chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous has been received from a nurse regarding to an unknown number patient of unknown age. The patients' concurrent condition, medical history, concomitant medication and drug allergies or reaction were not provided. On unknown dates, an unspecified number of patients were vaccinated with improperly stored dose of  GARDASIL 9 (lot # R020200, expiration date 05-MAY-2021 and lot # R004689, expiration date 29-NOV-2020), VAQTA (Lot # R021233, expiration date 05-SEP-2019, Lot # R025518, expiration date 15-NOV-2020, lot # R030120, expiration date 15-NOV-2019 and lot # R027431, expiration date 08-SEP-2019), ROTATEQ Orally (Lot # R017955, expiration date 05-MAY-2020, Lot # R016790, expiration date 20-APR-2020, Lot # R021650, expiration date 27-MAY-2020, Lot # R021649, expiration date 27-MAY-2020 and lot # R021390, expiration date 02-SEP-2020), PNEUMOVAX 23 (Lot # R024025, expiration date 02-SEP-2020), RECOMBIVAX HB (thimerosal free) (lot # R021372, expiration date 25-MAY-2021 and Lot # R001530, expiration date 07-NOV-2020) and M-M-R II (rHA)(lot # R024906, expiration date 30-AUG-2020). The administered doses of the vaccines experienced a temperature excursion at the lowest temperature 2 °C (-1.2 °C) for 2 hours and 43 minutes, and at the highest  temperature above 47 Fahrenheit degrees or 9°C (11.2°C) for 3 hours and 29 minutes. This report was called because of a data logger. Previous temperature excursion was involved. There were no adverse effects reported. No further information would be expected. This case is a non-valid, since there was no patient identifiers reported.
1st noticed red spots on both arms below the elbows and on my chest on 4/7/21. I had an upcoming appt. w/ a dermatologist on Friday 4/16, so I waited to see him before doing anything. He wasn't sure what it was, but thought with the location it could be Polymorphic Light Eruption. Was given TRIAMCINOLONE ACETONIDE CREAM 0.1% for the itch. On Monday 4/19 I call the dermatologist to ask if Sunlight Eruption would spread and was told no. It had spread to my thighs, calves, feet, back and the rest of my arms by this time and the itching was uncontrollable. On Monday the 19th I started my version of a dose pack with 30 mg of Prednisone for 6 days.
quarter size whelps 2hr p/vax, on hips;inc rash & whelps the following day w/lip swelling;stable @ d/c will be re eval in 48hr;returned in 2hr >condition worsen-adm;allerg rxn;
Flu vaccination: Nov 3, 4 p.m. Symptom: Fainted and fell from chair to the right side on Nov 5, 10 a.m.
Patient was administered the Pfizer bivalent as the first dose in the primary series.  No adverse reactions reported.
From telephone contact received from reporting nurse stated that a 20-year-old female patient received a Menomune A/C/Y/ W-135 vaccination on 27-Jun-2001. Two days after vaccination, the patient developed fatigue, neck and back pain and fever. Further information is requested
Patient had general malaise  unknown cause. Onsite EMS was called vitals were taken BP 202/74       100% O2 room air HR 74.Patient treated, Left aginst medical advice.   .
Recurring headaches, tinnitus, fatigue, dizziness, since 2nd shot   Onset of chest pains and numbness in limbs 3/22/22  Various medications with no improvements
Hep A dose given 6 days too soon. First dose 04/23/2018.
Administered a vaccine that has been refrozen; Vaccine vial punctured for more than 6 hours; A spontaneous report  was received from a healthcare facility administrator concerning a patient who received Moderna's COVID-19 (mRNA-1273) Vaccine and experienced expired product administered.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30 Dec 2020, a vial containing Moderna's COVID-19 Vaccine was thawed, and the vial was punctured. Afterwards, the vial was placed back into refrigeration overnight.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection from the same vial. The dose given was outside of the six-hour timeframe from the first puncture of the vial, and the patient experienced expired product administered.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event, expired product administered, was not provided.   The event, expired product administered, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of product storage error and out of specification product use for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product storage error and out of specification product use.
Sore arm. Soreness up into my neck and general shoulder area. Achy all over. No desire to get up and do anything. Still having trouble with soreness in arm. Hard to raise that arm above head.
This consumer report (initial receipt 17-Oct-2014) concerns a female patient who had a medical history of a hip replacement in 2004 in which she developed a rash (watery blisters which was associated with neomycin used during surgery) which became infected with 'staph' (staphylococcus) and treated with vancomycin which caused hospitalisation for an additional three months. Additional medical history included glaucoma, small ear canals and a drug reaction/allergy to neomycin. Concomitant medications included levothyroxine, fesoterodine, aspirin, timolol, latanoprost and dorzolamide. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported) and two doses of an unspecified pneumonia vaccine. Since the receipt of these vaccines, the patient had been diagnosed several times with acute bronchitis. The patient's last diagnosis was approximately one week ago. The patient developed a sore throat and chills and was later diagnosed with acute bronchitis. Treatments included a Z-PAK and MUCINEX. The patient believed that the Z-PAK did not work. Outcome was not recovered.
Started having mild chest pain 5 days after second dose. Still hurting a month later worse so I went to ER. Got diagnosed with Hypokalemia and I have inflammation around my heart causing my chest pains.
Oth complications following immunization, NEC, init on 2018-01-01.
Starting about 1 hour after administration of the vaccination, the patient started to feel some dull pain which has decreased over time but is still present to this day.
fever, headache, tiredness, aches, upset stomach most symptoms have subsided.   no treatment.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 26-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Got Covid-19 between 1st and 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Got Covid-19 between 1st and 2nd dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got Covid-19 between 1st and 2nd dose). At the time of the report, COVID-19 (Got Covid-19 between 1st and 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
day 3 of a fever/low grade fever/a fever more than 48 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (day 3 of a fever/low grade fever/a fever more than 48 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (first two doses were pfizer). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.   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 PYREXIA (day 3 of a fever/low grade fever/a fever more than 48 hours). At the time of the report, PYREXIA (day 3 of a fever/low grade fever/a fever more than 48 hours) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Pt recvd vax & 5-6 days p/2nd dose exp a half-dollar sized red itchy area @ inject site;
Diagnosis: G.B. Syndrome. 5/11/05 Sore throat, fatigue. 5/14/05 Numbness and tingling to hands and fingers. 5/15/05 Numbness/tingling to feet. 5/15/05 Deep throbbing, pain in arms up to elbows, pain in shoulders, increased NBC. 5/18/05 Difficulty with gait. 5/19/05 Hospitalized. 5/23/05 Transferred to another hospital and placed in ICU; Condition critical for 4 days. 5/24/05 Lumbar puncture. 5/25/05 LP findings, Guillain Barre. 5/30/05 Step down from ICU. 6/3/05 Admitted to physical therapy rehab facility. 7/28/05 As of this date, discharged planned for 8/2/05.   Received hospital medical records for 5/19-6/3/2005.  FINAL DX: acute inflammatory demyelinating polyneuropathy Records reveal patient experienced bilat ext numbness & tingling w/progressige arm/neck pain x 10 days prior to admit.  Had sore throat & fatigue approx 3 wks prior to onset of s/s.  Transferred from outlying hospital.  On admit to ICU, had weakness of all extremities, urinary retention, constipation, respiratory insufficiency. Neuro consult done.  Tx w/IVIG x 4.  Slow improvement & transferred to inpt rehab.  Per follow up report-Continued muscle weakness, numbness, tingling and pain to lower extremities.  Muscle instability.  Unsteady array gait. Per annual report-Continues to have numbness and tingling to lower extremities (feet & toes), balance is offset by this (numbness and tingling). Physical stamina has not returned to pre-illness level. Has decreased muscle strength in thighs and those muscles fatigue more easily.
I had an upper respiratory infection on 05-17-2021. I went to see my doctor who tested me for Covid and my test was negative on 05-19-2021. Post vaccine reaction I did have fatigue lasted longer than I thought I would. One week after my vaccine I had fatigue. On 04-11-2021, the fatigue was less than it had been, also had nausea. On 04-12-2021, I had dizziness during the night and I could not babysit the next morning because I was still feeling light headed. I also developed shingles after my upper respiratory infection and diagnosed on 05-31-2021, diagnosed on the 5th cranial nerve and had to go to the eye doctor to make sure my eye was not affected.
Spreading rash starting about 1 to 2 inches below injection site. Pt states rash is warm and arm hurts and rash is spreading down arm toward elbow.
2/6/2021 had painful inflammation and went to Clinic, less than 2 weeks after vaccinations and flu shots.  These were required by Agency for entrance to Spring Semester 2021.
flu like symptoms; body aches; clammy; sweating profusely; cold/ His skin is cold to the touch; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prior history of Covid shot(s).   On 25th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 26th October 2021, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, clamminess, excess sweating and feeling cold. On an unknown date, the outcome of the influenza-like symptoms, general body pain, clamminess, excess sweating and feeling cold were not recovered/not resolved.   The reporter considered the influenza-like symptoms, general body pain, clamminess, excess sweating and feeling cold to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient and his wife. The patient received the Shingrix shot 1 yesterday from the day of reporting in the left arm.  He did not have the lot number or expiration date of the shot but did provide contact information for the military clinic where the shot was given.  On the day of reporting the patient was experiencing flu-like symptoms including body aches, also sweating profusely and the sweat was soaking through his clothing.  The patient was cold and clammy.  They had not taken his temperature to see if he had a fever but the patient's wife did not think her husband has a fever.  His skin was cold to the (her) touch.  The patient was not shivering.  These symptoms had not resolved.  They believed these symptoms were a result of the shot.  The reporter consented to follow up.
chest pains, head ache dizziness, light headedness, soreness at injection site.
Patient was scheduled to receive 3 vaccines, one of which was the Meningitis conjugate (Menquadfi) vaccine, but Meningitis B (Trumenba) vaccine was given in error.  Meningitis conjugate was then given once error was identified.  Patient tolerated all vaccines well and there were no side effects observed within 15 minutes of receiving all 4 vaccines.
about 5 minutes after the vaccine pt sarted to get lightheaded and sat on the floor. He started to pass out and I laid him down and had someone call 9111. He woke up pretty quickly. His BP dropped again when the ambulance was here so he went with them
- Left upper arm redness and swelling at influenza vaccine injection site (1-2 days after Vaccine injection)  - Since Thursday, 01/09/2020, patient noted neck pain that was giving her headaches along with the bilateral arm and hand numbness and mild feet numbness.  Her symptoms seemed to be improving but on the 01/13/2020 pt noted tongue heaviness.  On the morning on the 01/14/2020, and while brushing her teeth, noticed that she was having difficulty holding water in her mouth.  Patient denies any sick contacts, nausea, vomiting, diarrhea, urinary retention or incontinence.  Patient did note having some lymphadenopathy in her neck that was tender to palpation.  Patient denies any issues with swallowing, walking, loss of motor function. On physical exam, bilateral facial nerve pulse was noted, inability to smile, puff cheeks of left her eyebrows.  Patient was admitted to the hospital, for work-up and diagnosis of her condition.  Initial differential diagnosis was Guillain Barré syndrome (GBS), multiple sclerosis, EBV infection, Lyme disease or Syphilis.  Work-up confirmed the diagnosis of GBS evidenced CSF Albumino-cytological dissociation. Patient still admitted in the hospital as of 01/18/2020, receiving IVIG (day 4/5).  Moderate improvement, bilateral upper and lower extremity numbness, and minimal improvement of bilateral facial palsy.
Itchy red rash on neck, abdomen, back, inner thigh. I took Zyrtec and it improved overnight. Faint rash the next day and resolving over few days.
Patient's mother called 5/3/21 to let us know that patient still has a bump at injection site, redness, warm to the touch and soreness. Patient was directed to use OTC meds and follow up with PCP
Pt completed two vaccinations 2/12/21 and 3/9/21; admitted with fever, chills, n/v on 6/20/22, diagnosed with COVID.
The patient had been struggling with C. diff since July 2020. She took her last dose of oral vancomycin on 4/20/21 and reported she finally had "perfect" bowels with consistently solid stools. She received vaccine dose 1 on 4/22/21. Her stools were notably softer starting 4/25/21 and were liquid again on 4/28/21. She took loperamide on 4/29/21 which helped, but the symptoms have not yet resolved. We advised her to seek medical care in case she did not get rid of her C. diff infection, so she is waiting to hear back from the doctor on when she can get in.
FEELING KIND OF LETHARGIC; FEELING VERY ANXIOUS; FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included azithromycin allergy, high blood pressure, broke back, and broke neck, and other pre-existing medical conditions included patient got disabled from physical injuries. patient was not able to keep up the metabolic energy with exercise. patient was steadily getting better from the injuries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced feeling kind of lethargic. On 03-JUN-2021, the subject experienced feeling very anxious. On 03-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUN-2021, had not recovered from feeling kind of lethargic, and the outcome of feeling very anxious was not reported. This report was non-serious.
Info has been received from a health professional concerning a female pt who in approx Oct 2002, was vaccinated in the right arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). The reporter indicated the pt had a reaction to pneumococcal vaccine 23 polyvalent. Subsequently in approx Oct 2002, the pt developed right arm soreness and mild edema. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
Pediatric HepA (Havrix) ordered by MD. Adult HepA (Havrix) administered by CMA. Error noted later during Inventory reconciliation.  MD notified parent of pediatric patient regarding  error made.  Per mother, intermittent diarrhea noted since 18 month visit on 4/19/23.  MD provided routine pediatric intermittent diarrhea treatment recommendations (dietary changes, probiotics, etc). Monitoring response.
Lyme symptoms, which had been dormant for 5+ years, began in earnest.  Pain, fatigue.  Unable to work a full day (he is still working full time).  As days progressed the pain worsened as well as the fatigue.  After the second vaccine (booster) he became lightheaded and dizzy.  Passed out at least once.  Needed help with shower.  Dizziness comes and goes, but is active more than inactive.  Appetite is small.
Rash on abdomen, head, face, neck, back, perineum, arm, foot, hand, leg.  Rash was inflamed and itchy.  Rash developed on 10/30/2019, one day after vaccine.  Rash started on wrists, spread to chest and eventually to most of his body area.  DNP diagnosed rash as varicella virus.  Diphenhydramine 12.5mg/5mL oral liquid prescribed to be taken every 4-6 hours as needed.
No additonal AE´s; the patient actually received two doses of VARIVAX.; This spontaneous report was received from a medical assistant, referring to a 4-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with the first dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (strength, lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis. On 05-AUG-2022, the patient received the second dose of the vaccine, but received an additional dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX). The healthcare professional reported that the subject received a larger dose than recommended (Extra dose administered) but she did not experience any side effects. No information was provided.
patient received an expired Pentacel, with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 year old female patient who received an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 12-Sep-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine injection at a dose of 0.5 ml total (lot UJ582AAA, expiry date: 10-Sep-2022) via unknown route in unknown administration site for immunisation.  On 12-Sep-2022 the patient received an expired pentacel, with no reported adverse event (expired product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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.
First day upon taking the vaccine, I had a elevated heart rate. Pharmacy got worried and gave me yogurt to drink. She wanted to call 911, but I insisted I was fine. I went home. I was sweating heavily as I got home. Severe sore arm for weeks and I couldn?t move my arm without pain, which I heard was normal. I didn?t want to act like a baby. During second shot, I started sweating and having elevated heart rate with sore arm too. However, after a day, I had the intense chills and shakes. Everything was spinning, and I couldn?t get out from under the cover because I felt deathly frozen. Next day the chills went away, but I kept throwing up like an exorcist, without control. I couldn?t eat, I had the worse experience than covid-19 from back in January. The vomiting was so intense I was throwing up for days so I had to request days off to recover. After third day I was vomiting blood. My kids saw the side effects, so they are too scared to take the shot, especially since my daughter is on humira, and cancer medications to help with her condition. It was the most craziest experience of my life. I coudn?t eat for days, and at the end, I was vomiting heavy blood. After a week, I started getting better because I was forcing myself to eat rice. But even then, vomiting rice was more painful than just drinking water. After a week and a half I stopped vomiting because I kept forcing myself to eat rice. I did continue having dizzy spells. It took two weeks for me to feel 100% normal. My kids refuse to take the shot after seeing what I went through, and I don?t blame them.
Large splotchy, red, itchy rash began appearing ~8 days after the vaccine. It seems to be growing rather than getting smaller. Have not needed to seek medical attention and have simply been treating symptoms with hydrocortisone 1% and benadryl topical.
Severe burning pain in Right leg.  Paralysis in right foot. Lasting 30 minutes.  Next day tingling and mild weakness in right leg