chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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. On or about 31-DEC-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, 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 or shingles. On an unknown date in 2016, the patient was treated by the physician for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is 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.
Patient received HPV9 Vaccine at 0950 in clinic. Father waited with patient for 20 minutes in waiting room following administration with no reaction. Patient ate and Apple juice and started feeling loopy so father returned with patient. Patient presented to the clinic feeling lethargic, stumbling, pale, slow speech. Vital signs stable. Focused assessment completed, patient reports pain in Left arm at site of injection radiating to left neck. Patient reports pain in Abdomen, chest, and in legs.  Patient on Nasal cannula, complained of difficulty breathing. Patient on NRB. Patient shaking and limbs rigid. Patient given Adult EPIPEN at 1125 and TYLENOL 480mg/15ml. Patient transferred to ER for continued care at 1155.
pt recv vax 9NOV98 & pt exp coughing & sneezing, eye swelling & upper resp congestion;pt treated w/DPH & Epi in ER;
about 30 minutes after vaccination, noted slight facial droop and right eye was not blinking. was seen and treated at UC. diagnosed with Bell's Palsy.
Narrative: 3 days after 2nd COVID Pfizer vaccine Patient experience hive-like rash on face, took 2 dose of 25 mg diphenhydramine with resolution.
redness at the injection site (size of a cookie)/Pancake-size less red are; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site (size of a cookie)/Pancake-size less red are) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cipro). Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM HCL and FUROSEMIDE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site (size of a cookie)/Pancake-size less red are). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site (size of a cookie)/Pancake-size less red are) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added patient demographics, concomitant drugs, updated the outcome of the event redness at the injection site from unknown to recovered
Two days after receiving vaccine - experienced (L) arm tenderness. By Nov 27, pain increased - very painful to move arm, stiff and now shoulder and neck are both sore.
Body aches Chills at times Sweating at times Nausea Swollen glands in armpits  Arm really hurts
3 months after getting the 4th vaccine (2nd booster) I experienced hay fever-like symptoms: severe sneezing and a scratchy throat. This might have been triggered by an allergic reaction to the cats at the home where I had spent the night.
? maculopapular rash with intermittent fever up to 102 degrees x 3 days following Prevnar #1.
Sore arm.  No other adverse  effects.  Reporting because patient received Moderna vaccine at age 13. Followed up with patient and mother.  She received second dose as pfizer.   Has no adverse events to either vaccine.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 16-JUL-2018, the patient was vaccinated with properly stored but expired dose of Oka-Merck PROQUAD lot # N001489, expiration date 12-JUL-2018 (strength, site of administration and route of administration were not reported) for prophylaxis. No adverse events were reported.
After the vaccine, a week and a half after in the morning I experienced shortness of breath and I could feel my heartbeat when I laid down at night and I could feel it in my head. I bought a blood pressure cuff and it's been 150-160. They put me on two medications and I've had horrible migraines every single day. I've been on a heart monitor twice and I'm going for my third today 10/08/2021. I've never had high blood pressure before.
Patient received Menactra booster, HPV 9, Bexsero (MEN B) vaccines.  After HPV vaccine administered, patient became stiff and eyes became dilated; lasted approx.4-5 seconds.  Post episode patient stated he was "fine" and was hungry.  No other side effects were noted.  RN recommended that patient call family PCP in regards to same.
This spontaneous report as received from a physician refers to one female patient seen in hospital obgyn (obstetrician/gynecologist) clinic who was of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patient developed swelling and phlebitis. The physician reported that the patient had a reaction severe enough to seek attention in emergency room. The outcome of phlebitis and swelling was unknown. Additional information was received from a pharmacist who called back and reported that the patient was administered PNEUMOVAX 23 (in the thigh after being given an epidural and after delivery of the baby. He noted that patient have complained of severe pain in his/her legs and had not been able to walk after being given PNEUMOVAX 23 (and also have needed to come back to the emergency room for unspecified treatment). He provided PNEUMOVAX 23 lot # H020684 with expiration date 17-APR-2013 and lot # H018441 with unspecified expiration date. "Lot check requested" by the pharmacist. At the time of report, the outcome of patient was unknown. This is one of the several reports from the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Severe hive like rash from arm pit to wrists on both sides (top and bottom) on both arms
I have been in menopause for over 2 years,and on Sept. 21 began bleeding. Heavy at first with cramps,and now Sept. 28 I still have cramps and spotting.
severe chills & systemic symptoms that lasted 48 hours w/ the 2nd dose of this vaccine. tolerated 1st dose with mild arm soreness only.
Fever 106(r); Irritable & not moving leg where shot given; #4 DTP, no problems with other 3 doses;
AFIB; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2022 09:30 (Lot number: FM0698) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP controlled" (unspecified if ongoing); "AFIB", start date: 2009 (unspecified if ongoing), notes: 2017. Concomitant medication(s) included: TOPROL XL; POTASSIUM; TEKTURNA. Past drug history included: Septa, reaction(s): "known allergies: Septa"; Eliquis, reaction(s): "known allergies: Eloquis"; Xarelto, reaction(s): "known allergies: Xaralto". The following information was reported: ATRIAL FIBRILLATION (hospitalization), outcome "recovering", described as "AFIB". The event "afib" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of atrial fibrillation: IV Cardizem, magnesium, digoxin, potassium.  No follow-up attempts are possible. No further information is expected.
24AUG98 1140AM pt reported arm was really sore & red as well as feeling warm to touch;stated that arm was really swollen & couldn't hardly move it;
Vaccine administered in retail environment so above manufacturer information is not accurate.  Hours after receiving  RSV and flu vaccine together she experienced an acute confusional episode.  Went to ER and had negative workup after which her mentation cleared.
Rash started 2 weeks after vaccine on legs and worked it's way up to her chest. She still has it currently. Doctor is contacted and approves the 2nd dose of the injection.
This spontaneous report as received from a nurse (Licensed Vocational Nurse) refers to a patient of unknown age and gender reported as child. On an unknown date the patient was inadvertently, instead of VARIVAX (Merck) vaccinated with PROQUAD (Merck), injection (dose, route and lot number not provided). This resulted receiving a 3rd dose of MMR II. No adverse effect was reported. The outcome of events was not reported. This is one of 2 reports from the same source. Additional information has been requested.
Achy; Chills; Arm for sore with 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), CHILLS (Chills) and VACCINATION SITE PAIN (Arm for sore with 2nd dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 029a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Achy), CHILLS (Chills) and VACCINATION SITE PAIN (Arm for sore with 2nd dose). On 05-Mar-2021, PAIN (Achy) and CHILLS (Chills) had resolved. On 07-Mar-2021, VACCINATION SITE PAIN (Arm for sore with 2nd dose) had resolved.            No concomitant medication provided. No treatment information provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-079157 (E2B Linked Report). This case was linked to MOD-2021-079157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: F/U-1 : To confirm no clinical information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079157:Wife Report
A little tired for a day; This is a spontaneous report from a contactable consumer (patient himself).   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization.  The patient'' medical history and concomitant medications were not reported.  The patient experienced a little tired for a day on an unspecified date. We are interested in our daughter, age 10, to participate in the vaccine trials done at (with held). She had expressed a strong willingness, and desire, to be vaccinated. She was typical, in excellent health, no exclusions listed in the study. the reporter had a couple questions of clarity about the study. Is the blood draw a typical arm draw or is it something simpler or more complex? Also, in this trial, and generally, participants who get the placebo are offered the effective shot at the end of the trial. the consumer stated that there was a 6 month blood draw, and also the study runs through 2022 and 2023. But there was some anecdotal reports that this shot would be offered for emergency use sometime in September. Part of our desire was to offer a chance for his daughter to get vaccinated as soon as possible. Ithe consumer stated that there was a possibility that she receives a placebo, and Im okay with that. Would there be any issue with her getting an effective shot in September from our doctor if she was currently in the study? Essentially, she could possibly get her shots this summer, or whenever the test was being run, and be potentially vaccinated in August or early September. But if she gets the placebo, could she get the regular shot or would she have to wait until the end of the test trial?. the consumer stated that his wife and he both got the shot. She had no ill effects, and he felt a little tired for a day. But its so worth it to feel better protected. Knowing that his daughter would soon be protected brings a great amount of closure to our concerns and worries over the past year. Even if we dont get to participate in the trial, he wanted  to say thanks. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
This case was reported by a consumer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with DTPa (with small D + P), manufacturer unspecified.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject's medical history included acid reflux and slow thyroid.  Concurrent medications included Omeprazole and Thyroxine sodium (Thyroxine).  On 11 July of an unspecified year, at 11:30 a.m., the subject received 1st dose of DTPa (with small D + P) (unknown).  The subject indicated that she was given a "TDAP vaccine" but was unsure whether or not it was a GSK vaccine.  On 13 July of an unspecified year, 2 days after vaccination with DTPa (with small D +P), the subject "woke up with" joint pain that included her right shoulder, right arm including her wrist, her left wrist, and both legs.  She was treated for pain at the emergency room as well as at the clinic where she received the vaccine.  The subject reported that a healthcare professional said the events were arthritis.  At the time of initial reporting the events were worse.
passed out; diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant) and diarrhea. On an unknown date, the outcome of the passed out and diarrhea were unknown.   It was unknown if the reporter considered the passed out and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's comment: This case was reported by a patient's wife via interactive digital media. The reporter's husband had a bad reaction to the vaccine.  The reporter wanted to know what were the components of Shingrix. The reporter was trying to determine if he was allergic to something.  The patient had diarrhea and passed out. The reporter ran across one reference for a few allergens in the shot. and wanted to know what was those allergens were so he could avoid them.  The reporter was trying to find out what was in there so he/she could research/make a decision.
Rash (small, fluid-filled, raised bumps) on chest, back, neck beginning day 3 of vaccination.  Fever of 99.8 degrees F.
This spontaneous non-valid report as received from an unknown source via Twitter refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced death (reported as "GARDASIL is killing"). The reporter considered death to be related to GARDASIL. Additional information is not expected as there were no contact details provided.
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age whom on an unknown date, were vaccinated with a dose of RECOMBIVAX HB (dose, route of administration and lot # not reported). The registered nurse reported that the patients may had been vaccinated with RECOMBIVAX HB  stored at lower than recommended temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
2:21 PM :Patient states she her chest feels itchy and says it feels hard to breathe.  Monitored patient's oxygen saturation and heart rate.  2:25 PM: Continue to monitor HR 2:29 PM Patient states her breath feels shallow and has to try to breathe really hard to take a deep breath. She also stated it might be related to her anxiety.  2:34 PM Patient was calm and able to communicate, denies shortness of breath. Patient was sent home. Nurse recommended for her to follow up with her PCP for any further concerns and to seek medical attention if she has a hard time breathing.
Within 2 hours of receiving the Varicella injection, my daughter had a bad case of the chicken pox. The chicken pox were over her entire body including her scalp and throat. She was in bed for 10 days and also had a fever.
Information has been received from a pharmacist concerning a female pt with asthma and sensitive skin, who was vaccinated IM with hep b vaccine. Immediately following vaccination, the pt experienced injection site redness and injection site warmth. It was also noted that red streaks appeared after vaccination, but disappeared quickly. No further information is available.
FALL, WEAKNESS, FEVERS, NAUSEA, VOMINGING SECODARY TO COUGHING, DECREASED APPETITE, WEIGHT LOSS, DYSURIA, DECREASED URINE, AND DIARRHEA
Injection site reaction. Golf ball sized edema, redness, warmth, tenderness, and itchy
PATIENT CALLED THE PHARMACY ON 03.05.19 STATING THAT HER RIGHT ARM IS SWOLLEN AND PAINFUL DUE TO GETTING PREVNAR 13 VACCINATION ON 02.28.19. PATIENT ALSO STATED THAT SHE FORGOT TO LET US KNOW THAT SHE HAD RECEIVED A PNEUMOCOCCAL VACCINATION 2 YEARS AGO, AND HAD A BAD REACTION TO IT. SHE IS NOT SURE OF WHICH PNEUMOCOCCAL VACCINATION SHE HAD RECEIVED. SHE HAS BEEN INSTRUCTED TO TAKE OTC PAIN MEDICATION FOR THE PAIN AND SWELLING.
Injection site pain, achy, massive headache, stomach pain, nauseous, chills, fever, hot, face swelling, eyelid swelling. Flu symptoms. Four days. 2 Alleve every eight hours did not help.
This spontaneous report was received from a 75 years old female consumer with fungus on chest (from living on a farm), high blood pressure, nerve pain, cholesterol and no drug reactions/allergies who refers to herself. The patient was vaccinated subcutaneously in left side with a dose of ZOSTAVAX (dose and lot# was not reported) on 20-NOV-2012. Concomitant medications: sulfamethoxazole (reported as "she takes a 7 day sulfur medication-for a chest fungus - 1 tablet twice a day 7 days-1st week of each month"). On 27-NOV-2012 the patient experienced bad reaction to the vaccine (reported also as reaction to the vaccine). The consumer stated that she had redness and soreness on both her breasts, which she described as purple red. The redness had spread to the face on the left side. The patient did not seek medical attention (on the other hand it was reported that both a family friend who was an OB GYN, and the local ER, through that she was having bad reaction to the vaccine, but it was not shingles). She was given antibiotics and pain pills for the adverse event treatment. No lab diagnostic tests were performed. Additional information has been requested.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    Concomitant product use was not provided by the reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12-Feb-2022. Of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions.  Treatment information was not provided.  This case contains information for the 14th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222: