chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lipoma
Clinical narrative: Lipoma; This is a spontaneous report received from a contactable other hcp. A 36-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EL1283),via an unspecified route of administration, at the age of 36 years old,administered in Arm Left on 14Jan2021 09:00 as Dose 1,single for covid-19 immunization .Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]); calcium carbonate, ergocalciferol (CALCIUM AND VITAMIN D) taken for an unspecified indication, start and stop date were not reported.The patient experienced lipoma on 21Jan2021 07:00.The patient was not pregnant at the time of vaccination.The patient had not received any other vaccine within 4 weeks.The adverse event lipoma was noted 1 week post vaccination.The patient was not diagnosed with covid prior vaccination and not tested for covid post vaccination.This adverse event didn't result in patient visit to hospital and physician clinic.The outcome of the event was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fear, Headache, Sleep disorder
Clinical narrative: she has not been able to sleep; she had diarrhea / runny stool; headache; Consumer said she is afraid to receive the 2nd dose; This is a spontaneous report from a non-contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer stated that since received the dose 1 on "Friday", she has not been able to sleep, she also said she had diarrhea, a runny stool, and headache. Consumer said she is afraid to receive the dose 2 and wants to know what will happen if she does not take it. This case assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration on 06Feb2021 (at the age of 30-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, enquired, the caller received 1st dose on Saturday (06Feb2021). On Monday, her brother, whom she lives with, tested positive for covid infection. The caller stated that, on Sunday and Monday she experienced a sore throat on an unspecified date in Feb2021. The caller asked whether the sore throat was from the vaccine or covid infection. Stated that, would the vaccine on Saturday protect her at all. If COVID-19 test results come back positive, did she need another 1st dose or when to get 2nd dose. The outcome of the event was unknown.  Information on Lot/ Batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: having headaches so bad; nausea; body aches; chills; she is vomiting; muscle aches; This is a spontaneous report from a contactable consumer (patient herself). A 68 (units: unknown) aged female patient of an received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date in 2021 it was reported as patient stated that she received the second dose of the Pfizer vaccine on 09Feb2021 and the side effects are extremely worse than the first dose. She had headache, nausea, body aches, muscle aches and chills and she wants to know if she can take Tylenol. After this second dose, she is having headaches so bad that she is vomiting. She is wondering if Tylenol is contraindicated with the product. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: having headaches so bad; nausea; body aches; chills; she is vomiting; muscle aches; This is a spontaneous report from a contactable consumer (patient herself). A 68 (units: unknown) aged female patient of an received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date in 2021 it was reported as patient stated that she received the second dose of the Pfizer vaccine on 09Feb2021 and the side effects are extremely worse than the first dose. She had headache, nausea, body aches, muscle aches and chills and she wants to know if she can take Tylenol. After this second dose, she is having headaches so bad that she is vomiting. She is wondering if Tylenol is contraindicated with the product. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: hip flexor pain; This is a spontaneous report from contactable Physician (Patient). This Physician reported similar events for three patients. This report is for 1st of three patient.  A 50-years-old female patient received bnt162b2 (BNT162B2, BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 17:30 (Batch/Lot Number: EL3249) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EM9810) as DOSE 2, SINGLE for covid-19 immunisation. Not pregnant at the time of vaccination. No other vaccine in four weeks. No covid prior vaccination. Covid not tested post vaccination. Medical history included hypertension, anxiety, attention deficit hyperactivity disorder, methylenetetrahydrofolate reductase deficiency, cytochrome P450 2D6 deficiency, food allergy. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); losartan potassium (COZAAR); dexmethylphenidate hydrochloride (FOCALIN XR ER); melatonin (MELATONIN). The patient previously took and experienced drug hypersensitivity (Thimerasol, sensitive to gluten, eggs, cheese). On 24Jan2021 patient experienced hip flexor pain. Patient received second dose (Pfizer EM9810) last night (09Feb2021) no new adverse reactions at this time. The adverse event result in any Doctor or other healthcare professional office/clinic visit. Treatment received for event includes Physical therapy. Approximately 5 days after vaccine, I started to get hip flexor pain. I do yoga regularly and did nothing that should have caused me this amount of pain that affects my daily activities (driving, putting on clothes, etc.). I'm now seeing a physical therapist for it. The pain/inflammation has now moved to ITB area. Doesn't make sense. I'm an EM physician. I know 2 others with similar experiences, and I've advised them to contact you also. Keep up the good work! Thank you for all that you do! The outcome of event was not recovered.    Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site pain
Clinical narrative: soreness at injection site; lethargy; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 09Feb2021 09:45 (at the age of 26-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no Covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EL3247), via an unspecified route of administration, administered in right Arm on 19Jan2021 10:00 am (at the age of 26-year-old) as single dose for COVID-19 immunization. On 09Feb2021 15:00, the patient experienced soreness at injection site, lethargy. The patient did not receive any treatment for the AE. The patient had not tested Covid post vaccination. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; muscle pain; joint pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 61-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:00 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. The patient's medical history included hiatal hernia, reflux, migraine and headaches. The concomitant medications included cholestyramine, colecalciferol (VIT D3), pyridoxine hydrochloride (VIT B6), cyanocobalamin (VIT B12) and zinc. The patient previously took amoxicillin, epinephrine and morphine and experienced known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Feb2021 21:30, the patient experienced injection site pain, tiredness, headache, muscle pain and joint pain. The patient not received treatment for the events. The outcome of the events was recovered in Feb2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: fever of 103; aches; chills; headache; This is a spontaneous report from a non-contactable consumer (patient's sister). A adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. It was unknown whether the patient received other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 10Feb2021 at 02:00, the patient woke up with fever of 103, aches, chills and headache. The patient texted the reporter that she reported the symptoms to her physician as well. It was unknown whether the patient received any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single (at the age of 77-year) for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. She took vaccine on 09Feb2021 and experienced lightheadedness in the afternoon. The patient asked that if she can take Tylenol. The clinical outcome of the event was unknown.  Information on the lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: severe injection site and shoulder pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history included AFib (atrial fibrillation) and had 2 leaking valves. The patient's concomitant medication(s) included apixaban (ELIQUIS) and hydrochlorothiazide (DIURETIC), 80 mg. On an unspecified date in 2021, the patient experienced severe injection site and shoulder pain. The patient mentioned that she had no rash, nausea or vomiting. She wanted to know if it's okay to take Tylenol. She queried if she could use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She wanted to know how long these side effects lasts, two or more days. Queried if she should exercise the sore arm or use ice packs. The outcome of the events was unknown.  Information requested on Lot/batch number.  Follow-up attempts are completed. No further information was expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: the worse headache of my life; made me throw up; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 at 10:50 (Age at vaccination: 44-years-old) as DOSE 1, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated that "Approximately 10pm-2am, caller experience, "the worse headache of my life", "made me throw up". Caller says, "I feel better this morning. little headache, but not as bad as it was" Caller says, "I'm scared to get 2nd dose, will the 2nd dose symptoms be worse?" on 11Feb2021. Caller stated that she received Pfizer Covid vaccine yesterday at 10:50AM. Stated that last night from 11Feb that she had the worst headache ever in her life where she was throwing up/vomiting. Stated still has headache but nothing like it was. Wanted to know if this is a side effect. Stated that she was afraid to get the second one because she does not want to go through that again. The outcome of the event headache was not recovered, and event vomiting was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer via Medical Information Team. A female patient of an unspecified age (Age: 88; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The concomitant medications included cetirizine hydrochloride (ZYRTEC), naproxen sodium (ALEVE), paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN), alprazolam (XANAX) and melatonin; all were taken for an unspecified indication, start and stop date were not reported. The patient experienced headache on an unspecified date. The clinical outcome of the event was unknown.  Information on Lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus
Clinical narrative: heavy arm; legs were itchy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 09Feb2021 at 16:00 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the caller was a consumer, asking whether she should take the second vaccine dose after experiencing an adverse reaction to the first. The caller reported that, she had the first dose of the COVID vaccine yesterday on 09Feb2021 at 16:00 and then around 17:00 her legs were itchy and she experienced a heavy arm. The caller reported that, she took some Benadryl and was now fine but not sure what to do about her second dose. Treatment was received for the events. The outcome of the events was recovered on an unspecified date in Feb2021.  Information requested on Lot/ Batch number. Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: chills; Headache; Pain on arm vaccinated; exhaustion on the day I got the 2nd dose vaccine; Fever at night, until the following day,with headache and sore arm; This is a spontaneous report from contactable consumer (patient). A 26-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247) dose 2 via an unspecified route of administration in left arm on 09Feb2021 at 09:45 AM (at the age of 26-year-old) as single dose for COVID-19 immunisation at workplace clinic. Medical history was not reported. Concomitant medications were none. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL32417) dose 1 via an unspecified route of administration in left arm on 19Jan2021 at 09:45 AM (at the age of 26-year-old) as single dose for COVID-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. On 09Feb2021 at 03:30 PM, the patient experienced chills, headache, pain on arm vaccinated, exhaustion on the day she got the 2nd dose vaccine. Fever at night on 09Feb2021, until the following day, with headache and sore arm. No treatment received for AE. No COVID tested post vaccination. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; Nausea; Chills; Arm sore; This is a spontaneous report from a contactable consumer (Patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 16:45 (at the age of 43-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient had no known allergies. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 10Feb2021 (at 12:00AM, as reported), the patient experienced Low grade fever, Nausea, Chills, Arm sore. Patient did not received treatment for adverse events. Outcome of the events were not recovered.       Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Parosmia
Clinical narrative: Intense waves of nausea; Fatigue; Phantom smells; This is a spontaneous report from a non-contactable consumer or other non-hcp (Patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 34-year) on 29Jan2021 as dose 1, single for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. Facility type vaccine was Workplace clinic as reported. No known allergies were reported. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 30Jan2021 the patient experienced intense waves of nausea, fatigue, phantom smells. The patient was received no treatment for the adverse events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient experienced rash. It was reported that female consumer was scheduled to get her 2nd dose of Pfizer's COVID vaccine today 10Feb2021. On Monday, she went to see her doctor for a body rash in which she was prescribed steroids (she was given a steroid injection) and he told her to delay her second shot for 1 month. The reporter wanted to see if she really needs to wait 30 days or if she can go in today for her second dose. Stated that it is a pretty bad rash all over her body. She declined to complete a report and just wanted to know if the second shot can be delayed. The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Decreased appetite, Fatigue, Nausea
Clinical narrative: loss of appetite; loss of appetite; Chills; body aches; Nausea; Fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 54-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EL9265; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 31Jan2021 11:30 ,at the age of 54 years old,as dose 1, single for an unspecified indication. Medical history included blood cholesterol, migraine, dyspepsia and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, pantoprazole; fluticasone propionate (FLONASE ALLERGY RELIEF); and azelastine hydrochloride taken for hypersensitivity, start and stop date were not reported.The patient experienced chills, body aches, nausea and fatigue on 02Feb2021 and loss of appetite on 09Feb2021.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Feb2021 and sars-cov-2 test: negative on 05Feb2021.The outcome of the event chills was Not recovered,body aches was recovering,nausea was not recovered,fatigue was recovering,and loss of appetite outcome was not recovering.The patient stated that she has been trying not to take any pain relievers because she read it could impact the effectiveness of the vaccine. However she did take ibuprofen on 04Feb2020 and the 05Feb2020 and did get some relief.The patient prior vaccination within 4 weeks included -DAP 21Dec2020; no product information to provide NDC, lot or expiration date; received at her primary care office.The patient family history included son was positive for COVID 19 02Feb2021.The patient was scheduled to receive her 2nd dose of Pfizer covid19 vaccine on 21Feb2021,but she was confused whether to get the second dose on that date or not.  Follow-up (10Feb2021): This is a follow-up spontaneous report received from a contactable Consumer. This 54-year-old Consumer reported loss of appetite was reported as worsened.Additional Information for Concomitant Products vitamin compound: Product is compounded and contains methyl B 12; Riboflavin; Co Q 10; Magnesium and B3.The adverse event didn't result in patient visit to emergency room.History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none.Vaccination Facility was reported to be education center.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: loss of appetite; loss of appetite; Chills; body aches; Nausea; Fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 54-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EL9265; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 31Jan2021 11:30 ,at the age of 54 years old,as dose 1, single for an unspecified indication. Medical history included blood cholesterol, migraine, dyspepsia and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, pantoprazole; fluticasone propionate (FLONASE ALLERGY RELIEF); and azelastine hydrochloride taken for hypersensitivity, start and stop date were not reported.The patient experienced chills, body aches, nausea and fatigue on 02Feb2021 and loss of appetite on 09Feb2021.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Feb2021 and sars-cov-2 test: negative on 05Feb2021.The outcome of the event chills was Not recovered,body aches was recovering,nausea was not recovered,fatigue was recovering,and loss of appetite outcome was not recovering.The patient stated that she has been trying not to take any pain relievers because she read it could impact the effectiveness of the vaccine. However she did take ibuprofen on 04Feb2020 and the 05Feb2020 and did get some relief.The patient prior vaccination within 4 weeks included -DAP 21Dec2020; no product information to provide NDC, lot or expiration date; received at her primary care office.The patient family history included son was positive for COVID 19 02Feb2021.The patient was scheduled to receive her 2nd dose of Pfizer covid19 vaccine on 21Feb2021,but she was confused whether to get the second dose on that date or not.  Follow-up (10Feb2021): This is a follow-up spontaneous report received from a contactable Consumer. This 54-year-old Consumer reported loss of appetite was reported as worsened.Additional Information for Concomitant Products vitamin compound: Product is compounded and contains methyl B 12; Riboflavin; Co Q 10; Magnesium and B3.The adverse event didn't result in patient visit to emergency room.History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none.Vaccination Facility was reported to be education center.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Fatigue, Headache, Myalgia
Clinical narrative: a wave a mild nausea; bad headache; muscle aches in my back and body; soreness; stomach pain; fatigue; This is a spontaneous report from a contactable pharmacist (patient). A 48-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: EC8982, expiration date was not reported), via intramuscular, administered in left arm on 01Feb2021 08:00 (at the age of 48-years-old) as dose 2, single for covid-19 immunization at hospital. The patient medical history was not reported. Concomitant medications included methylphenidate, vitamin d [vitamin d nos], calcium carbonate, ibuprofen, all taken for unknown indications from an unknown date. Other medications the patient received within 2 weeks of vaccination included methylphenidate, Vitamin D, Calcium carbonate, ibuprofen. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, lot number: EH9899, expiration date was not reported), via intramuscular, administered in left arm on 07Jan2021 02:45 PM (at the age of 48-years-old) as dose 1, single for covid-19 immunization. Patient was not pregnant at the time of vaccination. The patient does not have any Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The start date and time for events was reported as 08Feb2021 04:00PM. It was reported that, initially after the 2nd injection 01Feb2021, after the first 10 minutes she felt a wave a mild nausea that was gone within 2 hours. The next day at 5am she woke up with a bad headache for which she took 800mg ibuprofen. It got some better, but by the time the med wore off in 6-8h it was bad again and took another dose. The HA was gone by that night. However, 7 days later around 4pm 08Feb, she felt muscle aches in my back and body, like soreness, HA returned, she had stomach pain and mild nausea and good amount of fatigue. she didn't feel like prepping the dinner she bought, so her husband handled that and bedtime for kids. she took 800mg ibuprofen again. By 10pm, she felt some better, but woke up the next am 09Feb still fatigued & with HA. She went back to bed for an hour after getting kids off to school. After that she felt fine until about 4pm again when she felt stomach pain again, high up, soreness in back & fatigue. Lasted 3-4h. Today, 10Feb, she still have dull bothersome HA across my forehead and fatigue. Ibuprofen 800mg was received as treatment for adverse event. Therapeutic measures were taken for all events. The reporter assessed the seriousness as non-serious. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: a wave a mild nausea; bad headache; muscle aches in my back and body; soreness; stomach pain; fatigue; This is a spontaneous report from a contactable pharmacist (patient). A 48-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: EC8982, expiration date was not reported), via intramuscular, administered in left arm on 01Feb2021 08:00 (at the age of 48-years-old) as dose 2, single for covid-19 immunization at hospital. The patient medical history was not reported. Concomitant medications included methylphenidate, vitamin d [vitamin d nos], calcium carbonate, ibuprofen, all taken for unknown indications from an unknown date. Other medications the patient received within 2 weeks of vaccination included methylphenidate, Vitamin D, Calcium carbonate, ibuprofen. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, lot number: EH9899, expiration date was not reported), via intramuscular, administered in left arm on 07Jan2021 02:45 PM (at the age of 48-years-old) as dose 1, single for covid-19 immunization. Patient was not pregnant at the time of vaccination. The patient does not have any Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The start date and time for events was reported as 08Feb2021 04:00PM. It was reported that, initially after the 2nd injection 01Feb2021, after the first 10 minutes she felt a wave a mild nausea that was gone within 2 hours. The next day at 5am she woke up with a bad headache for which she took 800mg ibuprofen. It got some better, but by the time the med wore off in 6-8h it was bad again and took another dose. The HA was gone by that night. However, 7 days later around 4pm 08Feb, she felt muscle aches in my back and body, like soreness, HA returned, she had stomach pain and mild nausea and good amount of fatigue. she didn't feel like prepping the dinner she bought, so her husband handled that and bedtime for kids. she took 800mg ibuprofen again. By 10pm, she felt some better, but woke up the next am 09Feb still fatigued & with HA. She went back to bed for an hour after getting kids off to school. After that she felt fine until about 4pm again when she felt stomach pain again, high up, soreness in back & fatigue. Lasted 3-4h. Today, 10Feb, she still have dull bothersome HA across my forehead and fatigue. Ibuprofen 800mg was received as treatment for adverse event. Therapeutic measures were taken for all events. The reporter assessed the seriousness as non-serious. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Oropharyngeal pain
Clinical narrative: headaches; scratchy throat; dizziness; No energy; This is a spontaneous report from a contactable other hcp. A 56-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL3246) via an unspecified route of administration in Arm Left on 05Feb2021 16:00 (age at vaccination 56years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing, allergy to animal from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced that on 09Feb2021 04:00 she had headaches, scratchy throat, dizziness, no energy. Clinical course was reported as 4 days after vaccination, I had severe headaches, scratchy throat, and dizziness. I had no energy. This lasted for 2 days. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Pain in extremity, Pruritus
Clinical narrative: increased blood pressure/blood pressure elevated; itchiness; left arm sore/stiff; slight headache; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female received first dose of BNT162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: E13249) via intramuscularly in the left arm on 05Feb2021 at around 11:00 or 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included severe sinusitis diagnosed about a year ago. she had surgery for this in Dec2019. Concomitant medication was not reported. No additional vaccines administered on same date of suspect. No prior Vaccinations within 4 weeks. No events following prior vaccinations. On 05Feb2021 (on day of vaccination), patient had slight headache, itchiness and left arm sore/stiff. On 10Feb2021 (5 days after vaccination), patient had increased blood pressure/blood pressure elevated. She had itchiness and then a slight headache and it went away. Her left arm was sore and hurt for about 48 hours and then it went away. She has been feeling fine. Today she suddenly had a really bad headache. She took her blood pressure and it was really elevated. She was asking if this was from the vaccine. Reports the itchiness recovered within an hour. Her sore arm did not start till several hours after receiving the injection, did not feel it at first and wondered if she had even received the injection. Then that evening her arm was stiff and sore which recovered by sunday morning. She was wondering if she should go and get herself checked out and not sure if it was from the vaccine. She has not checked her blood pressure since she has been on hold. This morning when she checked her blood pressure it was elevated for her at 160/100. Then she checked it a few minutes later and it was 170/98, she wanted to make sure it was not in her head and rechecked it again and it was 175/101. No treatment was received. Events does not require a visit to emergency room and physician office. Lab test included blood pressure on 10Feb2021, was 160/100, 170/98 and 175/101. The outcome for event itchiness was resolved on 05Feb2021, left arm sore/stiff was resolved on 07Feb2021, headache resolved on 10Feb2021 and unknown for increased blood pressure/blood pressure elevated.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: little soreness in left upper arm; This is a spontaneous report from a contactable consumer (patient himself). A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Patient stated that "yesterday he received a Pfizer vaccine (he confirmed it was his First Dose on 09Feb2021 of Pfizer-BioNTech COVID-19 Vaccine) and after he received that vaccine the medical professional who administered the vaccine told to him that he should not have any other type of vaccination for some weeks. He now have a bone scan appointment and now require injection of some nuclear medicine. On an unspecified date in Feb2021 it was reported as patient stated that he generally very well, just had a little soreness in his left upper arm (injection site)". The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: dizziness that lasted about 10 minutes/Dizzy; headache like someone hit me in the center of my head; Real weak; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-year-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on an unspecified date in Feb2021 for covid-19 immunisation (at the age of vaccination 70-year-old). The patient's medical history included flu and her head was so heavy. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single for covid-19 immunisation. Patient had the second shot on Sunday. On next day in Feb2021, patient experienced dizziness that lasted about 10 minutes/ still dizzy/ real dizzy caused her to lay across bed but then it went away. This went on for 5 minutes and today, about 60 minutes ago, when got up, she had a headache in the center of her head and took 2 extra strength tylenol and it went away in Feb2021. In Feb2021, patient was also real weak. Patient wanted to know if this could be the flu or a side effect from the vaccine. She read where the headache could be a side effect but did not read anything about dizziness. Patient stated that she took a lot of other medicine so if could be those too. No further details provided. Therapeutic measures were taken as a result of headache with tylenol. At the time of this report, outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: excruciating abdominal cramps; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:00 (at the age of 61-years-old) (Batch/Lot Number: EN9581) as dose 1, single for Covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and rheumatoid arthritis. Concomitant medications included adalimumab (HUMIRA). The patient previously took sulfasalazine and experienced known allergies: Sulfasalazine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior and post vaccination. The patient had excruciating abdominal pain and diarrhea starting 16 hours after injection and lasting 4 hours which was comparable to labor pain on 04Feb2021 01:00. The patient did not receive treatment for the events. The outcome of events abdominal pain and diarrhea was recovered on 04Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Overdose, Pain, Poor quality product administered
Clinical narrative: Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; reported significant body aches.; Nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A contactable Physician reported similar events for fifteen patients. This is 1st of fifteen reports.   A patient of unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received COVID vaccine resconstituted with 1.3 ml instead of 1.8 ml on an unspecified date. It was reported that the patient experienced significant body aches, nausea, vomiting, diarrhea on an unspecified date. The seriousness of the events was reported as non-serious. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Product quality issue, Vomiting
Clinical narrative: Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; reported significant body aches.; Nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A contactable Physician reported similar events for fifteen patients. This is 1st of fifteen reports.   A patient of unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received COVID vaccine resconstituted with 1.3 ml instead of 1.8 ml on an unspecified date. It was reported that the patient experienced significant body aches, nausea, vomiting, diarrhea on an unspecified date. The seriousness of the events was reported as non-serious. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: Lots of pain in upper arm near shot location that resonates down and up the arm; Lots of pain in upper arm near shot location that resonates down and up the arm; Tired; This is a spontaneous report from a contactable consumer(patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EL3247) via an unspecified route of administration, administered in arm right on 09Feb2021 at 11:15 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Allergies to medications, food, or other products were reported as not applicable. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. On 09Feb2021 (reported as 9 hours 45 mins after the vaccination), the patient experienced lots of pain in upper arm near shot location that resonates down and up the arm and as well as a bit tired. The patient did not receive treatment for the adverse event. Since the vaccination the patient was not tested for COVID-19. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: "red itchy spot" next to the injection site, around the size of a quarter; She specified it doesn't itch all the time but "itches and stop, itches and stops".; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 2 via an unspecified route of administration on 08Feb2021 (at the age of 71-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. She received the second dose of the Pfizer-BioNTech COVID-19 vaccine on Monday (08Feb2021). In Feb2021, she has a "red itchy spot" next to the injection site, around the size of a quarter. She specified it doesn't itch all the time but "itches and stop, itches and stops". The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.