chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Electromyogram, Magnetic resonance imaging neck, Nerve conduction studies abnormal, Paraesthesia, Small fibre neuropathy
Clinical narrative: Tingling, felt in soles of feet, throbbing, unpleasant when walking barefoot - 5-7 days after yellow fever vaccine. Tingling proximal to upper calf, in fingers - seen by facility, Neuromuscular department. Prescribed gabapentin, completed cervical MRI, EMG, nerve conduction diagnosed small fiber neuropathy, post yellow fever vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Broke out in hives 5 days after the injection. They lasted 4 days.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: erythema and edema to inj site
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: (R) Bell's Palsy with onset 48 hrs after Pfizer Covid 19 vaccine. Treated with Valacyclovir 1 gm TID (#21); Prednisone 60 mg 1 day x 5 days; 50 mg 1 day;  40 mg 1 day; 30 mg, 20mg and 10 mg each 1 day. (R) eye ointment lubricant. Seen back 10/10/204 with complee recovery.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; This spontaneous report received from a patient via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient reported that he contracted Guillain Barre Syndrome from J&J Janssen Corona vaccine. He had three ER visits, 9 days in hospital. He was still suffering with extreme neuropathy in extremities, facial paralysis. All was  reported to CDC/VAERS. The patient took vaccine as a means of support with his wife. On an unspecified date, the patient experienced Guillain Barre Syndrome (dose in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain Barre Syndrome. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20240952993.  Additional information was received on 26-SEP-2024. It was determined that Manufacturer Case Number 20240952993 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20240921224.; Sender's Comments: V2: Follow up updates information about duplicate case, which does not alter previous causality. Guillain-Barre syndrome; The event has an unknown/unclear 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.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Eye disorder, Fall, Seizure
Clinical narrative: having convulsions and had one seizure after another; fell down; neweye condition; Partial memory loss; This serious case was reported by a consumer via call center representative and described the occurrence of convulsion in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (Patient had chicken pox twice as a child), shingles (Six episodes of shingles) and post herpetic neuralgia (treated with an unspecified injection in spine). Previously administered products included Shingrix (Patient received first dose on an unknown date).   On 03-JUL-2022, the patient received the 2nd dose of Shingrix. On 03-JUL-2022, less than a day after receiving Shingrix, the patient experienced convulsion (Verbatim: having convulsions and had one seizure after another) (serious criteria hospitalization and GSK medically significant), fall (Verbatim: fell down) (serious criteria hospitalization) and partial loss of memory (Verbatim: Partial memory loss). On an unknown date, the patient experienced eye disorder (Verbatim: neweye condition). The outcome of the convulsion and fall were unknown and the outcome of the eye disorder and partial loss of memory were not resolved.   The reporter considered the convulsion, fall and partial loss of memory to be related to Shingrix. It was unknown if the reporter considered the eye disorder to be related to Shingrix.     The company considered the convulsion, fall and partial loss of memory to be related to Shingrix. It was unknown if the company considered the eye disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-OCT-2024 The reporter is the patient. She stated that a couple of years ago she got the second Shingrix vaccine.  She got into the house and 15 minutes later, she fell and started having convulsions and had one seizure after another and she had to be rushed to the hospital and she was in there for a week and did not knew who she was for a week. She lost a whole gap of her memory during that time, and she still did not have it. She stated that she had a new eye condition which came up last year, she did not recall the name of it, but it was a rare eye condition and it was not macular. She stated that she had no family history of that rare eye condition.; Sender's Comments: Seizure and Fall are unlisted events which, due to the following criteria (strong temporal association) are considered related to GSK vaccine Shingrix.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Giant cell arteritis
Clinical narrative: Heahache started in the temple area the next day after getting the vaccine. Went to the ER . Was admitted and stayed about 126 days total. Was diagnosed with Giant Cell Temporial Ateritus- Biopsy surgery on right side Norcadia- Left arm surgury, Cryptococcosus- Blood stream. Developed 4 cysts on left arm and had to be cut off. Was taking predisone for about 3 years. Currently taking alot of medicine, down to taking 10 pills from 23 pills per day and still have weekly Actemra shots for the past 3 years. Now taking Qulipta for miagraines. I am tired of taking this medicine. I still have trouble standing up and walking because his legs get weak.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacterial infection, Biopsy skin abnormal, Blood test abnormal, Cryptococcosis, Cyst
Clinical narrative: Heahache started in the temple area the next day after getting the vaccine. Went to the ER . Was admitted and stayed about 126 days total. Was diagnosed with Giant Cell Temporial Ateritus- Biopsy surgery on right side Norcadia- Left arm surgury, Cryptococcosus- Blood stream. Developed 4 cysts on left arm and had to be cut off. Was taking predisone for about 3 years. Currently taking alot of medicine, down to taking 10 pills from 23 pills per day and still have weekly Actemra shots for the past 3 years. Now taking Qulipta for miagraines. I am tired of taking this medicine. I still have trouble standing up and walking because his legs get weak.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cyst removal, Dysstasia, Gait disturbance, Giant cell arteritis, Headache
Clinical narrative: Heahache started in the temple area the next day after getting the vaccine. Went to the ER . Was admitted and stayed about 126 days total. Was diagnosed with Giant Cell Temporial Ateritus- Biopsy surgery on right side Norcadia- Left arm surgury, Cryptococcosus- Blood stream. Developed 4 cysts on left arm and had to be cut off. Was taking predisone for about 3 years. Currently taking alot of medicine, down to taking 10 pills from 23 pills per day and still have weekly Actemra shots for the past 3 years. Now taking Qulipta for miagraines. I am tired of taking this medicine. I still have trouble standing up and walking because his legs get weak.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Migraine, Muscular weakness
Clinical narrative: Heahache started in the temple area the next day after getting the vaccine. Went to the ER . Was admitted and stayed about 126 days total. Was diagnosed with Giant Cell Temporial Ateritus- Biopsy surgery on right side Norcadia- Left arm surgury, Cryptococcosus- Blood stream. Developed 4 cysts on left arm and had to be cut off. Was taking predisone for about 3 years. Currently taking alot of medicine, down to taking 10 pills from 23 pills per day and still have weekly Actemra shots for the past 3 years. Now taking Qulipta for miagraines. I am tired of taking this medicine. I still have trouble standing up and walking because his legs get weak.
Age: 4.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Urticaria
Clinical narrative: Pt received Flu shot on Rt Deltoid. Pt had not problem previous years with Quadrivalent. After the immunization, pt started to have redness , soreness and swelling. Then started to have urticaria spreading to chest. No respiratory distress sxs or orofacial swelling.  Pt received Benadryl and urticaria improved. When pt followed up on 9/25/24 for a follow up urticaria was coming back when Benadryl worse off but interval had increased.  Swelling, redness and soreness had improved as well.  Pt has ho left distal forearm swelling which was evaluated.
Age: 4.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Erythema, Pain, Swelling, Urticaria
Clinical narrative: Pt received Flu shot on Rt Deltoid. Pt had not problem previous years with Quadrivalent. After the immunization, pt started to have redness , soreness and swelling. Then started to have urticaria spreading to chest. No respiratory distress sxs or orofacial swelling.  Pt received Benadryl and urticaria improved. When pt followed up on 9/25/24 for a follow up urticaria was coming back when Benadryl worse off but interval had increased.  Swelling, redness and soreness had improved as well.  Pt has ho left distal forearm swelling which was evaluated.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: tingling down the ulnar side of the arm on injection side; chills; sweats; dry throat; stuffy nose; body aches; headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Oct2024 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: PARAESTHESIA (non-serious), outcome "recovering", described as "tingling down the ulnar side of the arm on injection side"; CHILLS (non-serious), outcome "not recovered"; HYPERHIDROSIS (non-serious), outcome "not recovered", described as "sweats"; DRY THROAT (non-serious), outcome "recovering"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "stuffy nose"; PAIN (non-serious), outcome "recovering", described as "body aches"; HEADACHE (non-serious), outcome "not recovered".  Additional information: patient received a Covid 19 booster on 10/7/2024 and started having a reaction w/in hours. Symptoms include tingling down the ulnar side of the arm on injection side, chills, sweats, dry throat, stuffy nose, body aches, headache. The symptoms are slowly resolving but the patient is still having sweats/chills, mild headache and stuffy nose.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: tingling down the ulnar side of the arm on injection side; chills; sweats; dry throat; stuffy nose; body aches; headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Oct2024 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: PARAESTHESIA (non-serious), outcome "recovering", described as "tingling down the ulnar side of the arm on injection side"; CHILLS (non-serious), outcome "not recovered"; HYPERHIDROSIS (non-serious), outcome "not recovered", described as "sweats"; DRY THROAT (non-serious), outcome "recovering"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "stuffy nose"; PAIN (non-serious), outcome "recovering", described as "body aches"; HEADACHE (non-serious), outcome "not recovered".  Additional information: patient received a Covid 19 booster on 10/7/2024 and started having a reaction w/in hours. Symptoms include tingling down the ulnar side of the arm on injection side, chills, sweats, dry throat, stuffy nose, body aches, headache. The symptoms are slowly resolving but the patient is still having sweats/chills, mild headache and stuffy nose.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Dry throat, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: tingling down the ulnar side of the arm on injection side; chills; sweats; dry throat; stuffy nose; body aches; headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Oct2024 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: PARAESTHESIA (non-serious), outcome "recovering", described as "tingling down the ulnar side of the arm on injection side"; CHILLS (non-serious), outcome "not recovered"; HYPERHIDROSIS (non-serious), outcome "not recovered", described as "sweats"; DRY THROAT (non-serious), outcome "recovering"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "stuffy nose"; PAIN (non-serious), outcome "recovering", described as "body aches"; HEADACHE (non-serious), outcome "not recovered".  Additional information: patient received a Covid 19 booster on 10/7/2024 and started having a reaction w/in hours. Symptoms include tingling down the ulnar side of the arm on injection side, chills, sweats, dry throat, stuffy nose, body aches, headache. The symptoms are slowly resolving but the patient is still having sweats/chills, mild headache and stuffy nose.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report vaccines were administered after experiencing a temperature excursion.; This spontaneous report was received from a Licensed vocational nurse (LVN) (also reported as nurse), referring to an 18-month-old male patient. The patient's pertinent medical histories, concurrent conditions, previous drugs reactions or allergies, and concomitant medications were not reported.   On 23-JUL-2024, the patient was vaccinated with improperly store second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection in the left arm (deltoid), lot # x023975 which has been verified to be valid, expiration date reported and established as 18-APR-2025 (strength, dose quantity, route of administration, and vaccination scheme were not provided) as a prophylaxis. The vaccine was administered after a temperature excursion of 8.8 degree Celsius (C) during a time frame of 4 minutes and 45 seconds (product storage error). No previous temperature excursion was reported. No additional information was provided. No additional adverse event (AE) was provided.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2410USA001631: US-009507513-2410USA001321: US-009507513-2410USA001362: US-009507513-2410USA001364: US-009507513-2410USA001493: US-009507513-2408USA009052:
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP called to report TE where products were administered after stored improperly. No Additional information provided. No Additional AE/ No PQC.    0 hours 30 minutes 0 seconds @ -11.25c (prior) o hours 30 minutes 0 seconds @-11.63c (prior) 0 hours 44; This spontaneous report was received from licensed practical nurse concerning to a 13-year-old patient of unspecified gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 04-OCT-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #y010374, expiration date: 05-JUN-2026, 0.5 ml, administered as prophylaxis (strength, anatomical location, and route of administration were not provided) by a health care professional, that had gone through a temperature excursion (TE) after being improperly stored as follows: 30 minutes (min) at -11.25 degree Celsius (C), 30 min at-11.63 C, 44 min at -8.69 C, 36 min at -9.63 C, 44 min at -8.25 C (Product storage error).; Sender's Comments:  US-009507513-2410USA003525:MSD
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Lack of immunogenicity after the fourth dose; Lack of immunogenicity after the fourth dose; This spontaneous report was received from a company representative concerning to a male patient of unknown age. The patient's concurrent conditions, medical history, concurrent conditions and medical history was not provided.  On an unknown date, the patient was vaccinated with fourth dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (strength, formulation, dose, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported) (inappropriate schedule of product administration)       On an unknown date, after the patient received the fourth dose of the vaccine experienced lack of immunogenicity (vaccination failure)   The outcome of vaccination failure and inappropriate schedule of product administration was unknown.     The causality assessment between vaccination failure and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was considered to be related.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea
Clinical narrative: stomach pains; shortness of breath; dizziness.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2024, the patient received Shingrix. In AUG-2024, less than a day after receiving Shingrix, the patient experienced stomach pain (Verbatim: stomach pains), shortness of breath (Verbatim: shortness of breath) and dizziness (Verbatim: dizziness.). The outcome of the stomach pain, shortness of breath and dizziness were not resolved.   It was unknown if the reporter considered the stomach pain, shortness of breath and dizziness to be related to Shingrix.     It was unknown if the company considered the stomach pain, shortness of breath and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2024 The HCP (health care professional) reported that she had a patient that was vaccinated with Shingrix 5 weeks ago (from the date of reporting) and since the date of vaccination the patient stated that she had been experiencing shortness of breath, stomach pains and dizziness. No further information was known such as any patient demographics, date of vaccination and dose number.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 64-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 04-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria medically significant and life threatening). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.  Company Comment: This is a spontaneous case, concerning a 64-year-old male patient with no medical history reported, who experienced the serious (per medically significant and life threatening) unexpected AESI of Pulmonary embolism which occurred on the day after an unknown dose number of SPIKEVAX 2024-2025 KP.2 PFS received for COVID-19 Vaccination schedule. The event was resolving. No concomitant medication or treatment information was reported. Patient's age could remain a confounding risk factor. The benefit-risk relationship of SPIKEVAX 2024-2025 KP.2 PFS is not affected by this report.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: patient had injection site reactions, sore arm and red spots; patient had injection site reactions, sore arm and red spots; Initial information received on 20-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to US-SA-2024SA285980.  This case involves a 31 years old female patient who experienced injection site reactions, sore arm and red spots after receiving rabies (HDC) vaccine [IMOVAX Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2024, the patient received 0.1 ml of dose 1 of rabies (HDC) vaccine Powder and solvent for suspension for injection with strength standard (lot W1C931M and expiry date- 31-Oct-2025) once via intramuscular route in the left arm and on 16-Sep-2024 she also received an 0.1 ml of dose 2 of same vaccine (lot W1C931M and expiry date- 31-Oct-2025) once via intramuscular route in the left arm all for Immunization.  On an unknown date in Sep-2024 the patient developed injection site reactions, sore arm and red spots (vaccination site pain) (vaccination site erythema) (latency- approximately few days) following the administration of rabies (HDC) vaccine.  Reportedly, registered nurse provided patient information on 5 students that had potential adverse reactions from IMOVAX vaccinations. Caller stated that the institution only requires 2 shots.There was no other vaccines.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.; Sender's Comments:  US-SA-2024SA285980:
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Pallor, Tearfulness
Clinical narrative: Prior to vaccination verified w/ patient and mother if patient is/have sick, fever, n/v, diarrhea, drug allergies, medical conditions, and if patient had reaction to vaccines before.  Mom confirmed no and had vaccines before w/o complications.  After 5 minutes of administrations, patient complained of dizziness.  Patient was sweating, tearful, anxious, and lips where white.  Father stated patient was nervous and overthinking of the vaccinations prior to administration.  Patient was sitting down with parents.  Called 991 ambulance.  Paramedics checked vitals and stated they were strong and asked parents if they wanted to take patient to the ER.  Parents refused because patient was recovering by the time paramedics arrived and had more color, not pale and lips back to normal.  Parents and patient (layed on the couch) stayed longer to recover fully.  Also, parents gave patient child water and chocolate.  All left after 15-20 minutes - patient fully recovered and standing/walking.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Injection site swelling, Neuropathy peripheral
Clinical narrative: swelling to left deltoid and ulnar neuropathy
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Aural fullness, tinnitus
Age: 46.0
Sex: F
Vaccine: YF
Symptoms: Injection site discomfort, Injection site inflammation, Injection site rash
Clinical narrative: rash, inflammation, discomfort around injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Mom called and said pt left leg was swollen. She stated it started after she got the shot. I advised her to take her to urgent care. They gave patient ZYRTEC to calm the reaction.
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Hyperhidrosis, Muscle rigidity, Unresponsive to stimuli
Clinical narrative: Patient dizzy after 1st injection (Pfizer Covid) Patient became unresponsive after 2nd injection (flu) + sweaty + then became rigid. Wife shook him + he regained consciousness. 911 called. He repeated this episode while Paramedics on the seen + they took his to E.R
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling at site, fever, pain at site: right shoulder. Diagnosed as cellulitis. Treated with oral antibiotics. Also treating with antipuretics.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Hypoaesthesia
Clinical narrative: Hearing loss left facial numbness. pt was prescribed Medrol Dosepak after being evaluated by ER doctor @ Hospital.
Age: 8.0
Sex: F
Vaccine: DTAPIPV, TDAP
Symptoms: No adverse event
Clinical narrative: No reaction to the vaccine at this time. Patient will have a follow up for additional vaccines needed for school.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain, Pain in extremity
Clinical narrative: I woke up in the middle of the night with a burning pain in my left leg.  It radiated from my calf up to my thigh.  It was unusual.  It hurt so much I was agonizing.   I got up and went to the kitchen and it went away after five minutes.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered Prevnar 20 but Prevnar 13 was inadvertently administered; no reaction noted; no issues; provider notified and working to create plan for follow-up with patient; documentation correct
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue, Gait inability
Clinical narrative: Next day after receiving the injections, patient came down with fever, sore throat  a d extreme tiredness. He was unable to run and play as usual . He felt weak in his legs.. I treated him at home as I know some slight fever and  effects can occur after vaccines.  It took him about a week to recover.  Unfortunately  subsequently about every 4- 6 weeks after that patient  started to have episodes of sickness where he would come down with fever, become woozy, headache, extreme weakness, no strength , could only sleep and stay in bed. Each bout lasted about a week or so. JAN 2024 the sickness came back again. This time it was pretty severe.  He couldn't walk, or hold his balance straight.  He list partial function of his legs. I took him into for a doctor visit where he was transferred to the Er. They admitted him for 2 days. Gave him immunio therapy as he was diagnosed with Gullian Barre / some type of auto immune disease attacking his nerve coverings
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Headache, Illness, Immunoglobulin therapy, Laboratory test abnormal
Clinical narrative: Next day after receiving the injections, patient came down with fever, sore throat  a d extreme tiredness. He was unable to run and play as usual . He felt weak in his legs.. I treated him at home as I know some slight fever and  effects can occur after vaccines.  It took him about a week to recover.  Unfortunately  subsequently about every 4- 6 weeks after that patient  started to have episodes of sickness where he would come down with fever, become woozy, headache, extreme weakness, no strength , could only sleep and stay in bed. Each bout lasted about a week or so. JAN 2024 the sickness came back again. This time it was pretty severe.  He couldn't walk, or hold his balance straight.  He list partial function of his legs. I took him into for a doctor visit where he was transferred to the Er. They admitted him for 2 days. Gave him immunio therapy as he was diagnosed with Gullian Barre / some type of auto immune disease attacking his nerve coverings
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Musculoskeletal disorder, Oropharyngeal pain
Clinical narrative: Next day after receiving the injections, patient came down with fever, sore throat  a d extreme tiredness. He was unable to run and play as usual . He felt weak in his legs.. I treated him at home as I know some slight fever and  effects can occur after vaccines.  It took him about a week to recover.  Unfortunately  subsequently about every 4- 6 weeks after that patient  started to have episodes of sickness where he would come down with fever, become woozy, headache, extreme weakness, no strength , could only sleep and stay in bed. Each bout lasted about a week or so. JAN 2024 the sickness came back again. This time it was pretty severe.  He couldn't walk, or hold his balance straight.  He list partial function of his legs. I took him into for a doctor visit where he was transferred to the Er. They admitted him for 2 days. Gave him immunio therapy as he was diagnosed with Gullian Barre / some type of auto immune disease attacking his nerve coverings
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Next day after receiving the injections, patient came down with fever, sore throat  a d extreme tiredness. He was unable to run and play as usual . He felt weak in his legs.. I treated him at home as I know some slight fever and  effects can occur after vaccines.  It took him about a week to recover.  Unfortunately  subsequently about every 4- 6 weeks after that patient  started to have episodes of sickness where he would come down with fever, become woozy, headache, extreme weakness, no strength , could only sleep and stay in bed. Each bout lasted about a week or so. JAN 2024 the sickness came back again. This time it was pretty severe.  He couldn't walk, or hold his balance straight.  He list partial function of his legs. I took him into for a doctor visit where he was transferred to the Er. They admitted him for 2 days. Gave him immunio therapy as he was diagnosed with Gullian Barre / some type of auto immune disease attacking his nerve coverings
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction noted
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Pain in extremity
Clinical narrative: Currently breastfeeding (baby first nursed approximately 1hr post injections); left arm has soreness; headache (onset approximately 1-2hrs post injection, it stopped around 6hr post injection after taking Acetaminophen)
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted within 2 minutes of receiving vaccine
Age: 70.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Asthenia, Back pain, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Patient received vaccine and left the office.  He returned approximately 2-3 minutes later reporting weakness, chest tightness, shortness of breath, severe back pain, and lightheadedness.  He was seated and placed on oxygen, vital signs taken and within normal range.  EMS and Patient's wife were called.  Symptoms resolved within 10 minutes.  Patient deferred ER evaluation and was taken home by spouse.  Patient was called the next morning and reported only feeling tired.  He was notified to speak with his cardiologist regarding the above events.
Age: 70.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Fatigue
Clinical narrative: Patient received vaccine and left the office.  He returned approximately 2-3 minutes later reporting weakness, chest tightness, shortness of breath, severe back pain, and lightheadedness.  He was seated and placed on oxygen, vital signs taken and within normal range.  EMS and Patient's wife were called.  Symptoms resolved within 10 minutes.  Patient deferred ER evaluation and was taken home by spouse.  Patient was called the next morning and reported only feeling tired.  He was notified to speak with his cardiologist regarding the above events.
Age: 70.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Back pain, Chest discomfort, Dyspnoea, Feeling hot, Palpitations
Clinical narrative: Patient received vaccine and left the office.  He returned approximately 2-3 minutes later reporting weakness, chest tightness, shortness of breath, severe back pain, and lightheadedness.  He was seated and placed on oxygen, vital signs taken and within normal range.  EMS and Patient's wife were called.  Symptoms resolved within 10 minutes.  Patient deferred ER evaluation and was taken home by spouse.  Patient was called the next morning and reported only feeling tired.  He was notified to speak with his cardiologist regarding the above events.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Pt was informed of the medication error via phone. Pt verbalized understanding. Pt reported doing well and was seen by her OB/GYN  since the vaccine administration.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient experienced severe dizziness about 26 hours the shot was given. And has several episodes since then. But feels too uncomfortable with driving to see the doctor.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient was given the lower dose of covid vaccine for his age.  Recieved the 5-11year dose instead of the 12+ dose
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: Muscle aches, both shoulders and elbows.
Age: 89.0
Sex: M
Vaccine: RSV
Symptoms: Chest discomfort, Discomfort, Dysphonia, Productive cough, Rhinorrhoea
Clinical narrative: pt states about an hour after the vaccine his nose started running. He thought it was his allergies. He started using Flonase nose spray to treat symptoms. A few days later his voice became hoarse and coughing up phlegm. Now he has a heavy chest and throat. He has been using a steam treatment and flonase. He feeling like he is slowly recovering. He will follow up with his physician if is symtpoms worsen.
Age: 77.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Extreme soreness in the arm and pain in the neck area.
Age: 3.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No adverse event has been observed or reported.  Patient received a full vial of undiluted COVID vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Electrocardiogram, Myocardial necrosis marker, X-ray
Clinical narrative: Three days following vaccine, I had a non-stemi myocardial infarction.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received dose on 09/25 and received a second dose in error on 10/08
Age: 1.58
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No adverse event was observed or reported.  Patient received one vial of undiluted COVID vaccine.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Ear pain, Oropharyngeal pain, SARS-CoV-2 test, Tenderness
Clinical narrative: Cough, sore throat, rubs hurt, ears hurt
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction noted
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fine motor skill dysfunction, Pain in extremity, Surgery
Clinical narrative: pt states she had sore arm after vaccination. she went to Dr in December.  she having fine motor skill problem. she pre diabetic. she had surgery but she still having issue
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient received RSV vaccine at routine return OB visit at 35 weeks. A few hours afterward developed a red, indurated and golf-ball sized reaction at the site that over the next 24hrs increased in size to that of a baseball and stabilized. Patient otherwise well. Symptoms mildly, improved with Benadryl per report and patient encouraged to keep scheduled clinic follow up <1 week after reaction.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Heart rate increased
Clinical narrative: Elevated heart rate during sleep as detected by Watch. There were 9 high heart rate notifications during sleep. From 10:00 pm through morning the lowest recorded heart rate was 87 bpm.  Average resting heart rate is still at 80 bpm as of 12 hours later. Normal resting heart rate generally ranges from 65-70 bpm
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Swelling face, Swollen tongue
Clinical narrative: Anaphylactic reaction- Facial and tongue swelling, difficulty breathing, cough. MD in on rounds. ordered to give benadryl 50mg, placed on O2 3lpm and neb tx with positive effect spo2 99%. Follow-up at approx 3:20PM s/p po benadryl; Patient noted with no improvement to facial swelling, Respirations noted with SOB, RR at 22/min; Patient remains alert and oriented, states he feels like he's "having trouble breathing"; SpO2-96% on 3L/min via nasal cannula NP at bedside and orders EpiPen 0.3 mg/0.3 mL IM injection x one dose STAT, Solu-Medrol 125mg IM injection x one dose STAT, transfer to ED for further evaluation. RN administered EpiPen and Solu-Medrol per order, and RN remained at bedside until 911/paramedic arrived. Transferred at approx 3:35PM to Hospital.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Rash, Urticaria
Clinical narrative: Full body rash, hives
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Several weeks after Covid-19 vaccines (unsure if it was after 1st dose or 2nd dose) patient developed tinnitus in right ear. Tinnitus has been constant and ongoing since April 2021
Age: 1.25
Sex: M
Vaccine: COVID19, DTAP
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: COVID-19 vaccine was not properly diluted before given to the patient. One of our medical assistants diluted the 6m-4yr vaccine with 0.1 mL of diluent instead of the required 1.1mL of diluent.  The patient then received 0.3 mL of the improperly diluted vaccine.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt was given a flu shot (sanofi fluzone high dose lot u8499da) and the pfizer cominarty in the right arm, pt went into hospital but I was not given any details on what happened but the daughter claimed it was because of two shots administered together. I am sorry I do not have more information.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a flu shot for the second time this season. first shot on 7/29 and then received a second shot for this years flu again on 10/6. Patient reported no issues or adverse effects from the second shot when called upon discovery
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Dizziness, Full blood count normal, Immediate post-injection reaction, Laboratory test normal
Clinical narrative: Immediate dizziness, vision changes, weakness of legs after administration with prolonged symptoms, requiring hospitalization and IV hydration
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Metabolic function test normal, Muscular weakness, Visual impairment
Clinical narrative: Immediate dizziness, vision changes, weakness of legs after administration with prolonged symptoms, requiring hospitalization and IV hydration
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: patient received vaccine and minutes after receiving the vaccine patient passed out.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Injection site erythema, Injection site inflammation, Injection site warmth, Pain in extremity
Clinical narrative: My Arm was sore within a couple of hours after receiving the injection and remained sore for the rest of the day.   At about 4:30 while driving I had a very strange dizzy sensation come over my head and felt like my head and inner ears were rattling. I pulled over and it passed quickly and did not return.  My arm at the injection site has been red, warm and inflamed since the afternoon of receiving the shot, two days ago.   I have not had any other dizzy spells or other symptoms yet.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: I gave Fluad on 10/2 and again on 10/9.  I was supposed to have given her a Spikevax but pulled the incorrect vaccine.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: patient received the 2nd dose of HPV vaccine moments after patient passed out.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a dose of Abrysvo not realizing he had previously been vaccinated 11 months earlier. Patient was notified and also informed that he should not request another rsv dose. Patient stated he had not had any adverse events or effects.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client received high dose instead of regular flu. Not 65+
Age: 43.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Men B vaccine at the age of 43 years old.  NP gave due to traveling.  No history of Men B vaccine noted in chart.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adverse event: Patient given MMRV at age 13. Cutoff is age 12.                                                                                                                                                                                              She also received Hep B, IPV and Tdap during this encounter.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received Fluad and Flucelvax in left deltoid when Fluad and Covid-19 booster were requested. No symptoms observed following administration.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paraesthesia oral
Clinical narrative: Reports gradual onset of tongue tingling, right sided neck pain starting approx 5 hours after injection
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pollakiuria, Rash macular
Clinical narrative: about 1800 felt flu like symptoms,  went to bed early.  Next night slept with bad frontal headache all night, urinated 5 times during night. Headaches off and on for several nights. On Oct 8 at 1200 my left foot had blood splotchs all over, Red over 70% percent, and red markings up to buttock. Right foot less sploches. After I saw this, I went to ER, Dr said it is my body thinking it has covid and fighting it. As of Oct 11, slight headache at night but gone after breakfast
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Depression, Pituitary tumour, Systemic lupus erythematosus
Clinical narrative: Lost all my hair and diagnosed as Alopecia totalis and severe mental depression/anexiety. Then turned into many new symptoms and diagnosis including Lupus tumor on pituitary gland
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Cough, Cyanosis, Electrocardiogram normal, Fatigue, Hyporesponsive to stimuli
Clinical narrative: He received his first influenza vaccine at approximately 1315 on 1010/24.  He was observed for 15 minutes following vaccine administration and did well.  They then went to the supermarket, and mom states that patient looked more tired than usual.  In the car on the way back home, he continued to look more tired.  By the time he got home it was a little less than 1 hour post-vaccine and he had a large episode of NBNB emesis.  He also started having a couple episodes of coughing and sneezing and overall appeared very fatigued with decreased responsiveness and paleness.  He was very limp.  Mom tried to breast-feed and he would not latch to the breast which mom states is never happened before.  She also notes that he started breathing faster.  He had no wheezing, no difficulty breathing, no rash, no itching, no swelling of his lips or tongue, no shaking of his extremities, and did not return back to his baseline during this time.    They drove him over to urgent care, and he had an additional episode of emesis in the car.  At urgent care he was noted to have cyanosis around his nose, he was afebrile, HR 163, RR 40, SpO2 99% on RA, no BP taken at this time.  Given concern for anaphylaxis he was given epinephrine intramuscular 0.15 mg at 1545 and subsequently they called 911 so that he could be transported to emergency department.  Mom states that following the epinephrine, he was more alert awake and woke up crying. His color improved.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Hypotonia, Pallor, Poor feeding infant, Respiratory rate increased, Sneezing
Clinical narrative: He received his first influenza vaccine at approximately 1315 on 1010/24.  He was observed for 15 minutes following vaccine administration and did well.  They then went to the supermarket, and mom states that patient looked more tired than usual.  In the car on the way back home, he continued to look more tired.  By the time he got home it was a little less than 1 hour post-vaccine and he had a large episode of NBNB emesis.  He also started having a couple episodes of coughing and sneezing and overall appeared very fatigued with decreased responsiveness and paleness.  He was very limp.  Mom tried to breast-feed and he would not latch to the breast which mom states is never happened before.  She also notes that he started breathing faster.  He had no wheezing, no difficulty breathing, no rash, no itching, no swelling of his lips or tongue, no shaking of his extremities, and did not return back to his baseline during this time.    They drove him over to urgent care, and he had an additional episode of emesis in the car.  At urgent care he was noted to have cyanosis around his nose, he was afebrile, HR 163, RR 40, SpO2 99% on RA, no BP taken at this time.  Given concern for anaphylaxis he was given epinephrine intramuscular 0.15 mg at 1545 and subsequently they called 911 so that he could be transported to emergency department.  Mom states that following the epinephrine, he was more alert awake and woke up crying. His color improved.