chrisvoncsefalvay/vaers-outcomes huggingface dataset:
both shots and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of herpes zoster (on an unknown date patient received both shots and got shingles 6 weeks after the second in May of 21, refer case US2021AMR199545).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, between 5 and 6 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient received both shots and had shingles now (unspecified date). This was about the 4 to 5 time that the patient had it. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199545:same patient, same reporter
ADACEL was given to patient on 8-2-11. He stated that hives started to come out 2 days later and on 8-9-11, he said that he feels his (L) cheek is feeling numb. Pharmacist recommended a doctor's visit. Patient was not having difficulty breathing or other signs of serious allergic rxn.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In October 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. 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. Additional information has been requested.
t104.6 O @ 830PM on day of vax pt listless; exhibited throat & neck discomfort, whining; c/o neck & leg (lt) pain; pt taken to hosp for eval then sent home w/orders to alternate APAP & motrin
neck and shoulder soreness; neck and shoulder soreness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 49-year-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Mar2021, the patient began to experience neck and shoulder soreness that lasted until the time of the reported (specified as today). The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
herpes zoster/severe pain, fatigue; Post Herpetic Neuralgia/severe pain; CVA/Cilioretinal Artery Occlusion; CVA/Cilioretinal Artery Occlusion/vision loss; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On 08-MAR-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered severe pain, fatigue and vision loss, and was diagnosed with herpes zoster, postherpetic neuralgia (PHN), cerebrovascular accident (CVA)/cilioretinal artery occlusion. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt 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. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.   Herpes zoster, postherpetic neuralgia, retinal artery occlusion and cerebrovascular accident were considered as disabling events by the reporter.   Upon internal review, the events retinal artery occlusion and cerebrovascular accident were determined to be medically significant.
Screamed p/event inconsolably x 2.5 hr, given APAP & compresses stopped screaming; w/in 30-45min event interpreted as pain rxn immed that did respond (console);Did not feel rxn was of "Encephalopathy spectrum";
eye was red and irritated, thought it was pink eye; extremely tired; Pricking pain in left eye similar to a pen poke; burning sensation when eye was closed; Watering from the eye when opening it; slept most of the day; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Pricking pain in left eye similar to a pen poke), EYE IRRITATION (burning sensation when eye was closed), LACRIMATION INCREASED (Watering from the eye when opening it), SOMNOLENCE (slept most of the day) and OCULAR HYPERAEMIA (eye was red and irritated, thought it was pink eye) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced EYE PAIN (Pricking pain in left eye similar to a pen poke), EYE IRRITATION (burning sensation when eye was closed), LACRIMATION INCREASED (Watering from the eye when opening it), SOMNOLENCE (slept most of the day) and FATIGUE (extremely tired). On 06-Mar-2021, the patient experienced OCULAR HYPERAEMIA (eye was red and irritated, thought it was pink eye). At the time of the report, EYE PAIN (Pricking pain in left eye similar to a pen poke), EYE IRRITATION (burning sensation when eye was closed), LACRIMATION INCREASED (Watering from the eye when opening it), SOMNOLENCE (slept most of the day), OCULAR HYPERAEMIA (eye was red and irritated, thought it was pink eye) and FATIGUE (extremely tired) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Ten days after receiving flu shot, severe pain in left shoulder with limited movement numbness in hands/fingers. Persists as of this date. Physical therapy continuing. Dx Parsonage Turner Syndrome.
p/vax pt woke up & felt nervous, had h/a on back of neck & felt discomfort on both arms;felt depressed & crying;chills, h/a, burning of both arms & numbness of face;c/o weakness, malaise & feeling sleepy;
At 1345 patient reported having hives. Hives visible on right arm and face. Airway remained patent. First Responder called and 50mg IM Benedryl administered. Patient transported to ED.
Immun given approx 930AM mom called @ 330PM on same day saying pt had severe rash around neck & joint on extremities were swollen; Taken to ER given Adrenalin & DPH;
Information has been received from a pharmacist referring to a 20 year old female patient. On 11-SEP-2015 the patient was vaccinated with ZOSTAVAX (dose, strength unknown, lot # L003218, expiry date: 30-APR-2016) subdermally. On an unknown date in September 2015 the patient developed a large swollen mass on the back of her arm. The patient came into the pharmacy on 27-SEP-2015 and the mass was no longer on the back of the patient's arm. The events self-resolved on an unspecified date in September 2015. Causality between the event and the ZOSTAVAX was not provided. Additional information has been requested.
Hives over arms, stomach, back, and legs. Treated at hospital  with steroids, Benadryl, and anti acid. Slight pinkness left currently with some itching.
Swelling, erythema, tender 12 hours after injection site using heat and Advil.
Information has been received from a female who in October 2008, was vaccinated with the first dose of GARDASIL 0.5 mL, injection and after that experienced itchiness at the injection site. The patient stated that "she won't be getting rest of doses". The patient was not recovered. The patient did not seek medical attention. No further information.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL on 20-DEC-2010, the second dose on 16-JAN-2012 and the third dose on 20-FEB-2010. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number L051123 expiration date 13-OCT-2018, lot number L03065 expiration date 07-JUN-2018. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time: 5 hours. Digital data logger was involved, no previous exposures and no product quality complaint involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.
>12 hours post puncture were administered; Expired Moderna doses (>12 hours post puncture) were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (>12 hours post puncture) were administered) and PRODUCT STORAGE ERROR (>12 hours post puncture were administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 7:42 AM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Apr-2022 at 7:42 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (>12 hours post puncture) were administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (>12 hours post puncture were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses (>12 hours post puncture) were administered) and PRODUCT STORAGE ERROR (>12 hours post puncture were administered) outcome was unknown. Expired Moderna doses (>12 hours post puncture) were administered      For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Dose administered more than 12(US) hours post puncture. The vial was initially stored in the refrigerator on 15-Apr-2022. Date(s) and time(S) vial was first punctured- 19-Apr-2022 at 1 PM Central Time. HCP reported after the vial was punctured, the vial would then be placed back in a cooler with ice packs and a data temperature logger monitoring the temperature inside the cooler. HCP reported no temperature excursion occurred inside the cooler according to the data logger. Once a dose is drawn up, the vial is immediately placed back in the cooler. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 5 minutes  Treatment information was not provided.
Patient called and said after receiving the vaccine by few days she is having a tingling sensation in her arm.
mucus; runny nose; phlegm and mucus; dry cough; awake all night; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), INSOMNIA (awake all night), SECRETION DISCHARGE (mucus), RHINORRHOEA (runny nose) and PRODUCTIVE COUGH (phlegm and mucus) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Apr-2021, the patient experienced COUGH (dry cough) and INSOMNIA (awake all night). On 13-Apr-2021, the patient experienced SECRETION DISCHARGE (mucus), RHINORRHOEA (runny nose) and PRODUCTIVE COUGH (phlegm and mucus). The patient was treated with GUAIFENESIN (TUSSIN [GUAIFENESIN]) for Adverse event, at an unspecified dose and frequency and ASCORBIC ACID, CAFFEINE, CHLORPHENAMINE MALEATE, SALICYLAMIDE (CORICIDIN [ASCORBIC ACID;CAFFEINE;CHLORPHENAMINE MALEATE;SALICYLAMIDE]) for Mucus discharge and Runny nose, at an unspecified dose and frequency. On 13-Apr-2021, INSOMNIA (awake all night) had resolved.   At the time of the report, COUGH (dry cough), SECRETION DISCHARGE (mucus) and PRODUCTIVE COUGH (phlegm and mucus) had resolved and RHINORRHOEA (runny nose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   It is reported that patient has been given unknown prescription by HCP for Diarrhea. Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-076718, MOD-2021-076812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient's e-mail address updated.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an 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 provided.
Patient recieved COVID-19 and Flu shots on 10/06/2023. According to immunizer pharmacy technician, after vaccinated patient did not bleed. After a few minutes, patient presented to pharmacy counter with excessive bleeding from right arm. Patient stated that she is taking Aspirin and Clopidogrel. Patient was taken inside the immunitazion room once again and pressure was applied to the injection site until patient stopped bleeding.
Hives on thighs, arms and stomach; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 36-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9266), via an unspecified route of administration on 19Feb2021 18:00 on Right arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9269) , via an unspecified route of administration on 29Jan2021 08.30 AM on Right arm at single dose for covid-19 immunization. The patient experienced hives on thighs, arms and stomach on 19Feb2021 19:30 with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered at School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hives on thighs, arms and stomach within 45 minutes of injection. Hives subsided within a few hours. No treatment was received for the adverse event. The event was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products.
Patient inadvertently received 2nd dose of series 2 days early. Patient without symptoms.
Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less than 12 hours-no treatment needed Mild body aches that lasted less than 12 hours-no treatment needed Gastrointestinal upset/diarrhea that lasted less than 12 hours-no treatment needed
On Friday he stayed in bed all day with body aches, joints pains, fever 102. Then on Saturday he got up out of bed with complaints of chest discomfort (felt as if someone had punched him in the chest). On Sunday around 12:30 am he was still exp chest pain he was taken to Hospital. He got EKG around 1:45 am by that time he wasn't exp chest pains. Since early Sunday morning he hasn't had any chest pains starting to gradually feel better. On Monday he was able to do he normal routine.
Intense chills and muscle cramps. I put on insulated underwear and got some control over shaking. Took 5 ibuprofen and was able to get a few hours sleep.
Injection site pain, potentially diarrhea (may be related to antibiotics); Injection site pain, potentially diarrhea (may be related to antibiotics); This is a spontaneous report from a contactable Physician.  A 35-years-old female patient received first dose BNT162B2( lot number EJ1685) via an unspecified route of administration at Arm Left on 22Dec2020 15:30 at the 35 years old at single dose for COVID-19 immunization. The medical history included Migraines, COVID-19 not ongoing and Allergies to medications, food, or other products. The concomitant medication was amoxicillin, clavulanic acid(AUGMENTINE). On 23Dec2020 06:00 the patient experienced Injection site pain, potentially diarrhea (may be related to antibiotics). There was no treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Severe itching, swelling just below the injection site for over a week. Scratching it made it worse until the swelling went away. I used anti-itch remedies to help. Skin is discolored.
c/o ?hives lt forearm, lt arm on 19OCt98 took DPh @ home 10OCT98;erythema & warmth deltoid area & lt forearm wrist area;tx keflex;
Nausea, Dizzyness, Mettalic Taste, Vertigo, Weekness, Stomach Cramps, Bleeding, Foggy, ADHD Medication not working, Shortness of breath, tingling lips, fingers, back of head, rapid heartbeat, blurry vision
Immed /p adm of MMR vax, pt developed SOB, wheezing & angioedema (swollen eyes & nasal edema) Pt was adm Epinephrine /w positive results, transported via ambulance to ER & recvd Diphenhydramine & ice packs applied to eyes
(R) thigh redness and swelling at inj. site approx 3 1/2" x 4 1/2".
Initial unsolicited report received from health care professional via other company Pfizer on 16 Feb 2017. Manufacturer report number: 2017036187. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date (reported as 2005-2006). The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced high fever (type of reaction: allergic) and was hospitalized. Lab data and corrective treatment was not reported. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This is a poorly documented case in which patient experienced high fever after vaccination with INFLUENZA VACCINE. Time to onset is unknown. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
pt had recent hospitalization (11/1 - 11/4/21_ for HTN, stage IIIB kidney disease, dementia, pt was a DNR; dc'd home; presents to ED after a fall; hypoxic; no evidence of fx and trauma scan negative; found to be positive for COVID; COVID pneumonia; started on remdesivir, decadron, ABX, O2 supplementation; hypoxia continued to worsen; pt's condition deteriorated; pt made comfort care by wife and he passed away in the hospital
Received 2nd COVID-19 vaccine on 6/14 and developed headache and myalgia that evening. On 6/15, continued to have these symptoms then developed abdominal pain and vomited once.  Symptoms persisted on 6/16; then developed chest pain at 11:00PM and reported that pain seemed worse when inhaling and was sharp, shooting pain. Presented to ED at 12:00 AM on 6/17 and subsequently transferred to Pediatric ICU due to elevated troponin and d-dimer.  Initial EKG showed tachycardia. Cardiologist consulted. He had an echocardiogram on 6/17 AM that showed mildly depressed LV systolic function with EF ~58%. Troponin was elevated from 2.9 to 16.9. Due to echo and elevation in troponin patient received 100 gm IVIG (max dose based on  IBW). Has required one dose of 15 mg ketorolac IV and 650 mg acetaminophen PO x1 for chest pain. At 1:00 PM on 6/17, troponin increased to 54.6 and aspirin 81 mg started. Chest x-ray showed borderline cardiomegaly. On 6/18 repeat echocardiogram with normalized LVEF and considered a normal echocardiogram per cardiologist.