chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he continues to experience the outbreak of shingles/ Suspected Vaccination failure; rash across their chest, down both of their arms, hands, and legs; Shingles outbreak in upper, left quadrant; severe ache, which was lessened; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 2nd dose of Shingrix. On 22nd October 2020, the patient received the 1st dose of Shingrix. On 20th January 2021, less than a day after receiving Shingrix and 90 days after receiving Shingrix, the patient experienced shingles and ache. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and rash. The patient was treated with benadryl (nos) (Benadryl), valaciclovir (Valacyclovir), ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, ache and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, ache and rash to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR114253   Additional Information: GSK Receipt Date: 29-Jul-2022, 1-Aug-2022 Reporter's comment: The patient reported the case. The pateitn received a dose of Shingrix on 22nd October 2020 and other dose on 20th January 2021. Within a day of receiving second dose, the patient experienced a Shingles outbreak. The episodes began as little outbreaks, primarily in his upper, left quadrant.  early episodes were accompanied by a severe ache, which was lessened with more recent outbreaks.  The patient currently had a rash across his chest, down both of his arms, hands, and legs.   The patient was using oral Benadryly every 4 hours, as well as valacyclovir, when the Benadryl isn't effective in relief of symptoms.  He continued to experience the outbreak of shingles over his entire body.  He also states that he uses valacyclovir three times every 8 hours, Benadryl every 4 hours, topical Benadryl as needed and Ibuprofen as needed. The patient had never experienced an outbreak of Shingles prior to receiving the second dose of Shingrix.  He had experienced numerous and ongoing outbreaks since the date of the second dose of Shingrix.  The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR114253:same patient
This spontaneous report as received from a registered pharmacist reporting that a patient of an unknown age, on 30-MAY-2013, was vaccinated with a dose of ZOSTAVAX (lot # J000445, Exp. Date: 11-APR-2014) (dose and route not reported) with diluent, when the solution sprayed onto pharmacist skin due to elevated pressure in the ZOSTAVAX vial. This is one of several reports from the same source.  Follow up information was received via a vaccine adverse experience report. The reporter stated that the patient did not had an under dose, because he used a new vial of diluent. Their was no adverse event. Information of the vaccine administrator was provided. The vaccine was administered on 30-MAY-2013 AM. The route was also reported, but illegible. Back pressure filling diluent into ZOSTAVAX vial. It was also reported that "Diluent back flushed from ZOSTAVAX vial on diluent ...(illegible)".  Additional information is not expected.
she has passed away / had leukemia / was on chemotherapy; she has passed away / had / cancer / was on chemotherapy; she passed / from dementia he thinks; she fell at the house; This case was reported by a consumer via other manufacturer and described the occurrence of leukemia in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included cancer (Family History) (to mother).   On an unknown date, the patient received Shingles vaccine. In August 2019, unknown after receiving Shingles vaccine, the patient experienced fall. On an unknown date, the patient experienced leukemia (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant) and dementia (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy) and oxygen. On an unknown date, the outcome of the leukemia, cancer, dementia and fall were unknown.   It was unknown if the reporter considered the leukemia, cancer, dementia and fall to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's husband. Age at vaccination was not reported. It was reported that the patient was very tough hard and strong. The reporter stated that the patient had a reaction to shingle shot. The patient had leukemia and cancer and she was on chemotherapy. The patient also had dementia and she fell at house in august 2019. The reporter did not have product information for shingles vaccine lot number etc. The patient went a lot through cancer and was on oxygen 24x7. It was reported that more than a year ago the patient passed away. The patient died from unrelated cause. The reporter did not given consent to follow up.
Blood blisters have shown up on both forearms randomly about every week and a half since 2 weeks after the second Pfizer shot.
Patient reported tingling and swelling in both hands, subtle, observed for 40 mins, at which point symptoms fully resolved.
pt recvd Hep B vax on 22MAY92 & devel a flu-like illness characterized by lethargy, hot flashes & an aching sensation; also devel heat-like that itched throughout entire body;
Initial report received from a health care professional on 04 January 2012. A healthy pregnant female patient, with no reported medical/obstetrical history, had received an intramuscular dose of Tetanus Toxoid Adsorbed (lot number U3919A) on 07 January 2012 for a puncture wound. She did not experience any adverse events. It was reported that had been greater than 10 years since the patient had received her last tetanus vaccine. The patient's expected date of delivery is on 07 July 2012. Documents held by sender: None.
Extremely bad headaches, uncontrollable shakes, and sweats after 12hrs.  Random cluster headaches through each day for hours at a time for 1 week post injection.  Loss of feeling in left side of face on day 6 or 7. Off duty Nurse believed it to be mini stroke or palsy  Still have nuropathy in fingers on left hand.
On January 1, 2021,  patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021,  she was transferred to Rehabilitation Center for continued treatment.  She spent 16 days there.  She developed UTI and CDIF infections and was on/off oxygen.  She started physical therapy.  She was scheduled to  be released to go home on January 27, 2021.  On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine.  On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative).  Two days later,  she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative.  The only thing they could trace it to was an adverse reaction to the vaccine. After spending  11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly.
mild hardness at the injection site; joint pain; mild swelling at the injection site; temperature of 99.9F; fatigue; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (mild hardness at the injection site), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (mild swelling at the injection site), PYREXIA (temperature of 99.9F) and FATIGUE (fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 013L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE INDURATION (mild hardness at the injection site), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (mild swelling at the injection site), PYREXIA (temperature of 99.9F), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain). At the time of the report, VACCINATION SITE INDURATION (mild hardness at the injection site), ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (mild swelling at the injection site), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) outcome was unknown and PYREXIA (temperature of 99.9F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Body temperature: 99.9f (High) Increased. On 29-Oct-2021, Body temperature: 99.9f (High) Increased.         No concomitant medication was reported. No treatment information was reported.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/29/21 2nd dose01/26/21 Diagnosed covid positive:08/3021 Symptom onset:Asymptomatic Exposure: Symptoms:
Dizzy-lightheaded-occurred 1st, nausea, H/A, pulse 82-sat down, had a snack.
ABDOMINAL PAIN; ARM SORENESS; FEVER; FATIGUE; NAUSEA; HEADACHE; INJECTION SITE SORENESS (RIGHT DELTOID); This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was taking unspecified name of medication for birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced abdominal pain. On 11-APR-2021, the subject experienced arm soreness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced injection site soreness (right deltoid). Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, fatigue, nausea, headache, arm soreness, abdominal pain, and injection site soreness (right deltoid). This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 021/7A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by reporter. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On 07-Apr-2021, INSOMNIA (difficulty sleeping.), ILLNESS (ill from hr 4 - 40 hrs), PAIN IN EXTREMITY (sore right arm), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (headache) had resolved. No treatment medications provided by the reporter. This case was linked to MOD21-093144 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: significant follow up  received contains, patient demographics, 2nd dose start date, concomitant medication.; Sender's Comments:  MOD21-093144:cross linked id
Headache; Temperature; This is a spontaneous report from a Pfizer sponsored program via a non-contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 14Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and temperature. The patient wanted to know if she has to get the second dose of vaccine as she experienced side effects of headache and temperature following the first dose on 14Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician assistant concerning a 6-year-old patient with no pertinent medical history or allergies who on 14-AUG-2007 was vaccinated subcutaneous with a second dose of varicella virus vaccine live (Oka/Merck) (lot # "0856U"). There was no concomitant medication. On an unspecified date the patient developed a varicella-like rash of 50 lesions or less. The patient sought medical attention via an office exam on 12-SEP-2007. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Case number PHEH2014US019688 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 57 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Unrelenting headache from day 3 post second injection with eye focusing issues.; Unrelenting headache from day 3 post second injection with eye focusing issues.; This is a spontaneous report received from a contactable consumer (patient). A 57-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0153 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 09Apr2021 (at the age of 57 years), as a single dose for covid-19 immunization. The patient medical history included chronic neck back issue and concomitant medications received within 2 weeks of vaccination included diphenhydramine, trazondo (trazodone hydrochloride), gabapentin, and glimepiride for an unspecified indication. Known allergies included metformin (allergies to medications, food, or other products). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: RP8535 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 19Mar2021 at 10:45 AM, as a single dose for covid-19 immunization.  Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Apr2021, the patient had experienced unrelenting headache from day 3 post second injection with eye focusing issues. The patient had not taken any treatment medications for reported events. The outcome of the events was not recovered. The seriousness of the events was reported as non-serious.  Information on Lot/Batch number was available. Additional information has been requested.
Patient presented to ED on 4/11/21 with abdominal pain, nausea, and diarrhea. Patient was tested positive for covid in Dec 2020 and received 5 day course of remdesivir.  Patient tested positive for covid on 4/13 during admission. Patient was discharged on 4/14/21.
5 mins after Pt received Pfizer vaccine started to feel nauseated, felt like she was going faint, color pale white.
pt became diaphoretic-nauseated then vomited;applied cold rag;laid on exam table;
On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh.   The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.
Pain at Injection site and feverish (Friday); Saturday - I couldn't move my arm - pain was very severe from fingers to shoulder blade. I was taking two pills every four hours of Tylenol.  Had 100.3 fever on Saturday. Pain had spread to both arms I couldn't lift anything or hold anything on Sunday. Sunday fever was 100.5 to 100.7 -on Sunday. Pain had started receding on Friday evening. On Monday, it was receding still, but I still couldn't grip anything. On Tuesday, I had hard time grabbing anything, but pain was still receding. Wednesday - couldn't feel the pain anymore. Temperature dropped on Monday in the evening - it was just at 100.3. Tuesday it was 100 degrees and headache started that day slight pain in arms and muscle aches and tired. I went back to work on Wednesday no temperature. I was still feeling muscle ache; and headache had started on Tuesday, and I still had it. On Thursday, I woke up with a pain in my left side. I may have been dehydrated but was drinking and drinking water. At work, after about an hour, the pain got very bad and spread to right side and guts were feeling like they were on fire. I was very nauseated; I couldn't walk or see straight. My husband took me to ER where I started throwing up. My guts were still felt burning and I felt like I had a temperature but their temperature on the touch temperature was not showing a fever. ER couldn't figure out what was wrong with me. I told them I was still having reaction to vaccine. They prescribed antibiotics and gave me some pain relief and then released me. When I came home that day my ear thermometer was showing 100.3. They gave me IV saline at ER to hydrate me, but I still couldn't urinate that day. I was only about to do it sometime during the night. The painkillers helped some but my guts my insides were feeling like they were on Friday and Thursday before that. Diarrhea started Friday late afternoon. I was still having a temperature of 100.3 on Friday and Saturday. And then I started feeling better. My stomach is hurt and upset still but that can happen when I'm antibiotic. I felt better today and went back to work. I missed work last Thursday and Friday again. The sharp pain I had felt was gone by Friday. No muscle aches right now but just upset stomach and very, very tired. I try to eat. Bowels are not regular yet, but they are soft and not water anymore, at least. I'm still on the antibiotic which I started on Thursday.  I'm going to see a gynecologist about the cyst.
I got the shot last year now I have the shingles/Suspected vaccination failure; I got the shot last year now I have the shingles; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years 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.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got shot a year from reporting day and at the time of reporting patient had Shingles. Till the age of 58 years old, the patient did not had Shingles. The reporter stated that it said that it was preventable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.