chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; I had four Pfizer Covid vaccines, and one Moderna Covid booster. On 05Dec, I tested positive for Covid; I had four Pfizer Covid vaccines, and one Moderna Covid booster. On 05Dec, I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Dec2022, outcome "unknown" and all described as "I had four Pfizer Covid vaccines, and one Moderna Covid booster. On 05Dec, I tested positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) Positive. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; I had four Pfizer Covid vaccines, and one Moderna Covid booster. On 05Dec, I tested positive for Covid; I had four Pfizer Covid vaccines, and one Moderna Covid booster. On 05Dec, I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Dec2022, outcome "unknown" and all described as "I had four Pfizer Covid vaccines, and one Moderna Covid booster. On 05Dec, I tested positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) Positive. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Urinary incontinence
Clinical narrative: I have had leakage in urine and like I normally can control it but it seems like it just came out, just ripped out, it was enough that my penis got wet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: URINARY INCONTINENCE (non-serious) with onset 09Dec2022, outcome "unknown", described as "I have had leakage in urine and like I normally can control it but it seems like it just came out, just ripped out, it was enough that my penis got wet".  Additional information: Patient received last COVID shot (clarified as Pfizer COVID-19 Vaccine) on 09Dec2022 (reported as yesterday) and patient really did not have any side effects at all. So far it was only been about 24 hours but one thing patient noticed was, patient took a lot of prescriptions (unspecified medication). So, patient drank a lot of water but it seemed like for the last day patient had not been able to hold urination, it was twice in 24-hour period. Patient had leakage in urine and like patient normally could control it but it seemed like it was, patient did not know how to explain it, it just came out you know, just ripped out. It was not a lot but it was enough that patient's penis got wet. Only twice because patient usually urinated maybe up to 10 times per day. So, patient drank a lot of water with all the medication that patient took. Patient inquired if it was a common thing or was it, of any concern to patient because of the shot. It never happened before. The report was not related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV9, HEP, HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Added information to confirmation number Patient experienced a syncope episode shortly after vaccination. Guardian refused treatment assessment by EMS. Child was given a granola bar to eat and left with her father alert and oriented.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Livedo reticularis, Pruritus, Rash
Clinical narrative: He had an itchy rash on his arms. he says he is itchy all over today. he took 50 mg benadryl last night which helped the itching. he went to sleep shortly after. he has some bright red spots on various parts of his body. it has gotten better this morning but is still itching. pt is breathing normally.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash macular, Rash pruritic
Clinical narrative: He had an itchy rash on his arms. he says he is itchy all over today. he took 50 mg benadryl last night which helped the itching. he went to sleep shortly after. he has some bright red spots on various parts of his body. it has gotten better this morning but is still itching. pt is breathing normally.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: also after its beyond use date; No Adverse Event; HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (also after its beyond use date), WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients) and NO ADVERSE EVENT (No Adverse Event) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (also after its beyond use date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (also after its beyond use date), WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (also after its beyond use date) and WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster - to 2 adult patients).    No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Incorrect route of product administration, Injection site mass
Clinical narrative: VARIVAX was administered via IM route rather than SC route; small lumps; This spontaneous report was received from a nurse and refers to a 29-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, lot #, expiry date, and route of administration were not provided). On 28-NOV-2022, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter/once, valid lot# W011622, expiration date 06-APR-2024, administered intramuscularly (IM) route rather than subcutaneously (SC) route. The reporter stated that patient had small lumps at injection site immediately after injection. No treatment for the event was given to the patient. At the time of reporting, the outcome of the events was not reported.   The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) regarding both events was not applicable.   The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: no adverse event; Caller reported vaccines administered after temperature excursion.; Caller also reported vaccines were administered IM.; This spontaneous report was received from a medical assistant and refers to the patient of unknown age and gender. There was no information about patient's concurrent conditions, concomitant therapies, or medical history provided.  On 28-NOV-2022, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml, lot #U029619, and expiration date: 22-SEP-2023, albumin status has been verified as recombinant human albumin (rHA) (anatomical location was not provided); and dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #W005206, and expiration date: 14-FEB-2024 (anatomical location was not provided); both intramuscularly for prophylaxis (incorrect route of product administration). Administered doses of vaccines have been stored in the temperature of 58.5F for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and 24.3F for varicella virus vaccine live (oka/merck) (VARIVAX) for 3 hours (product storage error). There was no previous temperature excursion reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; The patient was administered an expired dose of PROQUAD; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug reactions/allergies were not reported.  On 05-DEC-2022, the patient was administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection (lot# L032757 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 24-FEB-2017; strength, dose, and route of administration were not provided) for prophylaxis (Expired product administered). No additional adverse events were reported. The outcome of the event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation reaction, Shock
Clinical narrative: Shock to body (hospitalized for 5 days); This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included treprostinil (Tyvaso) (batch number 2102219, expiry date 30th November 2023) for secondary pulmonary arterial hypertension.   Concurrent medical conditions included pulmonary arterial hypertension.   On an unknown date, the patient received Shingrix. On 27th January 2017, the patient started Tyvaso (inhaled) 90 ug 4 times daily (360 ug daily). On 9th October 2022, unknown after receiving Shingrix, the patient experienced shock (serious criteria hospitalization, GSK medically significant and other: serious as per reporter). The action taken with Tyvaso was unknown. On 11th October 2022, the outcome of the shock was recovered/resolved.   The reporter considered the shock to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: The patient received patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) currently delivered by Tyvaso Inhalation Device (TD-300/A), on 27 Jan 2017 for secondary pulmonary arterial hypertension. The current dose was reported as 90 µg (15 breaths), four times a day (QID) (off label use) via inhalation (IH) route. On an unreported date in Oct 2022, the patient was hospitalized due to issue with shingles vaccine causing a shock to his body (immunisation reaction, hospitalized and shock, medically significant, hospitalized) a month ago for 5 days. He said a nurse checks in with him weekly. On 09 Oct 2022, 5 years 8 months and 13 days after initiating Tyvaso, the patient was hospitalized due to issue with shingles vaccine causing a shock to his body. At the time of reporting, the outcome of immunisation reaction was resolved on 11 Oct 2022. Action taken with Tyvaso was not reported for the events of immunisation reaction and shock. At the time of reporting, the outcome of immunisation reaction and shock was unknown. The reporter did not provide causality for the events of immunisation reaction and shock with Tyvaso. The reporter's causality for the events of immunisation reaction with shingles vaccine was considered to be possibly related. The physician assessed the causal relationship between the Tyvaso and the events of immunisation reaction and shock as not related. The company had assessed the serious adverse events of Immunisation reaction and shock as not related to IH treprostinil and TD300/A device. The events were likely related to administration of Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nephrolithiasis, Pain
Clinical narrative: Kidney stones; Shingles on face; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of renal stone in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient's wife had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced renal stone (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the renal stone, shingles and pain were unknown.   It was unknown if the reporter considered the renal stone, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that his wife had shingles and she was insisted him to receive Shingles vaccine. The patient received Shingles vaccine and four days after receiving Shingles vaccine he experienced Shingles on his face and it was very painful but not as painful as his kidney stone. Additional supportive information: Follow-up would not possible as no contact details were available. As the start date for kidney stone was not available conservatively the kidney stone was captured as event.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Muscle swelling
Clinical narrative: Ridge under the injection; Rashes under the injection site; Muscle bulge a little; This case was reported by a consumer and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site induration, injection site rash and muscle swelling. On an unknown date, the outcome of the injection site induration, injection site rash and muscle swelling were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site rash and muscle swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR181753   Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: The reporter stated that the patient had side effects with both shorts of Shingrix. The reporter stated that the patient had muscle bulge a little, creating a ridge under the injection site which lasted for 3 to 4 days The patient developed two small rashes about a half inch under the injection site. One the size of a half dollar or a little larger. The other one is smaller the size of a quarter which lasted for 1 to 2 days. This case is linked with US2022AMR181753 same reporter, same patient second dose.; Sender's Comments:  US-GSK-US2022AMR181753:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Muscle swelling
Clinical narrative: Ridge under the injection site; Rashes under the injection site; Muscle bulge a little; This case was reported by a consumer and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (received 1st dose on an unknown date refer case US2022AMR181742).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site induration, injection site rash and muscle swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site induration, injection site rash and muscle swelling were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site rash and muscle swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR181742   Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: The reporter stated that the patient had side effects with both shorts of Shingrix. The reporter stated that the patient had muscle bulge a little, creating a ridge under the injection site which lasted for 3 to 4 days The patient developed two small rashes about a half inch under the injection site. One the size of a half dollar or a little larger. The other one is smaller the size of a quarter which lasted for 1 to 2 days.; Sender's Comments:  US-GSK-US2022AMR181742:Same reporter
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Engerix B pediatric administered to adult patient; Engerix B pediatric administered to adult patient; This case was reported by a nurse and described the occurrence of accidental underdose in a 21-year-old male patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 24th January 2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 ug. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.       Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: The nurse reported that the patient received pediatric dose Engerix B pediatric by accident. No harm reported. Additional supportive information: As adult patient received the pediatric dose of Engerix B which led to accidental underdose and adult use of a child product. This case has been linked with US2022158132, US2022158095 same reporter different patient.; Sender's Comments:  US-GSK-US2022158132:Same reporter US-GSK-US2022158095:Same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received three doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   On 25th November 2022, the patient received the 3rd dose of Shingrix. On 25th November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-DEC-2022. Reporter's Comment: The pharmacist had reported that the patient had received three doses of Shingrix. The reporter had consented to follow-up. Additional supportive information: The patient had received the 3rd dose of Shingrix vaccine, which had led to extra dose administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-DEC-2022 Reporters comment: The physician reported that a dose of Kinrix with expiration date of 30th September 2022 was given to a patient. The reporter consent to follow-up via email. Additional Supportive information: The patient received expired dose of Kinrix, which led to expired vaccine used.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Trigeminal neuralgia
Clinical narrative: Pain at injection site; Small shingles/ possible shingles; Blister; feels nerve pain on his face; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th December 2022, 6 days after receiving Shingrix, the patient experienced injection site pain, shingles, blister and facial neuralgia. On an unknown date, the outcome of the injection site pain, shingles and facial neuralgia were not recovered/not resolved and the outcome of the blister was unknown.   It was unknown if the reporter considered the injection site pain, shingles, blister and facial neuralgia to be related to Shingrix.     Additional Information: GSK receipt date: 05-DEC-2022 Reporters comment: The pharmacist reporting a possible case of shingles in a patient who received their Shingrix vaccine in the left arm at her pharmacy and experienced pain at the injection site and what appeared to be small shingles like blisters on the left arm that appeared this morning (reporting day) and also feels nerve pain on his face. The patient was also a doctor, he would go to his health care professional for further evaluation. The reporter consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: some of the vaccine went down her arm.; vaccine went down her arm; vaccine went down her arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st December 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's Comments:  The reporter reported that the patient received her Shingrix vaccine in the right arm.  The reporter was injecting the Shingrix vaccine the patient pulled away and some of the vaccine went down her arm.  The reporter was consented to follow up. Additional supportive information: The reporter reported that he injecting the Shingrix vaccine and patient pulled away some of the vaccine went down her arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes simplex test positive
Clinical narrative: blood test : HSV-1 Virus high; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex type i in a 35-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex type i. On an unknown date, the outcome of the herpes simplex type i was unknown.   It was unknown if the reporter considered the herpes simplex type i to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix vaccine and reported recently got a blood test back with the HSV-1 virus high. No further information reported to the agent by the patient. The reporter ended call before any further information could be collected. The reporter did not consent to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Received Pediarix instead of DTaP and IPV; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) 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 December 2022, the patient received the 2nd dose of Pediarix .5 ml and Pediarix Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine 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: Reporter's Comments:  The healthcare professionals (Medical Assistant) stated that a patient inadvertently received Pediarix.  The patient was to receive only DTaP, and IPV.  The adverse event was filed. Additional Supportive Information: The patient inadvertently received Pediarix, which led to wrong vaccine administered.
Age: 83.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose May 2022, 2nd 25Jun2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 83-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 25th June 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 25th June 2022, 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: 05-Dec-2022 The pharmacist called and reported that the patient was administered a second dose of the Havrix vaccine 1 month after receiving the first one. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. This case was 2 of 2. Additional supportive information: The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. This case is linked to the case US2022181960, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181960:Same reporter
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Sep 2022, 2nd 7Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 38-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 7th October 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, 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: 05-Dec-2022 The pharmacist called and reported that the patient was administered a second dose of the Havrix vaccine 1 month after receiving the first one. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. This case is 2 of 2. Additional supportive information: The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. This case is linked to the case US2022181959, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181959:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the adjuvant; Received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA729A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: The reporter was clinical supervisor.  The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine.  The reporter reported not being certain of whether this patient was the one who received only the adjuvant, as they had narrowed it down to two possible patients. The reporter consented to follow up.  Additional Supportive Information: The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022184438:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Completed suicide, Pain
Clinical narrative: COMITTING SUICIDE BECAUSE THEY COULD NOT HANDLE THE PAIN AND SYMPTOMS; ADVERSE EFFECTS; PAIN; This spontaneous report received from a consumer via a company representative via media concerned multiple patients (unspecified) of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry dates were not reported) dose, start therapy dates were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced adverse effects, pain and the patients were comitting suicide because they could not handle the pain and symptoms. The cause of death was suicide. It was unspecified if an autopsy was performed. As per reporter, "I know plenty of people who received your vaccine with the same adverse effects I have. People are committing suicide because they can not handle the pain and symptoms and the manufacturers do nothing to help us".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse effects and pain was not reported.  This report was serious (Death).; Sender's Comments: V0:20221225746- Committing suicide-  Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable; Reported Cause(s) of Death: SUICIDE
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: BLOOD CLOTS; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; WHOLE BODY HURTS AND CANNOT FIND RELIEF; TIRED; WEAK ALL THE TIME; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease (kept under control with exercise and Ibuprofen), and other pre-existing medical conditions included: At the time of report patient was healthy except autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included ibuprofen for autoimmune disease. On an unspecified date since the vaccine, the patient developed blood clots and started blood thinners, patient whole body hurts and cannot find relief, tired, and weak all the time. The patient stated that vaccine destroyed immune system and on an unspecified date, the patient did not had antibodies like science claimed which resulted into suspected immunological vaccine failure. Reporter stated that, "Took one covid vax. I already had an autoimmune disease. Since the vax I have had blood clots so I am on blood thinner, my whole body hurts and cannot find relief. I'm tired and feel weak all the time. I was healthy except for my autoimmune disease, which I kept under control with exercise and Ibuprofen which now you cannot take with my blood thinner. Thank God I only had one. Basically destroyed my immune system. Did not give me antibodies like science claimed" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, whole body hurts and cannot find relief, tired, and weak all the time, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality complaint: 90000262878.; Sender's Comments: V0: 20221225837- blood clots.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. 20221225837-suspected immunological vaccine failure . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; WHOLE BODY HURTS AND CANNOT FIND RELIEF; TIRED; WEAK ALL THE TIME; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease (kept under control with exercise and Ibuprofen), and other pre-existing medical conditions included: At the time of report patient was healthy except autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included ibuprofen for autoimmune disease. On an unspecified date since the vaccine, the patient developed blood clots and started blood thinners, patient whole body hurts and cannot find relief, tired, and weak all the time. The patient stated that vaccine destroyed immune system and on an unspecified date, the patient did not had antibodies like science claimed which resulted into suspected immunological vaccine failure. Reporter stated that, "Took one covid vax. I already had an autoimmune disease. Since the vax I have had blood clots so I am on blood thinner, my whole body hurts and cannot find relief. I'm tired and feel weak all the time. I was healthy except for my autoimmune disease, which I kept under control with exercise and Ibuprofen which now you cannot take with my blood thinner. Thank God I only had one. Basically destroyed my immune system. Did not give me antibodies like science claimed" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, whole body hurts and cannot find relief, tired, and weak all the time, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality complaint: 90000262878.; Sender's Comments: V0: 20221225837- blood clots.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. 20221225837-suspected immunological vaccine failure . The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sudden cardiac death (in 2011), and concurrent conditions included: no alcohol use, non smoker, tachycardia (heart issues), premature ventricular contractions (Pre-ventricular compression (PVCs)), sulpha allergy, and drug allergy (Steroids (Unspecified)), and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient had previously received elasomeran (Moderna covid-19 vaccine) (Dose number in series: 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, dose 1 administered on 27-JAN-2021 for covid-19 prophylaxis.  On an unspecified date following vaccination with elasomeran (Moderna covid-19 vaccine), the patient experienced allergic reaction (Dose number in series: 1). The outcome of allergic reaction was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: Unknown) dose was not reported, 1 total, dose 2 (first booster) administered in left arm on 13-SEP-2021 for covid-19 prophylaxis which was an off label dosing frequency associated with Off label use and revaccination with different covid-19 vaccine (Dose number in series: 2). Age at time of vaccination 74 years old. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series: 3) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: Unknown) dose was not reported, 1 total, dose 3 (second booster) administered in left arm on 19-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second booster of covid-19 vaccine ad26.cov2.s (Dose number in series: 3). This report was non-serious. This case, involving the same patient is linked to 20221227610.
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Cerebral thrombosis
Clinical narrative: BLOOD CLOT IN BRAIN; ANEURYSM; This spontaneous report received from a consumer (patient's husband) via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had issues with blood clots. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 09-APR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 08-NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in brain and had an aneurysm. On 14-MAY-2022, the patient died from blood clot in brain and aneurysm. It was unknown whether autopsy was performed (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is a duplicate of 20221227620.; Sender's Comments: V0: 20221227681- blood clot in brain. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.  20221227681- aneurysm. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT IN BRAIN; ANEURYSM
Sex: U
Vaccine: COVID19
Symptoms: Blood electrolytes decreased, Cerebrovascular accident
Clinical narrative: STROKE; ELECTROLYTES BOTTOMED OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, within the first 3 weeks after vaccination the patient experienced stroke. On an unspecified date, three months later the patient experienced electrolytes bottomed out and three months after that, patient experienced seizure, that almost killed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, and electrolytes bottomed out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221228686-stroke. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.