chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on her elbow; swelling is going to the lymph nodes; itching; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 37-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash on her elbow"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling is going to the lymph nodes"; PRURITUS (non-serious), outcome "unknown", described as "itching".  Additional information: the patient got the COVID-19 vaccine on a Wednesday (unspecified what date) as a booster and she had a non severe rash on her elbow and itching but there was nothing at the injection site. The rash and swelling was going to the lymph nodes. She wanted to know if this has been reported with this vaccine and if she needed medical attention. The pharmacist wanted to know if those were normal side effects of the new one.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Started menstruation two weeks after my last period. My period had ended the day before the shot, yet my next period came two weeks after receiving the injection (three weeks early for my normal cycle).
Subsequent to receiving one dose of varicella virus vaccine live, pt developed rash with approximately 60 lesions. Pt was afebrile.
BLOOD CLOT; This spontaneous report received from a consumer concerned a 24 year old female. 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, therapy start date were not reported, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced blood clot and was hospitalized (date unspecified) and it was reported caller said his brother would called to provide more information regarding the patient's case. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210552268-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
12 hours after the first vaccine, patient had abnormal menstrual bleeding and clotting for 2 weeks  after her second vaccine, the exact same thing happened.  Patient was on depo injections and getting no periods at time of injections
Patient reports malaise, nausea, and difficulty sleeping the night after injection. Developed redness, induration, and pain in the upper arm at the vaccination site. Two days later the GI symptoms had resolved but had persistent redness and soreness and induration of the upper arm.
Grapefruit size Injection site swelling; extreme discomfort; This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and discomfort. On an unknown date, the outcome of the extensive swelling of vaccinated limb and discomfort were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced grapefruit size swelling in left arm and extreme discomfort 3 days following vaccination.  The patient received vaccine at nursing home and came to clinic due to reaction. The reporter agreed to follow up from GlaxoSmithKline.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in an adult female patient 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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.            Patient was reported  in mid-fifties. No concomitant medication information was provided. Patient experienced vertigo in the evening after receiving the Moderna booster. Patient also had been drinking alcohol that evening so patient wasn't sure it was the booster. No treatment medication were provided.
No additional adverse events; Caller is HCP who reported that patient received dose of PROQUAD that has experienced temperature excursion. No additional adverse events/no product quality complaints.; Information has been received from a medical assistant, referring to a 4 year -old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # U028183 and expiration date on 08-MAR-2023 (administration route was not provided) for prophylaxis. No adverse effects were reported.  No additional details regarding the temperature excursion was reported.
Tdap given 5/21 - Pt notes 4 d  of redness and local swelling (L) deltoid.
patient felt cold to the touch and pale, BP was taken and recorded at 75/49 at 1313, nurse held patient in chair to prevent her from falling off her chair
hint of a taste in my mouth; peckish; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 22Feb2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included cancer, fatigue, peckish (low appetite) and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included rituximab (RITUXAN) for cancer on an unspecified date. The patient got first dose of vaccine on 22Feb2021 and takes Rituxin and was told by her pharmacist to wait 20days after Rituxin dose to get the vaccine. The patient says the vaccine enhanced symptoms she already has. The patient stated that immediately after first dose, she had a hint of a taste in her mouth during the 15 minutes waiting after dose and she felt peckish immediately after the dose on an unspecified date in 2021. The patient asked that, since she had effects after first dose, how will it be after second dose. The patient wants to report something probably not made clear to people getting the shot that are on immunosuppressive drugs and gave person example: patient get cancer medication every 2 months, Rituxin. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Right arm local reaction 3 1/2" x 3 1/2" redness, tenderness, swelling, warm to touch. To take TYLENOL or Ibuprofen.
ROTATEQ administered 12/2/10. Evening of 12/2 & 12/3 the baby was restless & occasionally cried out during sleep probable gassiness. On 12/4 evening baby vomited (projectile) x 2 with 6 PM & 9 PM feedings (exclusively fed breast milk). On 12/5 baby vomited blood after 10AM feeding and was taken to the ER. Also with darker stools (yellow -> brown) x 2 days afterwards.
Both eyes very swollen, watery and itching on evening of 3/16. Appeared pretty quickly. Could be 'normal' allergies, but was quite a bit more of a reaction than I would normally get. I don't believe I've had my eyes swell this much before that I can remember. During day of 3/16 did not do anything outside in or around normal triggers when doing something like yard work. Took Kroger brand max strength sinus relief pills and went to bed. Morning of 3/17 eyes still swollen but not as much...much less watering and itching. Still swollen some at the time of this submission.
Pt came in for initial dose and was administered an expired vaccine. No adverse reaction, just trying to follow up with documentation from clinic for system record to be accurate.
Severe Nausea; Headache; Fatigue; No appetite; Joint aches; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN9581), dose 2 intramuscular, administered in Deltoid Left on 10Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation (Patient Age at Time of Vaccination: 66 Years). Patient received historical vaccine of dose 1 bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248), dose 1 intramuscular, administered in Deltoid Left on 20Jan2021 13:30 as SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 12Apr2019 to 15Jun2019 Verbatim: Orthoscopic Surgery, influenza from 2019 to 2019, major depression from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine (VENLAFAXINE) taken for major depression from an unspecified start date and ongoing; bupropion (BUPROPION) taken for major depression from an unspecified start date and ongoing; l-methylfolate (L-METHYLFOLATE) taken for major depression from an unspecified start date and ongoing; armodafinil (ARMODAFINIL) taken for major depression from an unspecified start date and ongoing; estradiol (ESTRADIOL) taken for major depression from an unspecified start date and ongoing; losartan (LOSARTAN) taken for major depression from an unspecified start date and ongoing; rosuvastatin calcium (ROSUVASTIN) taken for major depression from an unspecified start date and ongoing. Vaccination facility type was Public Health Clinic. Patient did not receive other vaccine in four weeks of vaccination. Patient did not have relevant family history or tests. On 11Feb2021 09:00 the patient experienced severe nausea, headache, fatigue, no appetite and joint aches. The outcome for the event joint aches was unknown and rest all events was recovered. No Follow-up attempts are needed. No further information is expected.
Pt received the vaccination at 1006 22MAR2021. Pt reports having numbness of the left side of the face and back-left side of the tongue at approximately 1830-1900. Denies swallowing or facial muscle movement problems. No known allergies, no prior vaccination reactions.
Very anxious about receiving immunizations. Five min after shots became pallor, dry mouth, H2O given, cool compresses to neck and head. Lie down on exam table. Reassurance offered. Mom present. Full recovery.
Pt. had intial sore arm soon after vaccine.  She developed a large swollen supraclavicular lymph node 1 day after shot.  She also has headache.
Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer brand). She complained of left sided facial numbness with no facial droop or slurred speech present at the time. Her vitals were taken, she was monitored and seen by a PA. She was given an education handout on allergic reactions to medications and scheduled to follow up with her primary care physician regarding her elevated blood pressure (182/100). Patient did not report prior history of hypertension. She was discharged and able to ambulate our of the ED and drive home. Coure of care approximately 1 hour.
Patient developed spontaneous nosebleed, lasting 20  minutes, one day after injection. Patient reported 2nd spontaneous nose bleed lasting 10 minutes two weeks post injection. Patient has no known history of nosebleeds in the past, and no recent accidents, falls or other injuries to the head, neck or face. Patient experienced first ever migraine two weeks post injection.
Patient received FLUVIRIN flu shot on 9-8-09 and had no adverse reaction. He became swelling on next day 9-9-09. He went to ER & was given PREDNISONE. ER MD suspected may be due to flu shot.
shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2017, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and ill-defined disorder was not recovered. The reporter considered shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).
Skin rash (Pityriasis Rosea); This is a spontaneous report from a non-contactable physician. A 31-years-old female patient received bnt162b2 (COVID-19, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 12:00 (Batch/Lot Number: EL8982) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced skin rash (pityriasis rosea) on an unspecified date. The seriousness of the events was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
PATIENT REPORTED:  IMMEDIATELY AFTER VACCINATION SHE FELT WOOZY.  AROUND MIDNIGHT PATIENT REPORTS FEVER AND CHILLS THAT LASTED UNTIL 1-2AM (3/16/21).  PATIENT ALSO REPORTS HEADACHES FOR THE NEXT 2 DAYS.
~ 5 weeks pregnant at the time of 2nd vaccination. Miscarriage ~2 weeks later. Transvaginal ultrasound shows gestational age only 5 weeks when should have been 7. HCG level reflects only 4-5 weeks when should have been 7.
A non-serious spontaneous report of 57 year old receiving H1N1 LAIV was received from a health professional concerning a 57-year-old female. The patient's medical history was not reported. On 24-NOV-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Ever since the I have recieved the vaccine, I have been breaking out in intermittent Hives- which i have documented pictures of. I have never had hives prior to this vaccine. I tried coming off my medication to see if that was the cause, coming off certain food to see if that was the trigger of the hives- but still Hives keep appearing and nothing triggers them. They use to come once a day, now every few hours and they are all over my body. To the extent that my doctor has had to put me on cetirizine BID to see if that can control the hives. There is no cause for the hives- I got the vaccine and now i am developing severe Hives that are getting worse.
TENNIS BALL SIZE REACTION, SMALL REACTION STARTED ON 09/09/2008 WITH INCREASING SIZE AND REDNESS.  RED AND SWOLLEN
Extremely itchy arm and discoloration around injection site. Occurred about 5 days after the injection and the itching lasted around 2 days. The discoloration lasted about 10 days. The rash site was sore to the touch. I did receive the second dose 3 weeks later with no issues (other than the expected sore arm).
fever 102-18hr p/vax;h/a x 24hr;legs ache 18hr p/vax;runny nose started 9/2/99;
This spontaneous report was received from a medical assistant refers to unspecified 13 patient of unknown age and gender. This report pertains to the patient who on 14-OCT-2013 was vaccinated with VARIVAX, (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assitant reproted that improperly stored VARIVAX that was exxposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (same reporter link). Additional information has been requested.
This case was reported by a nurse and described an adult female pt who did not respond to the Engerix-B immunization series. On unspecified dates in 1986, the pt received the 1st "series" of hepatitis B vaccine. On an unspecified date in 2003, a hepatitis B surface antibody titer was "non-reactive". The pt then received a series of 3 doses of Engerix-B, with the 3rd dose administered on 7/26/04. On an unspecified date in 9/04, a hepatitis B surface antibody titer was also "non-reactive". The nurse considered the events to be probably related to vaccination with Engerix-B.
I was woken from sleep with severe chills and nausea.  I sat on the toilet b/c wasn't sure if going to have a BM or vomit, then the next thing I remember is waking up on the floor, so assumed loss of consciousness.  Couldn't move or get up from floor because so weak.  Another wave of severe nausea occurred and then my husband helped me sit up and lean on the toilet to vomit, and I lost consciousness again for 3 to 4 seconds.  Layed on the floor again for a bit, then made it to bed.  At 5 am had another wave of nausea and vomiting and started to have a bowel movement and vomit at the same time and lost consciousness again for a few seconds, my husband had to prop up my head.  I was able to make it into bed and then the symptoms gradually subsided.  I was able to eat around noon.  My husband and I are both physicians so didn't seek medical care.
3 day history of approximately 15 lesions on chest, back, femoral area. Lesions, erythematus macules, pustules and scabbed lesions.
Red, raised, inflamed (hot to touch), itchy, 5 inch  mark around injection site (left arm) appeared on day 8 with arm soreness and general fatigue. Commonly known as ?covid arm? Day 9 arm inflammation worsened, fatigue persisted. Days 10-12 inflammation residing, but redness still present.
On the morning of 01/27/2023, I was away at a business meeting, out of state. I felt warm and developed a cough and sinus congestion. I flew home and tested myself for COVID-19 and, I was positive. That night, I took Tylenol and Advil. I called my doctor the next morning. He advised that I take Paxlovid, which I started on 01/28/2023. Saturday and Sunday were no fun, but by Monday, I was feeling better. I was able to work remotely Monday and Tuesday. I finished the Paxlovid and had significant symptom relief. I was probably a full week before I felt normal. It was 17 days until I tested negative. During that day, I stayed home and isolated. With the acute event on the 27th, my ears became clogged. For about 6 weeks after, I would have intermittent ringing and popping in my ears with a bit of hearing loss. It wasn't constant. It slowly faded away on its own.
given the ACTHIB expired with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics who was given the HIB (PRP/T) vaccine [ACT-HIB] expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection dose, strength: not reported lot UJ798AB expiry date: 11-Sep-2023 via unknown route in unknown administration site for Immunization and given the acthib expired with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event given the acthib expired with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Last shot patient got made ill; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who experienced ill (illness), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication 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 expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, last shot made patient ill.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.