chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (first dose given on 08-Mar-2023 was the Moderna bivalent, which was an error because patient never received the initial series yet, a patient came in today for a second dose of Moderna).    Concomitant drugs were not reported.  It was reported that patient never received the initial series.  Treatment medications were not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine for her second Moderna Primary series dose; Patient received her second primary series dose 21 days after her first Moderna Primary dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 042C22A and 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.).    No concomitant medication was reported.    Expiration date was reported as 30-MAR-2023. No treatment information was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site; Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) and VACCINATION SITE ERYTHEMA (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 prophylaxis.   Patient did not have any allergy and diseases.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE DISCOLOURATION (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) and VACCINATION SITE ERYTHEMA (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) and VACCINATION SITE ERYTHEMA (Approximately 2 weeks after receiving the vaccine patient notice an orange or red circle at the injection site) 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.  Orange or red circle at the injection site was not painful, inflame or sore. Patient originally thought it would disappear.  No treatment information was provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 05-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine administered on 5APR2023. 2nd dose administered after the published expiration date.).    No concomitant medication details was reported. No treatment medication details was reported.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023; No adverse event; administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May), PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023) and NO ADVERSE EVENT (No adverse event) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May), PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered a first primary dose of Moderna COVID-19 vaccine, After she administered the dose she noticed that it expired in March and not in May) and PRODUCT STORAGE ERROR (Exp. Date 12MAR2023, the vial was initially stored in the refrigerator 10APR2023).    No concomitant medication were reported.  Nurse called to report that She wrote expiration date of 12-MAY-2023 on the vial by mistake. After she administered the dose she noticed that it expired in March and not in May. Individual vials with vial size of 5.5 ml Red Cap. The vial was initially stored in the refrigerator on 10-APR-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.). At the time of the report, IMMUNISATION REACTION (Contact stated her sister has received Moderna vaccines and now has to get a surgery on her arm.) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no AEs were reported; administered 1 patient with Moderna COVID-19 Vaccine Bivalent instead of monovalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered 1 patient with Moderna COVID-19 Vaccine Bivalent instead of monovalent vaccine) and NO ADVERSE EVENT (no AEs were reported) in a 21-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     The patient conditions were not known.  Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 10-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (administered 1 patient with Moderna COVID-19 Vaccine Bivalent instead of monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no AEs were reported). At the time of the report, WRONG PRODUCT ADMINISTERED (administered 1 patient with Moderna COVID-19 Vaccine Bivalent instead of monovalent vaccine) and NO ADVERSE EVENT (no AEs were reported) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no AEs were reported) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered 1 patient with Moderna COVID-19 Vaccine Bivalent instead of monovalent vaccine).    No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (He get sick every 2 months from the vaccine.) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product DIAMORPHINE (HEROIN) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DIAMORPHINE (HEROIN) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (He get sick every 2 months from the vaccine.). At the time of the report, ILLNESS (He get sick every 2 months from the vaccine.) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered ILLNESS (He get sick every 2 months from the vaccine.) to be related.    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.; The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT AVAILABILITY ISSUE (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.), PRODUCT ADMINISTRATION INTERRUPTED (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.) and NO ADVERSE EVENT (No adverse event) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.), PRODUCT ADMINISTRATION INTERRUPTED (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.), PRODUCT ADMINISTRATION INTERRUPTED (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT AVAILABILITY ISSUE (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.) and PRODUCT ADMINISTRATION INTERRUPTED (The patient states that her 17-year-old daughter received the first primary dose of Moderna on 23Feb2023. She's been trying for 2 hours to schedule her daughter's second dose.).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered to patient after temperature excursion; No adverse event; Temperature probes were being changed, Freezer 15 minutes - original temperature -19.8 celsius and temperature raised to -1.9 celsius and then up to -14.2 celsius; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature probes were being changed, Freezer 15 minutes - original temperature -19.8 celsius and temperature raised to -1.9 celsius and then up to -14.2 celsius), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after temperature excursion) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature probes were being changed, Freezer 15 minutes - original temperature -19.8 celsius and temperature raised to -1.9 celsius and then up to -14.2 celsius). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature probes were being changed, Freezer 15 minutes - original temperature -19.8 celsius and temperature raised to -1.9 celsius and then up to -14.2 celsius), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature probes were being changed, Freezer 15 minutes - original temperature -19.8 celsius and temperature raised to -1.9 celsius and then up to -14.2 celsius) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after temperature excursion).    No concomitant medication was reported.  Vaccine were provided from the lot number. 061F22A. No calls from patient in regards to side effects from the temperature excursion. No treatment information was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Primary series: 2nd dose was administered >36 days after the first dose.; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series: 2nd dose was administered >36 days after the first dose.) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 029L20A, 014C21A and 065K21A) for COVID-19 prophylaxis.     It was reported that patent did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 09-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series: 2nd dose was administered >36 days after the first dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series: 2nd dose was administered >36 days after the first dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series: 2nd dose was administered >36 days after the first dose.).    No concomitant medications was provided. No treatment medications was provided.   This case was linked to MOD-2023-719120 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, Pyrexia
Clinical narrative: High temperature; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (High temperature) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High temperature). At the time of the report, PYREXIA (High temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient got high temperature for half a day. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-719204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719204:Same reporter
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Myalgia, Pain, Paraesthesia
Clinical narrative: developed pain; numbness; tingling from her hips all the way to her feet; Sciatica; she is feeling is muscle pain up on her knee.; she had trouble walking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose 2, single (Lot number: EW0179) at the age of 83 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0179, Expiry: Unknown, Site: Left arm), administration date: 08Jul2021, when the patient was 83-year-old, for COVID-19 immunization, reaction(s): "No problem". The following information was reported: SCIATICA (non-serious) with onset 08Aug2021, outcome "recovering"; PAIN (non-serious) with onset 08Aug2021, outcome "recovering", described as "developed pain"; HYPOAESTHESIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "numbness"; GAIT DISTURBANCE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "she had trouble walking"; MYALGIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "she is feeling is muscle pain up on her knee."; PARAESTHESIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "tingling from her hips all the way to her feet". Therapeutic measures were taken as a result of pain, hypoaesthesia, paraesthesia. Additional information: The patient received her 2nd dose of the Pfizer covid vaccine back on 03Aug2021, on 08Aug2021 (also reported as 5 days after) she developed pain, numbness, and tingling from her hips all the way to her feet. The patient says it was first diagnosed as sciatica. The patient was asking if there is any way we can help her for the situation. She also says later on that what she was feeling was muscle pain up on her knee. She said that the 'sciatica' did not work and she went to 4 doctors and found out what it was. She heard it was a reaction to the second shot. She said that she went back and looked and she said that 5 days after receiving the shot, she had trouble walking. She takes no other medications just some Vitamins.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: developed pain; numbness; tingling from her hips all the way to her feet; Sciatica; she is feeling is muscle pain up on her knee.; she had trouble walking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose 2, single (Lot number: EW0179) at the age of 83 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0179, Expiry: Unknown, Site: Left arm), administration date: 08Jul2021, when the patient was 83-year-old, for COVID-19 immunization, reaction(s): "No problem". The following information was reported: SCIATICA (non-serious) with onset 08Aug2021, outcome "recovering"; PAIN (non-serious) with onset 08Aug2021, outcome "recovering", described as "developed pain"; HYPOAESTHESIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "numbness"; GAIT DISTURBANCE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "she had trouble walking"; MYALGIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "she is feeling is muscle pain up on her knee."; PARAESTHESIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "tingling from her hips all the way to her feet". Therapeutic measures were taken as a result of pain, hypoaesthesia, paraesthesia. Additional information: The patient received her 2nd dose of the Pfizer covid vaccine back on 03Aug2021, on 08Aug2021 (also reported as 5 days after) she developed pain, numbness, and tingling from her hips all the way to her feet. The patient says it was first diagnosed as sciatica. The patient was asking if there is any way we can help her for the situation. She also says later on that what she was feeling was muscle pain up on her knee. She said that the 'sciatica' did not work and she went to 4 doctors and found out what it was. She heard it was a reaction to the second shot. She said that she went back and looked and she said that 5 days after receiving the shot, she had trouble walking. She takes no other medications just some Vitamins.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2023) Negative; (08Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received covid treatment. Patient tested negative on 5th day of taking medication (paxlovid) with no symptoms. On 08Apr experienced some "brain fog" and tested positive. Patient did not have any known allergy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148681 same reporter/patient, different drug/event;
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic hives" (unspecified if ongoing), notes: unexplained chronic hives; "hypothyroid" (unspecified if ongoing); "Previous long covid lasting 1.5 years" (unspecified if ongoing); "Previous long covid lasting 1.5 years" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for COVID-19 treatment from 31Mar2023 to 05Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148518 Same patient/ reporter, Different drug (Paxlovid)/ event.;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective/COVID 19 Treatment; COVID-19/ COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Drug ineffective/COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID-19/ COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had treatment with Paxlovid from 29Mar2023 to 02Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148716 same reporter/patient, different drug/event;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8734), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FP2589), in left arm and on 01Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 27Ma2023 to 31Mar2023 for treatment of COVID-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination Failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 as dose 1, single (Lot number: ER8736), in left arm, on 26May2021 as dose 2, single (Lot number: EW0172), in left arm, on 03Jan2022 as dose 3 (booster), single (Lot number: 33025BO), in left arm and on 20Aug2022 as dose 4 (booster), single (Lot number: Fp7137) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "SLE" (unspecified if ongoing); "Liver Steatosis" (unspecified if ongoing); "Atherosclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: COVID 19 Treatment; (03Apr2023) Negative, notes: tested neg x2(Mon & Thurs); (06Apr2023) Negative, notes: tested neg x2(Mon & Thurs); (08Apr2023) Positive, notes: I have tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148525 same patient, different drug/event (Paxlovid);
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2.,Linked Report(s) : US-PFIZER INC-202300148530 same patient, different drug/event;
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound case of COVID19 following completion of Paxlovid. Symptoms began for second time three days following completion of Paxlovid series.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148548 Same patient/different product, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: 2007 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient was treated with Paxlovid from 29Mar2023 to 03Apr2023. Lot for dose 3 was misplaced or discarded. There were no Known allergies.  The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148662 same patient, different product/event;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2 NOS), on 30Sep2022 at 15:00 as dose number unknown , single (Lot number: GTS5342) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2022, stop date: 28Mar2023. The following information was reported: COVID-19 (medically significant) with onset 28Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 28Mar2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Felt good and tested negative; (28Mar2023) Positive, notes: COVID 19 symptoms and tested positive on  28Mar. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Had COVID 19 symptoms and tested positive on 28Mar2023; started taking Paxlovid on the same day. Finished Paxlovid in 5 days. Felt good and tested negative. But, four days later, symptoms came back, and tested positive again. The patient had no known allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148450 same patient, different drug/event;
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2 NOS), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient got a rebound of Covid after taking Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148451 same patient, different drug/event;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on home antigen test on Day 2; Negative, notes: Tested negative on home test on Day 9; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid from 27Mar2023 till 30Mar2023. Currently symptomatic with swollen glands, nasal congestion, sore throat, intermittent cough. Hoping this passes in day or two. Patient had no known allergies.  The information on the batch/lot number for BNT162B2 NOS has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148452 same patient, different drug/event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 19:00 as DOSE NUMBER UNKNOWN, SINGLE (lot number: 903) at the age of 39 years old, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (batch/lot number: unknown) for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Apr2023) Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug Ineffective, Covid-19.  The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.