chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalization; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalization) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    Concomitant products included PREDNISONE, MESALAZINE (ASACOL HD) and BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) for an unknown indication, MONTELUKAST SODIUM.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) outcome was unknown.            Treatment medication was not provided by the reporter.  Patient's medication was working well. The Covid booster put him in the hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with humira for the event(s) of hospitalization was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an elderly male patient with no medical history reported, who was hospitalized due to the unexpected serious event of Hospitalisation, in the context of a dose of mRNA-1273 as booster dose of COVID-19 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly male patient with no medical history reported, who was hospitalized due to the unexpected serious event of Hospitalisation, in the context of a dose of mRNA-1273 as booster dose of COVID-19 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient presented to the vaccination site on 10/18/21. The client notified RN that she received a single dose of the (Cansino) COVID vaccine in (April 2021). RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer. Per CDC guidance, approval to proceed with COVID vaccine Pfizer first dose with 30 minute observation was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Pfizer Lot# 30145BA on 10/18/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 1947.
Developed nausea, vomiting, abdominal pain, dizziness, fever 101.2 to 102F, generalized bodice, left arm. Every day nausea, generally not feeling well with decreased appetite. Side effect of nausea, vomiting, fever, abdominal pain started after about approximately 16 hour after vaccine injection. Left arm pain soon after injection.Continue to have nausea daily and low grade fever.
noticed the day after injection on left arm:  small "pimple" at injection site, light swelling around injection site, light rash around injection site, painful to touch area around injection site
Adverse reaction to Lyme disease vaccine; I now have severe degenerative arthritis. I have arthritis very bad in hip and many other places. Annual follow up states pt has not recovered. Headaches- painful swollen joints, degenerative arthritis ringing ears, chronic right side radiculopathy, many more symptoms, memory loss, fatigue - too many to list. Because of this vaccine, pt has chronic Lyme disease and I will be suffering for the rest of my life.
Fever, Flu like symptoms., chills/sweating for 72 hrs, Body aches and severe joint pain, disorientation, severe anxiety and jittery, rapid heart rate, Resting heart rate was between 130-140 beats per minute. Severe fatigue and weakness. Stayed in bed for 48+ hrs after adverse symptoms began with little relief.
4/24/21   8:30 pm  headache, dizziness, feverish, body aches 4/25/21  - 5/2/2021  all the time headache, dizziness 5/3/2021 -5:30 am headache and dizziness continued, it then at 6:15 am increased to point of almost blacking out, vision changes,  then returned to previous state 5/4/2021 - 5/18/2021 headache and dizziness remained constant until noon when dizziness increased accompanied by hot flash, then returned to previous state
This spontaneous report was received from a 45 year old female consumer referring on herself. Medical history and concurrent conditions were not reported. On 09-JUL-2013, the patient was vaccinated with the first dose of GARDASIL. Dose, route and lot number were not reported. On 05-SEP-2013 the patient received the second dose of GARDASIL. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. The patient reported that she developed a sore arm after her second vaccination with GARDASIL (approximately on 05-SEP-2013). The patient explained that her arm had felt sore since receiving this dose of the vaccine. The patient stated that only recently, some time in December 2013, had the arm begun to feel better. The patient also stated that she was unsure if would complete the series. The patient did not seek medical attention. The causality was not reported. Additional information has been requested.
DTAP given to Lt arm, showed redness 5 inch round & swelling. Returned for recheck 8/12/11. FU 8-11-11, 8-12-11.
Presented with bilateral facial weakness on 7/11. Prescribed 3 day course of steroids (7/14-7/16) without improvement. Presented again on 7/18 with worsening facial weakness in addition to bilateral upper and lower extremity weakness and difficulty walking. Admitted to hospital on 7/19. On the second day of his hospitalization he was no longer ambulatory. Diagnosed with likely AIDP based on CSF studies (albuminocytologic dissociation, negative infectious work-up). Treated with 3-day course of IVIG (7/21-7/23), after which he showed significant improvement in his upper/lower extremity and facial strength and ambulation. He is being discharged with ongoing outpatient physical therapy.
Chills at 12 am  8/17 which lasted two hours. Severe headache on 8/17 which lasted all day. Medicated with tylenol.  Headache disappeared during the evening of 8/17. No other reactions.
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21B) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised. Concurrent medical conditions included Multiple sclerosis.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported on 19May2021 that she received 1st dose of Moderna vaccine on 22Apr2021 and no symptom after vaccine administration. Yesterday she was diagnosed urinary tract infection and antibiotics was prescribed. She is patient of Multiple sclerosis and immunocompromised. No information of HCP, concomitant medication or expiration date of Vaccine. She schedule for 2nd dose of Moderna vaccine tomorrow. Her concern: Can she receive 2nd dose tomorrow? She agreed for verbal follow up with Safety.
Mother calls to report reaction of redness, swelling and pain. This child was not seen in person to assess physically this reaction  was reported via telephone call.
I was diagnosed with a blood clot in my right leg last week. It was swollen and I was having issues walking on it. The blood clot is located behind my right knee. I'm currently on medication for it. I had diarrhea for a week with fever and vomiting. The diarrhea episode was uncontrollable and I've never had it like that before. I was placed on 2 antibiotics.  3 weeks before I got COVID-19, I didn't have much symptoms other than the fatigue. And I got through it pretty easily.
Pt recvd DTP/OPV & on 27OCT91 exp "rash"; Taken to MD 28OCT91; Has warm erythema in 1/2 moon shape @ site of inject w/seedlike lesions & axillary node;
Large circular rashes on both arms, mirrored kidney shaped rashes on bilateral sides of abdomen, blisters back of R hand- no fever or change of demeanor
This is a 4-month-old male with no chronic medical history parents at bedside presenting with persistent fever x1 day.  Father states that patient received two 4-month vaccines yesterday.  Parents gave patient a dose of Tylenol prior to vaccines and have repeated Tylenol every 4 hours since vaccines yesterday.  Patient had similar postvaccine fever in June post 2-month vaccines and decided to split 4-month vaccines into 2 sessions.  Second 4-month vaccines are scheduled in 2 weeks.  Patient is bottle-fed and parents report normal appetite, wet diapers and bowel movements.  No diarrhea, vomiting.  Patient is not pulling at his ears and besides increased fussiness is otherwise acting appropriately.  Last dose of Tylenol was at 6 AM.  T-max of 102.2 at home.
On Monday night, Day 4, I woke at 11 p.m. with chills and shaking, temperature of 99.9 F. Went to the bathroom, urinated, took Tylenol and went back to bed. Woke again at 2:00 a.m, still chilled, and tried to stand up and my legs wouldn't hold me. I managed to lift myself to my feet and clutching furniture get to the bathroom, with complete loss of bladder control on the way. Took more Tyleonol, drank more water, put on clean pajamas but couldn't lift my knees to step into them, had to put them on the floor and pull them up. Went to sleep eventually. When I woke at about 5 a.m., all was completely normal. No fever, legs fine, usual bladder control.
Sudden dizziness when I turned my head or stood up: light-headedness and fluttering of heartbeat. After several days, the sudden dizziness symptoms went away. Light-headed symptoms occasionally remain. Atrial fibrillation continues.
vertigo; blurred vision; sour metalic taste in her mouth; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6207) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; DYSGEUSIA (non-serious), outcome "unknown", described as "sour metalic taste in her mouth"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  Additional Information: The reporter (patient's husband) was asking what they can do about the patient's symptoms.  No follow-up attempts are possible. No further information is expected.
making me nervous; hot; where I got my shot yesterday is red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (making me nervous), VACCINATION SITE WARMTH (hot) and VACCINATION SITE ERYTHEMA (where I got my shot yesterday is red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced NERVOUSNESS (making me nervous), VACCINATION SITE WARMTH (hot) and VACCINATION SITE ERYTHEMA (where I got my shot yesterday is red). At the time of the report, NERVOUSNESS (making me nervous), VACCINATION SITE WARMTH (hot) and VACCINATION SITE ERYTHEMA (where I got my shot yesterday is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-Jun-2021 and contain non significant information. Reporter asked to be removed from follow up list. Reporter does not have email or fax.
Patient is 20 weeks pregnant with a due date of 12/27/2021. Has factor V leiden mutation for which takes aspirin.  7-8 minutes after first dose, patient started getting dizzy and passed out. Did not suffer injury as was sitting in chair. Went to emergency room and was given CT to rule out blood clots and pulmonary embolism. Patient discharged feeling better.
Information has been received from a registered nurse concerning a 1 week old infant who on 21-MAY-2008 was vaccinated at the pediatrician's office with VAQTA (Merck) instead of with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  The nurse was contacted and it was reported that this was due to human error.  The patient was not experiencing any known symptoms.  At the time of the report the patient's status was unknown.  There was no product quality complaint involved.  No further information is available.
Every time she got the vaccine, tinnitus was a little louder; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID:.  A female patient received BNT162b2 (BNT162B2 NOS), 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; manufacturer unknown), for COVID-19 immunisation, reaction: "Tinnitus aggravated". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Every time she got the vaccine, tinnitus was a little louder". Additional information: The reporter spoke with a lady (patient) in the church that has the same problem as her husband, and that every time she got the vaccine, tinnitus got a little louder. The reporter thinks it was the COVID vaccine by Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT GIVEN VACCINE, WAITED IN ROOM 10 MINUTES, PT FELT FINE, WENT TO LEAVE AND FAINTED, ASSISTED HER TO CHAIR WHERE SHE PROCEEDED TO FAINT AGAIN. ASSISTED PT TO TABLE TO LIE FLAT.VITAL SIGNS MONITORED. PT MONITORED EVERY 5 MINUTES. SLOWLY BEGAN TO RAISE HEAD OF BED AS PT TOLERATED. AMBULATED PT BEFORE ALLOWING HER TO BE DISCHARGED. TOTAL TIME FROM REACTION TO DISCHARGE 1.5 HOURS.
Hospitalized (05/07/2022-05/18/2022); COVID-19 positive 05/07/2022; fully vaccinated plus booster  BRIEF OVERVIEW: Primary Care Physician at Discharge: MD  Hematologist/Oncologist:  Admission Date: 5/7/2022 Discharge Date: 05/18/2022 Patient's Discharge Disposition:  Rehab in stable condition.   Hospital course: 87 y/oM with pmHx bacterial endocarditis s/p MVR and ICD placement in 2007, CAD (50% occlusion of LAD), combined systolic and diastolic CHF with most recent EF 40%, multiple myeloma on Revlimid and bortezomib + decadron, afib on coumadin admitted with acute hypoxic respiratory failure and hypotension.  Patient currently lives with his daughter.  EMS was called after an episode of coughing and vomiting for which he became very dyspneic and distressed.  He presented to the ED on NRB, tachypneic, febrile, and  bradycardic.  Labs confirmed + UA, + COVID-19 PCR, BNP 4,100, INR 3.1.  BiPAP was initiated, patient received 2L IVF, blood and urine culture cultures obtained, and he was given a dose of ceftriaxone and azithromycin.  Despite IVF he was started on NE and admitted to the ICU.  Upon arrival, NE was weaned from .08 down to .02 and he was stable on BiPAP with normal RR.  He was started on remdesivir and decadron, abx broadened to vancomycin and zosyn.  He was able to wean off BiPAP and NE.  Repeat ECHO stable.  Patient evaluated by SLP and diet ordered.  On 5/8, patient improved and able to transfer out of the ICU.  Spoke with oncology service who accepted the patient under Dr.    The patient completed a course of abx with Zosyn on 5/12, Remdesivir on 5/11, and a 10 day course of dexamethasone on 5/16. He developed diarrhea during his admission but was c diff neg. He was started on scheduled Imodium and PRN Lomotil. Diarrhea was starting to improve by time of discharge. PT/OT evaluated and recommended SAR. Staff assisted with arranging and the patient was able to discharge to a facility via ambulance.   The patient was eating and ambulating with assistance at the time of discharge. Discharge medications and follow up as listed below. Answered all questions and the patient was comfortable with the discharge plan
Case number PHEH2014US020466 is an initial spontaneous report received from a pharmacist on 09 Oct 2014 with a follow up information received from a pharmacist on 06 Nov 2014. This case refers to a 19 year old female patient. Past medical history was not reported. Her concomitant vaccination included administration of a dose of FLUVIRIN (batch number: 1411001) at a dose of 0.5 ml intramuscularly on 08 Oct 2014. She was vaccinated with an initial dose of MENVEO (batch number: M13014) intramuscularly at a dose of 0.5 ml on 08 Oct 2014 at 12:16 and the vaccine was reported as expired. No adverse event was reported following this administration error. Follow up information received from a pharmacist on 06 Nov 2014: Updated concomitant vaccination, dose number, route and time of vaccination of suspect vaccine.
Patient presented to the Pharmacy for her Moderna Booster vaccine today.  During screening, she revealed that she was 33 weeks pregnant and was allergic to nuts and shellfish.  No other allergies or medical conditions were stated.  She was asked about prior reactions to the Moderna vaccine, specifically.  She stated that she had experienced flu-like symptoms with prior doses that lasted less than 24 hours.  She was counseled that she may have flu-like symptoms with this dose, as well as soreness or redness in her arm.  She expressed understanding.  She received vaccine without incident and moved to waiting area for 15 minute observation.  During this time, her husband asked for a container to use because his wife felt nauseous.  We provided them with a plastic bowl.  She began vomiting into bowl.  A technician and I, the Pharmacist, went out to attend to the patient.  We inquired if she needed to lay down or had itching or rash.  She stated that she did not feel like it was an allergic reaction and felt fine to remain seated.  We offered to call 911 for Paramedics, but she declined.  Patient was appearing clammy, so we provided a wet, cold cloth and ice packs.  She stated that she felt better and left the facility approximately 15 minutes later.  We asked her to let us know if her condition worsened and she had to go to the Emergency Room for further treatment.
Right Axillary Lymph node swollen. Treated with pain relievers. Swelling subsided on day 8. Rash and Hives randomly appeared on  abdomen and legs starting on Day 9, lasting for 3 days. Treated with anti-histamines until rash and hives subsided.
pt recv vax 18FEB97 & 4MAR97 pt devel approx 20 lesions;
Severe vertigo, nausea and vomiting 3 days later. persistent balance issue.
PATIENT PRESENTED TO PHARMACY AROUND 9:10AM ON 10/20/17 INQUIRING ABOUT POSSIBLE REACTION TO PNEUMOVAX VACCINE IN LEFT ARM. PT REPORTED REDNESS, SWELLING, AND PAIN BEGINNING ON MONDAY EVENING AFTER RECEIVING VACCINE WHICH HAS CONTINUED THROUGH OUT TODAY WITH REDNESS SPREADING FROM UPPER ARM DOWN TO ELBOW AREA. PT REPORTED TO HAVE BEEN CAMPING THIS WEEK SINCE RECEIVING THE VACCINES ON 10/20. WITH THE REDNESS & SWELLING IN THE AREA NOT RELATED TO INJECTION SITE, I ADVISED PT TO SEEK ADVICE OF PHYSICIAN TO DETERMINE WHETHER OR NOT SOMETHING OCCURRED WHILE CAMPING OR AT ANOTHER TIME, UNRELATED TO VACCINE ADMINISTRATION. PT SOUGHT TREATMENT FROM LOCAL URGENT CARE WHERE PHYSICIAN THERE DETERMINED AFTER EXAM THAT REACTION WAS DUE TO VACCINE. PT REPORTED BEING INSTRUCTED TO TAKE OTC NAPROXEN IF NECESSARY & THAT NO OTHER TREATMENT WAS ADMINISTERED OR NECESSARY.
first dose 3 years ago, never got 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose 3 years ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The patient never got the 2nd dose of Shingrix and asked that he/she had to start the dosing schedule again. The patient also asked that what should a patient do if their 2nd dose of Shingrix was later than six months after receiving the 1st dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Viral synd c/o generalized aches & pains, malaise & fever-flank pain;
From initial information received on 09/09/03 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 5 year old male pt received his fifth dose of TRIPEDIA, Lot # U1006AA, administered IM in the right thigh, a fourth dose of IPOL, Lot # W0704-2, administered SC in the right upper thigh, and a second dose of MMRII, Lot # U133N, administered SC in the left thigh on 09/03/03 at 16:00.  One hour later, at 17:00, the pt complained of onset of wheezing, generalized hives and itching. The pt was treated at and released from a local ER.  Reportedly, the pt recovered from this event.
Rash on face, chest, back and arm. Sore throat  with erythema Afebrile, tonsillar and posterior cervical lymphadenopathy
RASH- which started about 48h after vaccination and spread, started to improve 7-10d post vaccination
5 cm diameter swelling surrounding site of injection from MCV4 (R) deltoid area - cold compresses.
Pt rec'd 1st & 2nd dose of vax in 1989; On 21DEC90 she rec'd 3rd dose of vax using outdated product; @ time of report there were no adverse exp;