chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 minutes after receiving the first dose, I started feeling tachycardia; This is a spontaneous report from a contactable consumer. A 53-years-old non-pregnant female patient received the first dose of bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration, administered in arm left on 04Feb2021 08:30 (age at the vaccination: 53-years-old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included atopic dermatitis, reflux, allergy: crustaceans, allergy: various foods and allergy: environmental; all from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC); both taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 09:00, it was reported that 5 minutes after receiving the first dose, I started feeling tachycardia. No treatment was received for the adverse event. The outcome of the event was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected
Fever, chills, muscular pain, chest pain, shaking, paralyzed, vomiting
No adverse reaction was reported; missed their third dose of GARDASIL 9 that was supposed to occur six months after the initial dose; This spontaneous report was received from a consumer referring to her currently 16-year-old son, a male patient. His concurrent conditions, medical history, drug reactions/allergies were not reported. On an unknown date in October 2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). On an unknown date in  December 2018, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). It was reported that the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that was suppose to occur six months after the initial dose (onset date: Approximately April 2019) (product dose omission). No adverse reaction was reported. The outcome of product dose omission was unknown. No product quality complaint (PQC) was involved.  This is one of the two reports received from the same reporter.
administered expired Daptacel to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150850, 2019SA150840, 2019SA150852 and 2019SA150853 same reporter.  This case involves a 14 months old male patient who received fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C52028A, expiry date: 17-May-2019 via unknown route in unknown administration site on 21-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  It was unknown if any adverse event was occurred.  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 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.  Documents held by sender: none.
Discharge Provider:  DO  Primary Care Provider: DO Admission Date: 6/3/2023  Discharge Date: 6/6/2023 Clinical Narrative: Pleasant 60 y/o F was admitted for sepsis and respiratory failure d/t bilateral interstitial pneumonia.  She tested positive for COVID 19 and urinary antigens were negative.  No sputum culture was able to be collected during this admission.  Blood cultures were negative.  The patient was treated with Rocephin, Doxycycline, Remdesivir, and Solumedrol and improved more quickly than expected.  Her serial labs showed improvement.  She was off of supplemental oxygen the afternoon of 6/5/23, and her home oxygen evaluation on 6/6/23 still showed no supplemental oxygen needs at rest or with activity.     She was medically stable for discharge home on 6/6 to finish antibiotics and steroids at home.  She will have repeat CBC, BMP next Monday.  She will have a follow up CXR in 1 month.   COVID-19 virus infection Assessment & Plan Shortness of breath, headache, and sinus discomfort all improved.  Continue Solu-Medrol 40 mg q.12 hours and remdesivir. Patient has 1 dose of Remdesivir due tomorrow am, but is now on RA oxygen and feeling much better.   Ready for discharge Improved COVID labs Continue Decadron x 7 days and prn Mucinex after discharge today Monitor labs outpatient  Monitor glucose See home O2 with no supplemental oxygen needed.
Patient reports chest warmth, light headed, dizziness, tingling in ears. Transferred to ED for evaluation.  PMHX: Allergy to IV dye, shell fish Pre-medicated: 25mg Benadryl PO x 1
slight chills; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received second dose of bnt162b2 (Pfizer COVID 19 vaccine, Solution for injection, Batch/lot number: EL9266, Expiry date: 31May2021) via an unspecified route on 13Feb2021 (age at vaccination: 73-year-old), 0.3ml as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID 19 vaccine, Solution for injection, Batch/lot number: EL9262, Expiry date: 31May2021) via an unspecified route on an unspecified date (age at vaccination: 73-year-old), as a single dose for covid-19 immunization. Patient says on Saturday, his wife, his daughter and his self-went to get their second shot. On an unknown date, patient experienced slight chills and soreness at the injection site. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Revaccinated 04/09/21
Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Initial report received on 21 Jan 2010 from a physician via a sales representative. A patient with GERD, hyperlipidemia, coronary atherosclerosis, hypertension, and mild renal insufficiency and taking multiple concomitant medications received RECLAST 5 mg once yearly IV for osteoporosis in Nov 2009. She had received her flu shot (manufacturer unknown) during that time. Within two days, patient reported she was having chills and chest pain. She was admitted to the hospital. She had a cardiac catheterization while hospitalized. Outcome was reported as resolved.
RINGING IN THE EARS GOT REALLY LOUD; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced ringing in the ears got really loud. The action taken with covid-19 vaccine was not applicable. The patient recovered from ringing in the ears got really loud. This report was non-serious.  This case, from the same reporter is linked to 20211004089.
Two month old female baby for immunizations. Baby's skin color is slightly pale. Baby crying, threw up, difficulty breathing. RN noted emesis on the exam table consisted of moderate amount of thick clear mucous with a small amount of light red liquid consistent with the liquid infant Tylenol. Baby very lethargic, extremities flaccid, and responding slowly to painful stimuli. Oxygen applied at 4 liters by blow-by.
Within a few minutes after getting the vaccine, the client reported feeling dizzy. She felt like this for a few minutes before losing consciousness. She dropped her head forward and mom attempted to wake her and called for help. Mom shook the client with no reaction. Nurse came over and attempted to arouse the client. She finally awoke and then felt nauseous. EMS activated. Client did not go to the hospital. Mother took client home after about 30 minutes of additional observation.
About three days post-injection, I experienced dull aching, tingling, and numbness in my left shoulder, the left side of my back, and left arm. The symptoms lasted for four weeks and slowly improved during that timeframe. The symptoms seem to have cleared up at this time.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/got progressively worst) and FLATULENCE (Gassy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, 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 DIARRHOEA (Diarrhea/got progressively worst) and FLATULENCE (Gassy). At the time of the report, DIARRHOEA (Diarrhea/got progressively worst) and FLATULENCE (Gassy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: negative (Negative) Negative. On an unknown date, Stool analysis: negative (Negative) Negative. No concomitant medication was provided. Treatment medication was not provided by the reporter. Patient started to have diarrhea, which got progressively worst, a bad diarrhea, gassy, on 24May2021 it was bad, he's had it ever since, went to multiple doctors, he only receives treatment. This case was linked to MOD-2021-279487 (Patient Link).
I took the Moderna Booster shot on 10/23/21 at approximately 10:30am.  My left arm was sore and felt a mild sickness on 10/24/21. Later that night on 10/24/21 around 10:45pm, I started to feel like I had the flu.  On 10/25/21 at 3:30am, I called off of work due to having flu like symptoms.  I fell asleep and didn't wake up until 4:30pm on 10/25/21.  At this time I was feeling like myself again with no symptoms.
102 temp, rash all over body 1-2 days later.  Lasted 2 weeks, seen in ER for evaluation.  P.O. meds given, d/c to home, no admission.  Hx of eczema.
12 Apr - Dose 1 of Moderna COVID 19 19 Apr - From 10:00-10:30 p.m. experienced rapid onset of dizziness while driving home.  Drank plenty of fluids, went to bed, expected dizziness to be gone by morning. 20 Apr - Woke up with dizziness, vomited profusely around 2 p.m. and haven't really felt nauseated since.  Contacted primary care manager whose office referred me to local ENT. 21 Apr - ENT schedules were 3 weeks out, so went to ER. Did initial bloodwork and Eppley maneuver with negative results.  Released with referral to see on-call neurologist.  Neurologist schedules also 3 weeks out; began working. 23 Apr - 1st of 3 visits to chiropractor to see if adjustments could help; negative results. 27/28 Apr - 1st local ENT consult; audio test normal w/no hearing loss, balance tests negative.  Prescribed nasal rinse, fluticasone nasal spray, and ativan as needed.  Ordered MRI for 10 May. 30 Apr - 1st PCP consult; extensive bloodwork w/negative results. 10 May - Received Moderna dose 2.  Completed MRI w/ and w/out contrast. 12 May - Audio test; negative results.  Videonystagmography (VNG), caloric, and video head impulse test (vHIT) ; "diagnosis" of unilateral vestibular weakness of 74% in left ear. 17 May - Consult w/local neurologist; no concerns w/MRI results, emoxycillin for sinusitis. 18 May - Consult w/ neurologist; no concerns noted. 19 May - 1st of weekly vestibular rehab therapy (VRT) sessions w/ Audiology. 3 Jun - 2nd consult w/ neurology to discuss possibility of refined post-"diagnosis" MRI 7 Jun - Consult w/ophthalmology; multiple visions tests & eye exams; negative results.  25 Jun - Scheduled follow-up vHIT with Audiology A/O 10 Jun - Working referral to otoneurology to refine diagnosis/cause of vestibular "weakness."
1//22 Received the shot in the early morning. Sore arm later in the day.  1/23 Sore arm, sore swollen armpit lymph node that's palpable. Fatigue.  1/24 sore arm and still a sore swollen armpit lymph node.  1/25 sore arm, sore swollen armpit lymph node and fever
tinnitus! Never had, never had a problem with it. Now my head is a bell and this is horrible!
The patient received expired Bivalent booster beyond 30 days in the refrigerator; No adverse event; Vaccine was administered past 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date), PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date), PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past 30 days beyond use date) and PRODUCT STORAGE ERROR (The patient received expired Bivalent booster beyond 30 days in the refrigerator).    This case is for the patient number 12, out of 12 patients reported.  Concomitant medication of the patient was not reported.   The reporter was not sure if the patient received any other vaccines at the same time of Bivalent booster.  It was reported that the size of the vials was 2.5 ml and the vials were initially stored in the refrigerator on 13-Dec-2022. The vaccine vials were a case of 10 pcs and 7 vials from the case were used to administer vaccines from 13-Jan-2023 thru 22-Jan-2023. It was also reported that the label on case of vials advised that the vials should have been used before 12-Jan-2023. The vial did not undergo any temperature excursions.  It was unknown if the patient experienced any adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient
On 7/19/01, pt presented to clinic c/o swelling in left upper arm. Pt unreliable on reporting pain-at first says it hurts, then says it doesn't. Father reports pt acting and eating normally. Pt moves about frequently with active arm movement.
Patient was given Flu vaccine 0.50ml instead of 0.25ml that is recommended for children 3 years and under.
pt felt like she was breaking out in  rash, she was pointing to the interparts of her fingers and her legs.
Patient came to pharmacy in p.m. of 01/23/2020 stating arm in which vaccine had been administered was painful since receiving, and stated unable to lift arm fully.  Upon exam of patient's arm, I noticed a very faint area of possible previous inflammation, which if was the site of administration, appeared to be well within the zone of best practice.
given at an interval of greater than 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J27J, expiry date 6th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2020).   On 24th April 2022, the patient received the 2nd dose of Shingrix. On 24th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: Pharmacist reporting second dose of Shingrix given at an interval of greater than 6 months.  Reported information within adverse event was all that the health care professional (HCP) provided at this time. HCP gave consent for safety team to follow up. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Severe headache, took exceedingly and Tylenol, lasted 2 days, exceeding worked Joint pain, took Tylenol, last 3 days
Moderna Covid vaccine at 10:30 AM and by 8:30 PM she had chills, and difficulty staying awake. Went to ER the next day. Admitted for 26 hours with orthostatic hypotension, due to COVID vaccine.
Pt received Moderna Vaccines on 04/13/21 and 05/11/21. Pt presented to the ED on 10/22/21 after being exposed to COVID with complaints of generalized weakness, myalgias, cough, and decreased appetite. Pt was found to be COVID positive. Pt was not hypoxic and did not require remdesivir.
Pt was sitting in chair approximately 15 minutes following receiving the vaccine. he became unconscious, pale and sweaty. I checked and he had a pulse and was breathing and we called 911. I was able to yell at him and he regained consciousness and could tell me his name, date of birth and other info. He was able to grab my hand and squeeze. he said he he had been dehydrated and had had covid before. we gave him Gatorade and he felt better.  paramedics checked him out and said most likely a vasovagal response. pt refused transport to hospital. his mother came and got him and was going to monitor
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-DEC-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 01-FEB-2015, the patient was treated at a hospital for the onset of a rash, which was diagnosed as shingles. The patient was prescribed VALTREX and oxycodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was considered to be not recovered. This is an amended report, as corrected: The outcome of ZOSTAVAX did not prevent shingles as intended and persistent strain of shingles or herpes zoster was corrected to not recovered. Additional information has been requested.
back is hurting a lot; Numbness in hands; pain in hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands), PAIN IN EXTREMITY (pain in hands) and BACK PAIN (back is hurting a lot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in hands) and PAIN IN EXTREMITY (pain in hands). On 10-Mar-2021, the patient experienced BACK PAIN (back is hurting a lot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in hands) and PAIN IN EXTREMITY (pain in hands) outcome was unknown and BACK PAIN (back is hurting a lot) had not resolved.            No concomitant medication use was provided by the reporter.
Occasional soreness at injection site. Continued experience of tiredness, sleeping at 7 or 8 PM, when normally sleeping at 12 or 1 AM.
pt recv vax & devel sixth-nerve palsy;this is 1 of 2 pt who exp this event;
A  large amount of redness, swelling and pain on the upper arm where I got the shot. THe reaction has worsened each day.
rash down her arm after vaccinated; This spontaneous report was received from a medical assistant referring an approximately 13-year-old female patient. The patient's concurrent conditions, historical conditions, concomitant therapies, allergies, and risk factors were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (IM) as prophylaxis (dose, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported). On 13-AUG-2023, the patient had her last menstrual period.  On 15-AUG-2023, the patient experienced rash down her arm after vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Vaccination site rash). At the time of reporting, the outcome of the event was not provided.   The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Ongoing headaches, jaw pain/soreness, constant feeling of ear fullness requiring popping, memory fog, and trouble focusing.