chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: really bad headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient experienced really bad headache on an unspecified date. Verbatim and event description: Swap from FC. It was reported that, patient has received second dose of covid vaccine and had adverse reactions. She was on hold for 2 hours company and was disconnected. She wanted to report these reactions still. Advised company would be the appropriate place for reporting AE. She wanted to speak to a manager about the hold times and disconnected from company. Transferred call to supervisor.  The outcome of the event was unknown.  Follow-up (03Mar2021): This is a follow-up spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported for herself that; It was reported that, the patient received her second dose of the vaccine and had been suffering side effects ever since. Has had a really bad headache and wanted to know how long it will last. Called over to rep (Name) Pharmacist who will give her a call back. Faxing AE to Pfizer from Support  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, SARS-CoV-2 antibody test
Clinical narrative: a little fatigue; headache; dizziness; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date, patient experienced a little fatigue, headache, dizziness about 4 days after 2nd shot. Outcome of events was unknown. As patient works in healthcare, was tested for antibody to the spike protein: result was 2265 units / ml. Much higher than anyone else patient had talked to and much higher than people that actually had Covid. Patient has not had Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: terrible headaches; sore arms; This is a spontaneous report from a contactable consumer (Patient, reported for herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Feb2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after second dose patient experienced sore arms and terrible headaches. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea
Clinical narrative: headache; nausea; joint pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 27Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on Saturday (27Feb2021), and after getting the first dose she was experiencing headache, nausea, and joint pain. patient asked if that's normal. The outcome of events was unknown.  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient's Sister). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration, on 01Mar2021 as a single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient experienced headache. On 03Mar2021, the outcome of the event was reported as recovered.  No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified) via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after the first dose of vaccination the patient experienced headache. The outcome of events was reported as unknown at the time of report.  No follow up attempts are possible. No Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; experienced tiredness; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of unspecified age 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 1st dose, single for covid-19 immunization. The patient's medical history included swollen lymph nodes. The patient's concomitant medications were not reported. On an unknown date, the patient experienced headache and tiredness. The reporter wanted to know if Ibuprofen can be taken to relieve symptoms. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; tiredness; This is a spontaneous report from a contactable consumer (patient's husband) reported for a patient (wife) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced headache and tiredness. Caller wanted to know can you take advil to relieve symptoms. Caller also had swollen lymph nodes before vaccine. Cold transfer for AE side effect due to long hold. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced a headache across the forehead that became often/experienced pain from forehead down to her temple; This is a spontaneous report received from a contactable consumer (Patient herself) via Pfizer sponsored program.   A female patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccine patient experienced a headache across the forehead that became often. Afterwards, she had the second dose and experienced the same. She had pain from forehead down to her temple. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Mild HeadAche; Mild Body Aches for 36 Hours; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old elderly male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 02Mar2021 22:15 (at the age of 66-year-old) at a single dose for covid-19 immunisation. The patient's medical history included arthritis. The patient had no allergies. Concomitant medication included naproxen (NAPROXIN [NAPROXEN]). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 09Feb2021 01:15 PM (at the age of 66-year-old) at a 1st dose, single dose for covid-19 immunisation. The patient experienced mild headache, mild body ache for 36 Hours on an unspecified date in 2021. No treatment was given for adverse event. Patient did not had COVID prior vaccination and did not had COVID tested post vaccination. Patient did not had other vaccine in four weeks. Outcome of the events was resolved on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: got a slight headache over my eyes; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated that I do not think they connected me to the right person, I had my first shot of Pfizer (Unspecified Medication) in January, got a slight headache over my eyes like they said you would and then after that off and on I get that slight headache, I got my second shot in February, in fact it would be 2 weeks today that I had it and I was still giving the headache and some pain in my temple. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. .
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache over my eyes; some pain in my temple; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received Pfizer (Unspecified Medication) vaccine in January. The patient reported that it would be 2 weeks that the patient still had the slight headache over the eyes and some pain in temple. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: headache; extreme fatigue; joint pain; This is a spontaneous report from a non-contactable consumer. This consumer reported for a female patient. An unspecified age female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date: unknown), dose 1 via an unspecified route of administration in the right arm on 01Mar2021 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01-MAR-2021, the patient experienced headache, extreme fatigue, joint pain. The patient received an unknown treatment. The outcome of the events was recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Vaccination site discomfort, Vaccination site pain
Clinical narrative: headache; body aches; Extreme pain/discomfort at the injection site; hazy feeling in brain; Extreme pain/discomfort at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:00 (at the age of 58-year-old) at a single dose for COVID-19 immunisation at Pharmacy or Drug Store facility. Medical history included seizure disorder, seasonal allergies, depression, low back injury, DVT (Deep vein thrombosis) and obesity. Patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications (in two weeks) included Oxcarbazepine (TRILEPTAL), Sertraline, Acetylsalicylic acid (ASPIRIN LOW DOSE), Colecalciferol (VITAMIN D). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 15:15, the patient experienced headache, body aches, extreme pain/discomfort at the injection site and hazy feeling in brain. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Pyrexia, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 03Mar2021 (at the age of 62-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Mar2021, patient experienced headache, fever, chills, itching all over and face was swelling. Patient took couple of Tylenol as treatment for headache. No lab work was done. The outcome of all the events was unknown.mNo follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; pain/muscle soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL3248), via an unspecified route of administration in left arm on 03Mar2021 at 09:00 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included allergies with Penicillin. Concomitant medications included Ibuprofen (ADVIL); Cyano-cobalamin (B-12); Cannabidiol (CBD OIL); L-lysine (L-LYSINE (LYSINE)); Sumatriptan and Alprazolam (XANAX). The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 03Mar2021, patient experienced headache (about 6 hours following vaccination), pain/muscle soreness at injection site (about 12 hours following vaccination). No treatment was given for the events. Events recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: bad pain in both knees; I am having pain and swelling in the arm pit area on same arm the vaccine was injected.  Feels like a swollen gland.; I am having pain and swelling in the arm pit area on same arm the vaccine was injected.  Feels like a swollen gland.; I am having pain and swelling in the arm pit area on same arm the vaccine was injected.  Feels like a swollen gland.; tested positive for COVID the day after vaccination; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 07Mar2021 16:30 at age of 58 years old as a single dose for COVID-19 immunisation. Medical history included atrial fibrilation, gout. Concomitant medications included flecainide; alopurinol; carvedilol; alfuzosin.  The patient was tested positive for COVID the day after vaccination on 08Mar2021, patient was having pain and swelling in the arm pit area on same arm the vaccine was injected, feels like a swollen gland, all on 08Mar2021 22:00, bad pain in both knees on 11Mar2021 14:30.  The patient underwent lab tests and procedures which included tested for COVID-19: positive (nasal swab) on 08Mar2021, unknown (nasal swab) on 09Mar2021. The outcome of the events was not recovered. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There had no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. There had no allergies to medications, food, or other products. List of any other medications the patient had received other medications within 2 weeks of vaccination.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: bad pain in both knees; I am having pain and swelling in the arm pit area on same arm the vaccine was injected.  Feels like a swollen gland.; I am having pain and swelling in the arm pit area on same arm the vaccine was injected.  Feels like a swollen gland.; I am having pain and swelling in the arm pit area on same arm the vaccine was injected.  Feels like a swollen gland.; tested positive for COVID the day after vaccination; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 07Mar2021 16:30 at age of 58 years old as a single dose for COVID-19 immunisation. Medical history included atrial fibrilation, gout. Concomitant medications included flecainide; alopurinol; carvedilol; alfuzosin.  The patient was tested positive for COVID the day after vaccination on 08Mar2021, patient was having pain and swelling in the arm pit area on same arm the vaccine was injected, feels like a swollen gland, all on 08Mar2021 22:00, bad pain in both knees on 11Mar2021 14:30.  The patient underwent lab tests and procedures which included tested for COVID-19: positive (nasal swab) on 08Mar2021, unknown (nasal swab) on 09Mar2021. The outcome of the events was not recovered. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There had no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. There had no allergies to medications, food, or other products. List of any other medications the patient had received other medications within 2 weeks of vaccination.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: After a week from the date he received the 1st dose, he tested positive; runny nose; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A 68-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown, expiration date: unknown) via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Mar2021, patient experienced after a week from the date he received the 1st dose, he tested positive and runny nose on an unspecified date in 2021. The patient underwent lab tests and procedures which included SARS-COV-2 TEST: negative on by that Monday we were both reported as negative, he and his girlfriend, SARS-COV-2 TEST: positive on 04Mar2021 he had a swab test on this past Tuesday and it was confirmed positive as of yesterday, 04Mar2021. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache; Nausea; Muscle aches; Exhaustion; This is a spontaneous report from a contactable other Healthcare Professional (patient) reported for herself. A 66-year-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Mar2021 (age at vaccination was unknown) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies. The patient received concomitant medications within two weeks (not specified). On 03Mar2021, the patient experienced headache, nausea, muscle aches and exhaustion. The facility where the most recent COVID-19 vaccine was administered was other Prime Time. 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. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Painful headache; This is a spontaneous report from a contactable consumer. This consumer reported in response to vaccine follow-up questionnaire sent in cross-referenced case (patient, self-reported).  A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9809 and expiry date was not reported), via intramuscularly, in Arm Right, on 11Feb2021 at 12:00 noon, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK4176 and expiry date was not reported), via intramuscularly, in Arm Right, on 21Jan2021 at 11:00 AM, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that 11 days after receiving second dose on 22Feb2021, the patient had a painful headache. The patient was not prone to headaches and was wondering if that was a delayed reaction. The event did not require the initiation of new medication/other treatment/procedure. Outcome of the event was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pounding headache; This is a spontaneous reporter from a non-contactable consumer. A 59-year-old male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via unspecified route of administration on 04Mar2021 at 10:00(at the age of 59-years-old) as a single dose for COVID-19immunisation. The patient medical history was not reported. The patient had no history of allergies. The patient concomitant medications were not reported. 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 not been tested with covid-19. On 04Mar2021 the patient experienced pounding headache. The patient did not received any treatment. The outcome of the event is not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This is a Spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EN6199, Expiration date: 05Mar2021), via an unspecified route in the left arm on 05Mar2021 at 15:45, as a single dose for Covid-19 immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks. The patient did not take any medications within two weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient had not been tested for COVID-19 post vaccination.On 06Mar2021 at 09:00, patient experienced headache and sore arm. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she experienced a little headache; This is a spontaneous report was received from a non-contactable consumer (patient reported for herself) from a Pfizer-sponsored program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on 02Mar2021 as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of vaccine on an unspecified date. On 02Mar2021, after receiving the 2nd dose of the Covid vaccine yesterday, she had experienced a little headache. Caller was wondering if Pfizer is doing a clinical trial about how long the antibodies stay in your system. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; muscle aches; sore achy muscles; fatigue; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received BNT162B2(COMIRNATY, solution for injection, Batch/Lot number: EN6203), via an unspecified route of administration, administered in left arm on 04Mar2021 13:00 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included ongoing hypertension, ongoing pancreatitis, asthma from an unknown date and unknown if ongoing, overweight from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included hydralazine (HYDRALAZINE) taken for hypertension from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; insulin human injection, isophane (HUMULIN N) taken for diabetes mellitus from an unspecified start date and ongoing; insulin human (HUMULIN R) taken for diabetes mellitus from an unspecified start date and ongoing.  The patient previously took first dose of bnt162b2 for covid-19 immunisation, keflex [cefalexin monohydrate] and experienced drug hypersensitivity.  The patient experienced headache, muscle aches, sore achy muscles on 05Mar2021 04:00. Outcome of headache, muscle aches, sore achy muscles was unknown.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Lethargy
Clinical narrative: other vaccine same date vaccine date: 14Feb2021; headache; feeling nauseous; stomach queasy; chills; complete lethargy; feel very tired for most of the day; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 14Feb2021 as a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, thyroid disorder. The patient was allergic to penicillin. The patient did not have any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. The patient was not tested for CVID post vaccination. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), gabapentin (GABAPENTIN), atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication. It was reported that every few days the patient experienced for a short time, 1-2 hours, headache, feeling nauseous, stomach queasy, chills, complete lethargy. It resides with Tylenol. The patient then felt very tired for most of the day. The patient felt fine on the days in between. On 14Feb2021 the patient experienced headache, feeling nauseous, stomach queasy, chills, complete lethargy, feel very tired for most of the day, other vaccine same date vaccine date: 14Feb2021 (product use issue). The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Product use issue
Clinical narrative: other vaccine same date vaccine date: 14Feb2021; headache; feeling nauseous; stomach queasy; chills; complete lethargy; feel very tired for most of the day; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 14Feb2021 as a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, thyroid disorder. The patient was allergic to penicillin. The patient did not have any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. The patient was not tested for CVID post vaccination. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), gabapentin (GABAPENTIN), atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication. It was reported that every few days the patient experienced for a short time, 1-2 hours, headache, feeling nauseous, stomach queasy, chills, complete lethargy. It resides with Tylenol. The patient then felt very tired for most of the day. The patient felt fine on the days in between. On 14Feb2021 the patient experienced headache, feeling nauseous, stomach queasy, chills, complete lethargy, feel very tired for most of the day, other vaccine same date vaccine date: 14Feb2021 (product use issue). The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Muscle spasms, Nausea
Clinical narrative: Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date.  Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date.  Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Not consistence headache, severe pain and sharp pains in head; occurring every couple minute, every 3 minutes or so; Severe pain on the right side, around my eye; affecting my right side and it's affecting my eye; This is a spontaneous report from a contactable consumer (patient) or other non-Health Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date the patient experienced not consistence headache, severe pain and sharp pains in head; occurring every couple minute, every 3 minutes, patient further stated that severe pain on the right side, around eye affecting right side and it affecting eye. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose of vaccine on 02Mar2021 and then on 10Mar2021 had a positive PCR; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 08:30 (Batch/Lot Number: EN6201) at 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included oral surgery from 17Feb2021(the caller had oral surgery on 17Feb2021, she had local anesthesia, then on steroids and antibiotics which she finished. All of the medication was finished before the caller's first shot). The patient concomitant medications were not reported. The patient was calling about the covid vaccine, she received the first dose on 02Mar2021 and then on Wednesday 10Mar2021. The patient got a PCR test that resulted as positive. The patient was wondering if she should get her second dose and what she should do about this, she had her second dose scheduled on 23Mar2021. On 10Mar2021, the patient experienced first dose of vaccine on 02mar2021 and then on 10mar2021 had a positive pcr. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Mar2021. Outcome of the event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations, Urticaria, Wheezing
Clinical narrative: hives; wheezing; palpitations; rapid heart rate; This is a spontaneous report from a contactable consumer (patient, self-reporting).   A 52-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number: EN6206 and Expiration date was not reported), via an unspecified route of administration on 05Mar2021 at 12: 00 pm, on the left arm as second dose, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient had no known allergy. Patient's medical history included high cholesterol. The patient was receiving Other medications in two weeks. On 08Mar2021 at 10:00 pm (3 days after vaccination), the patient experienced broke out into large and hot hives all over the body, wheezing with palpitations and rapid heart rate. The patient did not receive any treatment for the events. The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on thigh; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (non-pregnant) received bnt162b2 (BNT162B2 solution for injection, Lot Number was EN6205, Expiration date: Not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient was had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient medical history and concomitant was not reported. It was reported that the patient experienced hives on thigh on 12Mar2021 15:00. No Treatment was received for the event. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: red bumps in little clusters, cluster of red dots, can feel them and they are raised up and I do not know if something bite me or if this a side effect,  Petechiae or something like that; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6025), via an unspecified route of administration, administered in Arm Left on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced red bumps in little clusters, cluster of red dots, can feel them and they are raised up and she do not know if something bite me or if this a side effect, petechiae or something like that on an unspecified date. It has been several weeks now. It is on my shoulder in two different places and it is kind of like three or four of them at one location. The outcome of the event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dry mouth, Headache, Insomnia
Clinical narrative: Headache; Dry mouth; Light headed or Dizzy; Not able to fall asleep; lost 11 pounds; Anxiety; This is a spontaneous report from a consumer (patient). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in an left arm on 06Feb2021 14:00 (lot Number: EL9263) for COVID-19 Immunisation. Patient medical history included allergy to Sulfa (Sulfonamide allergy) from an unknown date. Patient was not pregnant at the time of vaccination. Patient received concomitant medications (unspecified products) . Patient previously received the first dose of BNT162B2 on 16Jan2021 (lot number: EL1283) in the left arm at single dose for COVID-19 Immunisation. List of other medications the patient received within 2 weeks of vaccination was said available but not reported. Prior to vaccination and since the vaccination the patient was not tested with COVID-19. The patient experienced anxiety, lost weight (lost 11 pounds), insomnia (not able to fall asleep), lightheaded or dizzy, dry mouth, headache on 09Feb2021 03:00. The adverse events resulted in doctor or other HCP office/clinic visit. Treatment was not received for the events. The outcome of the all the adverse events was not recovered (still ongoing at the time of reporting).   No follow-up attempts are possible and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reporter information was updated (name was added, county removed, updated reporter phone number format and Email address added). Patient details were updated (name, patient race, patient address added). Relevant Med History and historical vaccine were added. Suspect product was recoded as BNT162B2 as a company product. Start time of vaccination added and dose number updated to 2. Vaccine Facility Information details captured. Physician Office Visit was reported for all events. Event onset time added. Treatment received captured as no. Concomitant Therapy updated as yes in corresponding data field. Anatomical location of vaccination was updated as left arm. Narrative was updated to reflect that events resulted in doctor or other HCP office/clinic visit. Stop date and time of vaccination was populated with 06Feb2021 14:00.
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Headache; Dry mouth; Light headed or Dizzy; Not able to fall asleep; lost 11 pounds; Anxiety; This is a spontaneous report from a consumer (patient). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in an left arm on 06Feb2021 14:00 (lot Number: EL9263) for COVID-19 Immunisation. Patient medical history included allergy to Sulfa (Sulfonamide allergy) from an unknown date. Patient was not pregnant at the time of vaccination. Patient received concomitant medications (unspecified products) . Patient previously received the first dose of BNT162B2 on 16Jan2021 (lot number: EL1283) in the left arm at single dose for COVID-19 Immunisation. List of other medications the patient received within 2 weeks of vaccination was said available but not reported. Prior to vaccination and since the vaccination the patient was not tested with COVID-19. The patient experienced anxiety, lost weight (lost 11 pounds), insomnia (not able to fall asleep), lightheaded or dizzy, dry mouth, headache on 09Feb2021 03:00. The adverse events resulted in doctor or other HCP office/clinic visit. Treatment was not received for the events. The outcome of the all the adverse events was not recovered (still ongoing at the time of reporting).   No follow-up attempts are possible and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reporter information was updated (name was added, county removed, updated reporter phone number format and Email address added). Patient details were updated (name, patient race, patient address added). Relevant Med History and historical vaccine were added. Suspect product was recoded as BNT162B2 as a company product. Start time of vaccination added and dose number updated to 2. Vaccine Facility Information details captured. Physician Office Visit was reported for all events. Event onset time added. Treatment received captured as no. Concomitant Therapy updated as yes in corresponding data field. Anatomical location of vaccination was updated as left arm. Narrative was updated to reflect that events resulted in doctor or other HCP office/clinic visit. Stop date and time of vaccination was populated with 06Feb2021 14:00.