chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Tiredness; headache; muscle pain; fever; feeling unwell; nausea; joints pain; injection site swelling/redness; injection site swelling/redness; This is a spontaneous report from a contactable nurse.  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),Batch/lot number: EK9231, intramuscular in the right arm, from 07Jan2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jan2021 02:30, the patient experienced tiredness, headache, muscle pain, fever, feeling unwell, nausea, joints pain and injection site swelling/redness. The outcome of events was not recovered.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tiredness; headache; muscle pain; fever; feeling unwell; nausea; joints pain; injection site swelling/redness; injection site swelling/redness; This is a spontaneous report from a contactable nurse.  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),Batch/lot number: EK9231, intramuscular in the right arm, from 07Jan2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jan2021 02:30, the patient experienced tiredness, headache, muscle pain, fever, feeling unwell, nausea, joints pain and injection site swelling/redness. The outcome of events was not recovered.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Very tiny bit of a headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, alprazolam (XANAX), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dosage regimen for an unspecified indication. Medical history included headache from an unknown date and unknown if ongoing (known to have headaches since her husband passed away in May2020). The patient's concomitant medications were not reported. The patient received the vaccine 2 hours (as reported) and experienced very tiny bit of a headache on an unspecified date. The action taken in response to the event for alprazolam was unknown. The patient inquired if they can take ibuprofen. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Facial nerve disorder, Paraesthesia oral
Clinical narrative: Left sided facial neuropathy, cheek, nose, ear and tingling lips; Left sided facial neuropathy, cheek, nose, ear and tingling lips; This is a spontaneous report from a contactable Other HCP.  A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3246, intramuscularly on 05Jan2021 16:00 at single dose  for covid-19 immunisation. Medical history included arthritis (degenerative arthritis). There were no concomitant medications. Anatomical Location: Arm Left  Facility location: Hospital. The patient did not eceived any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left sided facial neuropathy, cheek, nose, ear and tingling lips on 05Jan2021 16:45 with outcome of not recovered. The action taken was not applicable. No treatment received; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Malaise, Paraesthesia
Clinical narrative: felt a little bit dizzy; lightheaded; a little clammy; had tingling in the legs; general malaise; This is a spontaneous report from a contactable physician, the patient. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EK5730 & Expiry: 31Mar2021, via an unspecified route of administration on 19Dec2020 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included severe allergic reaction to a plant, reported as 23 years ago, and he has not had any other type of allergic reaction and hasn't had any reactions to any vaccine. Concomitant medications were not reported. On 19Dec2020, reported as within 10 minutes of receiving the vaccine, the patient felt a little bit dizzy, lightheaded, a little clammy, and had tingling in the legs, all of which went away quickly afterwards, within 5 minutes.  The patient also had the typical side effects after receiving the vaccine such as general malaise for 24 hours. He had felt fine ever since then. The patient was supposed to receive his second dose "tonight or tomorrow morning" and queried whether there was any guidance on pre-medicating with diphenhydramine (BENADRYL). The clinical outcome of the events felt a little bit dizzy, lightheaded, a little clammy, had tingling in the legs, and general malaise were resolved on Dec2020.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Had COVID infection 10 days after the getting the vaccine; Had COVID infection 10 days after the getting the vaccine; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular in right arm on 24Dec2020 09:00 at a single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to Covid vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. Patient has no allergies to medications, food, or other products. Physician would like to know if her patient can receive second dose of vaccine. Patient received vaccine 10 days ago. On 05Jan2021, the patient had Covid infection 10 days after the getting the vaccine. No treatment was received for the event. Patient tested positive for Covid after receiving vaccine. The patient underwent lab test  which included nasal swab: positive on 04Jan2021. The outcome of the event was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID 19 infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; chills; muscle aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). This 51--year-old female nurse reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1283/expiration date: unknown), via unknown route of administration, on 07Jan2021at 12:00 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 immunization at workplace clinic. Relevant medical history included chronic Fatigue. The patient have known allergies to penicillin (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ferrous sulfate 65 mg, daily. The patient previously received the first dose of BNT162B2 (lot number: EJ1685/expiration date: unknown) on 17Dec2020 at 01:00 PM (at the age of 51 years old) as a single dose in the left arm via unknown route of administration for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at 12:00 AM, after the second dose, the patient experienced fever, chills, muscle aches, headache, fatigue. No treatment was received for the events fever, chills, muscle aches, headache, fatigue. The outcome of the events fever, chills, muscle aches, headache, fatigue was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 (Batch/lot number: EJ1685) at a single dose on left arm, and received the second dose, intramuscular on 08Jan2021 (Batch/lot number: EK9231) at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded and flushed on an unspecified date. Treatment not received for the adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: chills; fever; intense body pain all over; headache; nausea; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 05Jan2021 17:30 in right arm at single dose for COVID-19 immunization. Medical history included hypopituitarism from an unknown date and unknown if ongoing. The patient received first dose of BNT162B2 (lot number: EJ1685), on 18Dec2020 10:45 in left arm at single dose. Concomitant medication included second dose of varicella zoster vaccine rge (cho) (SHINGRIX) for immunization, hydrocortisone acetate (CORTEF), levothyroxine sodium (SYNTHROID), desmopressin acetate (DDAVP), simvastatin, estrogens conjugated, medroxyprogesterone acetate (PREMPRO) and losartan potassium (LO). On 06Jan2021 08:00, the patient experienced chills, fever, intense body pain all over, headache and nausea. No treatment was given to the patient for the events. The patient recovered from the events in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient received SHINGRIX within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Pain at injection site; Transient fever; Chills; This is a spontaneous report from a contactable consumer. An adult male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 17Dec2020 at a single dose on left arm for COVID-19 immunization. The patient experienced pain at injection site, transient fever, and chills on 06Jan2021. No treatment received for adverse events. The patient underwent lab tests and procedures which included COVID test result = Negative on Dec2020.  The outcome of the events was recovering. The events were assessed as non-serious. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was also unknown Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on Dec2020, result was negative.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Significant painful lymphadenopathy in the R axilla; This is a spontaneous report from a contactable physician. A 27-year-old female patient received the the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL3248), intramuscularly in the right arm, on 06Jan2021 at a single dose for covid-19 immunization. The patient has no medical history. The patient has no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and OCP.  The patient experienced significant painful lymphadenopathy in the right axilla on 07Jan2021 20:00 with outcome of not recovered. The outcome of the event was not recovered. The patient did not receive treatment for the event. The patient did not have Covid prior to vaccination. The patient has not been tested for Covid post-vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Caller received the first dose of covid 19 vaccine and tested positive for covid.; Caller received the first dose of covid 19 vaccine and tested positive for covid.; Caller received the first dose of covid 19 vaccine and tested positive for covid.; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health professional (patient) reported that a female (age: 22; unit: not reported) patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of COVID 19 vaccine and tested positive for COVID on an unspecified date. She was under quarantine and wanted to know when and if she should get the second dose. Due date for second dose is 11Jan2021. The patient underwent lab tests and procedures which included Covid-19: positive on an unspecified date. The outcome of event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The association between the event lack of effect (Covid-19 test positive) with BNT162b2 can not be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test positive
Clinical narrative: had her 1st dose of Covid vaccine yesterday and started experiencing all expected side effects today including lost of smell and taste/ Rapid PCR Test which came back positive; had her 1st dose of Covid vaccine yesterday and started experiencing all expected side effects today including lost of smell and taste/ Rapid PCR Test which came back positive; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose of COVID vaccine yesterday, 07Jan2021 and started experiencing all expected side effects today (08Jan2021) including loss of smell and taste. She also had a Rapid PCR test done today which came back positive. She wanted to know if this could be a false positive result from the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: he "feels heated up, on the inside" from the waist up; This is a spontaneous report from a contactable consumer (spouse). An-82-year-old male patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown), via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan 2021, the patient experienced he "feels heated up, on the inside" from the waist up. The patient did not report fever.  The outcome of the event was unknown.  Information on lot number/batch number was requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Eh9899), via an unspecified route of administration in the left arm on19Dec2020 10:30 at a single dose for covid-19 immunization. The patient has no relevant medical history. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 19 December 2020, the patient experienced right arm pain. No treatment was given for the event. The outcome of the event was recovered. The vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Information on Lot/Batch has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, SARS-CoV-2 test, Tonsillitis, Uvulitis
Clinical narrative: chills; tonsillitis/tonsils were inflamed; uvulitis/uvula were inflamed; body malaise; This is a spontaneous report from a contactable nurse (patient).  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, then intramuscular on left arm from 06Jan2021 08:15 to 06Jan2021 08:15 as SINGLE DOSE for COVID-19 immunisation.  Medical history included eczema.  Historical Vaccine includes: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 16Dec2020 09:15. Concomitant medication included halobetasol propionate 0.05% ointment. On 07Jan2021, experienced body malaise (after 24 hours of receiving vaccine). On 08Jan2021, the patient experienced uvulitis, tonsillitis (after 48 hours of receiving the vaccine). The patient suddenly woke up from sleep feeling something was in his throat. Looked in the mirror and my uvula & tonsils were inflamed. On 08Jan2021, 08:00am, the patient experienced chills. No other symptoms accompanying the swelling of tonsils, uvula. The patient underwent nasal swab, L UMIRADX SARS-COV-2 AG test on 21Dec2020 with negative result. The outcome of the events was recovering at the time of the report. No treatment was given for the events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Throat irritation, Throat tightness
Clinical narrative: dry, tight, scratchy throat; dry, tight, scratchy throat; dry, tight, scratchy throat; This is a spontaneous report from a contactable pharmacist. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) intramuscular on 06Jan2021 18:15 (06:15 PM) at a single dose for COVID vaccine. Medical history included anxiety; known allergies to latex, penicillin, wheat, gluten. Concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. It was unknown if the patient received other vaccines within four weeks prior to the COVID vaccine and there were no documented other medications within 2 weeks of vaccination. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). On 06Jan2021 18:15, the patient complained of dry, tight, scratchy throat after receiving vaccine; assessed as non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was monitored and instructed to monitor at home. Treatment was not received for the events. It was unknown if she was diagnosed with COVID-19 prior to vaccination and also unknown if she had COVID-19 tested post vaccination. The outcome of the events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the left arm on 07Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included ankylosing spondylitis, migraine, anxiety, and insomnia. Concomitant medications included fluvoxamine (FLUVOXAMINE), and adalimumab (ADALIMUMAB). The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EJ1685) via unknown route of administration on the left arm on 17Dec2020 17:30 at a single dose for COVID-19 immunization. On 07Jan2021 18:00, the patient experienced Nausea, vomiting, fatigue, headache, lymphadenopathy, and body aches. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.  The patient recovered from the events in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the left arm on 07Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included ankylosing spondylitis, migraine, anxiety, and insomnia. Concomitant medications included fluvoxamine (FLUVOXAMINE), and adalimumab (ADALIMUMAB). The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EJ1685) via unknown route of administration on the left arm on 17Dec2020 17:30 at a single dose for COVID-19 immunization. On 07Jan2021 18:00, the patient experienced Nausea, vomiting, fatigue, headache, lymphadenopathy, and body aches. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.  The patient recovered from the events in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: sore throat; Fatigue; fever; injection site soreness; This is a spontaneous report from a contactable other HCP (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via uknown route of administration, on 06Jan2021 at 11:15 AM (at the age of 38 years old) as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history included anxiety and depression. The patient has known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 evening, the patient experienced injection site soreness at 6:30 PM, fatigue and fever at 7:30 PM. Fatigue and fever were gone by morning. Injection site soreness faded every day. On 08Jan2021, the patient experienced sore throat. No treatment was received for the events injection site soreness, fatigue, fever and sore throat. The outcome of the events injection site soreness, fatigue, fever and sore throat was recovering. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had been tested for COVID-19 via COVID test Nasal Swab on 08Jan2021 with pending result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain
Clinical narrative: Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the right arm on 07Jan2021 16:00 at a single dose for COVID-19 immunization. Medical history included depression. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA).  The patient experienced chills, body ache, headache, insomnia on 08Jan2021 02:00. Outcome of the events was not recovered. No treatment was given for the adverse events. The reporter assessed the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information of lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills
Clinical narrative: chills; This is a spontaneous report from a contactable healthcare professional, the patient. A 21-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL0142, intramuscularly in the left deltoid on 06Jan2021 at 08:00 (at the age of 21-years-old) at 0.3 "mg" as a single dose for COVID-19 immunization. Medical history included birth control use and obesity. Concomitant medications included ongoing ethinylestradiol/norgestimate (SPRINTEC) tablet for birth control. The patient did not receive any vaccinations within 4 weeks prior to the vaccination. The patient previously took methylphenidate hydrochloride (CONCERTA) 27 mg and experienced lack of appetite and was still having sleepiness (insomnia she guessed) and therefore was dropped to 18 mg and still had side effects; as well as guanfacine. On 07Jan2021 at 21:00, the patient experienced chills. She thought it was just her mom's house being cold, but she had a little bit of a chill all day today (08Jan2021). She didn't have a fever. The last time she took her temperature it was 98.5 degrees Fahrenheit, which was normal for her. The caller stated she did have a slower metabolism when it came to medication. She didn't know 100% if she hadn't been exposed to COVID, as she worked in healthcare and worked last on Monday. The event, chills, did not prompt an emergency room or physician office visit. The caller was worried if this was a normal side effect of the vaccine or if she was getting sick with COVID. She would go through with the COVID test she had scheduled for "tomorrow morning" as she was still experiencing side effects. The chills stayed the same or were a little worse. The clinical outcome of chills was not resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: With first shot just body aches; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), intramuscular in right arm on 17Dec2020 at a single dose for covid-19 immunization. Medical history included depression. Patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced with first shot just body aches on an unspecified date. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in jaw, Vaccination site pain
Clinical narrative: Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; This is a spontaneous report form a contactable physician. A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL0142, expiry date: not reported) intramuscular, on 07Jan2021 07:30 AM on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. It was unknown if patient was pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. On 08Jan2021 07:30 AM, the patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Treatment was not received for the adverse events. Outcome of the events was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: right sided facial tingling after receiving his first vaccination/ numbness and tingling lasted approx. 3 days; right sided facial tingling after receiving his first vaccination/ numbness and tingling lasted approx. 3 days; This is a spontaneous report from a non-contactable other healthcare professional. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration in right deltoid muscle on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient was seen at the COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination (Lot number: EK9231). He denied any history of previous adverse reactions to other vaccines but does note he had tingling to the right side of his face after his first dose that lasted 3 days. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience tingling to right side of face. Patient states he had right sided facial tingling after receiving his first vaccination but was not evaluated in the medical bay. He states the numbness and tingling lasted approx. 3 days. Denied weakness in right sided facial muscles at that time. Stable to go home and follow up with PCP. The outcome of the events was recovered.   No follow-up attempts are possible; information regarding lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle soreness at greater injection site; This is a spontaneous report from a contactable other healthcare professional. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number=EJ1685), intramuscular in left arm on 20Dec2020 16:00 at a single dose for Covid-19 immunization. Medical history included diabetes and hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has no allergies to medications, food or other products. The patient's concomitant medications included prescribed medication (unspecified). The patient experienced muscle soreness at greater injection site on 21Dec2020 at 06:00 AM. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival blister, Stomatitis
Clinical narrative: A series of several bumps have turned into sores inside of her mouth/ located on the right side of mouth inside the gum of her back bottom teeth and now turning into clusters of blisters; A series of several bumps have turned into sores inside of her mouth/ located on the right side of mouth inside the gum of her back bottom teeth and now turning into clusters of blisters; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686), via an unspecified route of administration in left arm on 31Dec2020 at 02:45 PM at a single dose for Covid-19 immunization. Medical history included Covid-19. Prior to vaccination, patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 at 05:45 PM, the patient experienced series of several bumps have turned into sores inside of her mouth. They are located on the right side of her mouth inside the gum of her back bottom teeth. They are now turning into clusters of blisters. It was unknown whether treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: mid-grade fever with a temperature of 100.4 degrees F. The temperature peaked 101.4 degrees F last night.; Chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included asthma, sulfur/sulfameds allergies, and iodine dye allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included estradiol (ESTROGEN), progesterone, colecalciferol (VITAMIN D), allergy shots, and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021 18:00, the patient experienced chills and were continuing today. She was experiencing a mid-grade fever with a temperature of 100.4 degrees Fahrenheit on 04Jan2021. The temperature peaked 101.4 degrees Fahrenheit last night (07Jan2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included rapid nasal pharyngeal COVID test which showed unknown results on 07Jan2021. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Discomfort, Feeling cold, Headache
Clinical narrative: It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Meningitis viral, Migraine, Nausea, Pain in extremity
Clinical narrative: It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Phobia, Photophobia, Tension, Tremor
Clinical narrative: It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: Facial tingling, itching and redness; Facial tingling, itching and redness; Facial tingling, itching and redness; This is a spontaneous report from a contactable nurse (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 08Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history included mild adrenal insufficiency. Concomitant medication included hydrocortisone to 06Jan2021. The patient previously took lidocaine and experienced allergies to lidocaine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. 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 and had not been tested for COVID-19 since the vaccination. The patient experienced facial tingling, itching and redness on 08Jan2021 10:45. Therapeutic measures were taken as a result of facial tingling, itching and redness and included treatment with self administered chlorpheniramine 12 mg. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever 101; Headaches; Bodyaches; Fatigue; This is a spontaneous report from a contactable physician. An adult male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek4231), via an unspecified route of administration from 06Jan2021 09:00 to 06Jan2021 09:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on 16Dec2020. It was reported that the patient experienced Fever 101, Headaches, Bodyaches and Fatigue on 06Jan2021. The patient took Tylenol as treatment. The outcome of the events was recovered on an unspecified date in Jan2021.