chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen until they are ready for administration; Administered Moderna vaccines beyond the use date and or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Administered moderna vaccine beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter. Moderna vaccines are kept frozen until they are ready for administration which means they would have been in the fridge about 1-3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and be ready for the patients when needed.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen until they are ready for administration; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about one to three days. They tend to store one to three bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        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 medications were reported. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen until they are ready for administration; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen after expiry and then administered; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen after expiry and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported as vial would be in freezer about 1-3 days  It was reported that 1 to 3 bottles of the vaccines were stored within the fridge to thawout and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No concomitant and treatment medications were reported by the reporter..
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines are kept frozen until they are ready for administration; Moderna vaccines administered beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccines administered beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccines administered beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccines administered beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Moderna vaccines are kept frozen until they are ready for administration which means they would have been in the fridge about 1-3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and be ready for the patients when needed. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated; some of our sites administered Moderna vaccines beyond the use date and or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines were kept frozen until they are ready for administration; Administered Moderna vaccines beyound the use date/expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: The caller states it looks like a similar reaction the caller had to the second dose Pneumonia vaccine, where arm became swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumococcal vaccine (dose 1, manufacture unknown), for immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "The caller states it looks like a similar reaction the caller had to the second dose Pneumonia vaccine, where arm became swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4; Dose Number: 1 23Dec2020, Dose Number: 2 10Jan2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2021 12:00 (Lot number: EL3249) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 1, Single, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 23Dec2020, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Jan2021, described as "Dose Number: 1 23Dec2020, Dose Number: 2 10Jan2021"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 06Nov2021 12:00 and all described as "Left axillary lymphadenopathy started on day 3 (Sat) now still painful and tender, day 4". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, lymph node pain. Additional information: The patient received dose 3 (BOOSTER), single with lot number: EW0173 on 11Nov2021 at 10:00 AM administered in left arm. No other vaccine in four weeks. Other medications in two weeks included lisinopril. No Covid prior vaccination, covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (21Mar2022): Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: she had a pneumonia shot before and it hurt; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "heart patient " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she had a pneumonia shot before and it hurt".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: Won't take it, had a bad reaction to prevenar 13. /had an allergic reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown. single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Won't take it, had a bad reaction to prevenar 13. /had an allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pyrexia
Clinical narrative: she had a fever; This time her fever has been way worse to the point she hasn't been able to work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Her First COVID vaccine was given at (with held), on 08Apr2021 ;lot EW0153.), administration date: 08Apr2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "After the first COVID vaccine, she just had pain in her arm, and she had to hold her arm". The following information was reported: PYREXIA (non-serious) with onset 01May2021, outcome "unknown", described as "she had a fever"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 01May2021, outcome "unknown", described as "This time her fever has been way worse to the point she hasn't been able to work". Therapeutic measures were taken as a result of pyrexia, loss of personal independence in daily activities.  Additional information: The Lot for Dose 2 was either EW0170 or EW0179. She took Aleve the first time at maybe 1-2 am. She then woke up and had to work. She took Aleve again at 8 am. Then, an hour after that she took Ibuprofen, 400mg. Her fever was getting really high. No Prior Vaccinations within 4 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pain, Paraesthesia oral, Taste disorder
Clinical narrative: Light headedness; More pain; Little shortness of breath; Tingling sensation in my lip; Funny taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light headedness"; PAIN (non-serious), outcome "unknown", described as "More pain"; DYSPNOEA (non-serious), outcome "unknown", described as "Little shortness of breath"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "Tingling sensation in my lip"; TASTE DISORDER (non-serious), outcome "unknown", described as "Funny taste in my mouth".  Additional information: Patient who is calling to report side effects of the Pfizer Covid vaccine, after taking the booster dose on 10Jan2022. Severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your or your child's vaccination provider may ask you your child to stay at the place where you or your child received the vaccine for monitoring after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: muscle twitching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Prev dose administration date=05May2021 , Prev dose number=1, Prev dose vaccine location=Left arm), administration date: 05May2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 26May2021, outcome "recovering", described as "muscle twitching". Therapeutic measures were not taken as a result of muscle twitching.  Additional information:If covid prior vaccination: No; If covid tested post vaccination: No;Known allergies: None;Other medical history: None;If other vaccine in four weeks: No;Other medications in two weeks: None  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: had the 1st 2 shots in Apr2021 and May2021; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis", start date: Jan2021 (ongoing), notes: Verbatim: Diverticulitis; "Retinitis pigmentosa" (ongoing), notes: Verbatim: Retinitis pigmentosa. The patient's concomitant medications were not reported.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "had the 1st 2 shots in Apr2021 and May2021"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: She was first told about her diverticulitis in Jan2021 and she had an issue in her sigmoid area, she had a micro perforation and a small abbess that they had to drain. She had an inflammation that was visible on a CT scan that they did on her pelvis. Arm Soreness: She says that the only symptoms that she had seemed to be that she was tired for so many hours after the 1st COVID vaccines and then she had a little arm soreness afterwards but nothing else. She confirms these were side effects were felt after her 1st and 2nd dose of the Pfizer COVID vaccine. She got those doses in her right arm and for some reason the pharmacist suggested that she have the booster dose in her left arm, which is a different arm. 1st dose ( 08Apr2021) Lot Number: She thinks the lot number is either EN6201 or EIV6201, the handwriting is hard to read.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: received your vaccine about 6 months ago and have not gotten my period since; received your vaccine about 6 months ago and have not gotten my period since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), MENSTRUATION DELAYED (non-serious), outcome "unknown" and all described as "received your vaccine about 6 months ago and have not gotten my period since". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Details: Forwarded as an Adverse Event by the team on 27Jan2022. Reporter provided verification of contact address on 26Jan2022. She received vaccine about 6 months ago and had not gotten her period since. She had been to the doctor and was not pregnant and it was nothing structural.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lymphadenopathy
Clinical narrative: Lymph node in left armpit was very swollen; Brain fog; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 29 year-old patient received bnt162b2 (COMIRNATY), administration date 27Jan2022 (Batch/Lot number: unknown) at the age of 29 years as dose number unknown (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "peanut allergy" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: mild asthma; "Eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose,Manufacturer Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Jan2022, outcome "unknown", described as "Lymph node in left armpit was very swollen"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "Brain fog"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Feeling abnormal, Magnetic resonance imaging, Multiple sclerosis, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Sep2021 (Lot number: EW0172, Expiration Date: 30Nov2021) at the age of 63 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "MS", start date: 1992 (ongoing); "Thyroid disorder", start date: 1975 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (medically significant) with onset Sep2021, outcome "recovered" (Sep2021), described as "Feeling like I was paralyzed"; MULTIPLE SCLEROSIS (medically significant) with onset Sep2021, outcome "unknown", described as "Aggravated my MS"; PAIN (medically significant), outcome "unknown", described as "Very painful throughout my body". The patient underwent the following laboratory tests and procedures: blood thyroid stimulating hormone (0.350-4.940): (22Dec2021) 1.300, notes: Normal; magnetic resonance imaging: (20Dec2021) unknown results; (22Dec2021) unknown results. Therapeutic measures were not taken as a result of paralysis, multiple sclerosis.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Pain
Clinical narrative: Loss of appetite; dizziness; extreme tiredness; extreme body aches; fever; pain in both arms; chills; swelling on the left side of the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion.), administration date: 06May2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left , Vaccine Administration Time: 03:00 PM, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization.  The following information was reported: DECREASED APPETITE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "Loss of appetite"; DIZZINESS (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "dizziness"; FATIGUE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "extreme tiredness"; PAIN (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "extreme body aches"; PYREXIA (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "pain in both arms"; CHILLS (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "chills"; SWELLING FACE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "swelling on the left side of the face". Therapeutic measures were not taken as a result of decreased appetite, dizziness, fatigue, pain, pyrexia, pain in extremity, chills, swelling face.  Additional information: Dose 3 administration time was 05:30 PM. No other vaccine were received in four weeks and no other medications received in two weeks. No known allergies. It was unknown If covid prior vaccination or not and if tested for covid post vaccination or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Swelling face
Clinical narrative: Loss of appetite; dizziness; extreme tiredness; extreme body aches; fever; pain in both arms; chills; swelling on the left side of the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion.), administration date: 06May2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left , Vaccine Administration Time: 03:00 PM, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization.  The following information was reported: DECREASED APPETITE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "Loss of appetite"; DIZZINESS (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "dizziness"; FATIGUE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "extreme tiredness"; PAIN (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "extreme body aches"; PYREXIA (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "pain in both arms"; CHILLS (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "chills"; SWELLING FACE (non-serious) with onset 31Jan2022 20:00, outcome "recovered with sequelae", described as "swelling on the left side of the face". Therapeutic measures were not taken as a result of decreased appetite, dizziness, fatigue, pain, pyrexia, pain in extremity, chills, swelling face.  Additional information: Dose 3 administration time was 05:30 PM. No other vaccine were received in four weeks and no other medications received in two weeks. No known allergies. It was unknown If covid prior vaccination or not and if tested for covid post vaccination or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Heart beat irregular and quick; Heart beat irregular and quick; Excessive sweating; Dizziness; Headache; Fever; Body and joint pain; Body and joint pain; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 09:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "chronic pain" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "anxiety" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "known allergies nsaids" (unspecified if ongoing), notes: known allergies Zofran and nsaids; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: Zofran", notes: known allergies Zofran and nsaids. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unknown , Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 10Jan2022, when the patient was 43 years old, for Covid-19 Immunization.  The following information was reported: HEART RATE IRREGULAR (non-serious), HEART RATE INCREASED (non-serious) all with onset 31Jan2022 13:00, outcome "recovered with sequelae" and all described as "Heart beat irregular and quick"; HYPERHIDROSIS (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Excessive sweating"; DIZZINESS (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Dizziness"; HEADACHE (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Headache"; PYREXIA (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Fever"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 31Jan2022 13:00, outcome "recovered with sequelae" and all described as "Body and joint pain"; FATIGUE (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate irregular, heart rate increased, hyperhidrosis, dizziness, headache, pyrexia, pain, arthralgia, fatigue.  Additional Information: If other vaccine in four weeks was reported as no. Other medications in two weeks was reported as yes. If covid prior vaccination was reported as yes. If covid tested post vaccination was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Hyperhidrosis, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Heart beat irregular and quick; Heart beat irregular and quick; Excessive sweating; Dizziness; Headache; Fever; Body and joint pain; Body and joint pain; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 09:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "chronic pain" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "anxiety" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "known allergies nsaids" (unspecified if ongoing), notes: known allergies Zofran and nsaids; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: Zofran", notes: known allergies Zofran and nsaids. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unknown , Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 10Jan2022, when the patient was 43 years old, for Covid-19 Immunization.  The following information was reported: HEART RATE IRREGULAR (non-serious), HEART RATE INCREASED (non-serious) all with onset 31Jan2022 13:00, outcome "recovered with sequelae" and all described as "Heart beat irregular and quick"; HYPERHIDROSIS (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Excessive sweating"; DIZZINESS (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Dizziness"; HEADACHE (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Headache"; PYREXIA (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Fever"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 31Jan2022 13:00, outcome "recovered with sequelae" and all described as "Body and joint pain"; FATIGUE (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate irregular, heart rate increased, hyperhidrosis, dizziness, headache, pyrexia, pain, arthralgia, fatigue.  Additional Information: If other vaccine in four weeks was reported as no. Other medications in two weeks was reported as yes. If covid prior vaccination was reported as yes. If covid tested post vaccination was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate, Palpitations
Clinical narrative: started feeling pain in chest/ my husband starts to feel the same thing; pressure in my chest/ my husband starts to feel the same thing; my heart was racing/ my husband starts to feel the same thing; shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 31 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) at the age of 31 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "started feeling pain in chest/ my husband starts to feel the same thing"; CHEST DISCOMFORT (non-serious) with onset Jan2022, outcome "unknown", described as "pressure in my chest/ my husband starts to feel the same thing"; PALPITATIONS (non-serious) with onset Jan2022, outcome "unknown", described as "my heart was racing/ my husband starts to feel the same thing"; DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "shortness of breath". The events "started feeling pain in chest/ my husband starts to feel the same thing", "pressure in my chest/ my husband starts to feel the same thing" and "my heart was racing/ my husband starts to feel the same thing" were evaluated at the physician office visit and emergency room visit. The event "shortness of breath" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter reported that she and her husband received their booster shot on 06Jan2022. She reported that 2 days later she started feeling pain/pressure in my chest, my heart was racing. After 1 month I went to emergency room, the doctors said everything was fine, but last Friday my husband starts to feel the same thing, he went to the hospital today everything looks good. this was heart pain. We want to know because the doctors say everything was okay. We had never had this before. Reporter again stated his heart was rolling too right now sometimes it was racing. Sometimes you know it was more 'a lot real' like that and he was feeling the same thing in the chest like the pain like the pressure and he went to the room, emergency room where they say that everything looks okay (Further not clarified) but we started feeling these after the booster you know what I mean. I just wanna know was this something like a reaction by the vaccine you know or something because we are confused because the doctor said that everything was ok but we do not feel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.