chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Skin warm, Tenderness
Clinical narrative: redness and pain at the injection site with redness spreading down the arm; stated it was very sensitive and felt warm to the touch; no treatment has been sought at this time
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: 24 hours post vaccine developed redness around the injection site on right arm. Redness spread throughout the day down right arm towards elbow. Redness still present but stopped migrating 48 hours post injection.
Age: 73.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Injection site erythema
Clinical narrative: patient presented with red area on his left inner upper arm 3 days post vaccine
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error, Pyrexia
Clinical narrative: pt was given the pediatric bivalent vaccine without mixing;  per mom, experiensed  slight fever 5/13,which resolved quickly
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Autism spectrum disorder, Personality change, Staring
Clinical narrative: Within 24 hours of taking this vaccine my child was like a completely different person staring off into space. I reported this to his family doctor at the time. Pt. has since been diagnosed with autism spectrum disorder
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back disorder, Central nervous system lesion, Disability, Eye disorder, Gait inability
Clinical narrative: Left side completely numb. Couldn't walk the next day went to a neurologist full-blown multiple sclerosis,  never had any idea that I was a carrier of M.S. the second I got the shot my body fought the shot not the MS many many lesions back neck brain and eyes on disability now I had to get the vaccine to go back to work and now I can't work because I got the vaccine. Worked 2 jobs before the covid vaccine, 7days a week. Now disability and getting half my salary. All because I couldn't go back to work without that damn vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Left side completely numb. Couldn't walk the next day went to a neurologist full-blown multiple sclerosis,  never had any idea that I was a carrier of M.S. the second I got the shot my body fought the shot not the MS many many lesions back neck brain and eyes on disability now I had to get the vaccine to go back to work and now I can't work because I got the vaccine. Worked 2 jobs before the covid vaccine, 7days a week. Now disability and getting half my salary. All because I couldn't go back to work without that damn vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple sclerosis
Clinical narrative: Left side completely numb. Couldn't walk the next day went to a neurologist full-blown multiple sclerosis,  never had any idea that I was a carrier of M.S. the second I got the shot my body fought the shot not the MS many many lesions back neck brain and eyes on disability now I had to get the vaccine to go back to work and now I can't work because I got the vaccine. Worked 2 jobs before the covid vaccine, 7days a week. Now disability and getting half my salary. All because I couldn't go back to work without that damn vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site induration, Injection site mass, Paraesthesia, Swelling
Clinical narrative: Local induration (hard lump) which occurred while administering. Lump formed to the right of injection site which reduced slowly in size after course of 15 minutes. Pt has not reported any s/sxs since. Also, pt reports of left extremity tingling that hasn't gone away when they left pharmacy and warmth.  Advised to go to ER if swelling doesn't go away and tingling worsens.   Later, reports of HA worsening when they got home.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L arm where both menveo and gardasil were injected became swollen and pink and warm to the touch all the way from the deltoid injection site down to the elbow. Patient was otherwise ok and he was not in any pain.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Temp of 1.5 degrees for 2 days. Home test positive congestion 3-4 days Not low on energy after that Phone visit with physician-prescribed Paxlovid Took Paxlovid 5 days Home test Negative on day 8 4/20/2023
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient did not complain of any adverse reactions. She had come in 5-12-23 requesting her 2nd dose. When rerifying her information, she should have not received the 1st dose. Patient is under 50 y.o. and states that she had no health conditions other than history of shingles.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Fatigue, Hypersomnia, Illness, Immediate post-injection reaction
Clinical narrative: The decedent died on 03/03/2023.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Infant irritability, Pyrexia
Clinical narrative: The decedent died on 03/03/2023.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: The decedent died on 03/03/2023.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Blood glucose, Blood glucose increased, COVID-19, Frequent bowel movements, SARS-CoV-2 test
Clinical narrative: I had my vaccination on 12/10/2022. I started to feel unwell on 04/15/2023 to include symptoms of sneezing and allergies. I woke up on 04/16/2023 with body aches and fatigue. I tested COVID-19 Positive on 04/16/2023. I was prescribed Paxlovid. I still feel unwell on 05/15/2023. I did have COVID-19 on 07/04/2022.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Vaccination failure
Clinical narrative: I had my vaccination on 12/10/2022. I started to feel unwell on 04/15/2023 to include symptoms of sneezing and allergies. I woke up on 04/16/2023 with body aches and fatigue. I tested COVID-19 Positive on 04/16/2023. I was prescribed Paxlovid. I still feel unwell on 05/15/2023. I did have COVID-19 on 07/04/2022.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Fatigue, Hypersensitivity, Malaise, Pain
Clinical narrative: I had my vaccination on 12/10/2022. I started to feel unwell on 04/15/2023 to include symptoms of sneezing and allergies. I woke up on 04/16/2023 with body aches and fatigue. I tested COVID-19 Positive on 04/16/2023. I was prescribed Paxlovid. I still feel unwell on 05/15/2023. I did have COVID-19 on 07/04/2022.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: I had my vaccination on 12/10/2022. I started to feel unwell on 04/15/2023 to include symptoms of sneezing and allergies. I woke up on 04/16/2023 with body aches and fatigue. I tested COVID-19 Positive on 04/16/2023. I was prescribed Paxlovid. I still feel unwell on 05/15/2023. I did have COVID-19 on 07/04/2022.
Age: 61.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Wrong product administered
Clinical narrative: No additional AE; was suppose to receive PREVNAR 20, but instead was accidently administered GARDASIL 9; 61 Years Old; This spontaneous report was received from a nurse and referred to a 61-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 19-APR-2023, the patient was supposed to receive pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), but was accidently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Wrong product administered, Product administered to patient of inappropriate age). No additional adverse event.
Age: 61.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; was suppose to receive PREVNAR 20, but instead was accidently administered GARDASIL 9; 61 Years Old; This spontaneous report was received from a nurse and referred to a 61-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 19-APR-2023, the patient was supposed to receive pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), but was accidently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Wrong product administered, Product administered to patient of inappropriate age). No additional adverse event.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never had 2nd dose; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was received about a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never had 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter had stated that he/she had the first shot a year ago and did not had the second shot. He/She had asked that, what were the option for him/her. The reporter had consented to follow-up. Until the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Improperly stored vaccine was administered to patient; This spontaneous report was received from a medical assistant and refers to a 15-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered intramuscularly in right thigh for prophylaxis,lot #W018828, expiration date: 14-JUN-2024 (lot #W018828 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) [VARIVAX]). Administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) had undergone temperature excursion on 05-DEC-2022 (product storage error). There were no adverse events reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007822:Original Case : 2303USA002114 US-009507513-2304USA007836: US-009507513-2304USA007843: US-009507513-2304USA007931:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Improperly stored vaccine was administered to patient; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported  On 08-FEB-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, administered intramuscularly in right thigh for prophylaxis, lot #W019627, expiration date: 19-DEC-2023 (lot #W019627 has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live recombinant human albumin [rHA] [PROQUAD]). Administered vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) had undergone temperature excursion on 20-JAN-2023 (product storage error). There were no adverse events reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007843: US-009507513-2304USA007837: US-009507513-2304USA007931:
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Varivax administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 13-month-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reaction or allergies was reported.  On 09-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # W006412 was confirmed to be valid, expiration date 23-FEB-2023, intramuscularly in the right thigh for prophylaxis. On 20-JAN-2023, the administered dose had temperature excursion range of -14 degree Celsius to -10 degree Celsius for 1 hour (product storage error). The call was because of a digital data logger. No additional adverse event reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; proquad administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reaction or allergies was reported.  On 09-FEB-2023, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHa)(PROQUAD) lot # W019627 was confirmed to be valid, expiration date 19-DEC-2023, intramuscularly in the right thigh for prophylaxis. On 20-JAN-2023, the administered dose had temperature excursion range of -14 degree Celsius to -10 degree Celsius for 1 hour (product storage error). The call was because of a digital data logger. No additional adverse event reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2304USA007686: US-009507513-2304USA007723: US-009507513-2304USA007759: US-009507513-2304USA007810: US-009507513-2304USA007844: US-009507513-2304USA007812: US-009507513-2304USA007860: US-009507513-2304USA007857: US-009507513-2304USA007848: US-009507513-2304USA007866: US-009507513-2304USA007836: US-009507513-2304USA007822: US-009507513-2303USA002114:Original Case US-009507513-2304USA007866:
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 09-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The vaccine administration facility was the same as primary reporter. VAERS details were reported for 1st dose. The reporter consented to follow up. Till the time for reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 11 out of 18.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: F
Vaccine: MEN
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Possible administration of a menomune dose past the expiration date with no reported adverse event; Initial information received on 09-May-2023 (with live follow up received on 10-May-2023) regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age female patient who had possible administration of a Meningococcal A-C-Y-W135 vaccine [Menomune] dose past the expiration date with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 2021, the patient had possible administration of a Meningococcal A-C-Y-W135 vaccine Powder and solvent for solution for injection (lot number, expiry date, strength, dosage- not reported) via unknown route in unknown administration site for Prophylactic Vaccination, past the expiration date with no reported adverse event (expired product administered) (latency- same day)   Reportedly, Physician stated that in 2021 a student received the Menomune vaccine, a meningococcal vaccine, that was discontinued in 2017. The physician stated that he needed to know whether this was acceptable or not or if student needs to sign a waver, or go get another vaccine. He has no record of the lot number or expiration date of the product that was administered. His question is whether it is at all possible that vaccine was in-date when administered in 2021? In other words, was the shelf-life such that if Menomune was received as late as 2017, that it could have been in-date during 2021?  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event    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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered ACTHIB reconstituted with 0.9% NaCl instead of the 0.4% NaCl that was originally provided with the vaccine with no reported adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who had administered acthib reconstituted with 0.9% nacl instead of the 0.4% nacl that was originally provided with the vaccine with no reported adverse event after receiving vaccine hib (prp/t) vaccine [act-hib].  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 HIB (PRP/T) vaccine Powder and solvent for solution for injection, unknown strength, dose, expiration date and lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) .  On an unknown date the patient developed a non-serious administered acthib reconstituted with 0.9% nacl instead of the 0.4% nacl that was originally provided with the vaccine with no reported adverse event (product preparation error) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event administered acthib reconstituted with 0.9% nacl instead of the 0.4% nacl that was originally provided with the vaccine with no reported adverse event.  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: 25.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: She received her first dose on 04May2023 and the second today( with no reported adverse event); Initial information received on 10-May-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 25 years old female patient and she received her rabies (HDC) vaccine [Imovax Rabies] first dose on 04may2023 and the second today ( with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-May-2023, the patient received a dose of suspect Rabies (HDC) Vaccine Powder and solvent for suspension for injection strength, dose: not reported lot V1D643M expiry date: 06-sep-2024 via unknown route in unknown administration site for On 10-May-2023 she also received a dose of the same vaccine for Post exposure dose (immunization).  On an unknown date the patient developed a non-serious she received her first dose on 04may2023 and the second today ( with no reported adverse event) (inappropriate schedule of product administration) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported "She received her first dose on 04May2023 and the second today. He would like to know what's the best course of action to space dose 3 and 4".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event she received her first dose on 04may2023 and the second today( with no reported adverse event).   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 11.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 26-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 25-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 10 Out of 18(12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 18 Out of 18(12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65) and NO ADVERSE EVENT (No Adverse event). At the time of the report, UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65) was resolving 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 UNDERDOSE (Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose/that all patients are over the age of 65).    No information about previous COVID-19 vaccination doses. Approximately 30 patients received a 0.25ml booster dose of the bivalent Moderna Covid-19 vaccine instead of the 0.5ml booster dose. All patients are over the age of 65. Concomitant medication not reported.  Treatment medication not reported.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Positron emission tomogram
Clinical narrative: Elevated blood pressure; Granulomas on elbow, chest, abdomen, confirmed as benign; This non-serious case was reported by a consumer via call center representative and described the occurrence of granuloma in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE BOOSTER) for prophylaxis.   The patient's past medical history included mastectomy (prior double mastectomy).   On 22-JUN-2022, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, the patient received Flu vaccine (right arm) and COVID 19 VACCINE BOOSTER (right arm). In JUL-2022, between 1 and 3 weeks after receiving Shingrix, an unknown time after receiving Flu vaccine and an unknown time after starting Cortison, the patient experienced granuloma (Verbatim: Granulomas on elbow, chest, abdomen, confirmed as benign). In JAN-2023, the patient experienced increased blood pressure (Verbatim: Elevated blood pressure). The patient was treated with cortisone (non-proprietary) (Cortison) and antifungals for topical use (Antifungal Cream). The outcome of the granuloma was not resolved and the outcome of the increased blood pressure was resolved.   It was unknown if the reporter considered the granuloma and increased blood pressure to be related to Shingrix and Flu vaccine.     It was unknown if the company considered the granuloma and increased blood pressure to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2023 The patient self-reported this case. The patient received flu vaccine and COVID booster around the time she received 2nd dose of Shingrix and stated that granuloma appeared just above the point of the right elbow around the beginning of July of 2022.  The granuloma got progressively bigger, as time passed.  The patient used fungal cream and cortisone on the spot, thought it was from a bug bite.  The patient saw dermatologist at the end of November/beginning of December of 2022, who diagnosed spot on elbow as a granuloma.  The dermatologist believed the granuloma was related to diabetes, but patient reported not being diagnosed with diabetes.  The patient reported experiencing elevated blood pressure in January of 2023, which resulted in pulmonologist ordering echocardiography and pet scan.  The patient reported granulomas in the chest and abdomen were discovered via the Pet scan.  The patient reported being referred to Oncologist, for biopsies of granulomas.  The patient reported granulomas were confirmed as benign.  The patient reported granulomas were simply present and did not bother them in any way.  The patient reported being uncertain of whether granulomas were related to receipt of Shingrix vaccine, but alleged they saw materials stating granulomas might be caused by vaccines. It was unknown if the company considered the granuloma and increased blood pressure to be related to COVID-19 VACCINE .  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: patient received an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 05-MAY-2023, the patient received Shingrix. On 05-MAY-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: patient received an incomplete dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 05-MAY-2023 The reporter reported that a patient received an incomplete dose due to vaccine leaking three drops from the syringe needle.  This was not a PQC due to GSK not manufacturing the syringe. The reporter stated that 0.45 ml may have been administered but was not sure.  The reporter did not consent to follow-up. The patient received an incomplete dose due to vaccine leaking three drops from the syringe needle, which led to Incomplete dose administered.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FEEL LIKE SHE WAS OUT IN OUTER SPACE/FEELING AWFUL; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a female patient of an unspecified age, race, and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported,1 total was administered on an unspecified date in 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on 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 in 2023, the patient experienced covid-19 infection and started treatment with Non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (tablet, route of admin, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for covid-19. On an unspecified date in 2023, after completing Paxlovid treatment the patient experienced different symptoms to that of she experienced for the first time and was back down again after being tested positive (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (Dose number in series 2). The patient hated Paxlovid as it was awful and was very intense and she also felt like she was out in outer space (Dose number in series 2) and few days later she felt like it had finally left her system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient recovered from feel like she was out in outer space/feeling awful, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230530647-Confirmed clinical vaccine failure. The event has a compatible/suggestive 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: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Unable to Sleep-Mild, Additional Details: patient has pacemaker.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Insomnia, Lethargy
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Unable to Sleep-Mild, Additional Details: patient has pacemaker.