chrisvoncsefalvay/vaers-outcomes huggingface dataset:
droopy; drugged; left pain in shoulder and neck; nausea; possible fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (droopy), FEELING ABNORMAL (drugged), ARTHRALGIA (left pain in shoulder and neck), NAUSEA (nausea) and PYREXIA (possible fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (droopy), FEELING ABNORMAL (drugged), ARTHRALGIA (left pain in shoulder and neck), NAUSEA (nausea) and PYREXIA (possible fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (droopy), FEELING ABNORMAL (drugged), ARTHRALGIA (left pain in shoulder and neck), NAUSEA (nausea) and PYREXIA (possible fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant medication included Thyroid Medication(Unspecified).   This case was linked to MOD-2021-298768, MOD-2021-296450 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. There are no onset dates for the events hence cannot establish any temporal association. Further information has been requested.
Information received from a registered nurse concerning a 4 yr old Caucasian male pt who on 11-APR-2000 was vaccinated in the right arm with a second dose of measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) (lot #0381D). There were no noted illnesses at the time of vaccination. There are no known allergies or past medical history. Gentamycin eye drops were noted as therapy for the pt; however indication and therapy dates were not specified. On 12-APR-2000 the pt developed a large reddened nodule on the right upper arm. The pt  was seen in the Dr's office on 13-APR-2000 at which time there was a 3/4 inch hardened knot at the injection site with slight erythema.
10 MINUTES AFTER INJECTION, PATIENT DEVELOPED DIZZINES, GENERAL MALAISE, FLUSH FACE, AND NAUSEA.  SHE WAS TAKEN TO A ROOM AND LAID ON THE TABLE- BLOOD PRESSURE READ 116/68, PULSE 54. DNP came in to evaluate after this reporter and the patient started with itchiness on tongue and spotty vision- the order was placed for Epinephrine 0.3 mg- administered right vastus lateralis IM  at 9:45 and 911 called for ambulance transfer by Reporter and  patient reported decrease in itching and flushing almost immediately. Pulse rate came up to 62 and continued to monitor symptoms until emergency services came and transported her to Hospital.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-DEC-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 22-JAN-2016, the patient was treated by a health professional for the onset of a vesicular rash which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Fatigue through out this time period which is going on 5 months; All lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks.; Then right shoulder pain began; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration in right arm on 16Feb2021 (Lot number: EM9810) (at the age of 67-year-old) as single dose for Covid-19 immunization. Facility type vaccine/Facility where the most recent COVID-19 vaccine was administered: Hospital. Other medical history was none. No known allergies reported. Covid was not tested prior or post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin (LIPITOR), paroxetine hydrochloride (PAXIL CR), zinc, colecalciferol (D3), cyanocobalamin (B12-VITAMIIN) and ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer, Lot number: EL9261) administered in right arm on 26Jan2021 11:00 AM (at the age of 67-year-old) for Covid-19 immunization and no reaction was reported. On 19Feb2021, all lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks. Then right shoulder pain began. Had clavicle swollen joints and "cists" develop in underarm, breast and shoulder. Fatigue throughout the time period which was going on 5 months. All occurred after the second vaccine on 16Feb2021. Privacy policy consent: Yes. Device timestamp/Device date: 05Jul2021. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received an unknown treatment in response to the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is expected.
Experienced severe headache in the afternoon after receiving the COVID19 vaccine (first shot) around noon. Took ibuprofen in the afternoon and in the evening before bedtime. Headache felt better the next day, but within 48 hours, experienced 'floaters' in my right eye.  Received second dose of COVID19 vaccine on 04/08/2021. Again experienced headache afterward, but not as bad as the first time.
Very sore arm; aching all thru body; 3 degree fever started around 3 PM.  Took acetaminophen & rested.  All symptoms lasted until 11/15/2014.
Menstral cycle was delayed/absent for 1 calendar month. I have no previous history of this ever happening (approx. 150 previous cycles experienced in lifetime)
Patient was given expired Hep B vaccine on 11/29/06 at approx 3pm. Patient developed no problems. Advised to revaccinate.
Child had three seperate episodes of twitching while awake. Each was rhythmic in nature and lasted at most 10 seconds. Child was seen in ER at time and evaluated. Physician had no concerns and dismissed them to home. Mom told us about the event at todays appt for 4 month checkup.
HYSTERECTOMY; This spontaneous report received from a patient via other company (Agency) concerned an adult female  The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: There was no reported medical history. The patient previously received covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  On an unspecified date, patient experienced endometriosis and fibroids following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date was not reported 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.  Non-company suspect drug included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication.  On an unspecified date, the patient experienced hysterectomy (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of hysterectomy was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220902080 (Dose number in series 1 case).; Sender's Comments: V0: 20220908814-covid-19 vaccine ad26.cov2.s-Hysterectomy. 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). Therefore, this event(s) is considered unassessable.
Headache, diarrhea, joint pain, fever, fatigue, palpitations.
PATIENT STATED IMMEDIATELY AFTER RECEIVING IMMUNIZATION THAT SHE HAD A "FLUSHING" FEEL, BUT THAT IT IS NORMAL FOR HER TO GET THAT WAY WITH CERTAIN THINGS. PATIENT WAS MONITORED BUT RECEIVED NO MEDICATION.
feeling lethargic; arm began to hurt; Scabs ich like crazy; Bumps; sporadic rash under bra strap and across shoulders; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (feeling lethargic), PAIN IN EXTREMITY (arm began to hurt), RASH PRURITIC (Scabs ich like crazy), SWELLING (Bumps) and RASH (sporadic rash under bra strap and across shoulders) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (in arms and legs due to spinal fusion.) and Weight loss (138lbs to 118lbs .). Concomitant products included CALCIUM, MAGNESIUM, ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced LETHARGY (feeling lethargic), PAIN IN EXTREMITY (arm began to hurt), RASH PRURITIC (Scabs ich like crazy), SWELLING (Bumps) and RASH (sporadic rash under bra strap and across shoulders). At the time of the report, LETHARGY (feeling lethargic), PAIN IN EXTREMITY (arm began to hurt), RASH PRURITIC (Scabs ich like crazy) and SWELLING (Bumps) outcome was unknown and RASH (sporadic rash under bra strap and across shoulders) had resolved.            Treatment medication included  Hydrocortisone twice daily Action taken with mRNA-1273 in response to the events were Not Applicable   This case was linked to MOD-2021-025222 (Patient Link).
Got shot on 9-16-13 at approx 8:00AM. Started to feel ill in afternoon 9-17-13 went to ER with shortness of breath, rapid heart rate. Was admitted to hospital, went to ICU for 2 days. Had heart tests done, everything came back fine. Been feeling fine ever since.
Extreme chills,fatigue, weakness, body aches, sore arm. The next day developed a bright red rash on my neck. Burning and itching. Black stools.
Patient fainted, fell and hit head on floor within 2-3 minutes of receiving vaccination. He regained consciousness within seconds. Stated feeling better. EMS was called and care handed off.
red bumps on wrist, leg, and abdomen 4 days post vaccination, not bothersome but slightly itchy
This case was reported by a other health professional and described the occurrence of incorrect product storage in a adult male patient who received BOOSTRIX (batch number 4EK53, expiry date 7th November 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. It was unknown if the reporter considered the incorrect product storage to be related to BOOSTRIX. Additional informations received: BOOSTRIX stored below recommended temperature ranges (-0.5 C) to a male adult patient. No more specific patient information.
Normal soreness at the site; headache; back ache; This is a spontaneous report from a contactable nurse reported for self. This female patient received the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 08Jan2021 at single dose in right arm for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously received first dose of BNT162B2 (Lot number unknown) at 18Dec2020 at single dose in left arm for COVID-19 immunisation and stated lymph node swelling noticed in the left clavicle area and did hurt at the beginning for a few days. The patient experienced "headache and back ache only" and "Normal soreness at the site" in Jan2021. The patient reported no lymph swelling after the second dose. The outcome of events was unknown.   Information on the lot/batch number has been requested.
two doses of Fluarix were given instead of two doses of Engerix B; two doses of Fluarix were given instead of two doses of Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Fluarix Tetra 2020-2021 season, Fluarix Tetra Pre-Filled Syringe Device, the 2nd dose of Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, an unknown time after receiving Fluarix Tetra 2020-2021 season, Fluarix Tetra Pre-Filled Syringe Device, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and overdose. On an unknown date, the outcome of the wrong vaccine administered and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details was reported as follows: The age at vaccination is not applicable to this reported. The patient received two doses of Fluarix quadrivalent instead of two doses of Engerix B. The reporter wanted to know the side effects to be expected with the Fluarix and when they would give the two doses of Engerix B to the patient. The reporter consented to follow up.
Patient complained of shortness of breath. Patient has a history of COPD, hypertension, and tachycardia. Patient give 3 Liters of oxygen by face mask. Vitals done every 5 minutes.  Monitored patient until no further intervention needed.  Patient left via wheelchair with his wife.
On 1/26/22 patient was assessed and was found to hav ea temp of 101.1. Tylenol was given and temp dropped to 100.8.
This spontaneous report has been received from a pharmacist referring to an 80 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 18-APR-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received.; Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013607: US-009507513-1705USA013608: US-009507513-1705USA013609: US-009507513-1705USA013610:
I received the astrazeneca vaccine 11/5/2020 and 12/3/2020 as part of a trial to test safety and efficacy. I had no side effects. After a year had passed, with no boosters offered in the trial, I left the trial to receive the moderna booster dose vaccine lot 048F21A for covid on 10/25/21. On 11/5/21 I developed sudden onset right sided sensorineural hearing loss, primary in the high frequencies at 4000hz up to 60 db. I have not had recovery despite a course of oral prednisone and intra trampanic membrane steroid injection by an ENT provider. I thought this should be tracked incase it is related. I am a health care provider and take care of covid patients and am pro vaccine but this has been difficult.
After 3 weeks shingles on left inner thighs. Pt seen in ER. PLWH: Impetigo, culture preferred. Treated with Keflex 100mg. Pt's mom instructed to keep area clean, dry and avoid scratching. Follow up in 2 weeks.
Began with left hip pain before Thanksgiving (before 11/26/09), proceeded to shoot down lower leg, extend across back and into right leg. 12/9/09 legs buckled while diapering child, difficult coming to feet, hands with increaed tingling and burning, more difficult to open jars.  Difficulty voiding, so is intermittently catheterizing, some slow down in bowel function.  Diagnosed by neurologist with transverse myelitis.
Patient admitted to the hospital with basilar artery aneurysm within 6 weeks of receiving COVID vaccination.
Severe headache for 3+ days, nauseous for 3+ days, stomach aches, dizzy, fever, chills
Hives; itching; shortness of breath; This is a spontaneous report from a contactable Other Health Professional, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), via an unspecified route of administration on 19Jan2021 at 16:00 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had unspecified concomitant medications that were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021, the patient experienced hives, itching, all over and eventually some shortness of breath. The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient was treated for the events with prednisone and a variety of (unspecified) antihistamines.  The patient was due to get the second dose of vaccination on Tuesday and the patient has been told she can get the second dose if she does it in the hospital under observation, and was requesting assistance in scheduling second vaccine. The clinical outcomes of the hives, itching, and shortness of breath were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Symptoms for 14 year old male were chest pains on left side, with difficulty taking deep breath?s. Symptoms worse when lying down. Symptoms began at 3:00 AM and Continued until the morning when mother took son to local emergency room. Bloodwork and diagnostic x-ray showed no abnormalities, patient was discharged at 11:49 AM with recommendation of rest, ibuprofen or Tylenol as needed for chest discomfort. Advice to return to ED for worsening pain.
Patient made an appointment for his second Moderna vaccine on the vaccine website.  He came in to get his 2nd dose.  After patient, the pharmacist, gave him his vaccine, he informed patient  that he "had a confession to make and this was not his second dose" but that he had had at least 2 other vaccines. Patient  saw he had 2 other Vaccine Cards on his person along with the one patient was giving him.  This was the first vaccine our pharmacy had given him.  He literally ran from the vaccine room after telling patient this information.
Severe arm pain, difficulty moving the limb for several days- still cannot move arm completely normally.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 03-NOV-2015 the patient was vaccinated with MMRII (lot # L012479, expiration date 10-APR-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was admitted for post-vaccine myocarditis after presenting with chest pain, shortness of breath, and an elevated troponin.
Patient presented to the emergency department via EMS on 5/26/2022 with shortness of breath, subsequently admitted from 5/26-5/31. Tested COVID-19 positive via PCR on 5/26. CHF. This meets criteria for vaccine breakthrough case review.
This study case was received on 07 February 2013 from the investigator in the trial. A male subject (age and birth date not reported) with a past medical history of smoking since unspecified date in 2012, experienced a dry cough, four days after the subject received the following vaccines on 23 January 2013: a left arm injection of ACAM2000 (SP Biologics Co., (lot number and route not reported); typhoid vaccine, manufacturer unknown; and anthrax, other manufacturer, (lot numbers, routes and sites not reported). On 27 January 2013, four days post vaccination; the subject reported four episodes of new onset, mild, dry cough, lasting two to three minutes, which resolved without intervention. The subject had no other symptoms and no clear etiology. The dry cough was reported as not resolved. The subject took no concomitant medications. Rapid and laboratory Troponin I were both reported as normal; and an electrocardiogram (ECG) was reported as normal. Treatments were reported as unknown. The subject was referred for care, but was unable to be reached for follow-up. According to the investigator, although unlikely, myopericarditis could not be excluded. The subject's outcome was reported as not recovered (not resolved) and also reported as lost to follow-up. According to the investigator, the events of dry cough and potential myopericarditis were considered possibly related to trial product. Documents held by sender: Medical Records.