chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Didn't get  2nd dose within 6 months window; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 10-Feb-2023. Reporter's Comment: On an unknown date, the patient did not receive the 2nd dose of Shingrix. Pharmacist stated she had a lot of patients that called in and asked if they need to restart Shingrix series if they do not get the second dose within 6 months of first dose. Pharmacist does not have any specific patient information, just that there were multiple patients who have gone past the 6 month window. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 28Aug2020, 2nd 10Feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number c28hc9, expiry date 31st May 2024) for prophylaxis.   Previously administered products included Shingrix (On 28th August 2020, received 1st dose).   On 10th February 2023, the patient received the 2nd dose of Shingrix. On 10th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     Additional Information: GSK Receipt date: 10-Feb-2023. Reporter's Comment: The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Hcp was in a hurry and was ok to be followed up via phone only. Additional Supportive Information: Patient received 2nd dose of Shingrix lately than the recommended schedule, which led to drug dose administration interval too long.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness
Clinical narrative: Dizzy; Chills; Decreased appetite/loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 10th February 2023, 1 days after receiving Shingrix, the patient experienced dizziness, chills and decreased appetite. On an unknown date, the outcome of the dizziness, chills and decreased appetite were unknown.   It was unknown if the reporter considered the dizziness, chills and decreased appetite to be related to Shingrix.     Additional Information: GSK receipt date: 10-FEB-2023 Reporter's comment: The case was self reported by the patient. The patient received dose of Shingrix in the series yesterday (the day before reporting), and today (on the day of reporting) began feeling dizzy, with chills and decreased appetite. The patient asked if her symptoms were normal side effect of the Shingrix vaccine.  Read from package insert, gave medical disclaimer, referred to healthcare professional. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Excursion  of -5.6°C for 8 hrs,Vx administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 9th March 2025) for prophylaxis.   On 10th February 2023, the patient received Engerix B. On 10th February 2023, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The reporter reported that the patient received an Engerix B vaccine which was not stable. The reporter stated that the vaccines had been exposed to a lowest temperature of minus 5.6 degree Celsius for 8 hours. No other information about the patient involved was available at the time of the call. The reporter did consent to follow up via email. Additional supportive information: The Engerix B vaccine temperature was exposed upto minus 5.6 degree Celsius, which led to incorrect storage of drug.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Infanrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 23rd January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's comments:  A medical assistant called in to asked for information regarding the administration of an expired Infanrix dose to a 6-year-old patient. The reporter had asked if the patient had to be, re vaccinated. The reporter had consented to follow-up. Additional supportive information: The patient had received an expired dose of Infanrix vaccine, which had led to expired vaccine used.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received Engerix-B pediatric/ Underdose; Adult patient received Engerix-B pediatric; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15th December 2024) for prophylaxis.   On 7th February 2023, the patient received the 1st dose of Engerix B pediatric. On 7th February 2023, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and accidental underdose. On an unknown date, the outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK receipt date: 13-FEB-2023 Reporter's comment: The medical Assistant reported that adult patient received by error Engerix-B pediatric formulation. The reporter consent to follow up by mail. Additional supportive information: The adult patient was given Engerix-B pediatric in error, which led to accidental underdose and adult use of a child product.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Leukaemia, Neutrophil count, White blood cell count
Clinical narrative: BORDERLINE CASE OF LEUKEMIA; LOCAL INJECTION RESPONSE TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a 61 year old female. 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: 205A21A,expiry: unknown) dose was not reported, 1 in total, administered on 03-MAY-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 61 years old. No concomitant medications were reported.  On 03-MAY-2021, right after vaccination, the patient experienced local injection response to the vaccine, which was expected. Several months following that, on an unspecified date the patient developed borderline case of leukemia. The patient stated that her white blood cell and absolute counts started going up and she believes that this is partially due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from borderline case of leukemia, and the outcome of local injection response to the vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20230235262- borderline case of leukemia- The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Lidocaine), Peanut allergy, Allergy to nuts (Treenut), Sesame allergy and Shellfish allergy.    On 04-Feb-2023 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Feb-2023, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent 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 WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose).    Concomitant medication was not provided. As per CDC, patient doesn't need to repeat the dose. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2023: Follow-up received and added reporter details, patient information, relevant medical history and case narrative updated.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product availability issue, Wrong product administered
Clinical narrative: Vaccine unavailable to order via weekly survey; No adverse event; Patient received a Moderna COVID19 vaccine bivalent as a second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose), PRODUCT AVAILABILITY ISSUE (Vaccine unavailable to order via weekly survey) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215k22a) for COVID-19 prophylaxis.     No known drug allergy. It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19.     On 09-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 09-Feb-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 (Patient received a Moderna COVID19 vaccine bivalent as a second dose). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Vaccine unavailable to order via weekly survey) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose), PRODUCT AVAILABILITY ISSUE (Vaccine unavailable to order via weekly survey) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose) and PRODUCT AVAILABILITY ISSUE (Vaccine unavailable to order via weekly survey).    Concomitant products were not provided. Patient received first dose was Moderna COVID19 vaccine monovalent 0.25 ml on 09Dec2022 at 13:05 Pm with lot AS1412B on left thigh. They advised was to redose the child immediately with Moderna monovalent since the bivalent booster dose is a suboptimal dose. Patient unable to receive the second dose within our practice, due to the vaccine expiration on 11Feb2023 and vaccine unavailable to order via weekly survey.  Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2023: Significant follow-up received contains Reporter address, Dosage information, Event and  narrative part updated.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14; No adverse reaction; administered doses of the bivalent booster which were beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14) and NO ADVERSE EVENT (No adverse reaction) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023 at 11:16 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Feb-2023 at 11:16 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14) and NO ADVERSE EVENT (No adverse reaction) 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 reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator-05-Jan-2023 and administered on 07-Feb-2023 at 11:14).    No concomitant medications were reported.  Pharmacist reported that they inadvertently administered 4 doses of the bivalent booster which were beyond the 30-day BUD. 2 doses were administered on 06-Feb-2023 and 2 doses on 07-Feb-2023.  It was reported the patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  It was unknown if the patient had any acute illness at the time of vaccination.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709192, US-MODERNATX, INC.-MOD-2023-710238, US-MODERNATX, INC.-MOD-2023-710239 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709192:Patient - Female US-MODERNATX, INC.-MOD-2023-710238:Patient - Male US-MODERNATX, INC.-MOD-2023-710239:Patient
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: 5 from Moderna that had similar reaction hives the whales; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the whales) in an adult patient of an unknown gender 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 URTICARIA (5 from Moderna that had similar reaction hives the whales). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the whales) had not resolved.        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.   Case contains information of 2 of 5 patients reported. No concomitant medications were reported. It was reported that there were a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna and that had similar reaction hives the whales. It  was further stated that they proceeded to get another vaccine. In some cases they had another similar reaction where they had the hives, the welts. but they at the time when they had them they took an antihistamine which relieved it. It was just resolved simply by taking an antihistamine. The hives had reappeared. They did not had any respiratory problems. They did not had any cardiac problems which was good. Treatment medication included antihistamines.   This case was linked to US-MODERNATX, INC.-MOD-2023-710286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710286:Master case (1 of 5 patient)
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: 5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) in an adult patient of an unknown gender 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 URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) had not resolved.        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.   Case contains information of 3 of 5 patients reported.  Concomitant products were not reported.  It was reported that it was whether patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the whales. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But they At the time when they had them they took an antihistamine and relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems, which was good.   This case was linked to US-MODERNATX, INC.-MOD-2023-710286 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710286:Master case (1 of 5 patient)
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: 5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) in an adult patient of an unknown gender 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 URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) had not resolved.        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.   Case contains information of 4 of 5 patients reported.  Concomitant products were not reported.  It was reported that it was whether patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the whales. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But they At the time when they had them they took an antihistamine and relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems, which was good.   This case was linked to US-MODERNATX, INC.-MOD-2023-710286 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710286:Master case (1 of 5 patient)
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: 5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the welts/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) in an adult patient of an unknown gender 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 URTICARIA (5 from Moderna that had similar reaction hives the welts/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the welts/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) outcome 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.   Case contains information of 5 of 5 patients reported.  Concomitant products were not reported.  It was reported that it was whether patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the welts. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But they At the time when they had them they took an antihistamine and relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems, which was good.   This case was linked to US-MODERNATX, INC.-MOD-2023-710286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710286:Master case (1 of 5 patient)
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (positive for Covid) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced COVID-19 (positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at a dose of third full dose. In February 2023, COVID-19 (positive for Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2023, SARS-CoV-2 test: Positive. On 10-Feb-2023, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient ethnicity reported. Patient was fully vaccinated and boostered. Patient had symptom developed 06-Feb-2023 Monday night, this past Monday night, it was slight sore throat, and it was very slight. Patient woke up in the morning it had moved on to chills, headache, and whole sore body. So, that evening he had a progress and had it tested with home test, he was very good at these and boom it was positive right off the bat for Covid. So, patient immediately started Paxlovid.  It would have been Tuesday night, patient started his first dose that night and morning and the evening, He just started the morning, evening in morning the next day that would have been Wednesday and Thursday again same thing.  He had retest, may be a little bit of headache, obviously some still sniffles that were going on, but patient was pretty impressed by the day patient completely symptomless. All his energy had returned, and patient was like okay let us go ahead and throw a test at it. So, at 3 pm PST, extended time it was negative. No symptoms testing negative.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Feb-2023, 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 10-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Covid 19 Bivalent vaccine that was first punctured on 09Feb2022 was accidentally administered on 10Feb2022 more than 12 hours after first puncture).    Concomitant product information was not provided by the reporter.   It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: No adverse event; Gave Moderna 6 month Monovalent vaccine to a patient and it was a vial they had from yesterdays/ Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Gave Moderna 6 month Monovalent vaccine to a patient and it was a vial they had from yesterdays/ Dose administered >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2023 at 9:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Gave Moderna 6 month Monovalent vaccine to a patient and it was a vial they had from yesterdays/ Dose administered >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Gave Moderna 6 month Monovalent vaccine to a patient and it was a vial they had from yesterdays/ Dose administered >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (Gave Moderna 6 month Monovalent vaccine to a patient and it was a vial they had from yesterdays/ Dose administered >12 hours post puncture).    Patient was administered with Monovalent 6 month to 5-year-old vaccine. Patient had 1 dose from 1 vial. The vial size was unknown. The vial was initially stored in the refrigerator someday in week between 06-Feb-2023 through 11-Feb-2023, Exact date was unknown. The vial was first punctured on 13-Feb-2023 in the afternoon (exact time was not written on vial).  Patient administered the vaccine on 14-Feb-2023 09:30 am.  The vial was stored in the room temperature post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8 degree C to 25 degree C or 46 degree F to 77 degree F) for less than 24 hours. The vial was not exposed to room temperature for more than 24 hours.   No concomitant medication reported. No treatment medication reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Blood oestrogen, Menstrual disorder
Clinical narrative: changes in the menstrual cycle of premenopausal women; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (changes in the menstrual cycle of premenopausal women) 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 MENSTRUAL DISORDER (changes in the menstrual cycle of premenopausal women). At the time of the report, MENSTRUAL DISORDER (changes in the menstrual cycle of premenopausal women) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood oestrogen: higher estrogen levels in body.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of 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)) (batch no. 022J21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First Booster dose) on 01-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 02-Dec-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 an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, 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.    Caller has had two Booster doses, one on 01-Sep-2022 which was Pfizer and then on 02-Dec-2022 which was Moderna. Caller said they had Moderna for the original COVID-19 boosters but then got the Pfizer's new modified version. Then they got the Bivalent booster of Moderna. Caller said they were told they can get the Moderna bivalent booster done after 2 months repeatedly. Caller said after 3 months it starts wearing off. The information they got said the vaccines starts tapering off. Dates for previous doses and monovalent boosters were not gathered to ensure given within authorized vaccine schedule. Caller declined contact information and declined consent for follow up.  No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, 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 23-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan) 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 EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan).    No concomitant medication were reported.  Stated that a dose was administered to 3 patients after the 30 days use by date wherein Moderna vaccine lot 044C22A beyond use by date (BUD) was 22-Jan-2023 and was given on 23-Jan-2023 and for lot 215K22A BUD was 20-Jan-2023 and was given on 23-Jan-2023.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706705 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Non significant live follow up On 31-Jan-2023: Follow up includes no new information. On 31-Jan-2023: Follow-up information received includes primary reporter details were updated. On 15-Feb-2023: Follow-up received included updated patient demographics, suspect vaccine batch number and event verbatim.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706705:Master Case
Age: 66.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered a bivalent vaccine today 2/13/2023 that was drawn up friday; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday) and NO ADVERSE EVENT (No adverse event) in a 66-year-old 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. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday) 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 EXPIRED PRODUCT ADMINISTERED (administered a bivalent vaccine today 2/13/2023 that was drawn up friday).    No concomitant medications were reported. It was reported that patient had primary vaccination series on 13-Apr-2021 and 11-May-2021. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; after the dose was administered they realized that expiration date was 06Feb2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after the dose was administered they realized that expiration date was 06Feb2023.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (after the dose was administered they realized that expiration date was 06Feb2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (after the dose was administered they realized that expiration date was 06Feb2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (after the dose was administered they realized that expiration date was 06Feb2023.).    No concomitant medications were reported. It was reported as unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that accidentally administered a 1st dose of Moderna primary series. However after the dose was administered they realized that expiration date.  No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Mammogram, Paraesthesia, Ultrasound breast
Clinical narrative: Tingling; numbness under the arm and the side of the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) and HYPOAESTHESIA (numbness under the arm and the side of the body) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling) and HYPOAESTHESIA (numbness under the arm and the side of the body). At the time of the report, PARAESTHESIA (Tingling) and HYPOAESTHESIA (numbness under the arm and the side of the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: ruled out anything pertaining to the breast. On an unknown date, Ultrasound breast: ruled out anything pertaining to the breast.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicine were reported. Lab data contains Mammogram in Sep-2021 with unknown result. The patient also informed to the lab technician that she was experiencing a sensation under her left arm. The patient was told that this could also be related to her neck problem so she did PT for 3 months but it did not offer any relief. No treatment medicine were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in an adult 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. ASKU) 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 CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome 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 medications were reported. No treatment medications were reported. It was reported that patient had a stroke after the booster. Company Comment: This is a spontaneous case concerning an adult patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Cerebrovascular accident which occurred on an unknown date after a booster dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine (unknown COVID-19 vaccination schedule). It was reported that patient had a stroke after the booster. No further clinical or diagnostic information was disclosed. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 4-year-old patient received Expired First Primary Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4-year-old patient received Expired First Primary Dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4-year-old patient received Expired First Primary Dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4-year-old patient received Expired First Primary 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 (4-year-old patient received Expired First Primary Dose).    No concomitant medications were reported.  It was reported that, patient received 1st dose of the Moderna primary series. Clinic staff then noticed that vaccine expiration was listed as 11-Feb-2023 and discarded remaining content. It was individual vials with vial size of 2.5 mL. On 10-Feb-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were reported.