chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abnormal postmenopausal uterine bleeding; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6207) via an unspecified route of administration in Arm Right on 18Mar2021 12:00 (age at vaccination: 53-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history reported None. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took metronidazole and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. In Mar2021 (nine days after first dose), the patient experienced abnormal postmenopausal uterine bleeding. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was reported as not recovered.  No follow-up attempts possible. No further information expected.
SINCE THE EVENING OF THE SHOT, SWOLLEN MASS (APPROX 4" X 3") AT INJECTION SITE. SKIN IS HOT TO THE TOUCH, ITCHY, SWOLLEN AND TENDER AND VERY RED.
Started with fever and body aches the day after the vaccine: fever lasted until 10/13 (not included), i.e., 4 days after the shot. Had to take pain medication.  Loss of apetite for 3 days after taking the shot.  Erectyle dysfunction (unknown to the day of the vaccine): no libido, no penile sensitivity or testicular sensitivity.  This was  about 90% loss on day 1 after vaccine, 80% on day 2, 50% of day 3, 50% on day 4, 40% on day 5, 20% on day 6 (today). Still not 100% recovered. Symptomes are great difficulty achieving an erection, no sensitivity around the genitalia.  Hematoma the size of a tennis ball on the left arm (flu and pneumonia vaccines).  Swollen enough for co workers to notice under garment. Painfull to the touch. Has subsided greatly after 6 days to non perceptible. No harsh reaction on the righ arm (Moderna).  Heart was a bit painful and difficulty exercising that lasted about 5 days (short of breath). Better now after 6 days.
Quarter sized welt appeared at the location of the administration of the flu shot.  The welt was red and raised.  It was also sensitive to the touch and it itched.  The welt began to disappear late Saturday night (10/17/2015), but it continues to itch even today (*10/19/2015).
Sore arm at injection site (hindered ability to drive car), all joints in legs, arms, hands painful, headache, fatigue, loss of appetite for >30 hours
The Moderna Covid vaccine for a full Primary Series dose is 0.5 ml.  The Moderna Covid Vaccine dose for a booster dose is 0.25 ml. The majority of the people coming into our Covid vaccine POD at this time are here for the booster dose. Inadvertently, a booster dose of 0.25 ml was given to this patient instead of the full dose of 0.5 ml which this patient needed since it was her very first vaccine. Upon realization of this error, the patient was notified.   A second 0.25 ml dose was given to equal the correct dosage of 0.5 ml. The patient did not experience any adverse reaction or experience any problems related to this.
after flu shots, patient got bad reactions; Initial information regarding an unsolicited valid non-serious case received from a consumer(patient) via social media on 15-Dec-2020.  This case involves a patient of unknown demographics who was reported to have after flu shots, patient got bad reactions (Adverse drug reaction), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown) after the administration of suspect the patient was reported to have after flu shots, patient got bad reactions (Adverse drug reaction).   It was not reported if the patient received a corrective treatment.  The outcome was unknown for adverse drug reaction.  There will be no information available on the batch number for this case.       The reporter assessed the causal relationship with suspect vaccine as related.
My significant other ended up testing positive for COVID-19 and had been home sick for about three days. Then I woke up feeling miserable, so I took a COVID-19 home test. I was out of work for about seven or eight days. I was fatigued, this major headache, and my body just hurt. I reached out to my healthcare provider, and they sent me to get an infusion of the antibodies. About two days into that I was feeling a little better. After recovering the headache did not stop. It has gotten so bad that I always have this dull ache in my head, and it will then turn into a migraine. I get about four or five migraine a week. I do have a medication that is supposed to help but I really constantly have this pain in my head, and it usually turns into a bad migraine and with pain that shoots and moves down my neck.
Redness, swelling, painful to touch at site of injection. Fussy and change in behavior.
Information has been received from a physician concerning a patient who was vaccinated with the third dose of Rotateq. Subsequently after receiving the third dose of Rotateq, the patient "came down with intussusception". Upon internal review intussusception was determined to be an other important medical event. Additional information has been requested.
Pneumococcal and flu vaccine given left deltoid 10-21-13, developed fever, malaise, and myalgias, some redness extending down left arm.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI669AA, expiration date: 30 June 2017 and site of administration was not reported) intramuscularly, 04 October 2016 (over the past month). Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medication was not reported. On an unspecified date, (over the past month), following the vaccination patient experienced injections site red, warm to touch and small hard raised bump. It was reported that the patient required emergency room or doctor visit. Lab data and corrective treatment were not reported. Sought out treatment was reported as none. The outcome of the events was reported as unknown. List of documents held by sender: none.
Information has been received from a medical assistant concerning a 15 year old female with allergy to CEFZIL and no relevant medical history who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported). In November 2007, the patient experienced headaches, stomach ache, dizziness, shakiness, dull and sharp aches all over. The patient also experienced joint pain all over, swelling of the right thumb, depression and insomnia. The patient had been set up with an appointment with a rheumatologist. Laboratory tests (included unspecified lab work, MRI of brain and X-ray of right hand (results unspecified). At time of this report, the patient's events persisted. According to the reporter, the patient's events prevented her from school schedule and were considered to be disabling. Additional information has been requested. 10/22/08-records received-presented on 8/8/08 with C/O headache,stomach ache, dizzy and shaking on and off for a while. Generalized pain. Abdominal pain. DX gastritis. Dizziness. 8/18/08 continues with C/O headaches and body aches. DX: arthrlagias, polymyalgias. Swelling of right thumb. Cephalgia. Dep ression. Insomnia. 9/3/08 continues with cephalgia, myalgias and depression.10/1/08-C/O abdominal pain.  12/31/08-records received for DOS 11/10/08-C/O arthralgia/back pain left limb pain. Vitamin D deficiency.
MMR vaccine was administered on June 18, around 10:30 a.m.  On Wed., July 20, patient began having seizures that were visible by eye twitches. She developed a fever that ran between 100.4 to 102 on Friday, June 22, 2007. After repeated phone calls from Wed (6/20)to Saturday (6/23), and one visit to the pediatrician (on 6/21), who said it was not a seizure, I took her to Emergency Room at which time the ER physician said immediately they were certainly seizures. Patient was admitted to Hospital from June 23 until discahrge on July 7, 2007. She was given 5 different meds before the seizures stopped and were no longer occurring. (There was some minor eye irritation on June 19, but we are not sure if that was the same twitching that began on June 20.) 8/30/07-recprds received for DOS 6/23-7/7/07-DC DX: Infantile hemiplegia. Conjunctivitis. Exotropia. Dermatitis due to drug and medicine taken internally. Unspecified anticonvulsant causing adverse effects in therapeutic use. Fever started yesterday and vomiting today. Fever 102. Patient saw PMD yesterday, probably had conjunctivitis. Temp in ED 100.7. Seizure like episodes described as 'zoning out' staring into space and drooling. Experiencing drainage from eye saw ophthalmologist who diagnosed conjunctivitis. Patient exhibited 2 episodes of seizure during exam consisting of rightward gaze, horizontal nystagmus, twitching bilateral eyelids. Annual followup 01/4/2010 MMR should be given separately (as 3 separate vaccines). I do not think thimerosal has anything to do with it, as ongoing controversy predicts. I do believe that 3 live viruses (MMR) option in one shot is welly too much for a child with known neurological injury and/or past seizures (see MMR vaccine P.I. enclosed). Many times this vaccine is given to children with no known cerebral injury but the is an underlying sine. This is dense and may cause problems. Obviously we (healthcare) cannot do MRIs on all children (whether known or unknown cerebral injury) before administering MMR vaccine. So why take a chance!?! Healthcare would benefit all around as would children and thier families. The health insurance companies would have to pay 3 administration vaccination fees, but that is pennies compared to what they later must pay for tests, therapy, hospitalization, specialist dr. visists, etc! Call a united you want to discuss this. Someone in poner of this needs to stand up for more children. Please share this with those who can affect  helpfull change!
VOMITING/THROWING UP/CAN'T HOLD ANYTHING DOWN; CAN'T GET OUT OF BED; This spontaneous report received from a consumer concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced can't get out of bed. On 27-SEP-2021, the patient experienced vomiting /throwing up/can't hold anything down. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting/throwing up/can't hold anything down, and can't get out of bed. This report was non-serious.
SMALL BUMP; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included type b diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1080529 expiry: UNKNOWN) dose was not reported, administered on left arm on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 16-MAR-2021, the subject experienced tiredness. On 17-MAR-2021, the subject experienced small bump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and had not recovered from small bump. This report was non-serious.
I received both the current influenza vaccine and Pneumovax23 on 9/5/2021. I experienced major swelling, redness and heat from my shoulder to my elbow. including me medical armpit and upper chest areas. I also had a fever and a headache for approximately 12 hours. Body aches and fatigue lasted approximately 30 hours.
Joint pain, aches, chills, feverish, nausea, vomiting starting at 0300 lasting all day.
The pt experienced a prolonged fever of greater than 102 for more than 3 days.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild
On day of vaccines given, he felt lightheaded/dizzy/nausea and sweaty within 2 minutes after both vaccines were given in left deltoid- laid down for 20 minutes with feet elevated and given juice in office and felt better within 20 minutes. He had immediate pain at site of injection for 3 days. The next morning on 11/13/18 7 AM, he started having painful of left upper arm with movement - especially moving arm  with raising above or lowering arm and that persisted even to this day (11/21/18) - tenderness to left posterior deltoid area.
1/2 hour after administration of the influenza vaccine patient developed a maculopapular rash on the upper extremities, neck and upper chest, Benadryl 25 mg every six hours prn
No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 16-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 10 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002451: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002491:
NO ADVERSE EVENT OCCURED.  PATIENT WAS UNDER AGE AT THE TIME OF VACCINATION, HOWEVER PER PARENT'S CONSENT VACCINE AUTHORIZED TO BE ADMINISTERED
not eating and drinking fluids as much as she usually does; herpetic gingivostomatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the parent.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL HERPES (non-serious) with onset Jun2022, outcome "unknown", described as "herpetic gingivostomatitis"; DECREASED APPETITE (non-serious) with onset 26Jun2022, outcome "unknown", described as "not eating and drinking fluids as much as she usually does".  Additional information: It was reported that patient (reporters daughter) who was two got vaccinated with her first dosage of Pfizer. Two days later she started not eating and drinking fluids as much as she usually does. The patient later started pointing non-stop to her mouth due to something bothering her. The before day of report, she was taken to the dentist to see if they saw something the reporter didn't see and dentist confirmed that she had herpetic gingivostomatitis. The patient was 100 % healthy before getting her vaccine. They believe that she was having a side effect.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received both injections in same arm, the next day he noticed a line going from the injection site up to his shoulder and around the front of his neck. There was also a bump on his neck. He noted shaking/sweats throughout the day after the vaccination also. Patient was not sure which injection site the line began from.
mild fatigue; mild arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "mild fatigue"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "mild arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
became unconscious w/in 1 min p/receiving MMR; had sz w/muscle tightening, teeth clenching & generalized stiffening of body; laid on floor, tourniquet applied above inject site; P68, too noisy to hear BP; unconscious approx 1 min;
Erythema, Maculo-papular rash in large oval patch over left deltoid with fairly clear center. Edge of rash has irregular border, rash cleared with HC recurred off and on when RX stopped. Now clear for 3 weeks on 11/10/06.
A few days after 2nd vaccine, while walking , my calves locked up (felt like muscle was going to pop) .  I didn?t have full range of motion and severe pain in legs.  This lasted  over 2 months with very little relief and got a little better towards the end of the 2 month period when I got an alternative allergy elimination treatment for the vaccine (NAET treatment) and I was able to walk normal  within a week.    I couldn?t walk for more than 10 minutes at an extremely slow pace because it was so painful and muscles stayed tight (I am normally active, play tennis 4 times a week,  so this was a huge lifestyle change.
Heart Arrhythmia starting a couple of hours after the shot and continuing several times a day
At 12 hours after the vaccination, the patient became feverish and  nauseous.  The patient sat down and became dizzy and lightheaded and passed out / fainted briefly, waking up with head on the floor several seconds later but no obvious head injury. These symptoms gradually improved over the next 12-16 hours and the patient did not pass out again.
Pain and swelling at injection site - 12/31/2020 to 1/2/2021 Decreased Pain and itching at injection site - 1/3/21 to present ******************************************************************** Headache - 12/30/2020 to present Fatigue/Tiredness - 12/30/2020 to present Arthralgia and Myalgia - 12/30/2020 to present Dizziness (Mild to Moderate) - 12/30/2020 to present Dry cough - 12/31/2020 to present Sore Throat - 12/31/2020 to present Swollen glands (Mild to Moderate) - 12/31/2020 to present Nausea - 12/30 and 12/31/2020 Diarrhea - 12/31/2020 Fever - 1/1/21 (1.6 degrees F above patient baseline)                 1/3/21 (1.7 degrees F above patient baseline)                 1/5/21 (1.4 degrees F above patient baseline) Chills - 1/1/21 to present
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced tested positive for COVID-19. It was reported that the patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 08Apr2021 and had a small family gathering with fully vaccinated people, with not fully vaccinated people, and everyone managed to get sick. The patient tested positive for COVID-19 on 21Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd 1st Engerix-B vax DEC90 & exp diarrhea on unspecified date (can't remember);  2nd vax JAN91 & exp wheezing, coughing, bronchial spasms that same month; respiratory sx tx w/proventil inhaler; 3rd vax 19JUN91 exp same sx as w/2nd vax
Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses. Dates of administration of vaccine were reported as 25-Oct-21, 26-Oct-21, 27-Oct-21 and 29-Oct-21. The vial did not undergo any temperature excursions.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.