chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Nausea, Off label use
Clinical narrative: inappropriate schedule of vaccine administered (Dose 1: 01Feb2021, Dose 2: 10Feb2021); inappropriate schedule of vaccine administered (Dose 1: 01Feb2021, Dose 2: 10Feb2021); Fever; chills; nausea; Dry-heaves; fatigue; This is a spontaneous report from a contactable consumer reporting for himself. A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El9269/expiration date: not provided), via an unspecified route of administration, on 10Feb2021 at 01:30 (at the age of 69 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 01Feb2021 at 01:00 (at the age of 69 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, hypertension, hypothyroidism. The had known allergies to peneciilin, sulfa, and doxycycline. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ramipril, hydroxychloroquine sulfate (PLAQUENIL) and amlodipine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Feb2021 (also reported as "09Feb2021 at 01:30" CLARIFICATION PENDING), the patient experienced fever, chills, nausea, dry-heaves, and fatigue. The patient did not receive any treatment for these events. The outcome of the events fever, chills, nausea, dry-heaves, and fatigue was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: inappropriate schedule of vaccine administered (Dose 1: 01Feb2021, Dose 2: 10Feb2021); inappropriate schedule of vaccine administered (Dose 1: 01Feb2021, Dose 2: 10Feb2021); Fever; chills; nausea; Dry-heaves; fatigue; This is a spontaneous report from a contactable consumer reporting for himself. A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El9269/expiration date: not provided), via an unspecified route of administration, on 10Feb2021 at 01:30 (at the age of 69 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 01Feb2021 at 01:00 (at the age of 69 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, hypertension, hypothyroidism. The had known allergies to peneciilin, sulfa, and doxycycline. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ramipril, hydroxychloroquine sulfate (PLAQUENIL) and amlodipine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Feb2021 (also reported as "09Feb2021 at 01:30" CLARIFICATION PENDING), the patient experienced fever, chills, nausea, dry-heaves, and fatigue. The patient did not receive any treatment for these events. The outcome of the events fever, chills, nausea, dry-heaves, and fatigue was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: severe outbreak of genital herpes; This is a spontaneous report from a contactable consumer (patient). This 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 09Feb2021 at 12:45 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included soy allergy from an unknown date and unknown if ongoing. The patient had not received any other vaccines in four weeks and did not have COVID prior to vaccination. Concomitant medications included lorazepam (ATIVAN) from an unknown date for an unknown indication and fexofenadine hydrochloride (ALLEGRA) from an unknown date for an unknown indication. The patient reported that two days after vaccination, she had a severe outbreak of genital herpes; she did not know if there was a connection. No treatment was provided for the event. The clinical outcome of severe outbreak of genital herpes was recovering. It was also reported the patient had not been COVID tested post-vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: headache; tired; achy; felt crappy/Felt very lousy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL9269) via an unspecified route of administration on 11Feb2021 at 10:45 (at the age of 80-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included osteoporosis, arthritis, high blood pressure, eyesight problems, heart murmur, and known allergies to shrimp and lobster, all from unspecified dates and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") included metoprolol succinate taken for an unspecified indication from an unspecified date at 100mg and ciclosporin (RESTASIS; eye drops) taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 the patient experienced headache, tired, achy and felt crappy/felt very lousy. The clinical course was reported as follows: "All good for 4 hours, then tired, achy, felt crappy, slight headache. Continued to next day, sometimes better, other times much worse. Third day still headache. Thought this would not happen after the 1st dose. Felt very lousy." The patient did not receive treatment for the adverse events. The clinical outcomes of the events headache, tired, achy and felt crappy/felt very lousy were all recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose increased, Fatigue, Headache
Clinical narrative: elevated fever; blood glucose level has spiked; headache; pain; joint pain; fatigue; She was in bed lethargic; This is a spontaneous report from contactable consumers (one was patient's daughter). A female patient of an unspecified age (reported as 82, unit unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 16Jan2021 for COVID-19 immunization and experienced shaking for about 5 minutes. On an unspecified date, the patient experienced elevated fever, blood glucose level had spiked, headache, pain, joint pain, fatigue and she was in bed lethargic. The patient underwent lab tests and procedures which included blood glucose: blood glucose level has spiked went up and down on an unspecified date, and blood glucose: normal on an unspecified date. Clinical outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: elevated fever; blood glucose level has spiked; headache; pain; joint pain; fatigue; She was in bed lethargic; This is a spontaneous report from contactable consumers (one was patient's daughter). A female patient of an unspecified age (reported as 82, unit unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 16Jan2021 for COVID-19 immunization and experienced shaking for about 5 minutes. On an unspecified date, the patient experienced elevated fever, blood glucose level had spiked, headache, pain, joint pain, fatigue and she was in bed lethargic. The patient underwent lab tests and procedures which included blood glucose: blood glucose level has spiked went up and down on an unspecified date, and blood glucose: normal on an unspecified date. Clinical outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: A very itchy rash on the upper part of her chest above her breasts; This is a spontaneous report from a contactable consumer (the patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269), via an unspecified route of administration in the left arm on 08Feb2021 14:00 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: celecoxib, omeprazole, and paroxetine, and a multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Feb2021 (reported as "03Feb2021 22:00"), the patient had a very itchy rash on the upper part of her chest above her breasts. No treatment was received for the event. The clinical outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Malaise, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (HCP). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiration date: unknown), second dose via an unspecified route of administration in her left arm on 12Feb2021 at 10:30 as single dose for covid-19 immunization. Medical history included asthma, gastrooesophageal reflux disease (GERD), attention deficit hyperactivity disorder (ADHD), depression from an unknown date and unknown if ongoing. Concomitant medication included trazodone, sertraline hydrochloride (ZOLOFT), methylphenidate hydrochloride (CONCERTA), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), all from an unspecified date for unspecified indication. The patient previously took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 20Jan2021 at 10:30 on her left arm for COVID-19 immunization. On 12Feb2021 at 18:00, the patient experienced swelling/pain at injection site, low grade fever, muscle aches, neck and back pain, nausea, decreased appetite and malaise. The outcome of the events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (HCP). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiration date: unknown), second dose via an unspecified route of administration in her left arm on 12Feb2021 at 10:30 as single dose for covid-19 immunization. Medical history included asthma, gastrooesophageal reflux disease (GERD), attention deficit hyperactivity disorder (ADHD), depression from an unknown date and unknown if ongoing. Concomitant medication included trazodone, sertraline hydrochloride (ZOLOFT), methylphenidate hydrochloride (CONCERTA), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), all from an unspecified date for unspecified indication. The patient previously took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 20Jan2021 at 10:30 on her left arm for COVID-19 immunization. On 12Feb2021 at 18:00, the patient experienced swelling/pain at injection site, low grade fever, muscle aches, neck and back pain, nausea, decreased appetite and malaise. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Pruritus, Vaccination site mass
Clinical narrative: afraid; lump formed at the site of the injection; Itches also; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration, in the left arm, on 09Feb2021 09:45 at a single dose (at the age of 68-years-old) for COVID-19 immunization in a public health department. The patient received the first dose of BNT162B2 (lot number: EL1283) on 19Jan2021 09:30, in the left arm (at the age of 68-years-old) for COVID-19 immunization. Medical history included asthma and known allergies with sulfa and penicillin (reported as "pennicillian"). Concomitant medications included losartan; amlodipine; potassium chloride (POTASSIUM CHLORIDE CR WM); and hydrochlorothiazide; all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had a lump formed at the site of the injection appearing the second day (11Feb2021) after injection. The lump was not going away. Itches also. The patient did not know if she should see a doctor or not. The patient wanted to know if she should take Benadryl or take pain relief. The patient was afraid. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The events were considered non-serious by the patient. The patient has not recovered from the events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle arrived one week early.; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the left arm on 05Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and was not allergic to medications, foods or other products. The patient did not have COVID-19 prior to vaccination. Concomitant medications included birth control pills from an unknown date for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her menstrual cycle arrived one week early on 09Feb2021; further stating her period was not supposed to start until 16Feb(2021). The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The outcome of menstrual cycle arrived one week early was recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms in left thigh, surging sensation in both thighs that woke me up; twitching on cheek next to the left side of my mouth; This is a spontaneous report from a contactable consumer (patient himself).  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left in Feb2021 (Lot Number: en5318) at single dose for COVID-19 immunisation. Medical history included high blood pressure, and pre diabetes. It was unknown if there was any known allergies. Concomitant medications included allopurinol, lisinopril, pantoprazole, metformin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021 (lot number: el1284) in Left arm at single dose for COVID-19 immunisation. The patient experienced muscle spasms in left thigh, surging sensation in both thighs that woke him up, and twitching on cheek next to the left side of his mouth on 07Feb2021 19:45. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. There was no COVID prior vaccination or no COVID  tested post vaccination. The outcome of events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Migraine, Pain, Pyrexia
Clinical narrative: Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 14:00 (at the age of 47 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date for COVID-19 IMMUNIZATION. Relevant medical history included Epstein Barr. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included "Fiornel" and ibuprofen (ADVIL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine. The patient received treatment for these events which included ibuprofen (ADVIL), acetaminophen, (TYLENOL) and "fiornel". The outcome of the events severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine was unknown. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 14:00 (at the age of 47 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date for COVID-19 IMMUNIZATION. Relevant medical history included Epstein Barr. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included "Fiornel" and ibuprofen (ADVIL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine. The patient received treatment for these events which included ibuprofen (ADVIL), acetaminophen, (TYLENOL) and "fiornel". The outcome of the events severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine was unknown. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: lethargy; felt tired; This is a spontaneous report from a non-contactable consumer for herself. A 45-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 09Jan2021 via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization in the hospital. The patient's medical history and concomitant medications were not reporter. The allergies to medications, food, or other products were unknown. The patient was not pregnant at the time of vaccination. It was unknown if the patient has been tested positive for COVID-19 and if the patient was tested positive since vaccination. On 09Jan2021 the patient felt tired, lethargic all weekend. The events assessed as non-serious by the reporter. The patient did not receive any treatment. The outcome of the events was recovered on an unspecified date of Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19, Drug ineffective
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms.; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested for COVID-19 and found out that she was positive for the infection, positive COVID-19 test with no symptoms. The patient was supposed to have surgery but she was tested for COVID-19 and found out that she was positive for the infection, she have not had any symptoms, she did not interact with anybody and she wears double mask. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Urticaria
Clinical narrative: exacerbated the hives; exacerbated the hives; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EM9809), via an unspecified route of administration in the right arm on 15Feb2021 at 08:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization and ampicillin (AMPICILLIN), via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication. Ampicillin was given within two weeks of BNT162b2. Medical history included penicillin allergy and sulfa drugs allergy; all from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks. The patient previously took nitrofurantoin (MACROBID) and prochlorperazine maleate (COMPAZINE); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient experienced exacerbated the hives on 15Feb2021 at 12:00. The patient had hives from ampicillin and believed that BNT162b2 exacerbated the hives. The patient went to the Emergency room/department or urgent care due to the event, exacerbated the hives. The patient received prednisone as the treatment for the event. The action taken in response to the event for ampicillin was unknown. The outcome of event, exacerbated the hives was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose increased, Chest pain, Chills
Clinical narrative: nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Joint range of motion decreased, Nausea, Pain in extremity
Clinical narrative: nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient had the first dose of the Pfizer COVID-19 vaccine on 30Jan2021 and tested positive on 12Feb2021; patient had the first dose of the Pfizer COVID-19 vaccine on 30Jan2021 and tested positive on 12Feb2021; This is a spontaneous report from a contactable consumer via Medical information team. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A female patient (wife) 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 30Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had the first dose of the Pfizer COVID-19 vaccine on 30Jan2021 and tested positive on 12Feb2021. The caller wanted to know whether they should repeat the dose or should they wait. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021166986 same reporter, suspect, events, different patient
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Fluid from my nostrils is running constantly and it has a terrible odor when it is coming out; This is a spontaneous report from a contactable consumer (patient) for himself. A 87-years-old male patient received BNT162B2 (solution for injection, Lot number: EL9261BUD53141) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included tamsulosin at a dose of 0.4 mg, finasteride at a dose of 0.5 mg both taken for an unspecified indication and vitamin. Consumer stated, that he took first vaccination on 28Jan2021 and it's been a week now and noticed yesterday and mostly today, my fluid from my nostrils is running constantly and it has a terrible odor on 04Feb2021, when it's coming out, and again stated that, "Well, and it is reported, I don't know how I got that problem but, I mean it started after a week after getting the vaccination, there was event treatment for the event. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: 145HR for approximately 5 minutes.; This was a spontaneous report from a contactable nurse herself (non pregnant). An 38-year-old female nurse (patient) reported received of first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscularly left arm on 05 Feb2021 09:30 am at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced 145 beats per minute Heart Rate for approximately 5 minutes on 05Feb2021 13:30. Facility type vaccine in hospital. The outcome in response to the event recovered in 2021.  Information about Lot/Batch number is requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on side of body injection site; This is a spontaneous report from a contactable other health professional (patient). A none pregnant 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection, Lot/Batch Number and Expiration Date unknown), via an unspecified route of administration, administered in right arm on 16Feb2021 at time of 13:00 (at the age of 30 years old, no pregnant at vaccination) at a single dose for COVID-19 immunization. The patient had no other medical history. No known allergies. There was no concomitant drugs. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not have covid prior vaccination and did not receive covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN, lot number unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced hives on side of body injection site on 17Feb2021. Therapeutic measures were taken as a result of "hives on side of body injection site" and included treatment with "use of diphenhydramine (BENADRYL) and paracetamol (TYLENOL)". The outcome of event was recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Nerve compression
Clinical narrative: Pinched nerve; Pain in his neck or shoulder; Pain in his neck or shoulder; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 28Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The first dose of the COVID-19 vaccine was on 28Jan2021. On 15Feb2021, the patient started experiencing pain in his neck or shoulder. On an unspecified date, the patient had pinched nerve in his neck; the patient was prescribed prednisone. They gave the patient prednisone to take but he was holding off to take prednisone because he was afraid it will hinder the immune response to the vaccine. The patient was holding off to take prednisone, but he wanted to get a professional opinion on when he should get or the time to start taking prednisone. The patient wanted to know if taking it will change the efficacy of the vaccine. The patient was asking if this would affect the vaccine's efficacy. The patient had the second dose on 17Feb2021 (day before the reporting) at 9:20 in the morning. The patient also asked if it was safe for pregnant women to get the vaccine. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: He was itching behind both ears and now it is in the crack of his butt and on his butt cheeks; It is big, welty, and red; It is big, welty, and red; Rash was reported as worsened.; Rash; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, lot #: EL3302), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL3302) as SINGLE DOSE for covid-19 immunisation. Medical history included gingival disorder from an unknown date and unknown if ongoing. Concomitant medications included doxycycline hyclate (DOXYCYCLINE HYCLATE), chlorhexidine gluconate (CHLORHEXIDINE GLUCONATE) taken for gingival disorder from 21Jan2021 to 06Feb2021. On 06Feb2021, the patient experienced rash, on an unspecified date he was itching behind both ears and now it is in the crack of his butt and on his butt cheeks, it is big, welty, and red, rash was reported as worsened. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of he was itching behind both ears and now it is in the crack of his butt and on his butt cheeks (pruritus). The outcome of the events was not recovered. The outcome of the event rash was reported as worsened was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration on 02Feb2021 at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing stage 4 lung cancer from Dec2019 and chemo from Apr2020. The patient had no concomitant medications. On 02Feb2021, the patient experienced nausea and chills. The patient reported that she had her first Pfizer shot on 02Feb2021. She had just a few problems in the middle of night afterwards- nausea and chills. That night she had nausea and chills. It lasted for about 30 minutes. She just laid in bed. She was fine after that and was fine the next morning. Outcome of the events was recovered on 02Feb2021.  Information on the Lot/Batch Number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: tired; lightheaded; This is initial spontaneous report from a contactable consumer (patient himself). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient received the COVID-19 vaccine last Wednesday on 03Feb2021. He was fine for a few days after it and then starting about 2 days ago and including today, he had become quite tired in Feb2021. He had been a little lightheaded (Feb2021) but more so very tired. The outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I had a swollen lymp node in my left armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient reported that first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot# EL9264), via unspecified route of administration on 04Feb2021 13:45 at single dose in the left arm for covid-19 immunization. Medical history included hypertension. Concomitant medications included Lycortin, Norvasc, Carvedilol, Aspirin, Doxycycline. The patient reported as, I had a swollen lymp node in my left armpit on 08Feb2021. Outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9810), via an unspecified route of administration on 05Feb2021 at a single dose on left arm for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient was asking if Pfizer had people, about 3 or 4 days later, get nausea and diarrhea after getting the COVID shot. She had a real bad fever 3 hours after the shot but felt fine the next day. But now she has nausea and diarrhea that started yesterday (08Feb2021). She normally does not that have that. Her nausea has improved because she took a nausea pill, ondansetron (ZOFRAN) 2 mg. Therapeutic measures were taken as a result of nausea. The outcome of the event fever was recovered on 06Feb2021, nausea was recovering, and diarrhea was recovered on 09Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood sugar spiked; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date, blood sugar spiked after getting the vaccine. The patient was brought to the emergency room (ER) to stabilize blood sugar level and went home after. The adverse event resulted in emergency room/department or urgent care. The outcome of the event was unknown (as reported).  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Incorrect route of product administration
Clinical narrative: I feel so tired; a little bit dizzy; Intravenous administration; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This female consumer of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intravenously on 13Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates the patient reported she felt so tired and a little bit dizzy. The clinical outcomes of she felt so tired and a little bit dizzy were unknown. The clinical outcome of intravenous administration was recovered on 13Feb2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: "Caller got his 1st dose a week ago (05Feb2021) and was tested positive of Covid-19 today/He had symptoms like headache, fever"; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number, UPC number, Batch/Lot number, Expiry date: unknown), via an unspecified route of administration on 05Feb2021 at single dose for covid-19 immunisation. Covid19 vaccine was a Pfizer product. Covid19 vaccine manufacturer was unspecified. Relevant medical history and concomitant medications were reported None. The patient got his 1st dose a week ago (05Feb2021) (reported as 8 days after the first dose) and was tested positive for Covid today (12Feb2021). His 2nd dose was on 28Feb2021. The patient stated, "I do not have that card." Investigation assessment was no. Patient was already negative in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test and results were positive (drug ineffective) on 12Feb2021. The outcome of event positive COVID-19 was recovered in 2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site rash
Clinical narrative: she felt tired; red circle on the injection area that starts to get bumpy; red circle on the injection area that starts to get bumpy; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported this female patient of unspecified age received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient felt tired and experienced a red circle on the injection area that started to get bumpy. The outcomes of tired and red circle on the injection area that started to get bumpy were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site.; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient's daughter), reporting for a patient (Mother). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 04Feb2021 as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On an unknown date in Feb2021 the patient experienced pain at the injection site. The clinical outcome of the pain at the injection site was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.