vaccination center, they mentioned that they have already seen side effects that looks like this. Now, she was just wondering if there was any reported events about this. Reporter stated that she got her first vaccine on 26Feb2021, that it left her with a kind of like a little lump at the site, tomorrow will be six weeks. Stated at the time it was surrounded by black and blue and that finally went away, exact date not provided. Left with the blemish, although it is a reddish mark lump. Got it over at the hospital. Seriousness of the events was not specified and was considered non-serious. The outcome of vaccination site lump and injection site mass was not recovered and vaccination site discoloration was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: he feels fine but not 100 percent well; 4 days later he tested positive for COVID-19.; This is a spontaneous report received from Pfizer sponsored program. A contactable male consumer(Patient himself) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 22Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Apr2021, After 4 days later the first dose received patient tested positive for COVID-19. Patient underwent lab test and procedure which included COVID-19 test and results positive for COVID-19. on 26Mar2021. Patient was in quarantine and came out on 05Apr2021, patient felt fine but not 100 percent well on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Arthralgia, Asthenia, Chills, Dizziness
Clinical narrative: dizziness; Weakness; Difficult staying awake; Unable to talk; Chills; Joint pain; This is a spontaneous report from a contactable consumer (patient) to a Pfizer-sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), 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. The patient wanted to report side effects after her first dose of covid-19 vaccine and stated that on an unknown date she experienced dizziness, weakness, difficult staying awake, chills, joint pain, and unable to talk. She was concerned about getting her second shot of covid-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: dizziness; Weakness; Difficult staying awake; Unable to talk; Chills; Joint pain; This is a spontaneous report from a contactable consumer (patient) to a Pfizer-sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), 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. The patient wanted to report side effects after her first dose of covid-19 vaccine and stated that on an unknown date she experienced dizziness, weakness, difficult staying awake, chills, joint pain, and unable to talk. She was concerned about getting her second shot of covid-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Pain in extremity
Clinical narrative: dizzy; very weak and tired; very weak and tired; Left arm is killing her and can't do anything with it; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program . A female patient of an unspecified age received the second dose of bnt162b2, via an unspecified route of administration on 19Mar2021 (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 previously received the first dose of bnt162b2, via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the second dose on 19Mar2021 and after getting the shot (Mar2021), she said her Left arm is killing her and can't do anything with it. And yesterday (04Apr2021) she also felt dizzy, very weak and tired. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
Clinical narrative: leukocytoclastic vasculitis; This is spontaneous report from a consumer (Patient) reporting for herself. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiry date: May2021), first dose via an intramuscular route of administration, in Arm Right, on 14Feb2021, 10:30, as a single dose for COVID-19 immunization. The patient did not administered her second dose yet. Medical history of patient included high blood Pressure, Arthritis, Uterus removal surgery, Appendix removal surgery. Concomitant medication included Levothyroxine 75 mcg for thyroid, Losartan 100 mg and Metoprolol 25mg for high blood pressure. Patient did not receive other vaccine in four weeks of vaccination.  It was reported that the patient experienced IGA vasculitis on 14Feb2021, at 22:00 hours and the patient was hospitalized for 11 days and the events requires the patient to visit emergency room, physician's office, also experienced small red dots on right ankle. The patient was at hospital and was getting treated by two doctors and after 5 days the doctors of the hospital were unable to treat the patient. The patient was transported via ambulance to medical center, the patient was treated by a team of doctors and specialists. She was discharged on 01Mar2021 and the rashes appears to stop spreading and no new ones has shown. The old rashes turned to bruises and the are clearing up slowly. The patient followed up with her rheumatologist after the discharger and the rheumatologist now tapering down the prednisone dosage. At the discharge were 80 mg per day and currently is at 60 mg per day, patient must drop 10 mg every 4 days until it comes reaches 20 mg. She has an appointment to visit her rheumatologist on 15Apr2021. The biopsy result from 01Mar2021 is leukocytoclastic (allergic) vasculitis. The biopsy result is IGA vasculitis. The doctors are not sure what has caused the rashes (AI) on the patient. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; sore throat; diarrhea; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer-Sponsored-Program. A female of an unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Mar2021 the patient experienced diarrhea, runny nose, sore throat and fever, on Friday (02Apr2021) caller went to the doctor and had a strep test and COVID-19 test, both were negative. The outcome of the events were unknown and fever stopped yesterday (recovered on 04Apr2021).   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: runny nose; sore throat; diarrhea; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer-Sponsored-Program. A female of an unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Mar2021 the patient experienced diarrhea, runny nose, sore throat and fever, on Friday (02Apr2021) caller went to the doctor and had a strep test and COVID-19 test, both were negative. The outcome of the events were unknown and fever stopped yesterday (recovered on 04Apr2021).   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 77-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 28Mar2021 at single dose for COVID-19 immunization. Medical history included compromised health due to chemotherapy. The patient had chemotherapy before the first dose of the vaccine. The patient's concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On 28Mar2021, the patient received his second dose of COVID-19 vaccine and the day after (29Mar2021), he experienced diarrhea and has been in the hospital since this past Sunday (04Apr2021). The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product supply issue, Vaccination site pain
Clinical narrative: pain at the injection site; They both received their 1st dose of the covid vaccine on 23Mar2021. They are scheduled to receive their 2nd dose tomorrow, 9Apr2021; They both received their 1st dose of the covid vaccine on 23Mar2021. They are scheduled to receive their 2nd dose tomorrow, 9Apr2021; This is a spontaneous report from a contactable consumer (reported for her husband) via Medical Information Team. Caller reporting on behalf of her husband and her mother-in-law (85-years-old). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller would like to know whether it is okay or safe to receive both doses of the covid vaccine 17 days apart. She explains the facility that gave the first dose doesn't have anymore dates available at 21 days or more. It says "unavailable vaccines" so they scheduled it at 17 days to get the second dose, which is 4 days before the recommended 21 days. Caller would like to know whether a person could die from receiving the 2nd dose of the vaccine so close; 17 days apart. She then states there is actually two people in the house that are getting the same vaccination. She clarifies her husband is also getting it and  his second dose is booked for 17 days. The patient experienced pain at the injection site (injection site pain) on an unspecified date, they both received their 1st dose of the covid vaccine on 23Mar2021. They are scheduled to receive their 2nd dose tomorrow, 09Apr2021 (inappropriate schedule of product administration) on an unspecified date. with outcome of unknown. The outcome of the events was unknown.  No follow-up information needed. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392477 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hallucination, Headache, Hypersensitivity
Clinical narrative: When I close my eyes at night, I saw like vague faces, and it would turn more gruesome; headache; chills; dizziness; allergic reactions; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced when she close her eyes at night, she saw like vague faces, and it would turn more gruesome, headache, chills, dizziness and allergic reactions. It was further reported that when the patient close her eyes at night, she saw like vague faces, and it would turn more gruesome, she would open her eyes and close them and it would happen again, vaguely for a couple of days and a short time. The patient mentioned that she didn't think it was a side effect, her friend who had the vaccine said, she had a hallucination, I looked on line, and found there are some hallucinations after vaccine, One person said after vaccine, not sure if Pfizer vaccine, think it was, had a bad hallucinations like taking mushrooms or something. Patient would like to know if it's safe for her to get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: has a lump on his armpit of approximately one inch/the lump could be a muscle contracture/ lymphadenopathy; This is a spontaneous report received from a contactable male consumer (patient) reported for himself received his first dose bnt162b2 (Solution for injection) 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. on 07Apr2021 he noticed that he has a lump on his armpit of approximately one inch, he consulted a physician and he stated that the lump could be a muscle contracture and prescribed anti-inflammatories. It was reported that lymphadenopathy is a reported side effect. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.