chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored after expiration date in the refrigerator; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
shivering/ Teeth chattering; he still felt very bad, and that general feeling of not feeling well; weight loss; something in lung; bleeding at injection site; sore arm; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix and Influenza vaccine. In October 2019, immediately after receiving Shingrix and Influenza vaccine, the patient experienced injection site hemorrhage, pain in arm, fever, shivering, feeling unwell, weight loss and lung disorder. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the injection site hemorrhage, pain in arm, fever, shivering and feeling unwell were recovered/resolved and the outcome of the weight loss and lung disorder were unknown.   It was unknown if the reporter considered the injection site hemorrhage, pain in arm, fever, shivering, feeling unwell, weight loss and lung disorder to be related to Shingrix and Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reports that he got Shingrix and a flu vaccination on the same day in late October 2019, around October 20. He had bleeding at the injection site for Shingrix immediately after vaccination. His arm was very sore for several days after getting the vaccine. About 12 hours after he got the vaccines he woke up with a fever, 3 degrees F above normal, and such intense shivering that his teeth were chattering. It took about 1.5 hours for the shivering to lessen so he could go back to sleep. The fever lasted about 6-12 hours after it started. Once the fever and shivering resolved he still felt very bad, and that general feeling of not feeling well continued. Five days after getting the vaccine he saw his HCP because he still felt terrible. He had a chest x-ray and the HCP saw something in his lung and was recommended that he take Mucinex. He continued to not feel well and was losing weight, so 3 weeks later he saw his HCP again. After the 2nd HCP visit, he continued to not feel well, but the symptoms gradually resolved. Consented to follow up. Emergency room Visit Required.
After receiving vaccine, started to experience hives that come and go. They are welt-like and tend to appear after showering and in the evenings. They are centered around lower back and waist area,  but occasionally appear on neck and arms; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 04May2021 at 17:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC), taken for birth control from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 17:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 22:30, after receiving the vaccine, the patient started to experience hives that came and went. They were welt-like and had tend to appear after showering and in the evenings. They were centered around her lower back and waist area, but occasionally appeared on her neck and arms. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event after receiving the vaccine experienced hives that came and went, they were welt-like and tend to appear after showering and in the evenings and centered around her lower back and waist area, but occasionally appeared on her neck and arms was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Case number PHEH2014US025001, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 09-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
75 y.o. male who presents with LLQ PAIN INTERMITTENT FOR 3 WEEKS.  PT STATES HIS "BOWELS HAVE NOT BEEN RIGHT" MEANING HE DOES NOT HAVE A STOOL EVERY DAY.  HE SAYS HE HAS BEEN TAKING A STOOL SOFTENER AND PROBIOTIC AND NOW STOOLS ARE "RUNNY" BUT PAIN PERSISTS AND IS WORSE WITH DEFECATION.  DENIES FEVER, CHILLS, NAUSEA OR VOMITING.  PT STATES HAS HEMORRHOIDS AND HAS HAD SOME BRIGHT RED BLOOD OCCASIONALLY WITH STOOLING.
The caller stated doses of improperly stored VARIVAX were administered to patients; No additional adverse events were reported; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W039294 with expiration date on 11-DEC-2024, administered for prophylaxis (dose, route of administration, and anatomical location were not provided) (product storage error). The excursion ocurred at a temperature of 17.4°F for 2 hours. No previous temperature excursions were reported, and no additional adverse events were reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 22-AUG-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, intramuscularly, 0.5 ml, lot # L037339, expiry date 09-FEB-2018 (anatomical location was not specified). The administered dose of GARDASIL 9 was stored at 90 Fahrenheit degrees for 14 days. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
asthma like symptoms (coughing, mild respiratory distress); My legs were also a bit swollen; The next morning(around 5:45 am) felt light headed and clammy after workout; The next morning(around 5:45 am) felt light headed and clammy after workout; I had a rash on my legs, trunk and arms; asthma like symptoms (coughing, mild respiratory distress).; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ENG208, expiration date was not reported) via an unspecified route of administration, in left arm, on 14Mar2021 15:30 (at the age of 55-years-old), at dose 1, single for covid-19 immunization from pharmacy or drug Store. Medical history included asthma. Concomitant medications included estradiol; progesterone; sertraline hydrochloride (ZOLOFT). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. It was reported that the next morning (15Mar2021 06:00), the patient felt lightheaded and clammy after workout, her legs were bit swollen, rash on legs, trunk and arms and experienced asthma like symptoms (described as coughing, mild respiratory distress). The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
Pt vaccinated w/MMR/OPV/HIB/TB Tine developed tonic/clonic generalized seizure w/out fever occured within 17 days of receiving lst MMR, 3rd OPV, HIB Vac, TB tine test.
Heart issues started shortly after second dose. Seemed more frequent at night when sitting down or resting. Pain where heart is, sharp and aching for times. Began happening during the day and would make me stop what I was doing completely.
Patient brought to the ED for syncope and confusion.  Patient admitted to hospital for Covid and cardiac workup and treated with remdesivir.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # L038669 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.    Additional information has been requested.; Sender's Comments: US-009507513-1707USA000600: US-009507513-1707USA000155: US-009507513-1707USA000599:
Body aches; Fever (102F); Chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 54 -year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 09:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number. EN6198) via an unspecified route of administration in the left arm on 27Feb2021at 09:00 (at the age of 54-years old) as a single dose for COVID-19 immunisation. On 20Mar2021 at 20:00, body temperature was measured and found to be 102-degree Fahrenheit. On 20Mar2021 at 20:00, the patient experienced a fever of 102-degree Fahrenheit, chills and body ache. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome for the events fever, body ache and body aches were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
I had a delayed local reaction. Itching, slightly red, swollen arm. I understand that  local reactions are usually 1-3 days after the vaccine but mine started 7 days after the injection. I researched my symptoms I found out that  it is rare to have a local reaction 7 days after the shot but there are others in the same situation. They suggested I report this to the CDC.
Within 24 hours after, I had significant pain and swelling in both of my legs. By later that evening by 8PM, I could barely walk. The swelling started to go down by the 25th. But the significant pain particularly if I was standing for a long time would hurt. I still have it. It went down over time. Within a month, because it was still significant, I went to see my doctor because I was concerned of a potential blood clot. Ultimately, I ended up having a scan done. I also had similar pain on my upper right arm. That took several weeks to start. We did a scan for blood clot in the veins on that arm, which were negative. The pain was consistent with what you may describe as having blood clots. It took several months to subside. My legs still have unusual pain even a year out. Which I did not have prior to the vaccine. There was also some irregular heartbeat. I have had 2 echocardiograms which have come back completely fine. The other thing that started post vaccine was pelvic pain that I sought treatment for. They found some cervical polyps that appeared to be benign and I am going to have surgically removed. They might have been there prior, but the pain started post vaccine. Within a couple of months of having the vaccine, I had reoccurring hemorrhoid situation. That lasted probably 2 months. There is still some undiagnosed unusual rectal pain.  I was told to start taking a low dose Aspirin every day.
received Pediarix by mistake; received Pediarix by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: received Pediarix by mistake) and inappropriate age at vaccine administration (Verbatim: received Pediarix by mistake).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 30 Aug 2023:: The reporter was a nurse supervisor who stated an adult patient (18+ Years old) received Pediarix by mistake, which led to wrong vaccine administered and inappropriate age at vaccine administration. No other information provided. The reporter consented to follow up.
Within 3 hours, mid facial and neck rash spreading to extreme neck, head/face and eyelid redness and edema within 24 hrs.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: Several minutes following vaccine, pt fell out of chair onto floor with short episode of convulsions. Returned to chair for 40 min, faint pulse, cold hands, pale, tired.
Left arm where the injection was given was still swollen but better; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Left arm where the injection was given was still swollen but better) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027#22A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Taking unspecified medication for high blood pressure) and Penicillin allergy.    On 17-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced VACCINATION SITE SWELLING (Left arm where the injection was given was still swollen but better). At the time of the report, VACCINATION SITE SWELLING (Left arm where the injection was given was still swollen but better) was resolving.            Concomitant product included unspecified high blood pressure medication. On 15-Feb-2021, the patient received first dose of Moderna vaccine with lot number 015M20A. On 15-Mar-2021, the patient received second dose of Moderna vaccine with lot number 002B21A. On 15-Nov-2021, the patient received first booster dose with lot number 033L21A. On 11-Apr-2022, the patient received second booster dose with lot number 005M21A. On 17-Oct-2022, the patient received third booster dose with lot number 027#22A. The patient never had covid positive test or diagnosis. The patient received booster dose and experienced arm was swollen. It was swollen and puffy. This was currently going in to the third day. The patient put an ice pack on it. The patient was able to move arm. She felt great as far as health wise. Her arms felt lumpy at the time of report. At the time of the report, patient's left arm where the injection was given was swollen but better.    Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Live follow-up information received included reporter details, patient details, events and narrative updated.
Approximately 1-2 minutes after injections patient became pale and fell to the ground. She cried immediately. Was clammy and flushed for 5-10 minutes after near syncopal collapse. Baseline after 30 minutes.
I am a nurse and was checking my blood pressure when I discovered the elevated blood pressure prior to vaccine. The doctor ordered a 24 hour urine test and placed me on amlodipine along with my order blood pressure medication. It brought my pressure down immediately but then my pulse was elevated and my blood pressure dropped to low. The doctor had me to stop the amlodipine and check my blood pressure for 2 days. A blood panel had been done at the same time Renin at 21 when normal result should be 5. After the vaccine, I had an MRI completed and I was provided with 5 diagnosis which were rotator cuff tendinosis with partial thickness tears of supra stenosis, infra-stenosis and sup scapula tendons, mild long head biceps tendinosis, moderate glenohumeral degenerative arthritis, joint effusion with synovitis, labral degeneration and SLAP tear, mild acromioclavicular joint degenerative arthritis, sub acromial subdeltoid bursitis. I was treated with a cortisone shot, continued physical therapy 3 times per week and scheduled with another specialist in my area. Report to the provider for this on Thursday. Developed pain in left arm and high blood pressure. Left arm determined to be joint issue.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 26-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddr; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Her arm is sore and swollen; Her arm is sore and swollen; dizziness; rapid heart rate/she started having a bounding rapid heart beat; SOB/Shortness of breath; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199 and expiration date not provided), via an unspecified route of administration first dose on 07Mar2021 at single dose for Covid-19 immunization. The patient's medical history included allergy history to a of number of medication and things (I'm prone to allergies). The patient's concomitant medications were not reported.  On 07Mar2021, the patient received the first dose and she went to sit in the observation area for 5 minutes. The patient was not anxious at all about getting it but she started having a rapid heart rate/ bounding rapid heart beat and SOB/shortness of breath that lasted about a minute. The EMT checked her out and asked her to stay longer and she did and after about 5 more minutes the same thing happened again. These episodes lasted about 1 minute and she had dizziness with it. Also she did not have any further episodes and she stayed a long time. Her concern was whether this was indicative of an allergic reaction and should she still get the second dose. The patient was asking for information about 2nd dose being given after 42 days. The patient stated that she has not had any more of those symptoms at all. The patient arm was sore and swollen that was all now. The events heart rate increased, dyspnea, pain in extremity, and peripheral swelling was assessed by the reporter as serious (medically significant). The outcome of the events heart rate increased, dyspnea, and dizziness was recovered and unknown for the remaining events.  Information on Lot/Batch number was available. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2014 the patient was vaccinated with VARIVAX (Merck) (lot# and expiration date not provided) of dose 0.5 ml (milliliters) subcutaneously. It was reported that VARIVAX (Merck) was exposed to an improper temperature for the third time on 29-MAY-2014 in which it reached a high temperature of 25 Farenheit (F) for 20.5 hours. There was no product quality complaint involved. No adverse effect was reported. Outcome of the medication error was unknown. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423, MARRS#1406USA005108,MARRS#1406USA005109, MARRS#1405USA014687). Additional information has been requested.