chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a flu product when she was pregnant with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid non-serious case received from health professional and patient. Agency number: 01280972  This case involves a 31-year-old female patient who was exposed to vaccine flu product (Influenza Vaccine) in context of received a flu product when she was pregnant with no reported adverse event. Data regarding this pregnancy were received retrospectively, i.e., after pregnancy outcome was known.   The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On unknown date in 2016, the patient during pregnancy received a dose of suspect flu product produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (exposure during pregnancy) same day latency. Patient had a flu product about 6 years ago when she was pregnant and had a normal Pregnancy/ delivery. It was reported that patient was currently 37 years old and was pregnant. The patient has some questions regarding the flu vaccine. Patient enquired about which SANOFI FLUZONE product; she should receive. Patient would also like some information regarding risk involved for the fetus. Patient had not received the vaccine product yet but is planning to receive it tomorrow on 16Sep2022. Patient had last menstrual period of sometime in April 2022. The estimated due date for current pregnancy was 13-Mar-2023.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event received a flu product when she was pregnant with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown with, and fetal outcome was reported as Normal/No Defect.
Severe pain at site of injection (thigh).  Patient could not walk.  Low grade fever developed afterward and lasted a few days.  Tonsils became inflamed.  Treated with Tylenol meltaways.  One week later, patient developed high grade fever and tonsil infection.
Patient was administered COVID 19 vaccine 1 day past BUD. Contacted manufacturer, who stated that the stability has been established for their vaccines for 10 weeks + 2 days out of the freezer. BUD noted on packages are for 10 weeks, so while this administration was within the stability window, it is still considered an "off label" use of the vaccine. Family to be contacted regarding this issue to see how they wish to proceed
Pt exp pruritis for several days following 2nd dose of Hep B vax;
joint pain; minimal aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 50's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; PAIN (non-serious), outcome "unknown", described as "minimal aches". The healthy patient was in late 50 years of age. No underlying conditions known.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had 100 fever. Then, I was freezing and then having hot flashes. Later, I had severe stomach cramps and a severe headache. This lasted for 3 days.
AKI (acute kidney injury)  Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present
The next day after vaccination, I woke up and had the worst migraine I have ever had and also had fever up to 102.0, body aches, fatigue, and generalized pain. I called the nurse line and they told me to take Tylenol. The symptoms was continued for 4 days. The migraine was so intense that I could not stand any light. I had to take off 3 days of work due to the migraine. On April 5, 2022, I went to the ophthalmologist and I was found to have damage to my optic nerve. At this time, it is possible that this was caused by my migraine and could impact me for the rest of my life. I am still being evaluated for ongoing eye nerve damage.
Patient accidentally given an unauthorized 3rd booster of Pfizer even though she was not eligible (17 years old).
pt recv vax JUL95 & APR96 pt exp an erythematous papular rash which became vesicular 4 days later;pt rash began as red papules became fluid filled & then began to dry out;no further details were provided;
Left arm has a red rash developed a few days after the vaccination.  Red rash is ichy on a scale of 3.  I continue to take Claritin as my sinues and allergies have flared up.  Arm is a bit swollen from the vaccination and has come down slightly.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on 06Jan2019 at single dose for immunization. Medical history been fighting cancer for 18 months and Immune system is not strong. The patient's concomitant medications were not reported. The patient experienced arm hurts, itchy and all red on Jan2019. The patient saw the doctor and was prescribed steroid medicine methylprednisolone 4mg. The outcome of the events was recovering. Information on the batch number has been requested.
Fatigue; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ARTHRALGIA (Joint Pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue) and ARTHRALGIA (Joint Pain). At the time of the report, FATIGUE (Fatigue) and ARTHRALGIA (Joint Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Had the shot on the 17th.  Arm was bruised and sore for a couple of days.  It's still slightly bruised.  Then on Sunday morning, the 21st, developed a headache.  Took 1-500 mg Tylenol, but the headache continued to get worse.  When the next dose of Tylenol was due, I took another 500 mg Tylenol tablet.  The headache got worse.  At times it feels like my head is being squeezed.  I started taking  2-500 mg Tylenol  tablets every 8 hours ever since.  My head usually gets to feeling better but then by the time the 8 hours is up, I am anxious to get another dose of Tylenol.
Has been sick ever since; It feels tight in throat/feeling throat closing up; Big lumps in head, one in ear; Throat felt like could not swallow; Something crawling up body; Itching all over the body; Perspiration all over body; Liquid came out from ear; Want to scratch; Chills; Headache terrible; Body aches; Waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow) and FORMICATION (Something crawling up body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN POTASSIUM (COZAAR) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 11-May-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 ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), HEADACHE (Headache terrible), MYALGIA (Body aches) and NAUSEA (Waves of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (Has been sick ever since), THROAT TIGHTNESS (It feels tight in throat/feeling throat closing up), MASS (Big lumps in head, one in ear), DYSPHAGIA (Throat felt like could not swallow), FORMICATION (Something crawling up body), PRURITUS (Itching all over the body), HYPERHIDROSIS (Perspiration all over body), OTORRHOEA (Liquid came out from ear), SCRATCH (Want to scratch), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Waves of nausea) outcome was unknown and HEADACHE (Headache terrible) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received contains no new information.
got th shot / got shingles/ suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and month later got shingles. The patient was glad to have the Shingles shot or they would have been so much worse. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Information has been received from a physician referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with MMRII (dose, route, lot# and expiration date were not reported) and VARIVAX (dose, route, lot# and expiration date were not reported). The physician stated that, in her experience, these patients cried much more when she administered red doses of MMRII and VARIVAX, than when she administered other vaccines (manufacturer unknown). Outcome of the event was not reported. Causality assessment was not reported. Additional information has been requested.
Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just about 30 seconds  swollen lymph node under right arm - persisting on day 3 post injection brain fog - lasted 2 days
This case was reported by a lawyer and described the occurrence of mercury poisoning in a 4 year old male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and pertussis vaccine absorbed for prophylaxis. This report was received via litigation process and a physician or other heath care professional has not verified this report. At an unknown time after receiving Hepatitis B vaccine, DTP/DTaP vaccine, Haemophilus vaccine, and/or MMR II vaccine, the patient experienced neurotoxic effects resulting in severe neurodevelopmental injuries. The event were attributed to mercury overdose and poisoning resulting from the thimerosal component of the vaccines. The multiple symptoms of the patient's injuries occurred and were first manifest no later than 01/01/2001. According to the attorney, the patient incurred medical expenses and will continue to incur medical expenses in the future as a result of his injuries. The attorney also alleged that the patient suffered significant impairments in his ability to enjoy life, faces significant obstacles to performing the tasks and activities of everyday living, and suffers ongoing physical and mental distress. This case was assessed as medically serious (OMIC).
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 01-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA003811: US-009507513-1806USA007090: US-009507513-1806USA007092: US-009507513-1806USA007093.
Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 12/17/2021 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 12/17/2021 UTI (URINARY TRACT INFECTION)
Pt recvd pneumococcal vaccine; concomitant therapy included methylprednisone for Horton Disease; 10nov97 devel pneumococcal pneumonia & hosp; pt recovered completely from pneumonia;
I had a headache, but it was on the crown of my head. It was a major pain, but it was a nagging consistent pressure. It wasn't a sensation I had never felt before in my head. I don't recall if I spoke with a doctor or not. I was able to take some aspirin and the sensation eventually went away. A few weeks ago, I began to notice blurred vision in my left eye. I am scheduled to see an eye doctor next week to address this issue.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 30-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB 10/0.1 microgram/ml, lot # K019502, expiry 04-FEB-2016, dose 2, 0.5 ml intramuscularly. No adverse effects were reported. It was reported that the vaccines were exposed to a temperature of 0 C for 3 weeks or 12C for 3 weeks during November 2015. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. This is 1 of the 2 reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
covid-19; covid-19; This is a spontaneous report received from contactable reporter The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 05Jan2021 as dose 2, single (Lot number: EL12B4), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 18May2022 at 13:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: other medical history: GERD; "Allergy" (unspecified if ongoing), notes: other medical history: Allergy; "Sinus" (unspecified if ongoing), notes: other medical history: Sinus; "Environmental allergies" (unspecified if ongoing), notes: known allergies: Environmental allergies. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid as Covid-19 treatment from 04Jul2022 to 08Jul2022. Patient received other medication in 2weeks.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Pain at injection site x 2 days. On 3rd day radiated to L shoulder at deltoid. Constant throbbing pain, restricts mobility. Severe enough to wake from sleep. On going problem.
Immediately after the shot, extremely sore arm for approximately 1 day. Roughly 10 minutes after the shot an overwhelming feeling of exhaustion lasting approximately 1 day. Approximately 1 hour after the shot, an extreme sense of nausea onset and proceeded for approximately 20 hours.
Patient received the Moderna vaccine as her second dose, when she received Pfizer as the first.  Patient was counseled in regards to receiving the Moderna in place of the Pfizer. She reported no adverse reaction from it.
swelling all over rash that doesnt go away aches in joints and a lot of headaches tired a lot cant sleep but to tired to do much her period is all messed up goes weeks at a time. 8/25/08-records received-office notes. 3/7/07-C/O shortness of breath, fever, chills times 2 days with cough today. Assessment URI, herpes simplex, asthma.  C/O fatigue, weight loss. received HPV4 and meningococcal vaccines. Assessment: hypothyroidism. 8/27/07-see in office for follow-up after ED visit for spider bite on left thigh. Assessment: abscess and cellulitis. Followed by visit 8/29/07-for incision and drainage of abscess. 9/5/07 second HPV 4 vaccine given. On 12/10/07-C/O rash for 2 months, itching all over body. 12/14/07-rash continues, asthma acting up, nausea. 12/21/07 rash all over, eyes swollen. Treated with steroids. Allergic reaction. 1/30/08 lips swollen times 2 days. 3/26/08-menstral cycle every 2 weeks. 8/6/08-rash continues but not as severe, occurs on walking and diminishes through the day.
severe shaking; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date.  This case is linked to cases 2019SA276203 and 2019SA276202 (same reporter).  This case involves a 70 years old male patient who experienced with severe shaking (tremor) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication   On 24-Sep-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ268AB via intramuscular route in the left deltoid.  On an unknown date, the patient experienced severe shaking (tremor) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   No Relevant laboratory test reported.  Final diagnosis was tremor.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as recovered for the events (lasted several hours).
Patient has swelling of right foot in and surrounding big toe with some redness. It is very painful and limits ability to walk. Swelling started Monday. He went to Dr. on Tuesday 06/01/2021. He has had gout in past, but his uric acid levels were normal.
Patient given booster dose (0.25ml) but patient had not received any doses previously. no adverse symptoms
HEADACHE; INJECTION SITE PAIN; CHILLS; TEMPERATURE CHANGE +2 DEGREES HIGHER; MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced temperature change +2 degrees higher. On 06-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain, chills, muscle pain, temperature change +2 degrees higher and headache was not reported. This report was non-serious.
Patient was incorrectly given the monovalent moderna vaccine, instead of the bivalent moderna vaccine.
Starting at 7pm developed severe nausea, vomiting, diarrhea, body aches. Went to the ER and CT abd/pelvis revealed transient intussusception. Symptoms eased but are still currently present. As of 5/6/2021 Pt still with nausea - controlled with Zofran, lower abdominal pain, inability to have effective BM. Pt is passing gas and small amounts of stool.
29 year old AD. On 11May2011, she received her 6th Anthrax vaccine (Lot# FAV 281).   The patient is now pregnant and her due date is 01Feb2012.  On 13May2011, she was given an hCG urine test and the result were negative.  On 28May11, another hCG urine test was done and results were positive.
4PM 16JUN94 pt became very drowsy, cranky, t102.8, neck stiffened, arms & legs limp, eyes crossed, blank stare, pinpoint pupils lasted approx 5 mins;
dose was correct formulation however it was not diluted, approximately 5 to 10 minutes after vaccination the patient fainted while being held by a parent.  All vital signs were normal including pulse, breathing and color, slight eye movement was noted.  Patient recovered on his own without intervention.  Father of the patient noted that he also has a history of fainting with vaccination.  Documentation was noted on patient profile, with doctor's office and corporate.  Follow-up call was completed with the father on Monday, event happened on Saturday.  Father noted that his son had a sore arm on Sunday but was feeling normal today, no additional adverse events were noted when asked.
Had first stroke about 5 days after getting the vaccine. The first paralyzed the first side. Had second stroke about 6 days after the first stroke . Second stroke affected speech and eating.