chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: if a dose of Kinrix had been administered to a 7 year old male patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: if a dose of Kinrix had been administered to a 7 year old male patient). The outcome of the inappropriate age at vaccine administration 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: 24-APR-2024 The healthcare professional called and requested data about how they should proceed if a dose of Kinrix had been administered to a 7 year patient, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: anaphylactic reaction; hives; trouble breathing; throat closing; This serious case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced anaphylactic reaction (Verbatim: anaphylactic reaction) (serious criteria GSK medically significant and life threatening), hives (Verbatim: hives) (serious criteria life threatening), difficulty breathing (Verbatim: trouble breathing) (serious criteria life threatening) and throat discomfort (Verbatim: throat closing) (serious criteria life threatening). The outcome of the anaphylactic reaction, hives and difficulty breathing were resolved and the outcome of the throat discomfort was not reported.   It was unknown if the reporter considered the anaphylactic reaction, hives, difficulty breathing and throat discomfort to be related to Shingrix.     It was unknown if the company considered the anaphylactic reaction, hives, difficulty breathing and throat discomfort to be related to Shingrix.   Additional Information: GSK Receipt date: 01-MAY-2024 The registered physician called to ask if patient can get a Boostrix vaccination if patient had anaphylactic reaction to Boostrix. She stated she did not know if this was reported as an adverse event since it happened at a healthcare professional office about 1 to 2 years ago. She stated the patient reported that after dose 1 of Shingrix she experienced hives, trouble breathing and throat closing about 6 hours after dose. She stated they told her she had an anaphylactic reaction. No other information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Laboratory test, Portal vein thrombosis
Clinical narrative: PORTAL VEIN THROMBOSIS; This spontaneous report was received from literature.This report concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: frequent airline passenger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. The patient presented with a two week history of abdominal pain, nausea, vomiting, and distention. He received the Ad26.COV2.S (recombinant) Janssen COVID_19 vaccine, one month before onset of symptoms. On presentation, lab results revealed hyponatremia, lactic acidosis, and leukocytosis. Computerized Tomogram abdomen and pelvis with contrast revealed moderate circumferential bowel wall thickening, prominent mesenteric vessels present, and a portal vein thrombus (dose series: 1) extending to the superior mesenteric and splenic veins. An extensive hypercoagulable workup was negative. Patient's history revealed he was a frequent airline passenger but was otherwise negative. Additional etiologies were examined before associating the COVID-19 vaccine with thrombosis and the penultimate diagnosis was only reached by exclusion of other causes after initial evaluation and further outpatient follow up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of portal vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Portal vein thrombosis. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: the first three that got had 24 hours of symptoms and they went away.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (the first three that got had 24 hours of symptoms and they went away.) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (the first three that got had 24 hours of symptoms and they went away.). At the time of the report, IMMUNISATION REACTION (the first three that got had 24 hours of symptoms and they went away.) had resolved.            No concomitant medication were provided. Treatments drugs were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseous". Additional information: The reporter stated she was nauseous and it walks away and then it goes back. In an attempt to clarify statement, "it walks away and then it goes back". Caller clarified statement as the reporter was walking away and the nauseous goes away, and then it comes back. She also mentioned that she wanted to see if this a normal vaccine response.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Celiac disease" (unspecified if ongoing); "Hypothyroidism-hashimoto" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct1985; CETIRIZINE HYDROCHLORIDE, start date: 01Jan2019. Vaccination history included: pfizer / biontech (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Sep2023, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 20Apr2024 to 24Apr2024).; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: when needle was "pulled out", a "pretty good amount of blood sprayed out"; there was a little bit more bruising for an epidural hematoma; resulted in the administration of a less-than-recommended dose; This is a spontaneous report received from a Nurse from medical information team.  A 6-month-old female patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 01May2024 at 11:00 as dose 1, single (Lot number: HH3252, Expiration Date: Jul2024) at the age of 6 months intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: UNDERDOSE (non-serious) with onset 01May2024 at 11:00, outcome "unknown", described as "resulted in the administration of a less-than-recommended dose"; VACCINATION SITE BRUISING (non-serious) with onset 01May2024 at 11:00, outcome "unknown", described as "there was a little bit more bruising for an epidural hematoma"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 01May2024 at 11:00, outcome "recovered" (01May2024 at 11:00), described as "when needle was "pulled out", a "pretty good amount of blood sprayed out"". Therapeutic measures were not taken as a result of vaccination site haemorrhage, vaccination site bruising, underdose.  Additional information: patient did not have prior vaccinations within 4 weeks. There is no medical history and family medical history relevant to adverse event. There is no other products and investigations. with regard to an infant, in that although nurse believes that full dose was administered to patient, with "no apparent loss of the vaccine", when needle was "pulled out", a "pretty good amount of blood sprayed out", which could have resulted in the administration of a less-than-recommended dose. Nurse states the needle hit the appropriate depth to get into the muscle and appeared more surface level as there was a little bit more bruising for an epidural hematoma and it appeared surface level and it had a pretty good spray that spayed 4 inches like for a test like water spraying and the total volume he would say of the blood that sprayed he would say or guess it was 0.2mL or maybe up to 0.5mL. It was just the initial squirt of the blood and that stopped pretty much immediately and other than the patient being mad at him as when he poke so many babies that is what he get. The event did not require the initiation of new medication/other treatment/ procedure. For the needles, nurse stated the company that manufactures them is BD and it is a safety slide needle.
Sex: M
Vaccine: FLUX, RSV, VARZOS
Symptoms: Incorrect route of product administration, Malaise, Pain in extremity
Clinical narrative: Abrysvo given subcutaneously; Slight arm pain; feeling under the weather; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Apr2024 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 08Apr2024 as dose number unknown, single) for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 08Apr2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Slight arm pain"; MALAISE (non-serious), outcome "recovered", described as "feeling under the weather"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Abrysvo given subcutaneously". Therapeutic measures were taken as a result of pain in extremity, malaise. Additional information: Slight arm pain and feeling under the weather for one day following Abrysvo vaccine. Took Advil and it resolved.  Causality for "abrysvo given subcutaneously" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very very tired; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "very very tired". Additional information: The reporter stated her husband (patient) and herself felt very very tired because they had it the same day. They slept it off. She thinks they slept for like 12 hours straight.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400097942 Same patient/vaccine, different dose;US-PFIZER INC-202400097943 Same vaccine, different patient/dose;US-PFIZER INC-202400097944 Same vaccine, different patient/dose;US-PFIZER INC-202400097945 Same vaccine, different patient/dose;
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation reaction
Clinical narrative: got a terrible immune reaction shingles I've been told by an emergency clinic; got a terrible immune reaction shingles I've been told by an emergency clinic; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (medically significant), HERPES ZOSTER (medically significant), outcome "unknown" and all described as "got a terrible immune reaction shingles I've been told by an emergency clinic". The event "got a terrible immune reaction shingles i've been told by an emergency clinic" required emergency room visit.
Sex: M
Vaccine: COVID19
Symptoms: Subdural haematoma
Clinical narrative: subdural hematoma; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUBDURAL HAEMATOMA (medically significant), outcome "unknown", described as "subdural hematoma".  Clinical course: The reporter wanted to know if others had the same issue like him. Reported that after Covid vaccine he had subdural hematoma like a brain bleed.   Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia, Urticaria
Clinical narrative: Pt got nausea and diarrhea about 3 hours after shot and also a fever and they also took plain Tylenol for fever;  took Benedryl because they broke out in severe hives on buttocks and lower extremeities but they are still treating there self with Benedryl;  Will go to the dr on Monday if not better;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Urticaria, Urticaria chronic
Clinical narrative: I began experiencing chronic urticaria after receiving my COVID vaccine. I had never had urticaria previously, and it began within less than 3 weeks of receiving the first shot.  The trigger each time it happens is exercise and/or my body getting warmer than normal, such as from sitting right in the sun. I visited an allergist in 2023 to get tested for any and all possible triggers, and no food, environmental or other allergic reactions were detected. I now get hives approximately once every 4-6 weeks, sometimes very severely.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection related reaction, Pruritus, Swelling face
Clinical narrative: 7 days afterwards, the injection site was still sore, I became extremely itchy all over and my face felt swollen. The next day (8 days afterwards) red spots emerged all over my body.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient only received the ajuvant solution.  It was not mixed with the powder vial with the active ingredient before administration.   Patient was contacted and will come in to get the actual vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Approx 3 inch area of swelling and redness surrounding both vaccine sites per parent. Itchiness noted at these sites.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Glomerulonephritis membranous, Inappropriate schedule of product administration, Proteinuria
Clinical narrative: Coincident with receiving the Shingrix vaccine, first in February of 2018 (both doses ~3 months apart) I was diagnosed with Idiopathic Membranous  Nephropathy in May of 2018, causing severe Proteinuria and related conditions.. I went through 2+ years of therapy with Cyclosporine with only limited improvement. My physician the prescribed a regimen of Rituximab, 4-1,000 mg infusions over 24 months which has provided a remission of the condition. I am now without symptoms for about 18 months.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: MMR vaccine was expired by 6 days at time of administration. Administered 4/18/24, expired 4/12/24
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Paraesthesia, Rash
Clinical narrative: Started having arm pain on left arm, with tingling down fingers, then rash.  Diagnosed with shingles
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: PEDIATRIC DOSE HEPATITIS B VACCINE WAS ADMINISTERD
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was ordered and administered in error. Patient is 2 months old, vaccine given was intended for patients 4-6 years old. Physician notified patient's mother and instructed to monitor for injection site swelling, vomiting, lethargy or other abnormal symptoms and return if any of these symptoms arise.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood calcium, Double stranded DNA antibody, Metabolic function test, Rash
Clinical narrative: Developed a rash on the right arm at the vaccination site 2 days after vaccination, that then spread to the bilateral arms, chest, back, and legs. Rash is raised, hyperpigmented, pruritic. Looks consistent with erythema multiforme. Rash is active at the time of assessment (5/3/24).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, Skin hyperpigmentation, Vaccination site rash
Clinical narrative: Developed a rash on the right arm at the vaccination site 2 days after vaccination, that then spread to the bilateral arms, chest, back, and legs. Rash is raised, hyperpigmented, pruritic. Looks consistent with erythema multiforme. Rash is active at the time of assessment (5/3/24).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Magnetic resonance imaging normal, Nausea
Clinical narrative: Extreme dizziness. Started suddenly. I woke up with extreme dizziness, couldn?t walk straight and was extremely nauseous from it. It was constant unless I sat perfectly still. Went to an ENT. Got an MRI and it was clear. It took about 2 weeks for it to completely go away. The pharmacist who did the booster hadn?t heard of this as a side effect, the primary care physician hadn?t heard of this either. The ENT hadn?t either.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Dizziness, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Actual symptoms started with dizziness after 10 days. Other symptoms were lost muscle strength and then started experience GBS syndrome symptoms for which he got hospital admitted  23 days later. Before getting admitted, patient went to see ENT physician and multiple out-patient visits.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Neurological symptom
Clinical narrative: Actual symptoms started with dizziness after 10 days. Other symptoms were lost muscle strength and then started experience GBS syndrome symptoms for which he got hospital admitted  23 days later. Before getting admitted, patient went to see ENT physician and multiple out-patient visits.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Tonight at 6:50pm, I had a patient come in for a covid vaccine. She had never had one before. I talked to her about allergic and adverse reactions and advised her to stay 15 minutes after the vaccine. Immediately after giving her Comirnaty, she said she felt pain and tingling. I asked her to remain seated and a few minutes later I heard a thud. I went to check on her and she was on the floor. She was still breathing and responsive. I asked her if she wanted me to call 911 and I did. They came out about 5 minutes later. We stayed with the patient and gave her water. She was at this point sitting cross-legged on the floor. The paramedics came and investigated. She was communicating with them but still complained that her arm was sore. They were concerned about her driving so her boyfriend was called to come and collect her. At this time: 7:36 pm, she is still sitting in the immunisation area.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Aura, Blood test, Burning sensation, Computerised tomogram head normal, Computerised tomogram neck
Clinical narrative: Vertigo, dizziness, nausea, visual auras, kaleidoscope vision, Reynauds in fingers, hands, toes. Numbness, tingling,  pin prick sensations, burning in arms, legs, face, scalp. Throbbing and twitching in legs. Aching in shoulders, elbows arms. Bending elbows makes lower arms go numb. Peripheral neuropathy from small nerves fiber  damage.  Pain treated with some success with Gabapentin, but still has significant pain at all times.  Auras stopped spontaneously after 6 months. Vestibular improved after physical therapy.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Computerised tomogram thorax normal, Dizziness, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Vertigo, dizziness, nausea, visual auras, kaleidoscope vision, Reynauds in fingers, hands, toes. Numbness, tingling,  pin prick sensations, burning in arms, legs, face, scalp. Throbbing and twitching in legs. Aching in shoulders, elbows arms. Bending elbows makes lower arms go numb. Peripheral neuropathy from small nerves fiber  damage.  Pain treated with some success with Gabapentin, but still has significant pain at all times.  Auras stopped spontaneously after 6 months. Vestibular improved after physical therapy.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia, Magnetic resonance imaging head normal, Muscle twitching, Nausea
Clinical narrative: Vertigo, dizziness, nausea, visual auras, kaleidoscope vision, Reynauds in fingers, hands, toes. Numbness, tingling,  pin prick sensations, burning in arms, legs, face, scalp. Throbbing and twitching in legs. Aching in shoulders, elbows arms. Bending elbows makes lower arms go numb. Peripheral neuropathy from small nerves fiber  damage.  Pain treated with some success with Gabapentin, but still has significant pain at all times.  Auras stopped spontaneously after 6 months. Vestibular improved after physical therapy.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nerve conduction studies normal, Nerve injury, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: Vertigo, dizziness, nausea, visual auras, kaleidoscope vision, Reynauds in fingers, hands, toes. Numbness, tingling,  pin prick sensations, burning in arms, legs, face, scalp. Throbbing and twitching in legs. Aching in shoulders, elbows arms. Bending elbows makes lower arms go numb. Peripheral neuropathy from small nerves fiber  damage.  Pain treated with some success with Gabapentin, but still has significant pain at all times.  Auras stopped spontaneously after 6 months. Vestibular improved after physical therapy.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin, Paraesthesia, Raynaud's phenomenon, Skin burning sensation, Small fibre neuropathy
Clinical narrative: Vertigo, dizziness, nausea, visual auras, kaleidoscope vision, Reynauds in fingers, hands, toes. Numbness, tingling,  pin prick sensations, burning in arms, legs, face, scalp. Throbbing and twitching in legs. Aching in shoulders, elbows arms. Bending elbows makes lower arms go numb. Peripheral neuropathy from small nerves fiber  damage.  Pain treated with some success with Gabapentin, but still has significant pain at all times.  Auras stopped spontaneously after 6 months. Vestibular improved after physical therapy.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vestibular disorder, Visual impairment
Clinical narrative: Vertigo, dizziness, nausea, visual auras, kaleidoscope vision, Reynauds in fingers, hands, toes. Numbness, tingling,  pin prick sensations, burning in arms, legs, face, scalp. Throbbing and twitching in legs. Aching in shoulders, elbows arms. Bending elbows makes lower arms go numb. Peripheral neuropathy from small nerves fiber  damage.  Pain treated with some success with Gabapentin, but still has significant pain at all times.  Auras stopped spontaneously after 6 months. Vestibular improved after physical therapy.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: Developed Hives after HIB Vaccine
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature increased, Feeding disorder, Headache, Malaise
Clinical narrative: (1) headache (2) Stomach ache (3) Unable to eat (4) sick (5) weak (6) Temperature (7) sick monday until friday
Age: 67.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: Inadvertly gave 67 yr old man one dose RSV & Pnemonia 20 In each arm. RSV left & Pnemonia 20 vaccine in Rt. ON 5/1/24. Pt had already had these vaccine on 2/16/24 this year by RN but not Initiated into the State WEB. I did not check our facility EHR system where these 2 vaccines were entered on 2/16/24. The Web system said Pt still needed RSV & Pneumonia 20 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Blood thyroid stimulating hormone increased, Dizziness, Feeling abnormal
Clinical narrative: My TSH levels had been normal my whole life.  two weeks after the vaccine my TSH levels were quite elevated.  Since then my levels have been up and down.  I have tested positive for Hashimoto's.  I never had any autoimmune issues or Thryoid issues until I got the vaccines.  My TSH levels went up every time I took a vaccine and when I had COVID.  I had blood tests done because I felt bad and dizzy.  So they were trying to figure out waht was wrong.  My doctor just after 3 years found what was going on.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Extended site reaction with induration, erythema, tenderness 10+ days from injection date
Age: 68.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Conjunctivitis, Extensive swelling of vaccinated limb, Headache, Illness, Influenza like illness
Clinical narrative: within 1 hour severe swelling of left arm up neck and face severe headache then flu like symptoms and illness then also became ill and then also had conjunctivitis severe swelling and pain with resulting illness
Age: 68.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pain, Swelling, Swelling face
Clinical narrative: within 1 hour severe swelling of left arm up neck and face severe headache then flu like symptoms and illness then also became ill and then also had conjunctivitis severe swelling and pain with resulting illness
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy heart, Blood test, Bundle branch block left, Cardiac disorder, Cardiac failure
Clinical narrative: Giant cell myocarditis, pacemaker, ICD, immunosuppression, anti rhythmic medications for palpitations, heart failure medications - July 2022 until present day. Palpitations started in Feb/March 2022 and were not showing up consistently on holter monitor. In July 2022 there were changes to the ekg showing left bundle branch block. Cardiac MRI in August 2022 revealed inflammation and infiltration.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion, Carditis, Electrocardiogram abnormal, Electrocardiogram ambulatory, Giant cell myocarditis
Clinical narrative: Giant cell myocarditis, pacemaker, ICD, immunosuppression, anti rhythmic medications for palpitations, heart failure medications - July 2022 until present day. Palpitations started in Feb/March 2022 and were not showing up consistently on holter monitor. In July 2022 there were changes to the ekg showing left bundle branch block. Cardiac MRI in August 2022 revealed inflammation and infiltration.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Immunosuppression, Implantable defibrillator insertion, Magnetic resonance imaging heart, Palpitations, Positron emission tomogram
Clinical narrative: Giant cell myocarditis, pacemaker, ICD, immunosuppression, anti rhythmic medications for palpitations, heart failure medications - July 2022 until present day. Palpitations started in Feb/March 2022 and were not showing up consistently on holter monitor. In July 2022 there were changes to the ekg showing left bundle branch block. Cardiac MRI in August 2022 revealed inflammation and infiltration.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Laboratory test
Clinical narrative: 8 weeks of extensive pain mostly in lower back on right side
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Chills, Discomfort, Heart rate increased
Clinical narrative: Chills, rapid heartbeat, back muscle pain, joint pain, pain and tenderness at the injection site,and general discomfort.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Chills, rapid heartbeat, back muscle pain, joint pain, pain and tenderness at the injection site,and general discomfort.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose in series delivered inappropriately to an older infant at 7 months old. Physician informed and reported via VAERS. Informed family within 24 hours. Warned about possible adverse effects to look out for that are similar to vaccine adverse effects.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: Spiked a 103 fever at 11:20am on 05/03 took to er could not keep down with medication had a febrile seizure at 7:20pm that lasted 3 minutes took to emergency room where he was diagnosed
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Chest pain, Dyspnoea, Hypersensitivity, Hypoaesthesia
Clinical narrative: Donor reported having shortness of breath, chest pain and left sided numbness on 5/2/2024. Donor stated EMS transported her from work to ER. It was reported that ER observed pt and diagnosed symptoms as allergic reaction. Donor was released with no further treatment after ER observation and diagnostic testing. Donor arrived to CSL plasma center on 5/4/2024 reporting adverse event from rabies vaccine on 4/29/2024.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Audiogram, Balance disorder, Dizziness, Electrocochleogram
Clinical narrative: Tinnitus, dizziness, balance issues
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging ear, Scan with contrast, Tinnitus
Clinical narrative: Tinnitus, dizziness, balance issues
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Patient received her first dose of shingles vaccine on 05/03/24. Patient reported to the pharmacy today complaining of soreness in the arm and overall weakness. Pt confirmed she was provided a VIS sheet and was explained the possible effects from the vaccine but wanted to confirm again her symptoms were from the vaccine. Patient was advised to keep hydrating and to take tylenol  as needed.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Mobility decreased, Pain
Clinical narrative: PATIENT STATED STARTED TO FEEL WHOLE BODY ACHES AND STIFFNESS THE NIGHT OF VACCINE ADMINISTRATION THAT PREVENTED HER FROM MOVING. REPORTS NO SWELLING OR REDNESS AT INJECTION SITE BUT FELT OVERALL DISORIENTED. SHE STATED THAT SHE TOOK 1 DOSE OF ALEVE AND TRIED WALKING AROUND WHICH SHE STATED HELPED REDUCE SYMPTOMS. SYMPTOMS DISAPPEARED AROUND MID-DAY ON MAY 03/2024. PATIENT CAME IN AT 2:45 ISH ON 05/04/24 TO REPORT INSTANCE. CURRENTLY FEELS NORMAL
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Client accompanied husband and 2 young children (1 & 3 yrs old)  to travel consult. Husband and one child receiving flu vaccine. Husband said wife should receive flu shot.  Had wife fill out paperwork while I prep vaccines. Young children fussy and being demanding.  Gave travel and flu vaccines. Then when scanning in vaccine to computer system reviewed clients immunization record and realized that she had already had flu vaccine in October 2023.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Juvenile idiopathic arthritis, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint
Clinical narrative: Developed pain and left hip approximately 1 week later, at first we attributed the pain to her intense gymnastics but the pain kept progressing.   After PT not working and MRI with contrast was done and identified as inflammation in sacroiliac joint and later diagnosed as Juvenile Idiopathic Arthritis.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Scan with contrast abnormal
Clinical narrative: Developed pain and left hip approximately 1 week later, at first we attributed the pain to her intense gymnastics but the pain kept progressing.   After PT not working and MRI with contrast was done and identified as inflammation in sacroiliac joint and later diagnosed as Juvenile Idiopathic Arthritis.
Age: 39.0
Sex: F
Vaccine: TYP, YF
Symptoms: Flushing, Heart rate increased, Hypersensitivity, Malaise, Rash
Clinical narrative: PATIENT REPORTED FEELING ILL 9 DAYS AFTER RECEIVING YELLOW FEVER VACCINE. SHE HAD COMPLETED THE VIVOTIF ORAL SERIES. SHE HAD SUDDEN ONSET RAPID HEART BEAT WITH FLUSHING THEN DEVELOPED HIVES/RASH OVER A LARGE PORTION OF HER BODY.  SHE WENT TO THE EMERGENCY ROOM. THEY TREATED HER FOR ALLERGIC REACTION WITH INJECTED STEROID THEN ORAL STEROIDS. SYMPTOMS RESOLVED ENOUGH THAT SHE WAS RELEASED SEVERAL HOURS LATER. SHE HAS NOT HAD OTHER SYMPTOMS.
Age: 39.0
Sex: F
Vaccine: TYP, YF
Symptoms: Urticaria
Clinical narrative: PATIENT REPORTED FEELING ILL 9 DAYS AFTER RECEIVING YELLOW FEVER VACCINE. SHE HAD COMPLETED THE VIVOTIF ORAL SERIES. SHE HAD SUDDEN ONSET RAPID HEART BEAT WITH FLUSHING THEN DEVELOPED HIVES/RASH OVER A LARGE PORTION OF HER BODY.  SHE WENT TO THE EMERGENCY ROOM. THEY TREATED HER FOR ALLERGIC REACTION WITH INJECTED STEROID THEN ORAL STEROIDS. SYMPTOMS RESOLVED ENOUGH THAT SHE WAS RELEASED SEVERAL HOURS LATER. SHE HAS NOT HAD OTHER SYMPTOMS.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Sleep disorder
Clinical narrative: We called the customer because he never returned for his 2nd dose. He said that his 1st dose was given by his doctor but that he has been having a problem with his arm since the day of the vaccine. He has pain at the injection site with pressure and is not able to sleep on his left site. There is a hard lump at the site. He called his physician weeks after the injection to discuss the issue and was told it would go away soon. He plans to talk to his physician about is at his next appointment.
Age: 83.0
Sex: M
Vaccine: HEPAB, PNC20, VARZOS, HEPAB, PNC20, VARZOS
Symptoms: Decreased appetite, Dizziness, Fatigue, Gait disturbance
Clinical narrative: DIZZINESS, LOSS OF APPETITE, DIFFICULTY WALKING, FATIQUE FOR THE PAST 4 DAYS
Age: 83.0
Sex: M
Vaccine: HEPAB, PNC20, VARZOS, HEPAB, PNC20, VARZOS
Symptoms: Cough, Fatigue, Headache, Nasopharyngitis
Clinical narrative: DIZZINESS, LOSS OF APPETITE, DIFFICULTY WALKING, FATIQUE FOR THE PAST 4 DAYS
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Exfoliative rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: MAIN ADVERSE REACTION: RASH. ONSET DAY 2 AFTER 2ND DOSE.  INITIALLY ONE SPOT, THEN INCREASING DAILY SPREADING TO FULL BODY.  INNUMERABLE. 1MM-3IN DIAMETER. ROUND AND OVAL. SCALY, ITCHY, VARIOUS SHADES OF LIGHT PINK TO BRIGHT RED.  RESOLVED AT 8WEEKS.
Age: 50.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient started seizing after receiving vaccines
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal discomfort, Anisocoria, Back pain, Cluster headache, Diplopia
Clinical narrative: Vision symptoms: blurry, double vision, dry red eyes, different pupil sizes at times.  Headache: sever cluster and occipital one sided head aches with severe eye and back of head pain, tearing, agitation.   Fatiue and muscle pain is unremitting. Dizzy, nausea, upset stomach. Hives all over body. New allergies never had prior. Nerve and back pain and spasms.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Dry eye, Eye pain, Fatigue, Headache
Clinical narrative: Vision symptoms: blurry, double vision, dry red eyes, different pupil sizes at times.  Headache: sever cluster and occipital one sided head aches with severe eye and back of head pain, tearing, agitation.   Fatiue and muscle pain is unremitting. Dizzy, nausea, upset stomach. Hives all over body. New allergies never had prior. Nerve and back pain and spasms.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity, Lacrimation increased, Muscle spasms, Myalgia, Nausea
Clinical narrative: Vision symptoms: blurry, double vision, dry red eyes, different pupil sizes at times.  Headache: sever cluster and occipital one sided head aches with severe eye and back of head pain, tearing, agitation.   Fatiue and muscle pain is unremitting. Dizzy, nausea, upset stomach. Hives all over body. New allergies never had prior. Nerve and back pain and spasms.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Neuralgia, Ocular hyperaemia, Urticaria, Vision blurred
Clinical narrative: Vision symptoms: blurry, double vision, dry red eyes, different pupil sizes at times.  Headache: sever cluster and occipital one sided head aches with severe eye and back of head pain, tearing, agitation.   Fatiue and muscle pain is unremitting. Dizzy, nausea, upset stomach. Hives all over body. New allergies never had prior. Nerve and back pain and spasms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anaphylactic reaction, Asphyxia, Chest discomfort, Choking
Clinical narrative: 2 days  after injection, throat closed off causing difficulty breathing and swallowing.  One week  after vaccine, both arms painful then went completely numb for 2 minutes. Blood pressure 250/130?s, HR 180?s, heart pounding, difficulty breathing.  One week after that, the same symptoms occurred and vital signs would not stabilize. Cardiac anrrythmias and difficulty breathing  - ongoing. A month later, throat tightening and strangulation with dysphagia. Swelling both sides of neck,  collarbone area, and underside of jaw. Difficulty breathing from throat and lungs. Severe flushing face and chest. Allergic reactions and some anaphylactic reactions to any new medication prescribed. Lacy rashes on upper arms, shoulders, chest at times. Difficulty breathing and strangulation with any physical activity. Heart pounding front and back of neck. Severely dry throat and dry eyes. Waking up in night choking and unable to breathe. Having to sleep up on 3 pillows to keep airway open. 6 months later, severe upper right abdominal pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dry eye, Dry throat, Dysphagia, Dyspnoea
Clinical narrative: 2 days  after injection, throat closed off causing difficulty breathing and swallowing.  One week  after vaccine, both arms painful then went completely numb for 2 minutes. Blood pressure 250/130?s, HR 180?s, heart pounding, difficulty breathing.  One week after that, the same symptoms occurred and vital signs would not stabilize. Cardiac anrrythmias and difficulty breathing  - ongoing. A month later, throat tightening and strangulation with dysphagia. Swelling both sides of neck,  collarbone area, and underside of jaw. Difficulty breathing from throat and lungs. Severe flushing face and chest. Allergic reactions and some anaphylactic reactions to any new medication prescribed. Lacy rashes on upper arms, shoulders, chest at times. Difficulty breathing and strangulation with any physical activity. Heart pounding front and back of neck. Severely dry throat and dry eyes. Waking up in night choking and unable to breathe. Having to sleep up on 3 pillows to keep airway open. 6 months later, severe upper right abdominal pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypersensitivity, Hypoaesthesia, Laboratory test, Pain in extremity
Clinical narrative: 2 days  after injection, throat closed off causing difficulty breathing and swallowing.  One week  after vaccine, both arms painful then went completely numb for 2 minutes. Blood pressure 250/130?s, HR 180?s, heart pounding, difficulty breathing.  One week after that, the same symptoms occurred and vital signs would not stabilize. Cardiac anrrythmias and difficulty breathing  - ongoing. A month later, throat tightening and strangulation with dysphagia. Swelling both sides of neck,  collarbone area, and underside of jaw. Difficulty breathing from throat and lungs. Severe flushing face and chest. Allergic reactions and some anaphylactic reactions to any new medication prescribed. Lacy rashes on upper arms, shoulders, chest at times. Difficulty breathing and strangulation with any physical activity. Heart pounding front and back of neck. Severely dry throat and dry eyes. Waking up in night choking and unable to breathe. Having to sleep up on 3 pillows to keep airway open. 6 months later, severe upper right abdominal pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash, Sleep disorder, Swelling, Swelling face
Clinical narrative: 2 days  after injection, throat closed off causing difficulty breathing and swallowing.  One week  after vaccine, both arms painful then went completely numb for 2 minutes. Blood pressure 250/130?s, HR 180?s, heart pounding, difficulty breathing.  One week after that, the same symptoms occurred and vital signs would not stabilize. Cardiac anrrythmias and difficulty breathing  - ongoing. A month later, throat tightening and strangulation with dysphagia. Swelling both sides of neck,  collarbone area, and underside of jaw. Difficulty breathing from throat and lungs. Severe flushing face and chest. Allergic reactions and some anaphylactic reactions to any new medication prescribed. Lacy rashes on upper arms, shoulders, chest at times. Difficulty breathing and strangulation with any physical activity. Heart pounding front and back of neck. Severely dry throat and dry eyes. Waking up in night choking and unable to breathe. Having to sleep up on 3 pillows to keep airway open. 6 months later, severe upper right abdominal pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: 2 days  after injection, throat closed off causing difficulty breathing and swallowing.  One week  after vaccine, both arms painful then went completely numb for 2 minutes. Blood pressure 250/130?s, HR 180?s, heart pounding, difficulty breathing.  One week after that, the same symptoms occurred and vital signs would not stabilize. Cardiac anrrythmias and difficulty breathing  - ongoing. A month later, throat tightening and strangulation with dysphagia. Swelling both sides of neck,  collarbone area, and underside of jaw. Difficulty breathing from throat and lungs. Severe flushing face and chest. Allergic reactions and some anaphylactic reactions to any new medication prescribed. Lacy rashes on upper arms, shoulders, chest at times. Difficulty breathing and strangulation with any physical activity. Heart pounding front and back of neck. Severely dry throat and dry eyes. Waking up in night choking and unable to breathe. Having to sleep up on 3 pillows to keep airway open. 6 months later, severe upper right abdominal pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel decompression, Constipation, Dyspnoea, Headache, Hypertension
Clinical narrative: I began w nausea and headaches. For over a year I had serious medical problems that changed symptoms and therefore I had different doctors. I went 2 ER 3 times. I saw gastro, neuro, cardio, orthodontist and ent. I was diagnosed w high blood pressure that was not high and suddenly went very high. I had headaches that began in my left side of my head and became so severe I was almost unable to function. I had severe constipation. I was diagnosed with TMJ & carpal tunnel. My breathing became difficult and because I had a previous tracheotomy I underwent 2 procedures. At 1 point I was on 17 meds. After it "traveled" through my body for over a year  I have slowly recovered and take 1 prescription now. I do not have high blood pressure or headaches or TMJ. I believe it all started w Covid booster
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nausea, Temporomandibular pain and dysfunction syndrome, Tracheostomy
Clinical narrative: I began w nausea and headaches. For over a year I had serious medical problems that changed symptoms and therefore I had different doctors. I went 2 ER 3 times. I saw gastro, neuro, cardio, orthodontist and ent. I was diagnosed w high blood pressure that was not high and suddenly went very high. I had headaches that began in my left side of my head and became so severe I was almost unable to function. I had severe constipation. I was diagnosed with TMJ & carpal tunnel. My breathing became difficult and because I had a previous tracheotomy I underwent 2 procedures. At 1 point I was on 17 meds. After it "traveled" through my body for over a year  I have slowly recovered and take 1 prescription now. I do not have high blood pressure or headaches or TMJ. I believe it all started w Covid booster
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was accidentally given a moderna spikevax that was past the 30 days beyond use date.  The beyond use date was 4/27/24.  No adverse event reported at this time.  Reporting that this was administered expired on accident.  Will contact manufacturer to see if a redose is needed.
Age: 36.0
Sex: M
Vaccine: FLU4, HEP, TDAP
Symptoms: Asthenia, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Impaired work ability
Clinical narrative: He said he got heplisav b, flu and boostrix vaccines on 2/26/24. He had fever and muscle ache for a few days but then after 7-10 days he was was not able to walk and very weak and then was hospitalized for 6 days. He did received IVIG treatment and was diagnosis as guillain barre sydrome due to getting  multiple vaccines.  Because to the condition he had to stop work and was in rehab hospital for 21 days.