chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; Dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "drug allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EK5730), administration date: 17Dec2020, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number: EK5730), administration date: 07Jan2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 09Nov2022, outcome "recovering"; VERTIGO (non-serious) with onset 09Nov2022, outcome "recovering". The events "vertigo" and "dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, dizziness.  Additional information: The patient was treated with Anti-histamine, physical therapy. The patient did not have COVID prior vaccination. The patient had not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Received immunization Dtap 7/13/04 seen in office 7/15/04 with Left UE red/swollen 12cmx16cm with arm circ 20.3 cm.
BLOOD CLOT IN LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient found a blood clot in leg after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220438559-Covid-19 vaccine ad26.cov2.s-Blood clot in leg.The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Severe vertigo with dizziness.  I?ve never had these symptoms of vertigo before.  Entire room was spinning when I woke up yesterday morning.  Almost fell over 2x.  This was one week after receiving the vaccine.
No adverse event; a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent).    No Concomitant medications were provided. It was reported that a patient was administered 0.5 mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent. No treatment medications were provided.
hours after receiving vaccination heart started racing, chest was heavy, started having to take intensely deep breaths.  Moments of heart fluttering/palpitations and pounding along with some dizziness and nausea for 5 days before seeking treatment
Subsequent to receiving vax, pt became crabby, and experienced decreased appetite. One day post vax, the pt awakened with rash around hair line, neck, behind ears and on back. Small raised reddened rash remains on legs at the time of this report.
Pt received Pfizer x2.  Pt tested COVID + on 8/11/21 and admitted to hospital for COVID on 8/12/2021. Pt received remdesivir and dexamethasone.
Pt admitted with ICH, likely secondary to increased ICP from nausea and vomiting after receiving her second pfizer covid vaccine.
Child developed urticaria on hands, arms, feet, legs, trunk, and face. Hands were swollen. Hives essentially resolved with Benadryl.
Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures; Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures; There were also 10 underage recipients.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.), PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.), PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  Storage condition at the time of the excursion: Refrigerated.  Excursion duration was unknown (12Jan2021- 22Apr2022).  No treatment medication was provided.
Red swollen itchy at injection site about the size of a baseball Hives on neck and arms ,better with benedryl, gone as of 10/20 Coughing with phlegm since the shot Swollen glands in neck , still swollen today and tender Exhaustion-still  Chills, fever, shakes first 3 days after the shot Full body cramps and stomach pains- first 2 days
Dizziness, nausea, and weakness. Later, around 3pm, I fainted (syncope) and I totally lost consciousness. I hit my head hard and many parts of the body.
slight fever; headache; soreness in arm; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced slight fever, headache, soreness in arm. The outcome of the events was unkown. Information on the batch number has been requested.
Right anterior thigh reddened area at needle site in middle, measures 50 mm, very warm to touch.  Child irritable and whinny when area touched.  Mom giving Tylenol and Ibuprofen with teaspoon, alternately.
Instead of receiving FLUZONE HD, patient by mistake received FLUARIX. The patient and her daughter whose name are the same were both receiving flu shots (one HD, one regular) and intern gave FLUARIX to the mother.
JOINT PAIN IN SPINE; JOINT PAIN IN PELVIC AREA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 13-MAR-2021 11:00, the subject experienced joint pain in spine. On 13-MAR-2021 11:00, the subject experienced joint pain in pelvic area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain in spine, and joint pain in pelvic area. This report was non-serious. This case associated with Product Quality Complaint number. The suspected product quality complaint has been confirmed to be confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.
This spontaneous report as received from a certified medical assistant refers to a 5 year old male patient. On an unknown date, the patient was vaccinated with the first 0.5 ml dose of RECOMBIVAX HB (lot # not reported) intramuscularly and received his second dose 8 months after the first dose, and the third dose after 6 months, At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This spontaneous report as received from a physician and a company representative refers to a 3 year old male patient. The patient's medical history included otitis in approximately 2015 (reported as about 1.5 years ago) treated with amoxicillin. One week later, the patient was given TAMIFLU and he broke out into erythema multiforme on an unknown date. It was unknown which medication caused erythema multiforme. There were no concomitant medications. On 30-AUG-2016, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). On the same date, he experienced an injection site reaction which resolved on an unknown date in 2016 (reported as shortly after). On 16-SEP-2016, the patient began to experience red papules on his torso, belly and back, with no fever. The physician reported that on 20-SEP-2016, the patient came to the office and that the papules progressed up the patient's torso, legs, private area and in his ears, like classic symptoms of chicken pox. The patient was sent home without treatment at this point. The reporter also noted that on 22-SEP-2016, the patient's mother sent pictures of the patient's rash to the physician and she felt as if the rash looked more like erythema multiforme (since an unspecified date in September 2016), described as large, red papules with pale centers and she might treat it with steroids. At the time of this report, no treatment was given for the adverse events and no lab diagnostics studies were performed. The outcome of erythema multiforme and rash varicelliform was reported as not recovered at the time of this report. The relatedness between the adverse events and VARIVAX was not provided. Upon internal review the adverse event of erythema multiforme was considered to be medically significant. Additional information has been requested.
(1) Vaccine give 11/30/16 in right arm. (2) Pt. presents today with swelling and firmness to upper right arm.
red welt with severe itching, patient itched so often it led to bruising, resolved on its own after a few days
Fever; Hives; rash symptoms that coated his entire body; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The reporter was not sure if the patient received Pfizer or Moderna COVID-19 vaccine. The patient's medical history and concomitant medications were not reported. On 16Aug2021, the patient experienced fever, hives, and rash symptoms that coated his entire body. Outcome of all events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101068628 same reporter and product; similar events; different patients
Approximately 1130 PM on 12/3/12 child awoke complaining of headache, T=100.1 degrees F and within 15 minutes vomited x 2. Tired in morning by 12 noon 12/4/12 seemed to be better according to mother.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: shakes-Mild, Systemic: Shakiness-Mild, Additional Details: pt fainted and had shakes/ convulsions for a few seconds.  after 30 seconds pt awake and stated ok , after 30 min pt stated ok after 30 min observastion. mom n dad brought to hospital dad called and said pt was ok . no unusual findings
BLOOD COMING DOWN FROM NOSTRILS; TERRIBLE HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood coming down from nostrils, and terrible headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible headaches and blood coming down from nostrils was not reported. This report was non-serious.
Information has been received from a literature article. The following neurological complications of varicella vaccine have been reported. Case 3: A healthy patient (gender unspecified) who was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose not reported) at 16 months of age. At 4 years, a zoster rash developed on the right arm, followed by meningitis (important medical event, upon internal review). The article does not state where the patient was vaccinated. Cerebrospinal Fluid (CSF) DNA was sent to the Centers for Disease Control (CDC), GA for strain typing, and the presence of Oka Varicella-zoster-virus (VZV) was confirmed. Polymerase Chain Reaction (PCR) of zoster lesions also identified VZV, but genotyping was not performed. Of note, in several cases, the zoster event occurred in the same extremity as had received the varicella vaccination or was the likely site of vaccination. Since 4 million children are immunized yearly in the country, the neurovirulence of the live attenuated vaccine is dramatically less than that of the wild-type infection. Only a few cases of zoster and meningitis secondary to vaccine virus have been reported since 1995. Nevertheless, these cases illustrate that vaccine virus can occasionally establish latency in the dorsal root ganglia, especially those providing sensory fibers to the arm. Of note, at least 4 children with wild-type Central Nervous System (CNS) disease had had one varicella vaccination. The authors now know that one dose is insufficient to assure immunity throughout childhood. Therefore, these children undoubtedly had breakthrough varicella. Two doses of varicella vaccine during early childhood are now recommended to avoid the problem of breakthrough infection with wild-type varicella. In summary, the aforementioned data from the most populous state in the country demonstrate a dramatic reduction in the CNS complications of wild-type varicella in children. Implementation of the 2-dose varicella vaccination policy should eliminate the few cases of breakthrough disease. The detection of only one case of vaccine virus-related zoster demonstrates a diminished neurovirulence of the live attenuated vaccine. Additional information has been requested. This is one of several cases from the same source.
ActHIB lypholized powder was mixed with Sterile water diluent and administered to patient. The patient's primary care physician was notified as soon as the mistake was found which was after the patient had left the office. The event happened at the end of the day on Friday 6/28/19. The Department of Public Health vaccine nurse was notified on Monday am 7/1/19. who referenced the immunization web site which stated the dose was invalid and  child needed to be re-vaccinated. Re-vaccination occurred on 7/5/19.
Pt complained about numbness at the site of injection. 12-31-18-Pt's son comes to the pharmacy to let us know pt had a reaction to vaccine given on 9/28/18. 1-2-19-We speak to PCP. They inform us that they saw pt on 11/2 and 11/19. 11/19 pt complained about numbness he felt from vaccine give on 11/2. (?) later on it was confirmed that vaccine was administer on 11/2. 1/3/19 pt was seen again. Given CELEBREX (anti-inflammatory) by MD. Per pt (1/13) he is feeling somewhat better.
43 days apart for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (43 days apart for second dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (43 days apart for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (43 days apart for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Pain, swelling, redness, and itchiness on right arm. Patient went to see her primary physician regarding the rash and was prescribed steroids by topical and oral route.
My daughter began to complain of a burning/warming sensation primarily in her head but radiated throughout her chest and stomach areas.  Also stinging sensation in chest area, headaches, extreme weakness in entire body.  Her hands and fingers could not hold a fork for breakfast the following day after the vaccine.  We took her to Hospital ER (9-10).  They performed the whole works: blood, urine ( came back normal). Also performed an MRI on brain, which also came back normal.  she was discharged and told to take ibuprofen for pain as needed and to follow up with pediatrician.  Its been a week since her vaccine and her symptoms have not diminished but have remained in tact.  We are worried for her health and would like to know what went wrong.  We strongly believe this vaccine caused her body to react in this manner.
Severe Period and back pain   Continuing for  5 days straight and still counting like never before.  Heave flow. Painkillers don't work
Has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
This spontaneous report was received from a licensed practical nurse referring to a 66 years old patient (gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on 31-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M041669, expiration date 09-JAN-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine dose was exposed to a temperature excursion between 15 and 46 Fahrenheit degrees for "at least 15 days"; digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005276.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: tested negative twice; (2023) Negative, notes: tested negative twice; (2023) Positive, notes: tested and was positive. Therapeutic measures were taken as a result of covid-19, drug ineffective which included paxlovid on 21Feb2023 to 26Feb2023. Clinical course: symptoms were just as bad as the patient's initial bout with COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.