chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Based on additional information received on 01-Apr-2019, this case initially considered as non-case was upgraded to valid case. Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse that time case process as non-case, Additional information was received on 01-Apr-2019 non-case to valid case updated because allergic reaction occurred due TENIVAC. This case involves Adult female patient who experienced allergic to the diphtheria component, while she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic to the diphtheria component (allergy to vaccine) (Unknown latency) following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult. (Other relevant tests included no lab data.) Final diagnosis was allergic to the diphtheria component. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergic to the diphtheria component. Follow up information received from Nurse on 01-Apr-2019. Based on Additional information case from non-case to valid case updated. List of documents held by send one.
Mild, non-itchy rash on upper legs, arms, and all over torso.
suspected vaccination failure; shingles; almost lost my R eye,; residual  pain; numbness; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, eye disorder, residual pain and numbness. On an unknown date, the outcome of the vaccination failure and eye disorder were unknown and the outcome of the shingles, residual pain and numbness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, eye disorder, residual pain and numbness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient was one of the 5 percent who got shingles after receiving Shingles vaccine. The patient almost lost right eye. At the time of reporting, the patient still had residual pain and numbness. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Report received from a pharmacist on 17-SEP-2010 (received via Merck WAES: 1009USA03785). A female patient in her 70s (initials unknown, date of birth unknown) received AFLURIA (lot number M50907, expiry 30-JUN-2011) on 16-SEP-2010 for vaccination. The patient had no pertinent medical history and had no concomitant medications. On 16-SEP-2010, the day of vaccination with the suspect drug, the patient complained of 'stings' when she received cold AFLURIA vaccines that were just taken out of the refrigerator. The patient sought medical attention. (This case was initially reported as two sisters who complained of stings. The sibling case is WAVES number 2010026496). The event outcome was not recovered. The reporter did not give a causality assessment. This case was reported as not serious. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 9 week old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot# K004468, expiration date 08-DEC-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Major RX- induration 30 mm erythema 21 mm with painful swollen RUE, and enopathy - exqusitery tender possible celluitis
This spontaneous report was received from a consumer refers to her daughter, a one year old female patient (present age of the patient reported as 4 years). The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified date of 2012 the patient was vaccinated with PEDVAXHIB (lot, expiration date and dose regimen were unknown). On unspecified date of 2012, the patient experienced high fever. The patient went to an unspecified emergency room to treat the high fever and was discharged the same day. The fever cleared up after about 3 days. The outcome of pyrexia was reported as recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. No further adverse event information was provided. Additional information is not expected because there is no correspondent details of the reporter.
A week after injection a round, hard, red rash appeared on near but not at the injection site. It is large (4? across), hot to the touch, and itchy.   Pregnancy due date: 11/21/21
Joint pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 12Mar2021 at 11:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, 7 days after second shot, the patient experienced joint pain and headache. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event joint pain and headache were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash (clusters & patches) on torso, extremities, scalp, face.  First patches now crusted over but new pustule rash developed 1/6/08 on shoulder & upper arm.  Afebrile.  Primary care physician prescribed Valtrex (1 dose) but not taken.
10-28-10 9:30AM Pt walks into clinic states last night she started feeling like she was having asthma s/s - used albuterol that was at her home - not her Rx it didn't help much. Started feeling better around midnight. Today has had headache suggest pt see PMD. Spoke with pt 4:00pm 10/28/10 feeling better - did not see PMD.
Pt was present for Shingles vaccine but was given a 3rd Pfizer vaccine
Hand hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in hand in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in hand. On an unknown date, the outcome of the pain in hand was recovered/resolved.   It was unknown if the reporter considered the pain in hand to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that his/her neighbor got shingles and she was crying from the pain and she stated that that it was hurts horrible. The patient stated that he/she went to get the shingles vaccine. After received shingles vaccine the patient experienced strong hurting in her hand which was lasted for few days. The patient reported that he/she hope he/she do not get it because it was horrible. Additional supportive information: Follow-up would not possible as no contact details were available
BLOOD CLOT; HEMORRHAGE IN BRAIN; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was admitted to the hospital and on 22-SEP-2021, she was found to have a blood clot with hemorrhage in the brain. The reporter stated that the patient remained sedated by in stable condition but had at least three surgeries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and hemorrhage in brain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211014208-COVID-19 VACCINE AD26.COV2.S-blood clot, hemorrhage in brain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Vaccine 1&2: Day 1:  Sore arm, tired for rest of day; Day 2:  flu-like symptoms- low grade fever, chills, body aches for 3/4 of the day; Day 3:  no symptoms  Booster: Day 1:  sore arm, little dizziness, mild pressure at sternum within 20 mins; dizziness subsided, still had anxious feeling in chest area Day 2:  flu-like symptoms throughout the day - low grade fever, chills, body aches for the day; Day 3: tired throughout the day, mild flu symptoms intermittently  Day 12 to current:   Hives and rashes - sporadically all over body, hot ears, pressure in sternum
LMP 6/25/03. Anthrax vaccine 7/16/03. Miscarriage 8/4/03.
This  61  year old    male received the Covid shot on  4/08/21    and went to the ED on 4/24/21   with shortness of breath   and was admitted  on   4/25/21     with  the diagnoses listed below.  U07.1, J12.82 - Pneumonia due to COVID-19 virus
Delayed extreme hypersensitivity. Covid arm. Paralyzed 1 +month. Superficial DVT hives vomiting diarrhea  rash. Extreme fatigue. Fever  headaches nerve pain, pins needles vibrating crawling. I?m allergic to contrast dye. I felt warm and immediately off as noted as soon as the vaccine was given and asked if it had contrast properties to it.
He felt pain in left side of chest and pointed to heart area about 3 hours after getting 2nd covid shot.  Heart beat felt fast on chest.  Lasted about 40 min to an hour.  Then felt better/ok after this.
Broke out with hives, rapid breathing, temp 101F (axillary) went to ER and treated with Benadryl.
1/26/21 am, Infant seen at Hospital ED with right-sided focal seizures. No fever or symptoms of illness except fussiness. Treated in ED for seizures - resolved. 1/27/21 EEG L hemisphere multifocal discharges c/w focal epilepsy.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On 20-JUN-2013 the patient was vaccinated with his first dose of GARDASIL (strength, route, indication, lot number and expiration date not reported). On 12-JUN-2014 the patient was vaccinated with his second dose of GARDASIL (strength, route, indication, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Information has been received from a doctor of pharmacy, concerning a 77 year old female patient with coronary disease and a history of colon cancer, who on approximately 01-DEC-2007 (possibly 30-NOV-2007) was vaccinated with the fourth dose of Pneumovax 23 (lot # not provided). On approximately 02-DEC-2007 ("within 24 hours") the patient experienced shortness of breath, and was examined by her cardiologist. Treatment included an increased dose of furosemide (LASIX), with no response noted. On 05-DEC-2007, the patient was diagnosed with pneumonitis and was hospitalized. A chest x-ray showed pleural effusion. At the time of this report, the patient was recovering from pneumonitis. The reporting pharmacist considered pneumonitis to be serious as disabling/incapacitating and as an other important medical event. Additional information has been requested.
Dizziness & Headache Narrative:  my menstrual cycle. I noticed I am delayed on my current cycle and I haven't been active so I doubt it can be anything pregnancy related. I also have had some slight pinching/sharp pain In my lower left pelvic area as well.
Occupational exposure to COVID-19. Developed symptoms on 1/12/2022. Tested positive on 1/15/2022 via rapid and PCR tests.
Severe hives all over body and diaphragm spasms. High liver enzymes.
12 hours after shot I had a high heart rate general exhaustion subsided in hours, heart palpitations continued, elevated blood pressure still consistent. Night sweats.
After the first shot in late June had mild chest pains for about a week. About a week after the second shot first of July began having problems eating. Various foods that were not spicy set my tongue on fire as if I had just ate the hottest of red peppers. This happened with foods I had ate my entire life. Meal times are now dreaded instead of looked forward to. Problems persist now 8 months after second shot though though some slight improvement. Cannot say whether boosters increase issues or not because I will only take a booster shot at gunpoint.
Headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US141059 .  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient reported that he received a COVID Vaccine last month. Afterwards he experienced headache and body aches. At the time his wife tested positive for COVID but his test came back negative.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified amount of patients were administered PROQUAD (dose, route, lot # and expiration date were not reported) that underwent a temperature excursion. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed shingles like rash approx. 2 weeks post vaccination. Initial treatment is valacyclovir. Aditional information is unkown to the pharmacy
A few hours after the immunization, the child developed a pink-red area around the injection site that spread over the next 3 days until seen. The patient had chills on the first day. It was swollen and tender to the touch. Prescribed prednisone and ZYRTEC.
4 days post vax pt developed two vesicular rashes inside her mouth with malaise and low grade fever of 99F. It was reported that three siblings experienced similar symptoms following vaccination with varicella virus vaccine live.
DAY 1/ Chills, fever, very tired,, after about 3-4 hours. DAY 2/ complete loss of appetite, somnolence, headache. DAY 3 / wake up with a swollen face, still somewhat evident on. the 8/10 Appetite has returned on day 3, still a bit tired on day 5.
DID NOT HAD MY NORMAL PERIOD; MILD ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced mild arm pain. On 15-MAR-2021, the subject experienced did not had my normal period. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm pain on MAR-2021, and had not recovered from did not had my normal period. This report was non-serious.
Patient had VARIVAX (#2) immunization on 12-30-2011 at Right arm. The Mother brought child back to office on 1-2-2012 for rash and redness about 3mm at injection site (R) arm. No fever or shortness of breath reported by the mother.
Difficulty swallowing (started within 5 minutes; lasted for 60 minutes then subsided). Constriction of the airway with a swollen throat with about 50% constriction (started within 5 minutes; lasted for 45 minutes then subsided). No change in heartrate. No change in blood oxygen level.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter reported that the vaccines were stored in freezer and they take out one to two vials and placed in fridge each day as needed.  No treatment medications were provided.
This was my 2nd booster shot. Approximately 24 hours after, I started experiencing numbness in my hands and difficulty walking. It got to a point I could no longer work. I work on a computer. That night (~1 am) I couldn't get out of bed without help, my legs and arms unresponsive. To be fair, I do have difficulty with walking and numbness in my hands due to MS but this was completely debilitating. I normally walk without the need for any assistive aid. This extreme effect lasted approximately 12 hours but a more moderate form lingered long after. It is now 6 days later and I'm just starting to feel back to "normal."
MYOCARDITIS; This spontaneous report received from a company representative via social media (twitter) concerned a patient of unspecified age, race, ethnicity and sex. 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, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced myocarditis. The action taken with covid-19 vaccine  was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211233715-COVID-19 VACCINE -myocarditis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient presented to Medical Center on 01/10/2022 for 1 week of diarrhea.  Patient stated family members in house have tested positive for Covid-19.  Admitted for AKI, given multiple fluid boluses in ED, started on a sodium bicarb qtt.  On 01/15/2022 patient was intubated and ventilated with severe covid PNA.  Placed on pressors, sedation and bicarb.  Patient received CRRT.  01/21/2022, patient refractory shock, unable to maintain perfusion pressure despite maximum vasopressors, unable to oxygenate or ventilate.  Patient expired on 1/21/22.
The patient received vaccine after it had been exposed to freezing temperatures of 30.9 degrees F for 2 hours, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 68 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after it had been exposed to freezing temperatures of 30.9 degrees F for 2 hours due to refrigerator malfunction (product storage error).  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no other concomitant vaccines.   On 22-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ453AB, expiry date: 30-Jun-2021, form: prefilled syringe) via intramuscular route in unknown administration site.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  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.