chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: After 1st shot patient experienced a "moderate" fever after the first dose and a "high" fever after the second dose.; This is a spontaneous report from a contactable consumer. An adolescent female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, single dose and  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as second dose, single dose for COVID-19 immunization. Medical history was reported as unknown. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. It was also unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there's any other medications the patient received within 2 weeks of vaccination. It was reported that after first shot, patient experienced a "moderate" fever after the first dose and a "high" fever after the second dose. It was unknown if treatment was received for the adverse event.  The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Nausea; Headaches; This is a spontaneous report from a contactable consumer, the patient.  A 73-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 11:00 (Batch/Lot Number: EN6207) as 1st dose, single dose for covid-19 immunization. The patient did not had any medical history. Prior to the vaccination she was not diagnosed with COVID 19. Since the vaccination, she had not been tested for COVID-19. The patient did not had allergies to medications, food, or other products. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine neither had any other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was reported to be other not specified. On an unknown date, the patient experienced dizziness so severe that she could not stand up and also experienced headaches and nausea. Second day in still have dizziness. Therapeutic measures were taken included, that patient visited the emergency department and meclizine was prescribed by the emergency room doctor. At the time of the report, the outcome of the events dizziness, headache and nausea was not resolved.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's last name added,Patient's first name added in patient tab,Patient's age/units added in patient tab,State was update from full name to two capital digital state in patient tab,AE onset date/time was updated,Emergency room visit was checked,Treatment received was ticked as Yes and Relevant med history was added as None.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle fatigue
Clinical narrative: Headache; Fatigue; Muscle fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; solution for injection; lot number: EN6203), via an unspecified route of administration on 11Mar2021 09:30 (at the age of 44 -years-old) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Mar2021, the patient experienced headache, fatigue, and muscle fatigue. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6203) via an unspecified route of administration, administered in left arm, on 12Mar2021 at 11:30 (at the age of 49 years old) as 2nd dose, single dose, for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of report. The patient has no known allergies. Concomitant medications included amlodipine, olmesartan and etonogestrel (NEXPLANON), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Feb2021 at 10:30 A.M, for COVID-19 immunization. The patient has no other vaccine in four weeks; she had no COVID prior vaccination and was not tested with COVID post vaccination. On 13Mar2021 at 03:00 A.M on Saturday morning, it was reported that the patient experienced chills and body aches. She took tylenol at 4 A.M which helped, and she also had a fever and body aches all day Saturday and into Sunday. Tylenol helped with symptoms. The outcome of the events were recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash developed on neck.; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced rash developed on neck on Mar2021 with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hot flush, Skin discolouration
Clinical narrative: the symptom extended to chest area.; flushed, hot hands, forearms and also chest.; a very slight pinkish tone to the affected skin.; This is a spontaneous report from a non-contactable pharmacist.  A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 05Mar2021 (Batch/Lot Number: EN6202) as 1st DOSE, SINGLE for covid-19 immunisation; Age at vaccination:88 years.The patient medical history was not reported.     The patient's concomitant medications includes: sertraline hcl (SERTRALINE HCL), via an unspecified route of administration from 05Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 50 mg for an unspecified indication . Facility type vaccine: Hospital. The patient previously took morphine and experienced drug hypersensitivity.  The patient experienced flushed, hot hands, forearms and also chest (non-serious) on 09Mar2021, a very slight pinkish tone to the affected skin (non-serious) on 09Mar2021, the symptom extended to chest area. (condition aggravated) (non-serious) on 11Mar2021.  The outcome of the events was recovered in Mar2021.The clinical course was reported as follows: Patient received Pfizer COVID-19 vaccine on 5Mar21, and on 9Mar2021 she started experiencing flushed, hot hands, forearms and also chest. She also had a very slight pinkish tone to the affected skin. It disappeared within 2 hrs but then returned in the AM. 11Mar the symptom extended to chest area. The patient also started Sertraline 50mg 5Mar21, same day as vaccine administration. They contacted PCP and she did not believe the rxn was due to the Sertraline. As of 15Mar21 the symptoms have subsided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced very bad chills for 4-5 hours and had a headache after the first dose on unspecified date. The patient received her 1st dose last 11Mar2021 then she experienced chills, and now she was complaining of her headache and she was asking which medication she could take as she does not want TYLENOL. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A male patient of unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11 Mar 2021 (at an unspecified age) at 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt pain in the shoulder. The patient would like to take pain medicine meloxicam and was asking if this will affect the effectiveness of the vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression
Clinical narrative: has a pinched nerve in her neck.; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported for herself, a female patient of an unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 13Mar2021 as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had vaccine a few hours ago and has a pinched nerve in her neck on 13Mar2021. She was wondering if and when she can take a pain reliver. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Right side of face swollen; This is a spontaneous report received from a contactable consumer, a patient. A 69-year-old non-pregnant female patient received BNT162b2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 7/21 en6207, ) as a single dose via unspecified route of administration on the left arm on 17Mar2021 at 09:30 (age at vaccination: 69 years) for COVID-19 immunisation.  The patients medical history included scleroderma and had allergy to penicillin. The patients concomitant medications included infedipine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and DEXILANT all for an unknown indication since an unspecified date. The patient received shigalar vaccine within 4 weeks prior to the vaccine.  The patients experienced his right side of the face was swollen on 17Mar2021 at 21:30.Patient had not received treatment for the adverse event. The clinical outcome of the event swelling of face was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Vision dim; This is a spontaneous report from a contactable patient. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER613; UNKNOWN DOSE, SINGLE DOSE), via an unspecified route of administration in the left arm on 17Mar2021 at 04:45 PM (at the age of 56-years-old) for COVID-19 vaccination. The patients medical history includes type 1 diabetes mellitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to food, medications or other. The patients past drug history was unknown. The patients concomitant medication includes insulin. On 17Mar2021, the patients Vision affected by flashing lights. There seemed to be a delay in images reaching her brain instead. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive treatment for adverse event. The clinical outcome of the event was found to be recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Dysstasia, Neuralgia, Photophobia
Clinical narrative: I could not  bear the light  coming  in my room; I could not stand and I had to close curtains and I stayed in the suite of secluded darkness for a couple of hours.; My neuropathic facial pain that for some strange reason flared up; My neuropathic facial pain that for some strange reason flared up; This is a spontaneous report from a contactable consumer. An elderly patient of unspecified age ("by the way in my 80's") and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation and gabapentin 2100 mg daily , route of administration, start and stop date, batch/lot number were not reported for an unspecified indication.  Medical history included ongoing trigeminal neuralgia, ongoing neuralgia, ongoing hypoacusis. The patient's concomitant medications were not reported.  Approximatively one hour after vaccination, when at home, patient experienced could not  bear the light  coming  in my room , could not stand and  had to close curtains and stayed in the suite of secluded darkness for a couple of hours, neuropathic facial pain that for some strange reason flared up.  The action taken in response to the event(s) for bnt162b2 was not applicable , for gabapentin was unknown. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021299378 similar report from same reporter
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162be (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse. Patient had allergies to medications, food or other products but it was not specified in the source report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Allegra, Flonase, Melatonin, Yaz and Benedryl all for unknown indications from unknown dates and unknown if ongoing. Vaccine was administered in a Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 16Mar2021, at 13.30 hrs the patient experienced heart palpitations. The patient did not receive any treatment for the event heart palpitations. The clinical outcome heart palpitations was resolved on an unknown date.   Information about lot number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EN6203) via an unspecified route of administration in left arm on 12Mar2021 at 10.00AM as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EL3247) via an unspecified route of administration in left arm on 19FEB2021 10:00 AM as a single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. Patient was allergic to Iodine. Prior to vaccination, patient was not diagnosed with COVID-19, since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 12Mar2021 at 23:00 hours. the patient experienced body temperature (101 degrees), headache, diarrhea, nausea, chills, fatigue and body aches. The clinical outcome of the reported events was recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EN6203) via an unspecified route of administration in left arm on 12Mar2021 at 10.00AM as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EL3247) via an unspecified route of administration in left arm on 19FEB2021 10:00 AM as a single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. Patient was allergic to Iodine. Prior to vaccination, patient was not diagnosed with COVID-19, since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 12Mar2021 at 23:00 hours. the patient experienced body temperature (101 degrees), headache, diarrhea, nausea, chills, fatigue and body aches. The clinical outcome of the reported events was recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Muscular weakness
Clinical narrative: couldn't movelower extremities. Some weakness inarms; No involvement with breathing; This is a spontaneous report from a contactable/non-contactable None[C.2.r.4 (Reporter Type)].  A 82[D.2.2a; age]-Year(s)[ D.2.2b; age unit]-old Male[D.5; gender] patient received BNT162B2[G.k.2.2; suspect product(s) generic name(s) BNT162B2[G.k.2.3.r.1] 1[dose number FDA.G.k.4.r.13] dose:,None[ G.k.4.r.1a; G.k.4.r.1b], None[route(s) of administration or unspecified route G.k.4.r.10.1], administered in Arm Left[add the anatomical location G.k.4.r.11.x1] on 202103171430[G.k.4.r.4; start dates or unspecified date; and time if provided], ER8727[G.k.4.r.7 batch/lot number [Lot #], Expiration date [EXPIRATIONDATE Expiration Date or indicate if they were not reported], [for vaccine indicate the following information] at the age of vaccination 82[FDA.D.2.1a]; as dose(s) with unit] single[DRUGDOSEFREQUENCY], for Covid-19 immunisation[G.k.7.r.1;  indication(s). Medical history included [any information regarding past medical history, concurrent conditions, social history, and family history].   Concomitant medication(s) included Suspect[G.k.1 with value of 2: all concomitant medication names] taken for [indication(s) (if provided)] from [start dates] to [stop dates]. The patient previously took [D.8.r.1; past product] for [indication] and experienced [past event]. The patient experienced couldn't move lower extremities. Some weakness in arms,No involvement with breathing[E.i.1.2; AE(s)] and [indicate the appropriate seriousness criterion at the appropriate point in the description] on 202103171630[E.i.4; AE(s) onset date(s)]. The patient underwent lab tests and procedures, which included [F.r.1 ;any information regarding laboratory tests and procedures]. [He/She] was diagnosed as having [provisional/differential/definitive diagnoses]. The [non-vaccine suspect product(s) only do not add this statement for vaccines products] was/were [action taken] on[date of temporary interruption/withdrawn to be included if applicable]. Therapeutic measures were taken as a result of [AE] and included treatment with [treatment product(s)] from [start date(s) of treatment product(s)] to [stop date(s) of treatment product(s)]. The patient recovering/resolving[E.i.7: outcome(s) of the event(s)]/died] on [E.i.5; AE(s) stop date(s)].
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Horrible headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 34 years old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on 15Mar2021 (at the age of 34 years old) as single dose for COVID 19 immunisation. Medical history and Concomitant medications of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any allergy towards medications, food, or other products. Prior to vaccination the patient had not been diagnosed with COVID-19. On an unknown date patient experienced horrible headache and fatigue. Therapeutic measures were not taken for the events. Advil did not help. Since the vaccination, the patient had not tested positive for COVID 19. The clinical outcome of the events headache and fatigue was recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 16Mar2021 at 07:30 (at the age of 47-year-old) as a single dose for COVID-19 immunization. The Patient's Medical history included Depression, arthritis, hypothyroidism and rhinitis from unknown date. Concomitant medications included Escitalopram (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates.  Allergies to medications, food, or other products were reported to Iodine contrast dye. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested positive for COVID-19 since the vaccination. The patient experienced lightheaded and Dizziness on 17Mar2021. Adverse event was resulted in Doctor or other healthcare professional office/clinic visit and Treatment included  Hydration by drinking water and vertigo medication. The clinical outcome of the Dizziness was unknown. No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: fluish symptoms; Headache; Sore throat; This is a spontaneous report from a contactable Consumer or Other Non-Healthcare professional, the patient. A 47-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via the right arm on 16Mar2021 16:45 as a single dose for Covid-19 immunisation. The patient medical history includes depression/anxiety. Concomitant medication includes Clonazepam (MANUFACTURER UNKNOWN), Sertraline (MANUFACTURER UNKNOWN), Venlafaxine (MANUFACTURER UNKNOWN), Trazodone (MANUFACTURER UNKNOWN). Allergies to medications include sulfa-meds, Biaxin. 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 had not tested positive for COVID-19 since having the vaccine. The patient was tested negative for nasal swab COVID-19 virus test in Mar2020, Jun2020, Jul2020, Oct2020. On 16Mar2021 20:00, the patient experienced exhaustion/lethargy, chills, body aches (fluish symptoms), headache, sore throat. The patient did not receive any treatment for the reported events. The patient was not recovered from flu symptoms. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) on 17Mar2021 at 09:00 at left arm as first single dose for COVID-19 immunisation. (Age at vaccination: 51 Years). Concomitant medications included Wellbutrin (MANUFACTURER UNKNOWN) 150mg and Estadiol (MANUFACTURER UNKNOWN) 5mg; all for unknown indications from unknown dates. Prior to the vaccination, the patient was diagnosed with COVID-19 and since having the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has tested positive for COVID-19 prior to vaccine. Patient was allergic to penicillin and oxy. On 17Mar2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, nausea and felt unwell. No therapeutic measures were taken as a result of events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, fever, nausea and feeling unwell were resolved. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) on 17Mar2021 at 09:00 at left arm as first single dose for COVID-19 immunisation. (Age at vaccination: 51 Years). Concomitant medications included Wellbutrin (MANUFACTURER UNKNOWN) 150mg and Estadiol (MANUFACTURER UNKNOWN) 5mg; all for unknown indications from unknown dates. Prior to the vaccination, the patient was diagnosed with COVID-19 and since having the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has tested positive for COVID-19 prior to vaccine. Patient was allergic to penicillin and oxy. On 17Mar2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, nausea and felt unwell. No therapeutic measures were taken as a result of events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, fever, nausea and feeling unwell were resolved. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Fever - highest 101.7; Muscle and joint aches and pain; Severe headaches; Elevated heart rate; Joint ache and pain; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6198) via an unspecified route of administration in the right arm on 16Mar2021 at 10:00AM (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medication were not reported. Patient was not allergic to medications, food, or other products. 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 was not tested for COVID-19 post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 23Feb2021 as a single dose for COVID-19 immunisation. On 17Mar2021 at 06:00AM, the patient experienced Fever - highest 101.7 (units unspecified), Muscle and joint aches and pain, Severe headaches and Elevated heart rate. The patient did not receive any treatment for the reported events. The clinical outcome of the event Fever - highest 101.7, Muscle and joint aches and pain, Severe headaches and Elevated heart rate was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: Metallic taste; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6202), via unspecified route of administration in the right arm on 25Feb2021 at 17:00 hours as a single dose for COVID-19 immunisation. Medical history includes major depressive disorder, ADD (attention deficit disorder), hyperprolactinemia, Prolactinoma, vitamin D deficiency, anemia (only during week of period or if ill) from an unknown date. The patient has sensitivities to Hydrocodone, latex, Neomycin, nuts, dairy, gluten. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID 19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included VYVANSE, hydroxychloroquine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) which were received within two weeks of vaccination. On 25Feb2021, the patient experienced metallic taste within 1 to 2 minutes of having the vaccine shot, which lasted 12 to 24 hours and headache within 3 to 4 hours after having the vaccine shot, which lasted 24 hours. Patient did not received treatment for the reported events. The clinical outcome of the events metallic taste and headache was recovered.   No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 pm (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP) and oyster allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 am as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 18Mar2021, patient experienced soreness at injection site, headache and chills. No therapeutic measures were received for any event. The clinical outcome of the events soreness at injection site, headache and chills was resolved on 18Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Headache; Fever; Nausea; Dizziness; Fatigue; This is a spontaneous report received from a contactable nurse, the patient. A 22-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EK9231), via an unspecified route of administration in the left arm on 06Jan2021 at 18:15 (at the age of 22-years-old) and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 18:15 (at the age of 22-years-old), as single doses for COVID-19 immunisation. The patient's medical history included anxiety, depression, eczema, and orthrexia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), TRI ESTARYLLA, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Jan2021 at 06:00, the patient experienced headache, fever of 102 degrees Fahrenheit, nausea, dizziness and fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the events headache, fever, nausea, dizziness and fatigue was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Fever; Nausea; Dizziness; Fatigue; This is a spontaneous report received from a contactable nurse, the patient. A 22-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EK9231), via an unspecified route of administration in the left arm on 06Jan2021 at 18:15 (at the age of 22-years-old) and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 18:15 (at the age of 22-years-old), as single doses for COVID-19 immunisation. The patient's medical history included anxiety, depression, eczema, and orthrexia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), TRI ESTARYLLA, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Jan2021 at 06:00, the patient experienced headache, fever of 102 degrees Fahrenheit, nausea, dizziness and fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the events headache, fever, nausea, dizziness and fatigue was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: after a week of receiving the first dose, he tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program.   A male patient of an unspecified age 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 08Mar2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that in Mar2021 ,after a week of receiving the first dose, he tested positive for Covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Mar2021 after a week of receiving the first dose, he tested positive for COVID. Outcome of the event is reported as unknown at this point of time.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Mar2021, the patient had a positive covid test done. Laboratory tests included sars-cov-2 test positive. It was reported that on 31Mar2021, the patient was scheduled to get second dose and she was wondering as now when can she get the second dose. The Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2
Clinical narrative: Exposed to Covid; Chills; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Covid19 vaccine, formulation: Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 21Mar2021 (at the age of 43-year-old) as 1st dose, single dose for covid-19 immunisation. The patient had no medical history. There were no concomitant medications. On an unspecified date in 2021, the patient was exposed to covid with a co-worker for the past two weeks and was held to quarantine for 14 days. On an unspecified date in 2021, the patient experienced chills. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (patient) reported.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6205) via an unspecified route of administration on 15Mar2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The Reporter stated, she tested, she got her first dose last 15Mar2021 and got exposed to the positive or carrier of Covid-19 virus. she tested positive as well and now she asked if she needs to restart the vaccine from the first shot or needs to return or continue the second shot instead." On 19Mar2021, the patient experienced symptoms and tested positive on 21Mar2021. The patient was tested on Friday as well but her next dose of second vaccine is past, and way past quarantine period, that is why she asked to start over or could she do the second one. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on 21Mar2021. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: everyone there seems to have COVID in various symptoms in the house; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 2 patients (Self and Boyfriend). This is the 2nd of 2 reports.   This consumer reported for a 71-year-old male patient (Boyfriend) received first dose of BNT162B2(Formulation: Solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in Arm Right on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included diabetes and blood pressure high. There were no concomitant medications.  On an unknown date, the patient experienced unknown if they have covid/she says that they never got tested, but everyone there seems to have covid in various symptoms in the house. Consumer reported that patient had their first Pfizer COVID-19 vaccine shot 04Mar and are due today for their second shot in. She says that patient got their first shot, but since then their household has come down with COVID and her daughter has it, yesterday she tested positive. She says she was supposed to get her second dose today, but she has not been tested, so she wants to know how long she can go with not getting the second shot, like if she needed to isolate or if she could go the site masked and get it, she has heard there is no effect on having COVID when you get the vaccine, whether you get it or not. She says a couple of days after they got the shot her boyfriend went to his clubhouse and was there a couple hours, that same day, he was out masked the rest of the day but he took it off to eat. She says that they never got tested, but everyone there seems to have COVID in various symptoms in the house and her daughter tested positive yesterday after she didn't feel well at all. She says her daughter did not have vaccine. Consumer reported that patient had first dose injected in their right arms, probably closer to 03:00 PM though their appointments were at 02:00 PM, there was a long line. Caller says that her boyfriend were diabetic, he was diagnosed last year and he has had high blood pressure for a while. Patient did not on insulin or anything for it. Consumer reported patient did not had any other recent vaccinations or started any new medications. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021333120 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her husband tested positive for Covid after 1st dose; her husband tested positive for Covid after 1st dose; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program. A male patient (husband) of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The Reporter husband tested positive for Covid after 1st dose. The patient tested positive for covid after first dose. Reporter and her husband would like to reschedule their 2nd dose of the vaccine. They wanted to cancel the schedule tomorrow (26Mar2021) as the patient tested covid-19 positive. Reporter would like to know as well what will be the effect if the 2nd dose is delayed. The patient underwent lab tests and procedures which included tested covid-19: positive The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: got exposed to their niece who has lymphoma and who also tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a female patient (her sister-in-law).A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number), via an unspecified route of administration as 1st Dose Single Dose for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number), via an unspecified route of administration as 2nd Dose Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got exposed to their niece who has lymphoma and who also tested positive for covid. She wants to know if they can still be infected with Covid even if they received both doses of the vaccine.The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: (name) receive vaccine 05Mar2021. Tested positive.; This is a spontaneous report from a contactable consumer (patient himself) via Pfizer sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that, received vaccine on 05Mar2021 and tested positive 09Mar2021 or 10Mar2021 (reporter is not quite sure) and scheduled second dose on 26Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: caller said she has COVID as well, but was vaccinated with both in Feb; caller said she has COVID as well, but was vaccinated with both in Feb; This is a spontaneous report from a contactable consumer (Patient).   A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 as 1st DOSE, SINGLE via an unspecified route of administration on Jan2021 and dose 2 on Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient had COVID, but was not affected that bad as she was already vaccinated. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she tested positive last 10Mar; chills; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported), via unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient stated received the first dose on 03Mar2021, she tested positive last on 10Mar2021, had chills and fever then she was fine after that. She wanted to know if she could take the 2nd shot on 31Mar2021. Any unaddressed medical questions was not referred or forwarded to Medical Information. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.