chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 23-MAR-2018 from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications are unknown. During July 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated at a medical center for the onset of a rash that was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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. Additional information has been requested.
Fever 102.4 R after imms no soreness, fussiness, or redness at site.
Shingles; This is a spontaneous report received from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine Facility in Pharmacy or Drug Store. Reporter stated, on an unspecified patient got Shingles in the same arm as the vaccinee 9 days later. patient happen to know two other people who also got shingles after their vaccine. It could be a coincidence, but patient thought it was worth reporting for your tracking purposes. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417121 same reporter/AE/drug, different patient
No additional AE; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion.; This spontaneous report as received from an administrator and refers to a patient of unknown age and gender. No information on patient's medical history and current conditions was provided. Concomitant therapies included sterile diluent.      On 12-JUL-2023 the patient was vaccinated with first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # W025277 and expiration date 10-AUG-2024, 0.5 milliliter for prophylaxis (route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion was -8.6 degrees Celsius and lasted for 51 minutes. There was previous excursion that lasted 1 hour, 16 minutes, 0 seconds and the temperature was -11 degrees Celsius.
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (dose, lot # and expiry date were not reported). The reporter stated that vaccine was administered too high in the deltoid. On an unknown date, the patient experienced oedema. The outcome of oedema was unknown. The relatedness between the event and the suspect therapy was not provided. Additional information is not expected, as there was no consent given to contact healthcare professional.
After the 2nd dose I had a lot of pain in my eye. Then, I started experiencing a really dry mouth and ended up getting a fungus in my mouth and have to use biotin daily. I also use eye drops for my eyes, but it my left eye bothers me the most.
hearing loss; Bouts of extreme dizziness/ was diagnosed with vertigo; labyrinthitis; vesicular neuritis; Tinnitus; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.       On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)"), the patient suffered bouts of extreme dizziness. She presented to the emergency room and was diagnosed with vertigo, labyrinthitis, vesicular neuritis, hearing loss and tinnitus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient 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 an proximate result of the Company´s conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   All the event were considered to be disabling, and upon internal review, the event of deafness was considered to be as medically significant.
This spontaneous report was received from a consumer, who was also a female patient of unknown age reporting on herself. The patient's concomitant medications included pregabalin (LYRICA), famotidine, escitalopram, and atorvastatin. The patient did not have any pertinent medical history or known drug allergies. In 2017, the patient was diagnosed with Renal cell carcinoma. She was only treated surgically with the removal of a portion of her left kidney. In 2019 reported as "approximately 3 years ago", the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) also reported as "pneumonia vaccine" (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prevention of pneumonia. In March 2021, April 2021 and October 2021, the patient was vaccinated with the first, second and third dose of elasomeran (MODERNA COVID-19 VACCINE) respectively (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prevention of Coronavirus Disease 2019 (COVID-19). In November 2021, her Renal cell carcinoma returned and had metastasized (renal cell carcinoma recurrent and metastatic renal cell carcinoma).  At the time of the report, the outcome of the events, as well as the causal relationship between the events and the suspect vaccines were unknown. Upon internal review, the events of renal cell carcinoma recurrent and metastatic renal cell carcinoma were determined to be medically significant.
Hiberix dose with sterile water instead of the supplied saline diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Hib (Hiberix) (batch number H43J7, expiry date 13-JUN-2024) for prophylaxis.   On 08-SEP-2023, the patient received Hiberix. On 08-SEP-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix dose with sterile water instead of the supplied saline diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-SEP-2023 At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter Nurse reported one of their newer nurses reconstituted Hiberix dose with sterile water instead of the supplied saline diluent and administered to a patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered  The reporter consented to follow up.
status epilepticus 2 1/2hrs p/shot w/fever 101.9;rx w/benzodiazepine
DEATH; This spontaneous report received from a consumer via a company representative from social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, frequency 1 total, start therapy date were not reported administered for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died. It was reported by consumer that his niece was died due to vaccine. No further information was provided. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210648251-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient came into the pharmacy with an influenza informed consent; we confirmed with patient she was here to get influenza vaccine. Processed it all, gave to patient after nurse again confirmed patient was here for influenza vaccine. After administration. She stated she was expecting a COVID vaccine.
Pt was given Pfizer as his first Covid vaccine on 5/29/21, and then was given Moderna as his second dose on 6/28/21 in error by NP.
she received her first vaccine dose on 03Apr. On 14Apr she tested positive for covid; This is a spontaneous report received from a contactable consumer(patient) and from a Pfizer sponsored program. A 40-year-old female patient of received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) on 03Apr2021 (at the age of 40-years-old) via an unknown route at single dose on the unspecified anatomical location for COVID-19 immunization. Relevant medical history and concomitant medication not provided.On 14Apr2021 she tested positive for COVID-19. The patient queried and recommended when to get the second dose of vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient developed symptoms of a cough on 09/08/2021. Tested positive for COVID-19 on 09/08/2021.
This spontaneous report as received from a 61 year old female patient with no pertinent medical history refers to herself. The patient developed fever after receiving an unspecified tetanus shot (dates not specified). On 15-OCT-2013, reported as around 15-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, standard dose, route reported as injection (lot number was not specified). Concomitant medications included unspecified vitamins. On 15-OCT-2013, reported as immediately after receiving the vaccine, the patient felt heat in her arm where the vaccine ws administered and she could see where the vaccine was traveling under her skin from the injection site down to her elbow. About 4 hours after receiving the vaccine, she broke out blisters on her thumb with progressed until her whole thumb has become covered in blisters. The patient stated that at the time of report her thumb nail looked as though it was rotted away and a new nail had grown but looked somewhat deformed and might be growing fungus in the nail bed near the cuticle (dates not specified). The patient also explained that on an unspecified date in 2014, reported as within the last 3-4 months, she had also developed blisters in the palm of her hand and her thumb area had become very sensitive to heat. The events were treated with unspecified salves and creams. The patient sought medical attention via office visits in November 2013 and January 2014. There were  no lab diagnostics studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, I could not stop shaking, joint pain in shoulders, knees, wrist. Followed by fever and vomiting.
Information has been received from a health professional concerning a female with unknown pertinent medical history and unknown drug reactions/allergies, who in approximately 2004 or 2005, was vaccinated with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Due to lack of documentation, the hospital conducted a rubella titer and the patient tested negative. On 14-AUG-2007 or 15-AUG-2007, the patient was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot number: 655414/14) intramuscular instead of SC. Within four hours of receiving the vaccination the patient experienced a fever of 102 degrees. The patient reported that the next day she experienced a fever of 104 degrees with body aches, a few small itchy bumps at injection site, no redness. The patient stated that she had an achy neck and she felt like her spine was "going to explode", she could still touch her chin to neck. No further AE information. There was no product quality complaint. Additional information has been requested.
Swollen face, shortness of breath, wheezing, cough, hoarseness. Reported by patient. Per patient given steroids & BENADRYL at ER. Not yet re-evaluated in office. Patients states having persistent difficulties.
Sciatica pain/intensified sciatica pain on left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 16:00 (Lot number: EN6206) at the age of 52 years as dose 1, single and administered in arm left, administration date 13Apr2021 13:30 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Ace inhibitors" (unspecified if ongoing), notes: Known allergies: Ace inhibitors; "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: POTASSIUM CHLORIDE; DOXAZOSIN; DILTIAZEM. Past drug history included: Gabapentin, reaction(s): "Drug allergy", notes: Known allergies: gabapentin; Amlodipine, reaction(s): "Drug allergy", notes: Known allergies: amlodipine; Metoprolol, reaction(s): "Drug allergy", notes: Known allergies: metoprolol. The following information was reported: SCIATICA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Sciatica pain/intensified sciatica pain on left side". The event "sciatica pain/intensified sciatica pain on left side" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sciatica.  No follow-up attempts are possible. No further information is expected.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event sciatica pain which included acupuncture treatment on both sides and homeopathic injection in the left buttock and left leg from 19Apr2021. It was reported that after using paracetamol (TYLENOL), heat and tens electric stim, the patient did not get relief. The patient had scheduled more treatment on 23Apr2021.
This case was reported by a nurse and described the occurrence of generalized tonic clonic seizures in a 15-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline, Gardasil (non-gsk) for prophylaxis. The subject's medical history included neurocardiogenic syncope and hives after Septra. On 15 June 2007, the subject received 1st dose of Havrix (unknown, left arm), and unspecified dose of Gardasil (unknown). On 15 June 2007, less than one day after vaccination with Gardasil and Havrix, the subject experienced generalized tonic clonic seizures, urinary incontinence and "tonic" cyanosis. The subject experienced a seizure while sitting in the waiting room after her vaccinations were administered. This case was assessed as medically serious by GSK. The subject was treated with oxygen and went to the emergency room and was later released. At the time of reporting, her vital signs were stable and the events were resolved.
A rash developed on my left arm surrounding the injection  site.  The rash is approximately 5" x 2" and itches only slightly.  I have not taken anything for it. It occurred 8 days after I received the vaccine.  The rash is still present today, day 9.
Initially felt very anxious 04/28 later felt my pups and listen to my heart rhythm and rate.   Discovered my heart was skipping a beat.   It skips a beat every few minutes which is new never experienced.  Also had intermittent pounding headache started 04/29/22.  Headache resolved 05/03/22.
extreme headache, extreme eye ache, aching joints, queasy stomach, low fever, diarrheas. Lasted 2 days
mixed doses from multiple vials to obtain a full dose and gave it to 2 patients; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (mixed doses from multiple vials to obtain a full dose and gave it to 2 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (mixed doses from multiple vials to obtain a full dose and gave it to 2 patients). At the time of the report, PRODUCT ADMINISTRATION ERROR (mixed doses from multiple vials to obtain a full dose and gave it to 2 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.    This case was linked to MOD-2021-028634 (Linked Report). This case was linked to MOD-2021-036880 (Patient Link).; Sender's Comments:  MOD-2021-028634:
pt recvd vax 7 10 days p/vax exp bilateral conjunctivitis, rt eye pain, rt head pain, rt arm pain; pt was seen by MD; bilateral conjunctivitis remains unresolved;
Urticaria over arms, scalp, .5cm lesions. Tx: Benadryl 50mg IM, Allegra 180mg q d, Vistoril 50mg q 6h.
myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, intramuscularly on 17Dec2020 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) from an unspecified date, for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 at 16:30, the patient experienced headache, nausea, chills, myalgias. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache, nausea, chills, myalgias was resolved on an unspecified date in 2020.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with GARDASIL (lot # K016966, expiration date 10-MAY-2017; lot# K010215, expiration date 05-MAY-2017). The vaccines were improperly stored during the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
48 hours after routine DTaP right upper arm; Mom brought to office with red, spreading lesion. Exam: indurated, fluctuant area about 5cm diameter round at right lateral deltoid. No fevers. Treatment: Keflex for 10 days. The follow up received on 6/2/03 states child not seen since 5/15/03; hx is that family was leaving for Texas the next day-no know forwarding address.  A 60-day follow up report received 8/5/03 indicates the pt has recovered.
Got the shot in the morning and that night my arm was sore any movement hurt, body aches, chills, fever, hot flashes, no appetite, migraine, and fatigue. Next morning I woke then after an hour slept again, woke for a few minutes and slept again. Woke up third time pain is just about gone, no fever and almost completely back to normal.
Shortness of breath for several days, feeling fatigue and week, pain in right elbow Diagnosed Apr. 17 in ER setting: acute segmental and subsegmental pulmonary embolism without acute cor pulmonale Acute thrombosis of superficial vena basilica right arm
Mother reports pt's arm became red hot, swollen, had slight fever. Reaction to vaccine. Sore arm.
30 to 40 mins p/vax father called stating pt devel hives told to return to clinic if possible; when returned noticed scattered bullous type bumps on face (hair line) area & neck; called MD who ordered DPH, respiration 16/min;