chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: diarrhoea; Searing headache; This is a spontaneous report from a contactable consumer (patient).A 52-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Expiration date: Unknown; Lot Number: EL3247), via unspecified route of administration in the right arm On 01Mar2021 at 09.00 (at the age of 52-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccination included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Lot Number: EL3247; Expiry date: Unknown), via an unspecified route of administration in the left arm on 08Feb2021 at 09:00 as single dose for COVID-19 immunization. On 01Mar2021 (at 20:00), after 11hours from vaccination, the patient experienced Searing headache, diarrhoea. The patient did not receive any treatment.The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: headache; Felt weak; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, brand: Pfizer-biontech, Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 at unspecified location as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-biontech, Batch/Lot number was not reported) for covid-19 immunisation on 08Feb2021 and had no side effects. On unspecified date the patient experienced, the day after second dose he experienced headache and felt weak however there was no fever, and he is feeling better now. Outcome of the events headache and felt weak was considered as recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe Headache; This is a spontaneous report from a non-contactable consumer (Patient).   A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6198), via an unspecified route of administration in Right arm on 25Feb2021 10:00 Am (43-year-old at the time of vaccination) as single dose for covid-19 immunisation. Medical history included asthma and Sulfa allergy (drug hypersensitivity). Concomitant medication(s) included escitalopram oxalate (LEXAPRO) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient did not receive any other vaccines in 4 weeks. Other medications the patient received in 2 weeks includes Lexapro, Zyrtec. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On26Feb2021, at 04:00 Am, the patient experienced severe headache on. No treatment was received for event. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: headache; really hot chills; body aches; This is a spontaneous report received from a Non-contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that after the administration, the patient experienced severe headache, really hot chills, and body aches. patient took 2 Advils which helped relieve the symptoms. The next day, she had the same symptoms, and for that she did the same took 2 Advils again, and then felt fine afterwards. After two weeks patient still had headaches hurt so bad, she finds it difficult to open her eyes. she also said she went back to the facility from where she received the vaccine and was told to go to the emergency room. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache
Clinical narrative: I get a headache this has lasted over a few days; I have completely lost my sense of taste and smell.; I have completely lost my sense of taste and smell.; This is a spontaneous report from a contactable consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in arm right on 01Mar2021 at 10:30 as 1st dose, single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (note: OCD- Obsessive-Compulsive disorder), post-traumatic stress disorder (note: PTSD: post-traumatic stress disorder) and food allergy (shellfish). The patient's concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 01Mar2021 at 11:00, the patient experienced i get a headache this has lasted over a few days, i have completely lost my sense of taste and smell. No treatment was given for the events. The outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Severe headache; chills; Fatigue/tiredness; dizziness; nausea; vomit; This is a spontaneous report from a contactable Pharmacist. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry dates were not reported) via an unspecified route of administration on an unknown date in Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021 the patient experienced with severe headache, chills, Fatigue/tiredness, dizziness, nausea and vomit. Patient received treatment with acetaminophen.  Patient whether tested for COVID-19 post vaccination was unknown. The outcome of the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe headache; chills; Fatigue/tiredness; dizziness; nausea; vomit; This is a spontaneous report from a contactable Pharmacist. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry dates were not reported) via an unspecified route of administration on an unknown date in Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021 the patient experienced with severe headache, chills, Fatigue/tiredness, dizziness, nausea and vomit. Patient received treatment with acetaminophen.  Patient whether tested for COVID-19 post vaccination was unknown. The outcome of the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abnormal dreams, Chills, Depressed mood, Headache
Clinical narrative: headache; intermittent nausea; bloating; sweats/day sweats; chills; hot flashes; leg weakness/ legs "tired" for no reason; feeling depressed; stressful dreams; aches; night sweats; This is a spontaneous report from a contactable consumer (patient) via A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 25Feb2021 13:00 as second dose single for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medications included clonazepam, naproxen sodium (ALEVE) and ALBUTEROL (SALBUTAMOL) all are taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient previously took hydrocodone and gluten intolerance and experienced known allergies. 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. Patient received second dose of the Pfizer vaccine, last Thursday 25Feb2021 around 1pm. Patient reports having a headache on and off ever since. Her worst day was yesterday, today is the first day she actually is going on a walk. She has experienced nausea, bloating, headache on 27Feb2021 17:00 and had to cancel a dental appointment. Patient does not remember exactly when the symptoms started but probably later in the day on Thursday. That night she had sweats, chills, but never had a fever the two times she checked. Patient did feel hot, like hot flashes though. Patient also experienced leg weakness starting on Sunday similar to if you had done strenuous activity the day before. Patient also reports feeling depressed from feeling run down and has had some stressful dreams, aches and night sweats on 27Feb2021 17:00. She declined being transferred to safety because she waited on hold for over 2 hours and then was hung up on. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Muscular weakness, Nausea, Night sweats
Clinical narrative: headache; intermittent nausea; bloating; sweats/day sweats; chills; hot flashes; leg weakness/ legs "tired" for no reason; feeling depressed; stressful dreams; aches; night sweats; This is a spontaneous report from a contactable consumer (patient) via A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 25Feb2021 13:00 as second dose single for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medications included clonazepam, naproxen sodium (ALEVE) and ALBUTEROL (SALBUTAMOL) all are taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient previously took hydrocodone and gluten intolerance and experienced known allergies. 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. Patient received second dose of the Pfizer vaccine, last Thursday 25Feb2021 around 1pm. Patient reports having a headache on and off ever since. Her worst day was yesterday, today is the first day she actually is going on a walk. She has experienced nausea, bloating, headache on 27Feb2021 17:00 and had to cancel a dental appointment. Patient does not remember exactly when the symptoms started but probably later in the day on Thursday. That night she had sweats, chills, but never had a fever the two times she checked. Patient did feel hot, like hot flashes though. Patient also experienced leg weakness starting on Sunday similar to if you had done strenuous activity the day before. Patient also reports feeling depressed from feeling run down and has had some stressful dreams, aches and night sweats on 27Feb2021 17:00. She declined being transferred to safety because she waited on hold for over 2 hours and then was hung up on. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: headache; intermittent nausea; bloating; sweats/day sweats; chills; hot flashes; leg weakness/ legs "tired" for no reason; feeling depressed; stressful dreams; aches; night sweats; This is a spontaneous report from a contactable consumer (patient) via A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 25Feb2021 13:00 as second dose single for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medications included clonazepam, naproxen sodium (ALEVE) and ALBUTEROL (SALBUTAMOL) all are taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient previously took hydrocodone and gluten intolerance and experienced known allergies. 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. Patient received second dose of the Pfizer vaccine, last Thursday 25Feb2021 around 1pm. Patient reports having a headache on and off ever since. Her worst day was yesterday, today is the first day she actually is going on a walk. She has experienced nausea, bloating, headache on 27Feb2021 17:00 and had to cancel a dental appointment. Patient does not remember exactly when the symptoms started but probably later in the day on Thursday. That night she had sweats, chills, but never had a fever the two times she checked. Patient did feel hot, like hot flashes though. Patient also experienced leg weakness starting on Sunday similar to if you had done strenuous activity the day before. Patient also reports feeling depressed from feeling run down and has had some stressful dreams, aches and night sweats on 27Feb2021 17:00. She declined being transferred to safety because she waited on hold for over 2 hours and then was hung up on. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: My wife reported headache post vaccination; This is a spontaneous report from a contactable consumer (patient's husband) via a medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, consumer called on behalf of his wife. Consumer states "me and my wife received the Pfizer COVID-19 vaccine yesterday. My wife reported headache post vaccination on an unspecified date in 2021. Enquired can consumer use antipyretics or pain reliever after vaccination with the Pfizer-BioNTech COVID-19 vaccine or not. He was been recording his wife's side effects on (smartphone-based tool name). Consumer states "Can consumer take alcohol post vaccination or not. It's been 24 hours since consumer got his vaccine. Consumer have read on the internet that doctor's stating drinking alcohol 24 hours after receiving the vaccine was considered safe." Consumer states "the fact sheet indicates 0.5 % people have reported swollen lymph nodes post vaccination. A few years back, he had swollen lymph node. However, it was treated with medication. He was feeling a lot better now. The symptoms due occur when he catches cold. He wants to know if the sides effects could accelerate with the vaccine. Caller didn't notice any swollen in the lymph nodes post vaccination. The event was considered as non-serious by the consumer. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Extreme hives all over/full blown hives that itch and hurt; itchy; This is a spontaneous report from a non-contactable 72-year-old female consumer reporting herself. A 72 years-old female patient received first dose of BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EL9264) via unspecified route of administration in the right arm on 31Jan2021 at 11:15 as a first single dose for COVID-19 immunisation (age at vaccination was 72 years). The patient's medical history includes atrial fibrillation. Concomitant medications included warfarin (WARFARIN, 5mg), metoprolol tartrate (METOPROLOL TARTRATE) and terazosin hcl (TERAZOSIN HCL). The patient was other medications received within 2 weeks of vaccination included Warfarin 5mg. Metoprolol Tartrate. Terazosin HCL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Feb2021 the patient experienced extreme hives all over, concentrated in my midsection. she started feeling itchy about 3 days before my second shot and once her got that it turned into full blown hives that itch and hurt. Patient was not diagnosed with covid prior to COVID-19 vaccination and Since the vaccination, patient not tested for COVID-19. Patient was not received treatment for the event. The case classified as non-serious. The outcome of the event was reported as not recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasopharyngitis
Clinical narrative: Headache; Tired; Muscular ache; Cold; This is a spontaneous report from a non-contactable consumer (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 was not reported), 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 unspecified date, the patient experienced headache, tired, muscular ache, cold. The patient got little bit headache, tired, muscular ache and some cold. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain in extremity
Clinical narrative: Sore arm; feeling weak; headache; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 26Feb2021 at 12:00 PM at 38 years, as single dose, for COVID-19 immunisation. Medical history was none. The patient did not have COVID-19 prior to vaccination. Patient had no known allergies. Concomitant medications were not reported. The patient experienced sore arm (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered, feeling weak (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered, headache (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Toothache
Clinical narrative: Severe headache later feel like I had relate to my teeth ache; Severe headache later feel like I had relate to my teeth ache; I got the funny hot kind, shoot through my whole body; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 26Feb2021 (age at vaccination 86-year-old) at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included diltiazem. It was stated, "patient got her first Covid shot yesterday (clarified as 26Feb2021) afternoon and last night, on an unspecified date in 2021, she got had a severe headache later feel like she had relate to her teeth ache, but then later in the, patient got the funny hot kind, shoot through her whole body, it was like when she had up her surgery, when they put dye (further not clarified) in her she feel hot and now that she get it few times, the 4 o clock this morning and she got it again and now what she had all and got it in her back, was this severe allergies or otherwise she was okay." When paraphrased the concern, consumer confirmed the same and stated, "Yes, you are correct its shooting hot like it was hard to explain that it get real kind of hot and it was going through her whole body, not all the time." It was stated, "she was on medications for Blood pressure." The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head colds; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the second of 2 reports.  A male patient (reporter's husband) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Jan2021 (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. The patient experienced head colds (non-serious) in 2021 with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216429 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26Feb2021 08:30 (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. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. On 26Feb2021 at 20:00, the patient experienced chills, fever and headache. The patient stated that "I had my second dose yesterday and I was fine all day I had it at 8:30 yesterday morning and then about 8 o'clock last night I started with the headache and then of course I got the chills and the fever which lasted all night. My fever broke this morning". The patient recovered from fever and chills on an unspecified date; the outcome of headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe headache; Hot flashes; Chills; Loss of appetite; Fatigue & exhaustion; Dulled sense of smell and taste; dulled sense of smell and taste; This is a spontaneous report from a non-contactable other hcp. A 31-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 (Batch/Lot Number: EL3247) as 2ND DOSE, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 25Feb2021 05:00, the patient experienced severe headache, hot flashes, chills, loss of appetite, fatigue & exhaustion, dulled sense of smell and taste, and with onset 15 hours after shot administered adverse effects duration 48 hours; dulled sense of smell and taste still on-going dulled sense of smell and taste. The outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hypogeusia
Clinical narrative: Severe headache; Hot flashes; Chills; Loss of appetite; Fatigue & exhaustion; Dulled sense of smell and taste; dulled sense of smell and taste; This is a spontaneous report from a non-contactable other hcp. A 31-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 (Batch/Lot Number: EL3247) as 2ND DOSE, SINGLE for covid-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 25Feb2021 05:00, the patient experienced severe headache, hot flashes, chills, loss of appetite, fatigue & exhaustion, dulled sense of smell and taste, and with onset 15 hours after shot administered adverse effects duration 48 hours; dulled sense of smell and taste still on-going dulled sense of smell and taste. The outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Low grade fever; sore throat; EXTREME lethargy; This is a spontaneous report from a contactable consumer (reporting for herself). A 41-years-old female (Non-Pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient medical history included known allergies: penicillin from an unknown date and unknown if ongoing. Patient concomitant medications were not reported. It was stated that patient approaching two full weeks of side effect symptoms. On 21Feb2021, the patient experienced headache, low grade fever, sore throat, and extreme lethargy. I have been to the doctor twice. Negative for covid, strep and flu. AE resulted in doctor or other healthcare professional office/clinic visit Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks. The patient not received other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Diarrhoea, Gastrointestinal pain, Vaccination site pain
Clinical narrative: Body chills 6 hours post injection - 12 hours post injection.; GI pain; Bloating; Diarrhea; pain at injection site; This is a spontaneous report from a non-contactable other hcp reported for herself.  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 26Feb2021, at the age of 25-years-old, (Batch/Lot Number: EN6205) as singe dose for covid-19 immunisation. Medical history included obesity and a known allergy to Amoxicillin and Penicillin. The patient was not pregnant. The vaccine was administered at the Hospital. No covid prior vaccination, no tested for covid post vaccination. The patient's concomitant medications were not reported. The patient experienced body chills 6 hours post injection - 12 hours post injection, (non-serious) on 26Feb2021 with outcome of recovering , gastrointestinal pain (non-serious) on 26Feb2021 with outcome of not recovered, bloating (non-serious) on 26Feb2021 with outcome of recovering, diarrhea (non-serious) on 26Feb2021 with outcome of recovering, pain at injection site (non-serious) on 26Feb2021 with outcome of recovering.    No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration in the left arm, on 01Mar2021 (at 12:00 ) as 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021, the patient experienced headache. The patient did not receive any treatment for headache. On 05Mar2021, the outcome of the event was reported as recovering.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive for Covid 19; This is a Marketing Program spontaneous report (Stimulated Report) from a contactable consumer (Patient) and via Pfizer sponsored program (CEP ID: 159558). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 01Mar2021 the next day after the vaccination the patient had Tested positive for Covid-19 as she was exposed to someone with Covid 19. Patient enquired about that she could take the second dose of vaccine on time that at the 3 weeks. The reporter stated the events as non-serious. The outcome of the event was unknown.  Follow up (04Mar2021): This is a follow up spontaneous report from a Pfizer sponsored program. Information about Lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: rash appeared on my chest/back.arms and eventually legs; headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number EL9265, expiration date unspecified), dose 1 via an unspecified route of administration in the left arm on 09Feb2021 at 09:00, as single for covid-19 immunization. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number EN6202, expiration date unspecified), dose 1 via an unspecified route of administration in the left arm on 02Mar2021 at 09:00, as single for covid-19 immunization. The patient's medical history included that she took erythromycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other medications within 2 weeks prior. On 09Feb2021, after the first shot, the patient experienced headache in the evening that went away with Tylenol and another headache in the morning that also went away with Tylenol. On 02Mar2021 15:00, about 6 hours after the second shot patient face turned red and inflamed. About 4 hours later a rash appeared on my chest which took about 12 hours to spread first to my back, then my arms, and eventually my legs. Now, 48 hours later, my face is a little better, but the rash on my body remains. It does not itch. The patient was treated with Tylenol for the events. The patient was not tested for COVID-19 since the vaccination. The outcome for the event headache was recovered on Feb2021, and the other event rash was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Tinnitus got worse about 10 days after dosage. Feeling like water in ear when touch; Headache; This is a spontaneous report from a contactable Consumer (patient).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 08:30 (Batch/Lot number was not reported) at the age of 61 years,  as single dose for covid-19 immunisation.  Medical history included tinnitus from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient previously took z-pak and experienced allergy. On 18Feb2021 16:00 the patient experienced tinnitus that got worse about 10 days after dosage (feeling like water in ear when touch), and   headache (Headache off and on for 3 days starting on 3 rd after receiving shot). The patient did not receive treatment. The events were non-serious with outcome of not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Vomiting; fever; dizziness; This is a spontaneous report from a contactable consumer reporting for himself.    A 22-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Feb2021 08:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included covid-19  before the vaccine.  The patient's concomitant medications were not reported.  The patient experienced vomiting , fever and  dizziness all on 26Feb2021 21:00 with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headaches; Nausea; Fatigue (more then normal); This is a spontaneous report from a contactable consumer. A 45-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 12:45 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient received dose 1 of BNT162B2 on 04Feb2021 02:00 PM. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced headaches, nausea, fatigue on 26Feb2021 07:00. The patient received treatment of Tylenol. The events assessed as non-serious. Outcome of the events was recovering.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, COVID-19, SARS-CoV-2 test
Clinical narrative: Height: Commented she has lost some inches; she tested Covid-19 positive after receiving the first dose; This is a spontaneous report from a contactable female consumer (patient).  A 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9267; Expiry date: unknown) via an unspecified route of administration, administered in arm left (left shoulder) on 24Feb2021 15:30 (3:30 PM) (at the age of 83-year-old) at a single dose for COVID-19 immunization. It was unknown if the reporter was a health care professional. It was unknown if reporter was the prescribing HCP. The patient's medical history included experienced sore arm (AEs following prior vaccinations: Stated nothing more than a sore arm with the Flu Vaccine (the patient always got this with the Flu Vaccine). It occurred with whatever part of arm got the injection in and it would hurt and bother her for a day or so). the patients concomitant medications were not reported. (Confirmed has no lot/Exp to provide). Patient received a call from HCP informed that on 04Mar2021, the patient tested positive for COVID 19. Patient is due to get her 2nd vaccine on 17Mar2021 and stated that she was in quarantine for 10 days. Patient asked whether the patient could still get her second vaccine dose on the 17th. Patient have been trying to get an answer to this question since 10:00 this morning. The reporter stated the patient has lost some inches of height which led to Body height decreased on an unspecified date. The patient did not visit physician office/emergency room. She mentioned she was at the doctor's office for a regular check-up and then it was discovered there she was positive for COVID. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. The patient underwent lab tests and procedures which included body height was she has lost some inches and Covid 19 was tested positive on 04Mar2021. The clinical Outcome for the events was unknown.  Follow-up (04Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported that: historical vaccine (sore arm with the Flu Vaccine), product details (lot number: EL9267, anatomical location: left shoulder, vaccination time: 3:30 PM), event details (Covid-19 positive onset date: 04Mar2021, reported new event height: commented she has lost some inches), lab details (04Mar2021- tested positive for COVID) were added.  Follow-up (04Mar2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient): event verbatim (patient tested Covid-19 positive after receiving the first dose on 24Feb2021) was added. Medical Information (Live Operators Only): there were no unaddressed medical questions referred or forwarded to Medical Information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: head ache; chills; fatigue; weakness; I had no appetite but drank water; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201; expiration date: unknown), via an unspecified route of administration, administered in left arm on 01Mar2021 11:15 (at the age of 76-year-old) as a single dose for covid-19 immunisation. The vaccine was administered at Public Health facility. The patient had no known allergies. Medical history included controlled high blood pressure. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 08Feb2021 11:15 (at the age of 76-year-old) at a 1st dose, single dose for covid-19 immunisation. Concomitant medications included lisinopril (LISINOPRIL); naproxen sodium (SYNFLEX DS); ascorbic acid, betacarotene, biotin, boron, calcium carbonate, calcium pantothenate, calcium phosphate, chromium picolinate, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, lycopene, magnesium oxide, manganese sulfate, nickel, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, sodium metavanadate, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (SENTRY SENIOR). On 01Mar2021 at 08:00 PM, the patient experienced headache, chills, fatigue and weakness. These symptoms lasted through the following day and the majority of the second day. The patient had no appetite but drank water. The morning of the third day the patient was back to normal, no more symptoms. No treatment received for adverse event. Patient did not had COVID prior vaccination and did not had COVID tested post vaccination. Patient did not had any other vaccine in four weeks. The outcome of the events were recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: strange little headache with a "prickly"; This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A 82-yerar-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown; expiration date: unknown), via an unspecified route of administration on an unspecified date, as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced strange little headache with a prickly. Caller mentioned that she had nothing to complain about the aches and pain but there is a strange little headache with a prickly (like little dots; no pain) sensation on the forehead 3-4 days after getting the shot. Caller was concerned about getting the second shot, and enquired about the efficacy after receiving only one dose of the vaccine Caller mentioned that she had heard a lot of possible problems like sterility and heart failure, and would like some clarification on the known risks of the Pfizer-BioNTech COVID-19 Vaccine. The outcome of events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Headache, Malaise, Nausea
Clinical narrative: dull headache; lite nausea at times/Occasionally light nausea; eye fatigue along with a sort of "off" feeling; No intense feelings just not a 100% well feeling/Uneasy feeling; This is a spontaneous report from a contactable consumer or other non health care professional. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration in left arm on 20Jan2021 at 14:00 as 2nd dose single for COVID-19 immunization. The patient medical history and patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration, as 1st dose single on 30Dec2020 at 12:30 for COVID-19 immunization. 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. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since vaccination. The patient reported that, he had the Pfizer COVID Vaccine and had the second dose about 6 weeks ago. And still even after the 6 weeks the patient still had some light headaches and some light fatigue and occasionally light nausea, nothing bad, no real intense feeling but just kind of general unwell feeling someday and when you read its side effects supposed to be one or two days. The patient just wanted to see if had still probably common because it still feels the same, he did little long. The patient never had any intense side effects at all it was just slight headache, uneasy feeling, little light nausea. The patient did not received treatment for the events. The outcome of events were recovering.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Chills; Headache; Fever as high as 101.4; Sore arm; This is a spontaneous report from a contactable consumer (patient) A 66-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 17:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .Age at vaccination:66 years.  Medical history included covid-19 prior vaccination.The patient's concomitant medications were not reported.  The patient experienced chills (non-serious) on 25Feb2021 11:30 with outcome of unknown , headache (non-serious) on 25Feb2021 11:30 with outcome of unknown , fever as high as 101.4 (non-serious) on 25Feb2021 11:30 with outcome of unknown , sore arm (non-serious) on 25Feb2021 11:30 with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: 101.4   on 25Feb2021  .   No treatment received . Additional information:Facility type vaccine : Hospital.No other vaccine in four weeks ;.The patient has not been covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 14:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included asthma, gastritis, Penicillin and seasonal allergy .Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; fluticasone (FLUTICASONE) taken for an unspecified indication, start and stop date were not reported; hydrocodone (HYDROCODONE) taken for an unspecified indication, start and stop date were not reported; acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported; cannabidiol (CANNABIDIOL) taken for an unspecified indication, start and stop date were not reported; salmeterol (SALMETEROL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced nausea  (non-serious) on an unspecified date with outcome of recovering , vomiting (non-serious) on an unspecified date with outcome of recovering , chills  (non-serious) on an unspecified date with outcome of recovering , fatigue (non-serious) on an unspecified date with outcome of recovering. No treatment received.Additional information:Facility type vaccine : Hospital.No other vaccine in four weeks ;No  covid prior vaccination.The patient has not been covid tested post vaccination   the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.