chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 28-FEB-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Reporting employee  seated a client for their observation period as they were finishing with her, they turned and saw the client falling from his chair. The client fell on his right side, hitting his right forehead on the floor. The rapid response was initiated at 1748, client was alert & oriented x4 to self, time, and location. Vital signs initiated q5 min all within normal limits. EMS called at 1806. Vital signs performed by Tenzin.   Ice packs, water, and food provided to alleviate client symptoms. Client expressed "I'm fine" towards the end of the scenario after the 2nd set of vitals which were taken at 1753.
right axilla adenopathy. really large and very tender. RX: motrin a couple times in the next 2 days. Outcome; resolved after 3 days
Redness- painful -  swelling (L) thigh - 3cm X 4 cm 1day post vaccination
Nausea-on and off since the following day Headache, chills, bodyaches, fatigue- 18hours Injection site pain-  still experiencing pain Injection side itch, red and swollen- still experiencing
A few moments after the patient received his second dose of Pfizer vaccine, he collapsed onto the ground and hit his head on the right side. His mom immediately called for help. He was responsive shortly after while laying on the floor. I (pharmacist) brought him a bottle of water and he was able to sit up slowly to drink some water. He gradually felt better but appeared to be pale and veins on the sides of his head were apparent, more apparent than usual per his mom. The patient felt dizzy and lightheaded throughout. He rested on the ground for a few minutes and then we moved him to the open waiting room area by the pharmacy to sit down. After talking to the patient, he mentioned that he only had a snack to eat all day. The store called EMS on the mom's behalf, the fire rescue team and EMS arrived shortly. His blood pressure was low per the EMS's observation. They took him to the hospital for further analysis.
PATIENTTWENT TO ER 06/06/2021  WITH FEVER, DISTENDED ABDOMEN WHICH WAS TENDER TO THE TOUCH & INCREASED BACK PAIN. PATIENT WAS ADMITTED TO HOSPITAL 06/07/2021
At 5PM on 3/14/21 I suffered a TIA; was ambulanced to the ER.
Patient developed swelling, heat and pain at the injection site in the evening. On the third day, she vistited her doctor, who prescribed her oral steroids, but no antibiotic.
No swelling, no redness, dull/sharp pain, left shoulder by site of injection.
touch of pneumonia; running a fever/temperature; running a fever/temperature; This is a spontaneous report from a contactable consumer (child of patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. Medical history included Alzheimer's. The patient's concomitant medications were not reported. The patient experienced running a fever/temperature and a touch of pneumonia on 11Feb2021. The clinical course was reported as follows: The day the patient was to go for her second dose, she was running a fever and was not able to go. The patient was diagnosed and had a touch of pneumonia. The patient was put on unspecified steroids and two unspecified antibiotics. The patient was running a temperature on an unspecified date but was better on 12Feb2021. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of running a fever and a touch of pneumonia was recovering.
Pt left clinic 15 min. after administration of vaccine. Pt returned to clinic 5 min later with complaints of shortness of breath. Pt placed on oxygen and given Benadryl 50mg/ml per protocol. Then was transported via ambulance to hospital. Pt was given more Benadryl upon arrival. Was also given Prednisone while in ER. Pt was sent home with Prednisone pack x 1wk.
4/28 (Wed) Morning - received vaccination afternoon - fatigue, nausea and headache night - high fever, chills, and shivering ---  took Ibuprofen (200mg) to help with the symptoms  4/29 Thurs morning and afternoon - fatigue, nausea, headache, fever, chills continue   took Ibuprophen (200mg) to help with symptoms Night - rash started appearing on arms  4/30 Friday Fatigue, nausea, headache, fever, chills were all gone  but red rash all over arms, face, chest, waist, back, some on legs   --- slightly itchy, slightly tingly, almost like a bad sunburn all over the body Took benedryl  (10mg) at night before going to bed  5/1 Sat Morning: rash much less.   Took some Claritin (5mg) in the morning and by the evening the rash had subsided
Shortly after I felt really tired and went to bed.  Had chills and a fever of 101 during the night.  I developed a headache and felt fatigued all throught out the next day and after about 24hrs all symptoms dicipated.  For the next 2 days after I felt run down but was still functional and by the 3 day I was fine.
headache and chest tightness started next day of the first shot. Took Tylenol but didn't work.  Day 2 after the shot, chest pain starts in the morning and felt difficulty breath and severe headache, numbness on injected arm. Went to ER, given pain relief and prescribed ibuprofen. chest tightness continued until day 19 after the shot and headache is still continued now (day 35 after the first shot /Jan 4. 2022)
It was reported that a 64 yr old female pt rec'd a flu vaccination on 11/15/99. Reportedly that same day the pt developed GI upset, cramps, diarrhea and weakness to the point of  feeling faint. Pt was treated with IV fluids at the hospital and released. Gastroenterologist evaluated pt. Sigmoidoscopy was normal with small hemorrhoidal bleeding. Pt was informed by hospital staff these reactions were not related to the flu vaccine.
Patient reports persistent but less obvious cognitive change described as being in a cloud x 2 weeks. Reports received second moderna covid vaccine 4/6 at which time she experience right facial swelling around eye, tongue numbness, difficulty swallowing and confusion that began 20 min after injection. Reports she drove around for 2 hours trying to remember/find her way home and couldn't/didn't think to call husband. Did not take benadryl or attempt to trt sx with any other medication. Reports similar but more mild rx to initial dose 3/9
has the intention of giving Shingrix to a 43 year-old patient; This case was reported by a physician via call center representative and described the occurrence of off label use in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 7th May 2021) and (batch number 7L355, expiry date 28th August 2021) for prophylaxis.   Concurrent medical conditions included herpes zoster (chronic in nature). Concomitant products included acyclovir.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The reporter stated that, he had the intention of giving Shingrix to a 43 year-old patient because the patient had zoster chronic and she was taking Acyclovir, which was a off label use. The reporter had bought this Shingrix vaccines 2 years ago of the reporting date and stored appropriately in the fridge for 2 years between 36 to 46 degree F. Lot Number for powder was 7L355 and expiry date 28th August 2021 and Lot Number for liquid portion was reported as TS7AA which was corrected to P57AA as per sales data sheet and expiry date 7th May 2021. Also, the batch number reported for powder seems to be of shingrix adjuvant as per sales data and therefore kept as per sales data sheet. The reporter consented to follow up.
throat and tongue swelling 5 minutes after vaccine.  Hard time swallowing. Sat at the facility for 1 hour under observation, then went to the ER.  by the time I got to ER, I  was short on breath.  Doctors immediately  gave epi and steroids.  Was diagnosed with anaphylaxis.
vaccine may have been stored under conditions that departed from the manufacture's recommended specifications. the manufacture deems the vaccine is not to be viable. no harm was caused; however, the patient may not received the optimum benefit of the vaccine.
Pregnant- due date 7/10/21- not considered high risk or with any complications   The night after the vaccine I was fatigued and ran a mild fever with chills. It seemed to be going away but the next night I was woken up in the middle of the night with extreme throbbing pain in my right knee. It was swollen but no injury had occurred. I couldn?t put any weight on it. I went to health. They diagnosed it as patellar bursitis with unknown cause. They checked my blood and ruled out gout and or trauma as a cause. My blood showed signs of an immune reaction (possible infection) but it was 2 days after vaccination. To be safe they put me on a 10 day course of antibiotics because of the rapid onset they were afraid it might be a localized infection that could spread (but couldn?t determine a cause as there was no injury or broken skin in the area).  I couldn?t put any weight on my knee and dr advised 3 days off work to elevate, compress, and ice. I am still using a knee brace at work and it is still mildly swollen. No known cause or signs of trauma.
This spontaneous report was received from a certified medical assistant concerning a male patient of unknown age. On 27-MAR-2012, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 26-MAR-2013, the patient was vaccinated with the second dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Pt. Vaccination was March 5,2021, became  immediately dizzy and light headed onsite paramedic walked with him around the site for observation and evaluation. Allowed to leave was fatigue and nap and when he awoke had the  within 24 hrs . Tenetus increase dramatically in high pitch and intensity that was constant.  Had disruptive sleep since the vaccine because of the ringing in ear. Average 4.5  and 5. Never straight sleep it is disruptive sleep. Three telehealth appt. March 26, 2021 because of anxiety because of the ringing.
Fully vaccinated and boosted 12/1/21.   COVID Infection breakthrough, asymptomatic.   Inpatient hospital stay for non COVID reason.
I was throwing up all night and I felt sick for the entire day after my shot. I had very bad cold sweats as well
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Endometriosis. Concurrent medical conditions included Drug allergy (Sulfa drugs). Concomitant products included VITAMIN D3.   On 04-Mar-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Nov-2020 and the estimated date of delivery was 18-Aug-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, Pregnancy test: positive Positive. On 13-Jan-2021, Ultrasound scan: normal Normal. On 31-Mar-2021, Culture urine: positive Positive for UTI. On 31-Mar-2021, Ultrasound scan: normal Normal.         No Treatment related information was reported. The 11-Nov-2020, was considered to be an estimated date of conception. Patient had 0 previous pregnancies. The patient was taking Pre-Natal Multi Plus DHA 100 ml as supplement.
ATRIAL FIBRILLATION on  04/05/2021. discovered on 4/15/2021 . started on Xarelto  20 mg at a cost of $488. gout dxed on4/16/2021 by dr behar. started on mitigare 0.6 mg bid.
Large red blotches all over my body. Extremely itchy, inflamed, red rashes. Moving from one area to another.  Started around 5:00 pm 3/5/2021 and still present. Taking  showers, taking Benadryl and using Serna lotion. Unbearable at times.  Not able to sleep well due to itching.
Area approximately 6 inches long and 4 inches wide became red and hot to the touch.  No rash or swelling but did itch.  This is 6th day after this occurred.  I saw the doctor yesterday (Wednesday) and showed him my arm.    He said if it wasn?t better by Friday to let him know and he would give me an antibiotic.
Herpes simplex keratitis; extreme eye redness; eye irritation; This case was reported by a consumer via sales rep and described the occurrence of herpes simplex keratitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant), eye red and eye irritation. On an unknown date, the outcome of the herpes simplex keratitis, eye red and eye irritation were recovered/resolved.   It was unknown if the reporter considered the herpes simplex keratitis, eye red and eye irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he had never taken any non-prescribed drug nor he drank alcohol. In June 2019, 2 months before the reporting date, the patient received 1st dose of Shingrix and experienced extreme eye redness and irritation which lasted a week. The patient's son indicated that his eyes problem could be herpes simplex keratitis and advised against taking second dose. The patient felt that he should complete the second dose and that eye problem was tolerable condition, if it prevents shingles. The reporter consented for follow up. For tolerance to 2nd dose, refer case US2019AMR150992.
had intermittent abdominal pain that hit at 72 hours (late last night, early this morning); began with nausea and it comes in waves/continues in waves along with the nausea, it comes and goes from moderate severe to low grade; headache; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID 19 vaccine on Wednesday close to noon and reported that, "I didn't notice any symptoms until yesterday morning (02Jan2021), I began with nausea and it comes in waves. I did have headache that began Friday evening (01Jan2021) and continues in waves along with the nausea, it comes and goes from moderate severe to low grade. I then had intermittent abdominal pain that hit at 72 hours (late last night, early this morning, 03Jan2021). No diarrhea associated with it. I can't find abdominal pain on the paperwork that was provided to me. is this also one of the expected or reported side effects?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information given over the phone from provider to PHN - PA. Fever of 101.9 and 97.6 with tonic-clonic seizing - seizures occurred 16-18 hours after vaccination. VALIUM was given - Medivaced to Hospital for evaluation. Monitored for 2 days. Doing well - No known sequela.
Myalgia, fatigue, neck pain, headache, small pauplo-vesicular rash (5-7 lesions). Temperature elevation 101.5.
1-1 1/2 hours after receiving HPV #2 developed an itchy rash. Presented the following morning at health dept with extensive hive-like reaction, Rx'd BENADRYL 50 mg every 4-6 hours.
The adverse events I experienced started about 20 minutes after I received the vaccine. The first event was an minor swollen tongue and throat. This is a typical response I have towards vaccines. The second event was because of the polyethylene glycol and other products in my regular environment. The third thing, the vaccine seemed to trigger a long term immune system an autoinflammatory response. Examples of this would be general anaphylactoid response, fatigue and exacerbation of existing medical conditions over the past couple of months. I would like to mention that my Dr. is currently evaluating long term additional causes of immune system and autoinflammatory symptoms.
Stated approximately 1 hour after receiving vaccine started experienced palpitations, shaking/shivering. Blood pressure elevated, redness on face. Patient went to ER stated they did EKG and blood work but found nothing conclusive and discharged.
her first shot was Moderna and her second shot was Pfizer; A spontaneous report was received from a reporter like a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and second dose was pfizer.   The patient's medication history was not reported. Concomitant medications not provided.  On an unknown date, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch unknown) in the anatomical location for prophylaxis  of COVID-19 infection.  On an unknown date,following the vaccine administration the patient had her first shot Moderna and her second shot was Pfizer.  No symptoms reported. No treatment information provided.  The outcome of the event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.; Reporter's Comments: This report refers to a case of wrong vaccine administered  for mRNA-1273, lot # unknown with no associated AEs.
This spontaneous report as received from a health care student refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 20-NOV-2014 the patient was vaccinated with ZOSTAVAX, intramuscularly ay an unspecified pharmacy (reported as came to pharmacy on 30-NOV-2014 to report). On an unknown date the patient experienced bone pain. Cancer and overdose was not reported. Product quality complaint was not involved. The outcome of bone pain was reported as not recovered/not resolved. Causality was unknown. Additional information has been requested.
This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M047660, exp. date: 02-DEC-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccines were stored under temperature -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001338.
she felt like she got hit by a train after receiving the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2 of 2 reports. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose on an unknown date in Dec2020 (reported as either 15Dec2020 or mid Dec2020) for COVID-19 vaccination.  Relevant medical history was unknown.  Concomitant medications were unknown. On an unknown date in Dec2020, the patient felt like she got hit by a train and laid in bed all day after receiving the COVID-19 vaccine. It was unknown if the patient received any treatment for event, felt like she got hit by a train and laid in bed all day. The clinical outcome of felt like she got hit by a train and laid in bed all day was recovered on an unknown date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Woke up shortly after falling asleep at night with a heaviness that I felt from head to toe that was accompanied with tingling in my hands, arms, legs, feet, and face combined with sharp pains that would come in go in all my extremities, face, chest, hips, and sides. I got up and had difficulty walking and weakness in my legs. Pain has persisted on and off since the vaccine to this date. Sharp pains will occur in my extremities + hands/feet, hips, chest, and sides. Random bouts of leg weakness has happened since the vaccine a few times after initial night.