chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 12:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:14 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.80.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 37 respectively. Total doses given for the day was 184 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM vaccine was moved to fridge on 09-Mar-2021 and. Vial was moved to clinic on 20-Mar-2021. 19 vials from 9 AM were sent to clinic. Vaccine BUD date was 08-Apr-2021 for 9AM.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, and 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Staff member felt brief lightheadedness. Blood pressure was 147/72 (normal for her). Staff member then felt fine.
I had post nasal drip before I got the injection.  because of the drip had a wet cough, then later day i started feeling tired. On Christmas eve i went to doctors care and they did a Covid test which was positive.   Two weeks later i got an anti-body test.
pt recv vax 17JUL95 & 24FEB98 pt devel a low grade fever for one day & mild case of chickenpox w/50-60 lesions over the entire body w/severe itching;tx w/DPH;
Information has been received from a health professional concerning a 36 year old female who at 11:00 am on 26-SEP-2008 was vaccinated mistakenly intradermally with a dose of PNEUMOVAX 23 vaccine (lot # 659487/1960U). Subsequently, the patient experienced mild local reaction, and local reaction of erythema, edema and itching on 27-SEP-2008 and 03-OCT-2008 respectively. The patient sought medical attention. At the time of reporting, it was unknown if the patient recovered. Additional information has been requested.
Two- three days after vaccine I had sever muscle pain, muscle twitching, muscle spasms,  muscle numbness, fatigue.  Overall muscle loss of strength and ability to pick up items. this has now been going on for over two months and is not much better.
Information has been received from a pt's mother and a physician concerning a 13 month old male with no past medical history and no known allergies who on 7/3/01 was vaccinated with varicella virus vaccine live (lot 638247/0495L). Concomitant vaccination included mumps virus vaccine live (636958/1042K, invalid lot this corresponds with measles virus vaccine live. She said yesterday, she noticed he had "2 pustules on his back and one on his arm". In follow-up, the pt's physician reported he was seen on 7/14/01 because of a rash. The pt ha a few flesh-colored papules but no ill symptoms. The dx at this time was atopic dermatitis versus "measles" immunization reaction versus varicella immunization reaction. On 7/20/01, the pt was seen again with 2 lesions on his back. One lesion was papular and the other vesicular. The pt also had vesicular lesions on his right arm. The dx at this time was probable mild atypical varicella following varicella immunization. No lab diagnostic tests were performed. The pt's final dx was probable atypical varicella following varicella immunization. On 8/23/01, the pt was vaccinated with measles virus live (lot 630227/0455K invalid lot this corresponds with mumps virus vaccine live). On 10/4/01, the pt was vaccinated with rubella virus vaccine live (second generation) (lot 638553/1873K). Additional information has been requested.
sz p/MMR given 19MAY92; seizure 27MAY92 (Afebrile);
PMH: dementia, hypertension; to er with generalized weakness and inability to carry out ADLs; tested positive for COVID and started on 2L supplemental O2; remdesivir, decadron, therapeutic lovenox; noted to have significantly elevated blood pressure HPI: Incontinent of urine admitted for further evaluation and treatment. Dx'd with anemia, anxiety, benign prostatic hyperplasia, dementia, hearing loss, hypertension, pseudophakia of both eyes Treatment: 09/12/21 dexamethasone 6mg oral daily, enoxaparin 1mg/kg, subfcutaneous q12h sch remdesivir 200mg iv once followed by remdesivir 100mg iv daily Hospital Course: pt found to have acute hypoxic respiratory failure due to COVID pneumonia; started on remdesivir, dexamethasone, and therapeutic lovenox; oxygen requirements escalated to require max 5 L nasal cannula; pt was found to have retroperitoneal bleed 09/20, requiring blood transfusion; his condition continued to decline with episodes of agitation and combative behavior as well as suicidal ideation.Family elected to pursue hospice care for home. Discharged from hospital on 09/27/2021. Pt died at home on 10/04/2021
On Thursday, the day it began. I felt a scratchy throat at work and a cough that I tried to suppress by drinking water. The next day, the cough felt like I was beginning to get the flu or cold. I took an at home test and it came back positive. The cough persisted and I went to sleep. The cough was a dry cough and a runny nose. Following that, I started getting sore around my belly and abdomen because of coughing so much. Saturday night I had a temperature at 101 at about 7pm and that lasted for about an hour. I had a good appetite and never lost my taste. No body aches, no diarrhea. Just the cough and runny nose and the fever that lasted for about an hour. Sunday, I began to come around. I never was down to the point where I had to be in bed, I just stayed in bed. And it was just like a flu. Contacted doctor on Friday as well and was prescribed the Paxlovid and started that medication that evening. Had to stop taking Rosuvastatin at this time so I could take Paxlovid.
After 7 hours after the injection, the injection site was itchy. It was not swollen or red, but there was an itchy, tingling sensation. A week later the injection site was swollen, red, and itchy.
Arm has liquid on it; Arm is hot; Arm is swollen, puffy, swelling is getting bigger; Arm is tender; Rash in my chest; Metal taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste in mouth), VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), RASH (Rash in my chest) and VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Attention deficit hyperactivity disorder.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) and VACCINATION SITE PAIN (Arm is tender). In January 2021, the patient experienced DYSGEUSIA (Metal taste in mouth) and RASH (Rash in my chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In January 2021, DYSGEUSIA (Metal taste in mouth) and RASH (Rash in my chest) had resolved. At the time of the report, VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) and VACCINATION SITE PAIN (Arm is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking medications for depression and ADHT.; Reporter's Comments: This case concerns a 44-year-old female with a nonserious unexpected event of dysgeusia, vaccination site warmth, vaccination site discharge, and expected rash, vaccination site swelling, and vaccination site pain. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Adult dose of Hepatitis A given (1440 elu) instead of pediatric dose of Hepatitis A (720 elu)
9 days after first MMR shot he presented with hives on his trunk and orchitis of the testicles. This lasted 1 1/2 days.  Unknown if fertility was affected.
On 11-16-05 approx. 2 hours after LAIV, developed dizziness, chills, exhaustion. 11-17-05, aching, prostration, vomiting, headache, fever. 11-18-05 cough, runny nose.
Pt recvd 3 doses of Engerix B according to 0,1,6 mos schedule. 10Dec91 it was determined that pt did not respond to the vax series.
Approx. 20 min after receiving immunizations patient became faint and felt nauseated. He vomited a small amount of clear liquid. No chest tightness, shortness of breath or skin reactions. Vital signs remained normal throughout. He was observed for 30min and released with symptoms resolved.
Case number PHEH2013US017248 is an initial spontaneous report received from a health care professional on 12 AUG 2013. This report refers to a patient of unknown age and gender. This patient medical history and concomitant medications were not reported. This patient was vaccinated with MENVEO (batch number: M12129) on an unspecified date. On 25 JUL 2013, after vaccination, this patient experienced scratchy throat. Outcome was reported as complete recovery on 28 JUN 2013. No further information was provided.  Following an internal review of the data received on 12 AUG 2013. It was observed that the event  "scratchy throat" was erroneously captured as sore throat; therefore it was correctly coded to throat irritation in the case.
This spontaneous case, initially received from other non-health professional on 07-Feb-2018 and concerns a 4-year-old, child of unspecified gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number and expiry date: not reported). The reporter assessed the event as non-serious.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with an expired GARDASIL (lot # 663452/0671Y, Expire date 18-SEP-2012) (vaccination site unknown) on 02-AUG-2012. This was the patient first dose. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Approximately one half hour of receiving  the vaccine I felt very unsteady. Within minutes, I began to have horrendous chills to the point of near continuous  shaking for nearly two hours. I tried to stay warm every way I could. These affects finally subsided into a low grade fever.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 31-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:same reporter
fainting; severe headache; nauseous; he usually eats really good and would eat all day and now he does not eat too much; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 10Sep2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports.   A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on 25Aug2021 at 14:20 (at the age of 13-years-old) at dose 2, single for COVID-19 immunization. Medical history included being insulin-resistant and circumcision on 2014 (7 years ago). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular 04Aug2021 (at the age of 13-years-old) at dose 1, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy or drug store. The reporter called regarding her 13-year-old twin sons who received their second dose of Pfizer COVID-19 vaccine on Wednesday, 25Aug2021. She mentioned that the patient has been having a severe headache from 25Aug2021 and has been nauseous from Aug2021. She wanted to know what she should do regarding these. She was concerned about how her son felt because he has had a headache for 2 days and he usually eats really good and would eat all day and now, he did not eat too much, on Aug2021. She was worried and wanted to know if it was dangerous to have the headaches for 2 days. She wanted to know if there were any complications since he was insulin resistant, if him being insulin resistant made the effects worse. She mentioned that she made the people aware of his condition before getting the vaccine. On 10Sep2021, patient's mother reported that both her sons experienced headache and fainting for a second, 2-3 times after the vaccine on 25Aug2021 at 15:00. She mentioned that it was a hard moment and they didn't want to go a hospital due to contagious COVID-19. The patient's mother didn't know if it was serious or not, but she was really worried. Therapeutic measures were taken as a result of fainting and headache and included treatment with TYLENOL. The outcome of the events fainting and headache was not recovered and unknown for all other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119413 same reporter and drug; similar events; different patients
Patient is a 68 y.o. male with past medical history of hypertension, anxiety, depression, who presents to the Emergency Department with chief complaint of as mentioned above.   Patient had first Covid vaccination injection on March 2.  After the injection, he had some malaise.  For the last 1 week, the patient has shortness of breath with exertion, generalized weakness, productive cough and feeling sick in general.  He has no significant cough or chest pain or leg edema, calf tenderness.  Patient has no urinary complaint.  Onset his condition was gradual with moderate symptoms.  Exertion aggravates his condition and oxygen helps   In the ER, the patient was hypoxic with oxygen saturation dropped down to the low 80s with ambulation.  He requires a couple liters of oxygen.  His viral panel was positive for COVID-19.  He had a chest x-ray and a CT scan of the chest.  The studies show right side pneumonia.  The patient was given dexamethasone in ER and subsequently was admitted to the hospital for COVID-19 infection, pneumonia, respiratory failure.
Husband got the vaccine years ago and got to shingles/Suspected vaccination failure; Husband got to shingles a month ago very painful; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 19-JUN-2022 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The patient and his wife got the vaccine years ago from the date of reporting and he got shingles a month ago from the date of reporting which was very painful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient reports low grade fever 24 hours after admin that lasted approx 12 hours. Headache, decreased concentration, fatigue and muscle aches. Pt took 1/2 day off from work as result.
On 05/22/2002, pt's mother called to report redness, swelling and itching at vaccination site.
developed that from a flu shot was disabled for the rest of her life in a wheelchair; Initial information regarding an unsolicited valid serious social media case was received from a non-healthcare professional (consumer) on 11-Dec-2020.  This case involved a female patient of an unknown age who was disabled for the rest of her life in a wheelchair (Physical disability), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the reporter knew a lady who was disabled for the rest of her life in a wheelchair from a flu shot (Physical disability) and reported that it was just a gamble to take.  No relevant laboratory details were provided.  The event of physical disability was assessed as seriousness criterion of disability.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as not resolved.  There will be no information available on the batch number for this case.; Sender's Comments: This case involved an unknown age female patient who presented with physical disability after receiving INFLUENZA VACCINE by an unknown manufacturer. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Incorrect vaccination administration interval.  Second Pfizer COVID-19 injection administered 14 days vice 21 days after first injection.  No adverse reaction noted or reported by patient or guardian.
used Prevnar 13 four times, and it has not worked.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's mother) reported that a 4-yearold female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), four times via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had used pneumococcal 13-val conj vac (dipht crm197 protein) four times, and it had not worked. The outcome of event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to a currently 19-year-old female patient. The patient's concurrent conditions and medical history were not reported. The patient had no concomitant medication, no drug reactions and no allergies. On an unknown date in 1998, the patient was vaccinated with the first dose of M-M-R II (dose, lot#, expiration date and route of administration were not reported). On an unknown date in 2002, the patient was vaccinated with second dose of M-M-R II (dose, lot#, expiration date and route of administration were not reported). On an unknown date, the patient developed chickenpox. On 13-JUN-2016, titers were drawn and the results were positive for varicella. On 29-JUN-2016, the immunity test was performed with a positive result for mumps and rubella and negative result for measles. According to negative result for measles, the patient was supposed to be administered the third dose of M-M-R II but was inadvertently administered a dose of PROQUAD lot# L024497 with expiration date: 01-JAN-2017, via subcutaneous route (dose was not reported). No third dose of M-M-R II was ultimately administered. Product quality complaint (PQC) was not involved. The outcome of the chickenpox and the patient was negative for immunity to measles was not reported. The relatedness between the chickenpox and the patient was negative for immunity to measles was not reported. The relatedness between the chickenpox and the patient was negative for immunity to M-M-R II was not provided. Additional information has been requested.