chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a persistent and severe vesicular rash, 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.
I tested positive six days after completing the treatment; I tested positive six days after completing the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "I tested positive six days after completing the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive six days after completing the treatment; Negative, notes: I had tested negative the day completed treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks was amlodipine and losartan. Paxlovid rebound-patient tested positive six days after completing the treatment. Patient had started feeling sick within 4 days, and tested positive on day 6 after treatment. Patient had tested negative the day completed treatment. Patient received Paxlovid (anti-viral) treatment from 13May2022 to 17May2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician referring to a 16 years old female patient. Pertinent medica history and drug reactions/allergies were not reported. On 15-JUN-2015 the patient was vaccinated with a dose of GARDASIL 9, (dose and expiration date were not reported, lot # was reported as K010574) intramuscularly to prevent HPV. Concomitant drug was not reported. On 16-JUN-2015, 1 day after administration of GARDASIL 9, the patient started experienced hairloss. The patient sought medical attention by calling the physician's office. At the time of reporting, the patient did not recover. The causality was unknown. Additional information has been requested.
Immediately upon administration on 1/5/2020, a lump formed at the site and patient felt she was bruised.  She suffered from insomnia that night due to the pain in her arm, and developed nausea on 1/6/2020.  On the night of 1/7/2020, her lip felt tight and developed into swelling on 1/8/2020.  Patient called the pharmacy on 1/8/2020 to report this new development.  She was counseled on signs and symptoms of allergic reaction and OTC treatment options.  She had diphenhydramine tablets on hand but was concerned about drowsiness AE as she was at work when she called.  She was told she can call her doctor or the pharmacy if she has any follow-up questions or concerns.  As of the conversation on 1/8/2020, she was declining calling the doctor or taking a Benadryl tablet at that moment for fear of side effects but knowing the dosing to take once she was ready to take it.
Pt received vaccine BUD. Vaccine expired on 7/7/22. Vaccine given on 7/9/22
They both had COVID after the 15th, after the first shot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This consumer (wife) reported similar events for herself and her husband. This is 1st of 2 reports.   A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization .  Medical history included blood pressure measurement. Concomitant medications were not reported. The wife reported that on 25Jan2021, she and her husband both had COVID after the 15th, after the first shot. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 25Jan2021. She reported that they were done with quarantine that day, 03Feb2021. Therapeutic measure was taken as a result of the event that included Zepac. And then, her husband took an additional like a steroid. She did not know what he took. But they both took Zepac and their doctor prescribed Zepac, and then her husband took a steroid too. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021133498 Same reporter/product,events, different patients
The patient jerked his arm as needle was inserted into the left deltoid. As plunger was depressed the needle came out resulting in spray and waste of vaccine dose. There was no injury to patient.
Itching; Burning sensation over entire body; Widely dispersed red spots on skin too; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:00 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "Renauds" (unspecified if ongoing), notes: Renauds; "fibromyalgia" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penacillin. Concomitant medication(s) included: ZOFRAN [ONDANSETRON]; FIORINAL CODEINA; ROBAXIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 31Mar2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 21Apr2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Itching"; BURNING SENSATION (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Burning sensation over entire body"; RASH MACULAR (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Widely dispersed red spots on skin too". Therapeutic measures were taken as a result of pruritus, burning sensation, rash macular.  Additional information: Patient did not received any other vaccine within 4weeks prior to the COVID vaccine and prior to vaccination patient not diagnosed with COVID 19 and since the vaccination patient has not been tested for COVID 19 and treatment received for the adverse event is hydroxyzine HCL 25mg.  The lot number for bnt162b2 was not provided and will be requested during follow up.
No additional AE; received the pediatric 0.5 ml dose of the vaccine instead of the adult 1.0 ml dose.; Product preparation error; This spontaneous report was received from a nurse and refers to a 74-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-APR-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 0.5 milliliters (ml) (pediatric dose) (lot #, expiry date, and route of administration were not provided) as prophylaxis (also reported as hepatitis a vaccine, inactivated (VAQTA), 0.5 ml, lot #W028555, expiration date: 10-JUL-2024, administered intramuscularly in the right deltoid for prophylaxis; conflicting information). It was reported that the error occurred during the preparation and the administration of the product (underdose, product preparation error).   No additional adverse event was reported (no adverse event).   This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2305USA000825:
Gave pt HIB vaccine with the wrong diluent not the one it comes with, and also gave pt a KINRIX DTaP/IPV so I gave pt double DTaP, what would be the outcome how can I take care of this, and can we revaccinate these vaccines.
got vaccinated and got shingles/ Suspected Vaccination Failure; got shingles; 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.   The patient's past medical history included shingles.   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 vaccinated and got shingles/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Mar-2023 This case was reported by a patient via interactive digital media. The patient did not understand, he/she got vaccinated and got shingles again. The patient asked to their doctor and doctor said yes, it could still give even after vaccination, it just would be softer. The patient did not understand, as he/she thought it was not going to give him/her more. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
fatigue; body aches; chills; fever; R arm is sore; This is a spontaneous report received from a contactable consumer (patient) reporting for herself. A female patient of an unknown age received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date as dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none. Concomitant medication was not reported. The patient stated that received second dose of COVID vaccine yesterday, today (on an unknown date) feeling excessive fatigue, body aches, chills and fever and R arm was sore. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Headache, chills, extreme site soreness, site swelling, tiredness, fever, nausea, stomach upset.
About 12 hours later I experienced extreme chills and a fever throughout the night. Full body ache and sore arm from injection. Later my lymph nodes swelled around my neck and collarbone area nearest my left arm. Extreme soreness.
sore throat started a few hours after injection. worsening sore throat with blistering in posterior pharynx on night 5 after vaccine. Resolved by day 6.
Information has been received from a medical assistant concerning an 18 month old male with no drug allergies who on 08-DEC-2007 was vaccinated IM with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U). Suspect vaccination administered during the same visit included a dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). On 17-DEC-2007, the patient developed a rash on his back described as a "clear, blister-looking, slightly red and raised area." The child also had "cold-like symptoms" including a fever, runny nose and congestion. The patient sought unspecified medical attention. The patient was not recovered at the time of this report. It was also noted that the patient's mother was pregnant and the office was concerned about risk of transmission but no symptoms with the mother were noted. There was no product quality complaint. Follow-up information has been received from the reporting medical assistant concerning a 15 month old (also reported male) who on 08-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U) in the left thigh. There was no illness at the time of vaccination. Suspect vaccination administered on that day at 10:00 included the first IM dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MDS) (lot # 653626/0426F) in the right thigh. Concomitant vaccinations administered on that same day at 10:00 included the fourth IM dose of Prevnar (lot # B54013H) in the right thigh and the first IM dose of Fluzone (U2502AA) in the right thigh. On 17-DEC-2007 at 07:00 the patient experienced a low grade fever and a chicken pox-like rash. At that same time the patient was pulling at his ear and spit up bloody phlegm. The patient sought medical attention at the clinic. The outcome was unknown. It was noted that the patient's mother was less than 3 months pregnant and did not know how serious the event would be for her. Additional information has been requested.
Patient is a 70 y.o. female patient of a HCF, CNP with history of DMII, ESRD, HTN  presented to a local Hospital with weakness .   Weakness Covid virus infection  Acute Hypoxic respiratory failure P/w weakness after dialysis Likely from Covid and Hypoglycemia  WBC 4.9, Hgb 13, Plt 160, NA 133, K 3.7, Creatinine 3.72 Date of onset of symptoms: unknown  Symptoms present on admission: weakness, hypoxia  Date of covid positive test: 11/28/22  Vaccination status: unknown  Imaging: CXR NAD  Oxygen requirements on admission: 1L Medical therapy: steroids, due ESRD not a candidate for remdesevir  Consultants following: none  Anticipated special isolation end date: 12/8/22  Wean oxygen as able PT/OT CRP 65  11/29/22 Currently on RA - O2 sat 94%. Rx for decadron x 10 days     Hypoglycemia Glucose 52 Started on D5 0.9% NS x 1 liter  Glucose every 2 hours x 4 then every 4 hours  11/29/22 FBS 182   HTN SBP 130s    Hyponatremia Sodium 134 No change in treatment in this ESRD patient     ESRD Per ER provider she is M-W-F dialysis Last dialysis 11/28/22   Discussed with patient that she needs to call her dialysis center and let them know she is COVID +
Urticarial lesion (macules) on chest, abdomen, back, cheeks, arms and legs
They gave patient a hepatitis B, Tetanus Diphtheria and Pertussis, and another unknown vaccination possible influenza. According to his Doctor. Doctors and nurses both are saying that patient condition is cause be the vaccination.
In late June I started getting Neck pain and migraine and I saw my PCP. I was having this for 4-5 days at a time and I had to go on family medical leave for them. I saw a Neurologist in late May. I had already been referred to for a pinched nerve in my neck. I had an MRI of my neck in June that came back normal. When I went to Neurologist, they ordered an MRI on my brain and found a Pineal Gland Cyst. I am getting a second opinion on April 12, 2022 with a new Neurologist with Neurologist. On 09/24/2021 I went into the ER Medical Center the blood clot was found when a CT scan was done of my chest. The ER provider prescribed Eliquis to take until March 24, 2022. 09/27/2021 I went back to ER because I felt like I was having a heart attack and check pain. They did another CT Scan to make sure it haven't traveled up to my heart and they said it was breaking up. I had a follow-up 09/28/2021 with my Neurologist stated that the cyst was not causing my symptoms and he checked my medications to see if they would cause any blood clots and they did not. On October 5th, I had a follow up with my PCP Dr. - for the Blood clot he referred me to a hematologist that I saw on October 22, 2021 did labs to see if there was a reason for the clotting and they came back normal. At The Cancer Center at Medical Center and he also referred me to Neurology and Gastroenterology (January 17th) my next follow-up is April 12th for both Gastroenterology and Neurology.
Extreme fatigue (3 hour nap, 12+ hours of nighttime sleep, awake for 3 hours, nap 5 hours) No appetite Mild body aches, headache, dizziness
Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his second dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Headache, Arthralgia, Injection site pain, Injection site erythema, Injection site selling, Fatigue Narrative: Patient experienced injection site symptoms for a week following the vaccination. General symptoms lasted 36 hours
Entire thigh red & swollen; afebride; redness is diffuse, not localized to the injection site and more prominent close to the knee.
Severe pain in right upper extremity at vaccine site. Has persisted for greater than 6 weeks.
Pt recvd 1st dose of Hep B vax (Recomb) on 4DEC90; w/in 24-48 hrs of receiving the vax pt devel a severe stiff neck, h/a, aching pain in arms & shoulders; sx lasted x 1 wk; also exp fatigue & slowing of speech; sx lasted x 6 mos;
Fever of 102.1, administered Motrin. Fever came down during the day then spiked at bed time again to 103. Came down 2 degrees with Motrin.
Breakthrough case admission after 4 vaccines Pfizer 2/1/21 Lot# EL9265;  pfizer 2/22/21 Lot# EL9267;  Pfizer 9/24/21 lot# FF2587;  Pfizer 4/1/22 lot# FK9894;
Extreme itching, no rash, on face, ears, under chin, neck, chest, under and on the underside of both breasts, back of hands
Flu vaccine received at 15:00 at my place of work. No reaction noted at time. At about 22:00, I noticed a rash/pustules around neck/upper shoulder. Pustules are small with white fluid inside. About 100 to 150. Took 25md Diphenhydramine; no effect.
Severe muscle weakness, redness and swelling at injection site, headache, muscle pain that seemed to  move throughout body, insominia, medal taste in mouth
Even though has latex allergy did take H1N1 vaccine as seasonal vaccine taken at office didn't give her a reaction, after 2009 H1N1 administered small bandaid applied. She felt itching almost immediately. Area became red. Ice applied, Benadryl 50mg p.o stat. Reaction -2 1/2 x 2 1/2 Reaction dissipated. 15min after Benadryl sent home by cab.
Vaccine 4/8/08. On 4/16, chilling, T=99. On 4/17 pt with body aches, skin hyperesthesia, T=101. Throughout the day, he had rapid, progressive confusion, headache, and anorexia. Presented to ER evening of 4/17/08 with T=99.4, aphasic, confusion to the point of inability to name self or spouse. On 4/18 mild headache, nausea, loose stools, improved confusion but still with word finding difficulty. On 4/18/08, pt received Decadron 20mg IV x1 and Ceftriaxone 1 gm IV x1. On 4/19/08, pt discharged home with improving transient confusional state. Pt did continue to experience tingling in ulnar area and in hands for 2 nights, as well as anxiety and insomnia through 4/23/08. In followup 4/25, pt felt back to baseline.8/1/08-records received for DOS 4/18-19/08-DC DX:allergic reaction to vaccine. Hypertension. Presented to ED with C/O confusion, headache, decreased appetite, increased sleep, fever 101. In ED somewhat aphasic saying only nonsense words. In morning alert oriented but still having some trouble finding words. C/O headache and feeling nauseous. Felt to have acute encephalomyelitis. Assessment-transient acute confusional state possibley due to recent yellow fever vaccination.
By early evening, Jade c/o'd of localized pain in LD, general malaise nnd headache.  She was warm to the touch and 325 mg APAP was given.  She slept on and off w/increasing c/o pain in her LD.  On Oct. 27th, she c/o'd of severe localized pain (as bad as when she broke her arm) and had a temp of 103.2 in the axilla per mercury thermometer.  She continued to c/o headache and vomited X2.  The reddened area had become slighltly raised, red, hot, extremely tender, and spread out from the immunization site to several areas in the LUE above the elbow.  She was seen by her pediatrician around noon, who dx'd cellulitis and possible allergic rx. She was tx'd w/APAP, Benedryl, & Keflex 1.5 t. qid from 10/27-10/29/2007 then switched to cefadroxil 500 mg 1 tab bid x 7d.  Note:  The medication was changed for convenience not ineffectiveness.  By 10/28 temp was down to 101.8 axilla and by 10/30/2006 she was pretty much back to normal.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 24-JUL-2007 and 17-MAY-2011, patient was vaccinated with Oka/Merck VARIVAX (dose, units, route and frequency not reported) (lot# and expiration date not reported) and on 08-AUG-2007 and 27-MAY-2011, patient was also vaccinated with (wistar ra 27-3) M-M-R II (dose, units, route and frequency not reported) (lot# and expiration date not reported). Patient was administered vaccines less than 4 weeks apart (inappropriate schedule of drug administration). No product quality complaint involved.
Has red rash on trunk & arm opposite of vaccination site. No hives. No difficulty breathing. Recommended BENADRYL.