chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Burning sensation, Chills, Dysgeusia
Clinical narrative: INTERMITTENT BLURRY VISION; SORE THROAT; RUNNY NOSE; LOW GRADE FEVER; FATIGUE; INCREASED BILATERAL TINNITUS; EXCESSIVE WATERING OF EYES; FEELING OF THROAT BEING SWOLLEN; BUE (BILATERAL UPPER EXTREMITY) JOINT PAIN/ BURNING SENSATION (RADIATION INTO ALL FINGER JOINTS); EXTREME CHILLS; SKIN PARESTHESIA; CHRONIC MIGRAINE; VESTIBULAR MIGRAINE; METALLIC TASTE IN MOUTH; TASTE BUDS FEELING BURNED; THICK FEELING TONGUE; PHONOPHOBIA; FACIAL FLUSHING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic vestibular dysfunction, sulfonamide allergy, bactrim allergy, drug allergy (Ajovy, Emgality), and chronic bilateral tinnitus (with hearing loss). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 16-DEC-2022 for covid-19 prophylaxis. Age at time of vaccination 48 years old. No concomitant medications were reported. On 16-DEC-2022, the patient experienced chronic migraine, vestibular migraine, metallic taste in mouth, taste buds feeling burned, thick feeling tongue, phonophobia, facial flushing, excessive watering of eyes, feeling of throat being swollen, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), extreme chills, skin paresthesia, and increased bilateral tinnitus. On 17-DEC-2022, the patient experienced runny nose, intermittent blurry vision, sore throat, low grade fever, and fatigue. On 18-DEC-2022, Laboratory data included: Body temperature 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic migraine, increased bilateral tinnitus, vestibular migraine, metallic taste in mouth, phonophobia, extreme chills, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), intermittent blurry vision, low grade fever, fatigue, and taste buds feeling burned, and the outcome of thick feeling tongue, facial flushing, skin paresthesia, excessive watering of eyes, feeling of throat being swollen, runny nose and sore throat was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing, Lacrimation increased, Migraine, Oropharyngeal pain
Clinical narrative: INTERMITTENT BLURRY VISION; SORE THROAT; RUNNY NOSE; LOW GRADE FEVER; FATIGUE; INCREASED BILATERAL TINNITUS; EXCESSIVE WATERING OF EYES; FEELING OF THROAT BEING SWOLLEN; BUE (BILATERAL UPPER EXTREMITY) JOINT PAIN/ BURNING SENSATION (RADIATION INTO ALL FINGER JOINTS); EXTREME CHILLS; SKIN PARESTHESIA; CHRONIC MIGRAINE; VESTIBULAR MIGRAINE; METALLIC TASTE IN MOUTH; TASTE BUDS FEELING BURNED; THICK FEELING TONGUE; PHONOPHOBIA; FACIAL FLUSHING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic vestibular dysfunction, sulfonamide allergy, bactrim allergy, drug allergy (Ajovy, Emgality), and chronic bilateral tinnitus (with hearing loss). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 16-DEC-2022 for covid-19 prophylaxis. Age at time of vaccination 48 years old. No concomitant medications were reported. On 16-DEC-2022, the patient experienced chronic migraine, vestibular migraine, metallic taste in mouth, taste buds feeling burned, thick feeling tongue, phonophobia, facial flushing, excessive watering of eyes, feeling of throat being swollen, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), extreme chills, skin paresthesia, and increased bilateral tinnitus. On 17-DEC-2022, the patient experienced runny nose, intermittent blurry vision, sore throat, low grade fever, and fatigue. On 18-DEC-2022, Laboratory data included: Body temperature 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic migraine, increased bilateral tinnitus, vestibular migraine, metallic taste in mouth, phonophobia, extreme chills, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), intermittent blurry vision, low grade fever, fatigue, and taste buds feeling burned, and the outcome of thick feeling tongue, facial flushing, skin paresthesia, excessive watering of eyes, feeling of throat being swollen, runny nose and sore throat was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pharyngeal swelling, Phonophobia, Pyrexia, Rhinorrhoea
Clinical narrative: INTERMITTENT BLURRY VISION; SORE THROAT; RUNNY NOSE; LOW GRADE FEVER; FATIGUE; INCREASED BILATERAL TINNITUS; EXCESSIVE WATERING OF EYES; FEELING OF THROAT BEING SWOLLEN; BUE (BILATERAL UPPER EXTREMITY) JOINT PAIN/ BURNING SENSATION (RADIATION INTO ALL FINGER JOINTS); EXTREME CHILLS; SKIN PARESTHESIA; CHRONIC MIGRAINE; VESTIBULAR MIGRAINE; METALLIC TASTE IN MOUTH; TASTE BUDS FEELING BURNED; THICK FEELING TONGUE; PHONOPHOBIA; FACIAL FLUSHING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic vestibular dysfunction, sulfonamide allergy, bactrim allergy, drug allergy (Ajovy, Emgality), and chronic bilateral tinnitus (with hearing loss). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 16-DEC-2022 for covid-19 prophylaxis. Age at time of vaccination 48 years old. No concomitant medications were reported. On 16-DEC-2022, the patient experienced chronic migraine, vestibular migraine, metallic taste in mouth, taste buds feeling burned, thick feeling tongue, phonophobia, facial flushing, excessive watering of eyes, feeling of throat being swollen, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), extreme chills, skin paresthesia, and increased bilateral tinnitus. On 17-DEC-2022, the patient experienced runny nose, intermittent blurry vision, sore throat, low grade fever, and fatigue. On 18-DEC-2022, Laboratory data included: Body temperature 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic migraine, increased bilateral tinnitus, vestibular migraine, metallic taste in mouth, phonophobia, extreme chills, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), intermittent blurry vision, low grade fever, fatigue, and taste buds feeling burned, and the outcome of thick feeling tongue, facial flushing, skin paresthesia, excessive watering of eyes, feeling of throat being swollen, runny nose and sore throat was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tinnitus, Vestibular migraine, Vision blurred
Clinical narrative: INTERMITTENT BLURRY VISION; SORE THROAT; RUNNY NOSE; LOW GRADE FEVER; FATIGUE; INCREASED BILATERAL TINNITUS; EXCESSIVE WATERING OF EYES; FEELING OF THROAT BEING SWOLLEN; BUE (BILATERAL UPPER EXTREMITY) JOINT PAIN/ BURNING SENSATION (RADIATION INTO ALL FINGER JOINTS); EXTREME CHILLS; SKIN PARESTHESIA; CHRONIC MIGRAINE; VESTIBULAR MIGRAINE; METALLIC TASTE IN MOUTH; TASTE BUDS FEELING BURNED; THICK FEELING TONGUE; PHONOPHOBIA; FACIAL FLUSHING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic vestibular dysfunction, sulfonamide allergy, bactrim allergy, drug allergy (Ajovy, Emgality), and chronic bilateral tinnitus (with hearing loss). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 16-DEC-2022 for covid-19 prophylaxis. Age at time of vaccination 48 years old. No concomitant medications were reported. On 16-DEC-2022, the patient experienced chronic migraine, vestibular migraine, metallic taste in mouth, taste buds feeling burned, thick feeling tongue, phonophobia, facial flushing, excessive watering of eyes, feeling of throat being swollen, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), extreme chills, skin paresthesia, and increased bilateral tinnitus. On 17-DEC-2022, the patient experienced runny nose, intermittent blurry vision, sore throat, low grade fever, and fatigue. On 18-DEC-2022, Laboratory data included: Body temperature 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic migraine, increased bilateral tinnitus, vestibular migraine, metallic taste in mouth, phonophobia, extreme chills, bue (bilateral upper extremity) joint pain/ burning sensation (radiation into all finger joints), intermittent blurry vision, low grade fever, fatigue, and taste buds feeling burned, and the outcome of thick feeling tongue, facial flushing, skin paresthesia, excessive watering of eyes, feeling of throat being swollen, runny nose and sore throat was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 9-week-old patient of unspecified age. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 08-NOV-2022 at 13:00, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter oral liquid, 2 milliliter, lot #1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2212USA000038: US-009507513-2211USA004171:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 9-week-old patient of unspecified age. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 08-NOV-2022 at 12:54, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter (ml) oral liquid, 2 ml, lot #1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000032: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2212USA000038: US-009507513-2211USA004171:
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 12-week-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 08-NOV-2022 at 16:14, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter(ml) oral liquid, 2 ml, lot #W004501, expiration date: 20-APR-2023, administered orally for prophylaxis after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000038: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2211USA004171:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 6-month-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 09-NOV-2022 13:02 PM, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter(ml) oral liquid, 2 ml, lot #1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000038: US-009507513-2211USA004171:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 4-month-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 10-NOV-2022 at 11:52 AM, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter(ml) oral liquid, 2 ml, lot #1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2211USA004171:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; "over the age of 15 weeks" received their first dose of ROTATEQ.; This spontaneous report was received from a nurse referring to a 4-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 07-DEC-2022 (over the age of 15 weeks), the patient received the first dose of rotavirus vaccine live, pentavalent (ROTATEQ) (2 ml/once; strength, anatomical location, lot#, and expiration date were not reported) orally for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Vaccination failure
Clinical narrative: Tingly; Sore; Had those shots, still got shingles/Suspected vaccination failure; Got shingles last month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced tingling and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the tingling and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, tingling and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles shots. The patient stated that he/she still experienced shingles in last month. The patient still had tingly and sore. The patient received medications for the treatment. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash really bad (reaction); This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-DEC-2022 Reporter's comments: The case was reported via interactive digital media. The patient got the shot for shingle and she had got a reaction and got the rash really bad. Additional supportive information:  Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced redness and swelling at injection site.  The reporter wanted to know if this was an allergic reaction. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Jan2022, no other dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (On an unknown date in January 2022, received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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:15-Dec-2022. Reporter's Comment: The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix 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 DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   In November 2022, the patient received Boostrix. In November 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comments: The pharmacy Supervisor called to get the expiration date of the Boostrix lot numbers they provided below.  The reporter mentioned a patient was possibly administered an expired Boostrix dose. The reporter mentioned they recorded the Lot in the system but threw away the vial and not sure if the patient was administered an expired vaccine due still investigating.  The reporter provided Lot no 4M2EZ Expiry 2023, 775YF Expiry 2023, XK524 expiry 8th October 2022, 2ZF9N Expiry 2023. Upon expiration dates provided to HCP.  The reporter stated thinks Lot number XK524 expiry date 8th October 2022 was the dose that was administered to the patient back in November 2022.  THe reporter unable to provide any patient details.  THe reporter confirmed dose was not administered at their facility because they were an ambulatory clinic that they provide the drug to inpatient pharmacies.  The reporter in a rush during call as they were still investigating the incident.  The reporter did not consent to follow-up. Additional Supportive Information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vx given at 3 months instead of 6 months; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose 3 months prior to the vaccination).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 15-Dec-2022 Reporter's comment: The reporter reported that if the 2nd dose of Havrix was mistakenly given at 3 months instead of 6 months. The reporter asked that they need to repeat the dose or the customer was still considered fully vaccinated. Lot and expiration date of the vaccine were unknown. Not all information was available. It was unknown if it was the adult or the pediatric formulation.  No patient information was provided.  No additional information was provided.  Reporter's demographics were unknown.  Pharmacy number was unknown. Phone number from pharmacy was unknown. Additional supportive information: The patient received the 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2022, the patient received the 1st dose of Shingrix. In October 2022, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment:  The reporter reported that the patient received Shingrix vaccine. The reporter stated that a week after receiving  Shingrix vaccine the presented an episode of Shingles. The reporter declined the information about vaccine like batch number and expiration date because the vaccine was received at a different pharmacy. The reporter consented to follow up via email.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Overdose
Clinical narrative: Got 2 doses within 24h of birth; This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-day-old female patient who received HBV (Engerix B) (batch number Zp72s, expiry date 15th December 2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 20th December 2022, the patient received the 2nd dose of Engerix B (intramuscular) .5 ml. On 20th December 2022, unknown after receiving Engerix B, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment:  The reporter reported that the infant patient got 2 doses of Engerix B within 24 hours of birth. He didn't report any adverse reaction to these vaccines. Did not consent to follow-up. No follow up to HCP. Additional supportive information: The patient received 2 doses of Engerix B vaccine within 24 hours of birth, which led to overdose.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Rash
Clinical narrative: Stomach pain; Back pain; Rash on stomach and back; This case was reported by a consumer and described the occurrence of stomach pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2022, the patient received the 1st dose of Shingrix. On 7th December 2022, 7 days after receiving Shingrix, the patient experienced stomach pain and back pain. In December 2022, the patient experienced rash. On an unknown date, the outcome of the stomach pain, back pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, back pain and rash to be related to Shingrix.   Additional Information: GSK receipt date: 15-DEC-2022 Reporter's comment: The patient was administered first dose of Shingrix on 30th November 2022 and one week after experienced stomach and back pain also after Eleven days rash on stomach and back from 7th December2022.  The Reporter mentioned seriousness criteria for one week after, stomach and back pain and Eleven days after rash on stomach and back as Intervention required.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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. 023H22A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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 aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 1st of 43 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 57 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:master case
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination date for 2-year-old was 06JUL2022 and 18AUG2022.).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689229:Original case
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 (Expired vaccine used).    No concomitant medicine were reported. Age of the patient was 29 Year 4 Month NDC 80777027310 No treatment medicine were reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Yes that's why I got the damn flu; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an adult and unknown gender patient who had flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the Initial information received on 17-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer.  This case involves Adult and unknown gender patient who had flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine  produced by unknown manufacturer(with unknown formulation, strength, dose, route, lot number , Expiry date and at unknown administration site) for flu (Influenza).  On an unknown date the patient was diagnosed with flu (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data were reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event. patient received a  dose of suspect Influenza vaccine  produced by unknown manufacturer(with unknown formulation, strength, dose, route, lot number , Expiry date and at unknown administration site) for flu (Influenza).  On an unknown date the patient was diagnosed with flu (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data were reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 52f for 1 hour and 37 minutes with no adverse event reported; administered the ipol (opened) after the excursion with no adverse event reported; Initial information received on 20-Dec-2022 regarding an unsolicited valid  non-serious case received  from  a other health professional.  This case is linked to case 2022SA515962.  This case involves temperature excursion in which a 14 years old male patient who experienced 52f for 1 hour and 37 minutes with no adverse event reported and was administered the ipol (opened) after the excursion with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi) hepatitis b vaccine rhbsag (yeast) (engerix) and hepatitis a vaccine inact (havrix), Verivax for Immunization  On 19-Dec-2022, the patient received a (series: N/A) suspect IPV (VERO)(Dose- 0.5mL)(Frequency-Total/once) (Batch/lot number -V1A021M)( Strength = Standard)(Formulation- Suspension for injection) (Expiry date-17-Feb-2024) via intramuscular route in the right deltoid for Immunization.    On an unknown date the patient developed a non-serious events 52f for 1 hour and 37 minutes with no adverse event reported (product storage error), administered the ipol (opened) after the excursion with no adverse event reported (poor quality product administered)  (Latency- Same day) following the administration of IPV (VERO).  It was reported IPOL(opened) was involved in a temperature excursion. She asks if it is safe to use. She adds that 3 different patient's were administered the IPOL (opened) after the excursion. She adds that none of the patient's experienced any additional AE's as a result of this. Products involved? IPOL (opened).  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Influenza
Clinical narrative: I used to have severe childhood asthma - haven't had an attack in 40 years.  Since having the vaccine - I have experienced a lot of 'chestiness' and vastly worse flu on x3 separate occasions than I am used to having.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the booster dose instead of the second dose of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) 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. AS7165B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient is allergic to Benadryl. Patient is taking medication for migraine (rizatriptan). Patient takes Clonazepam 3 times a day for anxiety and Trintellix for depression.;Question:Was there parental vaccine exposure?Answer:No.  Concurrent medical conditions included Migraine (Patient is taking medication for migraine (rizatriptan)), Anxiety (Patient takes Clonazepam 3 times a day for anxiety), Depression (Patient takes Trintellix for depression) and Drug allergy.    On 20-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 20-Dec-2022,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; lot that had been expired was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) 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 (lot that had been expired was administered to patient).    Patient age was reported as 58 Year 10 Month. No concomitant medication was provided. ID number was reported as 80777027399. Treatment medication was not provided by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Past lot that had been expired, administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) 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 (Past lot that had been expired, administered to patient).      ID number was reported as 80777027399.  Concomitant product use was not provided by the reporter.  It was reported that patient were administered Moderna vaccine between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.