chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient went to the emergency room on 10/12/18 with symptoms of visual disturbance (seeing lights), feeling shaky and nervous, and erratic blood pressure. She was diagnosed with pneumonia and a partially collapsed lung lobe. Since patient received flu shot just 48 hours prior, she was concerned her symptoms may have been caused by flu vaccine.
Information has been received from a physician concerning a 73 year old female with chronic foot pain who on 30-MAY-2007 at 15:30 PM was vaccinated SC in the right deltoid with a first dose of Zostavax (Oka/Merck).  One week after vaccination, on approximately 06-JUN-2007, the patient developed a painful rash on her right foot.  The patient also developed painless rashes on both of her arms and the physician noted that it was non-injection site reaction.  Five weeks after vaccination, on approximately 27-JUN-2007, the patient reported excruciating foot pain.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from the physician.  On 09-JUN-2007, 10 days after the vaccination, a rash developed on the left wrist and left foot.  Then the patient had increased swelling of the left foot.  She also experienced pain in the left foot.  The patient feels she developed shingles and post herpetic neuralgia from the injection.  No diagnostic laboratory tests were performed.  The patient's outcome was not specified.  No further information is expected.
Fluid on brain; Unconscious on bathroom floor; Seizures; Sepsis; Nausea; Vomiting; Unresponsive; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via intramuscular, administered in left arm on 05Mar2021 (age at vaccination was 38 years) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included known allergies from an unknown date and unknown if ongoing. The patient received first dose of bnt162b2 on an unspecified date via unspecified route as dose 1, single for covid-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. On 08Mar2021, 3 days after receiving the second vaccine, the patient experienced with nausea and vomiting and visited to 6 times to her doctor and her doctor said that was due to the virus. On 20Apr2021 patient was found unconscious on bathroom floor, then patient was taken to hospital where patient spent 9 days out of 2 days on ventilator, in the hospital the patient was diagnosed with seizures, sepsis, fluid on brain and unresponsive. The events resulted in physician office visit and hospitalization where the seriousness was hospitalization, disability, or permanent damage. The patient received treatment for the events with all kinds of antibiotics. The patient had tested with nasal swab for COVID-19 since the vaccination which came negative on 20Apr2021. The outcome of the events was recovered with sequelae on an unspecified date in 2021.  Information about the Lot/batch number has been requested. ; Sender's Comments: Based on plausible dose-event relationship the causal role of BNT162B2 cannot be excluded for the reported events..   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.
Significant pain in both shoulders and neck. Bilateral shoulder pain has lasted for 3.5 weeks despite only receiving vaccine in left arm, both times.  Pain feels arthritic in nature and has made it hard to function. After the first shot, I got my period early and after the second shot, I have not had my period/missed a period (I have never missed a period before in my life except when pregnant 6 years ago).  Also had left breast swelling that lasted around 1 week after the second shot.
An hour after 2nd dose, I experienced atrial fibrillation for the first time ever.
Pt returned to facility two days after his vaccinations with hives on both legs.  Mother stated it had started yesterday and was not spreading any more.  No difficulty in breathing.
After Tdap, single hive near site of injection. Then lower abdominal cramping, diarrhea within 10-15 min. Felt faint. (+) vomiting. No further rash, no respiratory symptoms BENADRYL 25mg IM given & sent to ER.
Received Pfizer vaccines on 3/12/21, 11/11, 21 COVID-19 positive by PCR on  3/17/22 admitted to hospital on 3/17/22 for new onset cough, lethargy, emesis, h/o dilated cardiomyopathy, CKD.
A week after my first Moderna injection, I developed the symptoms of what seems to be aclled COVID Arm. My right arm became itchy around the injection site, and a raised red patch that was hot to the touch developed that was three-inches it diameter. The area on my upper arm remained itchy, red, and warm to the touch for nine days. It was nothing serious, as I later learned.   After my second Moderna injection, my arm nearly immediately became moderately tender, and the following beginning at at approximatley 7 a.body temperature and will do so if it continues to rise.
On 19 June she received PNEUMOVAX 23 and within hours noted localized swelling at vaccination site which has progressively spread in dependent fashion over the past 24 hours to affect her right upper arm. She notes warmth and tenderness of affected area. She denies generalized cutaneous symptoms and rash. She denies laryngeal, pulmonary, GI, CV, and neurologic symptoms. She denies fever/chills, arthralgias/myalgias, and malaise.
Narrative: 78-year-old male with past medical history of SVT, history of pulmonary embolus on 5 years ago not on long-term anticoagulation, prostate cancer status post radiation, BPH, hyperlipidemia, GERD admitted to the hospital on 7/14/2021 for hip acute hypoxic respiratory failure secondary to COVID-19 infection. Pt received both doses of pfizer vaccine. Patient last transferred to ICU on 7/16/2021 morning for increased oxygen requirement. Chest x-ray on 7/22/2021 showed increased airspace opacity bilaterally more prominent at periphery of left midlung. Patient is status post remdesiver, Decadron but was not a candidate for Tocilizumab as CRP was 4.3. Patient had an episode of pleuritic chest pain on 7/25/2021, negative troponin and positive D-dimer and found to have a provoked submassive pulmonary embolism. Filling defect also noted in left upper lung and left lower lung. Nonspecific right ventricular prominence and CTA. EKG incomplete right bundle branch block with signs of right ventricular strain. proBNP 256 and PESI Class V. Echo on 7/26/2021 showed normal right ventricular function with trace regurg and no gross deformity. Patient currently on anticoagulation apixaban and was switched from Lovenox but patient was not on any chronic anticoagulation even with a prior episode of pulmonary emboli in 2015. Patient was okay for discharge by respiratory therapist and physical therapist and  is currently on 4.5 L nasal cannula.
Pt developed left shoulder pain with limitation in ROM 2d following flu vaccine administration in same arm.
On 2/10 pt complained of dizziness, weakness, swollen glands. Treated with Zithromax and duratuss per pt report. On 2/11, the pt complained of rash on abdomen, chest and neck and a fever of 99.8. On 2/14 the pt is feeling better, requested a release of medical records for report.
Sudden Pprom  and leakage at 23week and made me do a pregnancy termination.  Due date was determined sep 11,2021  and no related complication detected at 20 week ultrasound and examination It was my 2nd pregnancy ( 1 st pregnancy in 2017 with no complication , vaginal delivery full term)
Headache, body aches, fever, sore throat, nausea for four days. Saw doctor 10/04/2010. Negative for flu and strept. Diagnosed with virus. Treated with rest, fluids, and Ibuprofen. Still experiencing allergy type symptoms: itchy, watery eyes, scratchy throat.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions and medical history were reported. The week of 03-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (Lot # reported as L00374, expiration date, route and dose were not provided) as routine pre-employment Vaccinations. Concomitant medications were not provided. On an unknown date in August 2015, the patient experienced injection site redness and itching. The patient did not seek for medical attention. No treatment was given for the event. The outcome of injection site redness and itching was reported as recovered on an unspecified date in August 2015. The reporter did not assess the relatedness of (Oka/Merck) VARIVAX to the events. Lot # L00374 is Not valid as provided for (Oka/Merck) VARIVAX. This is one of several reports from the same source. Additional information has been requested.
at 430PM pt observed to have red rash on face, hands, upper body p/vax;c/o itching all over her body & vomiting x 1;denied any resp distress,sneezing, swollen watery eyes-DPH given;
Soreness at the injection site. Discomfort in the lymph node and the right arm pit. Increase in discomfort throughout the evening. When palpatated the area, could feel swelling of the lymph nodes and under right arm pit. Swelling has gone down, but not completely gone. Treated with warm compresses and one dose of Advil.
Temp Fri night 101.4 - given Tylenol.  Sat am 100.8 - rash right upper arm, decreased appetite, hot at injection site - dry following treatment.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 49 year old male of an unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre-diabetes. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: unknown) dose was not reported, dose 1, 1 total was administered on 22-MAR-2021 on left arm for covid-19 prophylaxis. Age at time of vaccination 47 years old. The patient received non-company suspect vaccine included: tozinameran (Pfizer/BioNTech) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 32030BD and expiry: unknown) dose was not reported, dose 2 was administered on 02-NOV-2021 on left arm for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient had covid-19 infection (coded as confirmed covid-19 infection) (dose number in series 2). The patient received non-company suspect drug paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 12-JUL-2022 to 16-JUL-2022 for treatment of covid-19. On an 20-JUL-2022 21:00, the patient had rebound infection and symptoms and positive test approximately 5 days after the last dose (dose number in series 2). On an unspecified date, the patient experienced confirmed clinical vaccination failure (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0:20220754276-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
About 1 month after vaccination, I started with a sore throat, headache, teeth pain, chest pressure, body aches, coughing, stuffy nose and I spit up a little blood. I also had some shortness of breath. On Sunday 5-15, I tested positive for Covid with a home test. On Monday 5-16-2022, I called my doctor and he prescribed paxlovid. I am alot better but still have some coughing and stuffy nose. I am reporting my breakthru case of covid.
Approximately 15 min following 2nd dose of COVID-19 vaccine, pt began experiencing throat swelling.  Administered epinephrine 0.3 mg IM x 1 (EpiPen autoinjector).  Transported to Emergency Department for further evaluation; additional medications were given, including: epinephrine 0.3 mg subQ x1, methylprednisolone 125 mg IV x1, diphenhydramine 50 mg IV x1, famotidine 40 mg IV x1.  Pt admitted to hospital for observation.  ***Due to reaction following 1st dose of COVID-19 vaccine that resulted in Emergency Dept visit, pt had pre-medicated with prednisone 60 mg/day x 3 days (8/25-8/27) and diphenhydramine ~30-60 min prior to vaccine***
This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were provided as follows: This case was reported by licensed practitioner nurse (LPN). The age at vaccination was not reported. The patient experienced pain and sore for two days after receiving BEXSERO. The reporter did not agree to follow up.
Heart palpitations, afib, one minor and limited taccychardia event, heart working excessively hard during normal activities. Started week after vaccination, very strong symptoms for about 5 weeks, subsided to minor symptoms for two weeks, now picking up again with increased palpitations.  Was prescribed beta blockers and blood thinners, also magnesium. Am still taking beta blockers but since heart monitor showed no other afib, am no longer on blood thinner.
PAIN IN NECK; HEADACHE; SWOLLEN LYMPH NODES; FEVER; NAUSEA; FEELS SO BAD; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's, and gluten sensitivity dairy. 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 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced feels so bad. On 19-AUG-2021, the patient experienced swollen lymph nodes. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced nausea. On 27-AUG-2021, the patient experienced pain in neck. On 27-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen lymph nodes, nausea, pain in neck, and headache, and the outcome of feels so bad was not reported. This report was non-serious.
C/o feeling numb, as if she can't walk. Sat down BPC 10:20 AM 98/52-60-12 at 10:32 BP 102/68, 12/18 after lying down for 10/12 minutes felt much better.
Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. It was alleged in litigation that a male patient of unknown age was vaccinated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 04-NOV-2013 at a Healthcare Center as recommended for routine adult health maintenance for the prevention of shingles. It was reported, that the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JAN-2016, the patient was treated at the Healthcare Center for a painful rash and nerve pain which was then diagnosed as shingles. On or about 01-FEB-2016, the patient was treated at the same facility for ongoing and worsening symptoms of shingles. Although shingles is an incurable viral condition, a physician has prescribed gabapentin for the management of the patient's symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L035637 and expiration date 09-JUN-2017, lot # L039638 and expiration date 23-AUG-2017, orally; exact doses were not reported). No adverse effect was reported. This is one of the several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Several years ago, the patient received a series of human papillomavirus (HPV) vaccines which interchanged GARDASIL and CERVARIX. It was unspecified how many doses of each vaccine were administered and what the dates of administration were (dose, route and lot# were also not reported). No symptoms were reported. Additional information is not expected since the medical assistant did not want to be contacted regarding this report and she did not want to provide further information.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 26-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot# M006141, expiry date 28-MAY-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius) and the second one lasting for 32 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt. with complaints of throat swelling, feeling of tightness and scratchy, audible expiratory wheezes
All day Saturday the right side of my face felt tingly and when pressed hurt. Was able to smile, talk and move my face. Tongue tingled a little, and lips (right edge of mouth) off and on until it finally stopped Sunday morning. Haven?t had any issues with it since then.  Never had that happen before, so was a bit concerning.
Patient became lightheaded and pale. Brief period of unconsciousness (5 seconds) and fully recovered. EMS called and evaluated - patient not transported. Ambulated to car.
Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012L20A and 012L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLUARIX QUADRIVALENT (Manufacturer - Seqirus, Lot number - 308455, Route - Intramuscular and Body site - Left Arm). Past adverse reactions to the above products included No adverse event with FLUARIX QUADRIVALENT. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), AMLODIPINE, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BACLOFEN, APIXABAN (ELIQUIS), ATORVASTATIN and LISINOPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up document received: Added reported information, added historical vaccine information.
I got the Covid-19 vaccine on Tuesday April 1st and then 2 days later on Thursday April 3rd I started developing headaches and they got worse and I would say they fluctuated to migraines. Every day I would have a degree of a migraine (which I do NOT have history of) and most days the head pain limited my activity significantly. I had 2 evenings where it got really bad. Once on Saturday April 3rd and then again on Wednesday April 7th. I have had headaches continueally since then. Some days better than others and some days worse.
Patient and parent came in for patient?s 2 Month physical and vaccines.  Patient was inadvertently given an expired dose of Pentacel, which is a combination of Dtap, IPV, and HIB.   The expiration date was 3/12/2022. Other vaccines given were Prevnar (PCV) and Rota Virus (RotaTeq), which were both current.
Your vaccine killed my son.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Your vaccine killed my son.". Your vaccine killed him my healthy 22yrs old son. He was gone because of your vaccine. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Your vaccine killed my son.