chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dermatitis allergic, Injection site bruising, Injection site pain, Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Joint Pain-Mild
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Taste disorder
Clinical narrative: Systemic: Food tastes differant ( changes in food tasting)-Medium
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Taste disorder
Clinical narrative: Systemic: patient got all 3 vaccines at the same time( changes if food tastes)-Medium, Other Vaccines:  VaccineTypeBrand: abrysvo; Manufacturer: pfizer; LotNumber: HM9865; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: pneumovax 23; Manufacturer: merck; LotNumber: X027348; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Chest pain, Confusional state, Dizziness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Pt was given flu shot first, then after shingrix, she started feeling 'funny' and breathing heavily.  She said she couldn't breathe and couldn't hold her head up.   It wasn't an allergic reaction.  She remained awake, barely, and was able to communicate with paramedics and was taken to hospital.   , Other Vaccines:  VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: ut8419aa; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 08/23/2024
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Lethargy, Paraesthesia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Pt was given flu shot first, then after shingrix, she started feeling 'funny' and breathing heavily.  She said she couldn't breathe and couldn't hold her head up.   It wasn't an allergic reaction.  She remained awake, barely, and was able to communicate with paramedics and was taken to hospital.   , Other Vaccines:  VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: ut8419aa; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 08/23/2024
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Pt was given flu shot first, then after shingrix, she started feeling 'funny' and breathing heavily.  She said she couldn't breathe and couldn't hold her head up.   It wasn't an allergic reaction.  She remained awake, barely, and was able to communicate with paramedics and was taken to hospital.   , Other Vaccines:  VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: ut8419aa; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 08/23/2024
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: bruising-Medium, Additional Details: a large bruise at the injection site. but patient said she bruises easily. I do not think it is due to incorrect administration., Other Vaccines:  VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: ut8419ba; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
Age: 9.0
Sex: F
Vaccine: HPV4, HEPA
Symptoms: Abdominal pain, Arthralgia, Autoimmune thyroiditis, Brain fog, Disturbance in attention
Clinical narrative: Vaqta administered on 16-MAR-2011 and 14-NOV-2012; This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2011 (at the age of 10-year-old), the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection. Subsequently, on 14-NOV-2012, she received the second dose of the vaccine (inappropriate schedule of product administration). Both doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 3 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097: US-009507513-2408USA008002:
Age: 9.0
Sex: F
Vaccine: HPV4, HEPA
Symptoms: Dizziness, Fatigue, Gastrointestinal disorder, Headache, Hypophosphataemia
Clinical narrative: Vaqta administered on 16-MAR-2011 and 14-NOV-2012; This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2011 (at the age of 10-year-old), the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection. Subsequently, on 14-NOV-2012, she received the second dose of the vaccine (inappropriate schedule of product administration). Both doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 3 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097: US-009507513-2408USA008002:
Age: 9.0
Sex: F
Vaccine: HPV4, HEPA
Symptoms: Hypothyroidism, Inappropriate schedule of product administration, Inborn error of bilirubin metabolism, Irritable bowel syndrome, Memory impairment
Clinical narrative: Vaqta administered on 16-MAR-2011 and 14-NOV-2012; This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2011 (at the age of 10-year-old), the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection. Subsequently, on 14-NOV-2012, she received the second dose of the vaccine (inappropriate schedule of product administration). Both doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 3 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097: US-009507513-2408USA008002:
Age: 9.0
Sex: F
Vaccine: HPV4, HEPA
Symptoms: Menstruation irregular, Osteopenia, Palpitations, Postural orthostatic tachycardia syndrome, Terminal ileitis
Clinical narrative: Vaqta administered on 16-MAR-2011 and 14-NOV-2012; This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2011 (at the age of 10-year-old), the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection. Subsequently, on 14-NOV-2012, she received the second dose of the vaccine (inappropriate schedule of product administration). Both doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 3 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097: US-009507513-2408USA008002:
Age: 9.0
Sex: F
Vaccine: HPV4, HEPA
Symptoms: Weight decreased
Clinical narrative: Vaqta administered on 16-MAR-2011 and 14-NOV-2012; This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2011 (at the age of 10-year-old), the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection. Subsequently, on 14-NOV-2012, she received the second dose of the vaccine (inappropriate schedule of product administration). Both doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 3 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097: US-009507513-2408USA008002:
Age: 9.0
Sex: F
Vaccine: HPV4, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaqta administered on 16-MAR-2011 and 14-NOV-2012; This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2407USA010097), concerning a currently 23-year-old female patient.  The patient's medical history, her concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2011 (at the age of 10-year-old), the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection. Subsequently, on 14-NOV-2012, she received the second dose of the vaccine (inappropriate schedule of product administration). Both doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).  This is one of the 3 cases received from the same reporter.; Sender's Comments:  US-009507513-2407USA010097: US-009507513-2408USA008002:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report an expired VARIVAX dose was administered to a patient.; This spontaneous report was received from a nurse practitioner referring to a 2-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 15-AUG-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis (lot #W024332, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 01-AUG-2024 [Expired product administered]; strength, and route of administration were not provided); sterile diluent (MK-9395) 0.5 milliliter (lot # W036676, has been verified to be a valid lot number, expiration date reported as 19-JUL-2026, but upon internal validation established as 19-JUL-2025) was also administered as medication dilution. No symptoms reported. There was no additional adverse event (AE) or product quality complaint (PQC).
Age: 6.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient has not experienced any additional AEs so far; a 6-year-old female patient who received her first dose of PROQUAD on 7/19/2023, received her second dose of PROQUAD on 7/25/2024, and received a dose of VARIVAX today, 8/16/2024.; This spontaneous report was received from a medical assistant referring to a 6-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-JUL-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose (lot #Y008787, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 30-OCT-2025) administered for prophylaxis (strength, exact dose, and route of administration were not provided). On 25-JUL-2024, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose (lot #Y008787, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 30-OCT-2025) administered for prophylaxis (strength, exact dose and route of administration were not provided). On 16-AUG-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose (lot #Y004554, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 20-FEB-2026) administered for prophylaxis (strength, exact dose and route of administration were not provided) (Inappropriate schedule of product administration). The patient had not experienced any additional adverse events (AEs) so far (No adverse event). No product quality complaint (PQC) or additional AE was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported PROQUAD was administered after a temperature excursion to one patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 16-AUG-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, once, administered for prophylaxis (lot #Y008786, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 30-OCT-2025; strength, exact dose, and route of administration were not provided). It was reported that the vaccine underwent a temperature excursion which was 7.9 degrees Fahrenheit (F) for 7 hours 25 minutes (product storage error). No previous temperature excursion was reported. There was no additional adverse event (AE) or product quality complaint (PQC) reported.; Sender's Comments:  US-009507513-2408USA006567:
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: extra dose administered inadverten; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-year-old female patient who received HAV (Havrix) (batch number BM4R5, expiry date 24-APR-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 16-AUG-2024, the patient received Havrix. On 16-AUG-2024, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: extra dose administered inadverten). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-AUG-2024 Medical Assistant  called to ask about safety/medical advise regarding an extra dose administered inadvertently to a female patient today (third dose), which led to extra dose administered. A second dose was administered 4 weeks ago The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: gave a Bexsero, back in February, and when she needed the 2nd dose, instead of coming back to us, she went to another pharmacy, and they gave the Trumenba instead of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number A2JX7, expiry date 31-OCT-2026) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On 01-FEB-2024, the patient received the 1st dose of Bexsero. On an unknown date, the patient received Trumenba. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: gave a Bexsero, back in February, and when she needed the 2nd dose, instead of coming back to us, she went to another pharmacy, and they gave the Trumenba instead of Bexsero). The outcome of the interchange of vaccine products 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: 16-AUG-2024 The reporter had an 18 year old patient that we gave a Bexsero, back in February, and when she needed the 2nd dose, instead of coming back to us, she went to another pharmacy, and they gave the Trumenba instead of Bexsero, which led to interchange of vaccine products. The reporter asked should they give her another Bexsero or she should go ahead and continue with the Trumenba series. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9, MEN, MENB
Symptoms: Skin induration, Skin mass
Clinical narrative: Product origin unknown; she has 2 hard lumps under her skin; This spontaneous report was received from the patient's mother and refers to a 12-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JUL-2024 (reported as 5 days ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, reported as HPV vaccine (dose, strength, lot #, expiry date, and route of administration were not provided) for prophylaxis, and also with meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) with (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided) and meningococcal vaccine a/c/y/w (MENINGOCOCCAL VACCINE A/C/Y/W) (dose, strength, formulation, lot #, expiry date, route of administration, and indication were not provided), the last two were administered in the same arm.  On an unknown date in July 2024, the patient had 2 hard lumps under her skin (Skin mass), one of them was not so hard. At the time of reporting, the patient had not recovered from the event of Skin mass.  The action taken with all suspect vaccines was not applicable.   The causal relationship between the event Skin mass and all suspect vaccines was unknown.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: No adverse event, Product administration error
Clinical narrative: Pt mistakenly received a Hib dose when none was required. No symptoms present.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Impaired work ability, Malaise
Clinical narrative: Fever, body aches, fatigue, malaise, body chills and sweats. Off work to rest x 2 days and returned to work.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches, fatigue, malaise, body chills and sweats. Off work to rest x 2 days and returned to work.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Impaired work ability, Malaise
Clinical narrative: Fever, body aches, malaise, fatigue, body sweats and chills.  Recovered after 2 days resting off work.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches, malaise, fatigue, body sweats and chills.  Recovered after 2 days resting off work.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Fatigue and body aches, pain at injection site. Able to work next day.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose today on August 16th 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 16-AUG-2024, the patient received the 2nd dose of Twinrix. On 16-AUG-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose today on August 16th 2024). The outcome of the drug dose administration interval too long 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: 16-AUG-2024 The pharmacist explained that a patient received first dose of Twinrix and a late second dose today (on the reporting day) The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Adminsitered meningicoccal vaccine to patient and it was not ordered by provider and it was not needed as patient had already had vaccine 1 year prior.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity, Product administered at inappropriate site, Weight bearing difficulty
Clinical narrative: Woke up with painful left arm; difficult to raise arim, bear weight, activities of daily living. Waited about two months thinking the symptoms would go away. On 03/12/2024 I saw Dr. for evaluation. He took an X-Ray and said that the vaccine had been put into the bursa and not the left deltoid. He gave me a cortisone shot and said I should get better in about six months. After numerous physical therapy visits, I saw Dr on 07/24/2024 for another evaluation. He also gave me a cortisone shot. i am not any better yet. So I decided to report this condition.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: X-ray abnormal
Clinical narrative: Woke up with painful left arm; difficult to raise arim, bear weight, activities of daily living. Waited about two months thinking the symptoms would go away. On 03/12/2024 I saw Dr. for evaluation. He took an X-Ray and said that the vaccine had been put into the bursa and not the left deltoid. He gave me a cortisone shot and said I should get better in about six months. After numerous physical therapy visits, I saw Dr on 07/24/2024 for another evaluation. He also gave me a cortisone shot. i am not any better yet. So I decided to report this condition.
Age: 1.0
Sex: M
Vaccine: MEN, MMR, PNC13
Symptoms: Enterovirus test positive, Erythema multiforme, Morbillivirus test positive, Neutropenia, Rhinovirus infection
Clinical narrative: Erythema multiforme; Enterovirus test positive; Morbillivirus test positive; Rhinovirus infection; Thrombocytopenia; Neutropenia; Information was obtained on a request by regulatory authority (AU-TGA-0000784158) via Public Case Detail on 19-AUG-2024.   This spontaneous case was reported by a consumer, and refers to 1-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. It was reported that the patient had not previous vaccine reactions.  On 22-FEB-2024, the patient was vaccinated with a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, dose, dose#,  ot #, expiry date, route of administration, anatomical site of vaccination and indication were not provided); with a meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX), (strength, dose, dose#, lot #, expiry date, route of administration, anatomical site of vaccination and indication were not provided); ; and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), (strength, dose, dose#,  lot #, expiry date, route of administration, anatomical site of vaccination and indication were not provided).   On 01-MAR-2024, the patient experienced erythema multiforme, neutropenia and thrombocytopenia. On an unknown date in 2024, due to the event of erythema multiforme he was admitted to the hospital. Management of the events of neutropenia and thrombocytopenia was reported as: self. On an unknown date, the patient experienced the events of Enterovirus test positive, Morbillivirus test positive and Rhinovirus infection. On an unknown date in 2024, he was testing for other Erythema multiforme (reported as: EM) causes: Herpex simplex virus (HSV), and mycoplasma etc) tests were negative, "Resp" multiplex polymerase chain reaction enterovirus (reported as enetro) test was positive, "Resp" multiplex polymerase chain reaction Rhinovirus (reported as rhino) test was positive, and nasal swab for measles virus (vaccine strain) (PCR) test was positive. At the time of reporting, the outcome of all the events was unknown (conflicting information, also reported as: outcome was unknown but ongoing). Further details as provided: would have ongoing outpatient gen paeds follow-up with blood monitoring.   The Agency considered all the events to be related to the suspect vaccines (reported as possible related).  Upon internal review the events of neutropenia, thrombocytopenia, and Erythema multiforme were determined to be medically significant.
Age: 1.0
Sex: M
Vaccine: MEN, MMR, PNC13
Symptoms: Thrombocytopenia
Clinical narrative: Erythema multiforme; Enterovirus test positive; Morbillivirus test positive; Rhinovirus infection; Thrombocytopenia; Neutropenia; Information was obtained on a request by regulatory authority (AU-TGA-0000784158) via Public Case Detail on 19-AUG-2024.   This spontaneous case was reported by a consumer, and refers to 1-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. It was reported that the patient had not previous vaccine reactions.  On 22-FEB-2024, the patient was vaccinated with a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, dose, dose#,  ot #, expiry date, route of administration, anatomical site of vaccination and indication were not provided); with a meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX), (strength, dose, dose#, lot #, expiry date, route of administration, anatomical site of vaccination and indication were not provided); ; and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), (strength, dose, dose#,  lot #, expiry date, route of administration, anatomical site of vaccination and indication were not provided).   On 01-MAR-2024, the patient experienced erythema multiforme, neutropenia and thrombocytopenia. On an unknown date in 2024, due to the event of erythema multiforme he was admitted to the hospital. Management of the events of neutropenia and thrombocytopenia was reported as: self. On an unknown date, the patient experienced the events of Enterovirus test positive, Morbillivirus test positive and Rhinovirus infection. On an unknown date in 2024, he was testing for other Erythema multiforme (reported as: EM) causes: Herpex simplex virus (HSV), and mycoplasma etc) tests were negative, "Resp" multiplex polymerase chain reaction enterovirus (reported as enetro) test was positive, "Resp" multiplex polymerase chain reaction Rhinovirus (reported as rhino) test was positive, and nasal swab for measles virus (vaccine strain) (PCR) test was positive. At the time of reporting, the outcome of all the events was unknown (conflicting information, also reported as: outcome was unknown but ongoing). Further details as provided: would have ongoing outpatient gen paeds follow-up with blood monitoring.   The Agency considered all the events to be related to the suspect vaccines (reported as possible related).  Upon internal review the events of neutropenia, thrombocytopenia, and Erythema multiforme were determined to be medically significant.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Arthralgia, Decreased appetite, Head discomfort, Headache, Nausea
Clinical narrative: She got her vaccines, and that day wasn't bad.  The next morning she woke up with an intense headache, and neck and shoulder pain on the entire neck.  Today is the first day that she feels a little bit better.  For sevearl days she did not have any appetite, she was nauseated, her head felt that there was a vice grip on her head squeezing both of her temples.  She did not call her doctor.  She has a neck wrap that she can heat and used ice on her back and shoulders.  She took Ibuprofen for her headache as well, and it is slowly getting better.  The neck and shoulders today are better, not having the pain.  She can still feel the headache, but it is not as intense as it was.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Neck pain
Clinical narrative: She got her vaccines, and that day wasn't bad.  The next morning she woke up with an intense headache, and neck and shoulder pain on the entire neck.  Today is the first day that she feels a little bit better.  For sevearl days she did not have any appetite, she was nauseated, her head felt that there was a vice grip on her head squeezing both of her temples.  She did not call her doctor.  She has a neck wrap that she can heat and used ice on her back and shoulders.  She took Ibuprofen for her headache as well, and it is slowly getting better.  The neck and shoulders today are better, not having the pain.  She can still feel the headache, but it is not as intense as it was.
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was given first dose of Rotateq after maximum first dose age of 14 weeks, 6 days. Child was 32 weeks when vaccine was given. No adverse outcome to date. No signs/symptoms reported.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site nodule
Clinical narrative: 1.5cm nodule present on left  upper arm where vaccines were administered.  Both doses were given very close together.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue, Tendon pain, Ultrasound biliary tract
Clinical narrative: Patient complains of severe fatigue and tendon pain 24 hours after injection. Lasted at the severe level for 48 hours. It lingered and has not completely gone away. Patient had a grilled cheese sandwich from a convenient store 18 days after her injection and 1.5 hours after eating her sandwich she experienced severe abdominal pain that put her in the ER. The ER did not find anything wrong definitively with her gallbladder, but did not rule it out. She feels like this is a side effect from the Shingrix vaccine that is lingering and her cecum muscle didn't contract properly due to the muscle fatigue and tendon pain due to the shingle vaccine.
Age: 8.0
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Medical Assistant, administered wrong vaccine to patient.
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: DUPLICATE FLU SHOT ADMINISTERED - NO ILL EFFECTS / ADVERSE EFFECTS REPORTED
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Started with a fever, pain in arm felt like bee stings in arm. Sore to the touch.
Age: 1.25
Sex: F
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PCV20  was accidentally given instead of Dtap
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Antiphospholipid antibodies positive, Computerised tomogram thorax, Echocardiogram, Electrocardiogram
Clinical narrative: MODERNA #1 3/9/2021 MODERNA #2 4/9/2021 DEVELOPED VACCINE INDUCED LUPUS ANTICOAGULANT IN 2022 AND PE RLL 2023 REQUIRING WARFARIN.  ADDITIONAL DIAGNOSIS OF COVID VACCINE SUBCLINICAL PERICARDITIS.  TREATMENT WAFARIN, HCQ, COLCHICINE, PROTOCOL
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pericarditis, Pulmonary embolism
Clinical narrative: MODERNA #1 3/9/2021 MODERNA #2 4/9/2021 DEVELOPED VACCINE INDUCED LUPUS ANTICOAGULANT IN 2022 AND PE RLL 2023 REQUIRING WARFARIN.  ADDITIONAL DIAGNOSIS OF COVID VACCINE SUBCLINICAL PERICARDITIS.  TREATMENT WAFARIN, HCQ, COLCHICINE, PROTOCOL
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient described severe aching in his left deltoid, radiating to his back to scapula and neck since about 24 hours after vaccine was given.
Age: 61.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Erythema, Rash, Rash pruritic, Skin warm
Clinical narrative: Developed rash on arms and legs 6 days after receiving vaccine. Rash is "itchy", no fever reported, her cheeks are red in appearance and "hot".
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 breakthrough Infection
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was inadvertently administered an expired vaccine. Physician, manufacturer and pt aware. No adverse side effects.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Arterial occlusive disease, Computerised tomogram abnormal, Dizziness, Hypertension, Hypoaesthesia
Clinical narrative: She got her vaccine, she started being dizzy and her eyes for some reason were not focusing right.  They were very tight and terrible.  Her left arm started getting heavy to the point that she could not lift it up and then her fingers went numb.  She then had a similar reaction again.  She was still very dizzy and having problems.  She felt that her head was going to bust open, she went to the doctor and went to the medical facility and her BP was very high 212/99 and they rushed her in the hospital.  She has been in the hospital since then last Friday and then she went to rehab which she did not like.  She was there for 2 weeks.  She was at Hospital and then to rehab  and came home on Friday 8/23/24 from there.  The rehab center is on the same grounds as the Hospital.  They did a CT scan and an MRI scan and found that she had a blocked artery and did a procedure.  She was fine before the vaccine, and eats very sensible.  She is still dizzy after the surgery and the rehab.  She is now on medications, and has to go back to medical facility and had to go and have her BP medicine lowered due to the reaction.  She had no problems with her BP prior to the vaccine.  The medicine is an on and off reaction, she is still not able to drive her car or do any shopping due to the dizziness.   She was walking up to 3 miles a day prior to the vaccine, very active, never sick, and now she's unable to do any of that.  She was walking around the rehab center to keep active.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Injected limb mobility decreased, Limb discomfort, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal
Clinical narrative: She got her vaccine, she started being dizzy and her eyes for some reason were not focusing right.  They were very tight and terrible.  Her left arm started getting heavy to the point that she could not lift it up and then her fingers went numb.  She then had a similar reaction again.  She was still very dizzy and having problems.  She felt that her head was going to bust open, she went to the doctor and went to the medical facility and her BP was very high 212/99 and they rushed her in the hospital.  She has been in the hospital since then last Friday and then she went to rehab which she did not like.  She was there for 2 weeks.  She was at Hospital and then to rehab  and came home on Friday 8/23/24 from there.  The rehab center is on the same grounds as the Hospital.  They did a CT scan and an MRI scan and found that she had a blocked artery and did a procedure.  She was fine before the vaccine, and eats very sensible.  She is still dizzy after the surgery and the rehab.  She is now on medications, and has to go back to medical facility and had to go and have her BP medicine lowered due to the reaction.  She had no problems with her BP prior to the vaccine.  The medicine is an on and off reaction, she is still not able to drive her car or do any shopping due to the dizziness.   She was walking up to 3 miles a day prior to the vaccine, very active, never sick, and now she's unable to do any of that.  She was walking around the rehab center to keep active.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Medical procedure, Ocular discomfort, Sensory disturbance, Therapy change, Vision blurred
Clinical narrative: She got her vaccine, she started being dizzy and her eyes for some reason were not focusing right.  They were very tight and terrible.  Her left arm started getting heavy to the point that she could not lift it up and then her fingers went numb.  She then had a similar reaction again.  She was still very dizzy and having problems.  She felt that her head was going to bust open, she went to the doctor and went to the medical facility and her BP was very high 212/99 and they rushed her in the hospital.  She has been in the hospital since then last Friday and then she went to rehab which she did not like.  She was there for 2 weeks.  She was at Hospital and then to rehab  and came home on Friday 8/23/24 from there.  The rehab center is on the same grounds as the Hospital.  They did a CT scan and an MRI scan and found that she had a blocked artery and did a procedure.  She was fine before the vaccine, and eats very sensible.  She is still dizzy after the surgery and the rehab.  She is now on medications, and has to go back to medical facility and had to go and have her BP medicine lowered due to the reaction.  She had no problems with her BP prior to the vaccine.  The medicine is an on and off reaction, she is still not able to drive her car or do any shopping due to the dizziness.   She was walking up to 3 miles a day prior to the vaccine, very active, never sick, and now she's unable to do any of that.  She was walking around the rehab center to keep active.
Age: 12.0
Sex: F
Vaccine: DTPPVHBHPB, MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt received wrong vaccine Vaxelis, should have received Tdap.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult was given a pediatric dose,
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Arthritis, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: About 2 days after receiving the shot, I began experiencing extreme pain in my left shoulder. I took a photo of the injection site which was high on my shoulder. I had no physical activity the week of the shot. Three weeks later the pain was still severe and movement was limited. On Aug 7, I saw a shoulder specialist. She said the bursae was inflamed on x-ray and the needle was high enough to hit the bursae.  6 weeks later, the pain has improved somewhat , but certain movements still cause significant pain. I was told to rest it and avoid certain movement like pushup or chest press for 4 to 6 weeks and return if not improved.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray limb
Clinical narrative: About 2 days after receiving the shot, I began experiencing extreme pain in my left shoulder. I took a photo of the injection site which was high on my shoulder. I had no physical activity the week of the shot. Three weeks later the pain was still severe and movement was limited. On Aug 7, I saw a shoulder specialist. She said the bursae was inflamed on x-ray and the needle was high enough to hit the bursae.  6 weeks later, the pain has improved somewhat , but certain movements still cause significant pain. I was told to rest it and avoid certain movement like pushup or chest press for 4 to 6 weeks and return if not improved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Mother reports that redness appeared around injection site on Saturday. Mother also reported that there were hives present that have since resolved. Mother denies use of any OTC medications.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Malaise, Nausea, Pallor, Vomiting
Clinical narrative: Patient was given MenQuadfi Injection at 0941. Patient started to feel sick and dizzy at 0943. Patient started to lose color in his face and stated he was going to puke. Patient was given a emesis bag and patient threw up a small amount of phlegm.    Patients vitals were checked at 0950 and BP was 88/57, oxygen 98% and pulse at 62. Provider informed and came in to check on patient. We monitored vitals again at 0956 and BP was going up and at 98/62 with  a pulse of 57. Patients color started to come back and patient was more verbal at this time.    Patient was given juice and crackers as he stated he did not have anything to eat prior to appointment.    Patients vitals were taken again at 1004 and BP was 110/72, temperature was 97.9, Pulse was 50 and Oxygen level was 98%. Provider reviewed vitals and patient and gave the ok for patient to leave clinic.    Patient was feeling much better and thankful for the help. Patient never loss consciousness during this event.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult was given a pediatric dose of a Hep B vaccine
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Partial dose of an inactivated influenza vaccine administered because recipient pulled away during injection.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin weeping
Clinical narrative: Patient had not had any reaction with first injection except sore arm at site of injection. On 8/20/24, patient called to say he had itchy rash on forearm. Patient was told to take Benadryl and call if symptoms worsened. On 8/22/24, patient came to pharmacy and had rash on both forearms from wrist to below elbow on top and bottom not sides and no rash or redness at site of injection. Pharmacist ask patient to come back to clinic in pharmacy that afternoon and be seen be the physician but patient did not do so. On 8/26/2024, Med Surge clinic called to inquire about shingles vaccination. Patient presented with rash on forearm that were weeping with additional rashes on body on 8/26/24. Pharmacy called patient on 8/27/24 to check on patient and patient's wife stated patient had been admitted to hospital.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On July 19, 2024 child presented for 3 yr WCC to see MD with supervising provider. At the time of visit child's age is 3yr and 8 mo old. Scheduled to start pre-k August 2024, school PE completed. Child was evaluated with appropriate physical completed by Dr. See encounter with plan of treatment from 7/19/2024 School required vaccines requested are: DTAP POLIO MMR Varicella, all administered to the patient Kinrix vaccine is a combination vaccine, based on manufacture recommendations patient received the right vaccine, based on scheduling the patient received the vaccine 4 months early, vs at the age of 4yr as recommended Email sent to vendor Rep for advisement on Pharmacy guidance.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Age-inappropriate vaccine formulation was given - Patient has had no apparent symptoms/complications - Error was incidentally noted at next routine well-child visit
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse administered vaccine too soon. Vaccine is not indicated in children under the age of 6 months. Patient is 10 days old. Provider notified of vaccine error.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 18 month old child was given a vaccine indicated for ages 4-6 years.
Age: 18.0
Sex: M
Vaccine: TDAP, YF
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Nausea, Presyncope
Clinical narrative: As RN entered room to administer vaccines, patient noted he was "more nervous than normal" to receive these vaccines.    After discussion, patient was agreeable to proceeding with vaccines. Immediately (within approximately 30 seconds) after administration of Tdap (Left Arm, Deltoid) followed by Yellow Fever (Left Arm, Subcutaneous), patient started to exhibit symptoms of a vasovagal episode. He noted that he was feeling lightheaded, nauseous, and felt "more tired". Patient laid down and then had one episode of emesis. He continued to complain of nausea and lightheadedness for approximately 20 minutes following administration but, during that time, noted that the symptoms were continuously improving.    Patient was monitored by RN for approximately 30 minutes following vaccine administration. Vital signs were taken at approximately 0930:   Blood Pressure: 101/66 Pulse: 63 bpm Sp02: 100%   Prior to dismissal, patient stated that all of his symptoms had resolved and he was feeling back to his baseline.
Age: 18.0
Sex: M
Vaccine: TDAP, YF
Symptoms: Vomiting
Clinical narrative: As RN entered room to administer vaccines, patient noted he was "more nervous than normal" to receive these vaccines.    After discussion, patient was agreeable to proceeding with vaccines. Immediately (within approximately 30 seconds) after administration of Tdap (Left Arm, Deltoid) followed by Yellow Fever (Left Arm, Subcutaneous), patient started to exhibit symptoms of a vasovagal episode. He noted that he was feeling lightheaded, nauseous, and felt "more tired". Patient laid down and then had one episode of emesis. He continued to complain of nausea and lightheadedness for approximately 20 minutes following administration but, during that time, noted that the symptoms were continuously improving.    Patient was monitored by RN for approximately 30 minutes following vaccine administration. Vital signs were taken at approximately 0930:   Blood Pressure: 101/66 Pulse: 63 bpm Sp02: 100%   Prior to dismissal, patient stated that all of his symptoms had resolved and he was feeling back to his baseline.