chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I received a second dose. The vial was punctured more than 12 hours since opening.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: second dose administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion). On 21-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported   This case was linked to MOD21-146513, MOD21-146835, MOD21-146840, MOD21-146854, MOD-2021-329506 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old was given the vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: first dose administered after temperature excursion; vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes) and EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes). On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion). On 18-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes) had resolved. On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. On 18-Sep-2021, the fridge and freezer storing vaccines experienced a temperature excursion  for a duration of 1 hour and 24 minutes. When excursion occurred, 10 vials(1 carton) of Moderna COVID-19 vaccine was reported to be stored in the fridge. On 17-Sep-2021, the vials were moved from freezer to fridge, a day prior to the excursion. On 20-Sep-2021, two doses out of the vial of the affected Moderna COVID-19 vaccine was administered to two patients and the remainder of the vial was discarded after use.   This case was linked to MOD-2021-329344, MOD-2021-329370 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Pain in extremity, Testicular pain, Testicular swelling
Clinical narrative: Testicles pain; Testicles swelling; slight arm pain sensation; slight disorientation; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation). At the time of the report, TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported. Patient reported that he received the vaccine and dont have Lot or any other information regarding vaccine. He experienced testicles pain and swelling days after getting vaccine and it was resolved shortly. Patient reports slight arm pain sensation and slight disorientation all resolved later.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial punctured for more than 12 hours/punctured vial left in the fridge; vial punctured for more than 12 hours/punctured vial left in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge). On 21-Sep-2021, PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.  The pharmacist reported that the vial was punctured on Monday at 12 P.M, the vial was then left in fridge and the vial would have expired by 21-Sep-2021 at 12 A.M. The vaccine was then administered from the vial on 3.59 P.M, 4.53 P.M, 9.15 P.M and 9.16 P.M. The patient presented with no symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling, Rash
Clinical narrative: Bump in arm; Big red whelp; mild ache in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bump in arm), RASH (Big red whelp) and ARTHRALGIA (mild ache in shoulder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced ARTHRALGIA (mild ache in shoulder). On 16-Aug-2021, the patient experienced PERIPHERAL SWELLING (Bump in arm) and RASH (Big red whelp). At the time of the report, PERIPHERAL SWELLING (Bump in arm), RASH (Big red whelp) and ARTHRALGIA (mild ache in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-329763 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination complication, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt), MYALGIA (Aches) and PYREXIA (Fever for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt), MYALGIA (Aches) and PYREXIA (Fever for a day). At the time of the report, VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt) and MYALGIA (Aches) outcome was unknown and PYREXIA (Fever for a day) had resolved. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: went back into Afib.; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (went back into Afib.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 016M20A and 027C21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Heart valve replacement. Concomitant products included TACROLIMUS (PROGRAF), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LEVOTHYROXINE SODIUM (SYNTHROID), LINAGLIPTIN (TRADJENTA), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), ROSUVASTATIN, AMLODIPINE, POLYCARBOPHIL CALCIUM (FIBER), ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced ATRIAL FIBRILLATION (went back into Afib.) (seriousness criterion medically significant). The patient was treated with WARFARIN for Atrial fibrillation, at an unspecified dose and frequency and METOPROLOL for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (went back into Afib.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On the day after receiving the third shot, he went into Afib again. Husband is scheduled for a chock on Friday.  This case concerns a 70 year-old male patient with medical history of atrial fibrillation and heart value replacement x2, who experienced the unexpected serious event of Atrial fibrillation. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The event is Medically significant based on reported treatment with medications. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 70 year-old male patient with medical history of atrial fibrillation and heart value replacement x2, who experienced the unexpected serious event of Atrial fibrillation. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The event is Medically significant based on reported treatment with medications. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Nausea, Pharyngeal abscess, SARS-CoV-2 test, Vomiting
Clinical narrative: Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included allergy to latex, all forms of formaldehyde. The concomitant medications of patient were not reported. The patient previously took formaldehyde and experienced drug hypersensitivity. Patient did not have Covid prior vaccination and Covid was tested post vaccination. On 13Jul2021, the patient experienced severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and cannot eat but a few bites of food here and there. She lost over 16 lbs. The patient underwent lab tests and procedures which included pharyngeal abscess: negative on 14Jul2021 and Nasal Swab: on 14Jul2021 and result was negative. Patient did not receive any treatment for adverse events. The outcome of all events was recovered with sequelae on an unspecified date of Jul2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included allergy to latex, all forms of formaldehyde. The concomitant medications of patient were not reported. The patient previously took formaldehyde and experienced drug hypersensitivity. Patient did not have Covid prior vaccination and Covid was tested post vaccination. On 13Jul2021, the patient experienced severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and cannot eat but a few bites of food here and there. She lost over 16 lbs. The patient underwent lab tests and procedures which included pharyngeal abscess: negative on 14Jul2021 and Nasal Swab: on 14Jul2021 and result was negative. Patient did not receive any treatment for adverse events. The outcome of all events was recovered with sequelae on an unspecified date of Jul2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body hurts; This is a spontaneous report from a contactable consumer (patient's mother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0164, expiry date: unknown) via unspecified route of administration, in right arm on 26Jul2021 (age at vaccination: 17-years), as dose 1, single for covid-19 immunisation. Vaccination facility type was physician office. Patients medical history included anxiety from an unspecified date and unknown if ongoing.. Concomitant medications included ongoing multivitamins 1DF daily, taken for unspecified indication. Patient experienced "body hurts" on 27Jul2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Her son also received the second part of his 16-years-old shots yesterday. He had to wait until he was 17 to get the second part. The outcome of event was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: dizziness; nausea; headache; chills; tired; fevers all day; everything hurts; she still feels bad and she doesn't know how long it will take for her to not feel bad; This is a spontaneous report received from a contactable consumer or other non hcp. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on 26Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jul2021 the patient experienced dizziness, nausea, headache, chills, tired, fevers all day, everything hurts, she still feels bad, and she doesn't know how long it will take for her to not feel bad. Clinical course was reported as 29-year-old female, received the Pfizer COVID-19 Vaccination 2 days ago. She feels bad with dizziness, nausea, headache, chills, tired, as well as fevers all day yesterday. She also reports everything hurts. She will get others sick due to her symptoms she is experiencing after her vaccination. She starts working on Friday. She asks if she will have to go to work on Friday if she is not feeling well still. She does not want to get others sick. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: dizziness; nausea; headache; chills; tired; fevers all day; everything hurts; she still feels bad and she doesn't know how long it will take for her to not feel bad; This is a spontaneous report received from a contactable consumer or other non hcp. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on 26Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jul2021 the patient experienced dizziness, nausea, headache, chills, tired, fevers all day, everything hurts, she still feels bad, and she doesn't know how long it will take for her to not feel bad. Clinical course was reported as 29-year-old female, received the Pfizer COVID-19 Vaccination 2 days ago. She feels bad with dizziness, nausea, headache, chills, tired, as well as fevers all day yesterday. She also reports everything hurts. She will get others sick due to her symptoms she is experiencing after her vaccination. She starts working on Friday. She asks if she will have to go to work on Friday if she is not feeling well still. She does not want to get others sick. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea for the past 4 days; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 16:00 (age at vaccination 61 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 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 four weeks prior to the vaccination. Patient visited doctor or other healthcare professional office/clinic visit. The patient had no allergies. The patient experienced severe diarrhea for the past 4 days on 27Jul2021 8 hrs hours after vaccine application. Patient received treatment for reported event (Prescription). The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Mouth swelling, Nasal congestion, Oropharyngeal pain
Clinical narrative: slight fever; diarrhea; sneezing; stuffy; feeling "yucky"; sores in mouth; swollen mouth; sore throat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 11Aug2021 at single dose for COVID-19 immunisation. Medical history included  had COVID-19 in 2020. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced slight fever, diarrhea, sneezing, stuffy, feeling yucky, sores in mouth, swollen mouth and sore throat. Event took place after use of product. The clinical outcome of events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing, Stomatitis
Clinical narrative: slight fever; diarrhea; sneezing; stuffy; feeling "yucky"; sores in mouth; swollen mouth; sore throat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 11Aug2021 at single dose for COVID-19 immunisation. Medical history included  had COVID-19 in 2020. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced slight fever, diarrhea, sneezing, stuffy, feeling yucky, sores in mouth, swollen mouth and sore throat. Event took place after use of product. The clinical outcome of events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces
Clinical narrative: Loose very foul smelling stool.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 74-years-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 02Aug2021 14:00 (at the age of 74-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included none. The patient concomitant medications were not reported. Patient had no known allergies. Patient received vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced loose very foul smelling stool. on 07Aug2021. Treatment was received for the event as pepto bismol per label. The outcome of the event was reported as recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: I have a real bad pain in my neck at the bottom by my shoulder on the same side of the vaccine; It can't move my head that hurts it is excruciating pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Aug2021 (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. Medical history included osteoarthritis from an unknown date and unknown if ongoing, bipolar from an unknown date and unknown if ongoing. Patient had concomitant medication (patient stated, "Yes" (Further clarification unknown)). Patient historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Jul2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient experienced as, i have a real bad pain in my neck at the bottom by my shoulder on the same side of the vaccine, it can't move my head that hurts it is excruciating pain on 14Aug2021. Reporter stated, It was the Pfizer Covid-19 Vaccine, the second dose. Patient had both shot. Patient got the shot last night and when he woke up in morning he have a real bad pain in his neck at the bottom by his shoulder on the same side of the vaccine. It ca not move my head that hurts it was excruciating pain. Event start date: patient stated "14Aug2021(Confirmed as 14Aug2021) less than 24 hours later". No treatment were received for the events (Consumer stated, "For my pain, no"). Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise
Clinical narrative: didn't feel well; couldn't work for several days; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 04Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 infection prior to getting the COVID vaccine from Jun2021 to an unknown date. The patient's concomitant medications were not reported. The patient mentioned that she was not able to get the second dose on her scheduled date as she had a lot going on and thought that she may have had antibodies enough since she already had COVID-19 infection before aside from the vaccine. On an unspecified date, the patient mentioned that she didn't feel well and couldn't work for several days after the vaccine but nothing out of the ordinary. The patient wanted to know if she can still get the second dose of the Pfizer BioNTech COVID-19 vaccine because she was worried about the Delta variant. She called today to question about getting the second dose of the vaccine and it being past six weeks. She was planning on getting this second dose. The patient wanted a clear answer regarding the effectiveness of the 2nd shot of the vaccine once administered past 6 weeks. It was just they have no information on how effective it would be. Outcome for all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.  Follow-up activities completed. Batch/lot number not available for [Vaccine BNT162B2], No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: has a spotted skin rash all around her body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Lot number and Expiry Date was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number and Expiry Date was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced a spotted skin rash all around her body, occurred two weeks after the second dose. The seriousness of the events was considered as non-serious. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Flatulence, Nausea, Vaccination site pain
Clinical narrative: soreness at the injection site; tiredness; occasional nauseous; gassiness; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 1, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported as a Pfizer Employee, patient received the first dose of the Pfizer Vaccination on Tuesday 10Aug2021. Patient instructed to expect symptoms very similar to an Influenza vaccination that would last a 1-2 days. Patient would like to report on 10Aug2021 extended tiredness and gassiness (flatulence) more than 48 hours after receiving the first Covid-19 dose. also experienced soreness at the injection site, which radiated through the front and back of shoulder as well as occasional nauseous. The soreness and nausea have subsided, but the tiredness and gassiness has not. symptoms are worse in the evening/night than they are in the morning and afternoon. did not experience these symptoms until approximately 7 hours after the first injection was administered. Outcome for the event soreness at the injection site and occasional nauseous was resolved on unspecified date in 2021 and for remaining events outcome was reported as not resolved at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (29Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash macular, SARS-CoV-2 test, Urticaria
Clinical narrative: I get small, red circular bumps that are extremely itchy; I get small, red circular bumps that are extremely itchy; hives; At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 07May2021 at 16:15 (04:15 PM) (at the age of 33-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included rheumatoid arthritis, COVID-19 (if COVID prior vaccination Yes). The patient received concomitant medication in two weeks which included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was COVID tested post vaccination. The patient previously took ibuprofen (was not previously but now ibuprofen) and experienced drug allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 16Apr2021 at 03:45 PM as dose 1, single for COVID-19 immunization. On 01Jul2021 at 20:00 (08:00 PM), the patient experienced I get small, red circular bumps that are extremely itchy, hives, at first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine. Adverse event: Developed an allergy to ibuprofen. Everytime I take ibuprofen I develop hives. I get small, red circular bumps that are extremely itchy. At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine (and he takes a different brand of ibuprofen). The patient underwent lab tests and procedures which included SARS-COV-2 test was negative (nasal swab) on 19Jul2021. The patient received Benadryl (just self-medicated with Benadryl each time) as treatment medication for all the events. Outcome of all the events was recovered with sequelae (recovered with lasting effects).  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: had a breakthrough infection; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on 18Aug2021 the patient experienced had a breakthrough infection. Outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Swelling of his throat; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported, expiry date was unknown), via an unspecified route of administration, administered in the right arm on an unspecified date as dose 1, single for COVID-19 immunization. Patient also received ceftriaxone sodium (ROCEPHIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced swelling of his throat on an unspecified date. Since unspecified date patient was allergic to Rocephin and it was not ongoing. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Palpitations, Panic attack
Clinical narrative: Heart palpitations; a strange hard beating in his chest; panic attack; This is a spontaneous report from a contactable consumer (Patient's wife). This consumer reported for her husband. A 41-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration, administered in Arm on an unspecified date in 2021 (at the age of 41-year-old ) as single dose for COVID-19 immunisation. The patient medical history was reported as none. About family history she has not heard of anything and is not 100 percent sure. Concomitant medications were not reported. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. No additional vaccines was administered on same date of the Pfizer suspect. Patient historic vaccine included first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-year-old) as single dose for covid-19 immunisation. On 19Aug2021 (guessing in the afternoon), the patient experienced heart palpitations, a strange hard beating in his chest and panic attack. As per the report, caller is a Pfizer employee calling on behalf of her husband. It is only suspected, but the call is regarding the Pfizer Covid-19 vaccine. She is actually reporting it today because he just suspected it today. He did get the vaccine back in Apr2021. He is getting some heart palpitations and does not know if it a true correlation. Today. Today was the day he told her he was feeling this way. He was just informing her today that he felt heart palpitations. It was like a strange hard beating in his chest. It was kind of like a panic attack. That is how he described it. Started today, she is guessing in the afternoon. He didn't give too many details. He has always been fully healthy. States they were vaccinated around the same time and that it was probably May2021 or Apr2021. States that he had both doses. She is unsure if he got the vaccines in the right or left arm. Patient was concerned and was going to probably see a heart doctor which to her, felt very concerning. Patient did not visit to emergency room or physician office due to adverse event. No relevant test was performed. The outcome of events was unknown.  Follow-up attempts are completed. No further information expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immunisation, Off label use
Clinical narrative: experienced soreness for at least 24 hours in her left shoulder; COVID Vaccine 3rd Dose Booster; COVID Vaccine 3rd Dose Booster; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received T162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in left arm on an unknown date as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown) on an unknown date as historical vaccine as dose 1 and 2, single for COVID-19 Immunization. On an unknown date, the patient experienced soreness for at least 24 hours in her left shoulder. This soreness was more than the 1st and 2nd shots. There were no other unusual symptoms. Event took place after use of product. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Extra dose administered, Off label use
Clinical narrative: experienced soreness for at least 24 hours in her left shoulder; COVID Vaccine 3rd Dose Booster; COVID Vaccine 3rd Dose Booster; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received T162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in left arm on an unknown date as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown) on an unknown date as historical vaccine as dose 1 and 2, single for COVID-19 Immunization. On an unknown date, the patient experienced soreness for at least 24 hours in her left shoulder. This soreness was more than the 1st and 2nd shots. There were no other unusual symptoms. Event took place after use of product. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Muscle spasms, Pain, Pain in extremity
Clinical narrative: mild back spasm in morning and severe back spasm by evening; sudden stabbing pain; spasm in her left calf; spasm in her left calf; difficult to walk; unusual aches in legs/feet; severe pain in her right knee; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in right arm on 16May2021 at 13:00 as dose 2, single for COVID-19 immunisation (age at vaccination was 62 years). The patient was not pregnant at time of vaccination. The patient medical history included ACL repair on left knee, hypothyroidism from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, has not bothered her. She had no known allergies. She was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine in four weeks prior COVID vaccine. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported, cobamamide (VITAMIN B12 (COBAMAMIDE)) taken for an unspecified indication, start and stop date were not reported and Beta vulgaris, Brassica spp., Cyanocobalamin, Folic acid, Pyridoxine hydrochloride, Saccharomyces cerevisiae (VEGAN B12) taken for an unspecified indication, start and stop date were not reported. The patient's concomitant medication included Levothyroxine, vitamin B12, Vegan (in two weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in right arm on 25Apr2021 13:00 (age at vaccination was 62 years) as dose 1, single for COVID-19 immunization. On 17May2021 at 19:00, the patient experienced mild back spasm on waking the morning of the vaccine, she had a severe back spasm by the evening. It made her scream when she walked as it was a very sudden stabbing pain. The next day or 2 it disappeared. The patient developed a spasm in her left calf so that it was difficult to walk. That went on for about a week. For the past 3 months, she had unusual aches in legs/feet and severe pain in her right knee. The patient underwent lab tests and procedures which included X-ray: X-ray showed no arthritis on an unspecified date. No therapeutic measures were taken as a result of events. The patient visited to doctor or other healthcare professional office/clinic as a result of events. The outcome of the events mild back spasm in morning severe back spasm by evening, sudden stabbing pain, spasm in her left calf and difficult to walk was recovered on an unspecified date in May2021. The outcome of the events she had unusual aches in legs/feet and severe pain in her right knee was not recovered.    Follow-up attempts are completed. No further information is expected.