chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: retested and was found positive; COVID-19 virus test positive; ear infection; sinusitis; Watery diarrhea; feeling sick; The following day I woke up with sinus congestion; Intense muscle aches; Headache; I began with a cough that night; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Batch/Lot Number: Er8727) as SINGLE DOSE; and first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:00 AM (Batch/Lot Number: En6200); both for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Public Health department (also reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (reported as List of any other medications the patient received within 2 weeks of vaccination) included benazepril, hydrochlorothiazide, protonix, oxymetazoline hydrochloride (CLARITIN ALLERGIC) and Methotrexate; all taken for an unspecified indication, start and stop date were not reported. The patient reported that:  "On 14Mar2021 at 10:00 PM, I began with a cough that night. The following day (15Mar2021) I woke up with sinus congestion, cough, muscle aches and headaches. The following day the same. I tested negative that day (Nasal Swab on 16Mar2021). The following day (17Mar2021) I received my 2nd dose of vaccine still feeling sick and cough which I informed PH nurse of. Later that night still same symptoms but with watery diarrhea.  No stomach cramps or pain to indicate diarrhea. I went the following day (18Mar2021) to my physician and was told I had ear infection and sinusitis. I was given meds. Yesterday morning I woke up with intense muscle aches and headache. I retested and was found positive (Nasal Swab) on 19Mar2021." The outcome of the events was not recovered. It was reported that treatment were received for the adverse event which includes: Amoxocillin, Flonase, albuterol and promethazine. The events resulted Doctor or other healthcare professional office/clinic visit.   Further information needed, further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: retested and was found positive; COVID-19 virus test positive; ear infection; sinusitis; Watery diarrhea; feeling sick; The following day I woke up with sinus congestion; Intense muscle aches; Headache; I began with a cough that night; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Batch/Lot Number: Er8727) as SINGLE DOSE; and first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:00 AM (Batch/Lot Number: En6200); both for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Public Health department (also reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (reported as List of any other medications the patient received within 2 weeks of vaccination) included benazepril, hydrochlorothiazide, protonix, oxymetazoline hydrochloride (CLARITIN ALLERGIC) and Methotrexate; all taken for an unspecified indication, start and stop date were not reported. The patient reported that:  "On 14Mar2021 at 10:00 PM, I began with a cough that night. The following day (15Mar2021) I woke up with sinus congestion, cough, muscle aches and headaches. The following day the same. I tested negative that day (Nasal Swab on 16Mar2021). The following day (17Mar2021) I received my 2nd dose of vaccine still feeling sick and cough which I informed PH nurse of. Later that night still same symptoms but with watery diarrhea.  No stomach cramps or pain to indicate diarrhea. I went the following day (18Mar2021) to my physician and was told I had ear infection and sinusitis. I was given meds. Yesterday morning I woke up with intense muscle aches and headache. I retested and was found positive (Nasal Swab) on 19Mar2021." The outcome of the events was not recovered. It was reported that treatment were received for the adverse event which includes: Amoxocillin, Flonase, albuterol and promethazine. The events resulted Doctor or other healthcare professional office/clinic visit.   Further information needed, further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: muscle spasms; muscle pain; This is a spontaneous report received from a female contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Right arm on 18Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, Muscle spasms and muscle pain on 19Mar2021. The patient reported, she received the Pfizer covid vaccine 18Mar2021 in her right arm. However, as of 19Mar2021, she is having issues on her left side: muscle spasms, muscle pain all down by her neck, her arm. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash
Clinical narrative: On sunday she developed a rash on her shoulder that looks like poison ivy; itchiness on her wrist; wake her up last night; This is a spontaneous report from a contactable consumer (patient's husband). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "Husband, calling on behalf of wife, cold transfer, received first dose of the Pfizer BioNTech Covid on Thursday. On Sunday she developed a rash on her shoulder that looked like poison ivy. The rash had since spread to her elbow and wrist. It had been getting better since treating with poison ivy cream, although the itchiness on her wrist did wake her up last night (23Mar2021)". Reported asked that "was this normal; could she get the second dose; and was it a good idea to treat with poison ivy cream, how could they treat it. Outcome of the event rash was recovering whereas other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: throwing up; stomach cramps; dry heaving; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 23Mar2021 11:30 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she got her first shot of the vaccine yesterday i.e. 23Mar2021 at 11:30 EST.  About 1:45 EST this morning i.e. 24Mar2021, she started throwing up and have been throwing up ever since. She had constant stomach cramps and dry heaving. She don't even know if get the second shot. She can't keep anything down. Even throwing up water. The outcome of event was unknown.  Information about batch/lot number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced headaches, chills, "loose stomach" i.e. diarrhea, all on Mar2021. The event outcome for events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Condition aggravated, Fatigue, Pain in extremity
Clinical narrative: weakness; tiredness; his knees, which were normally in a "constant state of pain", started "flaring up; his knees, which were normally in a "constant state of pain", started "flaring up; injection site also "flared up"; arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included constant state of knee pain. The patient's concomitant medications were not reported. It was reported that the caller was a 25-year-old male who received his Pfizer BioNTech COVID-19 vaccine at about 11:00AM on Monday and by Tuesday around 4:00-5:00, he started experiencing side effects that he would like to know if they were related to the vaccine. Caller stated that he was "struck with a feeling of weakness and tiredness" like he was sick. He also reported that his knees, which were normally in a "constant state of pain", started "flaring up." He also reported that the injection site also flared up around the same time. Caller stated that now his knees were back to normal, he does not feel fatigued, and that his arm soreness was "mostly gone." He was just unsure if these side effects could be related to the vaccine as they occurred "28 to 29 hours" after he received his dose. It was unknown if the patient received the treatment for the events. Outcome of the event fatigue, his knees which were normally in a constant state of pain started flaring up were recovered on an unspecified date, arm soreness was recovering and unknown for other events.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: weakness; tiredness; his knees, which were normally in a "constant state of pain", started "flaring up; his knees, which were normally in a "constant state of pain", started "flaring up; injection site also "flared up"; arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included constant state of knee pain. The patient's concomitant medications were not reported. It was reported that the caller was a 25-year-old male who received his Pfizer BioNTech COVID-19 vaccine at about 11:00AM on Monday and by Tuesday around 4:00-5:00, he started experiencing side effects that he would like to know if they were related to the vaccine. Caller stated that he was "struck with a feeling of weakness and tiredness" like he was sick. He also reported that his knees, which were normally in a "constant state of pain", started "flaring up." He also reported that the injection site also flared up around the same time. Caller stated that now his knees were back to normal, he does not feel fatigued, and that his arm soreness was "mostly gone." He was just unsure if these side effects could be related to the vaccine as they occurred "28 to 29 hours" after he received his dose. It was unknown if the patient received the treatment for the events. Outcome of the event fatigue, his knees which were normally in a constant state of pain started flaring up were recovered on an unspecified date, arm soreness was recovering and unknown for other events.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at the site of injection with a ring around it; This is a spontaneous report from a contactable consumer (patient) via Medical information Team. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching at the site of injection with a ring around it (non-serious) on an unspecified date. Caller has received his Pfizer Covid vaccine. Caller experienced itching at the site of injection with a ring around it. Caller asking if that's normal. The outcome of event was unknown.    Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: The patient was concerned that the vaccine did not work for her; This is a spontaneous report from contactable consumer reported via Medical information team. A female patient of unknown age received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) both via an unspecified route of administration on unknown date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that when she received her first dose of the BNT162B2, she was scheduled to receive her second dose 3 weeks later. However, she received an email that said that the vaccination site had run out of vaccines and her second dose was rescheduled for 4 weeks later instead, which she received yesterday. The patient stated that, she did not have any side effects after receiving both doses. She stated that she didn't even have a sore arm. The patient was concerned that the vaccine did not work for her because she did not have side effects. She wonders if it was because she was older and that's why she did not experienced any side effects. At the time of this report the event outcome was unknown.  Information about batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have tested positive today for Covid; I have tested positive today for Covid; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 10:00AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that he received other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that he had tested positive today for covid on 24Mar2021 11:00. No treatment received for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Mar2021 (Test Name: pcr). Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other hcp reported for herself.   A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 30 years old, intramuscularly administered in Arm Left on 23Mar2021 09:00 AM (Lot Number: EN5318), at single dose for covid-19 immunisation.    Medical history included Repaired coarctation of the aorta, bicuspid aortic valve, dilated ascending aorta from an unknown date and unknown if ongoing, Allergies to Sulfa drugs and propranolol. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN5318), at the age of 30 years old, intramuscularly administered in Arm Left on 02Mar2021 10:15 AM, at single dose for covid-19 immunisation.   Concomitant medications received within 2 weeks of vaccination included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), magnesium, fish oil, fexofenadine hydrochloride (ALLEGRA) as needed, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced Chills, sweats, body aches, headache, fever, all on 23Mar2021 with outcome of recovered on unknown date.  No treatment received for the adverse events.   No any other vaccines received within 4 weeks prior to the COVID vaccine, and Prior to vaccination, the patient was not diagnosed with COVID-19, has not been tested for COVID-19.   No follow-up attempts possible. No further information expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: multi-phase anaphylaxis/several anaphylactic reactions; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program. A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 17Mar2021 at 12:45 (at the age of 17-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to sticking plaster (adhesive) and diabetes type 1. Family history included allergies to some antibiotics in the mother. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced multi-phase anaphylaxis/several anaphylactic reactions in Mar2021, which caused hospitalization and was reported as an important medical event and life-threatening. The clinical course was reported as follows: The patient had multi-phase anaphylaxis following his first dose of vaccination. He went to three different hospitals and was in the pediatric intensive care unit (PICU) at the time of reporting. The patient was heavily sedated, intubated, and on a ventilator for 3 days. The clinical outcome of multi-phase anaphylaxis/several anaphylactic reactions was unknown.   Follow-up attempts are completed. No further information expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: severe reaction to the vaccine had a anaphylactic shock had 2 more the next day; This is a spontaneous report received from a contactable consumer. A 17-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), 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 includes diabetic (reported as Takes diabetic med humaran). It was reported that the patient experienced severe reaction to the vaccine had an anaphylactic shock had 2 more the next day. It was added that very sedated fighting it so he dont die. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive a few days after COVID vaccine; Patient tested positive a few days after COVID vaccine; This is a spontaneous report from a contactable consumer reported that a male patient of unspecified age received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE), on an unspecified date at single dose (Batch/lot number: Unknown) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient tested positive a few days after COVID vaccine. It was unknown if treatment received for the adverse event. The test for investigation of the patient was unknown, result was positive. The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics,  patient general health condition and the immune system function. On conservative basis, the possible causality cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2 RNs I work with got their 2nd dose and tested positive for COVID the same week.; 2 RNs I work with got their 2nd dose and tested positive for COVID the same week.; This is a spontaneous report from a contactable nurse. This was one of two reports. A patient of unknown age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration as a single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration as a single dose, both the doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported that 2 RNs I work with got their 2nd dose and tested positive for COVID the same week (as reported). The outcome for the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The contribution of the suspect drug to the onset of event 'drug ineffective' cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.,Linked Report(s) : US-PFIZER INC-2021328276 same reporter, drug and AE, different patient
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: The colitis has been controlled with Simponi for 5 years/had a flare up with rectal bleeding; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received dose 1 of bnt162b2 (covid 19 VCCINE; manufacturer not reported), via an unspecified route of administration, administered in left arm on 22Mar2021 11:15 (Batch/Lot Number: EP6955 6023162) as SINGLE DOSE for covid-19 immunization. Medical history included hemophilia B and ulcerative colitis. The colitis has been controlled with Simponi for 5 years. The patient also had sulfa allergy since an unspecified date. 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 hasn't been tested for COVID-19. Concomitant medication included multivitamins taken for an unspecified indication, start and stop date were not reported; and golimumab (SIMPONI) taken for an unspecified indication, start and stop date were not reported.  On 24Mar2021 22:30, the patient had a flare up with rectal bleeding had a flare up with rectal bleeding. He had to infuse with factor (BENEFIX) overnight and also take prednisone he had on hand. He will see the GI doctor tomorrow. The outcome of event was unknown. The reporter considered the event as serious, life threatening.   Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a contactable consumer received from Pfizer sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 21Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia  on an unspecified date with outcome of unknown. It was further reported that patient had 1st shot on 21Feb2021, missed second shot as she was taking antibiotics for her pneumonia. She's done taking medicine for more than a week now. Asking, if she's still allowed to take the second  shot.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia
Clinical narrative: Low grade fever 100.2; chills; malaise; This is a spontaneous report from COVAES. A 44-year-old male contactable consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 13:30 as single dose in left arm for covid-19 immunization. The patient medical history included mild food allergy to soy and tree nuts. Historical vaccine included bnt162b2 on 03Mar2021 (at 13:00 PM, vaccine location=Left arm, dose number=1, lot number=EL3247). Concomitant medications included cetirizine hydrochloride (ZYRTEC) from Mar2021 and multi vitamin. On 24Mar2021 at 21:00, the patient experienced low grade fever 100.2, chills and malaise. The patient did not received treatment for the events. The outcome of the events was recovering   Information on the suspect expiry date has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Soreness in arm at injection site.; General body aches and pains; intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Left Arm on 24Mar2021 01:15 am as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension (controlled w/medication). Concomitant medication(s) (received within 2 weeks of vaccination) included enalapril maleate (10 mg/day). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Other. Allergies to medications, food, or other products: No. Historical vaccine included BNT162B2 on 04Mar2021 01:15 am (First Dose, Left arm, Lot No EL3247). The patient experienced soreness in arm at injection site, general body aches and pains, intermittent headache; all (non-serious) on 24Mar2021 23:45. Treatment was not received for the adverse event Outcome of all events was recovering.    Follow up attempts are needed. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Soreness in arm at injection site.; General body aches and pains; intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Left Arm on 24Mar2021 01:15 am as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension (controlled w/medication). Concomitant medication(s) (received within 2 weeks of vaccination) included enalapril maleate (10 mg/day). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Other. Allergies to medications, food, or other products: No. Historical vaccine included BNT162B2 on 04Mar2021 01:15 am (First Dose, Left arm, Lot No EL3247). The patient experienced soreness in arm at injection site, general body aches and pains, intermittent headache; all (non-serious) on 24Mar2021 23:45. Treatment was not received for the adverse event Outcome of all events was recovering.    Follow up attempts are needed. Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness
Clinical narrative: Dizziness; confusion; This is a spontaneous report from a non-contactable consumer(patient).  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on left arm on 24Mar2021 at 15:30 (at the age of 54-year-old) at a single dose for COVID-19 immunization. The patient was vaccinated at Pharmacy/Drug store. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. Medical history included Pencillin allergy. Concomitant medications included Multivitamin and Vitamin D. The patient experienced dizziness and confusion on 24Mar2021 at 15:45. The events were reported as non-serious. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: nausea; headaches; body aches; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. An elderly female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number- ER8730), via an unspecified route of administration in right arm, on 24Mar2021 as a single dose for COVID-19 immunization. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Medical history included cancer a few times, blood pressure and cholesterol abnormal.  Concomitant medications included Vitamin D, Magnesium, selenium, multivitamin and unspecified medication for blood pressure and cholesterol. The patient experienced nausea, headaches and body aches on 25Mar2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he received the first Pfizer dose and later was diagnosed with covid; he received the first Pfizer dose and later was diagnosed with covid; This is a spontaneous report received from a contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that he received the first Pfizer dose and later was diagnosed with covid. Also he did received a monoclonal antibody treatment. He said he heard that he had to wait 3 months to get the vaccine again. Asking if he this would have a potential interaction with the vaccine and if he can get the second dose of the vaccine. Outcome of event was unknown.  Information on lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, on 15Feb2021 (Lot Number: GN6201) as single dose, dose 1st via an unspecified route of administration on 21Jan2021 14:00 (Lot Number: EL3302) as single dose for covid-19 immunization. The anatomical location for both was left arm. Medical history included chronic obstructive pulmonary disease. Concomitant medications included: heart pill within 2 weeks of vaccination. On 11Mar2021, the patient had lab nasal swab test and the result was positive. The patient did not receive any treatment for the events. Patient was not diagnosed with COVID-19 Prior to vaccination. The outcome of events was reported as unknown.  Follow up needed, further information requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: The patient underwent lab tests and procedures which included SARs-cov-2 test results positive for PCR test on unspecified date.; had a positive PCR COVID test; This is a spontaneous report received from a contactable consumer or other non-health care professional via a Pfizer sales representative. A 74-years-old female patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and first dose on unspecified date and unspecified route of administration both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced positive for PCR covid test after the second dose administration of Pfizer covid vaccine. The patient underwent lab tests and procedures which included SARs-cov-2 test results positive for PCR test on unspecified date. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Dizziness
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization, and experienced sore arm, dryness on tip of tongue, and feeling of the dryness felt after burn tongue lingered for several hours and resolved on own. The patient experienced low grade fever and arm soreness starting 5 to 6 hours after 2nd shot of vaccine. Patient had fever of 101 15 hours after shot. Patient also had chills, very cold feet, pain in feet, quads, hips and lower back, headache, nausea and faint feeling. The temperature was decreased to 99 with 1000 mg of paracetamol (TYLENOL). The outcome of the event "fever" was recovering; of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization, and experienced sore arm, dryness on tip of tongue, and feeling of the dryness felt after burn tongue lingered for several hours and resolved on own. The patient experienced low grade fever and arm soreness starting 5 to 6 hours after 2nd shot of vaccine. Patient had fever of 101 15 hours after shot. Patient also had chills, very cold feet, pain in feet, quads, hips and lower back, headache, nausea and faint feeling. The temperature was decreased to 99 with 1000 mg of paracetamol (TYLENOL). The outcome of the event "fever" was recovering; of other events was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Herpes zoster, Muscle spasms, Musculoskeletal pain
Clinical narrative: diagnosed with Shingles/zoster on 23Mar2021; Most concerning is the rash on upper right thigh. Began within 48 hours and has continued to spread. It is raised and sensitive to touch.; It began with fatigue within 3 hours of vaccination; Achy leg muscles.; Intense leg cramps began with in 36 hours; Achy lower back; progressed the achiness in right thigh, buttock and lower back; progressed the achiness in right thigh, buttock and lower back; This is a spontaneous report received from a contactable consumer (patient) and contactable Healthcare Care Professional. This Healthcare Care Professional reported in response to the HCP letter sent was processed together. A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date: Not provided) via unspecified route on 18Mar2021 at 09:45 PM in the right arm at single dose for COVID-19 immunization. Patient's medical history included stem cell transplant 2 years ago and allergic to Lobster and Penicillin. On 26Feb2021 the patient received Hepatitis B vaccine, MMR and PPV23 in the right arm. Concomitant medication included levothyroxine. The patient did not experience COVID-19 prior or post vaccination. On 18Mar2021 at 01:00 PM, within three hours after vaccination the patient had fatigue and achy leg muscles progressed the achiness in right thigh, buttock and lower back. Also, within 48 hours the patient experienced rash on upper right thigh and has continued to spread. It was raised and sensitive to touch. Not itchy. Moderate to severe leg cramping within 36 hours, achy lower back mostly on right side, rash within 40 hours, shooting leg pain and worsening/spreading rash. The patient diagnosed with shingles/zoster on 23Mar2021. famciclovir and Tylenol was given as treatment. Outcome of events was not recovered.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Rash
Clinical narrative: diagnosed with Shingles/zoster on 23Mar2021; Most concerning is the rash on upper right thigh. Began within 48 hours and has continued to spread. It is raised and sensitive to touch.; It began with fatigue within 3 hours of vaccination; Achy leg muscles.; Intense leg cramps began with in 36 hours; Achy lower back; progressed the achiness in right thigh, buttock and lower back; progressed the achiness in right thigh, buttock and lower back; This is a spontaneous report received from a contactable consumer (patient) and contactable Healthcare Care Professional. This Healthcare Care Professional reported in response to the HCP letter sent was processed together. A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date: Not provided) via unspecified route on 18Mar2021 at 09:45 PM in the right arm at single dose for COVID-19 immunization. Patient's medical history included stem cell transplant 2 years ago and allergic to Lobster and Penicillin. On 26Feb2021 the patient received Hepatitis B vaccine, MMR and PPV23 in the right arm. Concomitant medication included levothyroxine. The patient did not experience COVID-19 prior or post vaccination. On 18Mar2021 at 01:00 PM, within three hours after vaccination the patient had fatigue and achy leg muscles progressed the achiness in right thigh, buttock and lower back. Also, within 48 hours the patient experienced rash on upper right thigh and has continued to spread. It was raised and sensitive to touch. Not itchy. Moderate to severe leg cramping within 36 hours, achy lower back mostly on right side, rash within 40 hours, shooting leg pain and worsening/spreading rash. The patient diagnosed with shingles/zoster on 23Mar2021. famciclovir and Tylenol was given as treatment. Outcome of events was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 1st dose of Covid vaccine and then both of them got Covid.; received 1st dose of Covid vaccine and then both of them got Covid.; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This was the first of two reports. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient and her husband received 1st dose of COVID vaccine on 23Feb2021 and then both of them got COVID on unspecified date. Lab data included COVID-19 was positive on unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331602 same reporter, drug and event; different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 1st dose of Covid vaccine and then both of them got Covid; received 1st dose of Covid vaccine and then both of them got Covid.; This is a spontaneous report from a non-contactable consumer reported for on behalf of her husband via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This was the second of two reports. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The reporting consumer and her husband received 1st dose of COVID vaccine on 23Feb2021 and then both of them got COVID on unspecified date. Lab data included COVID-19 was positive on unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331587 same reporter, drug and event; different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Fatigue, Feeling abnormal
Clinical narrative: He got a covid test and has tested positive; He got a covid test and has tested positive; feeling bad; chills; fever; tired; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, it was reported that the patient was due to get his second shot tomorrow, but woke up 2 days ago feeling bad, chills, fever, and tired. He got a COVID test and has tested positive. The outcome of the event was unknown. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: He got a covid test and has tested positive; He got a covid test and has tested positive; feeling bad; chills; fever; tired; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, it was reported that the patient was due to get his second shot tomorrow, but woke up 2 days ago feeling bad, chills, fever, and tired. He got a COVID test and has tested positive. The outcome of the event was unknown. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she unknowingly had COVID-19 when she got the second dose of the Pfizer COVID-19 vaccine; she unknowingly had COVID-19 when she got the second dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A female patient of an unspecified age received her second dose and the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose, for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  Caller unknowingly had COVID-19 when she got the second dose of the Pfizer COVID-19 vaccine.  Outcome for events was unknown.   Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pyrexia
Clinical narrative: 101 F fever and he felt worst on 26Mar2021; has presented general malaise/feeling unwell; fatigue; This is a spontaneous report from a contactable consumer reported for self. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history included COVID-19, exposed to the virus/COVID-19 from 25Mar2021 and ongoing. Concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 24Mar2021 (Wednesday), he had been feeling unwell for two days, on 25Mar2021 and on 26Mar2021, he presented a 101 F fever and he felt worst on 26Mar2021, he recently became aware that he was exposed to the virus on 25Mar2021, apart from the fever he had presented general malaise and fatigue. During the call he mentioned that he felt similarly to when he was diagnosed with COVID-19, he was not sure if he had contracted the infection once again. Outcome of the events was unknown. The case was reported as non-serious.  Information on the lot/batch number has been requested.