chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-APR-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 30-JUN-2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
Sudden Earring loss in Left Ear and Tinnitus. Woke up with complete Hearing loss in my left ear. Tinnitus also began that day, but the severity of the tinnitus has gotten worse since it started. Many days the tinnitus is louder then what I am able to hear from my right ear.
covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0164), in left arm, on 21May2021 as dose 2, single (Lot number: EW0186), in left arm and on 13Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gerd" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; MONTELUKAST; ADVAIR; NIFEDIPIN. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2023, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2023) Positive, notes: Nasal Swab.; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-202300251628 same patient and different drug dose/events.;US-PFIZER INC-202300252274 same patient and different drug dose/events.;
The patient advocate (daughter) was concerned about her mothers red inflamed mark on the patients left arm.  The mark was approximately 3 inches bellow where the actual injection was (I performed the injection on the deltoid muscle, and the mark the patient was concerned about was on the patients bicep).  I advised icing it for 15 minutes, to use hydrocortisone cream 2 to 3 times per day on the red area which is away from where the vaccine injection was, to use 1 tab of claritin per day for 3 days, and fluticasone nasal spray incase this is related to an allergy or bug bite, will diminish the rash quickly. She stated it was itching pretty badly.
Within 7 hours I was violently shaking with chills.  I was shaking so bad my body was in pain. This lasted about 6 hours. The highest fever I ever recorded was 100.6 but it felt much higher. I had nausea, body aches, headache, and exhaustion for a full 24 hours. Within 48 hours, my chills and aches were mostly gone, but a sore throat, cough, and congestion developed. As of this morning, Friday 19 March, I?m still exhausted, but  all other symptoms have finally resided.
Arm hurts really bad, woke up heart racing and really warm in the middle of the night about 10 hours after shot.
28Jan97 pt recv 1 dose vax. 05Mar98 pt devel 11 vesicles "scattered over her". One of the pts siblings reported WAES98030689
Information has been received from a physician concerning a 16 week old male who received a second dose of Rotateq and developed diarrhea after getting the second dose of the vaccine.  It was reported that the diarrhea continued for several weeks.  It was reported that the patient sought unspecified medical attention and the patient was referred to a G.I. clinic a month after getting the dose (impression, treatment and diagnosis not reported).  A product quality complaint was not reported.  Additional information has been requested.
Anaphylaxis (urticaria, tongue swelling, subjective difficulty breathing) starting approx. 24hrs first moderna dose. No prior episodes of anaphylaxis/allergic rxn. Treated with Benadryl 100mg PO (prior to arrival, pt administered), famotidine 20mg IV, Epinepherine 0.3mg IM. Monitored in ED, complete resolution of symptoms, discharged home.
Pt received vaccination on 12/21/2020. The rash was noted on 12/23/2020. First noted on the thighs which later spread to the whole body. Developed fever on 12/25/2020. was brought to ED with fever and rash on 12/26/2020 In ED fever noted to be 102. PCR was positive for Varicella Zoster Fever resolved on 12/27/2020 Rash resolved in 10 to 12 days. NO hx of exposure to anyone other than parents. No hx of sick contact.
Shoulder/upper arm pain around injection site.  Trouble with mobility, pain worsens if lying on that side.
Patient's girlfriend called and stated that his testicles swelled immediately after receiving the vaccine and have not gotten any better in the last week.  I advised her to have him go to the ER since they do not have a PCP.
a little tired; Tested positive for COVID-19; Both legs started hurting; Her whole body was hurting; Felt pain in middle and lower back; Aches and pains, both arms hurt bad; Arm was a little sore; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, legs started hurting(pain in extremity), middle and lower back pain, whole body was hurting, a little tired(fatigue) COVID-19 infection.  The patient's medical history was not provided. No relevant concomitant medications were reported. The lab data information included test for COVID-19 with result positive. On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event arm was a little sore . On 27 Feb 2021, the patient experienced the event(s) aches and pains in both arms and felt like arms were going to fall off because they hurt so bad. On 1 Mar 2021, the patient experienced the event legs started hurting, middle and lower back pain, whole body was hurting. The patient reported to have tested positive for COVID-19 on 1 Mar 2021. On 5 Mar 2021, the patient reported that she was a little tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm little sore, aches and pains in both arms, legs started hurting, middle and lower back pain, whole body was hurting, a little tired was unknown on 5 Mar 2021.
First period came one week earlier, never had this my whole life and a really heavy period with headache for two days.  Very new for me.
Client had a syncopal episode after a few mins of vaccine administration. Client loss consciousness for a few seconds and quickly came back. He was sweating and was pale.  Water was given water and after a few minutes his color was back and was answering all questions with no problem.  EMS were called on site, client declined to be transferred to hospital. He was stable and walked with a steady gait to catch his ride.
Pfizer / BioNTech/ Treatment of COVID-19; Pfizer / BioNTech/ Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 03Jan2021 as dose 2, single (Lot number: EK3730), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech/ Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: No other medication in 2weeks. No known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out
PT NOTIFIED IMMUNIZER THAT SHE HAS HAD SYNCOPE AFTER RECEIVING VACCINATION ONCE PRIOR. PT WAS WALKED TO CHAIR AFTER VACCINATION TO BE OBSERVED. AT 2 MIN, PT SAID SHE FELT LIGHTHEADED. AT 3 MIN, PT SLUMPED OVER, STIFFENED UP, AND HAD A CLONIC SEIZURE THAT LASTED APPROX 30 SECONDS TOTAL. PT WAS LAID DOWN ON THE GROUND AND SHE WOKE UP AFTER APPROX 10 SECONDS. NO FUGUE STATE. PT REMAINED IN STORE APPROX 1 HOUR. WAS GIVEN SWEETS BY STORE MANAGER, THEN LEFT. RPHS ADVISED AGAINST DRIVING HERSELF; SHE TRIED TO CALL A FRIEND, BUT NO ANSWER, DID NOT WANT TO TAKE AN UBER. SHE WAS ADVISED NOT TO DRIVE HOME, BUT AFTER AN HOUR, DECIDED TO LEAVE ANYWAY. SHE WAS ADVISED TO PULL OVER IF SHE HAD ANY KIND OF OF UNUSUAL FEELING AND STATE POLICE WOULD BE ABLE TO ASSIST.
fever; chills; sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     Concomitant products included NAPROXEN, LORATADINE, FISH OIL, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), MULTIVITAMINS [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm). At the time of the report, PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It is reported as patient was not immunocompromised and patient none of family member had any reaction to the vaccine Patient look like had Pityriasis rosea (not official diagnosis). No treatment information were reported by the reporter.   This case was linked to MOD-2022-596241, MOD-2022-596367, MOD-2022-596143 (Patient Link).
A 74-year-old female patient had received an intramuscular dose of FLUZONE High-Dose No preservative 2012-2013 vaccine (batch number: U4714AA, dose number was not reported) in the left deltoid on 22 August 2013. The patient had no illness at the time of vaccination and no physician diagnosed allergies, birth defects and medical conditions. Concomitant medications were not reported. On 23 August 2013 in the morning, the patient woke up with a bruise about 2 inches in diameter at the injection site, beneath the bruise there was a red and blotchy area which was warm to touch. Corrective treatments were not reported. No laboratory investigations were performed. Corrective treatments were not reported. No laboratory investigations were performed. At the time of this report, the patient had not recovered from events. Documents held by sender: none
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-MAR-2009, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended. On an unspecified date in 2014, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. 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 suffer significant medical expenses, and pain and suffering (emotional distress), and other damages. The outcome of the events was unknown. Causality assessment was related.
Rash on chest, behind ears, on arms macular/papular with one/two pustules present.
fever, chills, headache from 12 hours post-vaccination through 36 hours. Full recovery after with slight lingering headache and cold sore.
were vaccinated to avoid Shingles! both 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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient was vaccinated to avoid Shingles!, but still got Shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187294:same reporter
Per history and physical on 12/28/21: a 41 y.o. male presenting to ED with HA, n/v which awoke him at 0400 this am. Had associated fever/chills at this time. Also reports significant coughing spells and shortness of breath this morning since waking. He is vaccinated for COVID 19 but has not yet received a booster. Hypoxia, 100% on 2L NC.
PATIENT COMPLAINS OF RASH ON LEGS, BREAST, HANDS AND WRIST
Rash developed 8 days after MMR injection to USQ. Rash located on trunk, arms and legs. Follow up on 05/14/04: "Reactive airway disease, bronchitis, increased respiration, cough, gagging."
Localized red raised area 8cm in diameter including 2cm bruise. Returned to doctor's visit 11/15/13. Instructed to apply cold pack and take TYLENOL.
pt recv vax; devel approx 30 chicken pox lesions; sx lasted for 5 days w/out fever,v,d but only mild pruritus;
Extreme arm pain....ongoing for four weeks following the injection.  Treated with steroids and alleviated for one week.  Upon completion of the steroids, the arm pain in the injected arm returned.
sudden onset dysmenorrhea and amenorrhea lasting 7 months, increase in ovarian cyst ruptures pericarditis confirmed by EKG
Within the first hour, I had confusion symptoms. 8 hours later I had a lot of sneezing - 50 + sneezes from 4 pm - 06 pm. A lot of sneezes! I took allergy pills but it didn't do anything. The following day, Sunday, I had a very bad headache on the left side of my head. I had that headache for three days. That headache was over and then by that time I had lost my sense of smell for five to six days. I would get nauseous when I would eat - had a mild cough; no fever and body aches. I had  COVID test taken. They told me to take Tylenol  if I had a fever but I didn't have one; but I took: Dayquil; Nyquil and Theraflu and those things helped. (Telemed Dr. visit - was what I had.)
Injection site 9/23 - 9/28 3 inch pink circle with 1 1/2" hard egg shaped center very painful to touch, hot to touch, achey. 9/29 - 10/3 1 1/2" hard egg shape, still painful & hot. 10/4 - 10/10 still 1 1/2 hard egg shape, gradually smaller each day, not painful or hot. Total 18 days had flu symptoms 9/22 - 9/26.
Dizziness; weakness; Chills; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness), CHILLS (Chills) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM, MIRTAZAPINE, FAMOTIDINE and PANTOPRAZOLE for an unknown indication.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (weakness), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (weakness), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information was received on 13 May 2021 which contains no new information, the reporter hung up phone after reason for call was explained.
After the Pfizer BiVal shot on 9/19/2022 I have experienced right jaw pain. I went to the dentist to make sure I didn?t have a cavity and also to my doctor on her recommendation.
SLIGHT REDNESS ONE DAY AFTER ADMINISTRATION OF DTAP AND IPV. THIS HAS SINCE PROGRESS 2 DAYS LATER.
Next day : 100 degree fever, Headache, body ache, tired. Day 2 : Diarrhea, tired Day 3 : ok
Soreness above the injection site; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer Sponsored Program. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that Initially wanted to ask if her fiance can take a vaccine since he is allergic to mangoes, then mentioned she had her vaccine and having soreness above the injection site. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information was expected.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 17-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020  for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009217: US-009507513-2001USA009218: US-009507513-2001USA009219: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009189: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254:
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-JUN-2015, the patient was vaccinated with a dose of RECOMBIVAX HIB, 2.5 microgram/0.5 ml (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which was improperly storage. No adverse events were reported. Additional information has been requested.