chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored post puncture vial was stored under refrigerator; Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  On 31-Mar-2022, The vial was initially stored in the refrigerator.  On 21-Apr-2022 at 10:20 am, The vial was first punctured.  On 23-Apr-2022 at 9:50 am - 4:05 pm, The vaccine was administered.  The patient has not reported any adverse reactions to the expired dose administered.   Post puncture vial was stored in refrigerator and the vial did not undergo any temperature excursions.  The vial was not exposed to room temperature for more than 24 hours.  No treatment drug was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; Vial stored post puncture vial was stored under refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator). On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. On 31-Mar-2022, The vial was initially stored in the refrigerator. On 21-Apr-2022 at 10:20 am, The vial was first punctured. On 23-Apr-2022 at 9:50 AM - 4:05 PM, patient received second booster dose.  The patient has not reported any adverse reactions to the expired dose administered.  Post puncture vial was stored in refrigerator and the vial did not undergo any temperature excursions. The vial was not exposed to room temperature for more than 24 hours. No treatment drug was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna doses administered past 12 hour; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 22APR2022 dose were administered to patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior. The patient had reported any adverse reactions to the expired dose administered.  Dose administered more than 12/24 hours post puncture Number of doses/vials was 7 doses. On 31MAR2022, the vial was initially stored in the refrigerator.  No concomitant medications were reported. On 21APR2022 at 10:20 AM, the vial was first punctured and administration of vaccine on 22APR2022 at 9:30 AM, 1:15 PM, 23APR2022 at 9:50 AM, 4:05 PM The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored post puncture vial was stored under refrigerator; Moderna doses administered past 12 hour; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 22APR2022 dose were administered to patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior. The patient had reported any adverse reactions to the expired dose administered.  Dose administered more than 12/24 hours post puncture Number of doses/vials was 7 doses. On 31MAR2022, the vial was initially stored in the refrigerator.  No concomitant medications were reported. On 21APR2022 at 10:20 AM, the vial was first punctured and administration of vaccine on 22APR2022 at 9:30 AM, 1:15 PM, 23APR2022 at 9:50 AM, 4:05 PM The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose) 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 02-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced OVERDOSE (Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose). At the time of the report, OVERDOSE (Got her 2nd booster & it was full dose of the Moderna Covid-19, instead of the half dose) outcome was unknown.            No concomitant medications were provided. The patient got her 2nd booster, & it was full dose of the Moderna Covid-19, instead of the half dose. The pharmacist told the patient that they only have the full doses, so the patient got the full dose. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period; On 18 Apr 2022 one patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 18 Apr 2022 one patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 18 Apr 2022 one patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 18 Apr 2022 one patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) and PRODUCT STORAGE ERROR (Expired vials stored in freezer) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vials stored in freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) and PRODUCT STORAGE ERROR (Expired vials stored in freezer) outcome was unknown. Not Provided. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that, the vials were continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine stored and then administered; On 28 Apr 2022, 1 Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 28 Apr 2022, 1 Patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 28 Apr 2022, 1 Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 28 Apr 2022, 1 Patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the vials were continuously stored in stable freezer environment. Only stored in fridge on date of administration for thaw period.  Concomitant drugs were not reported.  Treatment details were not given.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient potentially received a vaccine  that was exposed to room temperature for over 26 hours after; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient potentially received a vaccine  that was exposed to room temperature for over 26 hours after) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Penicillin allergy.    On 02-May-2022 at 6:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient potentially received a vaccine  that was exposed to room temperature for over 26 hours after). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient potentially received a vaccine  that was exposed to room temperature for over 26 hours after) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Patient was not diagnosed for COVID-19. It was reported that vial that was left out of the fridge at 3pm on 1-May-2022 and used on 02-May-2022 at 6:15pm.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Polymerase chain reaction
Clinical narrative: got really sick with the second installment; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick with the second installment) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (For cancer for which patient was diagnosed with, before having the Moderna COVID-19 vaccine.) since an unknown date. Concurrent medical conditions included Cancer.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick with the second installment). At the time of the report, ILLNESS (got really sick with the second installment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2022, Polymerase chain reaction: no antibodies for covid 19 were present. (Negative) No antibodies for COVID 19 were present, it was due to chemotherapy.         Concomitant medications were not provided by the reporter.  It was reported that patient took all the doses of the vaccine in the appropriate time frame, including the Moderna booster vaccine.  Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, SARS-CoV-2 test
Clinical narrative: Skin itchy and has a rash and she was diagnosed with Dermatographism; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Skin itchy and has a rash and she was diagnosed with Dermatographism) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00SM21A, 019A21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 25-Jan-2022. Previously administered products included for Product used for unknown indication: Flu shot (given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (Skin itchy and has a rash and she was diagnosed with Dermatographism). At the time of the report, MECHANICAL URTICARIA (Skin itchy and has a rash and she was diagnosed with Dermatographism) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         The symptoms started after the patient received the second booster. The symptoms reported are rash and skin itchiness. On the day of reporting she was diagnosed with dermatographism and her doctor said that the second booster might be the cause.  The patient had no allergies.   The patient was not on concomitant or regular medication. She was waiting for her prescription.   This case was linked to MOD-2022-557013 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I was told that the vaccine expired the day I was there; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I was told that the vaccine expired the day I was there) 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 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I was told that the vaccine expired the day I was there). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I was told that the vaccine expired the day I was there) outcome was unknown.            No Concomitant product use was reported.  The patient reported that they received Moderna booster vaccine yesterday on 02-May-2022, at a private pharmacy. While the patient was in the store the patient asked for how many months the booster vaccine was on the shelf. Reportedly, the patient was told that the vaccine expired the day the patient was there, and the vaccines lasts for six months and more.  No treatment information was provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Product temperature excursion issue
Clinical narrative: 3 patients received  a Dose administered >1224 hours post puncture; 3 patients received a second booster  and are not  immunocompromised or over 50 years of age; They state also that this vial did under went a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received  a Dose administered >12/24 hours post puncture), EXTRA DOSE ADMINISTERED (3 patients received a second booster  and are not  immunocompromised or over 50 years of age) and PRODUCT TEMPERATURE EXCURSION ISSUE (They state also that this vial did under went a temperature excursion) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: janssen (Patient received Janssen as primary series and booster dose.). Past adverse reactions to the above products included No adverse event with janssen.    On 03-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received  a Dose administered >12/24 hours post puncture), EXTRA DOSE ADMINISTERED (3 patients received a second booster  and are not  immunocompromised or over 50 years of age) and PRODUCT TEMPERATURE EXCURSION ISSUE (They state also that this vial did under went a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received  a Dose administered >12/24 hours post puncture), EXTRA DOSE ADMINISTERED (3 patients received a second booster  and are not  immunocompromised or over 50 years of age) and PRODUCT TEMPERATURE EXCURSION ISSUE (They state also that this vial did under went a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no Allergies  No concomitant medication information provided. No treatment medication information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 Moderna Date:20Feb2021 ,  Dose 2: Moderna Date: 28Mar2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Moderna Date:20Feb2021 ,  Dose 2: Moderna Date: 28Mar2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 008B212A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Moderna Date:20Feb2021 ,  Dose 2: Moderna Date: 28Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Moderna Date:20Feb2021 ,  Dose 2: Moderna Date: 28Mar2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  It was reported that the Ethnicity was Other   The treatment medication was not reported.   This case was linked to MOD-2022-557722 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: have a reaction after my second booster shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (have a reaction after my second booster shot) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNISATION REACTION (have a reaction after my second booster shot). At the time of the report, IMMUNISATION REACTION (have a reaction after my second booster shot) outcome was unknown.            No concomitant medication were provided No treatment details were provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm; Spot was sore; Swollen; Down below the injection site, there is a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PAIN (Spot was sore), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE RASH (Down below the injection site, there is a rash) 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 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PAIN (Spot was sore), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE RASH (Down below the injection site, there is a rash). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PAIN (Spot was sore), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE RASH (Down below the injection site, there is a rash) outcome was unknown.            No concomitant medication were reported. No treatment information were provided. Patient had her 2nd booster dose yesterday on 28-Apr-2022.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Myocarditis
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (non-serious), CARDIOVASCULAR DISORDER (non-serious), outcome "unknown" and all described as "someone had cardiovascular issues right now and has myocarditis". Clinical comment: The caller said that Pfizer took a piece of the HIV virus and inserted it into a spike so basically Pfizer injected people with the HIV virus that's why people are getting sick easier. He said that someone had cardiovascular issues right now and has myocarditis along with millions of other people around the world after getting the vaccine. It was asked to confirm if "someone" reported in Verbatim refers to one patient or not, since patient gender provided as Male. As a response the "someone" reported in the verbatim refers to one patient which happens to be a male. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8732) at the age of 70 years, in left arm for Covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 024C21A) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NYQUIL, start date: 11Apr2022, stop date: 14Apr2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 11Apr2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive, notes: home test; (16Apr2022) mildly positive, notes: home test; (24Apr2022) highly positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Symptoms of Covid began about 10Apr2022. The patient first tested positive using a home test on 11Apr2022 and began taking Paxlovid on 11Apr2022 and after five days the patient had no symptoms, but still tested mildly positive for Covid using a home test. About five days later on 22Apr2022 the patient had a resurgence of mild symptoms - nasal congestion, a cough and fatigue. Two days later the patient tested highly positive using a home test. Nasal congestion and fatigue have persisted for five days but appear to be receding. The patient had no known allergies. No follow-up attempts are possible. No further information is possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "throw up on most antibiotics and pain medications" (unspecified if ongoing), notes: I throw up on most antibiotics and pain medications. I did not react at all to any of the vaccines. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Apr2022, outcome "unknown" and all described as "I believe I did have COVID, and was contagious". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2022) Positive, notes: tested positive for COVID on 09Apr2022, both using an at-home test and in a clinic; (09Apr2022) Positive, notes: tested positive for COVID on 09Apr2022, both using an at-home test and in a clinic; (17Apr2022) Negative, notes: tested negative for COVID using an at-home test on 17Apr2022; (20Apr2022) Positive, notes: tested positive for COVID on 20Apr2022 and 21Apr2022; (21Apr2022) Positive, notes: tested positive for COVID on 20Apr2022 and 21Apr2022 tested positive at home. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: The patient was tested positive for COVID on 09Apr2022, both using an at-home test and in a clinic. She was given Paxlovid the same day and took her first dose that day. She took them as prescribed, three pills a day twice a day, until they were all gone, and felt very well - as if she had a light allergy - the entire time. She tested negative for COVID using an at-home test on 17Apr2022. She had dental surgery on 18Apr2022, and began to feel sick with a cold on 19Apr2022. She tested positive for COVID on 20Apr2022 and 21Apr2022, and felt very sick for the next week - far worse than she had ever felt before. She was just now beginning to feel better. She saw a nurse-practitioner on 20Apr2022 who told her she could not possibly have COVID and was "just shedding virus" and was not contagious, despite the fact that she did not test me for COVID and she had tested positive at home that day, as well as the next day. She believed she did have COVID, and was contagious. Known allergies: She throw up on most antibiotics and pain medications. She did not react at all to any of the vaccines.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Vaccination site pain
Clinical narrative: burning is more in left arm than right arm; Burning is all the way down arm and hand and where she got injected; whole left arm and hand was tingling; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2021 as dose 1, single (Lot number: EW981) at the age of 34 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's", start date: 2019 (ongoing), notes: Taking Levothyroxine in the meaning since 2019; "thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for autoimmune thyroiditis, thyroid disorder, start date: 2019 (ongoing); VITAMIN D [VITAMIN D NOS] (ongoing). Vaccination history included: Flu shot (She always got flu vaccine). The following information was reported: PARAESTHESIA (non-serious) with onset 14Jul2021, outcome "recovered" (14Jul2021), described as "whole left arm and hand was tingling"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning is more in left arm than right arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Burning is all the way down arm and hand and where she got injected".  Additional information: This report is not related to a study or programme. Patient stated that, she as an RN she always got flu vaccine. She was normal healthy person. She never had a problem with any vaccines before. She never got Covid and never got sick and she was healthy and feeling good and happy to get vaccine. She wanted to get vaccine to protect her family and son and thought she was doing the right thing. No additional vaccines administered on same date of the Pfizer suspect. Didn't get flu vaccine and got every year as a nurse. AE(s) following prior vaccinations or Family Medical History Relevant to AE(s) included none. Vaccination facility type was Pharmacy or drug store. Vaccine was not administered at private Facility. Vaccine administration Time (24hrs) was stated as sometimes in the morning (did not remember the time). No prior vaccination (within 4 weeks). Patient experienced burning more in left arm than right arm. Burning is all the way down arm and hand and where she got injected. Immediately after the first dose of vaccine was administered, patient whole left arm and hand was tingling that only lasted a few minutes, no other side effects. Patient stated first dose of vaccine was fine. Events Causality was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac failure congestive, Chest pain, Condition aggravated, Movement disorder
Clinical narrative: congestive heart failure; chest pain; today both shoulders are so painful she can barely move them; today both shoulders are so painful she can barely move them; symptoms worsened; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: .  A 67-year-old female patient received tofacitinib citrate (XELJANZ), since 2020 (ongoing) at 5 mg 2x/day, oral for rheumatoid arthritis; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "congestive heart failure"; CHEST PAIN (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), MOVEMENT DISORDER (non-serious), outcome "unknown" and all described as "today both shoulders are so painful she can barely move them"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "symptoms worsened". The action taken for tofacitinib citrate was temporarily withdrawn. Therapeutic measures were taken as a result of arthralgia, movement disorder.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Reported event of cardiac congestive failure could be due to an intercurrent medical condition, unrelated to the suspect drug.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30-year-old male patient received BNT162b2 (BNT162B2), solution for injection, on 28Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: known allergies: seasonal allergies; "Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts. Concomitant medication(s) included: BREO ELLIPTA taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 12Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 12Apr2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive; (Apr2022) faint positive line, notes: rapid COVID test; (Apr2022) fainter line; (20Apr2022) positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: adverse event Tested positive for COVID on 12Apr. Prescribed Paxlovid for COVID because of been at risk from asthma. Took for 5 days. Starting 13Apr ending 18Apr. Felt mostly better by the third day of Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: bilateral humming/whooshing sound in his ears following his Pfizer BioNTech Covid-19 booster dose; This is a spontaneous report received from contactable reporter(s) (Physician).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete manufacturer unknown), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "bilateral humming/whooshing sound in his ears following his Pfizer BioNTech Covid-19 booster dose". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient will visit an ENT on 29Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Injury, Nervous system disorder
Clinical narrative: women with injuries ER8731 all neurological bad batch; women with injuries ER8731 all neurological bad batch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), INJURY (non-serious), outcome "unknown" and all described as "women with injuries ER8731 all neurological bad batch".  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200642426 same vaccine/reporter/AE, different patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Condition aggravated, Diabetes mellitus, Electromyogram
Clinical narrative: Tingling, in both feet; Numbness in both feet; Burning in both feet; she saw her doctors because it was getting worse; doctor thinks that the booster shocked her system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 02Sep2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, Lot/batch number: EL3249 Expiry Date: unknown, Route, Anatomical Location: unknown), administration date: 15Jan2021, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (dose 2, single, Lot/batch Number: EM9809, Expiry Date: unknown, Route, Anatomical Location: unknown), administration date: 05Feb2021, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Burning in both feet"; HYPOAESTHESIA (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Numbness in both feet"; PARAESTHESIA (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Tingling, in both feet"; CONDITION AGGRAVATED (non-serious) with onset 12Sep2021, outcome "unknown", described as "she saw her doctors because it was getting worse"; SHOCK (medically significant) with onset Sep2021, outcome "unknown", described as "doctor thinks that the booster shocked her system". The events "doctor thinks that the booster shocked her system", "tingling, in both feet", "numbness in both feet", "burning in both feet" and "she saw her doctors because it was getting worse" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: normal, notes: everything is normal; Diabetes mellitus: normal, notes: everything is normal; Electromyogram: normal, notes: everything is normal; ultrasound: normal, notes: everything is normal. Clinical course: It was reported that about 10 days later, she experienced tingling, numbing, and burning in her both of her feet. Caller states that she saw her doctors because it was getting worse. Caller states that she saw a neurologist, and a dermatologist, and saw a total of four physicians, including her primary care doctor and she had all kinds of tests, including EMG, bloodwork, ultrasound, and a diabetic test, and everything was normal. It was reported that her doctor thinks that the booster shocked her system, but he was not really sure.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Paraesthesia, Shock
Clinical narrative: Tingling, in both feet; Numbness in both feet; Burning in both feet; she saw her doctors because it was getting worse; doctor thinks that the booster shocked her system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 02Sep2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, Lot/batch number: EL3249 Expiry Date: unknown, Route, Anatomical Location: unknown), administration date: 15Jan2021, when the patient was 59-year-old, for COVID-19 Immunization; BNT162b2 (dose 2, single, Lot/batch Number: EM9809, Expiry Date: unknown, Route, Anatomical Location: unknown), administration date: 05Feb2021, when the patient was 59-year-old, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Burning in both feet"; HYPOAESTHESIA (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Numbness in both feet"; PARAESTHESIA (non-serious) with onset 12Sep2021, outcome "not recovered", described as "Tingling, in both feet"; CONDITION AGGRAVATED (non-serious) with onset 12Sep2021, outcome "unknown", described as "she saw her doctors because it was getting worse"; SHOCK (medically significant) with onset Sep2021, outcome "unknown", described as "doctor thinks that the booster shocked her system". The events "doctor thinks that the booster shocked her system", "tingling, in both feet", "numbness in both feet", "burning in both feet" and "she saw her doctors because it was getting worse" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: normal, notes: everything is normal; Diabetes mellitus: normal, notes: everything is normal; Electromyogram: normal, notes: everything is normal; ultrasound: normal, notes: everything is normal. Clinical course: It was reported that about 10 days later, she experienced tingling, numbing, and burning in her both of her feet. Caller states that she saw her doctors because it was getting worse. Caller states that she saw a neurologist, and a dermatologist, and saw a total of four physicians, including her primary care doctor and she had all kinds of tests, including EMG, bloodwork, ultrasound, and a diabetic test, and everything was normal. It was reported that her doctor thinks that the booster shocked her system, but he was not really sure.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Malaise, Mental disorder
Clinical narrative: Gillian Barre disease; taken a toll mentally and physically and financially; taken a toll mentally; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Gillian Barre disease"; MALAISE (non-serious), outcome "unknown", described as "taken a toll mentally and physically and financially"; MENTAL DISORDER (non-serious), outcome "unknown", described as "taken a toll mentally". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Additional information: Patient stated that It's almost been a year since I received the second COVID shot, and ended up with Gillian Barre disease. I lost my job and hardly get to see my son and basically lost a year of my life. I can't get no help what so ever that's why I decided to reach out to you. Please help me I have all the medical records if you need proof. This the worst thing to have and it has taken a toll mentally and physically and financially. Please help me.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.