chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient here for her first vaccine dose. At 5:15 PM patient reported "itching left arm" initially 2/10 but then increased to 4/10. Patient is alert X3 and denies any difficulty breathing or swallowing. EMT was summed and arrived at scene immediately. Patient has no stridor or wheezing, breath sounds clear. Patient reports having an "allergic reaction" to her flu shot in 2018. VS taken B/P 152/98, HR 78, Resp 20, Temp 98.6, O2 Sat 99%. VS monitored. Patient denies SOB, CP, tongue swelling, lip swelling, difficulty swallowing, speech is clear and patient oriented X3. No visual problems, grips are equal, neuro exam is normal. Patient monitored until 5:50PM. Patient voices she is ready to go home. Patient was advised to see her doctor ASAP and recheck her P/B. IF her B/P continues to be elevated seek medical attention ASAP. HR 80, O2 Sat 99%. Patient to be transported by friend in private vehicle.
Headache, Myalgia, NauseaVomiting, Severe soreness at the injection site Narrative:  Other Relevant History:
Patient received FLUCELVAX and started to itch with facial swelling within one hour of vaccination. Patient received prednisone 20 mg taper and diphenhydramine 25 mg (100 mg dose) with no relief. Recovery time was approx. 2 days.
This spontaneous report as received from a Reimbursement OA Specialist, refers to a 45 year old patient of unknown gender. Information about the patient's medical history and concomitant conditions was not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter the patient was vaccinated outside of the indicated age range. The outcome of the event was unknown at the time of this report. This is one of several reports from the same reporter. Additional information has been requested.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient experienced sore arm, back pain, sore joints, and face became warm. She stated she took a tramadol for pain and an allergy tab. She is feeling much better the morning after receiving injection and has taken a Tylenol today. She did not go to a doctor.
Initial unsolicited report received from a healthcare professional (PAC) via other company (pfizer) (under manufacturer report number:2017520126) on 08-Feb-2018. This case involves a female patient of unknown age, who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINES) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history included clindamycin allergy- Ruptured blood vessel to Clindamycin, amotrigine allergy- Tremors. On an unknown date, following the vaccination, patient had anaphylaxis. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event, anaphylaxis. List of documents held by sender: none; Sender's Comments: Patient developed Anaphylaxis after vaccination. Time to onset is unknown. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Initial report was received 18 July 2008 from a health care professional. A 28-year-old female patient had received a subcutaneous left forearm injection of IPOL (lot number not reported), and one hour later she developed a 4 1/2 inch round, red, hot area was sensitive to touch. The nurse intended to administer TUBERSOL instead of IPOL. No other symptoms were experienced at the time of the report. According to the reporter, the patient's symptoms continued and the patient's recovery status was reported as unknown. Follow up information was received on 28 August 2008 for a health care professional. The patient received an injection of IPOL (lot number A0342) 0.5 mL. The patient was evaluated by a health care professional. No laboratory tests were performed. The patient's symptoms lasted approximately four days. The patient recovered.
Fever, chills, nausea, ataxia, paresis, collapse, hyporexia, joint & muscle pain, migraine then regular headaches, dehydration, rash with pruritus and pain  at injection site, lethargy, and brain fog.
Muscle and joint aches, Headaches, nausea, brain fog, fatigue, right arm injection site pain, swelling and redness, loss of appetite, chills and fever, extreme tiredness, irritability, hot cold sweats
Patient was in her usual state of health until she received her second Moderna vaccine and also took HCTZ, newly prescribed for hypertension. She subsequently developed acute dyspnea, nausea, and emesis. EMS was called, and she was hypoxic, given epinephrine, solumedrol, and benadryl.  She was admitted to the ICU for further care. She required supplemental oxygen but never required intubation.  Labs notable for extremely high D dimer and erythrocytosis. Workup for thromboembolism, including CTA chest and LENIs were negative.  She gradually improved with diuresis and was ultimately discharged.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature 34 Fahrenheit degree and the type of excursion was refrigerator (R). The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Noted had history of various allergies.  Received vaccine at 6:06 pm and about 10 minutes later noted headache. BP 150/70; p 86. Then neck pain, bilateral leg soreness, and hip pain; R foot tingling, felt warm, itching, no rash noted.  Treated with 25mg  benadryl at 0624 pm; BP 130/82. And went to ED for evaluation via wheelchair/personnel.
when she received her third dose she had an active case of shingles; had an active case of shingles; received a third dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In January 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient for herself. The patient received 2 doses of Shingrix about 2 months apart 18 months ago from the date of reporting Specific date not known.  The patient also received a 3rd dose of Shingrix last week from the date of reporting which led to extra dose administered.  When the patient received her 3rd dose she had an active case of shingles.  She reported that the next day, her shingles symptoms improved. The reporter did not consented to follow-up.
Pt was staying in rehab facility after a hospital stay for bladder outlet obstruction - bilateral nephrotomy tubes placed, UTI, colon mass, A Fib, and hypotension; pt had a positive COVID test in the facility on 1/13/22 and was placed in isolation; pt was found deceased in the facility on 1/18/22.  The facility was Healthcare and Rehab
Passed the 37 day mark for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark for second dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details was not provided.
5 days after injection, had sudden onset of severe back pain, tingling and burning in hands and down legs into feet.  Jerking extremities and seizure like activity. Facility staff called for ambulance to transport to ER.  No treatment, observed overnight, prescription for Tramadol.  Transferred back to facility. Extreme fatigue. Pain manageable with Tramadol.  4 weeks later: extreme fatigue continues.
This spontaneous report was received from a nurse midwife, referring to a 37 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. No information about her concomitant medications was reported. On 06-AUG-2016, the patient had her last menstrual period. On 10-AUG-2016, the patient was vaccinated with a dose of VARIVAX (expiration date 07-JUL-2017, lot #, dose and route of administration were not reported) as a routine vaccination. On an unknown date in 2016 (reported as "soon after vaccination"), the patient had a positive pregnancy test. The patient also underwent an ultrasound and a genetic screening on unknown dates in 2016 but the results were pending at the time of reporting. The estimated conception date was 20-AUG-2016 and estimated delivery date was 13-MAY-2017. The pregnancy outcome was pending and fetal outcome was unknown. Exposure to VARIVAX occurred in the patient's first trimester. Additional information has been requested.
Approximately 2 hours after vaccine, teen began to complain of rash on legs; legs felt warm to touch and were painful to palpation by self or family member; rash was red and barely palpable; no other new exposures per family.
4PM started feeling nauseated, whole body felt crawling sensation;lt arm swelling red, hot, sore 7cm diameter x 12hr;
inflammation at injection site; rash at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (inflammation at injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE INFLAMMATION (inflammation at injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). At the time of the report, INJECTION SITE INFLAMMATION (inflammation at injection site), INJECTION SITE RASH (rash at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Pt received vaccine 9/6/17 and states she noticed "welps" the following day on arms that also appeared on other areas of body. Pt states she took OTC Benadryl to relive itching, and improvement has been taking place since starting that. Pt states she contacted her primary care provider today 9/11/17 before calling pharmacy, however she states that that provider is out of town this week.
severe itching at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe itching at injection site after receiving Shingrix
This spontaneous report as received from a certified medical assistant to an 18 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
-fever -arthralgia  -myalgia  -headache  -rash -fatigue -pain at injection site
Sore/tender injection site - onset 8/13 through 8/17 Swollen lymph node at left arm pit and left side of neck - onset 8/14 through 8/16 Left jaw sore and could not open until I used hot compresses and massaged jaw - onset 8/16 in the AM and lasted 2 hours (not sure when it started, as I did not notice until I woke up that morning. Popped blood vessel in my left eye and nerve spasms on the outside of my left eye - onset 8/16 and still ongoing.  Spasms are frequent throughout the day (guesstimate of about 2-3 times per hour) and also occur when my eyes are closed at bedtime.
Patient received covid vaccine at 10:10 am. Sat in chair and felt light headed. Placed supine on floor and brought to stretcher. Vital sighns stable, 10:17 am Pulse 67, BP 100/50, SPo2 97% on room air. Patient alert and responsive. Went home at 10:35 am.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:54 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient age was reported as 71. The BUD date was reported as 26-Mar-2021 and Date of vaccine moved to fridge was reported as 24-Feb-2021.  Patient age was reported as 72.05.  The BUD date was reported as 22-Apr-2021 and Date of vaccine moved to fridge was reported as 23-Mar-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient experienced profuse sweating, dizziness, confusion. Patient was lethargic today when reporting this event. Patient felt like he was having an heart attack.
Red, puffy, warm at injection site and around arm through 10/1/11. Sunday - dizzy & nausea (10/3/11).
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------- ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/25/2023 CKD STAGE 5 (GFR <15) ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/25/2023 CKD STAGE 5 (GFR <15)
Child seen on 2/28/01 for well child 2 month exam. Received DTAP, HIB, Prevnar and HEP-B. Child seen on 4/12/01 for "fussy and stiff with decreased smile X 2 weeks". Child hospitalized. (+) RSV (bronchiolitis) on 2/16/01, treated with Augmentin. After exam, it was revealed spasticity and abnormal eye movements. She was seen by neurosurgery, neurology, development and genetics. The present concensus is that pt may have a metabolic disease. Parents state child is waking up more at night and screaming. Child was put on apnea monitor for swallowing disorder. Shows signs of cerebral palsy/eye movement disorder. Has persistent URI. He was also found to have bilateral otitis media and treated with Amoxil. Annual report dated 05/02/2003: Diag death 2 hours to genetic mitochondrial Dz. Date of death: 10/03/2001.
10/30/21 thru 11/1/21.....asymptomatic except injection site pain/tenderness 11/2/21 10pm-onset headache, chills, body ache, fatigue....afebrile 11/3/21 thru 11/7 - continued same symptoms...worse in afternoon and evening....afebrile 11/8/21-5pm sudden onset temp 102.4 (oral)...9 pm temp still 101.5 (o) 11/9/21-3 am drenching night sweats....remainder of day continued shaking chills, ha, body ache and fatigue.  Temp 99 to 100 (o) 11/10/21 3 am mild night sweating; 2 pm lab work....continuation of prior symptoms, afebrile. 10 pm notified of low potassium (3.0), elevated LFTs and directed to ER.   11/11/21- 3 am Lab indicated elevated Troponin I HS 383 IU/L and persistent elevated LFTs.....admitted to floor on heparin. 1 pm cardiac echo was normal....heparin stopped. Sx's ha, chills, malaise persist.....temp 100. 11/12/21 Troponin increase to 552 then decreased on a third draw.  Cardiac Cath, no obstruction.  Sx's unchanged. 11/13/21 improved LFT.  Discharged home.  Sx's persist unchanged, temp 98.8. 11/14/21 thru 11/16 Sx's unchanged. 11/17/21 Sx's resolved except fatigue.
p/vax next day pt devel swelling @ site of shot, underarm swelling & rash on back, chest, which itched;arm was painful;4/2/99 rash devel into pustules;4/5/99 saw MD advised DPH & anti-itch cream;no fever, no malaise;
Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03169, 2012-03170, and 2012-03172. A 59-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." Two weeks after vaccination, the patient developed diplopia, imbalance and gait ataxia. He experienced "right ptosis, bilateral vertical (upward and downward) and horizontal (abduction and adduction) ophthalmoplegia, absent vestibulo-ocular reflex, generalized areflexia, severe ataxia on finger-to-nose and heel-to-shin maneuvers." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 48 mg/dl. Electrodiagnostic testing on day 18 revealed "normal nerve conduction studies of the upper and lower extremities, the facial nerve and blink reflexes." The patient was diagnosed with Miller Fisher variant of Guillain-Barre syndrome. The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5 days)." The patient showed "slow improvement in eye movements, ataxia of gait and hands, persistent areflexia at the end of one week after IVIG." He resumed his "baseline level of activities by six months." The patient's outcome was recovered (date not reported). Authors also indicated that this patient who developed Miller Fisher variant of GBS fulfilled level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group. Documents held by sender: None.
Rash developed on both forearms. Rash was solid red in some parts and blotchy in others. Rash was sensitive to the touch.
Age related shakes are gone; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Age related shakes are gone) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Age related shakes are gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Age related shakes are gone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Pt has syncope and had jerky movement for a minute. Patients legs were elevated and monitored. Pt recovered after 45 min.