chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received.  No additional AEs were reported, no further inform; This spontaneous report was received from an other health professional and  refers to a 6-month-old patient.    The patient's concurrent conditions, medical history, drugs reactions or allergies were not provided.  On 25-AUG-2022, the patient was vaccinated with only one dose of improperly stored  rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # w002562 , expiration date: 12-OCT-2022 or with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # w004504 , expiration date: 16-JUN-2023 for prophylaxis. The vaccine was stored in temperature 11.3 degrees Celsius for a time frame of 34 minutes (product storage error). There was no previous temperature excursions. No additional adverse events were reported.
Dizziness, sinus congestion, runny nose, cough, sore throat, fatigue, mild body aches - 3 days Believe these to be due to the fact that I had Covid in November and reaction is to the first dose of vaccine.  Just wanted to report it for data collection purposes.
The patient developed muscle cramps, joint pain and muscle twitching.  Then developed right arm weakness and facial numbness associated with right eye visual disturbances.  Pt was seen be a neurologist and given Solumedrol x 3 doses followed by a tapering dose of prednisone.  All labs, EMG, eye exam are normal thus far.  Pt sts he was seen at hospital and is currently awaiting the results.  Pt reports symptoms have somewhat resolved.
human leukocyte antigen (HLA) sensitization subsequent to vaccination;  This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine conj, hepatitis b vaccine (recombinant) (manufacturer unknown), quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and  influenza vaccine inact  (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) all for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA010290: US-009507513-2209USA001761: US-009507513-2209USA010292: US-009507513-2209USA010293:
brain fog; feeling to being slightly drunk; This is a spontaneous report received from a contactable consumer.   A 28-year-old male patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number, UNKNOWN), via intramuscular route, administered at arm left on 14Apr2021 (age at vaccination was 28-year-old) as DOSE 2, SINGLE and first dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number, UNKNOWN), via an intramuscular route, administered at arm right on an unknown date (age at vaccination was 28-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history of the patient was included COVID back in Nov2020. Patient stated, that he had an allergy to milk (Lactose intolerant). Concomitant medications of the patient included Tylenol, Whenever something hurts. Regarding others vaccination (prior 4 weeks), patient stated, No. The first vaccine so the first Pfizer vaccine and then the second Pfizer so he did take another vaccine but that was the original first dose but other then he haven't had the flu or any of the other vaccine before. On 30Apr2021, the patient was getting brain fog again, like he had when he had COVID. Patient had it when he had COVID and then after his vaccine until now so about 3 or 4 months he had like brain fog all day. Patient didn't know if it may be just COVID because they didn't know everything about it yet. He didn't know if this, what so ever. He didn't know if this was just lingering effect or maybe you guys . He had 'no complaints' about the vaccine, That's what he was curious about. He was not saying Pfizer did anything wrong or anything like that. Patient stated regarding adverse event treatment as no, he was talked to his doctor about it, other than that no. He was wondering was long term brain fog after the COVID-19 Vaccine a side effect. When again probed for the concern, consumer stated, "patient stated, "Like a brain fog more of a fatigue but it was constant like brain fog, almost the feeling to being slightly drunk. When paraphrased the above concern, patient stated, "That's something which you guys are hearing about, that's what he was curious?. At the time of this report event outcome was unknown.  Follow-up attempts have been completed and no further information is expected.
became stiff, passes out-crys out then remains confused for about an hr; EEG nl; had sz;
rt arm, no external marks; certain movements across chest cause pain; taking clothes off;Motrin bid helps or awakens @ noc
whole body shaking, radical symptoms of everything shaking; having a rash to the legs; blood pressure dropped with having labored breathing; severely dehydrated; blood pressure dropped with having labored breathing; Initial information received on 04-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked with case 2019SA312694 (same reporter, Fluzone HD)  This case involves a 76 years old female patient who experienced whole body shaking, radical symptoms of everything shaking (Tremor), having a rash to the legs (Rash), blood pressure dropped with having labored breathing (blood pressure decreased and Dyspnoea) and dehydrated (dehydration), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Fluzone High-Dose in 2016 and experienced arms began flaying uncontrollably (Skin exfoliation) that afternoon after getting the vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Breast cancer.  On 01-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE (INFLUENZA VACCINE) produced by unknown manufacturer lot number not reported via intramuscular route in the right arm.  On 01-Oct-2019, the patient developed a serious whole body shaking, radical symptoms of everything shaking (tremor) shaking (Tremor), having a rash to the legs (Rash), blood pressure dropped with having labored breathing (blood pressure decreased and Dyspnoea) and dehydrated (dehydration) same day following the administration of INFLUENZA VACCINE. She was then sent to the ER. She was admitted to the hospital and placed in the intensive care unit (ICU). She was discharged on 27-Oct-2019  (Other relevant tests included blood pressure dropped.)  Final diagnosis was dehydrated, blood pressure dropped with having labored breathing, having a rash to the legs and whole body shaking, radical symptoms of everything shaking.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for all the events.  Information on the batch number was requested.; Sender's Comments: This case concerns a 76 years old female patient who presented with Tremor, Rash, blood pressure decreased, Dyspnoea and dehydration after vaccination with INFLUENZA VACCINE. The time to onset is compatible with the role of the vaccine. Patient had ongoing Breast cancer. Detailed information regarding patients past medical history apart from Breast cancer, concomitant medication at the time of onset, laboratory details is needed to fully assess the case.Based upon the reported information, the role of the suspect vaccine cannot be assessed.
had high pitched unconsolable screaming for 9-10 hrs following vax; no fever; leg swollen & red; refused feeding x 9 hrs; pt was given APAP as directed; has note from MD for DT only;
1. Hot throat 2. Dizzy 3. Face itchy 4. Hotflashes
I have had low-grade tinnitus for many years. It got much worse after my second vaccine shot in June, and now, six months later, it is still at an elevated level.
Red, itchy rash on face, arms, trunk 18 hours after injection which resolved by evening after taking oral antihistamines. Developed knee pain on 10/17/13, then ankle pain on 10/21/13, then knee pain again on 10/23/13, then bursitis in R hip on on 10/31/13.   This worsens until unable to walk on 11-3-13 due to pain.   Started on prednisone burst.  R wrist starts to swell and is extremely painful 11-6-13 and spreads to L wrist.  See physician on 11-14-13 and diagnosed with Migrating Polyarthritis secondary to flu shot.  Tested for Rheumatoid Factor, SSA (RO) Antibody, IgG, ENA SSB (LA) Ab, and ANA and all were negative.  Still having symptoms of pain in wrists and occasionally in other joints (12-17-13) and malaise.
Death.  Died on 7-9-21 (approximately 24 hours after vaccine).
Initial report received on 19 March 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 1 dose of TRIPEDIA; sanofi pasteur Inc. lot number U3282CA received on 24 June 2010, and 3 doses of PENTACEL; lot number C3304AA received on 26 May 2009, lot number C3362AA received on 11 August 2009 and lot number C3428AB received on 01 October 2009 (routes and sites of administration not reported). Approximately 15 months after the last dose, the subject developed a cough on 06 October 2011 and paroxysmal cough on 02 December 2011 without a whoop. The subject also experienced post-tussive vomiting. Laboratory testing included positive PCR on 05 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 06 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 06 December 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 61 days. The outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received from the authors of the published literature article. The authors enrolled participants from 12 of the original 15 communities in the 1981 immunogenicity study with a documented response to the primary plasma-derived hepatitis B vaccine series. Among the study participants at 30 years, they had 3 main groups: Group 2, persons who did not receive a booster dose at 22 years (because their 22-year anti-HBs level was greater than or equal to 10 mlU/mL); and group 3, persons (with anti-HBs level less than 10 mlU/mL) who received a booster dose of vaccine at 22 years. An anti-HBs level greater than or equal to 10 mlU/mL was considered protective. Study participants with anti-HBs levels less than 10 mlU/mL were offered an intramuscular booster dose of 10 ug of RECOMBIVAX HB given to assess immune response to an antigenic challenge. The authors attempted to determine the concentration of anti-HBs 30 days after the boost (median interval between booster and follow-up blood collection, 33 days). A positive booster dose response was defined as anti-HBs levels greater than or equal to 10 mlU/mL at 30 days after the boost. Among the 435 study participants, group 2: 129 who did not receive a booster vaccine dose at 22 years (owing to anti-HBs levels greater than or equal to 10 mlU/mL). In group 2, among the 36 persons tested 30 days after the booster dose, 33 (92%) responded with anti-HBs levels greater than or equal to 10 mlU/mL; the GMC was 419.8 mlU/mL. This case refers of the less 3 patients who after received a booster dose of RECOMBIVAX HB did not respond with anti-HBs levels greater than or equal to 10 mlU/mL. Among participants in group 2 with an anti-HBs level less than 10 mlU/mL at 30 years, those with a higher pre-boost anti-HBs level were more likely to demonstrate a booster response (antiHBs greater than or equal to 10 mlU/mL) than those with lower pre-boost anti-HBs levels. This suggests that even if the anti-HBs level at 30 years has waned to less than 10 mlU/mL, the close the level is to 10 mlU/mL, the higher the probability that the boost will succeed. This is one of two reports from the same literature source (linked to MARRS # 1608USA006505). Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored PROQUAD (Merck) (lot #L033692, expiration date 28-FEB-2017, therapy type: rHA) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
nausea, headache, bodyaches, dizziness- Symptoms lasted about 36 hours.  Treated with Tylenol. Currently breastfeeding 16 month old son.  He also spiked a fever of 102.5 at 5pm the day I received my vaccine.
Pt states he has she has numbness R arm from deltoid area up to neck and from deltoid area to wrist.  Pt advised to seek medical attention now, from Dr. or other provider.
Her husband started to feel ill 2SEP2021; Fever on and off; Positive covid-19 test; Whole body aches like with the flu; Her husband started to feel ill 2SEP2021 with weakness/Low energy; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough), COVID-19 (Positive covid-19 test), MALAISE (Her husband started to feel ill 2SEP2021) and PYREXIA (Fever on and off) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough) and MYALGIA (Whole body aches like with the flu). On 06-Sep-2021, the patient experienced COVID-19 (Positive covid-19 test) and PYREXIA (Fever on and off). On an unknown date, the patient experienced MALAISE (Her husband started to feel ill 2SEP2021). The patient was treated with IBUPROFEN at an unspecified dose and frequency; MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough), COVID-19 (Positive covid-19 test), MALAISE (Her husband started to feel ill 2SEP2021), PYREXIA (Fever on and off) and MYALGIA (Whole body aches like with the flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.  Their son came from school on 31 august 2021 and had tested positive for COVID-19 infection
Doses administered after more than 1 temperature excursion; It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; 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 (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 57.07  No concomitant medication was reported.  On 30-Mar-2021,vaccine moved to fridge and vaccine BUD date was reported as 29-Apr-2021.  Condition of vaccine prior to administration was reported Not frozen.   On 31-Mar-2021,vaccine excursion time were 8am and 9am at 32,32 degree F temperature. On 03-Apr-2021,vaccine excursion time was 9am at 34 degree F temperature.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. 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 medications were not reported.
same day of vax pt exp fever 101-103f, myalgia, malaise, also cramping, nausea & vomiting.
no adverse event; vaccine exposure during pregnancy; wrong vaccine administered; This spontaneous report was received from a nurse regarding a 32-year-old female pregnant patient.   The patient's medical history, concurrent conditions and concomitant medications were not provided.   At the time of reporting the patient was pregnant with 38 weeks.           On 12-DEC-2019,  (while the patient was 38 weeks pregnant) the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (lot no S026372, expiration date: 01-APR-2022) (dose, frequency, route of administration, lot#, and expiration date were not provided) for prophylaxis (vaccine exposure during pregnancy). The patient experienced no symptoms. It was verified that product confusion was not a factor in the administration of this dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The nurse states that "the nurse who administered the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) had intended to administer Tdap." The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) which was administered was taken from a shelf where the nurse thought the Tdap was stored (wrong product administered). No further information provided. No adverse event was reported. At the time of the report, the pregnancy outcome was unknown.
incessant crying;high pitched cry 10-15" intervals lasted total of 45";unable to comfort;went to MD for eval;no other sx;MD felt it was a rxn to vax & recommends DT in future;
1st day p/vax T102-103;given APAP or advil x 7 days;
rash about 2 - 3 inches away from the injection site. getting worse after 24 hours. pt managed with Benadryl and cortisone 1% for now.
Patient tested rapid antigen positive for COVID-19 on 12/19/2021. Tested because mother was symptomatic and positive. Patient has no symptoms.
Started hearing ring in right ear on 26Apr2021 at 4PM PSTIt hasn't stopped since, I noticed it intensified on 13May2021 evening and I think my left ear is experiencing a ring noise too/Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 09Apr2021 10:45 (Lot number: EW0153) as dose 1, single and intramuscular, administered in deltoid right, administration date 01May2021 10:00 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Preventative care", start date: 05May2021 (ongoing), notes: Preventative care; "Thoracic puncture wound", start date: 21Apr2018, stop date: 2018, notes: Thoracic puncture wound. Family history included: "Father deceased due to Leukemia" (unspecified if ongoing), notes: Father deceased due to Leukemia. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 26Apr2021 16:00, outcome "not recovered", described as "Started hearing ring in right ear on 26Apr2021 at 4PM PSTIt hasn't stopped since, I noticed it intensified on 13May2021 evening and I think my left ear is experiencing a ring noise too/Tinnitus". The event "started hearing ring in right ear on 26apr2021 at 4pm pstit hasn't stopped since, i noticed it intensified on 13may2021 evening and i think my left ear is experiencing a ring noise too/tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus. Additional information: Started hearing ring in right ear on 26Apr2021 at 4PM PST It hasn't stopped since, noticed it intensified on 13May2021 evening and he think his left ear is experiencing a ring noise too although the one coming from the right ear is more overpowering. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Woke this am with rash on back. Now on back, neck, arms, chest bad.
72-year-old male with a past medical history significant for diabetes, yesterday was brought to emergency room because of difficulty breathing. According to the record, patient was tested positive for COVID 3 weeks ago, but only recently noted dyspnea. Upon evaluation in emergency room chest x-ray reveal no pneumonia. Pulse oximeter was 90%. Patient start on Decadron and Lovenox for anticoagulation purposes.
SkinRash & Rash Narrative:  Rash hands ascended to cover arms, trunk & groin.
Shortly after receiving 1st dose of Moderna Covid vaccine, patient reported feeling hot, flushed, and lightheaded. Gave patient a bottle of water and an ice pack, and observed patient as he waited for a total of 30 minutes after the vaccine. Patient began to feel better almost immediately and was feeling normal by the time he left.