chrisvoncsefalvay/vaers-outcomes huggingface dataset:
102 fever; Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 33-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HPV VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Oct2023, outcome "recovering", described as "102 fever"; FATIGUE (non-serious) with onset 10Oct2023, outcome "recovering", described as "Exhaustion". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Covid prior vaccination and covid tested post vaccination was reported as unknown.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Pt. states started feeling flu like approximately 1 hr after injection. Body aches, weakness, fever 101.3, chills, laryngitis, tight chest, flushed face. Next morning fever was gone, felt a little weak. No treatment. Pt. states had same reaction after flu shot in 2010.
Runny Nose, Nasal Congestion, Sore Throat, Headache, Diarrhea, Nausea
2/23: Tetanus vaccine given L upper arm. 2/24: very painful, hot to touch, red, swollen L arm injection site. Area of redness about the size of a quarter. 2/26: redness and swelling now encompassing entire L upper arm. Still painful and hot. Saw PCP. Diagnosed with cellulitis.  Antibiotics prescribed and began taking that day. 3/3: Intense itching of L upper arm, swelling slightly decreased, but now area of redness has taken on a hexagonal pattern made up of many small itchy red dots encompassing L bicep. Consulted Dr again and she prescribed topical steroid cream. 3/13: redness finally fading away.
dilated left Ventricle of the heart; weight loss; prolonged rapid HR; nausea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:00 (Lot number: ER2613) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history and did not have covid prior vaccination. No Known allergies. Concomitant medication(s) included: BLISOVI FE 1/20. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number=EN6202, administration time=01:00PM, vaccine location=Left arm), administration date: 27Feb2021, when the patient was 26 years old, for COVID-19 immunization. No other vaccine received in four weeks.  The following information was reported: LEFT VENTRICULAR DILATATION (medically significant) with onset 18Aug2021 07:00, outcome "recovering", described as "dilated left Ventricle of the heart"; WEIGHT DECREASED (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "weight loss"; HEART RATE INCREASED (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "prolonged rapid HR"; NAUSEA (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "nausea"; DECREASED APPETITE (non-serious) with onset 18Aug2021 07:00, outcome "recovering", described as "loss of appetite". Adverse event: Discovered a dilated left Ventricle of the heart after experiencing symptoms of prolonged rapid HR, nausea, loss of appetite, weight loss (etc. not otherwise explained by another medical condition). Symptoms were intense and lasted for 2+ months. Still investigating the cause. The events "dilated left ventricle of the heart", "weight loss", "prolonged rapid hr", "nausea" and "loss of appetite" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (18Aug2021) prolonged rapid; sars-cov-2 test: (23Aug2021 PCR) negative, notes: Nasal Swab; (23Nov2021 Rapid antigen) negative, notes: Nasal Swab; weight: (18Aug2021) loss. Therapeutic measures were not taken as a result of left ventricular dilatation, weight decreased, heart rate increased, nausea, decreased appetite.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event Left ventricular dilatation and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with the third dose of GARDASIL (lot not reported). Later that night the patient experienced temperature of 103 degrees, nausea and vomiting. The patient's status was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Follow-up information received indicated that the 18 year old female student who had no previous medical history had received the third dose of GARDASIL (lot #659657)/1487U) IM in the deltoid on 25-Mar-2008 at 3:30 p.m. The patient's symptoms started at 11:45p.m. on the same day. She had a fever of 100.3 and vomiting. She felt ok prior to the injection and had no problems with previous injections. The patient reported the symptoms to the physicians office the day after vaccination, on 26-Mar-2008. Unspecified medical attention was sought at the doctors office. She was diagnosed with a virus. Subsequently, the patient recovered on 27-Mar-2008. No further information is expected.
Bruising at injection site - starting day of lasting 2+days Headache/body aches- starting day of lasting 36 hours Fatigue- staring day of lasting 24 hours
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 81 year old male of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 03-MAR-2022.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the reporter stated her husband (patient) and herself were trying to recover from Covid and had been very sick (suspected clinical vaccination failure, and suspected covid-19 infection) (dose number in series 2). They had the J and J shot and booster, as the physician said it could have been worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220304761. This report was associated with product quality complaint: 90000220206.; Sender's Comments: V0: 20220302858- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report was received from a registered nurse and refers to an approximately 14 years-old patient of unknown gender. On 25-FEB-2015, GARDASIL (lot # K004205, expiration date 12-JAN-2017 and lot # K005881, with expiration date 14-JAN-2017) was improperly exposed to 21.72F for 40 minutes for 1 cycle (incorrect product storage) (dose and frequency were unknown). On unspecified date, in approximately 2015, the patient may have received this improperly stored GARDASIL. There were no known adverse effects. The vaccine was, however, given via the correct route, as per the prescribing information. This is one of the several reports received from the same reporter. Additional information has been requested.
the pain went down her arm, intermittently; she experienced pain at the injection site; the injection site for the M-M-R II was raised, firm  and inflamed; the injection site for the M-M-R II was raised, firm  and inflamed; she received her first dose of M-M-R II on an unspcified date, approximately one year ago; This spontaneous report was received from a medical student, via company representative,referring to a 26 year old non-pregnant female patient. The patient was allergic to nonsteroidal anti-inflammatory drug (unspecified) (NSAIDs). The patient did not have any medical history or concurrent conditions. The sterile diluent was used for vaccine reconstitution.  In approximately April 2018 (also reported as "approximately one year ago"), the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported) (product administered to patient of inappropriate age).  On 18-APR-2019, the patient received a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported), along with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and an unspecified hepatitis b vaccine (manufacturer unknown) all of them for prophylaxis (dose, dose number, route of administration anatomical injection site, lot number and expiration date were not reported).  On the same date, the patient experienced pain at the injection site (vaccination site pain) and the pain went down her arm, intermittently (pain in extremity) for two weeks.  Besides, the patient stated that the injection site where she received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was raised, firm and inflamed (injection site induration and injection site inflammation) for two months. It was reported that all the adverse effects had resolved after the two months. It was unknown if the patient sought for medical attention, but she did not received any treatment for the events and no diagnostic laboratories or studies were performed to the patient.  The causality assessment between Hepatitis B Vaccine (manufacturer unknown), measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) with the aforementioned events was not reported.
Shakes and fever all the way through Tuesday. Very tired and drained. The next itching at the injection site.
Breakthrough case admission after 3 vaccines Pfizer 3/18/21 Lot# Er2613;  Pfizer 4/8/21 Lot# EW0158;  Pfizer 12/4/21 Lot# FD0809
Taken earlier that date at a doctor's office on 11/9/2021 at 1040- 120/80 Blood pressure taken 1650 (14mins post vaccine) after experiencing a headache- 145/103 Manual BP taken 1700- 148/110 Manual BP taken 1721- 142/102 Automatic BP taken 1744- 138/102  I was monitored until the doctor found it safe for me to be able to go home
PT presents to the ICC with c/o sore throat, ear pressure, congestion, cough, and back pain x 3 days. PT has been taking Mucinex for her symptoms. Pt is a smoker. PT did get the COVID-19 vaccination (Pfizer).  Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic.  HENT:     Head: Normocephalic.     Right Ear: Hearing, ear canal and external ear normal. No drainage or tenderness. A middle ear effusion is present. Tympanic membrane is not injected, erythematous or bulging.
Patient went to ER with fever of 106 F and Nausea and Vomiting 4 days post vaccination
dizziness; vertigo worse; This is a spontaneous case received from a contactable consumer (patient).  A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration 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, within thirty minutes after vaccination, the patient experienced dizziness and vertigo worsened and stated that she read that this could be severe allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt c/o arms feeling cool left walking to care w/parents;approx 2min later pt walked in to immun room accompanied per parents;mom states pt c/o h/a & numbness to arms, eyes rolled & arms started to twitch;referred to ER;
High fever - high as 104.1, then 103.3 - fluctuating. Right arm swelled, turned red from shoulder (top) to bellow elbow - constant, unrelenting pain. Still pain.
This is in follow-up to report(s) previously submitted on 5/16/2008. Information has been received from a health professional concerning an approximately 12 year old male patient who on 25-APR-2000 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot number, dose, route unknown). On 05-MAR-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U, dose, route unknown). Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown). On an unspecified date, the patient developed a localized rash at the injection site. The physician's office was contacted regarding this experience. This is the third of three reports of rash with the same varicella virus vaccine live (Oka/Merck) (lot number 659113/1360U). The patient recovered from injection site rash on an unspecified date. The caller requested a lot check for this lot number. There was no product quality complaint reported. A lot check has been requested. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Dizziness, Headache, Myalgia, Arthralgia & NauseaVomiting Narrative;
Caller stated the patient is now 24 years old and had bloodwork drawn for his new job which showed "no antibodies to varicella".; This spontaneous report has been received from a pharmacist referring to a 24-year-old male patient. The patient's previous drug reactions or allergies were not reported. His concurrent conditions included gastrooesophageal reflux disease, autism spectrum disorder, and hypothyroidism. The patient's medical history included drug hypersensitivity to azithromycin (ZITHROMAX). As concomitant therapies included levothyroxine and dicycloverine hydrochloride.  On 27-MAY-1999, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 milliliters for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On 27-MAR-2007 the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 milliliters for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On an unknown date, the patient had a bloodwork drawn for his new job which showed no antibodies to varicella (antibody test negative). The outcome of antibody test negative was not provided.  The causality assessment between both doses of varicella virus vaccine live (oka/merck)(VARIVAX) and the event of antibody test negative was not provided.
pt felt weak, dizzy, nauseous, monitored by provider until patient ambulated out of clinic unassisted
Inflammation of her RA; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Inflammation of her RA) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Inflammation of her RA) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Inflammation of her RA) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-081435 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-081435:2nd dose
This spontaneous case initially received on 06-Apr-2017 00:00 was reported by other non-health professional. Company suspect drug: FLUVIRIN (batch number: 1620301 and 1619701 with expiry date: 30-May-2017) (dose: 0.5 ml, unknown frequency, unknown duration, route of administration: unknown). Adverse reactions/events and outcomes: It was reported that there was a temperature excursion with FLUVIRIN product storage (characterized an Incorrect product storage) (Seriousness criteria: Non-Serious event), (Outcome-Unknown). Other non-health care professional reported that during the storage of vaccine the storage temperature reached minimum at 33.8 degrees F and maximum at 63.1 degrees F and there was a total of 6 excursions over a period of 7 days 17 hours and 10 minutes. He reported that an investigation was going on to determine whether the vaccine was given and there were no events been reported. Action taken with FLUVIRIN was not reported and outcome of the event was unknown. Reporter's Assessment: The other non-health care professional did not provide causality assessment for the event with FLUVIRIN. This case report was non-serious.
About 1 week prior to admission, patient had c/o gradually progressive neuropathy of his feet and hands along with ascending paralysis (More specifically, patient unable to ambulate, move hand, arms, and shoulders, or complete activities of daily living) following Pneumovax administration two weeks prior to admission.  Five weeks prior to admission, the patient had visited the hospital.  Upon presentation to the ED, the patient had a BP of 145/83, HR 85, Temp 98 degrees F, and pulse ox of 96% (room air).  Patient had a normal physical exam except for left upper extremity strength of 3-4/5, left/right lower extremity strength of 3/5.  The patient also had (+) neuropathy to the microfilament test.  Patient was admitted on 4/7/2007 to a general medical floor where he stayed until 4/10/2007 when he was found to have a vital capacity of 550, an extremely weak cough and paradoxical breathing.  The patient was electively intubated and transferred to the ICU for further management.  The patient treated with IVIG 35gm/day (400mg/kg) b/w 4/9/2007 and 4/13/2007 without improvement.  A short trial of corticosteroids (dexamethasone 6mg IV q6h, 4/10/2007 - 4-16/2007) was also used without improvement.  An NG tube was also placed during the patient's hospital stay.  Because the patient was not improving with the IVIG and steroid treatment regimen, the medical team transferred him on 4/19/2007 to the MICU for plasmapheresis (x 5 cycles) with a diagnosis of acute inflammatory demyelinating polyneuropathy. 7/11/07-records received from transferring facility for DOS 4/7-4/19/07- DC DX: Acute inflammatory demyelinating plymneuropathy. Transferred for plasmapheresis therapy. Essential tremor, endocarditis, status post mechanical aortic valve replacement 2000. One week history of progressively worsening neuropathy and ascending paralysis following a pneumovax two weeks prior to presentation. Elective intubation secondary to severe respiratory muscle weakness. No improvement after IVIG. Treated for pneumonia and pseudohyponatremia. 7/25/07-recods received from receiving facility for DOS 4/19-5/15/07-DC DX: Guillain Barre syndrome. Ventilatory dependent failure. Ventilator associated pneumonia. Staphylococcus communis bacteremia. Pseudomonas urinary tract infection. Depression. Atrioventricular nodal reentrant tachycardia. Chronic obstructive pulmonary disease.  Ascending paralysis treated with IVIG and high dose steroids with minimal improvement. Intubated and trached. Treated with plasmapheresis with some improvement. Discharged to long term rehabilitation facility with tube feed diet