chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got inoculation and got shingles/ suspected vaccination failure; Shingles; Horrible and painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got inoculation and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Horrible and painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. The reporter stated that, it was horrible and painful, she knew several people including her poor late husband who had got the inoculation and had shingles again in spite of the inoculation another equivocated result. This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available. This case was linked with US2023AMR039354 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR039354:Same reporter
Information has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JUN-2017, the patient was vaccinated with an expired dose of VAQTA with lot number M003025 with expiration date of 26-MAY-2017 (strength, dose, anatomical location and route of administration were unknown) for prophylaxis. No adverse effects were reported.
Fever of 103, body aches, pain, swelling and redness at injection site.  Swollen, painful lymph nodes under the left (injection site) arm.  Also many bruises all over legs and thighs.  All symptoms lasted 4 days.
Patient states he has sore left shoulder, needs assistance to dress.  Vaccine administered to RIGHT arm.
PATIENT RECIEVED BOTH DOSES OF PFIZER VACCINE ACCORDING TO DATABASE  ON 1/22/21 AND SECOND DOSE ON 2/12/21 AND IS CURRENTLY HOSPITALIZED WITH US IN THE ICU. HE HAS BEEN VENTILATED AND UNDERGOING SLED FOR DIALYSIS. HAS BEEN ON PRESSURE SUPPORT MEDICATIONS (LEVOPHED), BUT CURRENTLY OFF
Febrile seizure - ER visit treated with MOTRIN and TYLENOL.
p/vax pt devel an upper resp infect for which was treated w/augmentin;pt sought unspecified med attention;CBC revealed a low platelet count 55,000;WBC 10,800 9sl abn % but absolute numbers nl);
This spontaneous report was received from a female registered nurse of unknown age, referring herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-SEP-2017, the patient was inadvertently vaccinated with ZOSTAVAX, one dose, lot # M024700 and expiration date on 18-JUL-2017 (route of administration was not provided) for prophylaxis; which was reconstituted with sterile diluent (MRK). It was additionally reported that, there was no adverse effects and no any product quality complaint was present.
PT EXP GEN RASH AFTER 1ST INJECTION OF ENGERIX-B LASTING FOUR DAYS. NO TREATMENT.  PLAN TO CONTINUE INJECTIONS.
Flu like symptoms,  extreme muscle and joint pain, rash beginning at injection site, swollen lymph node in neck and armpit on left side, nausea, pain at injection site, chills, fatigue
Pt founds unresponsive and transferred to the hospital. Pt was intubated after being given Narcan with no response. Pt was GCS 3 at the scene. Medical History of alcoholism, frequent falls and CAD, Hep C, etc. Pt Neurosurgery was consulted due to SAH and admitted to the trauma service. DX: Acute alcohol intoxication; Coma; TBI with loss of consciousness; Traumatic subarachnoid hemorrhage. COVID + on admission.  Pt expired on 8/8/2021.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about June 2014 at her primary care physician's office for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. In approximately June 2014 [reported as shortly after receiving the ZOSTAVAX], the patient developed severe and painful itching on her back. Thereafter, the patient presented to her primary care physician and was diagnosed with shingles on her back and left forearm. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Fever. Chills. Tiredness. vomit  shaken These systems happed in every ~2 hours starting at ~16th hour until the 24th hour after the short..
Sore throat, nasal congestions, followed by fever, body aches, chills, and headache.
I had a sore throat, sniffles, a cough and a fever of 100. I tested myself for COVID-19 and it was positive. I called my doctor and they prescribed PAXLOVID for 5 days. I have finished the medication. All of my symptoms resolved prior to beginning the medication. I feel I have completely recovered from all my symptoms.
pt devel a fever of 104 p/vax;fever persisted for several days;pt recovered;
The pharmacy received a urgent product removal on 10/12/22 and the patient received the vaccine on 10/03/22. The removal was due to drug expiring on 9/30.  Patient received the expired vaccine.
The pt developed a fever of 101 the following morning. The pt experienced erythema of the thigh, with swelling or induration. Residual transient red spots ensued. Infant not taking milk as much or as usual.
Pt recieved 10ug dose dose rather than recommended 25ug. Parent advised dose needs to be repeated.
did not feel that great after Covid vaccines; SHINGLES; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (SHINGLES) and IMMUNISATION REACTION (did not feel that great after Covid vaccines) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In May 2022, the patient experienced HERPES ZOSTER (SHINGLES). On an unknown date, the patient experienced IMMUNISATION REACTION (did not feel that great after Covid vaccines). At the time of the report, HERPES ZOSTER (SHINGLES) outcome was unknown and IMMUNISATION REACTION (did not feel that great after Covid vaccines) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  The reporter's causality for the event of Shingles and did not feel that great after Covid vaccines with Humira was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment medication was provided by the reporter.
Patient administered 1st dose. C/o pain and tingling 2-3 days post vaccine. Returned to clinic 4.5 weeks post administration . Stated that  arm is still painful. Advised to use Ibuprophen, order for x-ray and Shoulder/Arm provided to rule out injury. Awaiting results. Nexts steps to evaluate results and refer to Neuro for consultation.
Received vaccines 6/16/06. Rash area noted by family member on left arm at injection site 3"x2.5"x1/4" raised. No itching. Lasted 2 days - better today (6/20). Treated with Tylenol, Benadryl, cold cloth.
chills, sweats, fever, headache.  Lasted approximately 36 hr. starting the evening I received the second vaccine.
Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It was localized and did not radiate. It was not made worse by standing, sitting, laying, moving, eating, drinking. I was not short of breathe nor did breathing hurt. The pain was mild - a 2 to maybe a 3. Enough to know it was there but it did not limit me in any way. It has continued through the present.   Saturday (3-13-2021) I started to notice a very rapid heart rate, from just walking across my house. I went down the basement stairs and walked up and I felt my heart was racing and pounding (this is something I do multiple times a day with ease). I have an oxometer and my heart was very high. I tried resting (by sitting) and my heart rate didn?t drop below the high 80s. I walked through a room and up a flight of stairs and down (in my home) and my heart rate peaked at 154 (wearing oxometer). My BP was also high for me 148/94. I called my primary care physicians office, spoke with a nurse that recommended I go to the emergency room.   Tests were normal and I  was released. The burning sensation remains. Since returning home heart rate gets high very easily and I can feel it pounding when I walk, though fortunately it hasn?t gone over the mid 130s. My blood pressure when checked at home was still high for me but quite a bit lower than when I first checked it at home. To be honest, I?m far from a pro at taking my BP so I?m not sure of the accuracy of either measurement.
Patient stated that she has fever and icky the day after receiving the vaccine.  Then the fever went away later of the day.  A week later, rash and itchy occur on the body and arms, and later went down to the legs.  Patient went to doctor, was given Benadryl.  After taking Benadryl the itchy is better but the rash still persist.  After 4 days the rash still not improve, patient contact the pharmacy.  Patient was prescribed Prednisone the date she notify pharmacy.
Hives over trunk and extremities, head not involved.  I took 2 Benadryl and a cool shower.  Hives started subsiding in about 25 minutes.  Still visable but no longer raised at about 10:30 AM.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2013, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 09-MAY-2016, the patient was treated by a physician for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed gabapentin for the management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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.
shaking; chills; fever between 100-102F; bone aches; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration in left arm on 11Mar2021 17:45 (at the age of 59-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing HIV undetectable for 23 years, Hepatitis C and ongoing immunodeficiency (immune system is not in tip top shape). Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV and ongoing. No additional vaccines administered on same date of the BNT162B2. Prior to vaccination, the patient did not receive any vaccines within four weeks. His mother's side has, heart attack and high coronary disease, stroke blood pressure. The patient experienced fatigue and body aches on an unspecified date in Mar2021, fever between 100-102F and bone aches on 16Mar2021, shaking and chills on 19Mar2021 09:00. In the afternoon of vaccination, he started spiking fevers and bone aches. On 17Mar2021, he reported a fever of 101, reported that he tried to keep it under 100 so he was not shaking so much. One day before this report, nothing until last night early in evening on 18Mar2021, temperature was 100.6 F, Patient stated he took Tylenol 500 mg (Lot: P121400; Expiry date: Aug2023) and brought it back down, went to bed and woke up this morning shaking so hard couldn't hold the phone or put a thermometer in his mouth. When he finally got the thermometer in his mouth, his temperature was 103.4 on 19Mar2021. Stated that he is in bed with 4 quilts on him. His doctor is the infection disease specialist and he said that there should be no problem with any of the medications he's on, and he should go ahead and get any of the vaccines. Took 2 Tylenol (1000 mg) at 10:30 a.m. and not shivering as much and feels like fever is actually a fever and not that he is freezing shaking cold. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Fever of 101.2 degrees; piercing headache; muscle ache; sneezes; mild sore throat
Dark redness (roast beef color) and hard swelling at injection site, the evening of the vaccine, and achiness in gland under arm pit and right groin. Woke up the next morning on 05/31/2013 with flu like symptoms, extreme fatigue, achy, pain in gland under left arm pit, and hard quarter sized bump at injection site, diarrhea, then followed by cupped palm sized swelling of the outer upper left arm at the roughly 25 to 26 hour mark, and mild and intermittent chills, followed by intense chills for hours, and low grade fever and body ache. Took Motrin and Benadryl from the late afternoon, which took some of the fatigue and achiness away, but the intense chills lasted till I fell asleep at about 1:00 AM. At 7:00 AM woke with some chills, and the same amount of cup sized swelling around the quarter sized red vaccine site. Diarrhea only lasted for several hours.
I got my second covid booster shot on May 31, 2022 around 12:00pm. I had a mammogram done on June 10 at 12:15pm. The mammogram gave me excruciating pain. I was shaking and crying while it was being conducted. I went home and the pain persisted to the point that I had to take oxycodone. I felt like I had been very badly beaten or in a bad accident. I have broken bones in the past and been in accidents, and the level of pain was equal to those. Even the oxycodone didn't completely get rid of the pain. Once that wore off, I was back in pain, though it is slowly feeling better. I had not had any breast tenderness after my second booster shot. The only reaction I had to the shot was a sore arm for a few days. But they need to redo the mammogram on the left side, which is where I had my shot. I think the more women who have a mammogram soon after a covid shot will show that terrible breast pain is a possible side effect. If I can help one woman from having this horrible pain, then it is worth my time in reporting it.
Pt noticed 3 days later that there was a giant swollen welt spanning the entire upper arm area almost down to the elbow. It was blue and purple in color and lasted more than 10 days. It was very painful and pain was constant the entire >10 day period. She did not take any pain medication for it. Did not start getting better until after at least 10 days, and even then it took a long time to go away. She mentioned a similar thing happens with her pneumonia vaccine, only that was a much bigger much more painful welt. However flu vaccine does not do that so it is not exclusively an injection site reaction. So it is unique just to pneumonia shot and covid shot. Pt stayed 30 minutes after 2nd dose. Arms looked fine when she left.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Losartan, reaction(s): "Known allergies: Losartan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 04Jan2023 to 08Jan2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Beginning Saturday morning, I began to experience hives, coming and going throughout the day. There were 2 significant episodes on Saturday, one Sunday morning, two throughout the day on Monday. Beginning Tuesday morning, I experienced hives that continued throughout the day. Starting around 1:00 pm, they moved from a more localized area on my upper trunk to covering my entire body, head to toe. I became hypotensive (lowest was 90/60), tachycardic (pulse rate ranging from 100-125), low grade temperature (100.4), noticed a tingling feeling in my lips, a new onset sore throat, and ringing in my ears. My pulse ox remained stable, no oxygen required. I took a claritin chewable approximately 10 minutes after onset of worsening symptoms, then 50 mg of benadryl 3 hours later.  I have continued to take 25 mg of benadryl BID since Tuesday and have remained without any new onset of hives. No medical admissions were required, although I do work in a medical clinic and close observation was available for me.  Only symptom remaining is fatigue, unsure if this is related to benadryl usage or remaining vaccine reaction.
Immediate injection site pain - vasovagal reaction. Reported difficulty word finding "passed out". Now having daily headache and tinnitus.
The Pfizer vaccine was kept in the refrigerator past the date of removal/expiration. The patient was notified about the expired dose given, had no signs of an actual adverse reaction to the vaccine, and did not want to receive an additional booster at this time. He will call in 1 month for an additional booster.
Expired COVID-19 vaccine given to patient. COVID vaccine lot FL2757 expired 09/30/2022 (also thawed on 09/30/2022) and was given  on 10/4/2022.  no adverse events reported.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix and has since contracted shingles.  The patient was inquiring on how to proceed with the 2nd dose.
I Tested positive again; I Tested positive again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3249), on 14Feb2021 as dose 2, single (Lot number: EL9269), on 16Aug2021 as dose 3 (booster), single (Lot number: FC3181) and on 19Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing); "Anemia caused by low iron" (unspecified if ongoing), notes: Anemia caused by low iron; "Asthma" (unspecified if ongoing); "Anemia caused by low iron" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; ALLEGRA; SUNOSI; EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL] taken for tension; ALBUTEROL [SALBUTAMOL]; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]. Past drug history included: Zanaflex, reaction(s): "known allergies: Zanaflex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I Tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (21Jun2022) Negative, notes: I tested negative on 21Jun2022 and 23Jun2022 and my symptoms were gone except for the fatigue; (23Jun2022) Negative, notes: I tested negative on 21Jun2022 and 23Jun2022 and my symptoms were gone except for the fatigue; (25Jun2022) Positive, notes: On 25Jun2022 my sore throat and congestion returned, so I used an at home antigen test and I Tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
irritability on 8APR, 9APR, 10APR;? fever on 11APR;inc irritability & fever 12APR;3min gen sz on 12APR;tx in ER lt otitis med & viral urine confirmed;WBC 6,100, Hgb 11.7, platelets 209,00 diff 63.9%, lymph 36.1% polys;febrile sz;
pt devel varicella-like illness 2wk p/vax;h/a, nauseated papulovesicular rash 25 lesion;
Emergency hospitalization for chest pains in October 2021, 3 months after second dose.  Blood clot in right groin area.
Patient was given vaccination at pharmacy. Patient's right arm was red and swollen and warm to touch.