chrisvoncsefalvay/vaers-outcomes huggingface dataset:
went to the emergency room due to having a migraine; almost passed out; a massive bout of diarrhea; severe nausea; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 49-year-old female patient who experienced severe nausea (nausea), a massive bout of diarrhea (diarrhoea), almost passed out (loss of consciousness) and went to the emergency room due to having a migraine (migraine), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient gets the shot every ten years and has never reacted.  Medical history, medical treatment(s) and family history were not provided.  List concomitant: no other vaccines.  On 31-Aug-2020, the patient received dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5669AA, expiry date-09-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 31-Aug-2020, the patient developed non-serious severe nausea (nausea) on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 02-Jul-2020, the patient developed non-serious a massive bout of diarrhea (diarrhoea) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 03-Jul-2020, the patient developed a non-serious almost passed out (loss of consciousness) 3 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 07-Jul-2020, the patient developed non-serious went to the emergency room due to having a migraine (migraine) 7 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  Patient went to the emergency room due to having a migraine, corrective treatment was unknown for rest of the events.  Outcome was unknown for all the events at the time of reporting.
A non-serious, spontaneous report of head throbbing severe headache has been received from a health professional concerning herself, a female patient, subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. The patient received FLUMIST, intranasal on an unknown date. The following day the patient experienced a severe, head-throbbing headache. The patient recovered from the events on an unknown date. The reporter considered the event as related to FLUMIST.
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 51 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. On an unspecified date, the vaccine was refrozen (Incorrect product storage) (Dose number in series 1) and on 05-APR-2021, the patient received refrozen vaccine (Out of specification product use) (dose number in series 1). The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 20-MAY-2022) dose was not reported, 1 total administered on 17-DEC-2021 in left arm for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported.  On an unspecified date, the vaccine was refrozen (Incorrect product storage) (Dose number in series 2) and on 17-DEC-2021, the patient received refrozen vaccine (Out of specification product use) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220537548. This case, from the same reporter is linked to 20220537683, 20220538238, 20220537532, 20220539045, 20220538428, 20220538573, 20220538480, 20220538149, 20220538627, 20220540853, 20220540611, 20220541180, 20220540524, 20220540570, 20220538316, 20220540688, 20220537688, 20220537507, 20220538437, 20220538666, 20220538292, 20220538411, 20220537356, 20220538425 and 20220538758.
throat sore; feeling like losing her voice; congested; very thirsty; can't swallow; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she took Pfizer COVID vaccine first dose on 25Aug2021, since then experiencing few symptoms but main thing, throat sore and feeling like losing her voice and it was reported as she no longer is feeling this way, "she was congested and very thirsty for one day, drank more water than usual and tired all weekend Saturday and Sunday and can't swallow all on an unspecified date in 2021, she went to get the shot on last Wednesday and she had COVID in May." On an unspecified date in May2021, the patient underwent lab tests and procedures which included COVID test was positive. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.
Heightened pain in areas that I normally have pain in.  Neuropathy in feet is more pronounced.  Ankle tear in left ankle and wrist pain is also more pronounced.  Right ankle from surgery two years ago is more pronounced.
Narrative:  Pt was a 74 YO male with PM of BPH, HLD, prostate cancer, DM2, PVD, and OA who presented to the medical center with sepsis. Pt continued to worsen despite aggressive treatment. Pt's family elected to switch to compassionate care. Pressors were discontinued & pt passed away. No evidence that death was caused by COVID-19 vaccine.
PT. RECEIVED HPV AND VARICELLA IMMUNIZATIONS. UPON LEAVING, WHILE WALKING IN HALLWAY, MOTHER STATES THAT PT. LOOKED PALE, FAINTING AND HITTING HEAD AGANIST WALL. PT. TAKEN TO EXAM TABLE IN CLINIC-VITAL SIGNS B/P118/68, P-68,R-16, ELEVATED LEGS WHILE PT. LYING DOWN, RESPONDED TO TIME, PLACE, DAY, PURPOSE OF VISIT. CHECKED FOR ANY BRUISING, OPEN AREAS, LUMPS, BLEEDING, NON VISIBLE. STATED COULD SEE ME. MONITORED FOR 20 MINUTES, NO OTHER S/S NOTED. MOTHER STATED THIS EPISODE OF FAINTING OCCURED WHEN 5YRS. OLD DURING A FINGERSTICK. MOTHER STATED THAT THIS TIME, PT. "WORKED HERSELF UP" OVER "SHOT".  ADVISED MOTHER TO TAKE PT. TO ER FOR FURTHUR EVAL, HOWEVER, STATED PT. WOULD BE FINE AND SHE WOULD TAKE HER HOME FOR DINNER. IF ANY OTHER S/S OCCURRED, SHE WOULD THEN TAKE HER TO ER. AT INITIAL ASSESSMENT MOTHER DID NOT MENTION PREVIOUS EPISODE OF FAINTING-PT. DID HAVE LUNCH.
her back feels like shards of glass when touched, can not bear clothing to touch skin, no eruptions but nerve pain resembles previous shingles episodes
approx 5.5 hours after injection, felt fatigue, fever, headache, body aches and chills approx 9 hours after injection, took 400mg of ibuprofen before sleep  the next morning, only slight headache and body ache that went away the next day
Patient had hives on both legs. I gave her Benadryl and she applied calamine lotion. This helped but they came back the following evening but worse. She took another Benadryl and applied more calamine and they have not returned.
Pt recvd vax late morning; pt had well visit & was in good hlth; awaked 2AM fussy w/t105 R; temp down 101 following day-seemed fine;
Fever (101º), chills, muscle aches, moderate discomfort at injection site, but that was minor compared to all the other. Lasted almost 2 whole days, better by Sunday (felt guilty for not going to church).  SIDE NOTE, when I described my side effects to my  brother he went ballistic saying that the government is lying to us, the vaccine was not suppose to contain live virus and me getting sick was proof that it did. I explained that my symptoms were a result of my immune system gearing up for a fight once it had been given the instructions as to how it should fight the battle, but no explanation would convince him otherwise (he falls for every conspiracy theory that comes along).
p/vax pt devel urticaria on legs; given benadryl w/relief
Severe headache, muscle aches and uncontrollable shivering (for over an hour the shivering persisted; I climbed in scalding hot shower at 0400am to get under control). Body ache and headache persist 24 hours later.
Patient complained she was feeling hot.  Vitals were taken:  BP 82/52, heart rate 66, respiration 10, O2 99%, temp 96.8.  Patient was pale ,clammy, and sweating.  Patient had not eaten; advised to eat and drink juice. EMS was called at 9:41.  EMS arrived and assessed patient; blood glucose: 60, EMS advised patient to transport.  Patient refused stated I feel better EMS cleared patient.
Hepatitis A administered 04/03/07.  Pt developed shortness of Breath, and Headache 04/04/07. Experienced a seizure 04/05/07 taken by ambulance to hospital, and was observed for several hours and discharged after 6 pm
A backache (mainly my upperback) began about six hours after vaccination, along with nausea. At about eight hours after vaccination, chills began and backache worsened. I began taking 1000 mg of ibuprofen every six hours. The backache interfered with activities and prevented sleep. Eleven hours after vaccination I was light-headed (dizzy) along with the continuing backache and chills. The dizziness was enough that I had to sit down after walking from one room to another in my house. It prevented me from driving. I called the the facility (where I received the vaccination) and reported my symptoms to a nurse. She suggested filling out this form and continuing to take ibuprofen for the back pain. The chills stopped about 20 hours after vaccination and the dizziness stopped after about 24 hours after vaccination. The backache decreased about 26 hours after vaccination, but seemed to progress to my lower back also. Now, at 44 hours since vaccination there is still a mild backache in both my upper and lower back, but it is no longer interfering with normal activities. I have stopped taking the ibuprofen.
At site of injection there was immediate bump and I gave patient cold pack to apply. I spoke to patient 3 hours later and her arm was almost back to normal.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 03-FEB-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 444 and 336 hours respectively. The lowest recorded temperature was -3 (-3 Celsius degrees). The highest recorded temperature was 59 (15 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Exactly a week after receiving my second shot I had a heart attack.  No family history, no risk factors.  Low blood pressure and low cholesterol, no smoking, no drugs.  Hospitalized at Heart Institute.
shot #1 on 28-Jul-2021/ shot #2 on 30-Jul-2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4N2ab, expiry date 10th February 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th July 2021, the patient received the 2nd dose of Shingrix .5 ml. On 30th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provide are as follows: The case was reported by pharmacist. The reporter reported that a patient received 2nd dose of Shingrix  0.5 ml in unknown arm earlier than the recommend interval, which led to shortening of vaccination schedule. The Vaccine Administration Facility was the same as Primary reporter. The reporter consented to follow-up.
Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna, Astra Zeneca and vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: 9h9693) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Oct2021 as dose 3 (booster), single (Lot number: 039021A), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (ASTRAZENECA COVID-19 VACCINE), on 05Nov2020 as dose 1, single (Lot number: A03324), in right arm and on 04Dec2020 as dose 2, single (Lot number: A03324), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "recovered", described as "vaccine brand other=Moderna, Astra Zeneca and vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative, notes: Tested positive 3 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Oct2023 to 15Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350676 same patient, different drug/event;
Took flu shot at 6pm Friday  Got sick Saturday - around morning or noon  Started getting dizzy and lost balance on Sunday around 5pm (likely had a stroke) Called EMS at 2:30am that night
the needle getting loose from the hub; tiredness; only 2/3 of the vaccine was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (tiredness), UNDERDOSE (only 2/3 of the vaccine was administered) and DEVICE CONNECTION ISSUE (the needle getting loose from the hub) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced FATIGUE (tiredness) and UNDERDOSE (only 2/3 of the vaccine was administered). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (the needle getting loose from the hub). At the time of the report, FATIGUE (tiredness), UNDERDOSE (only 2/3 of the vaccine was administered) and DEVICE CONNECTION ISSUE (the needle getting loose from the hub) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Patient reports that later on the same date that she developed a fever, nausea, and severe joint pain after recieving her second rabies vaccine on 06/23/07.  The patient reports that she was in a lot of pain and took in tital a codeine, and oxycodone(at different points) and got temporary relief.  The patient reports that the following day she felt a little better, but remained nausea until about 06/27/07.  The patient also reports that on 06/28/07 she awoke to a numb jaw, and her knee "gave out" after getting out of a swimming pool.  The patient states that these symptoms resolved after about 10-15 minutes.  The patient denies having hives, chest pain, or diffuculty breathing throughout these episodes, but does report feeled "winded" while performed her normal duty of swimming.  The patient reports a history significant for epstein barr, and denies any other symptoms.  The patient did contact her primary care doctor on 06/24/07.
Pt did not feel good and had swollen lymph nodes.  Mom took her to been seen and was told it was all caused by MCV4 vaccine which she had previously gotten the week before.
I had an intense sore throat, and I felt fatigued. I also noticed my breathing was more shallow, and my pulse may have been faster.  I normally have a cough but it had gotten worse. I took a COVID-19 test the next day and it was positive. Two days later I started to get a stomach ache, nasal congestion, runny nose, and in intermittent headache. Yesterday I had a virtual appointment with my doctor and they prescribed me Paxlovid.  I am still experiencing symptoms.
No additional AE reported; patient was administered an expired dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding patient's medical history, concurrent conditions and concomitant therapies was provided.  On 03-FEB-2022, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #T020442, expiration date: 26-JAN-2022 (strength, dose number, route and site of administration were not provided) for prophylaxis (Expired product administered).  No adverse event were reported (No adverse event).
rash started on neck & face 21MAR93; mom says getting worse & is now painful; no fever or URI;
felt faint; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as dose 1, single for covid-19 immunisation. Medical history included AFIB (atrial fibrillation) on an unknown date, complex cardiac history from an unknown date and recent hospitalization on an unknown date. The patient's concomitant medications were not reported. It was reported that patient had 1st vaccine the previous day afternoon. This morning on 25Feb2021 at about 9:30 AM, the patient felt faint and his defibrillator went off. Has a follow up with cardiology tomorrow. It was reported that event took place after use of product. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Nasal congestion, sore throat, cough, fever, headache, body aches. Temp 98/3 (tympanic) Prescription for Z-pak given.
Case number PHEH2014US016872 is an initial report received from the medical assistant on 20 Aug 2014 with a follow up information received from a physician on 22 Sep 2014. This report refers to 19 years old male patient. He had no medical history and concomitant medications. His vaccination status was up to date. His vaccination history included a dose of meningococcal ACYW-135 vaccine (unknown manufacturer, batch number: not reported) on 08 Aug 2007. He was vaccinated with a dose of MENVEO (batch number: not reported) on 21 Oct 2013 which was well tolerated. It was reported that within a gap of 10 months, she received another dose of MENVEO (batch number: M14044) intramuscularly at a dose of 0.5 ml in the left deltoid on 19 Aug 2014 at 15:28. No adverse event reported after the maladministration. Follow up information received from a physician on 22 Sep 2014: Patient demographics (height and weight), dose, site and time of MENVEO vaccination updated.
Patient was given flucelvax vaccine (4 years and older) and she is currently 2 years old.  (Born in 2018). Mom gave the wrong date of birth multiple times using her older child?s date of birth by mistake (born in 2016). While administering the vaccine, patient moved and only received half of the dose (0.25 ml instead of 0.5 ml).  Tried contacting doctor but office is closed. Will call on Monday 10-19-20
Itching and rash at injection site almost immediately  after injection. Blood pressure went down to 104/50 ( normally it is 120/80).  Was given Benadryl.  By 10:40 blood rose back up to 148/89.
This spontaneous report as received from a physician assistant via company representative. The physician assistant reported that then doses of RECOMBIVAX HB (40 mcg)(lot number, expiration date and route not provided) dialysis formulation had been administered to up to ten unspecified non-dialysis patients on unspecified dates since July, 2012. Company representative did not know if any of the patients could have received more than one dose of RECOMBIVAX HB dialysis formulation. No adverse effects reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Chills, body aches, fever happened on Day 1 and day 2  of receiving the vaccine.  swollen lymph node and cough started on day 3.
Patient is a 75 y/o male with hx of DMII, HTN, HLD who presented to the ED after a fall. Patient reports he has had some difficulty urinating recently and reports hematuria as well as dysuria recently. Today he reports he was in his usual state of health and he went to his bank today to transfer some money over. He recalls entering the bank and approaching the teller, and remembers nothing after that until awakening in the ED. Per ED physician, patient was noted to fall backward, striking the back of his head. There was no report of any seizure activity and no tongue bite; however, it was reported patient did lose control of bowels. Patient denies any history of seizure activity. He is currently alert and oriented x 3 but seems to be having some difficulty with comprehension. He otherwise denies complaints at this time.   In the ED, patient is noted to be borderline hypotensive with SBP 80s-100s and otherwise hemodynamically stable. Laboratory studies are significant for WBC 1, platelets 109, sodium 130, bicarbonate 19, BUN 17, creatinine 1.3, glucose 56, lactic 4.5, procalcitonin 6.6. COVID-19 is positive. ABG reveals pH 7.39, pCO2 30, pO2 90 on room air. CT Head reveals several hyperdense foci which are felt 2/2 hemorrhagic foci vs underlying tumor as well as questionable SAH vs SDH. MRI brain is recommended. CT Chest/Abdomen/Pelvis reveals no acute abnormality. Patient has been given an amp of D50 for hypoglycemia. Neurosurgery has been consulted from the ED and hospitalist service is asked for admission. Neurology was alerted of patient and is available for consult if needed pending results of MRI.  PT IS CURRENTLY INPATIENT.