chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not inform to the pharmacist that two previous doses were administered.  The pharmacist reported that the patient received 3rd dose of Shingrix, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022019047:Same reporter
Allergic reaction, rash, streaking, itching, bumps, pain at site over 15 areas of my body. Took antihistamines, prescribed prednisone and Triamcinolone Acetonide Ointment. Lasting 8 days.
Day 1:  sore arm. Day 2: severe bladder pain with chemical smell to urine ( 6 hours), mild headache resolved with APAP, fatigue, mild stiffness. Day 3: bladder pain gone but mild chemical smell to urine, increasing stiffness and  joint pain, mild muscle pain. Day 4: chemical smell in urine slight but still present, severe joint pain and swelling requiring narcotics, mild muscle pain, moderate stiffness, moderate fatigue. Day 5: chemical smell gone, severe joint pain and swelling requiring narcotics, drenching sweats, significant stiffness, fatigue  with 12-14 hours sleep, inability to manage ADL w/o help; Days6-8 same as Day 5; Day 9-10 mod fatigue, less jt pain, no narcotics, able to do ADL's w/o help;
Covid Vacination History:  Pfizer 1 on 1/30/2021, Pfizer 2 on 2/20/2021, Moderna booster 10/22/21, Pfizer booster 5/6/2022 and Pfizer bivalent booster 9/16/22    11/25/2022 Crowded international flight. Regrettably I did not mask.    2/26/2022 Ssore throat overnight that resolved the next day.    11/28-29/2022  Drove to my home in MD with an dry cough and some head congestion.    11/29/2022  Evening   A Flowflex strip test was strongly positive for Covid infection. I was feeling poorly but had no other symptoms except the cough and some congestion.  I have had three serious bouts of pneumonia in my past.  My personal physician prescribed Paxlovid. I take no medications other than vitamins.    11/30/2022 3:00 am begin Paxlovid course.  During Paxlovid I developed a very dry mouth and metallic taste.  I continued to have some light head congestion but a typical cold is worse.  I never developed a fever.  My main symptom was not really fatigue per se, but lack of energy, lethargy. There is also a slight dizziness or nausea reminiscent of motion sickness that still persists 20 days later.      12/19/2022  I am now doing normal daily activities but still feel some dizziness and am not fully recovered.
received an expired dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-month-old male patient who received HBV (Engerix B) (batch number 5Z9S2, expiry date 12th March 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 1st April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient received expired dose of Engerix B, was expired on 12th March 2021, which led to expired vaccine used. The healthcare professional consented the follow up via email or mailing address. The reporter consented to follow up.
The patient had minor reactions to the Anthrax immunization that progressed from shot to shot.  The fourth immunization was more severe; he had swelling, erythyma and pain down to his hand.  He also had pain in his axilla. The swelling lasted about a week and resolved.  Pt is in the military and given a temporary exemption.  VAERS report completed as requirement for the temporary exemption.  Was not present at the time of the event.
Seizure (very first event 8/4/18) Preceded by rapidly alternating chills and fever, very tired. Went to bed at 8 rather than typical 11pm. Started to drift off then wife got a call, and then took some time to fall asleep. Very strange dream that started as an interesting flow of small woven objects but at the end became fearful & chaotic & seemed to be spinning & puling me down. Wife observed convulsion with rhythmic jerking and grunting sounds but could not wake me. Loss of bladder control. She called 911 (I was at that time able to hear her but unclear about what had happened). Was not able to stand up for paramedics, transported out and admitted to ER. BP&P, EKG, X-Ray, CT and blood workup all reported normal. In ER/ED at about ~3am Saturday out at ~8am. Drove wife home. Saturday (afternoon) chills and fever now gone and we both felt the vaccine side effects were lessening but for redness & swelling near injection site, general soreness, muscle pain and tiredness. (Wife had less severe reactions during both first and second SHINGRIX vaccinations). Sunday gradual improvement but still injection arm redness & swelling, still tired and large muscle soreness. Still have problems lifting legs from sitting position. Top and inside of thighs sore and painful lifting them up. Monday More improved. Redness starting to fade but skin quite hot. Still have sore muscles in abdomen and upper thighs, but continue gradually improving. Saturday Fully recovered from symptoms.
Left arm swollen and red to elbow; no complaint of pain. Reported to office on 7/24/03; advised ice and Tylenol or Motrin for pain.
I am running my temperature 100.1; Chills; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; This is a spontaneous report from a contactable consumer (patient) and a contactable other health professional.  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. On Jan2021, the patient reported that: "I am running my temperature 100.1, chills in my body and my body is still painful. I don't have shortness of breath, but I am very painful. I took 2 TYLENOL. I woke with chills, I have my body achy, my back hurts. I am in pain, every joint hurt in me. I took my temperature and I realized it was 100.1". The patient outcome of fever and chills was unknown, the outcome of the other events was not recovered.   Information on Lot/Batch has been requested.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On unknown dates, the multiples unspecified patients were vaccinated with RECOMBIVAX HB, (lot#, expiry date, dose, frequency, route and indication not reported). The medical assistant reported that the multiple unspecified patients were administered RECOMBIVAX HB that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 22SEP97 & the following day pt exp fever 102, body aches all over & a local rxn, 5 inches in size, consisting of swelling, redness, heat & induration;pt could hardly lift arm;pt also c/o earache but MD check ear & was clear;
Pt found to have bilateral subsegmental pulmonary emboli. No right heart strain. Otherwise determined to be low-risk PE but will require anticoagulation.
NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.
Rapid onset of warmth feeling followed quickly by "visual changes" and dizziness.  Brief syncope sitting without falling occurred with rapid recovery. Little to no diaphoresis or nausea.  Low normal range BP's recorded in the range of 90-100 sys and 50-60 diastolic.   Pulse 70-80.  02 sat -98% No orthostasis.  Typical vasovagal reaction.   Discussed with father & patient.
0.03ml dose given from vial diluted with 0.18ml saline instead of 0.3mL dose give from vial diluted with 1.8ml saline. Discovered after administration and patient had left. No 3mL syringes were available at that time.  It appears based on math that correct amount of vaccine was given, but not as diluted as it should have been. No ill effects noted by patients while present 15minutes directly after administration.
She states her left arm was a little bit sore but she is mainly concerned about the right.  She states she had a large area that was swollen and red that seems to be a lot better today.  She felt like she was hot yesterday but did not think she had a fever.  She thinks she's had pneumonia vaccines in the past without any history of reaction.  She denies shortness of breath or swelling to her throat.  No other concerns
This spontaneous report has been received from a medical assistant referring to a 3 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction, allergies, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with an improperly stored  VARIVAX with lot # M033905, expiration date 20-JUL-2018 (strength, route of administration, anatomical location, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine  was >5F but <14F and the time frame was 5 days, 9 hours, 12 minutes, and also >14F but <46F for 24 minutes, also she stated that the previous temperature excursion was not involved, this information was registered in a digital data logger. No adverse effects were reported nor product quality complaint was not involved. Additional information has been requested.
4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive; 4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive; runny nose; sore throat; sneezing; watery eyes; headache; fever; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EN6207), in left arm, on 06Apr2021 at 11:00 as dose 2, single (Lot number: EWD150), in left arm, on 12Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 06Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "melanoma" (unspecified if ongoing), notes: Other medical history: melanoma; "brain cavernoma" (unspecified if ongoing), notes: Other medical history: brain cavernoma. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "not recovered" and all described as "4 days after my last dose of Paxlovid my symptoms returned/I took a Covid antigen test when I took the last Paxlovid dose, and it was still positive"; COUGH (non-serious) with onset 2022, outcome "not recovered"; PYREXIA (non-serious) with onset 2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2022, outcome "not recovered"; RHINORRHOEA (non-serious) with onset 2022, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "not recovered", described as "sore throat"; LACRIMATION INCREASED (non-serious) with onset 2022, outcome "not recovered", described as "watery eyes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of rhinorrhoea, oropharyngeal pain, sneezing, lacrimation increased, headache, pyrexia, cough.  Clinical course: No known allergies reported. Device timestamp was 06May2022.   No follow-up attempts are possible. No further information is expected.
On 10/29/2018 patient called this nurse to report she was going to see her doctor on 10-30-2018 because she was still having problems with pain after receiving the flu shot. Pt. reports she was having pain "every now and then", especially when putting on her bra and getting her shirt off. Pt. reports she has experienced this pain starting on the day she received the flu shot but it did not get better. Patient call back on 10-30-18 at 3:20 pm and reported she saw her doctor and received a steroid and Toradol shot about 9:30 a.m. and that her arm was already feeing better.
3x3 cm of erythema and mild warmth along moderate tenderness and mild induration at the site of the Johnson and Johnson COVID-19  injection
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Sick with Covid) in a patient of an unknown age and 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 fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Sick with Covid). At the time of the report, COVID-19 (Sick with Covid) had not resolved.            Concomitant medication list was not provided. It was reported that the patient had completed the four Moderna COVID-19 vaccines that were available to the patient. Patient was on day 4 of being sick with COVID-19. Patient hardly ever got sick. Patient thought that it would be beneficial to have a local medical faculty draw a blood sample, figure out which variant had got the patient down and fix the vaccines, so it does not happen to others. Treatment information was not provided.
Erythema, induration and warmth over right deltoid area, approximately 6cm diameter.
This spontaneous report as received from a physician refers to a 22 year old female patient. On 15-NOV-2013 the patient was vaccinated with PNEUMOVAX23 25/0.5 Y, 0.5 ml, intramuscular. On 15-NOV-2013 the patient experienced redness around the injections site that spread down her arm and up her shoulder, severe vomiting, and fever. The patient sought medical attention by calling the physician. The patient was treated with Prednisone. The outcome of fever, redness around the injection site that spread down her arm and up her shoulder and vomiting was reported as not recovered/not resolved. Additional information has been requested.
Post vax, the patient developed abdominal hives, palmar itching, swelling and angioedema of her lip.
Pt reports swelling of deltoid where vaccine was given, rash on inner upper arm, pt reported pain in the shoulder and upper arm. No fever reported.
Severe Arm Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced severe arm pain. The pharmacist asked if there was any information on immunity with 1st dose of Shingrix vaccine. The reporter did not consent to follow-up.
Next morning: Hives on trunk, flushing on neck and face, dry eyes, headache. No treatment. Expected to Resolve on its own in 7 days, as that was the experience for the previous dose of Shingrix
6x5 cm hematoma to left upper arm. No redness noted, not warm to touch, recommended Benadryl.
This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. The patient's concurrent conditions included chronic obstructive pulmonary disease and her medical history included an allergic reaction to tetracyclines. On 30-SEP-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, anatomical site of injection and frequency were not reported). Concomitant therapies included SYMBICORT and XANAX. On the same date in the evening, the patient experienced swelling, redness and blisters at the injection site, which had an inch in diameter and were filled with pus. On 03-OCT-2016, the patient sought medical attention at the reporter's office. The reporter stated that the patient had been taking TYLENOL and aspirin (manufacturer unknown) as treatment for the event (doses and frequencies were not reported), however, no laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the reporting time, the outcome of the event was unknown. The reporter did not provide causality assessment between the event and the ZOSTAVAX. Additional information has been requested.
Recent memory loss; Slight confusion; Pain in the hip and right flank; chills; Difficult for her husband to walk; Pain in the hip and right flank; This is a spontaneous report from a contactable nurse (patient's wife). A 87-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported.The reporter stated that, patient have received the vaccine last Friday and reported that patient experienced symptoms as chills, pain in the hip and right flank, slight confusion (which was new), and recent memory loss. She stated that it was difficult for her husband to walk and was still experiencing pain in his hip, but his movement had improved a little today. The patient did not had these symptoms before the vaccine and wanted to know if their symptoms are related to the vaccine. The outcome of the events difficult for her husband to walk was recovering and the outcome of other events were unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Sudden onset of diabetes / Diagnosed 10Feb22 after having severe symptoms for many months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 12:00 (Lot number: FE3594) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]. Past drug history included: Tetraycyclines, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (lot number=EN6201, prev dose administration time=12:00 PM, prev dose vaccine location=Left arm, dose 2, single), administration date: 16Feb2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (lot number=EL8982, prev dose administration time=12:00 PM, prev dose vaccine location=Left arm, dose 1, single), administration date: 26Jan2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (disability) with onset 10Feb2022, outcome "not recovered", described as "Sudden onset of diabetes / Diagnosed 10Feb22 after having severe symptoms for many months". The event "sudden onset of diabetes / diagnosed 10feb22 after having severe symptoms for many months" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Feb2022) negative.  Clinical course: Facility type of vaccine was Pharmacy or Drug Store. The patient took no other vaccine in four weeks. Patient had no covid prior vaccination and was tested for covid post vaccination. The patient took Nexium 40 mg in two weeks. The patient no family history of diabetes. The patient experienced Sudden onset of diabetes subsequent to administration of Pfizer COVID 19 vaccines. Diagnosed 10Feb2022 after having severe symptoms for many months. Treatment for Adverse Event was prescription insulin-mealtime and long acting.   No follow-up attempts are possible. No further information is expected.
Patient complained of numbness in left cheek. Monitored vitals; pronounced tachycardia. EMS transported patient to hospital.  MD note: 55 year old female who had numbness on left cheek and forehead after vaccination. Patient given Benadryl prior to vaccination. Patients states no prior similar allergic reaction. Patient states no change in voice or cardiopulmonary; no symptoms, wheezing, shortness of breath. Requested vitals be repeated. Patient's tachycardia persists. Patient states no history of tachycardia. Recommend transport to emergency department for possible allergic reaction and concern of tachycardia. EMS contacted to transport. Emergency Department notified about patient.
Pt given PNEUMOVAX 10/4/2011 - within 24 hours developed T201, vomiting, severe pain at injection site & cough.
Impetigo, Fever - Information has been received from a physician's office concerning a 2 year old Spanish female patient with wild type varicella exposure who on 29 Jan 1999 was vaccianted with a first dose of varicella virus vaccine live in the left thigh.  On 24 May 2000, the patient developed a really bady case with infected lesions, a couple on her face about 3 cm around her mouth, nostrils, ears, and all over her body.  she had a fever last week, but on 31 May 2000 at the office visit, she did not.  The patient was treated with topical antibiotics.  Follow up information from a physician's office indicated that on 31 May 2000, the patient presented with large lesions on her right earlobe and around her mouth and nostrils.  The lesions wore 3 cm and became infectious.  The patient was diagnosed with impetigo and treated with amoxicillin triphydrate (+) clavalanate potassium (Augmentin) 400 mg and mupirocin (Bactroban) ointment.  On 07 Jun 2000 the patient recovered.