chrisvoncsefalvay/vaers-outcomes huggingface dataset:
acute appendicitis; I had severe abdominal pain beginning on 02Apr; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 43 years, on 30Mar2021 10:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 03Apr2021 to an unknown date. Concomitant medications included paracetamol (TYLENOL) and nystatin (STATIN [NYSTATIN]), both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2, at the age of 43 years, on 09Mar2021 in the left arm at single dose for COVID-19 immunization. The patient stated, "I had severe abdominal pain beginning on 02Apr2021; I went to the emergency room at 3am on 03Apr2021 and was diagnosed with acute appendicitis". The patient was hospitalized for the events. The outcome of the events was recovered on an unspecified date.   Information about Batch/Lot number has been requested.
mom contacted clinic about rash on pt today;had vax 2 days ago;rash onset today red, splotchy skin sl raised;seen by MD;
This spontaneous report was received from a medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 22-JAN-2015, the patients were vaccinated with VAQTA, lot # J016216 (expiration date- 18-AUG-2016) and lot # K012457 (expiration date- 04-JUN-2017) intramuscularly which had underwent unsupported temperature excursions (incorrect product storage). No adverse effect was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
5/17/19 - experienced itching behind right knee in the morning, noticed redness behind right knee in the afternoon. affected area: 6" along leg x 4"across.  Patient applied clobetasol around 1p, redness and itching began to go down.  Patient will visit PCP next monday regarding this reaction.
When I woke up and sat up in bed the room was spinning.  I sat there for about 5 minutes before attempting to get out of bed.  The vertigo finally stopped.  I have never experienced vertigo before.  The evening on the day I received the shot, my left upper arm was sore, red and swollen.
Oct 24, 2007 Wed. Yearly Exam, Chest  Xrays, Shingles Vaccine Shot; Oct 25 - Oct 26-Fri Burning on small patchs of skin; Oct 27-Sat, Oct 28-Sun These two days slept most of time Low fever; Oct 29 mon) As soon as Doctor opened on Monday at the Clinic went down; Chest Xray - Pneumonia (Amoxicillin 125mg I had no cold could not breath so short of breath; Nov 2, 2007 Back to Dr. (new medicine) Levaquin 750mg; Still not over it.
This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) in a 78-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. LITERATURE REFERENCE: Immune thrombocytopenia following COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) to be related. No concomitant and treatment medication were reported. Company Comment: This literature non-study case concerns a 78-year-old, female patient with no reported medical history, who experienced an unexpected, medically significant AESI Immune thrombocytopenia following a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the event immune thrombocytopenia relative to vaccination cannot be determined with unknown event's start date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported in this case version. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement. Sender's Comments: This literature non-study case concerns a 78-year-old, female patient with no reported medical history, who experienced an unexpected, medically significant AESI Immune thrombocytopenia following a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the event immune thrombocytopenia relative to vaccination cannot be determined with unknown event's start date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported in this case version. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 3 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ, lot#K004480, expiration date 05-FEB-2016 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
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 06-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) 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 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.
I had really sharp abdominal pain, nauseous, fever, chills and dizziness.
The patient reported that they can't move their arm without a sharp pain. There is a large red spot between the shoulder and the elbow. It also burns and tingles and hurts when her shirt touches the area. The patient said she would be contacting her primary care physician on Monday.
Got the vaccine on Thursday, March 18. Friday, March 26 I woke up with my upper left arm (the injection site) red, tender, and swollen, with slight body fever at the site. The area is currently about two and a half inches by two and a half inches.
bo known side effects; administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-SEP-2021, the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot # T025943, expiration date 30-JUL-2022 (formulation, strength, dose, anatomical location and route of administration were not reported) for prophylaxis. The patient had no known side effects (no adverse event). The reporter stated there were 2 excursions from July and they had no data information at all for temperatures during August and September. They discovered their freezer was having issues and were not aware because the alarm had accidently been turned off after having maintenance performed on freezer. Insufficient data to evaluate vaccines. The reporter stated they knew they were warmer than refrigerated temperatures but were not able to provide warmest temperature or length of time out of range.
pt presents to ED after being seen earlier in the day by urology for lithotripsy; pt started to have fever, become tachycardic and have SOB; O2 supplementation; found to be positive for COVID; admitted; given remdesivir, ABX, decadron; over time, respiratory status worsened; no signs of PE; pt coded multiple times with CPR administered; wife then chose to not have any more aggressive measures done and pt passed away in the hospital
Arm swelled up (all over) after Tdap shot & seven days later spit up 2-3 tablespoons of blood will give blood samples to hospital.
Dizzy, elevated heart rate, shortness of breath, fatigue - symptoms were worst upon waking in the morning approximately 15 hours post vaccine so elevated heart rate noted during sleep (Garmin heart rate monitor/watch) starting as early as 1 a.m. on 1/21 or around 10 hours post vaccine. The above symptoms subsided some approximately 24 hours post vaccine and were resolved by approximately 40 hours post vaccine. However, 1 p.m. on 1/22, noticed injection site was itchy, red, swollen, and sore. Took Benadryl that evening and swelling subsided some by next morning and completely resolved by 1/25.
13JAN93 several episodes of unusual crying, difficult to console, longest epiosde lasted 1 hr; vomiting x 1; sx t101, large swollen, reddened area @ inject site on lt arm; 14JAN93 APAP given;
Hives started on right leg middle inside near knee One day after the vaccine. Hives started spreading. April 1 I went to dermatologist Dr. she gave me steroid creams and instructed me to take three Allegra a day for a month. Hives continued to spread and Dr. prescribed oral steroids instructed me to start taking two weeks after vaccination. Today was my first day of oral steroids. Hives seem a little better not as angry.
within 5 min pain in ears 30 min neck and jaw pain 45 min ringing in ears next day - joint and muscle pain, headache, fatigue day two slurring speech, nose burning day 4- ears ringing and fatigue, dizzy
According to the patient, began low grade "fever a couple" days ago, tylenol not helping, sore arm not tender to touch or red or swollen but "feels better if massaged". Feeling "off" today and Neighbors in action, who comes twice per week, helped take her temperature which was 99 degrees F. RN advised to continue tylenol and try icing for pain, continue to massage if helpful.
His heart disease was a side effect of the covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US146170_OS.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "His heart disease was a side effect of the covid vaccine.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1) Swelling, pain, tenderness, redness of entire left arm from shoulder to wrist, fever 100.5. Physician observed and ordered Augmentin x 7 days. Symptoms slowly improved over about two weeks. 2) Tachycardia, irregular heart beat, chest pressure, shortness of breath, fatigue beginning two days after vaccine and although I feel better now, symptoms are still present at the time of this report (lasting over a month)
Joint Pain for 72 hours, headaches, brain fogginess/confusion, fatigue.
The patient developed a red, slightly raised rash the morning after the influenza vaccination. Rash was itchy. It was starting to resolve by Friday afternoon.
Initial report received on 03 September 2009 from a physician. A 12-year-old male patient, who is enrolled in a clinical trial for ADHD with a tricyclic investigational drug, but who has no known allergies, had received a dose of MENACTRA (lot number, route and site not reported) on 10 August 2009 (at an alternate facility) after being screened for a clinical trial and days prior to the patient being randomized and receiving a tricyclic investigational drug (which is in early phases of clinical development). Approximately 2-3 weeks after receiving MENACTRA, and an unknown number of days after receiving the tricyclic investigational drug, the patient developed pruritic maculo-papular rash on his feet and legs which migrated proximally to his face and scalp. He subsequently developed mid-epigastric abdominal discomfort and nausea (date not reported). The patient was treated with a MEDROL-dose pack for the rash which improved, but had not resolved at the time of this report. Per the reporter, the adverse events were assessed as being related to the study drug versus possible enteroviral gastroenteritis that was circulating in the area. At the time of this report, the patient had not recovered.
This is a spontaneous report from a non-contactable consumer. It was reported that an unknown patient (sex/age/race unknown) received an unknown number of doses of PREVNAR 13. The medical history and concomitant medications were unknown. On an unknown date or dates, the patient experienced Streptococcal pneumoniae meningitis, drug ineffective, otitis media, seizure, upper respiratory tract infection (URI) with fever, pale, bulging fontanelle, and fussiness. It is unknown if the patient recovered.
Heart stopped, passed out and heart restarted several times over the course of 5 days until a Medtronic pacemaker was implanted.
Persistent, sometimes severe headaches. Has occurred daily for past 9 weeks. Take Tylenol daily. Frustrated that I can?t overcome these headaches. Didn?t report previously because I thought they would go away.
approximately 1 week after my vaccination i started experiencing a large injection site rash that quickly spread to my forearms and hands to include my fingers. The rash has also spread to my legs and feet as well as my ears and nose . The rash consist of large red extremely itchy bumps / hives
I started experiencing nausea and black diarrhea on September 18,2021. I went to the Dr. September 28, 2021, thought it was Diverticulitis. The symptoms came back on October 26, 2021, feeling very nausea, barely could walk asked son to assist me. I saw my doctor on 11/1/2021 was referred to Gastroenterology & Hepatology.
Woke up to go to bathroom about 3:50 am and couldn't get out of bed.  I was  completely off balance.  I tried to walk and couldn't.  Sat down again but had to do so I hung on to the bed, walls, and doors to steady myself to get to bathroom.  Had a little diarrhea.  Managed to take 2 Tylenol and drank lots of water.  I held on to everything again and got back to bed but sat up instead of laying down.  I still had diarrhea so I held on to every thing again and took one Anti-Diarrhea pill.  Went back to bed sitting up and tried to sleep.  Got up around 8 am and felt better but still a little woozy.
pt recv vax 1OCT96 & on 8APR97 pt devel chickenpox;
This spontaneous report as received from a pharmacist and the patient himself refers to a male patient of unknown age. On 08-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot # J005850, exp 01-AUG-2014) in the left upper arm (dose and route unknown) at his local pharmacy (Name and location unspecified). The patient stated a couple days later (in approximately January) he experience redness, swelling at the injection site. The redness and swelling has dissipated some, but his arm was now was extremely painful with any movement. The patient had a physical therapy appointment. On JAN-2014 the patient experienced swelling at the injection site, arm is now is extremely painful with any movement and redness at the injection site. The outcome was also reported as not recovered/not resolved. Additional information has been requested.
Inadvertent Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 40-year-old patient who received MMR (Priorix) (batch number AA25SS, expiry date 01-NOV-2024) for prophylaxis.   On 15-JUN-2023, the patient received the 1st dose of Priorix (left deltoid). On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration). The outcome of the incorrect storage of drug 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 Information: GSK receipt date: 5-JUL-2023 Nurse reports patient was administered priorix after a below temperature excursion inadvertently. The Vaccine Administration Facility was the same as primary reporter. Consented to follow up.
Parts of it turning even yellow so hemoglobin breakout; area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that's over 10 cm; swelling at the site; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious received from physician and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00826520).  This case involves a male patient who experienced area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that over 10 cm (erythema), parts of it turning even yellow so hemoglobin breakout (Extravasation blood) and swelling at the site (swelling) when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that over 10 cm (erythema), parts of it turning even yellow so hemoglobin breakout (Extravasation blood), swelling at the site (swelling) (one day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "I have been a big component of it and have had it myself ever since it was introduced and just a few days ago, I got an unexpected reaction myself to the vaccination. I have never had anything like this to any vaccination. The area became very red, erythema extending, over the next day, all the way down to the antecubital fossa and that over 10 cm. Parts of it turning even yellow so hemoglobin breakout. No other symptoms and swelling at the site. So this is my question, I wonder if there has been any change to the formulation for the 2021-2022 product. Your quadrivalent. Something is different because I have never had anything like this. This was remarkable, grade 3, I have a 10 centimeter."   Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for the events (erythema, extravasation blood, swelling).  As per reporter the causal relationship for events (erythema, Extravasation blood) with the FLUBLOK QIV was not reported.  There will be no information available on the batch number for this case.
Bruised arm; Itchy; Accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old; A spontaneous report ( was received from a pharmacist concerning a 15-year-old, female patient to who accidently received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental administration of the Moderna COVID-19 vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, itchy/pruritus and bruised arm/contusion.  The patient's medical history was not provided. No concomitant product use was reported.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L29A) in the right arm intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021, a 15-year-old female patient received an accidental dose of the Moderna COVID-19 vaccine and experienced an itchy arm.   On 28 Jan 2021, the reporter noted the patient had a bruised arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, was considered resolved on 25 Jan 2021.  The outcome of the events, itchy and bruised arm, were considered unknown.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 12L29A, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No additional AEs were reported; The nurse reported that 33 patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-MAR-2022, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # U026217 and expiration date 02-NOV-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 34.3 degree fahrenheit (F) for 55 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001821: US-009507513-2204USA001816: