chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe and debilitating shingles outbreak across her back and stomach, consisting of burning and stabbing pain; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On or around 23-AUG-2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (route of administration, lot# and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe and debilitating shingles outbreak across her back and stomach, consisting of burning and stabbing pain. These symptoms lasted approximately six months and were caused by zoster vaccine live (ZOSTAVAX). As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, she suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The event of shingles was considered to be disabling.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with VAQTA (lot#, 0.5 ml) intramuscularly. The reporter reported that VAQTA were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored VAQTA were administered to an unspecified amount of patients. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient ID: is a 70 y.o. female.   History: This is a very pleasant 70-year-old female who comes into the office today for an acute visit.  She is unaccompanied.   Her primary complaint is cough.   She completed both Pfizer Covid vaccinations, last dose given on 3/6/2021.  She began on 3/9/2021 with chest congestion, cough, and fatigue.  The symptoms have progressed over the past few days.  She is feeling short of breath with exertion, but not at rest.  She is not dizzy or lightheaded.  She does not have any GI complaints.  She has been monitoring her temperature daily and has not had any fever.
patient described redness and itchiness around the vaccine site starting on 11/5/2023 (date of vaccination was 10/31/2023)
Erythema multiforme 2 wks after first vaccine and 6 days ater 2nd.
booster; fever; exhaustion; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE , UNKNOWN MANUFACTURER.), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initially began feeling fatigued and soreness at the injection site. Later in the evening, developed a fever, severe chills, body aches, and severe headache. Fever progressed up to 103 degrees and along with other symptoms, lasted for approximately 24 hours. Body aches, headache, and fatigue lasted for 24 more hours.
4/15/99 pt recv vax & 4/20//99 strep throat;4/26/99 onset of bell's palsy;
10-10-10 Received flu shot PP23 (LD) about 1130 am. 2 A 10-11-10 woke up feeling weak. At 4 pm 10-11-10 went to hosp. Hospitalized for COPD and atrial fib. Currently being worked up for an infection. Still not feeling well
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jan2021. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment, Paxlovid, Brand=Pfizer, Treatment start date=19Jul2022, Treatment stop date=20Jul2022, Lot number=GC9431. Patient received Omepra-zole start date=01Jan2021 other medication in 2weeks. The patient Known allergies: Compazine and other medical history: asthma. Adverse event: Severe abdominal pain, vomiting for over 12 hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
t103 R responded to APAP but would go backup p/30 mins or so; fever for 3-4 days & jerking/twitching; seen by MD told ear infect & febrile sz was given Amoxicillin but devel rash;
Pt came back crying. Provider look at where. Vaccine were given. Local reaction on left leg where vaccine given. Give TYLENOL in office has at tomorrow.
Vaccinee is a ER physician who is Hep C+, has a h/o PAF, controlled with beta blocker and Fleccanide. About 3-4 weeks after vaccination developed refractory A Fib/Flutter. Saw cardiologist. Had normal LFT's prior to vacc. and now with elevated LFT's. Had appendectomy 8/03, five months after vacc.
presented to ED on 9/11/2021 with complaints of right upper extremity weakness and discoordination.  The patient stated he awoke this morning and noticed paresthesias of his right arm, had a tingling sensation from his right shoulder down into his fourth fingers excluding his thumb and when he attempted to hold his comb he was unable to coordinate his grip and was also unable to hold a fork to eat his breakfast.  He denied any headache/dizziness/change in vision, no facial droop or dysarthria.   This morning, he noticed paresthesias of his right arm and incoordination.  Patient states that he has tingling from his shoulder down into his 4 fingers excluding his thumb and when attempting to hold his comb he could not angle his comb correctly to comb his hair.  Similarly he had difficulty with his toothbrush and not being able to "get it to do what I want".  No headache.  No fever chills.  He has not been ill as of late.
At 8pm I felt tried and went to bed- starting at 9pm I began having shivers and could not get warm. My temperature  was 102, then  my fever rose to 104.5 for most of the night. I did not sleep because my body was shaking and shivering. My body ached all over, especially my lower back. It felt like a very bad flu. My fever continued onto the next day and stayed around 103.7. I slept most of the day- had to call out of work. Tuesday morning my fever was gone and I went to work then went home because my fever spiked again to 101 about mid day. I slept all day and took Tylenol. By Wednesday my Fever was gone but I was still very lethargic. Thursday I felt fine.
This spontaneous report as received from a nurse refers to 10 patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. Post 16-JUL-2014, date unspecified, 10 patients were vaccinated with VARIVAX (lot K002046, expiration date 10-FEB-2016, injection, 0.5 ml) subcutaneously. The nurse reported that there were two times temperature excursions affecting these VARIVAX products. The first excursion was on 16-JUL-2014 and was supported. The second excursion was on 21-JUL-2014 and was also supported. No adverse effects was noted/reported by any patient. Patients did not seek for medical attention. No product quality complaint (PQC) involved. This is one of several reports received from the same source.  Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to 16 patients of unknown age and gender. The patients' concurrent conditions or medical history were not reported. On unspecified dates since 11-JAN-2017, improperly stored doses of PEDVAXHIB (lot # M032150, expiration date 21-APR-2019; dose, site and route of administration were not reported) were administered to the patients. The vaccine was stored over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 6 minutes. There was previous temperature excursion of over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 30 minutes. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007854: US-009507513-1701USA007841: US-009507513-1701USA007855.
7/9/2022 At home COVID 19 test was negative, but COVID 19 PCR test was positive, I was experiencing just a runny nose.  Doctors prescribed Monoclonal Antibody Treatment.  I did develop slight cough.    I received the infusion of Antibodies on 7/10 and felt better on 7/11.
Developed cough 12 hours after shot.  Developed severe indigestion, chills, fever, and exhaustion 24 hours after shot.  Stomach problem continued and developed hives 3 weeks after.
Moderna vaccine 1st dose, Pfizer 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine 1st dose, Pfizer 2nd dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prophylaxis.    No medical history was provided by the reporter.    On 17-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine 1st dose, Pfizer 2nd dose). On 17-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine 1st dose, Pfizer 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provider by the reporter.  Treatment information was not provided.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-APR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000964: US-009507513-1907USA000965:
did not receive the ACT-HIB portion of the vaccine with no reported adverse event; Initial information was received on 04-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old female patient who did not receive the act-hib portion of the vaccine with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.   On 15-Dec-2021, the patient received a dose (0.5 ml total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with strength 0.5 ml, lot number UJ569ABA with expiration date 11-Sep-2022 (ACT-HIB lot number- UJ569AB; Expiration date- 11-Sep-2022) via intramuscular route in the right thigh as immunization.    On 15-DEC-2021 the patient developed a non-serious event "did not receive the act-hib portion of the vaccine with no reported adverse event"? (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.   It was not reported if the patient received a corrective treatment for the event (did not receive the ACT-HIB portion of the vaccine with no reported adverse event).   At time of reporting, the outcome was Unknown for the event did not receive the act-hib portion of the vaccine with no reported adverse event.     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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: lactose intolerant" (unspecified if ongoing); "Known allergies: jack fruit  Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (02Sep2022) Negative, notes: Day 9 felt better, tested negative; (05Sep2022) Positive, notes: 2 days later I felt worse and tested positive on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Bitter grape fruit aftertaste for duration of course of medicine Lost of appetite and was nauseous I also had a relapse. Day 9 felt better, tested negative and then 2 days later I felt worse and tested positive on day 12. Known Allergies: lactose intolerant and jack fruit  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient felt her chest get tight and numbness in her jaw at 1410.  After sitting for 30 minutes patient now feels fine.  BP 138/92, Sp02% 97%, Hr 86
High fever up to 105 around 6 PM. Generalized tonic/clonic seizure about 9:30 PM same day lasting for few minutes about 5 minutes.
Temp (tactile), high pitched cry for one night head lag, tongue thrust lasting on and off for two days; always alert. Seen in ER on 01/21/2002.
This spontaneous report as received from a pharmacist refers to approximately 60 year old female patient with pain, unspecified back pain and no drug reactions and allergies. Concomitant medications: unspecified pain medications. On 14-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J007856, expiration date: 28-SEP-2014, dose 0.65 ml) subcutaneously. On an unknown date in 2013, (reported as a few days after the patient was administered ZOSTAVAX, the patient developed intense itching on unspecified locations on her body and slight shoulder pain. The pharmacist reproted that there was no rash and nothing visible on the patient's skin. The patient was reporting the feeling of itching not only at the ZOSTAVAX injection site. The patient went to the routine appointment with an unspecified physician on 16-DEC-2013 and was prescribed an unspecified topical steroid (manufacturer unknown) and betamethasone (manufacturer unknown). The patient sought medical attention via contacting pharmacist. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. No laboratory diagnostic studies were performed. Additional information has been requested.
First, let me start by saying I had COVID-19 in March 2020.  I had my antibodies tested and still had positive antibodies in March 2021.  I had the first vaccine and experience multiple adverse events over a 2-3 week period.  The expected were sore arm, tiredness, chills, headache, body aches.  The unexpected were: bad joint pain, feeling like someone was putting a searing hot poker in body, terrible vertigo (never had this before) and a slight dizziness/wooziness that lasted a couple of weeks. I opted out of the 2nd dose....
ALMOST DIED; This spontaneous report received from a consumer 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) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced almost died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was non-serious. This case, from the same reporter is linked to 20221252705.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
The pt developed a fever of 99 degrees with excessive mucous secretions, foul body odor, "strong" urine, reflux, heartburn, and "chronic" constipation. He also "stopped learning and had no physical growth". A diagnosis of autism was reportedly made. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes that the preservative thimerosal is related to the development of autism.
Patient reports she received the 1st covid 19 Moderna vaccine lot number 039K20A on 12/30/20 in her left arm in the vaccine clinic. patient reports on the day after her arm was sore. She reports she noted on 1/6/2021 lymph node swelling on the left side axillary and at clavicle. she reports she also had joint pain for.  She reports on 1/7/2021 she had a fever of 101.8 with headaches . Patient reports on 1/8/21 she noted red swollen hot painful left arm on 1/8/2021 for a couple of days then resolved. Symptoms of fever lasted 24 hours.  patient reports she was OOW 1/7/2021, and 1/08/2021 due to fever and had a negative covid test. patient reports her lymph nodes are less swollen and all other symptoms are resolving.
Patient reports day following the vaccination that a sore on inner low lip developed. She said the sore spread to outer lip and "feels like lower lip has sunburn". Patient denies food allergies. Patient denies: new lipstick, new chapstick, acidic foods, drinking or eating hot food, history of HSV, prolonged sun exposure, or being in environment with high winds. Patient reports lesion on lip is still present. Patient denied throat swelling or itching. Patient denied rash.
Fatigue Headache Arm soreness--especially under arm area  Significant bruising about one week after injection.  I had a minor arm injury on the arm where I received my vaccine.  The bruising was significant and pooled around the Band-Aid that I placed on the injury
within several hours my left shoulder was in pain.  still to this day I cannot lift my left arm to the side without pain