chrisvoncsefalvay/vaers-outcomes huggingface dataset:
acute myasthenia gravis crisis; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLULAVAL QUADRIVALENT, administration date 07Oct2021; ELIQUIS; HYTRIN; PLAVIX. Vaccination history included: Bnt162b2 (Prev dose lot number: EL9261,, prev dose administration date:19Feb2021,, prev dose administration time: 03:30 PM, prev dose dose number: 2,), administration date: 19Feb2021, when the patient was 78 years old, for Covid-19 immunization; Bnt162b2 (prev dose vaccine location: Right arm , prev dose lot number:EL3246,, prev dose administration date: 28Jan2021,, prev dose administration time: 02:30PM, prev dose dose number: 1,, prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 02Nov2021, outcome "unknown", described as "Booster"; MYASTHENIA GRAVIS CRISIS (hospitalization, medically significant) with onset 11Nov2021, outcome "recovering", described as "acute myasthenia gravis crisis". The patient was hospitalized for myasthenia gravis crisis (hospitalization duration: 25 day(s)). The event "acute myasthenia gravis crisis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result, notes: If COVID tested post vaccination: Yes. Therapeutic measures were taken as a result of myasthenia gravis crisis. Clinical Course: Acute myasthenia gravis crisis began on evening of 11Nov2021 followed by emergency admission to ICU .Treatment given for AE was Ventilator, plex, medication, IVIG.COVID prior vaccination was no. COVID tested post vaccination was yes.   The lot number for bnt162b2 was not provided and will be requested during follow up.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Information has been received from a physician concerning a 10 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. Now, on approximately 4/12/2005 the patient experienced mild chicken pox with less than 50 lesions. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
On 9/25/2021 at 4:30pm I went into atrial fibrillation. I contacted my cardiologist. After talking to on call doctor it was suggested I go to emergency room. They confirmed atrial fibrillation. I was then prescribed Metoprolol. After about 8 hrs. form onset my heart rate converted back to sinus rhythm. I spent the night at the hospital. They treated me for atrial fibrillation. The next day they released me. They were managing the atrial fibrillation. They switched between metoprolol and nebivolol. They started me on Eliquis at the start in September. On 1/29/2022 I started having angina symptoms. They decided to do an angiogram, they discovered a minor blockage and they inserted the second stint.  Then they put me on Plavix and took me off metoprolol and nebivolol.
April 14th (Day of shot): Dizzy, light sensitive, confusion/ head fog, headache, sore arm, chills at night and couldnt sleep                                           April 15th: same symptoms, nothing improved April 16th: same symptoms, eye sight was worse, light sensitive, blurry, more head fog, rapid heart rate and palpitations all day, tight chest and trouble breathing, almost went to the ER April 17th: same symptoms, more anxious because I was having a bad reaction , hard to breathe, no focus, slept all day, increased/rapid heart rate, foggy head, dizzy April 18th: same as previous day April 19th: same as previous day, could not breath at night, did not get sleep, waking up gasping for air, had to leave class because of sweating, rapid heart rate, confusion, and dizzy feeling Went to urgent care on April 19th, called Moderna and  and they said symptoms were not normal  Still short of breath, rapid heart rate, weird vision, no focus, dizzy
Diarrhea since two days after first shot until present day; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201) via an unspecified route of administration, administered in Arm Left on 20Feb2021 15:15 as DOSE 1, SINGLE and second dose via an unspecified route of administration, administered in Arm Right on 13Mar2021 14:15 (Batch/Lot Number: EN6208) as DOSE 2, SINGLE (at the age of 65-year-old) for covid-19 immunisation. Medical history included insomnia. Concomitant medications included eszopiclone. Prior to 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 4 weeks prior to the COVID vaccine. On 22Feb2021, the patient experienced diarrhea since two days after first shot until present day. Therapeutic measures were taken as a result of diarrhea since two days after first shot until present day (diarrhoea). The outcome of the event was resolved.  No follow-up attempts are possible. No further information is expected.
Recurrence of prior atrial fibrillation about 3-4 weeks after vaccination.
Dizziness, enlarged lymph nodes from axilla to mandible on same side as shot.  Body aches, chills, headache.
Irritation on the site of injection 2.5 inch in diameter and lasted for more than 10 days.
Morbilliform rash, left arm (where the injection was given), 3x4cm oval, pink, slightly itchy, no pain. Pfizer COVID vaccine, booster, no prior rxns. Appears typical of DTH Rx documented in the NEJM.
This spontaneous report was received from a pharmacist, concerning 39 year-old male patient. There were no concurrent conditions or medical history reported. The patient did not have any drug reaction or allergy, and his concomitant medications included clonazepam, lisinopril (manufacturer unknown), venlafaxine, metoprolol, oxycodone, oxymorphone, gabapentin and glipizide. On 19-JUN-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX23 (dose and frequency were not reported) lot # N010105 with expiration date of 15-NOV-2018, for prophylaxis (reported as "prevent pneumonia"). On 20-JUN-2017, the patient returned to the pharmacist complaining that his arm was "swollen and the injection site was very warm to touch". The pharmacist mentioned that "upon inspection, the injection site was very warm to touch, swollen, the skin was tight and the patient complained of pain from the back side of his shoulder around his chest". The pharmacist advised the patient to take his temperature, apply ice at the injection site and to take MOTRIN for the pain; also, if his conditions did not improve or worsened he needs to consult medical treatment. No laboratory diagnostics or studies were performed to the patient. At the time of the report, the outcome of the aforementioned events was unknown. The causality between the events and PNEUMOVAX23 was unknown. Additional information has been requested.
GOT FIRED FOR CONTINUALLY BEING  DISABLED; SEVERE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for covid-19 prophylaxis. 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 12-MAR-2021, the patient experienced severe side effects. On an unspecified date, the patient experienced got fired for continually being disabled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe side effects and got fired for continually being disabled was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
DIFTUSE PINK RASH ARMS, LEGS, TRUNK BRANCHABLE 2 DAYS AFTER TDAP VACCINE
Patient complaint of dizziness and anxiety. Patient noted to be pale. Legs elevated. Patient provided with water and powerade . EMS called and evaluated patient. Patient requested to lay down. Patient assisted to stretcher to lay down. Patient began to feel better after laying down. Color noted back on patient . Patients stated that she is feeling better.
showing symptoms of COVID-19; showing symptoms of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Exposed to COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "showing symptoms of COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. Clinical course: The reporter had the primary series and a booster dose of the Pfizer COVID-19 vaccine. She recently tested positive for COVID-19 and her daughters (includes the patient) were exposed to COVID-19 after they received their first dose of the Pfizer COVID-19 vaccine pediatric formulation. Both of her daughters are showing symptoms of COVID-19 and they have been tested but have not received their test results yet. The patient was scheduled to take the second dose at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) US-PFIZER INC-202200027211 same reporter, different patient, same product, same events; US-PFIZER INC-202200027212 same reporter, different patient, same product, similar events
Patient reported "For 8 days and nights I had the tingling/crawling feeling in my arms and legs, sometimes my body felt that. After that went away I have not had any other symptoms."
Burning legs, pain, flu like aches and fatigue immediately following and the next day, two hours of migraine like aura followed by loss of vision in one eye.
Narrative: Hospitalization-fully vaccinated, admitted for orthostatic hypotension/dizziness, found COVID positive on admission. Asymptomatic except for dizziness.
Persistent pain immediately after injection unlike prior years flu shots. Pain continuing since injection date and worsening. Pain from 5-10 range with limited range of movement.
she had broke out in hives from tip of her fingers and all over; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (she had broke out in hives from tip of her fingers and all over) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 031F21, 019B21A and 010A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product AMOXICILLIN for an unknown indication.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started AMOXICILLIN (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (she had broke out in hives from tip of her fingers and all over). At the time of the report, URTICARIA (she had broke out in hives from tip of her fingers and all over) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient did not take maintenance medication.   On Sep-2022 for dental appointment and for many years the patient took amoxicillin before dental appointment.  The patient received 3rd booster dose on 26-Oct-2022, lot number 021H22A.  No treatment medications were reported.   Reporter did not allow further contact
Left deltoid area 3 inches x 3/5 inches=of induration, warmth, and erythema itchy, warm.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received via an employee via a nurse. This case involves two child patients (age was reported as under 18 years) who was vaccinated with a dose of FLUBLOK QIV instead of FLUZONE (lot number, expiry date, dose, dose in series, route and site of administration was not reported for both the vaccines) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. The patients were administered with FLUBLOK since the packaging was looking the same as FLUZONE. It was not reported whether the patients experienced any adverse events following the vaccination. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Constant itching, rash breakout, with spots that looks similar to psoriasis lesions.  Breakout on the left side where the vaccine was administered.  Also areas in the face.
On  or about 3/31/21 I began feeling extremely week and lethargic. On 4/6/21 I came home from work about 7:00 am due to an extreme headache and muscle weakness. By the afternoon my fever was up to 101. On 4/7 my fever went up to 102.7 and I was shaking uncontrollably, sweating , dizzy, headache, and had heaviness in my chest. I felt as if I were going to have a stroke. The headache was excruciating. I took acetaminophen 500 x 2 and 400 mg of ibuprofen, and Theraflu to try and alleviate the symptoms. On 4/9/21 my fever broke, but the weakness, dizziness and headaches have continued. I currently have ongoing headaches and dizziness. I have not gone to the doctor because I do not have a PCP. I am looking for one now.
48 hours after administration of IPV and Dtap to left arm, there was swelling and redness noted. The patient was taken to the emergency department, diagnosed with cellulitis and started on oral antibiotics. Symptoms progressed with 2 blisters forming. 12 hours later she returned to the emergency department with greater than 50% of arm red with 2 blisters. This required admission for less than 24 hours, treatment with one dose IV antibiotic and then 10 day oral course, with resolution.
After 15 min. of monitoring patient she thought she might have a hive on her forehead and her face felt a little itchy.  No report of facial or tongue swelling or any difficulty breathing.  Monitored another 15 min and symptoms did not change.  Patient then took 2 diphenhydramine 25mg and sat in waiting area another 10 minutes.  She said she was feeling better (face not as itchy) and no additional symptoms.  I explained to her and her mom what signs and symptoms would be of concern (facial swelling, tongue swelling, any s/s of difficulty breathing, any airway issues, generalized hives, etc) that they should call 911.  She said she has nut allergy and understood what s/s I was explaining.  She stated that sometimes her tongue tingles with nut allergy- I told her that yes, it would be similar.  I will follow up with the patient tomorrow.
Large red swollen patch at sight of injections, L arm measuring at, R arm measuring at. Pt reported to medical and was treated with single dose of Benadryl (8 Mar 2023 @ 1200) and icing  of the area. Skin marker was applied at the boarder of swelling/redness to keep track of spread.
sore arm; some vaccine leaked out; Syringe snapped; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), UNDERDOSE (some vaccine leaked out) and DEVICE CONNECTION ISSUE (Syringe snapped) in a 44-year-old female patient who received mRNA-1273 (batch nos. 016C21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event nor concomitant medications were reported.).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), UNDERDOSE (some vaccine leaked out) and DEVICE CONNECTION ISSUE (Syringe snapped). On 01-May-2021, UNDERDOSE (some vaccine leaked out) and DEVICE CONNECTION ISSUE (Syringe snapped) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was not applicable.       Patient reports that while receiving her second dose of Moderna COVID-19 vaccine the syringe snapped and some vaccine leaked out.
Pt developed new onset atrial fibrillation when seen on 8/5/2021.  she is concerned it might be related to the vaccine series above. we do not know for sure when the atrial fibrillation started, but based on records started sometime between April and August of 2021.
made eyes feel weird first time, worst the second time,   fever for 5 hrs seeing things. redness around shot 4 inches round  fouth day still there . didnt eat for three days, head ache.   felt like arm was going to fall off.   fourth day feel better, arm still red.
Pt came into clinic for 11yo shots, patient received Boostrix and Menveo in left arm. Patient vasovagal immediately, unable to catch her, she received laceration above right eye.
I received my vaccine around 10:00 a.m. Over night, I was sore on my arm, shoulder, neck, and chest on the side that I received my vaccine. When I woke up in the morning, my lymph node under my arm pet on the vaccine side was swollen and sore. 2 days later, it seems to be getting smaller.
Fever and chills, headache, syncope (experienced around 6:30 am following the morning after vaccination was received)
This initial spontaneous report was received from the mother of a "college aged" female patient via a company representative. Concurrent conditions included an unspecified heart condition. Concomitant medications were not provided. On unspecified dates, the patient received her first, second and third doses of the human papilloma virus (HPV) vaccine (manufacturer not specified). The company representative stated she had heard of a mother (gave mother's first name) who was telling people that her daughter died after receiving the third dose of a series of HPV vaccine. It was not stated which HPV vaccine the patient received. The mother has already filed a federal lawsuit. The cause of death was not specified. Upon internal review, death was considered medically significant. Additional information is not expected as there was no contact information.
Patient presented today for a COVID-19 booster. She was administered the pediatric dosage from the orange capped pfzier bottle when she should have had the adult dosage from the gray bottle. She recieved 0.2ml of the pediatric dosage rather than 0.3ml of the adult dosage. No immediate adverse reactions.
got sick for One day; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received last shot in 2014 (name not specified). The patient recently received shingles shot and got sick for 1 day. The patient mentioned that, it was some thing the older people needed. The follow up would not be possible as no contact details were available. For the 2nd dose, refer case US2021AMR113623, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113623:same reporter, same pateint, same AE, different dose (2nd dose)
Noticed that patient was COVERED in a rash.  No other symptoms--no fever, no itching, etc.  At this point, it is still just the rash.
About an hour after getting my first shot i started to have back and leg pain, a headache was developing.  about an two and a half hours I started feeling weak. It was hard for me to lift and carry things, I was getting winded walking across the building and the i would feel a little nauseous but that would go away after standing still for a few minutes.