chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Eyelid ptosis, Facial paralysis
Clinical narrative: Full Blown up/Droopy eyes; Bell's Palsy; Droopy Mouth; This spontaneous case was reported by a nurse and describes the occurrence of BELL'S PALSY (Bell's Palsy) and FACIAL PARALYSIS (Droopy Mouth) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant) and FACIAL PARALYSIS (Droopy Mouth) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced EYELID PTOSIS (Full Blown up/Droopy eyes). The patient was treated with ACYCLOVIR [ACICLOVIR] for Bell's palsy, at an unspecified dose and frequency and PREDNISONE for Bell's palsy, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy), FACIAL PARALYSIS (Droopy Mouth) and EYELID PTOSIS (Full Blown up/Droopy eyes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received both vaccination doses in June (beginning and end of June).  Company Comment: Very limited information regarding the dates of vaccine administration and the start date of the events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding the dates of vaccine administration and the start date of the events have been provided. Further information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Nausea
Clinical narrative: Nausea; Fatigue; Irrirability; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0198 and expiration date: not reported), via intramuscular, on upper Left arm, on 25Jun2021 at 09:00 (at the age of 27-year-old), as DOSE 2, SINGLE for covid-19 immunization at pharmacy/drugstore. The patient had no medical history. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, solution for injection; lot number:EW0187and expiration date: not reported) via intramuscular, on upper Left arm, on 04Jun2021 at 13:00  (at the age of 27-year-old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy/drugstore and experienced Confusion, Blurry Vision  and Dizziness. On 25Jun2021 at 10:30 also reported as 1.5 hrs. after given 2nd dose the patient experienced nausea, fatigue and, irritability which took 36hrs to go away. The outcome of the events was recovered on 26Jun2021 at 22:30.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Vomiting
Clinical narrative: Vomiting; body aches; fatigue aroumd 3:00 AM; Chills around 2:00 AM; Nausea around 2:00 AM; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 28-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318, Expiration date: Unknown), via an unspecified route of administration, in Left Arm on 12Feb2021 at 12:00 as Dose 2, single for Covid-19 immunisation. Patient received first dose of bnt162b2 (Solution for injection, Lot number: EL1283, Expiration date was unknown), via an unspecified route of administration in Left Arm on an unspecified date as dose 1, single for Covid-19 immunisation. The patient medical history was not reported. The patient received concomitant medications within 2 weeks included Tri-Lo-Sprintec. Patient was not diagnosed covid prior vaccination. Patient did not receive any other vaccine within 4 weeks. Patient had not been tested for COVID-19, after the vaccination. On 12Feb2021 at 02:00, the patient experienced chills and nausea while around 3:00AM, she had vomiting, body aches and fatigue. Patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Vaccination site pain
Clinical narrative: abscess in her mouth; sore arm at injection site; This is a spontaneous report from a Pfizer-sponsored program a Regulatory Authority .   A contactable female (Patient) of an unspecified age (Age: 66; Unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 24Feb2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not re-ported. On 24Feb2021, the patient experienced sore arm at injection site and on an unspecified date she experienced abscess in her mouth. Patient was prescribed with 500 mg Amoxicillin to take, while patient wanted to know would that affect efficacy of the vaccine. The outcome of the events was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: virtually no reaction to the second(except when I touched the site of injection I felt a little sore arm.; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 13Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) in response to consumer letter sent via follow-up letter. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EM9810; expiration date: 30Jun2021) dose 2, via intramuscular, administered in arm left on 19Feb2021 09:00 (age at vaccination 69-year-old) as single dose for covid-19 immunisation. Medical history included, ongoing hypertension, family history included hypertension and heart disease, gall bladder removal on an unknown date Jun2015, cataract surgery on an unknown date 2016. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EL9262; expiration date: 31May2021), via intramuscular, administered in arm left on 28Jan2021 16:30 as single for COVID-19 immunisation and experienced sore arm. Concomitant medication included lisinopril taken for hypertension (taken for years). The patient experienced virtually no reaction to the second (except when i touched the site of injection i felt a little sore arm on an unspecified date. The patient reported that called to Pfizer to get info about people who experienced no reactions. and if this made them more suddenly to get COVID. Patient reported that had no adverse reaction. Patient contacted Pfizer to find out if booster shots were planned as of that date none had been planned although the current variant didn't exist. Patient was concern with her lack of any reaction and that Patient would be less covered by the vaccine than those experienced AE's. Patient still remain concerned as to how effective your vaccine will be in protecting against the variants, unsure if body made any antibodies. Asked doctor if patient could get a fiter test just for peace of mind. Knowing that, the doctor said was not being advised at this time. Patient was concerned about breakthrough vaccines and wish he could receive a booster. Since patient was totally vaccinated almost five months ago patient worry that he will be less protected when increased cases hit the area this fall. Patient did know that people can still be protected even if they didn't exhibit an outward reaction. But without knowing patient had antibodies, patient did not feel comfortable removing her mask indoors or with large groups. Please make a booster and offer it to those like me who remain uncertain as to our immunity. No treatment medication was received for the adverse event. The outcome of the events was unknown.  Follow up activities are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headachy; arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from a Pfizer-sponsored program.   A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration (at the age of 69-years), administered in arm on 23Feb2021 09:00 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration (at the age of 69-years), administered in arm on 19Mar2021 09:15  as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date , the patient experienced headachy and arm soreness. Not sure why I received this but only side effect was headachy and arm soreness. The treatment was not received for the event. Caller concerned and was calling and indicating that she got her 1st dose of the vaccine last 23Feb2021, and scheduled on 19Mar2021, for the second dose (more than 21 days). She wanted to know as well since she got dental surgery and took antibiotics in between of 1st dose and 2nd dose she wants to know if that will make the 2nd dose less effective. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.  Follow-up(12Jul2021): The initial case was missing the following minimum criteria: [No adverse effect]. Upon receipt of follow-up information on 12Jul2021 this case now contains all required information to be considered valid included first and second dose date of vaccination, events, treatment with outcome.   Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Chest pain, Cough, Headache, Lethargy
Clinical narrative: pain in chest/slight pain in chest; light cough; lethargic; fever; headache; As soon as I received my second dose, my period stopped; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient).   A 28-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 28-years) on 20Mar2021 12:09 as dose 2, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient historical vaccine included first dose of BNT162B2 Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration received on 26Feb2021, for COVID-19 immunization and patient had no issues with first injection with the exception of some pain in the injection area. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 (as soon as I received her second dose), the patient experienced her period stopped. On 21Mar2021, she experienced lethargic, fever, and headache. On 23Mar2021, she experienced pain in chest/slight pain in chest, and light cough. It was stated that she started back up again after over 48 hours, period basically stopped (was bleeding heavily before, but only produced pink dis-charge after the injection). The patient was on Day 3 of period when she received second dose. It was stated that normally she would have 6-day cycles. She wanted to address this, because she could not found any data in terms of women's periods/pregnancy/fertility/etc. The patient just thought it was really strange. The treatment was not received for the event. The event period stopped was reported as resolved on 23Mar2021, while other events resolved on an unspecified date in 2021.  No follow-up attempts were possible; information about batch number could not be obtained. No further information was expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain in chest/slight pain in chest; light cough; lethargic; fever; headache; As soon as I received my second dose, my period stopped; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient).   A 28-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 28-years) on 20Mar2021 12:09 as dose 2, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient historical vaccine included first dose of BNT162B2 Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration received on 26Feb2021, for COVID-19 immunization and patient had no issues with first injection with the exception of some pain in the injection area. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 (as soon as I received her second dose), the patient experienced her period stopped. On 21Mar2021, she experienced lethargic, fever, and headache. On 23Mar2021, she experienced pain in chest/slight pain in chest, and light cough. It was stated that she started back up again after over 48 hours, period basically stopped (was bleeding heavily before, but only produced pink dis-charge after the injection). The patient was on Day 3 of period when she received second dose. It was stated that normally she would have 6-day cycles. She wanted to address this, because she could not found any data in terms of women's periods/pregnancy/fertility/etc. The patient just thought it was really strange. The treatment was not received for the event. The event period stopped was reported as resolved on 23Mar2021, while other events resolved on an unspecified date in 2021.  No follow-up attempts were possible; information about batch number could not be obtained. No further information was expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: achy; skin hurts; Tired; sore arm; low grade fever; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration on the right arm on 24Mar2021 as a single dose for COVID-19 immunisation. It was reported that medical history was unknown. It was unknown if patient has received any other medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. It was unknown if the patient has any allergies to medications, food or other products. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced tired, achy, sore arm, low grade fever and skin that hurts. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the events tired, achy, sore arm, low grade fever and skin hurts was recovered on an unknown date.   Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked in slide 1.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6203) via an unspecified route of administration in the left arm on 04Mar2021 at 14:30 as single dose (at the age of 62-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6955) via an unspecified route of administration in the left arm, on 25Mar2021 at 09:30 as single dose (at the age of 62-year-old) for COVID-19 immunisation. The patient medical included rheumatoid arthritis. Concomitant medication includes methotrexate (MANUFACTURER UNKNOWN), hydroxychloroquine (MANUFACTURER UNKNOWN), LEUCOVORIN [FOLINIC ACID] (MANUFACTURER UNKNOWN), low-dose naltrexone (LDN) (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 08Mar2021, the patient experienced tinnitus, ringing in ears which was never before, and was constant. The patient did not received any treatment for the reported adverse event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event tinnitus was not resolved.   No follow-up attempts are needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility information, Best Doctor details added, Concomitant drug leucovorin code as LEUCOVORIN [FOLINIC ACID]. In narrative solution for injection as unspecified route of administration, the patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19 was added.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Night sweats, Pain in extremity
Clinical narrative: sore arm; night sweats after 2nd dose; lethargy for 12-24 hrs; This is a spontaneous report from a non-contactable consumer. A 37-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on  an unspecified date in Mar2021 as single dose for covid-19 immunisation. Medical history and Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient was tested for COVID-19, since the vaccination. On an unspecified date in Mar2021, the patient experienced sore arm, night sweats after 2nd dose and lethargy for 12-24 hrs. The patient did not receive any treatment for the reported events pain in arm, night sweats and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, night sweats and lethargy was recovered on unspecified date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.   Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility. Events start date and stop date added "Mar2021". Narrative ending sentence updated to "No follow-up attempts are needed; information about lot/batch number cannot be obtained".
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair on legs & arms fell off.; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and expiration date was unknown) via unspecified route of administration in the right arm, on 04Mar2021 at 19:00 (at the age of 39-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. On 11Mar2021, the patient's hair on legs & arms fell off. The reported seriousness was non-serious. Patient didn't receive treatment for the adverse event. The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Relevant medical history none was deleted since not reported on source, final sentence updated as 'No follow-up attempts are needed; information about lot/batch number cannot be obtained' and the whole narrative corrected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Chills; nausea; severe vomiting; diarrhea; chest pain; shortness of breath; tingling on fingers; headache; fever; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8732) via an unspecified route of administration, administered on the right arm on 26Mar2021 12:45 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fish oil (OMEGA 3 FORTE [FISH OIL]) and birth control pill. The patient previously received first dose of BNT162B2 on 07Mar2021 for COVID-19 immunisation (at 09:00 PM, Lot number: ER8732). On 26Mar2021 22:00, the patient experienced chills, nausea, severe vomiting, diarrhea, chest pain, shortness of breath, tingling on fingers, headache, fever. The events resulted in Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the events which included IV fluids, EKG (unknown result), chest X-ray (unknown result) and nausea medicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Chills; nausea; severe vomiting; diarrhea; chest pain; shortness of breath; tingling on fingers; headache; fever; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8732) via an unspecified route of administration, administered on the right arm on 26Mar2021 12:45 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fish oil (OMEGA 3 FORTE [FISH OIL]) and birth control pill. The patient previously received first dose of BNT162B2 on 07Mar2021 for COVID-19 immunisation (at 09:00 PM, Lot number: ER8732). On 26Mar2021 22:00, the patient experienced chills, nausea, severe vomiting, diarrhea, chest pain, shortness of breath, tingling on fingers, headache, fever. The events resulted in Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the events which included IV fluids, EKG (unknown result), chest X-ray (unknown result) and nausea medicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; nausea; severe vomiting; diarrhea; chest pain; shortness of breath; tingling on fingers; headache; fever; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8732) via an unspecified route of administration, administered on the right arm on 26Mar2021 12:45 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fish oil (OMEGA 3 FORTE [FISH OIL]) and birth control pill. The patient previously received first dose of BNT162B2 on 07Mar2021 for COVID-19 immunisation (at 09:00 PM, Lot number: ER8732). On 26Mar2021 22:00, the patient experienced chills, nausea, severe vomiting, diarrhea, chest pain, shortness of breath, tingling on fingers, headache, fever. The events resulted in Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the events which included IV fluids, EKG (unknown result), chest X-ray (unknown result) and nausea medicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache for 2 weeks; Light headed and dizzy for 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6208) via an unspecified route of administration, administered on the left arm on 20Mar2021 13:30 as single dose for COVID-19 immunisation. Medical history included COVID-19 (prior vaccination). Concomitant medication included ixekizumab (TALTZ). On 21Mar2021 12:00 AM, the patient experienced light headed and dizzy for 2 weeks, headache for 2 weeks. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was not recovered.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dizziness, Fatigue, Pyrexia, Vomiting
Clinical narrative: severe asthma attack; throwing up; head rush/dizziness; fever; fatigue/slept all the rest of the day; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 30Mar2021 at 12:00 (at 59 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included asthma, hypersensitivity, and high blood pressure; all from unspecified date. The patient had no known allergies. Concomitant medication included beclometasone dipropionate (QVAR) and antihistamines, both from unspecified date for unspecified indication. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that approximately 48 hours after vaccine dose, the patient experienced a severe asthma attack including throwing up and having to use albuterol sulfate nebulizer. Note: Day of vaccine the patient had severe cytokine-antivirus response symptoms with head rush, dizziness, fever, fatigue, slept all the rest of the day. The date of adverse events was on 31Mar2021 at 12:00. Outcome of the events was recovered on unspecified date in 2021.   Information on batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: menstrual spotting (patient was menopausal and have not had a period in a few years); This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6199) via an unspecified route of administration, administered on the left arm on 12Mar2021 14:00 as dose 1, single for COVID-19 immunisation. The patient's medical history included menopausal (have not had a period in a few years). Concomitant medication included curcuma longa (TURMERIC [CURCUMA LONGA]) and once a day vitamin. Two days after the injection (14Mar2021 at 11:00 AM), patient had some menstrual spotting (patient was menopausal and have not had a period in a few years). It was fairly light and went away in 24 hours. It returned 19 days after the injection and was light again. No treatment was received for the events. The facility where the vaccine was administered was in a pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534 and expiration date: not reported), via an unspecified route of administration in left arm, on 03Mar2021 at 14:30 (at the age of 63 years old) as dose 1, single for COVID-19 immunization in a facility reported as other. Medical history included chronic fatigue syndrome. The patient was allergic to amoxicillin, clavulanate (AUGMENTIN) and amoxicillin. Concomitant medications included diltiazem. The patient didn't receive any other vaccines in 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient didn't had COVID-19 and post vaccination, the patient was not tested for COVID-19. Two days after the vaccination, the patient experienced diarrhea on 05Mar2021. It was continued for the past 14 days, and still persists. The patient was treated with loperamide hydrochloride 2 mg for this event. The event led to doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Dizziness, Headache
Clinical narrative: Vomiting continuously for three days; joints and muscle aches; joints and muscle aches; Chill; Very severe headache; dizzy spells; Lost of balance when walking/balancing unable to drive; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EV6203), via an unspecified route of administration, in left arm on 08Mar2021 16:15 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took prednisone and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting continuously for three days, joints and muscle aches, chills, very severe headache continuous for 7 days, dizzy spells and loss of balance when walking on 08Mar2021 19:00. The patient has not been able to go back to work after receiving first dose due to dizzy spells and balancing as she is unable to drive. The events resulted in emergency room visit and physician office visit. Emergency physician & personal doctor recommended the patient not to take the 2nd dose. The patient underwent lab tests and procedures which included blood test for COVID-19: negative  on 12Mar2021, nasal swab for COVID-19: negative on 12Mar2021, head and chest X-ray as a part of treatment. The patient was also prescribed medications for the events. The outcome of the events was recovered with sequalae.; Sender's Comments: Based on a plausible temporal association, all the events (vomiting, joints and muscle aches, chills, headache, dizzy spells and loss of balance when walking) are assessed as related to BNT162B2.   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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test, Vomiting, X-ray
Clinical narrative: Vomiting continuously for three days; joints and muscle aches; joints and muscle aches; Chill; Very severe headache; dizzy spells; Lost of balance when walking/balancing unable to drive; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EV6203), via an unspecified route of administration, in left arm on 08Mar2021 16:15 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took prednisone and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting continuously for three days, joints and muscle aches, chills, very severe headache continuous for 7 days, dizzy spells and loss of balance when walking on 08Mar2021 19:00. The patient has not been able to go back to work after receiving first dose due to dizzy spells and balancing as she is unable to drive. The events resulted in emergency room visit and physician office visit. Emergency physician & personal doctor recommended the patient not to take the 2nd dose. The patient underwent lab tests and procedures which included blood test for COVID-19: negative  on 12Mar2021, nasal swab for COVID-19: negative on 12Mar2021, head and chest X-ray as a part of treatment. The patient was also prescribed medications for the events. The outcome of the events was recovered with sequalae.; Sender's Comments: Based on a plausible temporal association, all the events (vomiting, joints and muscle aches, chills, headache, dizzy spells and loss of balance when walking) are assessed as related to BNT162B2.   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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Ophthalmic herpes zoster
Clinical narrative: His eye doctor feels this vaccine has re-activated his shingles in his left eye which has been asleep for over 2 years.; His eye doctor feels this vaccine has re-activated his shingles in his left eye which has been asleep for over 2 years.; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 09Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included sleep apnea, afib and shingles in his left eye (asleep for over 2 years). Concomitant medications included levothyroxine; hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE); aspirin [acetylsalicylic acid]; colecalciferol (VIT D3); rivaroxaban (XARELTO); atorvastatin; prednisolone acetate; chondroitin sulfate, glucosamine (MOVE FREE [CHONDROITIN SULFATE;GLUCOSAMINE]). The patient's eye doctor felt this vaccine has re-activated his shingles in his left eye on 12Mar2021 which has been asleep for over 2 years. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included increase dosage of the prednisolone ac 1% and is now taking Valacyclavir HCL. The facility where the vaccine was administered was in a 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. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dry mouth, Swelling face
Clinical narrative: Face swelling; dry mouth; dehydration; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER2613) via an unspecified route of administration, administered on the left arm on 23Mar2021 13:00 as dose 1, single for COVID-19 immunisation. Medical history included asthma and seasonal allergies. The patient had other medications in two weeks but was not unspecified. The patient previously took amoxicillin sodium;clavulanic acid (AUGMENTIN), levofloxacin (LEVAQUIN), sulfamethoxazole/trimethoprim (BACTRIM), clindamycin, codeine, erythromycin, omeprazole, oxycodone, sulfa and antihistamine and patient experienced allergies. The patient experienced face swelling, dry mouth, dehydration on an unspecified date. The events resulted in Emergency room/department or urgent care visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of the events which included steroid injection. Outcome of the events was recovered on an unspecified date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: having trouble breathing/can't walk to my bathroom without gasping for air. I can't stand up long enough to brush my teeth without panting; having trouble breathing/can't walk to my bathroom without gasping for air. I can't stand up long enough to brush my teeth without panting; feverish; nauseated; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8730) via an unspecified route of administration, administered on the left arm on 25Mar2021 as single dose for COVID-19 immunisation. Medical history included COPD. Concomitant medications included tramadol; hydrocodone; milnacipran hydrochloride (SAVELLA) and gabapentin. On 01Apr2021 patient got feverish and nauseated just like last time for a few days which she expected, but that has gone away but she was still having trouble breathing. She can't walk to her bathroom without gasping for air. She can't stand up long enough to brush her teeth without panting. No treatment was received for the events. The patient just thought we should know since this isn't a reaction listed on the typical adverse reactions. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Vaccination site pruritus
Clinical narrative: The site where patient had received shot felt like a mosquito had bit, very itchy.; Small spot red and raised; Small spot red and raised; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis. It was unknown if the patient had allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 26Feb2021 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Concomitant medications included Over The Counter (OTC) multi vitamin, taken from an unknown date for an unknown indication. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, 13 days after the second vaccination, the patient experienced that the site where she had received the shot felt like a mosquito had bit her, very itchy, small spot about the size of the eraser end of a pencil, red and raised, which lasted about two hours and then faded away. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the event, site where she had received the shot felt like a mosquito had bit her, very itchy, small spot about the size of the eraser end of a pencil, red and raised was resolved on 02Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Hyperhidrosis, Lip swelling
Clinical narrative: Throat was closing; Tongue swelled up; Heavy sweating; Fogging brain; Feeling of passing out; Lips swelled up; Weak; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 01Apr2021 at 13:45 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 19:30, the patient felt that the throat was closing, lips and tongue swelled up, heavy sweating, fogging brain, feeling of passing out and weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure taken as a result of the events experienced included benadryl (MANUFACTURER UNKNOWN). The clinical outcome of the events throat was closing, lips and tongue swelled up, heavy sweating, fogging brain, feeling of passing out and weak were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.