chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Peripheral coldness
Clinical narrative: Arm  where received injection still hurting; arm Feels damaged; fingers are cold; arm feels numb,  like the whole arm died; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2022, the patient received the 2nd dose of Shingrix. On 3rd November 2022, 1 days after receiving Shingrix, the patient experienced pain in arm, arm discomfort, fingers cold feeling of and numbness of upper extremities. On an unknown date, the outcome of the pain in arm, arm discomfort, fingers cold feeling of and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, arm discomfort, fingers cold feeling of and numbness of upper extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment: Reporter was the patient who received her Shingrix dose. Patient stated that her arm where she received the injection was still hurting and while it had gotten better but it felt damaged, numb and the fingers were cold and it felt like the whole arm died, which forced her to switch from right handed to left handed. Patient declined providing her demographics at the beginning of the call and suggested possibility of sharing her contact information towards the end of the call. Patient requested speaking to a supervisor regarding her symptoms and abandoned the call while on hold while agent was assisting with her request, and as such additional adverse event details could not be obtained, including consent for follow up, HCP's information and product details (lot number, expiration date, dose, formulation and route of administration).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: RECEIVED ONLY THE ADJUVANT PORTION; RECEIVED ONLY THE ADJUVANT PORTION; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   On 10th October 2022, the patient received the 1st dose of Shingrix. On 10th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment: The reporter stated that the patient received only the adjuvant portion of the Shingrix vaccine on October 10th, 2022. The vaccine administration facility is the same as primary reporter. Additional supportive information: As the patient only received adjuvant portion of Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Note: The clarification was requested as however as per narrative start date 10th October 2022 was captured conservatively.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media (J&J Corporate) via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death within 2 weeks after vaccination. It was unknown if an autopsy was performed. The reporter states- "My son died within 2 weeks after being forced to get shot" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221138328-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 64 year old female. Initial information was processed along with additional information on 18-NOV-2022. The patient's weight was 175 pounds, and height was 64 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. Concomitant medications included hydrochlorothiazide, and lisinopril.  The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on DEC-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  The patient had COVID-19 infection, symptoms included congestion and sneezing throughout and on 13-OCT-2022, patient had tested positive for covid-19 (confirmed covid-19 infection) (dose number in series 2) which resulted to confirmed clinical vaccination failure (dose number in series 1) for which patient received non-company suspect Paxlovid ((pf-07321332), ritonavir) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, first dose administered on 13-OCT-2022 for covid-19 treatment. Date of last dose of administration was 18-OCT-2022. On 23-OCT-2022, Laboratory data included: COVID-19 virus test Negative (5 days after last dose of paxlovid). On 25-OCT-2022, patient experienced rebound covid-19. Laboratory data included: COVID-19 virus test Positive (7 days after last dose of paxlovid).  On 31-OCT-2022, Patient tested positive for covid-19.  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000259921.; Sender's Comments: V0: 20221140777-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 09-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported.  On 09-NOV-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20221141786 and 20221141814.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 09-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 09-NOV-2022, the patient experienced expired vaccine given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine given was not reported. This report was non-serious. This case, from the same reporter is linked to 20221141659 and 20221141814.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 09-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 09-NOV-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20221141659 and 20221141786.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter reported that, "I got the Johnson an Johnson an 3 weeks later I had to use a walker an got GBS spent 5 days in the hospital had to go to therapy to get so I could walk still have muscle issues " On an unspecified date (3 weeks after vaccination), the patient was unable to walk hence used walker and experienced guillain barre syndrome (GBS). The patient was hospitalized on an unknown date for 5 days where patient received therapy so patient could walk but still patient had muscle issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221142500- Guillain Barre syndrome. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I did experience Covid recently; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I did experience Covid recently) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PREDNISONE for an unknown indication.    Concurrent medical conditions included Chronic urticaria, Illness and Hives.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PREDNISONE (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (I did experience Covid recently). At the time of the report, COVID-19 (I did experience Covid recently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided by reporter. No Treatment medication was provided by reporter.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.; No adverse event; Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions.).    No concomitant product use was reported.  Reporter stated that between 24-May-2022 and 03-Oct-2022 several patients received monovalent and bivalent moderna Covid-19 vaccine that had undergone several temperature excursions.  No other adverse events were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673878, US-MODERNATX, INC.-MOD-2022-673836, US-MODERNATX, INC.-MOD-2022-673869, US-MODERNATX, INC.-MOD-2022-673181 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673878:same reporter US-MODERNATX, INC.-MOD-2022-673836:same reporter US-MODERNATX, INC.-MOD-2022-673869:same reporter US-MODERNATX, INC.-MOD-2022-673181:same reporter
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022; No adverse event; administered with vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2022, 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 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022).    Concomitant drugs were not reported. It was reported that the bivalent vial of 2.5 ml was initially stored in refrigerator on 09-Nov-2022 and post puncture was stored in room temperature for 20 hours. The vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022 1 dose at 11:00 am and 2 doses at 01:00 pm. The vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-674355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674355:same reporter
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: No adverse event; Patient received a 0.5mL dose of the Moderna COVID-19 vaccine bivalent; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Patient received a 0.5mL dose of the Moderna COVID-19 vaccine bivalent) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Dose 1) on 29-Oct-2021 and Pfizer COVID-19 vaccine (Dose 2) on 09-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 17-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Nov-2022, the patient experienced OVERDOSE (Patient received a 0.5mL dose of the Moderna COVID-19 vaccine bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (Patient received a 0.5mL dose of the Moderna COVID-19 vaccine bivalent) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OVERDOSE (Patient received a 0.5mL dose of the Moderna COVID-19 vaccine bivalent).    No concomitant medications were reported. No additional doses were reported. No symptoms were reported. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022; No adverse event; administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 immunisation.     No Medical History information was reported.    On 16-Nov-2022, 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 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022).    Concomitant drugs were not reported. It was reported that the bivalent vial of 2.5 ml was initially stored in refrigerator on 09-Nov-2022 and post puncture was stored in room temperature for 20 hours. The vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022 1 dose at 11:00 am and 2 doses at 01:00 pm. The vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-674355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674355:same reporter
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 bivalent booster dose that underwent a temperature excursion; No adverse event; The bivalent Moderna Covid-19 vaccine that was in the refrigerator when a power outage occurred vaccine reached 50 degrees Farenheight for 30 minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The bivalent Moderna Covid-19 vaccine that was in the refrigerator when a power outage occurred vaccine reached 50 degrees Farenheight for 30 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 bivalent booster dose that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) 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 14-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The bivalent Moderna Covid-19 vaccine that was in the refrigerator when a power outage occurred vaccine reached 50 degrees Farenheight for 30 minutes). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 bivalent booster dose that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The bivalent Moderna Covid-19 vaccine that was in the refrigerator when a power outage occurred vaccine reached 50 degrees Farenheight for 30 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 bivalent booster dose that underwent a 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 (The bivalent Moderna Covid-19 vaccine that was in the refrigerator when a power outage occurred vaccine reached 50 degrees Farenheight for 30 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 bivalent booster dose that underwent a temperature excursion).    Concomitant product use was not provided by the reporter.  The vial size was 2.5 ml.  Vaccine was visualized and looks normal. It was reported that only one vial was involved and that vial was discarded and the vaccine was transferred to pharmacy from another pharmacy.  Treatment information was not provided.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received an expired monovalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent 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 an expired monovalent 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent dose).    No concomitant medications were reported. Vial size was reported as 2.5 mL.. Vial was initially stored in the refrigerator on 01-Nov-2022.Vial did not undergo any temperature excursions. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin irritation, Tenderness
Clinical narrative: little redness/experienced red skin and irritation after vaccines; tenderness; experienced red skin and irritation after vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little redness/experienced red skin and irritation after vaccines), TENDERNESS (tenderness) and SKIN IRRITATION (experienced red skin and irritation after vaccines) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (little redness/experienced red skin and irritation after vaccines), TENDERNESS (tenderness) and SKIN IRRITATION (experienced red skin and irritation after vaccines). At the time of the report, ERYTHEMA (little redness/experienced red skin and irritation after vaccines), TENDERNESS (tenderness) and SKIN IRRITATION (experienced red skin and irritation after vaccines) outcome was unknown. No relevant concomitant medications were reported. Patient started treatment on 27-OCT-2021 (booster number one) and JUN-2022 (second booster) with Moderna COVID-19 Vaccine at Dose 3 and Dose 4 for COVID-19 immunisation. It was reported the patient got a little redness and tenderness, nothing out of the ordinary after a vaccine and he experienced red skin and irritation after his vaccines. No treatment information was provided
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: she can't function at all; unbelievably dizzy; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't function at all) and DIZZINESS (unbelievably dizzy) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. Patient had no history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: flu vaccine (given within 1 month prior to Moderna COVID-19 vaccine) in 2022. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Sulfonamide allergy (Sulfas).    On 15-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't function at all) and DIZZINESS (unbelievably dizzy). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she can't function at all) and DIZZINESS (unbelievably dizzy) had not resolved.            No concomitant drug was reported. Patient received first dose on 06-Feb-2021, second dose on 06-Mar-2021, first booster dose on 30-Nov-2021, second booster on 13-May-2022 no lot number recorded for previous four doses. The patient has not experienced a similar event in the past. It was reported that patient did not seek medical care. No treatment drug was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Oropharyngeal pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was out from work for 1.5 days) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age 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 OROPHARYNGEAL PAIN (Sore throat), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was out from work for 1.5 days) and PAIN IN EXTREMITY (Sore arm). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was out from work for 1.5 days) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant medication was not provided.  Reporter's daughter had a drastic reaction after vaccination.  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, No adverse event
Clinical narrative: Pharmacy Technician was administering the Moderna bivalent vaccine to a patient, and some of the vaccine spilled out of the syringe because the syringe needle was not appropriately attached.; syringe needle was not appropriately attached; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Pharmacy Technician was administering the Moderna bivalent vaccine to a patient, and some of the vaccine spilled out of the syringe because the syringe needle was not appropriately attached.), DEVICE CONNECTION ISSUE (syringe needle was not appropriately attached) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth 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 ACCIDENTAL UNDERDOSE (Pharmacy Technician was administering the Moderna bivalent vaccine to a patient, and some of the vaccine spilled out of the syringe because the syringe needle was not appropriately attached.), DEVICE CONNECTION ISSUE (syringe needle was not appropriately attached) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Pharmacy Technician was administering the Moderna bivalent vaccine to a patient, and some of the vaccine spilled out of the syringe because the syringe needle was not appropriately attached.), DEVICE CONNECTION ISSUE (syringe needle was not appropriately attached) 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 ACCIDENTAL UNDERDOSE (Pharmacy Technician was administering the Moderna bivalent vaccine to a patient, and some of the vaccine spilled out of the syringe because the syringe needle was not appropriately attached.) and DEVICE CONNECTION ISSUE (syringe needle was not appropriately attached).    No concomitant medication was provided by the reporter.  It was reported that Pharmacy Technician was administering the Moderna bivalent vaccine to a patient, and some of the vaccine spilled out of the syringe because the syringe needle was not appropriately attached.  No treatment medication was provided by the reporter.   This case was linked to MOD-2022-674378 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series; Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series), WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series), WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series), WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Potential administration error: patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series) and WRONG PRODUCT ADMINISTERED (Patient possibly administered with Moderna Bivalent vaccine instead of 1st dose of primary series).    No concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dysgeusia
Clinical narrative: Bad after taste; Covid-19; Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Bad after taste), COVID-19 (Covid-19) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Bad after taste), COVID-19 (Covid-19) and DIARRHOEA (Diarrhea). At the time of the report, DYSGEUSIA (Bad after taste), COVID-19 (Covid-19) and DIARRHOEA (Diarrhea) outcome was unknown.            No concomitant medications were reported.  Patient still contracts the virus after being vaccinated. Patient had Moderna since patient started in May of last year so, patient had four doses. Patient had to wait 90 days after she get down with this COVID before getting third booster.  No treatment medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Breast swelling, Breast tenderness, Erythema
Clinical narrative: Today her breast is heavier; Today her breast is red, tender; Today her breast is  swollen; Today her breast is  red; red stripey thing; noticed she was a little achy; right breast is hurting, breast is hurting more; This spontaneous case was reported by a patient and describes the occurrence of BREAST PAIN (right breast is hurting, breast is hurting more), BREAST DISCOMFORT (Today her breast is heavier), BREAST TENDERNESS (Today her breast is red, tender), BREAST SWELLING (Today her breast is  swollen) and ERYTHEMA (Today her breast is  red) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71668) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced BREAST PAIN (right breast is hurting, breast is hurting more) and PAIN (noticed she was a little achy). On 17-Nov-2022, the patient experienced BREAST DISCOMFORT (Today her breast is heavier), BREAST TENDERNESS (Today her breast is red, tender), BREAST SWELLING (Today her breast is  swollen), ERYTHEMA (Today her breast is  red) and IMMUNISATION REACTION (red stripey thing). At the time of the report, BREAST PAIN (right breast is hurting, breast is hurting more), BREAST DISCOMFORT (Today her breast is heavier), BREAST TENDERNESS (Today her breast is red, tender), BREAST SWELLING (Today her breast is  swollen), ERYTHEMA (Today her breast is  red), IMMUNISATION REACTION (red stripey thing) and PAIN (noticed she was a little achy) had not resolved.            The concomitant medications was not reported.  Patient received the Moderna COVID-19 vaccines by intramuscular injection Dose 1 on 15-FEB-2021 (lot number 015M20A, expiration date unknown), Dose 2 on 15-MAR-2021 (lot number 002B21A, expiration date unknown), Dose 3 on 12-NOV-2021 (lot number 939902, expiration date unknown) and Dose 4 on 15-APR-2022 (lot number 048L21A, expiration date unknown). On 16-NOV-2022 patient noticed she was a little achy and right breast has been hurting. On 17-NOV-2022, breast was hurting more, red, heavier, tender, swollen, and has a red stripey thing. This notably was on a side opposite to injection.  No other treatment medications was reported by patient .
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain
Clinical narrative: Today her breast is heavier; Today her breast is red, tender; Today her breast is  swollen; Today her breast is  red; red stripey thing; noticed she was a little achy; right breast is hurting, breast is hurting more; This spontaneous case was reported by a patient and describes the occurrence of BREAST PAIN (right breast is hurting, breast is hurting more), BREAST DISCOMFORT (Today her breast is heavier), BREAST TENDERNESS (Today her breast is red, tender), BREAST SWELLING (Today her breast is  swollen) and ERYTHEMA (Today her breast is  red) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71668) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced BREAST PAIN (right breast is hurting, breast is hurting more) and PAIN (noticed she was a little achy). On 17-Nov-2022, the patient experienced BREAST DISCOMFORT (Today her breast is heavier), BREAST TENDERNESS (Today her breast is red, tender), BREAST SWELLING (Today her breast is  swollen), ERYTHEMA (Today her breast is  red) and IMMUNISATION REACTION (red stripey thing). At the time of the report, BREAST PAIN (right breast is hurting, breast is hurting more), BREAST DISCOMFORT (Today her breast is heavier), BREAST TENDERNESS (Today her breast is red, tender), BREAST SWELLING (Today her breast is  swollen), ERYTHEMA (Today her breast is  red), IMMUNISATION REACTION (red stripey thing) and PAIN (noticed she was a little achy) had not resolved.            The concomitant medications was not reported.  Patient received the Moderna COVID-19 vaccines by intramuscular injection Dose 1 on 15-FEB-2021 (lot number 015M20A, expiration date unknown), Dose 2 on 15-MAR-2021 (lot number 002B21A, expiration date unknown), Dose 3 on 12-NOV-2021 (lot number 939902, expiration date unknown) and Dose 4 on 15-APR-2022 (lot number 048L21A, expiration date unknown). On 16-NOV-2022 patient noticed she was a little achy and right breast has been hurting. On 17-NOV-2022, breast was hurting more, red, heavier, tender, swollen, and has a red stripey thing. This notably was on a side opposite to injection.  No other treatment medications was reported by patient .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Chills, Headache, Illness
Clinical narrative: She's been so sick , sick as a dog; headache that doesn't go away ,It's like a burning headache; She has fevers going up and down - not extremely high, but 99 or 100; She has chills; She's trembling; body pain; body is burning; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), ILLNESS (She's been so sick , sick as a dog) and HEADACHE (headache that doesn't go away ,It's like a burning headache) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced ILLNESS (She's been so sick , sick as a dog). In November 2022, the patient experienced TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), HEADACHE (headache that doesn't go away ,It's like a burning headache), PYREXIA (She has fevers going up and down - not extremely high, but 99 or 100) and CHILLS (She has chills). On 13-Nov-2022, ILLNESS (She's been so sick , sick as a dog) had resolved. At the time of the report, TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), HEADACHE (headache that doesn't go away ,It's like a burning headache), PYREXIA (She has fevers going up and down - not extremely high, but 99 or 100) and CHILLS (She has chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Body temperature: not extremely high, but 99 or 100.         No concomitant medications were reported.  The patient took 4 shots of Moderna. The patient states that she got very sick from the last one that she took in Dec-2021.  No treatment medications were reported.   This case was linked to MOD-2022-674590.