chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
The patient received a dose of an expired covid vaccine. The vaccine expired 5/25/21 and was administered about 10.5 hours later. The patient was made aware of the situation and was consulted with the medical provider. As of this submission, the patient has not reported any adverse event.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA226774, 2018SA226817, 2018SA226818, 2018SA226819 and 2018SA226820 and 2018SA227033 (same reporter). This case involves adult female patient (age not reported) who was vaccinated with a 0.5 ml dose of MENACTRA (Batch number: U5833AA and expiry date: 25-Feb-2019) via intramuscular route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because stability on MENACTRA, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. Documents held by the sender: None.
Given flu shot, had headache shortly after and very weak for about 24 hours. No vomiting.
RASH/2 BLISTERS ON CHIN UNDER LIP; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the subject experienced rash/2 blisters on chin under lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash/2 blisters on chin under lip. This report was non-serious.
Diffuse morbilliform rash 4 days after vaccination. Also had mild foot swelling. Resolved spontaneously.
Day of shot had bruising from Varicella vaccine.  Day after shot had raised red swelling, a little itching. About 3 inches across.  1 week later, still red but swelling gone and redness decreasing in circumference.
Felt very dizzy; felt a rush of adrenaline for 2-3 minutes; my HR was 125 at rest for more than a few hours; A spontaneous report (United States) was received from a Health Care Professional concerning a 50 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dizziness, Norepinephrine increased, and Heart rate increased.  The patient's medical history was provided as allergies to preservatives. Relevant concomitant medications were reported as CLARITINE, MUCINEX, ADVAIR, SINGULAIR, TURMERIC, IMMUNE BOOST, NAPROSYN E.  On 08 JAN 2021, prior to the onset of event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) in left arm for prophylaxis of COVID-19 infection.  On 08 JAN 2021, the patient experienced Dizziness, Norepinephrine increased, and Heart rate increased.  Laboratory details was provided as Heart rate 125, which was increased in that time. Treatment information was provided as albuterol and Benadryl.  Action taken with mRNA-1273 in response to the events was unknown.  On 08 JAN 2021, the outcome of the event's Norepinephrine increased, and Heart rate increased was considered as resolved. At the of this report, the outcome of the event's Dizziness was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Flu vaccine administered @ 10 a.m. At 1:20 p.m. patient presented @ flu clinic c/o swelling of eyes, face,hands and eye tearing. Shortly started complaining of throat tightness. Resp 22; B/P 120/78; MD Assessment by Dr.; Epi .4mg give  sugq per RN. Benadryl 50 mgm IM.
Injection site is red, swollen, painful, and warm to the touch. Im experience some muscle weakness in my left arm and feeling slightly dizzy.
Pain; Feeling abnormal/ patient experienced spaciness; Fatigue; Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021; Feeling unwell /Not feeling good; Fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell /Not feeling good), FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness), PAIN (Pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021). In May 2021, the patient experienced MALAISE (Feeling unwell /Not feeling good) and PYREXIA (Fever). In October 2021, the patient experienced FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Pain). At the time of the report, MALAISE (Feeling unwell /Not feeling good), FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness), PAIN (Pain), PYREXIA (Fever), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021) outcome was unknown.            No concomitant medications were reported.  on 11-OCT-2021, patient received Booster dose of Moderna vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for Humira (adalimumab) for the events of fever, not feeling good, spaciness, fatigue and pain was not provided.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a registered nurse referring to a currently 11 year old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N022584, expiry date: 15-JUN-2020) for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA007189: US-009507513-1801USA007190: US-009507513-1801USA007191:
Large bruise left forearm; left forearm swollen; left forearm painful; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: BR128733) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously received iodine (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication on an unspecified date and experienced drug allergy and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On an unspecified date in Mar2021 at 12:00, the patient experienced large bruise in the left forearm, swollen, painful, fever, fatigue and nausea. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events large bruise on left forearm, swollen arm, painful left arm, fever, fatigue and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial report received from a healthcare professional on 4 October 2013. Two patients received FLUZONE QUADRIVALENT (Lot # unknown, expiration date unknown). After vaccination, the patient experienced a red raised area at the injection site. Documents held by sender: none.
a patient experienced syncope and urination; a patient experienced syncope and urination; This spontaneous report was received from a physician and referred to a 12-year-old female patient. The patient's pertinent medical history included seizure. The patient's concomitant medications and drug reactions/allergies were not reported.   On an unknown date in February 2023 (reported as last week), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, anatomical location, strength, lot #, and expiry date were not provided) intramuscularly for prophylaxis and the patient was also vaccinated with another unspecified vaccine.  On an unknown date in February 2023 (reported as last week), the patient experienced syncope and urination (micturition disorder) after administration. On an unknown date in February 2023 (reported as the same day of event occurred), the patient recovered from both events. It was unknown whether the patient was given treatment and It was unknown whether the patient had sought medical attention. The causal relationship between both events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event syncope was determined to be medically significant.
5 year old child was given Adacel instead of Daptacel, no AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 year old male patient who administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 24-Aug-2020, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5669AA and expiry date: 09-Oct02021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered.  At the time of report no adverse event was reported.  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 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.
DIED; This spontaneous report received from a consumer via social media via company representative concerned 5 patients of unspecified sex, age, race and ethnic origin. The patient's height, and weight were not reported. The patients were healthy.  The patient received Covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered 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 reporter stated that, "Tell it to the families of the five healthy people we know of personally that have died within 48 hours of your Johnson and Johnson Jab." On an unspecified date, the patients died from unknown cause of death. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patients died from unknown cause of death. This report was serious (Death).; Sender's Comments: V0-20211222684- covid-19 vaccine ad26.cov2.s -Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Large muscle aches, chills (possible fever - no thermometer), loss of appetite, fatigue. Started in the morning after vaccination. No treatment. Expecting symptoms to go away in another day or two.
Patient's husband called and reported that his wife has been fatigued, had body aches, a fever, and a "racing heartbeat" a few days after receiving her flu vaccine. After further questioning, the fever is between 102-103 (F) and the heart rate is around 85 bpm with a blood pressure of 138-87 (not a typical BP for the patient).
Spells of extreme dizziness/vertigo about 2 hours after the vaccination; it subsided about 10 hours after vaccination. Sharp pain in the chest/side/back (opposite the arm it was injected in) but I am also guessing this was stress related pain as I was very nervous about the vaccine (wanted to report anyway just in case) the pain subsides with 400mg ibuprofen. Then swelling, redness, and itchiness at the vaccination site starting the next day (3/6) and growing in intensity after (today). Currently the swelling is about 1.5 inches in diameter, it does not seem serious so I'll be treating it with topicals to ease the itching.
Induration and warmth to left thigh area. About 10x10 cm area.
Pain, swelling site. 7.5 cm weal with eryth and warmth.
Took a fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Took a fall) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Mar-2021, the patient experienced FALL (Took a fall). At the time of the report, FALL (Took a fall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Soreness at injection site, headache, chills, body aches Symptoms started about 11 am and increased in severity over the next 24 hours.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Feels like she ran over by a mac truck,that she was aching in places that she didn't even know she had. She feels like she overworked at the gym, even her toes. Everything is achy/She has aches and pains) and HEADACHE (Has a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced MYALGIA (Feels like she ran over by a mac truck,that she was aching in places that she didn't even know she had. She feels like she overworked at the gym, even her toes. Everything is achy/She has aches and pains). In November 2021, the patient experienced HEADACHE (Has a headache). At the time of the report, MYALGIA (Feels like she ran over by a mac truck,that she was aching in places that she didn't even know she had. She feels like she overworked at the gym, even her toes. Everything is achy/She has aches and pains) and HEADACHE (Has a headache) outcome was unknown.  No concomitant medications were reported.No treatment medications were reported.The patient reported that It wasn't until 10 Nov 2021 that she was aching in places that she didn't even know she had. This case was linked to MOD-2021-382861 (Patient Link). Reporter did not allow further contact.
Pt had been quiet most of day around 6PM mom took temp which was 105 & went to 105.6 x 3 days; Taken to ER-felt rxn was from vax;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever of 101.6; Body aches; Chills; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 08Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 on an unspecified date at single dose for COVID-19 immunization. The nurse reported that her neighbor (patient) who is a nurse at a Hospital, mentioned this weekend that she received her second dose of the Pfizer vaccine on Friday, 08Jan2021, and had some side effects when she woke on Saturday, 09Jan2021 included fever of 101.6, body aches, and chills, her reaction subsequently improved on Saturday, 09Jan2021, around noon. The nurse (reporter) has read that these are expected reactions and the patient is feeling fine now, but nurse wanted to report this event. Outcome of the events was recovering.   Information on the Batch/Lot number has been requested.
"Moderna COVID-19 Vaccine EUA":  Developed chills during the night after receiving  Moderna COVID 19 Vaccine.  12/31/20, 4:45am - Chills, shaking, weakness, dizziness, and fever.  Checked temp 6:00 am - 101.2.  Took Tylenol 1000 mg every 8 hours starting at 6:15am.  Fever all day until the following morning.  1/1/21- Severe body aches - 1/2/21..  Symptoms improved except fatigue.  Symptoms better 1/3/21.,
Less than 6 hours later had a fever of 101, body aches and chills. Headache started around 12 hours after shot. Experienced fatigue, fever and nausea for 48 hours after shot. I was experiencing rapid HR for 48 hours. Contacted doctor they thought I had an allergic reaction to second dose so I did take a benadryl and it did seem to help with my heart rate. I am still experiencing headaches that come and go after a week of getting my second dose. I have been extremely fatigued more than usual as well.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient stated the many on her senior residence had the same headaches as her.  No treatment information was provided.
Mother of baby states pimple like rash started on her back, side and up the neck 3 days after receiving vaccines. She states baby was taken to doctor on that same day and was told it was probably from the chickenpox vaccine. No fever but has symptoms of upper respiratory infection.