chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 1st and 2nd dose more than 6 months apart; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received 1st and 2nd dose more than 6 months apart).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter was the patient's wife who stated her husband received first and second dose of Shingrix more than 6 months apart last year. The reporter refused to provided address, date of birth, phone number and any other information missing in this report. The suspect product start date was reported as 2022. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter did not consent to follow up.
Soreness, redness, swelling and discomfort around injection site and around arm - with difficulty raising arm - administered on 1/29/08 - patient took Tylenol with good effect - seen by PCP 2/1/08 - still some redness, swelling and soreness.
This case was reported by a pharmacist via call center representative and described the occurrence of myalgia upper extremities in a 74-year-old male patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia upper extremities. On 31st August 2018, the outcome of the myalgia upper extremities was recovered/resolved. It was unknown if the reporter considered the myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced muscle pain from site down to elbow the same day as his injection. It was noted to be a muscle pain. The pain lasted for 4 days and then resolved.
IN THE HOSPITAL 3 DAYS AFTER JANSSEN VACCINE; DEATH (LOST THE FIGHT 3 WEEKS LATER); This spontaneous report received from a consumer via a company representative concerned a female of unspecified age and unknown 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 not reported, batch number: Unknown) dose, one total administered, 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.  it was reported that on an unspecified date, the patient was in the hospital fighting for her life 3 days after taking the vaccine. She lost the fight 3 weeks later (death). It was mentioned that the patient believed the propaganda and lost her life. The patient died due to unknown cause. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210650080-COVID-19 VACCINE AD26.COv2.S-In the Hospital 3 days after Jannsen vaccine, Death(Lost the Fight 3 weeks later). This event(s) is considered un-assessable. 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
Patient received his shots on Oct. 12, 2007. On Oct. 30, 2007 my husband and I noticed that he had a bruise and could not figure out how he got it. Then the next morning he had petechiae on his feet and legs.He also got another bruise between that night and morning. We took him to see Dr. He sent us to the Lab to get A CBC. His platelets were 6. He then called the Hospital and they told us to bring him on down there. 11/30/07-records received for DOS 10/31-11/207 and 11/4-11/6/07-DC DX: for both admissions:Idiopathic thrombocytopenic purpura. Anemia and Acute otitis media. Admitted for increasing bruising and low platelets. Increased bruising noted past 2 days. Prior to second admission fussy and pulling at his eat. Treated with WinRho and IVIG.
severe leg muscle pain x 5 days severe headache and fatigue x 2 days swelling the size of a half dollar at injection site - red, hot - painful.
Acute and sudden blurred vision  Posterior vitreous detachment diagnosed and the blurred vision a secondary thing Sore eyes and unable to focus flashes of light, floaters and headaches
Systemic: pain in leg. Was diagnosed with a blood clot, but pain in leg was present prior to vaccine-Moderate
High fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had high fever 24 hours after the booster.  No concomitant medication was provided.  No treatment medication was provided.
Thrombocytopenia. Platelets went from 175K day of vaccine to 56K four days later. Petechiae on feet and legs morning after vaccine.   Additionally, cold sweats overnight. Woke up with headache, body aches and extreme fatigue, as well as injection site soreness.
This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K007264 with expiry date 02-MAR-2017, (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient states developed rash and bumps at the site of injection and spread throughout the deltoid. When she came in to report the reaction only had a few bumps at site of injection
Little soreness in the arm after the 1st dose of the vaccine yesterday; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) received from a Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced little soreness in the arm after the 1st dose of the vaccine yesterday. It was further reported that Caller is calling for her friend who had breast enhancement surgery and she had a reaction to the anesthesia. Is it safe for her friend to get the Pfizer COVID-19 vaccine? Caller mentioned that she had the first dose of the Pfizer BioNTech COVID-19 vaccine yesterday (09Feb2021) and had a little arm soreness from it. Caller declined to report the adverse events to DSU. The clinical outcome of the event little soreness in the arm after the 1st dose of the vaccine yesterday was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Pt received a Moderna dose IM on 8/11/21 at our facility- lot number 033C21A. On 8/12/21 while auditing charting for COVID doses, noticed pt's 8/11/21 first Moderna dose did not decrement in . Noticed in pt?s  account documentation of a Janssen dose on 5/21/21 administered by  Health Department. Called pt and spoke to his caregiver listed in his chart who shared that per pt?s fiduciary pt had been admitted to a skilled nursing facility, but was unsure if he had received the Janssen dose. Caregiver  has not been able to retrieve records from the skilled nursing facility. Gave them my number and suggested we might need to remove the 9/8 second dose appt if he did indeed receive Janssen, explained that Janssen is one dose series and Moderna is a two dose series. Caregiver  will call facility for records. Meanwhile, contacted  Health Department and confirmed pt did indeed receive Janssen dose on 5/21/21.  On 8/13/21 called pt?s caregiver who also confirmed via skilled nursing facility records that pt received Janssen. Agreed to cancel appt for his second Moderna dose. RN agreed to follow up with CDC and agreed to follow up with pt and caregiver if any new information is learned about this particular scenario.  The concern here is that the pt received a Janssen dose 5/21/21 followed by one Moderna dose 8/1//21. I have canceled his appointment for his second dose. Assuming we would not administer a second Moderna dose in this context. I know there is no information at this time on booster doses after a Janssen dose. Caregiver reported that pt is doing well.
flu-llike symptoms; chills are uncontrollable; body is so sore; chills; muscle pain; aches; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle pain), PAIN (aches), HEADACHE (headache) and INFLUENZA LIKE ILLNESS (flu-llike symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event since an unknown date.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (chills), MYALGIA (muscle pain), PAIN (aches) and HEADACHE (headache). On 28-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-llike symptoms), CHILLS (chills are uncontrollable) and PAIN (body is so sore). At the time of the report, CHILLS (chills), MYALGIA (muscle pain), PAIN (aches), HEADACHE (headache), INFLUENZA LIKE ILLNESS (flu-llike symptoms), CHILLS (chills are uncontrollable) and PAIN (body is so sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Indurated, erythematous area around 4x8cm  inferior to vaccine administration site.
pt recv vax;exp lightheadedness & fainted;also felt weak,nauseous & had diaphoresis;
This spontaneous report as received from a consumer refers to her 16 years old daughter. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported) on 28-AUG-2012. On 29-AUG-2012 the patient experienced nausea, dizziness and headache, 24 hours after therapy. The outcome of nausea, dizziness and headache was reported as not recovered/not resolved. Additional information is not expected.
Severe Headache. Severe Body Aches and Pains. Fever 101-101.5. Chills. Sweating/Clammy. Extreme Fatigue.
Febrile seizure approx 8-9 hrs after immunization administration, seizure lasted approx 2-3 min per mom; taken to ER and diagnosed with AOM, temp in ER 102.6, recieved ceftriaxone x1 dose.
rash on legs noticed in the morning of 11/19, not seen the night before, vaccine was administered at school vaccine clinic
allergic reaction to the vaccine; rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction to the vaccine) and RASH (rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included SUMATRIPTAN for Migraine, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ALBUTEROL [SALBUTAMOL], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and IBUPROFEN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body). On 02-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction to the vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROXYZINE on 06-Apr-2021 at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergic reaction to the vaccine) and RASH (rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication also included steroid shot.
Pt complains of tiredness and headache. Also nausea, blurry vision and anxiety.  Has trouble sleeping.  These symptoms started about 2 or 3 weeks after the vaccination and have been getting progressively worse.
Vertigo, nausea, hearing loss in right ear, constant humming noise in right ear, sensitivity to sounds, tunnel like feeling in ear. I?ve tried various medicines provided by my doctor. None have worked.  The only thing that has helped much at all is blocking out sounds with noise blocking ear covers. It?s been 9 days now and I?m still having the same problem. It makes me nauseous all day long.
no additional AE's; the administration of an expired VAQTA vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 25-MAR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA), 1 dose, lot # S037821 has been verified to be a valid lot#, expiry date: 07-JAN-2021 (formulation, strength, route of administration were not provided) for prophylaxis. There was no adverse event reported.
About a few days or a week after getting the vaccine I noticed that my face and scalp was itching quite often as well as other body parts .  I was just starting to get over a month long period of extreme fatigue and other strange symptoms so maybe this itching was unrelated to the vaccine. The itching and sometimes prickly, pin-prick sensations  continued and I consulted a neurologist in early September. A series of blood tests were performed which were all negative. A skin biopsy showed some signs of nerve damage as did an electrical test on my legs. The Doctor put me on Gabapentin for symptom management.
Major heart attack; her chest and left arm was hurting; she went to bed she was so hot she couldn't even sweat; chest was hurting/ her chest and left arm was hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Lot number: 30135BA) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer Covid 19 Vaccine, 1st dose received on 20Sep2021 by injection in right arm. Lot: FC3184, Expiry: Unknown), administration date: 20Sep2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 20Oct2021, outcome "recovering", described as "Major heart attack"; CHEST PAIN (non-serious) with onset 20Oct2021, outcome "unknown", described as "chest was hurting/ her chest and left arm was hurting"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2021, outcome "unknown", described as "her chest and left arm was hurting"; FEELING HOT (non-serious) with onset 20Oct2021, outcome "unknown", described as "she went to bed she was so hot she couldn't even sweat". The patient was hospitalized for myocardial infarction (start date: 21Oct2021, discharge date: 22Oct2021, hospitalization duration: 1 day(s)). The events "major heart attack", "chest was hurting/ her chest and left arm was hurting" and "her chest and left arm was hurting" were evaluated at the physician office visit and emergency room visit.  Clinical outcome: Vaccination Facility Type was Health Department. Patient had heart attack on 20Oct2021, but she didn't know it. Her chest was hurting, but she overlooked it and went about her day. When she went to bed she was so hot she couldn't even sweat. When she woke up the next day, 21Oct2021, her chest and left arm was hurting her. That's when she went to the doctor's office. The doctor's office put her in an ambulance and sent her to the hospital. She had a stent placed that day, 21Oct2021, and she was admitted to the hospital for 24 hours. Reporter verified that the heart attack was not going, but stated that patient improved since she had the heart attack. Patient had no idea what diagnostic tests might have been done while she was in the hospital. No further clarification was provided. Investigation assessment was unknown.   No follow-up attempts are possible. No further information is expected.
Patients caregiver states that patientcan't move her arm.  Said it not just a sore arm but can't move it.  Caregiver said went to hospital but did not mention vaccine adverse effect.  I advised caregiver to seek healthcare, hospital or primary care, since she can't mover her arm.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified) on 12-OCT-2012. No concomitant medications were reported. ZOSTAVAX was given via the intramuscular route and expiry date of the vaccine was 18-AUG-2012. Additional information has been requested.
Sore arm, severe headache, 101.2 fever, chills, body aches i have had 3 vaccinations at a time,  all in the same arm and NEVER gotten sick at all.
headache; tiredness; muscle pain; fever; nausea; feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/lot number: EL9262;) via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. Medical history included parkinson's disease ongoing. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA) for Parkinsons disease, clonazepam. The patient previously received first single dose of bnt162b2 for Covid-19 immunization (she had no side effects after the first dose of the vaccine). Patient had Parkinsons disease received the second dose of the Pfizer COVID-19 vaccine yesterday, 26Jan2021, and today she was experiencing most of the symptoms listed including: injection site pain in Jan2021, on 26Jan2021, had tiredness, headache (Had a headache, headache for the most part gone but still lingering), muscles pain, fever, nausea and feeling unwell. The caller states that she had no side effects after the first dose of the vaccine. The caller wants to know how long her symptoms are going to last. The outcome of the event Injection site pain was unknown, rest of the events was not recovered.
This is a spontaneous report from a non-contactable consumer (patient himself). A 36-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 27Jan2021 at 08:30 as single dose for COVID-19 immunisation at Workplace clinic. The patient medical history was not reported. No known allergies were reported. Concomitant medications in two weeks were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Jan2021, the patient experienced sore arm 8 to 36 hours post injection, chills and aches 24-36 hours post injection. No treatment was received for the events. The outcome for all events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
He got a seizure on august 13, 2022. He was just staring at one place and then went unresponsive for few minutes. His right did not respond and started drooling. The whole seizure lasted for about 5 minutes.
PT STATES THAT 2 HOURS AFTER INJECTION, HIS LEFT ARM WAS PARALYZED AND 4 HOURS AFTER HAD A FEVER OF 102, AROUND MIDNIGHT OF THE SAME DAY, FEVER BROKE AND ARM WENT BACK TO NORMAL
Information has been received from a physician, via a company representative , concerning a 15 year old female patient, who on unspecified date was vaccinated with the first dose of Gardasil (Lot # not provided). After an unspecified duration of time following the vaccination, the patient developed hives. Treatment included unspecified steroids. At the time of this report, the outcome of the event was unknown.
High blood pressure/heart rate, chest tightness, light headed, dizziness.  Went to the Hospital.  Was released as GERD. Immediately following I started having deep pains in my arms and legs, extreme hot flashes, numbness in my right arm, and both hands.  My GP saw me two weeks after the shot.  Ran blood work and sent me for ultrasounds on my arms and legs, negative for DVT.  Symptoms continued to worsen, now left elbow will not straighten and right shoulder has issues.  Knees are always painful and my hands are extremely painful when I first wake and at different times of the day and it's difficult to walk upon initially standing.  I have to have chiropractic care, and have massages every 2-3 weeks to keep moving because my muscles are tight and all my joints are painful.
Arthus reaction involving (L) deltoid and 2-3 days following flu vaccine. Self-resolved.
Seen in clinic 12:30pm-immunized. Seen again at 7:30pm in clinic. Presented with c/o irregular hearbeat, fever, retractions with wheeze. Exam per Dr pending-WNL. No tx given. "Will observe and call."
Booster dose given early. Pfizer series started on 3/19/2021 and completed on 10/07/2021.  Moderna booster dose administered on 11/29/2021 after patient attested to being due.
immunothrombocytopenia refractory to platelet transfusions, starting steroids and IVIG