chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Meningitis bacterial
Clinical narrative: Bacterial meningitis; This serious case was reported by a nurse via sales rep and described the occurrence of bacterial meningitis in a 5-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, 4 days after receiving Pediarix, the patient experienced bacterial meningitis (Verbatim: Bacterial meningitis) (serious criteria GSK medically significant). The outcome of the bacterial meningitis was unknown.   It was unknown if the reporter considered the bacterial meningitis to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the bacterial meningitis to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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: 02-JUN-2023 The nurse reported that a friend had a child that contracted bacterial meningitis 4 days after receiving a dose of Pediarix.  They gave the information which identified the nurse. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient did not receive the second dose of Shingrix The reporter stated that she was going to follow up and would get the second dose at the time of reporting. The reporter had limited details to provide during the call. The reporter consented to follow up. Details reported for 1st dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix (Late 2nd dose); This non-serious 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 (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix (Late 2nd dose)). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The case was received via web form. The reporter asked if they need to restart the series or just get the second shot. It had been over 2 years since the first shot. The Vaccine Administration Facility was the same as Primary Reporter. No more information that the one provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: dizzy; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-JUN-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 03-JUN-2023, 2 days after receiving Shingrix, the patient experienced dizziness (Verbatim: dizzy). On 04-JUN-2023, the outcome of the dizziness was resolved (duration 1 day).   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient self-reported this case. The patient received 2nd dose of Shingrix, 2 days later he woke-up and was dizzy.  The dizziness resolved in the afternoon.  The patient would also report this to his doctor. The reporter did not consent to follow-up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Stinging on his left arm; Itching; Redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Stinging on his left arm), pruritus (Verbatim: Itching) and erythema (Verbatim: Redness). The outcome of the pain in arm, pruritus and erythema were not resolved.   It was unknown if the reporter considered the pain in arm, pruritus and erythema to be related to Shingrix.     It was unknown if the company considered the pain in arm, pruritus and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was the patient's wife.  She stated that the patient received a dose of Shingrix on Saturday. The patient experienced redness, itching, and stinging on his left arm, which had not resolved. This case has been linked to the case US2023079166 reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023079166:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: Postherpetic Neuralgia; Shingles rash; Pain; Shingles; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Shingrix. On 12-MAR-2023, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: Pain). In MAR-2023, the patient experienced rash (Verbatim: Rash). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Postherpetic Neuralgia) and vesicular rash (Verbatim: Shingles rash). The outcome of the shingles was unknown and the outcome of the post herpetic neuralgia and pain were not resolved and the outcome of the vesicular rash and rash were resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, vesicular rash, pain and rash to be related to Shingrix.     It was unknown if the company considered the shingles, post herpetic neuralgia, vesicular rash, pain and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient was self-reported this case. The patient reported that the she contacted GSK via web. The patient stated that she received first dose of Shingrix vaccine on Wednesday and experienced first symptoms of shingles on Sunday. The patient stated that it was just a coincidence. The patient first developed pain on sunday. Three months later, patient still in severe pain. On 14th March 2023 she went to the emergency room as she thought she had a heart attack. The patient was diagnosed with the shingles during the emergency room visit. The patient did not noticed she had rash until this time. The shingles rash had gone but the patient experiences post herpetic neuralgia. Patient wanted to know if she can receive second dose even though she suffering from post herpetic neuralgia. The reporter did consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix -Administration of an expired dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 90-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57GJ2, expiry date 29-MAY-2023) for prophylaxis.   On 05-JUN-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix -Administration of an expired dose.). 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: 05-JUN-2023 The reporter was a medical assistant. The reporter wanted to know how to proceed with the patient. The reporter did consent to follow up. The patient received a Boostrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had not received the 2nd dose yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th May 2018).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Had not received the 2nd dose yet.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number J477y, expiry date 05-MAY-2023) for prophylaxis.   On 05-JUN-2023, the patient received Twinrix. On 05-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Patient received an expired dose of Twinrix). 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: 05-JUN-2023 The reporter did not consent to follow up. The patient received a Twinrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: has been suffering from shooting arm pain that extends to the fingers; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 2hc4l, expiry date 09-JUL-2024) for prophylaxis.  On 12-APR-2023, the patient received the 2nd dose of Shingrix. On 12-APR-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: has been suffering from shooting arm pain that extends to the fingers). The outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to Shingrix.  It was unknown if the company considered the pain in arm to be related to Shingrix.  Additional Information: GSK Receipt Date: 05-JUN-2023 Information about event, vaccine and patient provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the diluent portion of Shingrix was administered to the patient; Only the diluent portion of Shingrix was administered to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Shingrix. On 08-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only the diluent portion of Shingrix was administered to the patient) and inappropriate dose of vaccine administered (Verbatim: Only the diluent portion of Shingrix was administered to the patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter reported that the patient received only the diluent portion of Shingrix. The reporter stated that she became aware of this a couple of weeks ago and the patient had no adverse effects.  The vaccine administration facility was the same as primary reporter. The reporter reported that the lot number provided was from the lyophilized portion, the vial for the diluent portion was discarded. The reporter did consent to follow up via postal. The reporter gave by error Shingrix diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 18.0
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody, Overdose, Product administered to patient of inappropriate age, Therapeutic response decreased, Viral titre
Clinical narrative: Low titers; adult dose given to pediatric patient; adult dose given to pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 25-MAY-2023, the patient received Engerix B adult. On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 25-MAY-2023, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B, Engerix B and Engerix B, the patient experienced adult product administered to child (Verbatim: adult dose given to pediatric patient) and overdose (Verbatim: adult dose given to pediatric patient). On an unknown date, the patient experienced therapeutic response decreased (Verbatim: Low titers). The outcome of the therapeutic response decreased, adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was an Office staff member. The patient completed the series as a child, but her titers came back low, so the physician wrote to restart the series and the adult dose given on 25 May 2023 was dose one of the repeat series.  The reporter did not consent to follow up. 18-year-old patient received Engerix B adult which led to adult product administered to child and overdose.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Dose administered during temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 03-JUN-2023, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Dose administered during temperature excursion). The outcome of the incorrect storage of drug 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: 05-JUN-2023 The reporter called to inform that dose of Kinrix was administered to a patient while the temperature dropped in a temperature excursion, the minimum temperature of that excursion was 30°F. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. Kinrix was administered to a patient while the temperature dropped in a temperature excursion, which lead to incorrect storage of drug.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 17-May-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) 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.   The index number was reported as m6976676.  No concomitant medication information was reported. No treatment medication information was reported.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.  No Medical History information was reported.  On an unknown date, 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 17-May-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) 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.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The index number was reported as m6763677.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient had received 0.25 ml when they should have received 0.5 ml; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 ml) and NO ADVERSE EVENT (No adverse event) 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. 022H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 ml) 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 UNDERDOSE (Patient had received 0.25 ml when they should have received 0.5 ml).    No concomitant medications were provided. Dosage text for suspect drug was unknown.  The date of administration was unknown, but this was last week.  Patients did not experience adverse reaction. The pharmacist did not know the COVID-19 vaccination history of patient. No treatment medication was provided. This case contains information for the 2nd of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727606 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727606:Patient 1 out of 4 patients
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event) 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. 022H22A) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) 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 UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported   This case was linked to US-MODERNATX, INC.-MOD-2023-727606 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727606:Patient 1 out of 4 patients
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jun-2023 at 9:30 AM, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Jun-2023 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)) 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 EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)).    Concomitant medication not reported. The dose was initially placed at room temperature at 11:47 AM on 31MAY2023 and initially punctured at 2:30 PM on 31MAY2023. No reported symptoms. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2023: Live Follow-up received contains updated patient initials, date of birth of patient, administration date, dose no, route of administration, batch no and narrative.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Effects of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Effects of the Moderna vaccine) 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 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 IMMUNISATION REACTION (Effects of the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Effects of the Moderna vaccine) 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.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2023: Non-significant follow-up appended
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Caller states that her son got COVID for the second time; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Caller states that her son got COVID for the second time) in a male 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 COVID-19 (Caller states that her son got COVID for the second time). At the time of the report, COVID-19 (Caller states that her son got COVID for the second time) outcome was unknown.        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 medications were provided. Patient took some medicine to help with symptoms.
Sex: M
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge) in a male 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 SWELLING (my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge). At the time of the report, SWELLING (my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge) 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 medication information was reported. The reporter stated that the patient came to visited one day after he had received the vaccination, and the left side of his body was completely swollen and huge. No treatment medication information was reported   This case was linked to US-MODERNATX, INC.-MOD-2023-727504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727504:Reporter's Case
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023; No adverse event; 3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Latex allergy.   On 12-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023) 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 (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A) and PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023).    No concomitant information was reported. The vaccine use by date was reported as 18-May-2023. The administration date of 3 vials was19-May-2023, 21-May-2023, 25-May-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727682, US-MODERNATX, INC.-MOD-2023-727687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727682:same reporter US-MODERNATX, INC.-MOD-2023-727687:same reporter
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; An expired Moderna Bivalent Vaccine was administered to patient as the second booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired Moderna Bivalent Vaccine was administered to patient as the second booster dose) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 02-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 02-Jun-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 (An expired Moderna Bivalent Vaccine was administered to patient as the second booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired Moderna Bivalent Vaccine was administered to patient as the second booster dose) 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 (An expired Moderna Bivalent Vaccine was administered to patient as the second booster dose).    No concomitant medications were provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) 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 EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.) 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 EXPIRED PRODUCT ADMINISTERED (hey had a clinic on Saturday and they gave out expired doses to one patient and found it was 1 week expired.).    No concomitant medications were reported.  The patient was 65 and older.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event) 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. 022H22A) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) 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 UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.).    It was unknown if patient received any other vaccine 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  They were wondering if Moderna has any information on handling these 4 patients. Date of administration was unknown, but this was last week. The pharmacist reports that the 4 patients did not experience any adverse reaction. One of the patients did come back and get the other half of the dose. She was not sure the location of vaccination, but she assumes it was at her workplace. The pharmacist did not know the patients' COVID19 vaccination history. All 4 of the patients were adults over 18 years old.  Treatment information was not provided.  This case contains information about patient 1st  out of 4 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-727655, US-MODERNATX, INC.-MOD-2023-727656, US-MODERNATX, INC.-MOD-2023-727657 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727655:Patient 2 out of 4 patients US-MODERNATX, INC.-MOD-2023-727656:Patient 3 out of 4 patients US-MODERNATX, INC.-MOD-2023-727657:Patient 4 out of 4 patients
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: SEVERE PAIN INTIALLY, HAS DECLINED TO MODERATE BUT CONSTANT LEVEL OF PAIN FOR MORE THAN 2 WEEKS POST VACCINATION
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: 13 Year old female on a catch up schedule, Tdap was administered on the left Deltoid. Mother was holding child while administering vaccine. Pt then fainted. As per mother patient has hx of syncope after vaccines. Pt was positioned with her feet elevated while seated and performed sternal chest rubs. Patient was observe 1hr after vaccine administration.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No harm and no adverse event due to error that was reported .  Patient was under dosed due to receiving the wrong label Moderna bivalent at 0.2/10mcg, instead of the .25mcg for both doses.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: night sweats that started the first night after the vaccine. I had mild swelling and moderate pain around the site initially. Then on 6/6, I developed moderate erythema and swelling surrounding site. I e also had intermittent nausea and malaise with excessive tiredness.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Night sweats, SARS-CoV-2 test negative
Clinical narrative: night sweats that started the first night after the vaccine. I had mild swelling and moderate pain around the site initially. Then on 6/6, I developed moderate erythema and swelling surrounding site. I e also had intermittent nausea and malaise with excessive tiredness.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site induration, Pain
Clinical narrative: injection site induration, pain,
Sex: M
Vaccine: PNC20
Symptoms: Abdominal discomfort, Dehydration, Gastrointestinal disorder, Malaise, Renal failure
Clinical narrative: gastronomic distress; dehydrated; renal failure; it could be something like a virus of some sort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immune system definitely compromised" (ongoing), notes: antirejection therapy for organ transplant; "organ transplant" (unspecified if ongoing). The patient took concomitant medications (immunosuppressive drugs). The following information was reported: ABDOMINAL DISCOMFORT (hospitalization), outcome "unknown", described as "gastronomic distress"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated "; RENAL FAILURE (hospitalization), outcome "unknown"; VIRAL INFECTION (hospitalization), outcome "unknown", described as "it could be something like a virus of some sort". Clinical course: The patient took immunosuppressive drugs because of an organ transplant so his immune system is definitely compromised on purpose. His pulmonologist recommended Prevnar 20 and he got the vaccine. Shortly after the vaccine he became very ill with a gastro problem and wound up in the hospital with renal failure. The doctors couldn't find anything, they said it could be something like a virus of some sort. He did have side effects. He had gastronomic distress to the point where he got so dehydrated that his kidneys failed. The patient reported the events as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Viral infection
Clinical narrative: gastronomic distress; dehydrated; renal failure; it could be something like a virus of some sort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immune system definitely compromised" (ongoing), notes: antirejection therapy for organ transplant; "organ transplant" (unspecified if ongoing). The patient took concomitant medications (immunosuppressive drugs). The following information was reported: ABDOMINAL DISCOMFORT (hospitalization), outcome "unknown", described as "gastronomic distress"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated "; RENAL FAILURE (hospitalization), outcome "unknown"; VIRAL INFECTION (hospitalization), outcome "unknown", described as "it could be something like a virus of some sort". Clinical course: The patient took immunosuppressive drugs because of an organ transplant so his immune system is definitely compromised on purpose. His pulmonologist recommended Prevnar 20 and he got the vaccine. Shortly after the vaccine he became very ill with a gastro problem and wound up in the hospital with renal failure. The doctors couldn't find anything, they said it could be something like a virus of some sort. He did have side effects. He had gastronomic distress to the point where he got so dehydrated that his kidneys failed. The patient reported the events as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Headache, Incoherent
Clinical narrative: Headache, incoherent speech, dizziness, fever of 100 degrees, body aches, unsteady on feet (requiring cane). Just feeling misterable for the past 5 days
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Walking aid user
Clinical narrative: Headache, incoherent speech, dizziness, fever of 100 degrees, body aches, unsteady on feet (requiring cane). Just feeling misterable for the past 5 days
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site haemorrhage, Injection site pain, Neuralgia
Clinical narrative: Not positive what type of hep b but it was first shot of hep b. The whole experience was weird and I believe she did the shot too high on my arm. A 25 gauge needle doesn?t hurt and it didn?t hurt going in but afterwards it felt like a nerve was hit and I know what that feels like due to nerve pain I?ve experienced for years. when she pulled the needle out I was bleeding a lot and that has also never happened with a shot before. Nothing was prepared (bandaid, cotton ball, wipe) anything at all. Very very painful as of now and it?s been 2 and a half hours.
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient had arm pain and was unable to use arm the next day. He has still not regained full use of arm even after two steroid shots and physical therapy.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antinuclear antibody, Blood glucose, Blood lactic acid, Blood test, Brain natriuretic peptide
Clinical narrative: Diagnosed with Congestive Heart Failure.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac failure congestive, Chest X-ray, Echocardiogram, Electrocardiogram, Full blood count
Clinical narrative: Diagnosed with Congestive Heart Failure.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lipase, Lipids, Metabolic function test, N-terminal prohormone brain natriuretic peptide, Red blood cell sedimentation rate
Clinical narrative: Diagnosed with Congestive Heart Failure.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Serum ferritin, Transferrin, Troponin T
Clinical narrative: Diagnosed with Congestive Heart Failure.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED 3 DOSES OF SHINGRIX RATHER THEN THE RECOMMENDED 2 DOSES.  SHE RECEIVED 1ST DOSE ON 10/31/2021, 2ND DOSE ON 04/14/2022, AND A THIRD DOSE ON 05/09/2023.  PATIENT DID NOT REPORT ANY ADVERSE SIDE EFFECTS, JUST WAS QUESTIONING IF SHE RECEIVED 3.