chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: Fatigue; Chills; Throbbing headache; Muscle aches; Nausea; Inappetence; Unable to work and do normal daily; This is a spontaneous report from a contactable consumer. A 45-years-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, in left arm on 16Feb2021 10:45 (at 45-years age) as single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in left arm on 26Jan2021 10:30 AM (at 45-years age) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); atorvastatin (LIPITOR [ATORVASTATIN]); fish oil (FISH OIL); meloxicam (MELOXICAM). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced fatigue, chills, throbbing headache, muscle aches, nausea, inappetence, unable to work and do normal daily activities on 17Feb2021 10:00. Patient not tested for COVID-19 after the vaccination.  No treatment received for reported adverse event. The outcome of the events was resolving.  Follow-up (04Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Apologies for the typo. patient became aware of my clinical signs on 17Feb2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Fatigue; Chills; Throbbing headache; Muscle aches; Nausea; Inappetence; Unable to work and do normal daily; This is a spontaneous report from a contactable consumer. A 45-years-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, in left arm on 16Feb2021 10:45 (at 45-years age) as single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in left arm on 26Jan2021 10:30 AM (at 45-years age) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); atorvastatin (LIPITOR [ATORVASTATIN]); fish oil (FISH OIL); meloxicam (MELOXICAM). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced fatigue, chills, throbbing headache, muscle aches, nausea, inappetence, unable to work and do normal daily activities on 17Feb2021 10:00. Patient not tested for COVID-19 after the vaccination.  No treatment received for reported adverse event. The outcome of the events was resolving.  Follow-up (04Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Apologies for the typo. patient became aware of my clinical signs on 17Feb2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Throat irritation, Urticaria
Clinical narrative: Rash and hives on face; Rash and hives on face; throat itchiness; swollen face around eyes; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 15Feb2021 at 09:15 (at the age of 44-year-old) as a single dose for Covid-19 immunization in Hospital. The patient had known allergies: sulfa, penicillin, latex. The patient did not had any other medical history. 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. Concomitant medications (in two weeks) included melatonin, magnesium, cetirizine hydrochloride (ZYRTEC), and azelastine hydrochloride, fluticasone propionate (DYMISTA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number EL9262, expiry date: unknown) via an unspecified route of administration in left arm on 25Jan2021 at 08:15 as a single dose for Covid-19 immunization. On 20Feb2021 at 7:30, the patient experienced rash and hives on face, throat itchiness, and swollen face around eyes. Patient received treatment with Oratidine, Benadryl, and Prednisone for the events. The outcome of the events of rash and hives on face, throat itchiness, and swollen face around eyes was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain and pulling under the right arm; This is a spontaneous report from a contactable consumer (patient herself).   A 46-Year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: BN6203), via an unspecified route of administration on 23Feb2021 at 05:15 pm on the right arm as a single dose for covid-19 immunisation. The patient's medical history included allergies, anxiety and depression. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 25Feb2021 at 04:00 am, the patient reported pain and pulling under the right armpit. Patient stated that she did not took any treatment medication for the events. The outcome of the events was not resolved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Pyrexia
Clinical narrative: low fever (<100.0); joints ache; slight headache; injection site is sore; This is a spontaneous report from a contactable consumer (patient, self-reported). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported), via unspecified route of administration in left arm on 18Feb2021 at 13:00, as single dose for COVID-19 immunisation. The patient's medical history included AERD and asthma. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported), via unspecified route of administration in left arm on 28Jan2021 at 13:30, as single dose for COVID-19 immunisation. On 18Feb2021 at 23:00, the patient experienced low fever (<100.0), joints ache, slight headache and injection site sore. The adverse event does not required the treatment. No COVID prior vaccination and not COVID does not tested post vaccination. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Sensitive skin, Vaccination site pain
Clinical narrative: Skin sensitivity; mild pain on all areas of the skin; Skin sensitivity/mild pain on all areas of the skin, not just at injection site; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration, administered in left arm on 19Feb2021 15:00 (at the age of 44-years-old) as single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 29Jan2021 (discrepant information: also reported as 29Feb2021). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included moderately high blood pressure and drug allergy to penicillin. Concomitant medication included cholecalciferol (vitamin D). On 20Feb2021 09:00, the patient experienced skin sensitivity/mild pain on all areas of the skin, not just at injection site. (For example, mild pain when rolling up sleeves to wash hands. The patient did not receive any treatment. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills; muscle aches; This is a spontaneous report from a contactable consumer(patient). This 43-Year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247; Expiry date: Unknown) in the left arm as a single dose for COVID-19 immunization on 25Feb2021 at 09:00 AM. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247; Expiry date: Unknown) in the left arm as a single dose for COVID-19 immunization on 03Feb2021at 09:30 AM. The patient did not have any known allergies. The patient reported that she did not have any other vaccines in four weeks. The patient did not have any other medications in two weeks. The patient did not have COVID prior to vaccination and was not tested for COVID prior to vaccination. On 25Feb2021 at 9:00PM, the patient experienced chills and muscle aches. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swelling of lymph nodes in armpit of arm where injection was administered.; This is a spontaneous report from a contactable Consumer.   A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247, expiration date unknown), via an unspecified route of administration, administered in Right arm on 24-FEB-2021 11:45 (at the age of 43 old) as single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247, expiration date unknown), via an unspecified route of administration, administered in Right arm on 03Feb2021 11:00 AM for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (D3), fish oil and centrum multivitamin (patient medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021, the patient had experienced swelling of lymph nodes in armpit of arm where injection was administered. The patient not received treatment for the event. The adverse event did not resulted in emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of this report event outcome was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Chest discomfort, Chills, Dyspnoea
Clinical narrative: Fever of 105.3; tightness in chest; burning when breathing rapidly onset; fatigue; slight breathing issues; chills without fever; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 25-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, expiration date not reported), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 08:45 as single dose for COVID-19 immunization. Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283) was administered as a first dose on 21Jan2021 in arm left for COVID-19 immunization. The facility type for vaccine was hospital. Known allergies were reported with Penicillin, Cephalosporin, Ceclor, Sulfas and Tetanus Vaccine from an unknown date and unknown if ongoing and experienced drug hypersensitivity. Concomitant medications in two weeks included galcanezumab (EMGALITY), propranolol hydrochloride (PROPANOLOL) and armodafinil (NUVIGIL) taken for an unspecified indication, start and stop date were not reported. There were no other vaccines in 4 weeks. Patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Reportedly, sore arm and chills without fever began approx. 3 hours post inoculation at 11:45 on 13Feb2021 and persisted through the day. Chills progressively worsened throughout the day. Fever of 105.3, tightness in chest, and burning when breathing rapidly onset while sleeping (approx. 02:00). Symptoms lasted until approx. 19:30 the next day 14Feb2021 with fatigue and slight breathing issues (tightness and burning) lasting until two days post-inoculation 15Feb2021. The patient underwent lab tests and procedures which included body temperature as 105.3 on 14Feb2021. No treatment was taken for adverse event. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever of 105.3; tightness in chest; burning when breathing rapidly onset; fatigue; slight breathing issues; chills without fever; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 25-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, expiration date not reported), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 08:45 as single dose for COVID-19 immunization. Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283) was administered as a first dose on 21Jan2021 in arm left for COVID-19 immunization. The facility type for vaccine was hospital. Known allergies were reported with Penicillin, Cephalosporin, Ceclor, Sulfas and Tetanus Vaccine from an unknown date and unknown if ongoing and experienced drug hypersensitivity. Concomitant medications in two weeks included galcanezumab (EMGALITY), propranolol hydrochloride (PROPANOLOL) and armodafinil (NUVIGIL) taken for an unspecified indication, start and stop date were not reported. There were no other vaccines in 4 weeks. Patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Reportedly, sore arm and chills without fever began approx. 3 hours post inoculation at 11:45 on 13Feb2021 and persisted through the day. Chills progressively worsened throughout the day. Fever of 105.3, tightness in chest, and burning when breathing rapidly onset while sleeping (approx. 02:00). Symptoms lasted until approx. 19:30 the next day 14Feb2021 with fatigue and slight breathing issues (tightness and burning) lasting until two days post-inoculation 15Feb2021. The patient underwent lab tests and procedures which included body temperature as 105.3 on 14Feb2021. No treatment was taken for adverse event. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: swollen painful vaginal area- difficulty walking; swollen painful vaginal area- difficulty walking; difficulty walking; This is a spontaneous report from a contactable consumer (patient). A 84-year-old non-pregnant female patient received the BNT162B2 (COMIRNATY, Solution for injection, Lot number: EL9262) via unspecified route on left arm on 24Feb2021 at 10:15 (at the age of 84 years) as single dose for COVID-19 immunization.The patient had no medical history and no known allergies. The concomitant medication included Venlafaxine taken in two weeks of vaccination. There were no other vaccines administered in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021 patient experienced swollen painful vaginal area- difficulty walking. The patient did not receive treatment for the events. The clinical outcome of the event not recovered.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Oropharyngeal pain, Rash, Rhinorrhoea
Clinical narrative: Sore throat; runny nose; dizziness; diarrhea; face rash; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 24Feb2021 17:00 (Lot Number: EN6198) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Sertraline, Vitamin D NOS, cyanocobalamin (VITAMIN B12) for unknown indication. The patient experienced sore throat, runny nose, dizziness, diarrhea and face rash all on 24Feb2021 21:00. Outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a contactable other healthcare professional. A 54-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported), via an unknown route of administration on an unknown date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced body aches. It was reported that intermittent body aches since stop that may be due to recent covid-10 vaccination. MD aware and was changing medications. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Rash
Clinical narrative: I broke out with a rash, rash all over my body; Fever; I was pretty sick; This is a spontaneous report from a contactable consumer (Patient). This 64-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE; Solution for injection; Lot Number: EN5318; Expiry Date: Unknown), dose 2 on an unspecified route of administration on 19Feb2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history included High Blood Pressure. The patient's concomitant medications included Losartan Every morning for High blood pressure. The patient previously received first dose of bnt162b2, lot number EL3248 for Covid-19 immunization. Patient reported that I had my second Covid vaccine done on Friday and I was pretty sick on 19Feb2021, Saturday ran a fever on 20Feb2021. Sunday I felt better but Sunday night I broke out with a rash on 21Feb2021. I have a rash all over my body. I just got home from the doctor's office and he told me to call and report that I have a body rash from this. He gave me some steroids and some cream to put on the rash but I wanted to report that. Treatment received for rash as Prednisone and he gave me Triamcinolone cream. The outcome of the events illness and pyrexia were recovering and outcome of the event rash was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Pruritus
Clinical narrative: Itchy; Chills; sore eyes; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female (non pregnant) patient received first dose of Pfizer BNT162B2 (BNT162B2, Solution for injection, Lot number; EN6203 and expiry date was not provided) via an unspecified route of administration,  administered in left arm region on 25Feb2021 16:15 (at the age of 54-year-old) as single dose for COVID-19 immunisation.  Patient was not pregnant at the time of vaccination. Patients medical history includes known allergies to Penicillin. The concomitant medications were not provided. The patient was not diagnosed with COVID prior to vaccination. And  patient had not tested for COVID post vaccination. On 26FEB2021 12:00 AM, the patient experienced itchy, chills and sore eyes. No treatment was taken for the events. The outcome of the events was reported as not recovered.  No follow up attempts are possible. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: feelings of sadness; This is a spontaneous report from a non-contactable other healthcare professional (patient).   A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Feb2021 16:00 (4:00 PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included chronic pelvic pain, depression, Anxiety, Pudendal nerve neuralgia, Endometriosis, factor V leiden all from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient had no covid prior vaccination and is not covid tested post vaccination. The patient was vaccinated at a School or Health Clinic. There were no other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) lamotrigine (LAMICTAL); venlafaxine hydrochloride (EFFEXOR); ondansetron (ZOFRAN [ONDANSETRON]); topiramate (TOPAMAX); levorphanol (LEVORPHANOL); all taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone, levoquin and cipro [ciprofloxacin] and experienced drug hypersensitivity. It was reported that the patient experienced feelings of sadness on 01Mar2021 at 01:15 AM. The outcome of the event was not recovered. It was unknown if treatment for the event was initiated.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3247), via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient did not have COVID prior to the vaccination. It was reported that the patient got a headache on 24Feb2021, the day after receiving the vaccine. The patient was tested for COVID via a nasal swab on 25Feb2021 with a result of negative. The outcome of the event was unknown.   No follow-up attempts are possible; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: her son did not feel good; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that her son did not feel good after receiving his COVID-19 shot. Caller called to ask about the possible reactions she could experience when she gets her first shot. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: UNK
Symptoms: Ageusia, Arthralgia, Drug interaction, Dry mouth, Headache
Clinical narrative: Interaction with blood thinners and cholesterol medicine (Plavix and Lipitor); Dry mouth; Joint pain; Muscle pain; I haven't slept in three days; Headache; Fever; Nausea; I cant taste Water; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization; atorvastatin calcium (LIPITOR), with route of administration, therapy dates, dose and frequency unspecified, for abnormal cholesterol; and clopidogrel bisulfate (PLAVIX), with route of administration, therapy dates, dose and frequency unspecified, as blood thinner. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had dry mouth; BNT162B2 had interaction with the patient's blood thinners and cholesterol medicine (clopidogrel bisulfate and atorvastatin calcium); joint pain; muscle pain; had not slept for three days; headache; fever; nausea; and could not taste water. The action taken in response to the events was not applicable for BNT162B2; and was unknown for clopidogrel bisulfate and atorvastatin calcium. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: UNK
Symptoms: Myalgia, Nausea, Pyrexia, Sleep disorder
Clinical narrative: Interaction with blood thinners and cholesterol medicine (Plavix and Lipitor); Dry mouth; Joint pain; Muscle pain; I haven't slept in three days; Headache; Fever; Nausea; I cant taste Water; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization; atorvastatin calcium (LIPITOR), with route of administration, therapy dates, dose and frequency unspecified, for abnormal cholesterol; and clopidogrel bisulfate (PLAVIX), with route of administration, therapy dates, dose and frequency unspecified, as blood thinner. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had dry mouth; BNT162B2 had interaction with the patient's blood thinners and cholesterol medicine (clopidogrel bisulfate and atorvastatin calcium); joint pain; muscle pain; had not slept for three days; headache; fever; nausea; and could not taste water. The action taken in response to the events was not applicable for BNT162B2; and was unknown for clopidogrel bisulfate and atorvastatin calcium. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Vertigo
Clinical narrative: chills; dizziness; spinning; nauseous; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (BNT162B2 Batch/Lot Number not provided) dose 1 on an unspecified date via an unspecified route of administration as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. O an unspecified date the patient experienced chills, dizziness, spinning, nauseous. Patient also wanted to know if she was going to get a medical certificate once she was done with the second dose of the vaccine since she had to travel to different country. outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Sunburn
Clinical narrative: front of both thighs looked sunburnt, were beet red; front of both thighs looked sunburnt, were beet red; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, expiry date:30Jun2021) via intramuscular at left arm on 24Feb2021 as single dose for COVID -19 Immunization. Patient medical history included Floxin, Penicillin, Prednisone, lacerated cornea and Bee Stings and allergic to chigger bites. He did have to use Prednisone for a lacerated cornea last year and he had to put drops in his eye, but he doesn't have any leftover or anything to provide for the report. Concomitant medication was not reported. No prior vaccination received within 4weeks. On 24Feb2021 patient experienced front of both thighs looked sunburnt, were beet red and thighs looked totally sunburn. He stated that the sunburn didn't hurt. He had no pain. No treatment was given to the event. Outcome of event was recovered on 25Jan2021.  Caller declined to take down the report reference number. No further details were provided or obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: tested positive for covid 19; tested positive for covid 19; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the female patient of an unspecified age (reported as 41, units unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After her first dose the patient was tested positive for covid 19 on 24Feb2021 (tested positive 2 weeks later for covid). The patient also stated that she still had a little bit of a headache but should complete isolation soon. Her second dose was schedule for 01Mar2021. Patient would like to know if it was safe for her to proceed with second dose and when she should receive her second dose, timing-wise, after having COVID-19 and that her doctor mentioned waiting 90 days after having COVID-19. The patient was called today (04Mar2021) to see when she should take her second dose or how she should go about getting vaccinated now. The outcome of the events headache was not recovered and other events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Chills; FEVER 99.8; Foggy Brain; Fatigue after 12 hours-slept 20 hours (extreme); This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL2302), via an unspecified route of administration, administered in Arm Left on 23Jan2021 12:30 as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medication included Levothyroxine (LEVOTHYROXINE) (MANUFACTURER UNKNOWN) taken for an unspecified indication from 2000 and ongoing; Dulera (FORMOTEROL FUMARATE, MOMETASONE FUROATE) (MANUFACTURER UNKNOWN) taken for an unspecified indication from 2018 and ongoing; salbutamol (ALBUTEROL HFA) (MANUFACTURER UNKNOWN)  taken for an unspecified indication from 2017 and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taken for an unspecified indication from 2016 and ongoing; alprazolam (XANAX) (MANUFACTURER UNKNOWN)  (Do not take day before or week after) taken for an unspecified indication from 2000 and ongoing. On 23Jan2021, patient experienced severe fatigue after 12 hours slept (total fatigue was 5 days (with initial being worst)). Patient experienced Chills, foggy brain (4 days) on an unspecified date. Patient experienced fever 99.8 after each dose, side effects were twice as bad after 2nd dose, but didn't start until after 12 hours. No admission to hospital due to the event, No Any treatment received. The outcome of the event Fatigue after 12 hours slept, Chills was recovered. The outcome of the events Chills and Foggy Brain were unknow.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She woke up Friday 26Feb2021 with pain under the right breast and right arm that went down to the waist; This is a spontaneous report from a contactable consumer. A 84-year-old female patient (non-pregnant at the time of vaccination) received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Unknown) (age at vaccination: 84 years) via an unspecified route of administration on right arm on 25Feb2021 03:45 PM as single dose for covid-19 immunization. The patient medical history included allergies (unspecified). 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 Concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2, Batch/Lot Number: unknown), via unspecified route of administration on left arm on 04Feb2021 at 04:30 PM. The patient had not received any other vaccine in 4 weeks. On Friday, 26Feb2021 at 08:00 AM, patient woke up with pain under the right breast and right arm that went down to the waist. The patient did not receive any treatment for the events. The Outcome of the event was recovering  No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: lower HTN (160/98); This is a spontaneous report from a contactable other healthcare professional. A contactable other healthcare professional reported in response to HCP Letter sent in cross-referenced case.  A 65-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an intramuscular route of administration, in deltoid right on 28Jan2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient medical history included, first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, frequency (0.3cc) solution for injection, Batch/Lot Number: EH-9899), via an intramuscular route of administration in Lt Deltoid (Arm Left) on 23Dec2020; 15:48 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE (s) includes, Father, HTN died ago 80 Lung cancer (Fire fighter), Sister: HTN. Concomitant medications included Losartan (MANUFACTURER UNKNOWN) taken for indication, suspected underlying HTN from 07Jan2021 and Continues. Most recent dose (daily dose and regimen including Formulation, Route, Frequency): 50mg PO (per oral) Daily; clonidine (MANUFACTURER UNKNOWN) taken for an unspecified indication from 28Jan2021 to an unspecified stop date.   On 28Jan2021 at 12:48 (15 min after admin), patient had low HTN (160/98) resolved with Clonidine at site. Adverse event required visit to the physician office, visit to Emergency Room was not required. Relevant Tests were None. The outcome of event was recovered.   Causal Relationship, a reasonable possibility that the event is related to suspect product/s was reported as Yes.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Hypertension cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fear, Headache, Pain, Pyrexia
Clinical narrative: made ill like had covid; body ache; high fever; no energy/weakness/low energy today; felt like dickens/terrible; headache; This is a spontaneous report from a contactable consumer (patient himself). This (age:64 unit: unknown) male consumer reported that the patient received first dose of bnt162b2(bnt162b2, Formulation: Solution for injection, Lot Number: unknown, Expiry date: unknown) via an unspecified route of administration as a single dose on 05Mar2021 for COVID-19 immunization. The patient's medical history included COVID in October, COVID infection turned into pneumonia and the patient had stage 4 lung cancer survivor. The patient's concomitant medications were not reported. On 05Mar2021, the patient experienced ill like had COVID, high fever, body ache, no energy, weakness, low energy today, felt like the dickens, terrible and headache. There was no way that he was going to take the 2nd shot. He felt like the dickens. Everything was fine. The storm hit Friday night, lasted all day yesterday. He still have the headache and weakness, low energy today. That shot made him feel like he got COVID like he did in October. He heard people who had COVID have real bad reactions after the 2nd dose than the first. If it didn't make him feel like he had COVID then he would take the 2nd dose. It was terrible. Caller wanted information regarding efficacy of 1 dose.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: made ill like had covid; body ache; high fever; no energy/weakness/low energy today; felt like dickens/terrible; headache; This is a spontaneous report from a contactable consumer (patient himself). This (age:64 unit: unknown) male consumer reported that the patient received first dose of bnt162b2(bnt162b2, Formulation: Solution for injection, Lot Number: unknown, Expiry date: unknown) via an unspecified route of administration as a single dose on 05Mar2021 for COVID-19 immunization. The patient's medical history included COVID in October, COVID infection turned into pneumonia and the patient had stage 4 lung cancer survivor. The patient's concomitant medications were not reported. On 05Mar2021, the patient experienced ill like had COVID, high fever, body ache, no energy, weakness, low energy today, felt like the dickens, terrible and headache. There was no way that he was going to take the 2nd shot. He felt like the dickens. Everything was fine. The storm hit Friday night, lasted all day yesterday. He still have the headache and weakness, low energy today. That shot made him feel like he got COVID like he did in October. He heard people who had COVID have real bad reactions after the 2nd dose than the first. If it didn't make him feel like he had COVID then he would take the 2nd dose. It was terrible. Caller wanted information regarding efficacy of 1 dose.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: I received both dose of the vaccine and I developed asthma after the first dose and it was worse after the second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 75-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown), both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received both doses of the vaccine and developed asthma after the first dose and it was worse after the second dose. The asthma is gone now but she had it for 2 months. The events assessed as non-serious. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive Covid 19 test; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACINE; lot number EN5318) via an unspecified route of administration on 11Feb as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, he had the 1st Pfizer vaccine dose on 11Feb and on 12Feb he received antiviral treatment for a positive Covid 19 test. My 2nd Vaccine dose was due on 04Mar. When can he get 2nd vaccine dose. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 12Feb2021. The outcome of COVID-19 was unknown.   Information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient with unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on Monday, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified Monday, the patient tested positive. The patient asking if she should still receive the second vaccine. The patient underwent lab tests and procedures which included COIVD-19 test which was positive. Outcome of the event was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Maternal exposure during pregnancy
Clinical narrative: patient's sugars spiked by 40-60 points and sustained at elevated levels despite not eating any triggering foods; pregnant :Yes; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 at 04:15 (at the age of 40 years) as single dose in the left arm for COVID-19 immunization. Medical history included gestational diabetes and asthma. Last menstrual period was on 11Jun2020. Concomitant medications included pyridoxine hydrochloride (B6); doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]); acetylsalicylic acid (BABY ASPIRIN); magnesium. The patient previously took methylprednisolone (MEDROL DOSEPAK) and had allergies. 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 became pregnant while taking BNT162B2. The patient was 38 weeks pregnant at the onset of the event and was due to deliver on 01Apr2021. On 10Mar2021, the patient's sugars spiked by 40-60 points and sustained at elevated levels despite not eating any triggering foods. It was unknown if patient receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product leakage
Clinical narrative: This is a spontaneous report received from a contactable other health professional via a Pfizer Sponsored Program. A patient of unspecified age and gender received BNT162B2 (Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a physician manager who was administering Pfizer covid-19 vaccine in her area. She mentioned, while she was preparing the vaccine and mixing it, there was 1 vial that leaked out since it was not in full amount. She wanted to know what she could do moving forward. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had his first dose of the covid-19 vaccine/10 days later tested positive for covid-19; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported for himself that a male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via unspecified route of administration on 01Jan2021 at a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient stated that he had his first dose of the covid-19 vaccine on 01Jan2021, 10 days later tested positive for Covid-19 on 11Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caller received 1st dose of Covid vaccine 20Feb and tested positive for Covid 22Feb.; This is a spontaneous report from a Pfizer-sponsored program from contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 20Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Reporter states patient received 1st dose of COVID vaccine 20Feb2021 and tested positive for COVID 22Feb2021. patient wondering if she would be valuable in a clinical trial for COVID vaccine. The outcome of event was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This is a spontaneous report from a contactable nurse (patient's daughter) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via an unspecified route of administration on 03Mar2021 (lot number and expiration date were not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient tested positive for covid on Monday, 08Mar2021. The patient have their second vaccination scheduled for 24Mar2021. The nurse wanted to know if the patient tested negative in two weeks could she take the second vaccination. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT16B2, a temporal relation between the event Covid-19 and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I didn't know I was pregnant when I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unspecified), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient didn't know she was pregnant when she got the vaccine. She wanted to see if she can be of any help.  Information on the lot/batch number has been requested.