chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: Increased heart rate (85 compared to normal resting rate of 65); sweaty feet and hands; slight headache; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6207) via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (age at vaccination 38-years-old), as dose 1, single for covid-19 immunization. Medical history included psoriatic arthropathy, Known allergies to Penicillin, sulfamate drugs. Patient had a reaction to an iron infusion. Concomitant medications included vitamin d2 dose of 50,000 mg (MANUFACTURER UNKNOWN), mecobalamin (B12 MECOBALAMIN), calcium levomefolate (METHYL FOLATE), and zinc (MANUFACTURER UN-KNOWN) all received in two weeks. The patient previously took sulfameth/trimeth and experienced drug hypersensitivity. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 09:15, the patient experienced increased heart rate, sweaty feet and hands, slight headache. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Nausea
Clinical narrative: Fatigue; chills; headache; nausea; sore throat; runny nose; cough; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 46-year-old male patient. A 46-year-old male patient received bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 08Mar2021 15:00 as dose 1, single (age at vaccination: 46 years) for covid-19 immunisation. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX); rosuvastatin calcium (CRESTOR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); vitamin a [retinol] (VITAMIN A [RETINOL]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), all from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies to medications, food, or other products. On 09Mar2021 02:00 PM, the patient experienced fatigue, chills, headache, nausea, sore throat, runny nose, cough, chills. No treatment was received. The clinical outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Fatigue; chills; headache; nausea; sore throat; runny nose; cough; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 46-year-old male patient. A 46-year-old male patient received bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 08Mar2021 15:00 as dose 1, single (age at vaccination: 46 years) for covid-19 immunisation. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX); rosuvastatin calcium (CRESTOR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); vitamin a [retinol] (VITAMIN A [RETINOL]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), all from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies to medications, food, or other products. On 09Mar2021 02:00 PM, the patient experienced fatigue, chills, headache, nausea, sore throat, runny nose, cough, chills. No treatment was received. The clinical outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Hyperhidrosis
Clinical narrative: right arm injection site was throbbing and swollen; right arm injection site was throbbing and swollen; lymph node under right arm is very swollen and painful and becoming red; General malaise, low grade fever, joint aches morning of 06Mar; General malaise, low grade fever, joint aches morning of 06Mar; dizziness; chills; drenching sweats; lymph node pain and swelling on right side; lymph node pain and swelling on right side; Low grade fever and painful injection site starting evening of 05Mar; Low grade fever and painful injection site starting evening of 05Mar; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported for herself. A 34-year-old non pregnant female patient received bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EN6204) via an unspecified route of administration in arm right on 05Mar2021 as dose 2, single (age at vaccination: 34 years) for COVID-19 immunisation. Medical history included asthma, IBS, hypothyroidism, known allergies: penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]); levothyroxine (LEVOTHYROXINE); hyoscyamine (HYOSCYAMINE), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9266) via an unspecified route of administration in arm right on 12Feb2021 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 05Mar2021 04:00 PM, the patient experienced low grade fever and painful injection site starting in the evening. On 06Mar2021, general malaise, low grade fever, joint aches morning and by afternoon, fever rose to 103.5, experienced dizziness and chills, drenching sweats and lymph node pain and swelling on right side. On 07Mar2021, had fever of 101.2, but feeling better. On 08Mar2021, afternoon right arm injection site was throbbing and swollen, lymph node under right arm is very swollen and painful and becoming red. On 09Mar2021, seeking medical care. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 103.5 on 06Mar2021 and 101.2 on 07Mar2021. The clinical outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: right arm injection site was throbbing and swollen; right arm injection site was throbbing and swollen; lymph node under right arm is very swollen and painful and becoming red; General malaise, low grade fever, joint aches morning of 06Mar; General malaise, low grade fever, joint aches morning of 06Mar; dizziness; chills; drenching sweats; lymph node pain and swelling on right side; lymph node pain and swelling on right side; Low grade fever and painful injection site starting evening of 05Mar; Low grade fever and painful injection site starting evening of 05Mar; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported for herself. A 34-year-old non pregnant female patient received bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EN6204) via an unspecified route of administration in arm right on 05Mar2021 as dose 2, single (age at vaccination: 34 years) for COVID-19 immunisation. Medical history included asthma, IBS, hypothyroidism, known allergies: penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]); levothyroxine (LEVOTHYROXINE); hyoscyamine (HYOSCYAMINE), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9266) via an unspecified route of administration in arm right on 12Feb2021 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 05Mar2021 04:00 PM, the patient experienced low grade fever and painful injection site starting in the evening. On 06Mar2021, general malaise, low grade fever, joint aches morning and by afternoon, fever rose to 103.5, experienced dizziness and chills, drenching sweats and lymph node pain and swelling on right side. On 07Mar2021, had fever of 101.2, but feeling better. On 08Mar2021, afternoon right arm injection site was throbbing and swollen, lymph node under right arm is very swollen and painful and becoming red. On 09Mar2021, seeking medical care. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 103.5 on 06Mar2021 and 101.2 on 07Mar2021. The clinical outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain
Clinical narrative: right arm injection site was throbbing and swollen; right arm injection site was throbbing and swollen; lymph node under right arm is very swollen and painful and becoming red; General malaise, low grade fever, joint aches morning of 06Mar; General malaise, low grade fever, joint aches morning of 06Mar; dizziness; chills; drenching sweats; lymph node pain and swelling on right side; lymph node pain and swelling on right side; Low grade fever and painful injection site starting evening of 05Mar; Low grade fever and painful injection site starting evening of 05Mar; This is a spontaneous report from a contactable consumer. This 34-year-old female consumer (patient) reported for herself. A 34-year-old non pregnant female patient received bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EN6204) via an unspecified route of administration in arm right on 05Mar2021 as dose 2, single (age at vaccination: 34 years) for COVID-19 immunisation. Medical history included asthma, IBS, hypothyroidism, known allergies: penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]); levothyroxine (LEVOTHYROXINE); hyoscyamine (HYOSCYAMINE), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9266) via an unspecified route of administration in arm right on 12Feb2021 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. On 05Mar2021 04:00 PM, the patient experienced low grade fever and painful injection site starting in the evening. On 06Mar2021, general malaise, low grade fever, joint aches morning and by afternoon, fever rose to 103.5, experienced dizziness and chills, drenching sweats and lymph node pain and swelling on right side. On 07Mar2021, had fever of 101.2, but feeling better. On 08Mar2021, afternoon right arm injection site was throbbing and swollen, lymph node under right arm is very swollen and painful and becoming red. On 09Mar2021, seeking medical care. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 103.5 on 06Mar2021 and 101.2 on 07Mar2021. The clinical outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Pain in extremity
Clinical narrative: Right arm was sore; Felt generally ill; fatigued; joints hurt the day following injection; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL 3247) dose 2 via an unspecified route of administration in right arm on 12Feb2021 02:30 PM (at the age of 36-year-old) as single dose for COVID-19 immunisation at Workplace clinic. Medical history and concomitant medications were not reported. Historical vaccine included received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number EL 3247) dose 1 via an unspecified route of administration in right arm on 20Jan2021 02:00 PM (at the age of 36-year-old) as single dose for COVID-19 immunisation. She had sore and swollen lymph node in neck, she was tired, arm she was injected was sore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Feb2021, her right arm was sore. Felt generally ill, fatigued, and joints hurt the day following injection. Symptoms started to resolve 2 days after injection. No treatment was received for the adverse event. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057929 Same reporter, patient, and product different doses.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Resting heart rate rose to 135 to 150 beginning an hour after injection and lasting for about 15 hours.; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received bnt162b2 (Pfizer; formulation: solution for injection; lot number: EN6203), dose 2 via an unspecified route of administration, administered in right arm on 01Mar2021 at 11:30 as dose 2, single (at the age of 77 years) for covid-19 immunisation. Medical history included pericarditis and atrial fibrillation from Jul2020 and unknown if ongoing. Patient had no known allergies. Concomitant medications included hyoscyamine and atorvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no covid prior to vaccination and patient did not test for covid post vaccination. The patient historical vaccine includes BNT162B2 (Pfizer; lot number: EM9809) dose 1, single (at the age of 77 years) on 08Feb2021 at 11:30 for covid-19 immunisation. The patient reported that the resting heart rate rose to 135 to 150 beginning an hour after injection and lasting for about 15 hours on 01Mar2021 at 12:30. Patient did not receive any treatment for the event. The outcome of the event was recovered in Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Patient is my brother; for 24 hours after his second vaccination shot, he had a fever and bad headache; Patient is my brother; for 24 hours after his second vaccination shot, he had a fever and bad headache; This is a spontaneous report from a contactable consumer. An adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number EN6206), via an unspecified route of administration on 08Mar2021 as a single dose for covid-19 immunization. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch number EL9267), via an unspecified route of administration on 18Feb2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. it was unknown whether the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Mar2021,24 hours after his second vaccination shot, he had a fever and bad headache. It was unknown if patient received any treatment for the events. The outcome of the events was recovered on an unknown date 2021   No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Soreness; tiredness; This is a spontaneous report from a non-contactable male consumer reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) dose unspecified, 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 soreness and tiredness. Swap from FC, received 2 doses of covid vaccine. Not many side effects besides soreness and tiredness. Received and email about a survey. Says it does not seem to be a pfizer official email. Outcome was unknown for both the events.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Rash, SARS-CoV-2 test
Clinical narrative: insomnia - woken up in the middle of the night with elevated heart rate; elevated heart rate; Rash on my back; This is a spontaneous report from a contactable consumer or other non hcp.   A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Right at Public Health Clinic/Veterans Administration facility on 26Feb2021 (at 02:00 PM) as a single dose for covid-19 immunization (at the age of 56-years-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el9265), dose 1 via an unspecified route of administration, administered in Arm Right (at 04:00 PM) on 05Feb2021 as a single dose for covid-19 immunization (at the age of 56-years-old). Patient was not diagnosed with COVID-19 prior to the COVID vaccine. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient visited to Doctor or other healthcare professional office/clinic visit. Patient had taken treatment of topical cream for reported events. On 27Feb2021 (at 02:00 PM), the patient experienced insomnia - woken up in the middle of the night with elevated heart rate, elevated heart rate, rash on my back. The patient underwent lab tests and procedures which included sars-cov-2 test (SCREENING PANEL (WH) NASOPHARYNX SP LB, 230471, Nasal Swab): negative on 05Mar2021. The outcome of the events was not recovered.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Maternal exposure during pregnancy, Myalgia, Pyrexia
Clinical narrative: maternal exposure during pregnancy; Fever; chills/rigors; diffuse myalgias; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is a {enter maternal or fetus/baby} report.  A 31-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: EL9264) via intramuscular route, administered in right arm on 12Feb2021 11:15 as single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia and polycystic ovaries from an unknown date and unknown if ongoing. She had known allergies to Sulfa (sulfonamide) and had reaction of urticaria. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMIN); fish oil; thioctic acid, ubidecarenone (COENZYME Q10 + ALIPOIC ACID); vitamin d [vitamin D NOS]; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported. The patient previously took TDAD vaccine in left arm on 21Jan2021 for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: EL3247) via intramuscular route, administered in right arm on 22Jan2021 11:45 AM as single dose for COVID-19 immunisation.  It was reported that there was no COVID prior vaccination and no COVID tested post vaccination. The patient experienced fever with chills/rigors, diffuse myalgias on 13Feb2021 02:00. The patient underwent lab tests and procedures which included body temperature: 100.8 Fahrenheit on 13Feb2021. She was 34 weeks pregnant at the administration of BNT162B2 vaccine (maternal exposure during pregnancy). The LMP date was given as 17Jun2020 and Due Date was given as 24Mar2021. She received acetaminophen as treatment. The seriousness of events was reported as non-serious. The outcome of Fever, chills/rigors,diffuse myalgias events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives on stomach, hip arm and shoulder blades; Rash and hives on stomach, hip arm and shoulder blades; This is a spontaneous report from a contactable consumer (patient). A 94-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 94-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 07Jan2021 at 09:00 as SINGLE DOSE for covid-19 immunisation. Medical history included allergy with penicillin, and also many other cholesterols. The patient's concomitant medications were not reported. No other vaccine received in four weeks; no other medications received in two weeks. No covid prior vaccination. Not tested covid post vaccination. The patient previously took Bactrim and experienced allergy. On 11Jan2021 at 09:00, the patient experienced rash and hives on stomach, hip arm and shoulder blades. No treatment was received for events. No seriousness was reported. The outcomes of events were not recovered.  Information about lot/Batch number has been requested.  Follow-up (18Jun2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; fatigue; myalgia; sore arm; chills; This is a spontaneous report from a non-contactable pharmacist. A 77-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on Mar2021, as dose 2, single for COVID-19 immunization. The patient Medical history included , systemic inflammatory response syndrome from an unknown date and unknown if ongoing. The patient concomitant medications was not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on Feb2021 as dose 1, single for COVID-19 immunization. Patient did not experience any systemic reaction after the first dose. The patient was not pregnant at the time of vaccination.The patient did not received other vaccines in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19, and COVID-19 was not tested post vaccination. It was unknown that patient took other medications in two weeks and it was also unknown that patient had known allergies. On unspecified date, after second dose the patient experienced low grade fever, fatigue, myalgia ,sore arm , chills. The patient was not received treatment for the adverse events. The outcome for the events was recovered on unspecified date.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: My temperature yesterday all day was 101.8 F; I have achy and a horrible headache; I have achy and a horrible headache; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 67-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6205) via an unspecified route of administration, in left arm on 06Mar2021 as dose 1, single (at the age of 67-years-old) for COVID-19 immunization. Patient medical history included liver disorder, autoimmune disorder, blood cholesterol increased all from an unknown date and unknown if ongoing and COVID-19, thyroid. Patient stated he was asked us get vaccine and he has had Covid. The concomitant medications included obeticholic acid taken for liver disorder, pitavastatin calcium (LIVALO) at a dose of 1 mg every alternate day taken for blood cholesterol, pantoprazole 40 mg once a day, levothyroxine at a dose of 100 mcg (100 ug) start and stop date were not reported taken for thyroid. The patient experienced temperature yesterday all day was 101.8 F on 07Mar2021, patient had achy and a horrible headache on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit. Patient had the shot on Saturday (06Mar2021) and her temperature yesterday (07Mar2021) all day was 101.8 F. This was her first shot not the second. Patient took Levothyroxine for her thyroid but she did not have thyroid, 100 mcg. Therapeutic measures were taken for adverse events. Patient had been taking Tylenol 325 mg as a treatment. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart felt like it was going to pouind out of his chest; This is a spontaneous report from a contactable consumer (patient) via sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Feb2021 as dose 1 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received 1st vaccine on 20Feb2021. 2nd day "heart felt like it was going to pound out of his chest lasted 10 minutes than slowed down to a tolerable rate felt like he took a hit of speed" didnt do it until day after the shot wonders if he should get 2nd. I was just calling to let you guys know that I had a reaction through the first dose that I got. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6198), via an unspecified route of administration, in left arm, on Mar 3, 2021, at 16:30, single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia. Concomitant medication included Terazosin 5 mg and Finasteride 5 mg. Patient received the 1st dose of BNT162B2, via an unspecified route of administration, left arm, on Feb 10, 2021, at 16:30 (batch/lot number: EN6201), single dose, for COVID-19 immunisation. The patient tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Mar 4, 2021, at 07:00, patient experienced extreme pain in upper left shoulder area; increasing intensity, from 2nd shot through 8th day afterwards. Day 1 only slight pain. Days 2-3, no pain at all. Days 4-8, pain increased, each day. Patient did not receive any treatment for the events. At the time of this report, the outcome: not recovered. Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; body aches; fatigue; headache; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old non-Pregnant female patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No other vaccine was given in four weeks. No known allergies were reported. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in arm left on 15Feb2021 15:00 (at the age of 52-years-old) as single for COVID-19 immunization. Patient experienced sore arm after first dose. No Other medications was given in two weeks. On 07Mar2021 at 11:00 the patient experienced fever, body aches, fatigue and headache. The patient did not receive any treatment for the events. The outcome of the events was recovered on unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urinary tract infection
Clinical narrative: The rash was almost gone when she got her second vaccine; She was on an antibiotic for a urinary tract infection and took her last pill Friday morning; This is a spontaneous report support received from contactable consumer (patient) from a sponsored program.  A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date, as Dose 1 single, for COVID-19 immunization. Medical history and concomitant medication were not reported. Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she had her second dose on Friday 05Mar2021. She said that she might have done some thing wrong and reported that she was on a antibiotic for a urinary tract infection, on an unspecified date and took her last pill Friday morning. She said that she took Benadryl for the rash, occurred on an unspecified date, while she was on the antibiotic. She clarified that the antibiotic was Cipro and the rash was almost gone when she got her second vaccine. The patient's daughter, who was a nurse, sent her to get the Covid-19 vaccine and her daughter told her that she did not need to mention the rash. She said that the rash was just about gone and she did not think that the vaccine did anything to the rash. No further details provided. Therapeutic measures were taken as a result of rash with Benadryl and urinary tract infection with antibiotic- cipro. The outcome of the event rash was recovering and urinary tract infection was unknown, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Headache, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Itchy watery red eye with headache on left side; Itchy watery red eye with headache on left side; Itchy watery red eye with headache on left side; Itchy watery red eye with headache on left side; This is a spontaneous report from a non-contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 10:00 AM, (Batch/Lot Number: EN6208) as DOSE 1, SINGLE (at the age of 68-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. On 11Mar2021 at 08:00 PM, the patient experienced itchy watery red eye with headache on left side. The events were non serious and did not result in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Fever; Chills; Malaise; Headache; This is a spontaneous report from a contactable health care professional (Pharmacist) reported for himself. A 29-year-old male patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number:ER5318) via intramuscularly, administered on left arm on 25Jan2021 (at 13:30) (age at the time of vaccination was 29-year-old) as Dose 2 single for covid-19 immunization. The patient had medical history of Illness: Covid 19 from 05Apr2020 to 10Apr2020.On 11Nov2020, the patient was tested positive for SARS-Cov 2 (Covid-19) antibody Test. Historical vaccination included the patient received first dose of bnt162b2 (Formulation: Solution for injection, Batch/Lot number: EL1284, via intramuscularly administered on left arm (age at the time of vaccination was 29 years) on 04Jan2021 for Covid-19 immunization. On 26Jan2021 (at 01:00), the patient experienced Malaise, Fever/Chills and Headache. There was no treatment received for the events. The outcome of the events Malaise, Fever/Chills was resolved on 26Jan2021 while the outcome of the event headache was resolved on 30Jan2021.  Causal relationship: Is there a reasonable possibility that events Malaise, Fever/Chills and Headache was related to suspect products: Yes  The patient provide information to you regarding the reported adverse event with use of the Pfizer product and consider the Pfizer product had a causal effect with the adverse events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in my finger on the hand I had shot on my left arm; I got in between my elbow and where I had shot; Tingling; Feels like kind of burning; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199, NDC number and Expiry Date: Unknown), via an unspecified route of administration on 05Mar2021 (last Friday) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated I have been doing okay until this morning (on an unspecified date in 2021) I got up and I started to have numbness in my finger on the hand that I had shot on my left arm, I got in between my elbow and where I had shot, it felt like kind of tingling, burning, would that be any kind of side effect? When probed for vaccine expiration date, consumer stated, "Looks like, I had it 03May2021, I don't see, no (expiration date). The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: My left cheek started tingling and then it moved across my whole face and was numb for 3 hours; My left cheek started tingling and then it moved across my whole face and was numb for 3 hours; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 11Mar2021 16:45 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. Medical history included Known allergies: PCN (drug hypersensitivity) from an unknown date and unknown if ongoing. Patient did not test for COVID prior vaccination nor tested post vaccination. She did not receive other vaccine in four weeks. She had other unspecified medications in two weeks. On 11Mar2021 17:00 the patient experienced my left cheek started tingling and then it moved across my whole face and was numb for 3 hours. No treatment received for events. The outcome of the events was reported as recovered on 11Mar2021 20:00. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: felt it in my heart; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 57 years old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9261) via an unspecified route, administered in Left Arm on 29Jan2021 at 09:15 AM (57-year-old at time of vaccination) as Dose 1, single for Covid-19 immunization. The patient's medical history included High blood pressure and rapid heart rate. Meds control it. The patient had no known allergies. The patient's concomitant medications were not reported. Facility type vaccine was reported as Administration facility. The patient had no covid prior vaccination. The patient was not Covid tested post vaccination. The patient had no other vaccine within four weeks of Covid-19 vaccination. On 30Jan2021 ay 09:15 AM, (it was reported that 20 minutes after vaccination), the patient had felt it in her heart. The patient had not received any treatment medications for the resulted events. The outcome of the event was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information was expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chills, Fatigue, Headache
Clinical narrative: Fever; Chills; Headache; fatigue; Fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. I had a recent blood test confirming the presence of antibodies & I believe that my; stomachache; Sore arm; Insomnia; Tachycardia; Throbbing teeth; Body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 09Mar2021 at 12:00 pm (age at vaccination was 65 years) as dose 2, single for COVID-19 immunization. The patient's medical history included hypertension from an unknown date and COVID-19 from 04Apr2020 to an unspecified date (patient's positive COVID test was almost a year ago on 04Apr2020). The patient did not have any known allergies. Concomitant medications the patient received in 2 weeks included candesartan, atorvastatin, hydrochlorothiazide (MICROZIDE [HYDROCHLOROTHIAZIDE]), clonazepam (KLONOPIN) all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 16Feb2021 at 13:00 pm (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient underwent lab test which included Sars-cov-2 test: positive on 04Apr2020. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 16:30 pm, the patient experienced fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. She had a recent blood test confirming the presence of antibodies & she believed that her severe reaction was intensified due to their presence. She took Acetaminophen & Ibuprofen round the clock for the next 48 hours. The patient received treatment with over the counter medications. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Headache; fatigue; Fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. I had a recent blood test confirming the presence of antibodies & I believe that my; stomachache; Sore arm; Insomnia; Tachycardia; Throbbing teeth; Body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 09Mar2021 at 12:00 pm (age at vaccination was 65 years) as dose 2, single for COVID-19 immunization. The patient's medical history included hypertension from an unknown date and COVID-19 from 04Apr2020 to an unspecified date (patient's positive COVID test was almost a year ago on 04Apr2020). The patient did not have any known allergies. Concomitant medications the patient received in 2 weeks included candesartan, atorvastatin, hydrochlorothiazide (MICROZIDE [HYDROCHLOROTHIAZIDE]), clonazepam (KLONOPIN) all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 16Feb2021 at 13:00 pm (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient underwent lab test which included Sars-cov-2 test: positive on 04Apr2020. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 16:30 pm, the patient experienced fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. She had a recent blood test confirming the presence of antibodies & she believed that her severe reaction was intensified due to their presence. She took Acetaminophen & Ibuprofen round the clock for the next 48 hours. The patient received treatment with over the counter medications. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tachycardia, Teething
Clinical narrative: Fever; Chills; Headache; fatigue; Fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. I had a recent blood test confirming the presence of antibodies & I believe that my; stomachache; Sore arm; Insomnia; Tachycardia; Throbbing teeth; Body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 09Mar2021 at 12:00 pm (age at vaccination was 65 years) as dose 2, single for COVID-19 immunization. The patient's medical history included hypertension from an unknown date and COVID-19 from 04Apr2020 to an unspecified date (patient's positive COVID test was almost a year ago on 04Apr2020). The patient did not have any known allergies. Concomitant medications the patient received in 2 weeks included candesartan, atorvastatin, hydrochlorothiazide (MICROZIDE [HYDROCHLOROTHIAZIDE]), clonazepam (KLONOPIN) all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 16Feb2021 at 13:00 pm (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient underwent lab test which included Sars-cov-2 test: positive on 04Apr2020. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 16:30 pm, the patient experienced fever, chills, headache, fatigue, body aches, nausea, stomachache, sore arm, insomnia, tachycardia, throbbing teeth. She had a recent blood test confirming the presence of antibodies & she believed that her severe reaction was intensified due to their presence. She took Acetaminophen & Ibuprofen round the clock for the next 48 hours. The patient received treatment with over the counter medications. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.