chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves adult female patient (age reported as mid 60s), who was vaccinated with first and second dose of TYPHIM VI (lot number: N1K801M and expiry date: 15-Oct-2019) via intramuscular route in the deltoid NOS on 15-Nov-2018 (in morning). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TD VACCINE for Immunisation; and TWINRIX for Immunisation on an unknown date. It was a case of syringe issue because some drops of the vaccine leaked out of the syringe, where the Luer-Lok attached to the syringe itself. It was also a case of actual medication error due to vaccine under dose because patient did not get enough of the TYPHIM VI dose. It was unknown if any adverse event occurred or not following the vaccination. 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 Directive and Module VI of the 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. Documents held by sender: none.
pt recv vax & exp fever for a couple of days, burning of eye for 1 day & a h/a;
1st dose 01/02/21 pfizer,Lot#EL0142 2nd dose: 01/23/21,Pfizer,Lot# EL9262 Diagnosed with Bell's palsy on 6/30/21; patient believes this is related to the Pfizer COVID vaccine, which she received on 1/2/21 and 1/23/21, reports she developed right-sided facial droop.  She was evaluated at ED, reassured, prescribed oral steroid and anti-viral medication. states her symptoms are improving; she is still experiencing some dryness in her R eye for which she has been prescribed moisturizing eye drops.
3 hours after vaccination she developed migraine headache, sweats, fever 100.1, took Tylenol, then had vomiting and diarrhea, soreness & tenderness at injection site; took several more doses of Tylenol, today temp 99.9
following morning after injection, fall out of bed, weak, lethargic, did not respond well to questions, impaired walking and balance, shaky knees, following morning fall off the couch
Sore arm; Received her second dose of vaccine 43 hours earlier; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Received her second dose of vaccine 43 hours earlier) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Received her second dose of vaccine 43 hours earlier). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and OFF LABEL USE (Received her second dose of vaccine 43 hours earlier) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Warm texture to the sight red about 2-3 inches in width and swollen in right thigh.
Started with chills and muscle fatigue at 8pm.  Once chill subsided felt feverish and could not fall asleep at about 1 am on 4/8.  Sweating followed by better rest until waking at 6am for day, but felt fatigued from lack of restful sleep during night.  Was able to nap during day (4/8) and felt much better by evening.
Patient broke out in a chicken pox rash within hours of shot being administered. Started on her buttocks and proceeded to spread all over her body except for palms of hands, feet, and face. There were several variations of the rash on her body including initial bumps blisters filled with clear fluid and scabs. Her whole body was covered in rash by 1400 on Saturday. Rash was not itchy and did not present with any fever. From onset of rash to dissipation was 8 days. Treatment was mostly supportive including corn starch, bathing, lots of fluid, and lots of rest. Mother called the nurse line at the clinic and was told not to bring child in and that this couldn't possibly be a vaccine reaction because they don't ever see more than a few spots as a vaccine reaction. Child had several hundred spots all over her entire body.
Parent missed their 2nd dose, past 36 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Parent missed their 2nd dose, past 36 days.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information was provided by reporter.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Parent missed their 2nd dose, past 36 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Parent missed their 2nd dose, past 36 days.) had resolved.            Concomitant product use was not provided by the reporter.   No treatment information was provided.
No adverse reaction Reported. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient reported being hospitalized day after vaccination:  symptoms included severe vomiting, chills, fever, fatigue.  Could not keep food down during stay.  Given IV medications for vomiting.
High fever approximately 12 hours after injection of second shot and drowsiness approximately 4 hours after injection. During the fever, had significant trouble walking and moving any part of body. Significant arm soreness at site of injection.  All symptoms resolved themselves within 24 hours of receiving the vaccine aside from the arm soreness which resolved itself within 72 hours.
redness to injections site, warmth, swelling longer than 6 days; nausea, chills, body aches x 6 days; Treated with warm compress/ ice packs, covered with clindamycin for possible infectious area to injection site.
uncontrollable crying for 3 1/2hr on the evening of 3DEC97-remained fussy the next day as well;
This spontaneous report as received from a consumer (patient's mother) refers to a 21 year old female patient. The patient had no medical history, concurrent conditions, drug reactions/allergies and concomitant therapy. On an unspecified date in 2008, the patient completed the vaccination series with GARDASIL, intramuscular for HPV vaccination. Reporter stated that approximately in December 2017, the patient got a Papanicolaou (PAP) smear done at the physician's office and it was clear. On 29-JAN-2018, she again had a PAP smear done at the same physician's office. The patient received her results on 06-FEB-2018 that were positive for HPV. She required medical attention. No treatment was provided for the adverse event. Outcome of the event was reported as not recovered. Reporter stated that the patient also scheduled for a biopsy on 13-FEB-2018 at the same physician's office. Causality assessment was not provided.
On 1/10 parent noticed a "red bumpy patch" almost the size of half dollar coin,hot to the touch but not hard.Pt said it was itchy on thigh.On 1/11, size has decreased to smaller than quarter. Parent says looks like a bruise w/red spots
I received my first Pfizer vaccine dose at the Fairgrounds, run by medical group. I received my shot and went to sit in the observation area. The first 10 minutes of the waiting period were totally fine, and all of the sudden, I felt weak, lightheaded, cold, and my heart rate rose rapidly. I fainted about 20 seconds after feeling these symptoms.  I woke up about a minute later on a bed in the facility. The doctor on site came over and assessed the situation. He was very dismissive of any possible problems from the vaccine. The nurses, however, were nervous about my reaction to the vaccine. Two other younger adults had passed out just that morning. Within 10 minutes of waking up, 3 other people passed out within the building. The EMTs arrived and highly suggested I go to the ER to get checked out. I agreed and was seen in the Emergency Department at  Hospital. I received bloodwork and an EKG, and all read as normal. I do not have a history of reacting to shots. I have fainted one other time in my life, about 8 years ago, and did not need medical attention.
Shortness of breath, fatigue, muscle and joint ache/pain and dizziness.
accidentally gave a patient expired typhim vi with no reported adverse event; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter stated that accidentally gave a patient expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (strength, formulation, lot number was unknown and expiry date: 03-Sep-2022) not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of accidentally gave a patient expired typhim vi with no reported adverse event (expired product administered) (latency: unknown) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  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.
1/27/21 seen in ER c palpitations, EKG shows RBBB 1/31/21 - 2/1/21 admitted to hospital for palpitations & near syncope. Stress test, ECHO done. Referred for heart catheterization. Wearing heart monitor
82-year-old gentleman enrolled in palliative care w/ PMH of parkinson's disease, alzheimer psychosis possibly related to PD, HoH, pancreatic tumor (s/p resection) and GERD who presented from home to the ER on 1/23 w/ a CC of weakness. The patient was unable to participate in the history collection process due to underlying dementia. His wife and family therefore provided  the history. The patient's wife noted that the day of admission he was talking to people who were not present and trying to push against walls. He has been increasingly agitated in recent times w/ adjustment to his risperidone which seemed to help at the time per family. He is currently enrolled in palliative care as per family he did not qualify for hospice. Patient's wife states that his wish was to be DNR/DNI.
fever, headache, fatigue lasting over 48 hours - then itchy all over with a raised rash on torso.  Today (02/10/2021) is five days after the injection and I still have an itchy rash on my torso.
Swelling of lips and face, racing pulse. 50 mg of Benadryl
Injection site pain; Nausea; Throwing up; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd August 2019 and experienced injection site pain).   On 6th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, nausea, vomiting and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, nausea, vomiting and fever were unknown.   It was unknown if the reporter considered the injection site pain, nausea, vomiting and fever to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination experienced throwing up, nausea, fever and pain at the injection site. This case has been linked with case US2019AMR203530, reported by the same reporter.
adverse event reported to clinc 1JUl93; mom states that following immun given on 16APR92, temp got to nearly t105 R; would not go down using APAP; cried & screamed & could not be comforted; had sx x 1 on the same date 16APR92;
Extreme headache for a day after the 2nd vaccine.Chronic headaches for 8 months following second vaccine, still occurring.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: Em6198) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Em9810, Location of injection: Arm Left), administration date: 04Feb2021, when the patient was 24 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Extreme headache for a day after the 2nd vaccine.Chronic headaches for 8 months following second vaccine, still occurring.". The event "extreme headache for a day after the 2nd vaccine.chronic headaches for 8 months following second vaccine, still occurring." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information:Prior vaccinations within 4 weeks and other medications within 2 weeks were reported as none. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination patient has been tested for COVID-19. The patient had no known allergies. Extreme headache for a day after the 2nd vaccine. Chronic headaches for 8 months following second vaccine, still occurring. Device Date: 13Nov2021  No follow-up attempts are possible. No further information is expected.
"Covid arm" or swelling and painful arm; Urinary tract infection; "Covid arm" or swelling and painful arm; Stomach issues; Diarrhea; Weakness; Drowsiness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced ASTHENIA (Weakness) and SOMNOLENCE (Drowsiness). On 26-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues) and DIARRHOEA (Diarrhea). On 29-Jul-2021, the patient experienced PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm) had not resolved and ASTHENIA (Weakness) and SOMNOLENCE (Drowsiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.   No known allergies to medication or food.
about 45 min after shot....bronc spasms, could not speak or move, unable to move..... , passed out. In intense pain for 24 hours approx even wet my pants due to inability to move.  My body is a hyper-adrenaline stimulator (per cardio med DX)...It is like a built in epi shot. I honestly think I would not be here without it.   It seems with the odd reactions this year....there is the similar ingredients......all PEG or their renamed cousins.   It started with MIRALAX and 2 019 flu shot.
Fever high 102 with apical pulse 160's PM of 9/15/04 with fussiness. Fever and increased react rate continues and still present on 9/20/04 with temp 99-101 and HR 120-124 as of 9/20/04 child still had fever.
Day after recieving vaccines pt experienced general weakness, nausea and sore  L arm. On 05/06/23 and 05/07/23 pain began radiating to left side chest.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sweating profusely, H/A's, 1 episode of urinary incontinence, malaise.
blood clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Clinical course: Reporter also knew of two people that had blood clots.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021192614 same reporter/drug, different patients/AE;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with drug hypersensitivity and diabetes mellitus. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included PNEUMOVAX 23. On an unknown date the patient experienced vaccination error. The outcome of vaccination error is unknown. The reporter considered vaccination error to be not related to PNEUMOVAX 23 and ZOSTAVAX.  {Additional information has been requested. / Additional information is not expected.}
Swelling, then migratory macular rash up/down arm, neck, face, across chest, feeling unwell, itching.
chills, R axillary lymphadenopathy, head ache (as expected), mild chest discomfort that is reproducible with inhalation and movement
This spontaneous report as received from a physician refers to a 25 year old female patient. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown date, the patient was vaccinated with first and second doses of M-M-R II injection. On 25-FEB-2016 the patient was vaccinated with third dose of M-M-R II injection (dose, route, site of administration not reported). On 21-APR-2016, the patient sought medical attention, visited physician's office and underwent serologic testing (via an unspecified blood test) for evidence of immunity which revealed that the patient was serologically too low to be considered immune to the measles component of the vaccine. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.