chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue, dizziness, nausea, and chest tightness. Started about a week after the 2nd dose of the vaccine and was the worst approximately 2.5 weeks out. Slight improvements after 3 weeks but symptoms persist. Not able to stand/move for more than 5-10 minutes at a time. Chest tightness worsens when sitting upright and is slightly improved when lying on side. Had multiple labs run and all were within normal range. Doctor's only recommendation is to wait for symptoms to resolve on their own.
Patient complained of fatigue and muscle weakness. Patient was febrile and in bed for three days per mom.
Pt noticed a rash that was about 2 inches long from site of injection to her elbow. This began the day after injection. There was no improvement until Friday morning (11/13) after taking BENADEYL for a couple days.
patient called late afternoon  stating that she is experiencing itching all over the body after taking her 1st Covid dose  in the morning
This spontaneous report as received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 03-JUL-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot# N012618, expiration date 21-APR-2019 and lot# M041080, expiration date 06-OCT-2018 (dose, route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit (also reported as 32.5 degrees Fahrenheit) for 30 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-00507513-1708USA001511: US-00507513-1708USA001606:
Diagnosed with Bell's Palsy on 03/14/2021 left side of face, could not close left  eye, left side mouth would not move, could not wrinkle left forehead..
This spontaneous report as received from a medical assistant refers to a 18 year old female patient with no pertinent medical history and with no drug reactions or allergies. The patient was not pregnant. On 26-APR-2013 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot# not provided) at an unspecified pediatrician's office. No concomitant medications. On 26-APR-2013 the patient experienced hands and feet that were numb, tingling and swelling. On the night of 30-APR-2013 the patient started experiencing nausea and vomiting and the swelling and tingling of the hands and feet have gotten worse. On the morning of 01-MAY-2013 the patient could not get out of bed. The patient sought medical attention by going to the emergency room over the weekend and then visit to this office on 29-APR-2013. The patient was given BENADRYL for treatment and follow up with an unspecified neurologist. At the time of this report the patient was not recovered. The reporter did not assess drug relationship. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.
03/30/07--Client awoke with moderate HA, increasing in intensity over 8 days. 04/05/07--Client TIA S/S--weakness in knees, inability to control limbs, tingling of RT side including leg,arm, face, speech garbled, repeated short series of words, some conversation was not understandable or correct in nature for 45-60 minutes. When speech cleared, it was deliberate speech as if to force mouth to obey.  04/09/07 S/S seem to be resolving.  Menactra verified and updated in VAERS.  04/19/2007 MR received for 2 day hospitalization (04/5-6/2007 for c/o of 7 day hx. of headache with resolution that day, but onset of expressive apahasia, bilateral arm weakness, and facial numbness. Upon PE there are no apparent deficits except for significant inability to express thoughts, formulate thoughts or express and state words.  Symptoms resolved approx. 5 minutes after exam. Assessment:  Transient expressive aphasia with neurological deficits s/p meningitis vaccine.  Possible variant of Guillain-Barre. 06/04/2007 Per CDC: Please add the info below to the NURFU for VAERS # 275804: "VAERS 275804 is NOT GBS according to person from CISA."
Headache, dizziness, nausea, redness, itchy, and inflammation at injection site.  Measured at 3 inches raised at injection site.  "Sick feeling".
pentacel vaccine was administered to a patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203233, 2020SA203126, 2020SA203423, 2020SA202232, 2020SA202831, 2020SA202832, 2020SA203422 and 2020SA207050 (same reporter).  This case involves a 4 month old female patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] after a temperature excursion of minus 1.25 degree Celsius (Product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) injection for prophylactic vaccination.  On 30-Jun-2020, the patient received a 0.5 ml one time dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ026ABA, expiry date: 24-Apr-2021) via unknown route in the left thigh for prophylactic vaccination.  This was a case of an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible battery issue. The vaccine got frozen temperature several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  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.
After my second vaccine,  and few weeks later, I suffered a miscarriage on 02-18-2021. I went to see my OBGYN who performed an ultrasound. My baby at that time was 6 weeks old.
Patient with previously stable left-sided Meniere's disease. He noticed exacerbation with increased vertigo, aural fullness and fluctuation  ~ 10 days after first dose of vaccine.
Severe chest pain within 10 minutes. 24 hrs later had reduced sensation on entire (L) side (arm, leg & head). 36 hrs later, lost fine motor coordination, disoriented, short of breath cardiac arrhythmias. Hand tremors, still unresolved. Sensitivity to sound & lights. Visual perception reduced.
Twenty-four hours after the vaccine I started to have Bronchospasms. I normally only use a rescue inhaler once a month. I was having trouble catching my breath and I consulted a doctor. I took steroids for one week and I had to use my inhaler several times per day. It took five days before I stopped coughing and my Asthma symptoms subsided. It went back to normal after one week. I was also given antibiotics.
Information has been received from a pharmacist concerning an 86 year old female on outpatient hemodialysis who on 5/27/03 was inadvertently vaccinated IV instead of IM with a dose of hepatitis B virus vaccine. On 5/27/03 the patient developed hypotension, chills, fever, and flushing. On 5/27/03 it was reported that the patient was stabilized at the dialysis unit and that the physician recommended that the patient go to the emergency room. It was also noted that the patient might be admitted. On 5/30/03 the pharmacist reported that she did not have any further information on this patient. She noted that the patient was not at her facility but that she was at another outpatient facility. She reported that she did not know if the patient was admitted to the hospital but did know that the patient did not want to go to the hospital because she reported to the doctor that she felt fine. Upon internal review, hypotension was determined to be an other important medical event (OMIC). No further information is available.
Really sick after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick after the second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pertussis shot (Bad reaction when a child). Concurrent medical conditions included Drug allergy (Many medication). Concomitant products included GABAPENTIN, PROBIOTICS NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (Really sick after the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (Really sick after the second dose) outcome was unknown.            Other concomitant medicine include allergy pills.   This case was linked to MOD-2021-377080 (Patient Link).
fever, chills, fatigue, arm pain, hip, elbow and knee pain after booster 10/5/21 kidney stone - nausea, vomiting, abdominal pain 11/8/2021
pt had sore arm to start, and it looked like a big black and blue mark.  however, the arm showed severe necrosis.  pt presented with the upper arm with a wound about 7.5 cm circumfrence.  pt has been doctoring with a specialist.  the wound currently looks like it is healing nicely.
Pain at injection site increasing each day for 14 days after vaccine administration. Now too painful to move.
This case was reported by a consumer and described the occurrence of pregnancy in a 15-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  Previous and/or concurrent vaccination included unspecified vaccines given on 8 April 2008; VARIVAX given on 8 April 2008.  There were no concurrent medications.  On 8 April 2008 the subject received unspecified dose of BOOSTRIX (unknown, unknown arm) while pregnant.  Less than one day after vaccination with BOOSTRIX, the subject experienced swelling on her right arm.  At the time of reporting the outcome of the pregnancy was reported as unresolved.  The outcome of the event of swelling on right arm was unspecified.
Information has been received form a RN concerning a 6 year old Caucasian male student  who on 05/14/99 was vaccinated with a dose of varicella virus vaccine live. On 04/12/04, the pt developed approximately 20 lesions, per the pt mother. The pt had a MD visit and the MD DX chickenpox. On 04/19/04, the pt returned to school. It was noted that the pt recovered. Additional information is not expected.
Pt recv vax on 10/9/97; on 10/23/97 pt exp migraine headache, dizziness, foggy feeling & unclear thinking; tx=Motrin & Tylenol; M.D. tx=Midrin.  Pt seen by chiropractor & imp
Approximately 30 seconds after immunization pt had LOC with jerking motion rt and rt leg, lasted for 45 seconds. Witnessed by MA with tongue biting, no tongue biting, no loss of bladder or bowel function. Pt recovered fully with normal vital signs. Was sent to ER for eval.
pt recvd vax & 4 hrs after vax had high pitched cry & sz like behavior; rigidity; head turned to rt; admit to hosp;
The resident received his third dose of COVID-19 vaccine on 9/24/21 d/t immunocompromising condition. On 10/22/21 he tested positive for COVID-19 during routine surveillance testing. He was asymptomatic until 10/26/21 and treated with MAB at the nursing home d/t high risk condition. On 10/27/21 he experienced respiratory distress, was febrile with a new need for supplemental oxygen and was transferred to the hospital. He received IV therapy and was started on  dexamethasone.  Impression from CXR- probable evolving bilateral acute on chronic infiltrates.  Resident remains in isolation for COVID-19.  On 10/28/21 he had additional symptoms of loss of taste and smell.
PFS: 1 particle approximately 1 mm long floating inside the liquid; The HCP did not administer the vaccine to any patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid), INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030498) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3030498) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid), INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid), INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid) and INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT CONTAMINATION (PFS: 1 particle approximately 1 mm long floating inside the liquid) and INTERCEPTED MEDICATION ERROR (The HCP did not administer the vaccine to any patients).    No concomitant and treatment information were reported.  Reporter reported that there was a white solid substance inside of the thawed product, it might be a crystal, but it is only 1 particle approximately 1 mm long floating inside the liquid. Vaccine was not administered to patients.  Device Problem codes
Left arm went numb and hand went numb for 6 hours.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left arm went numb and hand went numb for 6 hours.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden thrombophilia since 02-May-2017, Homocystinaemia (MTHR blood disorders) and Clot blood (6 blood clots in the past). Concomitant products included APIXABAN (ELIQUIS) from 02-May-2017 to an unknown date for an unknown indication.    On 11-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 9:00 PM, the patient experienced HYPOAESTHESIA (Left arm went numb and hand went numb for 6 hours.). On 12-Mar-2021, HYPOAESTHESIA (Left arm went numb and hand went numb for 6 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-174517 (Patient Link).
Large local reaction with erythema. Small local axillary node, non-tender. Considered probably vaccine reaction but treated with Augmentin, in case of cellulitis. We felt this simply a local reaction. Mother felt (dirty needles; MA).
This spontaneous report as received from a physician via company representative refers to physician's mother of unknown age. On an unknown date in September 2013 (reported as about a week ago) the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot# not reported). Concomitant therapy included unspecified blood pressure medication. On an unknown date in September 2013, the patient experienced localized reaction around the injection site from shoulder to the lower third of her arm. Symptoms included swelling, warmth, inflammation and edema. The patient sought unspecified medical attention. The outcome was reported as recovered/resolved (on an unknown date in September 2013) within 48 hours from onset date. Additional information has been requested.
pt recv vax 16JUL97 & 26JUL97 pt devel a varicella-like rash consisting of approx 5-6 papular erythematous lesions on face, neck, & chest;lesions never broke or scabbed;pt recovered from sx on 28JUL97;
Pt received flu mist and shortly after had a severe migrane headache, chills, nausea and ultimately vomited x1.  Given Aleve 440mg and 1 ES Tylenol per DO order.  Placed in a darkened room and allowed to sleep for one hour.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-MAY-2016 the patient was vaccinated with an improperly stored dose of VAQTA 10Pk 50U/1ml (lot # L017757, expiration date 08-APR-2018, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion three. The total cumulative excursion time of the first time was 528 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the third time was 168 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Fever to 102, screaming the evening of vaccines, Tylenol given.  Patient continued with fever screaming until 9/14/11 where he was fussy, but no fever.
On 08/07/01, started with Headache then her eyes started swelling. Her right arm started hurting and got swollen around 5 PM day of vaccine. Also had "upset stomach". Given Naprosyn for pain and IM Benadryl, on 08/08/01 followed by po Benadryl.
Numbness of extremities; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs), the second episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs) and HYPOAESTHESIA (Numbness of extremities) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028-A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced the first episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs), the second episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs) and HYPOAESTHESIA (Numbness of extremities). At the time of the report, last episode of HYPOAESTHESIA (numbness started at her arms down to her hands and wrist, this went down to her legs) had not resolved and HYPOAESTHESIA (Numbness of extremities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness.  No fever but tested positive using home test; Got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness.  No fever but tested positive using home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 25Mar2021 as dose 2, single (Lot number: EP6955) and on 09Apr2022 as dose 3 (booster), single (Lot number: FK9894) at the age of 63 years, all in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM; VIT D [VITAMIN D NOS]; FISH OIL; BIOTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "recovered" and all described as "Got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness.  No fever but tested positive using home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive, notes: Covid test type post vaccination=Nasal Swab,covid test name post vaccination=BinaxNOW,covid test date=14May2022, covid_test_result=Positive. Therapeutic measures included ibuprofen (ADVIL) for aches, guaifenesin (MUCINEX) for other symptoms, were taken as a result of drug ineffective, covid-19.  Additional information: Patient got booster shot on 09Apr2022 and came down with Covid symptoms a month later on 13Apr including chills, aches, severe sore throat, and tiredness. No fever but tested positive using home test kit from Abbott. Patient has no covid prior vaccination, no other vaccines taken if four weeks, and no known allergies.
Patient reported headache, rhinorrhea, sore throat, cough, low fever of 100F, painful at the injection site.  All symptoms persisted for 2 to 3 days.
01aug90 pt vax hepta B. pt devel itching bumps that appear intermittently and resolved spontaneously. 29nov90 pt vax 2nd hepta B. pt ex severe rash. dx as having a allergic reaction. exam revealed welt-like urticaria shoulders/back see worm