chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of ear pruritus in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received the 2nd dose of SHINGRIX. On 1st October 2018, less than a day after receiving SHINGRIX, the patient experienced ear pruritus. On 2nd October 2018, the patient experienced pain, tiredness, runny nose and influenza-like symptoms. On an unknown date, the outcome of the ear pruritus was recovered/resolved and the outcome of the pain, tiredness and runny nose were not recovered/not resolved and the outcome of the influenza-like symptoms was unknown.  It was unknown if the reporter considered the ear pruritus, pain, tiredness, runny nose and influenza-like symptoms to be related to SHINGRIX. Additional information received as follows: The patient reported that, at 15:24, on the day before reporting, he received SHINGRIX. The patient felt itchy at night on the same day of vaccination and he felt achy and tired, runny nose at morning of reporting day. The patient was asking if this was normal. The reporter asked if GlaxoSmithKline could call his wife for the further details. The call was done to the patient's wife (the patient was resting). The patient's wife said that the patient experienced itchiness of ears and that had resolved. In morning of the reporting day, the patient experienced achy and flu-like.
Patient received both immunizations and 5-10 minutes later had a "reaction". Pt became pale, moist with heart rate decreased to 40. Pt remained alert and oriented. ED response called and pt's vital signs improved with oxygen and time.
Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek9231, expiration date was unknown), intramuscularly on the left arm on 08Jan2021 (at 11:00 PM as reported; pending clarification) at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included that the patient had known allergies to medications, food, or other products, but was not specified. Concomitant medications included ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), curcuma longa (TURMERIC) as supplement, and an unspecified multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021 (at 11:15 AM as reported; pending clarification), the patient experienced lightheaded, tachycardia, and blotchy rash, which resulted in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of lightheaded, tachycardia, and blotchy rash, which included diphenhydramine (BENADRYL) and steroid. The patient was recovering from all the events.
Patient received 3 vaccines on 11-11-04, Typhoid Vi, Tetanus/Diphtheria, and Polio (IPV) for an upcoming trip.  The following evening, on 11-12-04, patient developed generalized itching and then on Saturday, 11-13-04, she developed itchy hives on her neck, hands, knees, feet and stomach that have persisted through today (11-17-04).
pt recv vax & 1wk later devel weakness & pain in the lt arm;weakness progressed to lt leg;pt also had edema in the lateral arm & shoulder which resulted in a frozen shoulder;pt was admitted to neurology service,all test were non-diagnostic
Pt developed a headache. Had a glass of wine and took aspirin. Injection site pain, dizziness, nausea. Drank ginger ale. Vomited x 4 hours. Eye itching, burning, watery. Abdominal cramping and diarrhea. Fever, chills.
Immediately following the shot in my left upper arm, I experienced a cold sensation in my upper left arm. That sensation gradually moved throughout my arm. A bit later I felt pins and needles in both hands. The cold sensation in my arm and pins and needle feelings in my hands lasted for 2-3 hours following the shot, then went away. There was no pain but it was disconcerting. I was told to report the reaction.
74 Year old female seen and given a tetanus immunization on 8/24/06 on left deltoid cane in to report on 11/28/06 that two weeks after her shot she developed muscle twitching, numbness, dysthesia, swelling and sharp pain left upper extremity never had this in the past. 05/29/07-records received for DOS 10/31-11/2/07-DX: Complex regional pain syndrome. Reflex sympathetic dystrophy.  C/O 5 days worsening edema and pain in left arm triggered by an injection. Noted to have hyperalgesia and allodynia.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was ordered on 01-Nov-2021 and 15-Nov-2021.  The beyond use date of the vaccine was reported as 01-Dec-2021 to 15-Dec-2021.  The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed.   They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.  The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was provided.
CONFIRMED CASE OF CHICKENPOX ON 2-3-04 AFTER RECEIVING VARICELLA VACCINE ON 8-3-98
Booster given 6 days early.  No computerized information available for previous vaccines. Recipient self-reported her previous vaccine was received on 08/19/2021. She presented to our clinic requesting a Moderna booster. She would be eligible to receive this on January 19th, 2021.  She presented to our clinic requesting a booster on January 11, 2021 and was denied the vaccine then because she was too early. She returned on January 13, 2021 and a booster was administered.
Pain at site of injection progressed to redness, swelling, warmth extending down (L) arm. Treated with anti-histamine, antibiotic, and prednisone.
BLOOD CLOTS; This spontaneous report received from a consumer via  media via company representative concerned a female of unspecified age and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots. The reporter stated that "Neighbors he had stroke and she had blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter was linked to 20211223284.; Sender's Comments: V0: 20211222253 -COVID-19 VACCINE AD26.COV2.S- Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
I was 6 weeks pregnant prior to getting the H1N1 vaccine.  I began bleeding the following morning and miscarried that day.
Bilateral Shingles  on face and scalp Continued nerve pain after shingle healed On anti virals for 8 weeks Burning on head face and eyes Nerve pain in right eye Steroid eye drops  Pain management with Tylenol 3 with codeine  Trips to eye doctor No relief in pain
Subject in pneumococcal vaccine trial, with severe COPD, died on 7/10/2008 in home due to myocardial infarction and high cholesterol. Vaccination took place on 4/9/07. According to the physician, the relationship to treatment is 'None". We would be happy to forward the Study's SAE Report Form upon request.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-SEP-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # K009471 and expiry date: 03-JAN-2016) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Gave flu and pneumo shot in same left arm.  Arm was sore that night.  Started to feel achy that night.  Had fever and chills next day.  Arm couldn't move.  Red and swollen arm.  Took Aspirin.  Large 4 inches.
dose administered from a vial at room temperature for greater then 24 hours; dose administered from a vial at room temperature for greater then 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours) 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 medication was reported.  No treatment medication was reported.  2 doses administered. # of doses and vials: 2 doses given from 1 vial  Total amount of time vial exposed to room temperature range (8-25 C or 46-77 F): Room temperature for greater then 24 hours. Approximately 24Aug2021 10:30AM to 25Aug2021 12:45pm date and time of dose administration.
A 60-year-old female patient with a history of hypothyroidism, cancer in 1985 that was treated with radiation, and allergy to Compazine, had received an intramuscular injection of IPOL, in the left deltoid, a subcutaneous injection of YF-VAX , in the right arm and a primary intramuscular dose of Hepatitis A vaccine, in the left deltoid on 30/Mar/2006.  Forty days post0immunization, the patient developed pain and tingling in both of her feet.  She was seen by a podiatrist, and was prescribed an unspecified oral pain medication.  At the time of this report, the patient had not recovered from these events adverse events.
Information has been received from a physician concerning a 2 year old male who on 7/19/02 was vaccinated with a dose of varicella virus vaccine live. On 8/31/04, the patient developed shingles. Unspecified medical attention was sought. The patient was treated with Acyclovir and subsequently recovered. There was no product quality complaint involved. Additional information has been requested.
Initial c/o tingling lips, pale, sweaty. No c/o SOB or diff swallowing, vision changes. Vital signs stable. No acute distress. Later developed 101 degrees temp and rash over entire body. Self treated with BENADRYL and TYLENOL with symptoms gradually resolving over 3-4 days.
J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 9/27/2021 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 URINARY RETENTION R09.02 HYPOXIA 9/27/2021 URINARY RETENTION J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 PNEUMONIA R09.02 HYPOXIA 9/27/2021 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 WEAKNESS R09.02 HYPOXIA 9/27/2021 WEAKNESS J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 BACTEREMIA R09.02 HYPOXIA 9/27/2021 BACTEREMIA J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 BACTEREMIA R09.02 HYPOXIA 9/27/2021 BACTEREMIA J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 BACTEREMIA R09.02 HYPOXIA 9/27/2021 BACTEREMIA J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 ADENOMATOUS POLYP, COLON R09.02 HYPOXIA 9/27/2021 ADENOMATOUS POLYP, COLON J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 PNEUMONIA R09.02 HYPOXIA 9/27/2021 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 3/4/2021 PNEUMONIA R09.02 HYPOXIA 9/27/2021 PNEUMONIA
Patient had fever, body aches, poor appetite, dizziness, weakness, and lump to injection site.
CLINIC HDC/CHD RECEIVED CALL FROM CLIENT @ 11:30 AM ON 8/26/2013 REPORTING THE FOLLOWING SYMPTOMS: CHILLS, HEADACHE, WEAKNESS, NAUSEA (NO VOMITING), FATIGUE AND PAIN AT INJECTION SITE (LD)/ARM. CLIENT REPORTED THAT THESE SYMPTOMS PRESENTED ON THE EVENING OF 8/23/13. CLIENT STATED THAT SHE HAD NOT BEEN EVALUATED BY MEDICAL PERSONNEL OR HER PHYSICIAN FOR THESE SYMPTOMS AT THIS TIME. CLIENT URGED TO SEEK MEDICAL EVALUATION OF SYMPTOMS WITH PHYSICIAN OR ER.  CLIENT SPOKE WITH CLINIC SPV RN WHO ALSO URGED CLIENT TO SEEK MEDICAL EVALUATION OF SYMPTOMS. RN REPORTED CLIENT TO REPORT A MD APPT THIS AFTERNOON FOR EVALUATION.
Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Feb2021 (Lot number: EN5318) at the age of 30 years as dose 2, single and intramuscular, administration date 28Jan2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "recovering" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Facility type vaccine: clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the vaccination failure and covid19 and the suspect drug BNT162B2.
ACUTE PULMONARY EMBOLISM 7/19/2022 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE PULMONARY EMBOLISM 7/19/2022 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE PULMONARY EMBOLISM 7/19/2022 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE PULMONARY EMBOLISM 7/19/2022 CHEST PAIN ACUTE PULMONARY EMBOLISM 7/19/2022 ANEMIA ACUTE PULMONARY EMBOLISM 7/19/2022 NONTRAUMATIC INTRACEREBRAL HEMORRHAGE, INTRAVENTRICULAR
Regularly get chills every day.  Muscle soreness.  Discomfort at injection site.  Difficulty lifting right arm.
Patient reports ongoing right sided joint pain and stiffness to his elbow, hips (bilateral), knee, and ankle
Heart rate sudden increase to 115, dizzy, weak, almost fainted while seated. Lasted 5 minutes.
4/28/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  " swimmy headed".   Assessment : Time of assessment. 1300, ,Alert and oriented.   Actions taken:  Vitals sign taken  form obtained and completed by registered nurse.   1300- VS- BP-148/95, P-82, O2- 99%, water and snack given, recheck VS at 1315- BP- 160/86, P- 81, O2- 100%, recheck at 1338- BP- 144/94, P- 74, O2- 100%- reports feeling better, just tired.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. with husband,     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/28/2021 12:45 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8736
Patient experienced as 15- 20 second syncopy spell when he sat up frpm a sitting position after receiving the covid vaccine   initial vitals 102/60   pulse 40   after regaining conciousness BP was 111/60    pulse at 60   patient prior to fainting appeared diapharatic, pale and cool to the touch  there were no signs of llegeric reaction including flushing of the face lack of hives or angiodema no wheezibg, no strider or labored breathing patient complained of dizzness upopn standind equal to 30 mins.. EMS was notrified when arrived patient was up and alert without dicculties  EMS recommended patient be released to his gaurdian  BP at release 112/57 pulse 62 father advised to call physician if any concerns arise or go to nearest hospital in an emergent situation
4/5/21: 4:35pm - shot given 5:30pm - injection arm throbbing, light headache 9:00pm - exhausted, chills, injection arm throbbing, headache 4/6/21: All day - extreme exhaustion (barely awake for 2+ hrs in a time), intense headache, chills, dizzy, injection arm hot, achy muscles 4/7/21: All day - still very tired, light headache Afternoon - facial hives appeared 4/8/21:  Lagging energy, facial hives, slight bruising at injection site
Jittery; Dizzy; Swollen upper lip; Pain from elbow down to hand; This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (Jittery), DIZZINESS (Dizzy), LIP SWELLING (Swollen upper lip) and LIMB DISCOMFORT (Pain from elbow down to hand) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING JITTERY (Jittery), DIZZINESS (Dizzy), LIP SWELLING (Swollen upper lip) and LIMB DISCOMFORT (Pain from elbow down to hand). At the time of the report, FEELING JITTERY (Jittery), DIZZINESS (Dizzy), LIP SWELLING (Swollen upper lip) and LIMB DISCOMFORT (Pain from elbow down to hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5 1/4 x 3 1/2 in area of erythema to L thigh surrounding vaccination site. Treated with Keflex orally tid x 10 days. Patient seen in clinic 01/13/2014.
This spontaneous report was received from a physician refers to a male patient of unknown age. There was no pertinent medical history and there were no drug reactions or allergies reported. On unknown dates the patient was vaccinated with dose 1 and 2 of RECOMBIVACX HB 1 ml, intramuscular (lot number reported as J008227 and expiration date unspecified for dose numbers 1 and 2 in the series. Th patient received the third dose on an unknown date (lot # J008505, expiration date 07-FEB-2016) 1 ml, intramuscular. Thimerosal status of the vaccine was not reported. There were no concomitant medications reported. On an unknown date the patient experienced negative hepatitis B titers. The physician reported that the patient had the titers measured 31 or 32 days after the third dose, and they measured less than 5 which was determined to be negative. No additional symptoms were reported. It was reported that there was no treatment given for the patient. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The causality of the event was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt recvd MMR on 14JAN92 when condition was good; evening pt became irritable, feverish 103 & listless; Seen again 16JAN92 pt was feverish 103.2 pale, irritable; WBC 17,000, 97% SEG, 8 STAB, BS 97, NA 132, K 4.4, CO2 18, Cl 100 hospitalized;
Experiencing chills, fever, headache, nausea and light-headedness. Tylenol taken (2 325mg tablets) at 8am on May 7th.