chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Bursitis, Joint swelling
Clinical narrative: Joint swelling; Bursitis; Initial information received on 25-Mar-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/ Non-Healthcare Professional.  This case involves a 75 year old female patient who experienced joint swelling and bursitis after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose], COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine] and RSV vaccine prot. subunit PreF 2v [Abrysvo].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rosuvastatin; Omeprazole; Chondroitin sulfate, Glucosamine hydrochloride (Osteo bi-flex) for Product used for unknown indication; Vitamins NOS; and Paracetamol (Tylenol) all for Product used for unknown indication.  On 03-Jan-2025, the patient received an unknown dose 1 of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination, received an unknown dose 1 of Abrysvo not produced by Sanofi Pasteur Injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination and received an unknown dose 1 of Novavax COVID-19 Vaccine not produced by Sanofi Pasteur lot number not reported via intramuscular route in unknown administration site for COVID-19 immunization.   On 18-Jan-2025 the patient developed joint swelling and bursitis (latency- 15 days).  Information on the batch number cannot be requested corresponding to the one at time of event occurrence.   Reportedly, swelling of elbow.   Action taken was not applicable.  The patient was treated methylprednisolone (MEDROL A) and Joint fluid drainage for both the events.   At time of reporting, the outcome was Unknown for both the events.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: administered a dose of IPOL MDV which was involved in a temperature excursion with no reported adverse event; Initial information received on 21-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an infant and unknown gender patient who was administered with a dose of IPV (VERO) [IPOL] which was involved in a temperature excursion of low temperature which reached 48° fahrenheit with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Mar-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot X1C891M, expiry date 31-Oct-2026; strength standard, frequency once) for Immunisation.  On 15-Mar-2025, the patient was administered with a dose of Ipol MDV which was involved in a temperature excursion of low temperature which reached 48° fahrenheit with no reported adverse event (poor quality product administered) (product storage error) (latency same day).  Reportedly, the vaccine Program Manager reporting that a clinic possibly administered a dose of Ipol MDV which was involved in a temperature excursion. There is no extended stability data cover for the excursion.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or side effects reported; Physician called to report a T/E on PROQUAD and one dose was administered to a patient today, 3/3/2025. No symptoms or side effects reported.; This spontaneous report has been received from a physician regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 03-MAR-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection, at a dose of 0.5 mL, administered as prophylaxis (lot number reported as Y015992, which has been verified as valid, expiration date reported and validated as 23-MAR-2026), with sterile diluent (BAXTER STERILE DILUENT).  The administered dose was exposed to a temperature excursion of 40 Fahrenheit degrees (F) for 1800 hours. No symptoms or side effects reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02762610-02762603 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V5aViYAJ|03032025230058|1370 , Central date : 2025-03-04 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02762610 , MNSC interaction number : 02762603 , Integration log UniqueID : 500UW00000V5aViYAJ|03032025230058|1370 , Service cloud CaseID : 500UW00000V5aViYAJ
Vaccine: VARCEL, VARCEL
Symptoms: Product dose omission issue
Clinical narrative: no adverse event; patient ran out of medication; missed dose; This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   From 29-Jan-2025 to 19-feb-2025 (exact dates were unknown), the patients had missed doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for prophylaxis (schemes, doses, routes of administration, anatomical locations, lot numbers, and expiration dates were not reported) due to a delay of shipment (missed dose) (patient ran out of medication).  No other information was known or provided.; Reporter's Comments:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Frequent bowel movements, Gastrointestinal disorder, Nausea
Clinical narrative: nauseous; felt lousy/does not feel like herself; having frequent bowel movements; stomach bothering; feeling very tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose on unknown date).   On 18-MAR-2025, the patient received the 2nd dose of Shingrix (right arm). On 18-MAR-2025, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: feeling very tired ). On an unknown date, the patient experienced nausea (Verbatim: nauseous ), feeling bad (Verbatim: felt lousy/does not feel like herself), frequent bowel movements (Verbatim: having frequent bowel movements) and stomach discomfort (Verbatim: stomach bothering). The outcome of the tiredness, nausea, feeling bad, frequent bowel movements and stomach discomfort were not resolved.   It was unknown if the reporter considered the tiredness, nausea, feeling bad, frequent bowel movements and stomach discomfort to be related to Shingrix.     It was unknown if the company considered the tiredness, nausea, feeling bad, frequent bowel movements and stomach discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-DEC-2024  Consumer was the reporter. Reporter stated that she received her second dose of Shingrix 18th March 2025 in her right arm. Consumer stated she began feeling very tired last night and was still feeling tired today. Consumer stated she felt lousy and does not feel like herself. Stated she was nauseous and having frequent bowel movements. Stated if she had known the second dose was going to make her feel like this she would not have had the dose administered.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles a few weeks ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles a few weeks ago). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAR-2025 The case was received from the patient via interactive digital media. The patient had both shots and got shingles a few weeks ago. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st and 2nd dose).
Age: 75.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Rash
Clinical narrative: PATIENT CALLED ROUGHLY 6 HOURS AFTER THE VACCINES WERE ADMINISTERED WITH A CC OF GENERALLIZED RASH ON THE TRUNK FROM BELOW THE BREASTS TO THE ABDOMEN
Age: 62.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: WRONG VACCINE GIVEN. PATIENT HAD ZERO REACTIONS OR SIDE AFFECTS ONCE ERROR WAS FOUND AN HOUR LATER
Age: 2.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Angioedema
Clinical narrative: 2yo Male presented to Immunization Clinic for travel vaccines with provider prescription.  Vaccines were administered as follow IM Route:  Typhoid (Typhim VI): 0.5 ml Lot# X1A261M Meningococcal ACWY (Menveo):  0.5ml Lot # AMAB056A Subcutaneous Route:  Yellow Fever (YF-Vax): 0.5ml Lot# UK134AA Vaccines were administered around 1411. 24 minutes later, father of patient called for help because he believed the patient was having an allergic reaction. Upon assessment, he displayed signs of facial angioedema, watery eyes and cough. Epinephrine Autoinjector (0.15mg) lot # 3FE588 was administered immediately in the left vastus lateralis at 1435 and Rapid response team was activated.  Initial set of vitals signs taken at 1438  BP: 139/91 RR :30 breaths per minute O2 :100% HR 117 bpm  Rapid Response Team showed up at 1438 (within 3 minutes) and transferred patient to the Emergency Department for further treatment and observation.   Father of patient denied any history of allergies or adverse events following vaccination. Prior to vaccine administration, he answered "no" to all relevant questions as listed in DD 3110 "Routine Immunization Screening Form: Pediatric"  Routine Vaccine Screening   Routine vaccine peds sick today :   No  Routine vaccine peds serious reaction :   No  Routine vaccine peds allergies :   No  Routine vaccine peds nervous system :   No  Routine vaccine peds health problem :   No  Routine vaccine peds immune system :   No  Routine vaccine peds immune system :   No  Routine vaccine peds blood products :   No  Routine vaccine peds intussusception :   No  Routine vaccine peds asthma :   No  Routine vaccine peds splenectomy :   No  Routine vaccine peds vasovagal :   No  Routine vaccine peds recent vaccines :   No  Routine vaccine peds pregnant :   No
Age: 1.67
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and full body rash
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Injected sterile diluent into patient without mixing vaccine component.  Realized error and corrected error, injected vaccine correctly with a new syringe.  No adverse effects seen.  Patient aware of error and was understanding of situation.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Injected limb mobility decreased, Nasopharyngitis, Quality of life decreased, Stent placement
Clinical narrative: Could not lift my right arm  above my shoulder for nearly a year. Caught a horrible cold after the first shot. I hadn't had a cold for a consecutive 15 years and only 3 colds (that lasted a day or less) within 30 years. Started having blood pressure issues. After the second shot, caught a cold that lasted a week. Blood pressure issues increased and affected quality of life tremendously.  Difficulty finding a medication that I don't have adverse reactions to it
Age: 49.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult patient, 49 y.o male administered dtap in error. Should have received TDAP
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Patient assessment after 10 minutes: Reaction: Patient requested bottled water.  When this nurse came back into room patient appeared pale, diaphoretic, and his eyes were closed. Patient woke with a sternal rub, remained  pale, patient followed commands. RN at patient chair side Patients  heart rate 64, pulse ox 98%  rapid response called by Dr.   Dr.   and Rn visualized patient. Patient responded to RN  however reamained pale and diaphortic patient eyes open, patient response to  verbale stimuli. Guardian verbalized that patient passes out whenever he has labs  drawn or receives injections. Dr. verbalzied to bring patient to ER if  needed. Rn  pivoted patient from chair to wheelchair. At that time  pharmacy, security, laboratory started to depart and patient was brought over to  the ER with guardian by RN assisted patient.
Age: 53.0
Sex: F
Vaccine: HEP, MMR, PNC20
Symptoms: Cough, Lip blister, Lip swelling, Swollen tongue
Clinical narrative: Patient started to have swelling in her lips/tongue. Patient reports a blister appearing on the upper part of her lip. Patient developed a cough.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: pt fainted shortly after i gave Boostrix vaccine
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Injection site swelling, Liver function test increased, Syncope
Clinical narrative: Patient felt fatigue, dizziness 3 days after receiving vaccine, Patient's left arm was swollen at the injection side. Patient had syncope episode 3 days after receiving vaccine. Patient was rushed to ER. Her Liver function tests were elevated at the hospital
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Pain in jaw, Trigeminal neuralgia
Clinical narrative: After receiving the second dose of the Pfizer COVID-19 vaccination, I started to have pain on the right side of my job. The started about 2 days after receiving the dose. At first I thought it was tooth pain. I went to the dentist multiple times, but they didn't see anything. I was diagnosed with trigeminal neuralgia. I have had flares off and on ever since then. Currently I am in a flare that is unbearable. There has never been a way to tie it officially to the vaccine. However, this all started right after receiving it and I have never had these issues before I received the vaccine. I want to note that I am not someone who is against vaccines. But this needs to be known by people because my pain is intense and I don't think I am the only one who has had this effect from these vaccines.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Herpes simplex test negative, Herpes zoster
Clinical narrative: Seen 3/21/25 for apparent 3rd episode of Zoster this time different body location than the previous two. Cause felt to be related to post vaccination infection rather than naturally occurring chicken pox.
Age: 17.0
Sex: M
Vaccine: HEP, MMRV, TDAP, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient had vaccination error at our clinic. He had got ProQuad and Varivax instead of MMR and Varivax. Talked with pt.'s dad and pt has not had any adverse reactions at this time. Notified to call clinic if pt develops fever, redness or swelling at injection site or rash. Pt has no adverse reactions at this time. Public Health notified and was instructed to fill out this form in case he gets a reaction.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Injection site mass, Pyrexia, Vomiting
Clinical narrative: Fever of 101.4 for 4 days after injection. Gold ball size knot to Left deltoid for 10 days. Vomiting  and diarrhea for 4 days. Symptoms started 4 hours after injection.
Sex: F
Vaccine: COVID19, FLU3, RSV, COVID19, FLU3, RSV
Symptoms: Bursitis, Joint fluid drainage, Joint swelling
Clinical narrative: Bursitis; Joint swelling; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025-NVX-US-00214 (Novavax).  A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Jan2025 as dose 1, single (Batch/Lot number: unknown) intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 03Jan2025 as dose 1, single) intramuscular for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 03Jan2025 as dose 1, single) intramuscular for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; TYLENOL; VITAMINS NOS; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; OMEPRAZOLE. The following information was reported: BURSITIS (medically significant) with onset 18Jan2025, outcome "unknown"; JOINT SWELLING (non-serious) with onset 18Jan2025, outcome "unknown". Therapeutic measures were taken as a result of bursitis.  Clinical course: On 07Feb2025, a non-serious initial Regulatory Authority report was reported by a consumer or other non health professional via Centers of Disease Control and Prevention via Vaccine Adverse Event Reporting System (VAERS ID: 2825282-1) and was received by Novavax on 17Mar2025 and concerns a 75 year-old female who experienced JOINT SWELLING and BURSITIS on 18Jan2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 16 Day. FLUZONE HIGH DOSE and ABRYSVO were also considered suspect. Treatment included Joint fluid drainage and Medrol. At the time of the report, the outcome of the events of Joint swelling, Bursitis was Unknown. The CDC's adverse event description (narrative) was provided as follows: Don't know that elbow bursitis is a reaction. Swelling of elbow. It was drained today and Medrol was prescribed. A discrepancy was identified where the event of Joint fluid drainage was captured as a treatment based on the information provided in the adverse event description section of the source document. Company Remarks (Sender's Comments) : This 75 year-old female experienced Joint swelling and Bursitis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Joint swelling was reported as non-serious. The event Bursitis was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between the vaccine and the events is considered Possible.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLU3, RSV, COVID19, FLU3, RSV
Symptoms: Bursitis, Joint swelling
Clinical narrative: Bursitis; Joint swelling; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025-NVX-US-00214 (Novavax).  A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Jan2025 as dose 1, single (Batch/Lot number: unknown) intramuscular for immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 03Jan2025 as dose 1, single) intramuscular for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 03Jan2025 as dose 1, single) intramuscular for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; TYLENOL; VITAMINS NOS; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; OMEPRAZOLE. The following information was reported: BURSITIS (medically significant) with onset 18Jan2025, outcome "unknown"; JOINT SWELLING (non-serious) with onset 18Jan2025, outcome "unknown". Therapeutic measures were taken as a result of bursitis.  Clinical course: On 07Feb2025, a non-serious initial Regulatory Authority report was reported by a consumer or other non health professional via Centers of Disease Control and Prevention via Vaccine Adverse Event Reporting System (VAERS ID: 2825282-1) and was received by Novavax on 17Mar2025 and concerns a 75 year-old female who experienced JOINT SWELLING and BURSITIS on 18Jan2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 16 Day. FLUZONE HIGH DOSE and ABRYSVO were also considered suspect. Treatment included Joint fluid drainage and Medrol. At the time of the report, the outcome of the events of Joint swelling, Bursitis was Unknown. The CDC's adverse event description (narrative) was provided as follows: Don't know that elbow bursitis is a reaction. Swelling of elbow. It was drained today and Medrol was prescribed. A discrepancy was identified where the event of Joint fluid drainage was captured as a treatment based on the information provided in the adverse event description section of the source document. Company Remarks (Sender's Comments) : This 75 year-old female experienced Joint swelling and Bursitis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Joint swelling was reported as non-serious. The event Bursitis was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between the vaccine and the events is considered Possible.  Batch/lot number is not provided, and it cannot be obtained.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Biopsy skin, Blister, Body temperature increased, Rash, Skin lesion
Clinical narrative: Varicella zoster virus infection; This spontaneous report was received from a physician and refers to a 3-year-old male patient. The patient's medical history and concomitant therapies were not provided. Current conditions included peanut allergy.   On 23-JAN-2023 (reported as at age 1), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot number W008711, with no expiration date provided that was verified to be valid with expiration date was established as 14-MAR2024, with sterile diluent administered on right thigh for prophylaxis (strength, specific dosage, dose number, route of administration and date were not provided).  On 11-MAR-2025, the patient experienced maximum temperature of 38.0 C and herpes zoster rash involving right ear, scalp and face. Patient had multiple number of lesions distributed on dermatomal in cranial nerve V distribution. On 17-MAR-2025, vesicle/lesion skin sample was collected. On an unknown date in March 2025, he was hospitalized due to the rash with initial concern of Herpes Simplex Virus (HSV) that was found to be Varicella zoster virus (VZV) and on 19-MAR-2025, at hospital discharge was improving from the event (recovering)  The causal relationship between the event and suspect vaccine was not provided.   Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella zoster virus infection; This spontaneous report was received from a physician and refers to a 3-year-old male patient. The patient's medical history and concomitant therapies were not provided. Current conditions included peanut allergy.   On 23-JAN-2023 (reported as at age 1), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot number W008711, with no expiration date provided that was verified to be valid with expiration date was established as 14-MAR2024, with sterile diluent administered on right thigh for prophylaxis (strength, specific dosage, dose number, route of administration and date were not provided).  On 11-MAR-2025, the patient experienced maximum temperature of 38.0 C and herpes zoster rash involving right ear, scalp and face. Patient had multiple number of lesions distributed on dermatomal in cranial nerve V distribution. On 17-MAR-2025, vesicle/lesion skin sample was collected. On an unknown date in March 2025, he was hospitalized due to the rash with initial concern of Herpes Simplex Virus (HSV) that was found to be Varicella zoster virus (VZV) and on 19-MAR-2025, at hospital discharge was improving from the event (recovering)  The causal relationship between the event and suspect vaccine was not provided.   Lot # is being requested and will be submitted if received.
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Eye haemorrhage, Heart failure with reduced ejection fraction, Hypertension
Clinical narrative: stroke; heart failure ef factor lowered; had bad eye bleed; struggle continually with HBP; 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)), 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; HEART FAILURE WITH REDUCED EJECTION FRACTION (medically significant), outcome "unknown", described as "heart failure ef factor lowered"; EYE HAEMORRHAGE (non-serious), outcome "unknown", described as "had bad eye bleed"; HYPERTENSION (non-serious), outcome "not recovered", described as "struggle continually with HBP".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.83
Sex: M
Vaccine: HEP, PNC20
Symptoms: Abnormal faeces, Diarrhoea, Dyspnoea, Lethargy, Pyrexia
Clinical narrative: Extreme vomiting that started 3 hours after vaccination, almost requiring ER visit due to child struggling to breathe with constant vomiting. Extreme vomiting lasted 6 hours. Low grade fever and lethargic.   Very strong smelling loose stools for 1 day after. Then loose stools for a few days after vaccination.
Age: 0.83
Sex: M
Vaccine: HEP, PNC20
Symptoms: Vomiting
Clinical narrative: Extreme vomiting that started 3 hours after vaccination, almost requiring ER visit due to child struggling to breathe with constant vomiting. Extreme vomiting lasted 6 hours. Low grade fever and lethargic.   Very strong smelling loose stools for 1 day after. Then loose stools for a few days after vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen and pain in right arm.  Pain in shoulder joint, elbow, and wrists.  Arm is numb and there is a bruise.   One week has gone by, swelling is down, but arm still in pain and still numb.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Brain operation, Central venous catheterisation, Cerebrospinal fluid leakage, Computerised tomogram, Craniopharyngioma
Clinical narrative: Headaches and migraines after HPV Vaccination. Then more severe migraines,  partial blindness in one eye. Leading up to discovering a craniopharyngioma on July 27, 2023. Surgery to remove craniopharyngioma on Aug. 3, 2023. CSF leak on Aug. 10, 2023. Lumbar drain put back in on Aug. 14, 2023.  Aug.  16, 2023 - Starts Vasopressin/DDAVP every 12 hours. On Aug. 18, 2023 the nurse removed too much CSF 20-40 ml which caused severe head and neck pain, he also started on hydrocortisone every 8 hours. Started taking Levothyroxine every morning before breakfast. Due to surgical removal of craniopharyngioma - he now has panhypopituitarism. Aug. 23, 2023 PICC line and lumbar drain are removed. Aug.  25, 2023 patient is released from the hospital. On March 7, 2024 patient starts on Norditropin.  On 12 March 2024, patient has nose surgery to clean up scar tissue from brain surgery. 11 July 2024 patient has hip surgery for SCFE
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Drain placement, Epiphysiolysis, Headache, Hip surgery, Hypopituitarism
Clinical narrative: Headaches and migraines after HPV Vaccination. Then more severe migraines,  partial blindness in one eye. Leading up to discovering a craniopharyngioma on July 27, 2023. Surgery to remove craniopharyngioma on Aug. 3, 2023. CSF leak on Aug. 10, 2023. Lumbar drain put back in on Aug. 14, 2023.  Aug.  16, 2023 - Starts Vasopressin/DDAVP every 12 hours. On Aug. 18, 2023 the nurse removed too much CSF 20-40 ml which caused severe head and neck pain, he also started on hydrocortisone every 8 hours. Started taking Levothyroxine every morning before breakfast. Due to surgical removal of craniopharyngioma - he now has panhypopituitarism. Aug. 23, 2023 PICC line and lumbar drain are removed. Aug.  25, 2023 patient is released from the hospital. On March 7, 2024 patient starts on Norditropin.  On 12 March 2024, patient has nose surgery to clean up scar tissue from brain surgery. 11 July 2024 patient has hip surgery for SCFE
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Lumbar spinal drainage complication, Magnetic resonance imaging head abnormal, Migraine, Nasal operation, Neck pain
Clinical narrative: Headaches and migraines after HPV Vaccination. Then more severe migraines,  partial blindness in one eye. Leading up to discovering a craniopharyngioma on July 27, 2023. Surgery to remove craniopharyngioma on Aug. 3, 2023. CSF leak on Aug. 10, 2023. Lumbar drain put back in on Aug. 14, 2023.  Aug.  16, 2023 - Starts Vasopressin/DDAVP every 12 hours. On Aug. 18, 2023 the nurse removed too much CSF 20-40 ml which caused severe head and neck pain, he also started on hydrocortisone every 8 hours. Started taking Levothyroxine every morning before breakfast. Due to surgical removal of craniopharyngioma - he now has panhypopituitarism. Aug. 23, 2023 PICC line and lumbar drain are removed. Aug.  25, 2023 patient is released from the hospital. On March 7, 2024 patient starts on Norditropin.  On 12 March 2024, patient has nose surgery to clean up scar tissue from brain surgery. 11 July 2024 patient has hip surgery for SCFE
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Visual impairment
Clinical narrative: Headaches and migraines after HPV Vaccination. Then more severe migraines,  partial blindness in one eye. Leading up to discovering a craniopharyngioma on July 27, 2023. Surgery to remove craniopharyngioma on Aug. 3, 2023. CSF leak on Aug. 10, 2023. Lumbar drain put back in on Aug. 14, 2023.  Aug.  16, 2023 - Starts Vasopressin/DDAVP every 12 hours. On Aug. 18, 2023 the nurse removed too much CSF 20-40 ml which caused severe head and neck pain, he also started on hydrocortisone every 8 hours. Started taking Levothyroxine every morning before breakfast. Due to surgical removal of craniopharyngioma - he now has panhypopituitarism. Aug. 23, 2023 PICC line and lumbar drain are removed. Aug.  25, 2023 patient is released from the hospital. On March 7, 2024 patient starts on Norditropin.  On 12 March 2024, patient has nose surgery to clean up scar tissue from brain surgery. 11 July 2024 patient has hip surgery for SCFE
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Autopsy, Death
Clinical narrative: Death.  Infant found deceased face down in crib the morning after vaccines administered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Pyrexia
Clinical narrative: Patient reported that after receiving the Novavax Covid-19 vaccine, she reported the "worst symptoms and every side effect possible from a vaccine". Confirmed that this was chills, fever, general malaise, shoulder soreness etc. Patient is still experiencing these side. Patient did not report taking any treatments to help alleviate these symptoms. As of time of entering, patient states that they are feeling  much better today (3/29/2025) compared to yesterday (3/28/2025).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Blistering, severely painful rash along left buttock radiating down to the left leg. No local injection site reaction. No hives. No angioedema or anaphylaxis.
Age: 16.0
Sex: M
Vaccine: HPV9, MNP
Symptoms: Malaise, Syncope, Vomiting
Clinical narrative: Syncope and vomiting a few minutes after the second vaccination.  Mother states that he has had a similar reaction in the past to vaccines so we were prepared. He came to after about 5 minutes. I had him to drink water and take a mint to suck on. He laid down on the floor for a few minutes until he was feeling well enough to stand. I  helped him up to stand and he sat in the waiting area chair for a few more minutes until he was feeling well enough to walk out with him mother to go home.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT INADVERTANTLY RECIEVED TWO DOSES ONE MONTH APART
Age: 53.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt came to the pharmacy today reporting of redness, swelling, and pain in both injection sites as well as a fever starting the night of the injection that has calmed down after a few days. She also reported shortness of breath lasting a couple days. Patient took Tylenol and Motrin to help with the symptoms.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Aphasia, Confusional state, Depressed level of consciousness, Fear, Hyperhidrosis
Clinical narrative: Pt was sitting in chair, administered tdap vaccine and within seconds pt became floppy and non verbal. Pt was difficult to arouse for at least 20 seconds, when she came to she was diaphoretic, confused and scared.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Hypotonia
Clinical narrative: Pt was sitting in chair, administered tdap vaccine and within seconds pt became floppy and non verbal. Pt was difficult to arouse for at least 20 seconds, when she came to she was diaphoretic, confused and scared.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Migraine, Sleep study
Clinical narrative: Pain in eyes leading to temples to migrine head ache now into the 33th month
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient stated to me on 3-28-25 that when the vaccinator gave her the shot it was painful. Her arm got swollen and red and marks were radiating outward from vaccination site. the redness went down to elbow area and there was a bump above elbow. she went to the dermatologist because her primary doctor was unavailable. she was given a prednisone taper.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Joint stiffness, Joint swelling, Pain, Polyarthritis
Clinical narrative: Generalized body ache, migratory poly arthritis, joint stiffness, swelling of both ankles
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccine in Aug 2023, came into pharmacy and asked for the RSV vaccine and it was administered again. Spoke with patient the day after vaccination and she reported no adverse events or excess symptoms besides sore arm (also received Shingrix vaccine in opposite arm)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Red, hot, hard, itchy injection Site
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: By later on same day, patient reports soreness of site. By next day, swelling/fullness in area of vaccine with pain, warmth, tenderness to touch. These same symptoms continued and worsened by around day 3 after vaccination. Patient sought care on 3/28/2025 due to ongoing symptoms BUT symptoms had already began to improve day by day.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient is experiencing  severe pain at the injection site in the left shoulder that is persisting for over a month
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient is experiencing  severe pain at the injection site in the left shoulder that is persisting for over a month
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Same day, after injection I experienced diarrhea, tiredness and pain at the injection site
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Loss of consciousness, Magnetic resonance imaging head normal, Magnetic resonance imaging heart normal
Clinical narrative: During the summer of 2021 I began having odd symptoms, as if someone had smacked the back of my head, giving me a momentary feeling of passing out, really only a second in duration. This continued for months, on and off, and Impassedmitmoff as stress induced due to work and family issues. In Aug Imreported it to my PCP and she referred me to neurologist and cardiologist. I had a brain MRI and heart testing. Both were negative. I received the Moderna booster in Nov of that year. Then in Jan 2022, I tested positive for Covid and had a very mild case. In Oct of 2022, Imreceived the Moderna booster. Then in Feb of 2023, I had several instances of much more serious case of momentary blackout. Again, seconds in duration. Followed up with neurology and cardiology. Placed on metoprolol succinctness xl 25 mg as I had a very minor case of svt and possible ocular migraines, although no headaches.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: During the summer of 2021 I began having odd symptoms, as if someone had smacked the back of my head, giving me a momentary feeling of passing out, really only a second in duration. This continued for months, on and off, and Impassedmitmoff as stress induced due to work and family issues. In Aug Imreported it to my PCP and she referred me to neurologist and cardiologist. I had a brain MRI and heart testing. Both were negative. I received the Moderna booster in Nov of that year. Then in Jan 2022, I tested positive for Covid and had a very mild case. In Oct of 2022, Imreceived the Moderna booster. Then in Feb of 2023, I had several instances of much more serious case of momentary blackout. Again, seconds in duration. Followed up with neurology and cardiology. Placed on metoprolol succinctness xl 25 mg as I had a very minor case of svt and possible ocular migraines, although no headaches.
Age: 53.0
Sex: M
Vaccine: PNC21
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient complain of continues soreness and pain on right arm/shoulder especially when trying to left up his hand. this started since the day on vaccination . Pt has tried OTC Ibuprofen and Tylenol, but no relief.  Pt plans to see an MD for examination
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Facial pain, Fatigue, Herpes simplex test, Myalgia
Clinical narrative: fever, generalized myalgia, fatigue, right sided facial soreness, left arm swelling and pain, blistering rash on left upper lip
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash vesicular, Varicella virus test
Clinical narrative: fever, generalized myalgia, fatigue, right sided facial soreness, left arm swelling and pain, blistering rash on left upper lip
Age: 55.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient received adacel and capvaxive in the left deltoid on 3/28/25. Patient reported on 3/30/25 that her arm was red-streaking down arm, sore hot and itchy. No other symptoms were reported upon further questioning. Told patient to use ice, ibuprofen and benadryl for symptoms and to check in with pcp tomorrow when opened from the weekend or sooner if symptoms progressed in severity.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus
Clinical narrative: 45 Minutes after getting it, I started feeling itchiness on my back,  arms, legs, scalp, I dont have rashes  but my body itchiness is terrible on and off.
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Severe bruising at injection site and severe redness and swelling on injection arm upper arm bicep
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV, UNK, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: 48 hours after vaccines, developed a welt on right thigh, 10 cm red, warm, indurated, still there at 72 hours-- tylenol/ibuprofen/ice and reassure
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Patient says that midday on same day of vaccine he experienced a headache that lasted for two days. He says it was treated with Tylenol OTC and then resolved. Per patient the headache was not severe enough to seek medical attention at the time.
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Injection site redness, soreness and rash
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired on 3/15/25. Patient was called immediately to inform him of the error. Pt was still in the store waiting his 30 min grace period post vaccine. Pt didn't report any adverse resections at that time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pt came in and requested to get second dose of Shingrix vaccine to complete the series, she doesn't know when was the first dose given. I double checked on pt's clinical service but did not check STC. Shingrix was given and pt requested to print out all vaccine records and it showed she already completed the series in 2023 and also it showed she got 3rd dose after that and the dose today was 4th. I went thru with patient on potential adverse reaction and let us know if she experiences. Pt understood and stated that she got many shots and did not keep track, now she had the report of all the vaccines to keep track of.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient says she felt numbness in the arm where she got the injection. She claims that she couldnt feel it when you would pinch her arm from shoulder to elbow. Symptom lasted 3 days and went away on its own.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came into pharmacy wanting the Tdap vaccine. It was not caught that patient had received the vaccine on 7/24/2024 and vaccine was administered. Pharmacy Manager tried to reach patient but got voicemail and had to leave a message. Pharmacy will continue to try reaching patient and error has been reported properly through our Corporate Office.
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Swelling
Clinical narrative: erythema ( redness) and slight swellings starting the day after vaccine administered
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Adverse reaction, Extra dose administered
Clinical narrative: Duplicate Administration-no adverse reactions reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given Pfizer-BioNTech vaccine for children 5-11yo as well as the vaccine was expired (12/14/2024)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Patient received incorrect vaccine. Pfizer BiotNtech for children 5yo-11yo and vaccine was expired 12/16/2024
Age: 62.0
Sex: F
Vaccine: HEPAB, PNC20, TDAP
Symptoms: Mobility decreased
Clinical narrative: Patient couldn't move her arm
Age: 71.0
Sex: M
Vaccine: MMR, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second Arexvy shot because he did not remember he had one in October 2023.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling
Clinical narrative: Swelling ,redness and pain at  and around injection site.
Age: 72.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PT WAS GIVEN A SECOND DOSE OF PREVNAR 20, FIRST ONE WAS IN 2022, NO SIDE EFFECTS
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: AFTER THE VACCINATION, HE GOT UNCONSCIOUS FOR FEW SECONDS, THEN FEEL LIKE HE HAD SEIZURE ATTACK.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Fever and high heart rate (190 bpm)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchoscopy abnormal, Chills, Dizziness, Dyspnoea, Eosinophilic granulomatosis with polyangiitis
Clinical narrative: September 2,2021- had redness, pain and swelling at injection site.  Later that night had chills, fatigue, dizzy, muscle aches and feel nauseated with shortness of breath.  This continued and progressed with a fever and swollen lymph nodes.  I called the dr office to notify them of my reactions and was told not to go into the office due to COVID at the time and to try to wait but if symptoms worsened to go to the ER.  My symptoms progressively got worse in less than 2 weeks I was coughing up blood and my wife took me to the emergency room.  I have continued to cough up blood since 2021 and have since that date been diagnosed with a rare autoimmune disease EGPA Vasculitis, Churg Strauss Disease
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haemoptysis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: September 2,2021- had redness, pain and swelling at injection site.  Later that night had chills, fatigue, dizzy, muscle aches and feel nauseated with shortness of breath.  This continued and progressed with a fever and swollen lymph nodes.  I called the dr office to notify them of my reactions and was told not to go into the office due to COVID at the time and to try to wait but if symptoms worsened to go to the ER.  My symptoms progressively got worse in less than 2 weeks I was coughing up blood and my wife took me to the emergency room.  I have continued to cough up blood since 2021 and have since that date been diagnosed with a rare autoimmune disease EGPA Vasculitis, Churg Strauss Disease
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: September 2,2021- had redness, pain and swelling at injection site.  Later that night had chills, fatigue, dizzy, muscle aches and feel nauseated with shortness of breath.  This continued and progressed with a fever and swollen lymph nodes.  I called the dr office to notify them of my reactions and was told not to go into the office due to COVID at the time and to try to wait but if symptoms worsened to go to the ER.  My symptoms progressively got worse in less than 2 weeks I was coughing up blood and my wife took me to the emergency room.  I have continued to cough up blood since 2021 and have since that date been diagnosed with a rare autoimmune disease EGPA Vasculitis, Churg Strauss Disease