chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; Patient was inadvertently, concomitantly administered VARIVAX, PROQUAD on 02/06/2023.; The patient is a 14-year old; This spontaneous report has been received from a nurse and refers to a 14-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2023, the 14-year-old patient was inadvertently, concomitantly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number W023865 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and established as 29-OCT-2023) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot number W008711 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and established as 14-MAR-2024), subcutaneous injections, both administered for prophylaxis (strength not provided) (product administered to patient of inappropriate age) (product administration error).
Age: 14.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: No additional AE reported; Patient was inadvertently, concomitantly administered VARIVAX, PROQUAD on 02/06/2023.; The patient is a 14-year old; This spontaneous report has been received from a nurse and refers to a 14-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2023, the 14-year-old patient was inadvertently, concomitantly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number W023865 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and established as 29-OCT-2023) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot number W008711 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and established as 14-MAR-2024), subcutaneous injections, both administered for prophylaxis (strength not provided) (product administered to patient of inappropriate age) (product administration error).
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; VAQTA was administered after a temperature excursion of 47.9°F for 47 min on 01-DEC-2022; This spontaneous report was received from a certified medical assistant and refers to a 5-year-old male patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history, and concomitant therapy were not reported.  On 01-DEC-2022, hepatitis a vaccine, inactivated (VAQTA), lot # W023937, expiration date 06-DEC-2023 had temperature excursion of 47.9 Fahrenheit degrees (°F) for 47 minutes as a result of reading from Data Logger.  On 16-DEC-2022, the patient was vaccinated with this incorrect storage second dose of hepatitis a vaccine, inactivated (VAQTA), intramuscularly in left deltoid, lot # W023937, expiration date 06-DEC-2023 for prophylaxis (quantity dose was not reported) (product storage error).    No additional adverse event and nor product quality complain were reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: repeated cold sores on lip; This case was reported by a consumer via call center representative and described the occurrence of cold sores lip in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received her first 2 shingles shots, did not have the name of the vaccine or the date received) and Shingrix (received 1st dose on on 01January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was not recovered/not resolved.   It was unknown if the reporter considered the cold sores lip to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient reported case for herself. The patient reported that she received her first 2 shingles shots (patient did not have the name of the vaccine or the date received) and then a year later her pharmacist told her they did not work. The patient then received 2 Shingrix shots. The patient did not have the date for her 2nd Shingrix shot, and said she most likely received the vaccines in her right arm.  The patient had repeated cold sores that start on one side of her lip and would cover almost her entire lip.  The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pediarix instead of Dtap (Infanrix); With Pediarix, now has 4 doses of hep b; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 26th October 2025) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were 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: 2-Feb-2203 Reporter's comment: Nurse assistant reported by getting Pediarix, the patient now had received 4 doses of Hepatitis B, 4th dose of Dtap and reporter was unaware of where patient was in series for IPV. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Pediarix (extra dose for Hepatitis B), Hiberix (Hib) and Prevenar instead of Infanrix, Hiberix and Prevenar, which led to wrong vaccine administered and extra dose administered.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Infanrix instead of Tdap vaccine; 29YO received infanrixby error; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 29-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 2-Feb-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Infanrix vaccine instead of Tdap vaccine by error at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Received a 3rd dose of Rotarix; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a infant male patient who received Rota (Rotarix lyophilized formulation) (batch number K33EZ, expiry date 31st July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 2 doses of Rotarix on an unknown date ).   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: 2-Feb-2023 Reporter's comment: The date the vaccine was administered was unknown.  Field representative stated that it could had been one or two days ago but this was not confirmed.  At the moment of the report to GlaxoSmithKline field representative, the parents had not been notified.  Parents had not reported any adverse event as well until now. The reporter consented to follow up. Additional supportive information: The patient received the 3rd dose of Rotarix mistakenly, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Administered subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult male patient who received Herpes zoster (Shingrix) (batch number 3922H, expiry date 17th February 2024) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter called stating that the Shingrix vaccination series was administered subcutaneously (wrong route of administration). Additional Supportive Information: Shingrix administered subcutaneously, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 7th February 2023, the patient received Havrix. On 7th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The pharmacist reported that an unknown patient received an expired dose of Havrix.  The vaccine was expired on 16th December 2022. The HCP (health care professional) did not had any patient details at the time of report. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   On 7th February 2023, the patient received Havrix. On 7th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Feb-2023 Reporter's comment: Nurse reported a patient was administered expired Havrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: As patient received expired Havrix vaccine which led to expired vaccine used.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose  2 years ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose about 2 years ago in 2021).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, 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: 08-Feb-2023. Reporter's Comment: The patient did not remember the exact date of the first vaccine and did not know which brand he received. The patient did not get the second dose. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose of Hepatitis A vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Herpes zoster, Post herpetic neuralgia, Quality of life decreased, Vaccination failure
Clinical narrative: constant nerve pain now, destructive to my life; anxiety; This ongoing issue has been very destructive to my life; Never had issues until got shots, shingle outbreaks/ suspected vaccination failure; constant shingle outbreaks, breaking point for overall health/6+ times is now a breaking point for me; This case was reported by a consumer and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased, hypothyroidism and osteoarthritis. Concomitant products included rosuvastatin, levothyroxine (Levothyroxin) and meloxicam.   On 22nd September 2021, the patient received Shingrix. On 29th November 2021, 68 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia, anxiety and quality of life decreased. The patient was treated with clonazepam and valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, anxiety and quality of life decreased were unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, anxiety and quality of life decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-FEB-2023 Reporter's comments: The patient self-reported this case. The patient never had any issues until she got Shingrix shots.  If she would had knew that, she was going to have the shingles just about every month then she would had not gotten the shots for preventing shingles, following the physician orders.  This ongoing issue had been very destructive to her life with the constant nerve pain now, along with never knowing when it would arise again. Six plus times was now a breaking point for her with the anxiety and overall health (constant shingle outbreaks). The symptoms were treated. The reporter gave permission to contact. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Adverse event (AE) outcome captured conservatively and clarification was raised to confirm the same.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    Concomitant medications were not reported.  The 17 month pediatric patient whose first dose was Pfizer Covid-19 vaccine, second dose was Moderna. They were here for their booster dose. Treatment medications were not reported.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) 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 08-Nov-2022, 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 08-Nov-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 08-Nov-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. 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. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    Concomitant and treatment medications were not reported.   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Maternal exposure during breast feeding; Moderna Bivalent given as second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose) in a 30-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 28-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 28-Dec-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose) 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and WRONG PRODUCT ADMINISTERED (Moderna Bivalent given as second dose).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 33-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 29-Dec-2022, 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 29-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 29-Dec-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. 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. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.     Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 36-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 11-Jan-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 11-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 11-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. 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. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.  Index number was reported .   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 33-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 12-Jan-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 12-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 12-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. 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. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 32-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 19-Jan-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 19-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 19-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. 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. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) 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 18-Nov-2022, 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 18-Nov-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 18-Nov-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. 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. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 42-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 28-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 28-Nov-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. 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. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    Concomitant and treatment medications were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administer five days after the 30 day storage limit; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) 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)) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) 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 (Vaccine was administer five days after the 30 day storage limit).    No concomitant medications were reported.  No treatment medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: he was given a Moderna bivalent booster instead of the primary second dose.; accidentally gave booster the first time around; Extra dose administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-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 31-Jan-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around), EXTRA DOSE ADMINISTERED (Extra dose administered) 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 WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around) and EXTRA DOSE ADMINISTERED (Extra dose administered).    Patient was accidentally given booster the first time around. Patient wanted to know what was the time frame to receive primary series. Patient got booster on December 28th. Patient first primary series was given on 03 Jan. Patient received booster before primary series doses. The medical assistant stated patient was given the bivalent booster instead of the primary series. On 31-Jan-2023, patient was given a moderna bivalent booster instead of the primary second dose. He states that the patient has not reported any side effects. No concomitant medication were reported. No treatment medication were reported.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 patients were administered with 1st dose of Moderna COVID-19 Vaccine beyond use date/Patient number 2 received the vaccine on 6Feb2023 but the vaccine expired on 21Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients were administered with 1st dose of Moderna COVID-19 Vaccine beyond use date/Patient number 2 received the vaccine on 6Feb2023 but the vaccine expired on 21Jan2023) and NO ADVERSE EVENT (No adverse event) in a 15-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Ear infection, treated with Amoxicillin.  The patient's past medical history included Ear infection. Previously administered products included for Ear infection: AMOXICILLINE [AMOXICILLIN]; for Product used for unknown indication: PENTACEL and PNEUMOCOCCAL CONJUGATE VACCINE. Past adverse reactions to the above products included No adverse event with AMOXICILLINE [AMOXICILLIN], PENTACEL and PNEUMOCOCCAL CONJUGATE VACCINE.    On 06-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients were administered with 1st dose of Moderna COVID-19 Vaccine beyond use date/Patient number 2 received the vaccine on 6Feb2023 but the vaccine expired on 21Jan2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients were administered with 1st dose of Moderna COVID-19 Vaccine beyond use date/Patient number 2 received the vaccine on 6Feb2023 but the vaccine expired on 21Jan2023) 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 (2 patients were administered with 1st dose of Moderna COVID-19 Vaccine beyond use date/Patient number 2 received the vaccine on 6Feb2023 but the vaccine expired on 21Jan2023).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was reported that patient number 2 did not experienced any AEs after getting the vaccine.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered with 1st dose of Moderna COVID-19 Vaccine beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     The patient's past medical history included Gastroesophageal reflux (treatment Lansoprazole). Previously administered products included for Drug use for unknown indication: influenza tetravalent, Vaxelis and oral rotavirus (oral). Past adverse reactions to the above products included No adverse event with Vaxelis, influenza tetravalent and oral rotavirus.    On 03-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 03-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (administered with 1st dose of Moderna COVID-19 Vaccine beyond use date).    No concomitant medications were reported.  It was reported Caller mentioned patient number 1 did not experienced any AEs after getting the vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708811 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708811:Patient 2
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: :I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (:I'm calling to report that I administered 1 dose of Moderna Covid-19 Vaccine (Monovalent) 2 days beyond manufacturer expiration date.).    No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result Positive; covid test result Positive; This is a spontaneous report from a contactable consumer from product quality group. The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single, as dose 3 (booster), single and as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "arthritis". Concomitant medication included: CYCLOBENZAPRINE. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant) all with onset 18Oct2021, outcome "unknown" and all described as "covid test result positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2021) Positive, Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus, Vertigo
Clinical narrative: Vertigo; Tinnitus; Ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown". The events "vertigo", "tinnitus" and "ear pain" required physician office visit. Therapeutic measures were taken as a result of vertigo, tinnitus, ear pain.  Additional information: Patient did not have Other Conditions and Other Products. When probed for COVID-19 Vaccine LOT number, consumer stated, I did not had that in front of me, I am sorry. When probed for treatment for occurred events, consumer stated, I had been to several doctors but there was no treatment. Actually, I need to go back on that one. I did go and they put me on antibiotics. Date and time of vaccination, consumer stated, 19Dec2022. I did not know. It may be around 1 o'clock. Vaccination facility type, consumer stated, it was at a Pharmacy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blisters on three of his fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10-month-old male patient received BNT162b2 (BNT162B2), on 06Feb2023 as dose 2 (maroon cap), single (Lot number: FX5095) at the age of 10 months, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Date: 28Dec2022, Anatomical Site of injection: In the thigh, unsure which one. , Batch/Lot number: FX5095), administration date: 28Dec2022, when the patient was 9-month-old, for Covid-19 Immunization. The following information was reported: BLISTER (non-serious) with onset 07Feb2023, outcome "not recovered", described as "blisters on three of his fingers". Therapeutic measures were not taken as a result of blister.  Additional information: Vaccine for covid, the second dose, was administered around 9:50am in morning. Indication was Mom is a ball of anxiety when it comes to covid and vaccinated whole family. Onset Time: Around 8am it was noticed, Seriousness criteria was not provided. Reporter later clarified it's on three of his fingers. She knows for sure it's on his index, pinky, but unsure of what the other one is. She just put him down for a nap. AE required visit to: None. AE Outcome: Still ongoing, persisting. Treatment: None, called the doctor this morning to ask if this was a vaccine side effect and they indicated they had not heard of that yet. The doctor of will call back. The event did not require the initiation of new medication/other treatment/ procedure. Vaccine was not administered at Facility. No other conditions. No Investigations.