chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's mother). A 18 year old male patient of an unspecified ethnicity received, on an unspecified date, TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the next day after the vaccination, the patient was unable to lift or mover arm and it was painful. The mother mentioned that her son was still in pain; while clinical outcome of the other adverse event was unknown.
Generalized aching; Flu like symptoms; Peripheral swelling; Back arthritis; This is a solicited report received from contactable reporter (Consumer) for a Pfizer sponsored program (not available). The reporter is the patient.  A 50-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPONDYLITIS (medically significant) with onset Sep2021, outcome "recovered" (2021), described as "Back arthritis"; PAIN (non-serious), outcome "recovered", described as "Generalized aching"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Peripheral swelling"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms". Clinical details: On unknown dates, the patient experienced flu like symptoms and body aches and swelling of fingers and toes. In Sep2021, the patient experienced back surgery due to laminitis. In 2021, the back surgery due to laminitis resolved. On an unknown date, flu like symptoms and body aches resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of spondylitis. The reporter's causality for the event of back surgery due to laminitis, flu like symptoms and body aches unknown onset, swelling of fingers and toes and flu like symptoms and body aches unknown onset with Humira (Adalimumab) was no reasonable possibility. The reporting company's opinion is that there is no reasonable possibility that the events of back surgery due to laminitis, flu like symptoms and body aches unknown onset, swelling of fingers and toes and flu like symptoms and body aches unknown onset are related to Humira (Adalimumab).  The reporter's causality for the events of Generalized aching, Flu like symptoms with BNT162B2 was reasonable possibility.  The reporter's assessment of the causal relationship of the events Back arthritis, Peripheral swelling with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
I was weak , larthygic, had low grade fever, nausea, exhaustion, headache lasted 4 days.
Pt did not convert p/2 series of 3 Engerix-B vax; Recvd 1st series 19FEB90, 20MAR90, 21AUG90; 11OCT90 titer neg; recvd 2nd series of 3 Engerix-B vax 24OCT90, 13DEC90 & 25APR91 & 5JUN91 titer neg;
I woke up with stabbing shingles pain the next day. I could feel where the virus was coming out of my back. In the thoracic area in my back and going around my ribs. I took the antiviral for shingles and the pain went away within a day and a half. I've had the two shingles vaccine and the first one when I was 57. I've had 3 total. I also had the worse case ever of Herpes 2 and it seemed to clear up in a couple of days. The antiviral is both the same for shingles and herpes. It then came back with a vengeance and its been about a week that I've had it. I haven't had herpes 2 since 2007 and it hasn't been anything like that. On 06/06/2022I met some friends and I gave a woman shorter than I am a hug and something snapped in my neck. I steel have swelling right behind my collarbone. I had a frozen shoulder. I had this minor thing turn into a huge problem where I had all this pain in my shoulder and spasms in my bicep. It was the worse thing. It probably cleared up around 07/17/2022. I haven't had fibromyalgia symptoms in years and then all of a sudden its horrible. I was taking 2 aspirin and a Tylenol a day just so I wasn't feeling horrible. I had chronic fatigue and was drinking sometimes 3 huge cups of coffee a day to help deal with it. Yet I was still tired. The swelling behind my collarbone is about the size of an egg.
I experienced a red, itchy rash/hives on my stomach about 1-week after receiving my first dose of vaccine. Over the next 2-3 days, the systemic rash and itchiness was present on my hands, legs, and face. I took 1 dose of 10mg Zyrtec and the rash subsided, but 2-3 days later the systemic rash and itchiness would reappear anywhere on the body. I took a dose of Zyrtec and the rash subsided. On the day before my scheduled second dose shot (apprx 3-weeks) systemic rashes on my stomach, hands, and face appeared, but were less red, itchy, not as large. I received my second dose on March 22, 20201. I did not experience any allergic symptoms immediately after the shot, however, in the evening (approx 7 hours) after receiving the shot, I experienced a red, itchy, large rash on my stomach. I took 1 dose of Zyrtec, and the rash subsided for 24hours. I am planning to continue to take Zyrtec for the next few days and monitor the rash and itchiness.
headaches felt hot & has continued ears ringing continues sore arm over 3 days cloudy head, thinking not clear continues on and off continues back and joint pains tx tylenol, water, cold washcloth, icepak for back
Headache, Myalgia, Fever, H/A muscle aches, fatigue, felt feverish, sore arm, Narrative:
No adverse event. Patient received Moderna vaccine as initial dose, as patient's age is not recommended by Moderna.
facial tick; This case was reported by a physician via call center representative and described the occurrence of facial spasm in a 7-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. In September 2019, several weeks after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced facial spasm. On an unknown date, the outcome of the facial spasm was not recovered/not resolved.   The reporter considered the facial spasm to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of flu vaccine in the fall of 2018. Few weeks after vaccination with dose of Flu vaccine, the patient experienced facial tick. The reporter described that, the patient tick as pulling face to the right. The reporter stated that, the patient's parents thought that, the facial tick might be related to the vaccine. The reporter did not provide any additional information.
Left Foot numbness after hour of vaccine on 04/27/21, and reocurred on may 11 and went to medical facility.
This spontaneous report as received from a registered nurse refers to a 44 year old male patient. On 12-DEC-2014 the patient was vaccinated with an expired dose of MMR II, human serum albumin (HSA) (lot # H020255, expiration date 08-NOV-2014, 0.5 ml, subcutaneously). Potency was supported. No adverse effects noted. Additional information has been requested.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 12/1/2022  &   12/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vomiting, diarrhea (foul smelling), fussiness, irritability, orange loose stools with occasional mucus.
This case was reported by a dentist and described the occurrence of not responding to therapy in a 47-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 28 October 2005, 6 December 2005 and 8 May 2006 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown, right arm). On 6 December 2005 and 8 May 2006 with the 2nd dose and 3rd dose of ENGERIX B, the subject experienced inappropriate schedule of vaccine administered. On 7 January 2010, 4 years after vaccination with ENGERIX B, the subject experienced not responding to therapy. The dentist reported that he immunized his employee subject with ENGERIX B, she was about to undergo a surgical procedure, had pre-surgical consult with test performed. On 07 January 2010, the pre-surgical results for Hepatitis B revealed the subject was not immune. Relevant test results included Hepatitis B revealed the subject was not immune.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-FEB-2017, the patient was vaccinated with and expired dose of M-M-R II (lot # K024825, expiration date: 02-DEC-2017) (dose, route of administration and injection site were not provided). No adverse effects were reported. No previous temperature excursions were reported. Additional information has been requested.
15 min following vaccine, pt developed rash on chest, itching, warm all over, tightness of throat. Was given IV BENADRYL. IV SOLU-MEDROL, and IV ranitidine. Then rapidly improved.
5 days post ZOSTAVAX immunization pt. came back w/ fist sized, red, swollen spot at injection site. Also she complained of joint & jaw pain on her left side (same side as inj. site). RPh recommended that she see her MD. We contacted her 24 hours later - she did not end up seeing MD because she was now feeling much better & inj. was markedly improved.
Pericarditis, I took Anti-Inflammatories as treatment, Got mostly better in 2-3 weeks. Still not sure if I am 100%
CAN BARELY WALK ON MY LEG; LITTLE SWELLING IN ARM; ARM WAS NUMB; ARM WAS VERY PAINFUL/RIGHT LEG IS REALLY BAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced can barely walk on my leg, arm was numb, little swelling in arm, and arm was very painful/right leg is really bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm was very painful/right leg is really bad, and can barely walk on my leg, and the outcome of arm was numb and little swelling in arm was not reported. This report was non-serious.
Pt caregiver contacted clinic and reports pt received 2nd Hep B vaccine 5-3-21.  Upon waking in the morning on Tuesday 5-4-21, pt c/o swelling in ankles, feet and hands, along with severe generalized joint pain.  Pt called nephrologist on Wednesday, 5-5-21 and was instructed to take Benedryl.  Pt caregiver reports pt had some pain relief when taking Benedryl, however; explains that when the medication wears off the severe pain returns.  Instructed pt to call primary care provider and go to the hospital ED.
broke out in rash over entire body 1wk p/vax;nausea, vomit, & diarrhea;t106;mom took pt to pediatrician & stated that pt had a case of rubeola;
Information has been received from a health professional concerning a 5 year old female pt who on 7/31/97 was vaccinated with varicella virus vaccine live (lot 620626/1400D). Concomitant therapy included Tylenol. On 4/19/01, the pt developed 15-25 varicella lesions on the chest, back and left ear lobe. The pt also developed a fever, cough, on 4/17/01. On 4/20/01, the child presented to the office with 15-20 vesicular lesions. Subsequently, the pt recovered. Additional information has been requested.
Extreme burning pain in left shoulder (NOT at injection site) that extended up to left side of neck. Locked neck muscles and temporary paralysis (approx 30 mins) of neck. Began evening after getting injection and lasted 8 days. Worst was on days 3 and 4.
Pt recvd Engerix-B given 29JUN90, 27JUL90, 14DEC90; There was non-response to the 3 dose series of Engerix-B vax;
This Non-valid spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA Lot/Exp: N020689, 22-OCT-2018; Lot/Exp: N030287, 22-JAN-2019; N026997, 11-OCT-2018, and ROTATEQ Lot/Exp: N024294 26-FEB-2019; Lot/Exp: unknown, 28-MAY-2019 (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. The Nurse confirmed that VAQTA lot# N020689, expiration date 22-OCT-2018 and lot# N026997, expiration date 10-NOV-2018 were not administered after their expiration dates. The temperature involved was: VAQTA Lot: N020689; Temperature/Time frame: 47 degrees F to 77 degrees F (48.6 F) for 1 hour. ROTATEQ: Lot: N024294; Temperature/Time frame:47 degrees F to 77 degrees F (48.6 F) for 1 hour and: VAQTA: Lot: N030287; N026997; Temperature/Time frame: 47 degrees F to 77 degrees F (multiple excursions) for 7 hours. ROTATEQ: Lot: unknown; Temperature/Time frame: 47 degrees F to 77 degrees F (multiple excursions) for 7 hours. There was no previous excursion. A data logger was involved, specifically because of audit.
Severe pain in left arm in lymphnodes under arm (arm pit) and at elbow swelling and redness, heat. Still being treated.
Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose; Fever; Fatigue; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; Sore arm and red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site) and VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose), PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Waited 6 weeks to get the 2nd dose as she got adverse events after 1st dose) outcome was unknown and PYREXIA (Fever), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore arm and red rash at the injection site), VACCINATION SITE ERYTHEMA (Sore arm and red rash at the injection site) and VACCINATION SITE RASH (Sore arm and red rash at the injection site) had resolved.            No concomitant medications provided. No treatment information was provided.   This case was linked to MOD-2021-017852 (Patient Link).
Patient was administered by mistake with Covid- 19 Moderna Booster Only Dose (Monovalent) instead of Covid-19 Updated Booster (Bivalent). Patient was contacted no side effects or adverse events were reported.
Pt received Pfizer COVID-19 vaccine on 4/5/21 & 4/26/21. Pt became SOB on/around 1/8/22. Diagnosed with acute, severe COVID 1/13/22. Required ICU admission. Developed PE & R atrial thrombus, requiring thrombectomies. AKI on CKD, treated with CRRT and IHD (pt was CKD 3 prior to admission). Respiratory failure requiring intubation. Pt extubated 1/19/22 & currently on 4L O2. Was not on O2 supplementation PTA. Thus far hospitalized for 9 days. Just transferred to medical floor today from ICU. Palliative care consulted. If not made hospice, will likely go to another facility.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patient received improperly stored GARDASIL (Incorrect product storage) (lot # K0210215, expiry date: 05-MAY-2017) (one dose). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006821, 1509USA006822, 1509USA006823, 1509USA006824 and 1509USA006825 (same reporter link). Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On17-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L031066, expiration date 18-AUG-2017; dosage, route and dose number were unknown). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Full body rash with (illness) fever and malaise about 10 days, post vax. Pt was seen in MD office with measles-like rash; no other illnesses. Resolved after "several days".
This is a spontaneous report from a contactable nurse practitioner through Pfizer Sales Representative. This nurse practitioner reported for a patient (age, race and gender unknown) who received a dose of PREVNAR 13 on an unknown date for immunization. The relevant medical history included cellulitis. Relevant concomitant medications were unknown. It was reported that on an unknown date after the patient received PREVNAR 13, developed itch on her/his arm and her/his arm was dark red which was elaborated as it was about 5 inch in length and 4 inches in diameter. At the time of this report therapeutic measures taken to treat the reported events, if any, were unknown. At the time of the report clinical outcome of the reported events was unknown.
suffers cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp (non health care professional).  This case involves a 24 years old and unknown gender patient who suffers cardiac arrest while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient suffers cardiac arrest (cardiac arrest) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (suffers cardiac arrest).  At time of reporting, the outcome was Unknown for the event suffers cardiac arrest.; Sender's Comments: Sanofi Company Comment dated 04-Feb-2022. This case involves a 24 years old and unknown gender patient who suffers cardiac arrest while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Nausea; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201, Expiration date: 31Mar2021), via an unspecified route on 15Feb2021 (at the age of 64-years) as dose 1, single for covid-19 immunisation. The patient medical history included breast cancer, cholesterol from an unknown date and unknown if ongoing. The patient concomitant medications included Atorvastatin 40 mg for cholesterol, Tamoxifen, calcium carbonate (CALTRATE) from an unknown date and unknown if ongoing. On unspecified date, the patient experienced nausea. Patient stated, "I woke up with it, actually it woke me up, I am too nauseous to eat anything, I am just restricting my water. I had several Lab test, everything was normal." The outcome of the event was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.