chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cramping real bad; sick all night; Chills; hurting; could not keep the Tylenol down, it came back up; stayed in the bathroom, you know I was just dribbling sometimes; This is a spontaneous report from a contactable consumer for herself. A 68-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269, Expiration date: Unknown) on 08Feb2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history included cholesterol and thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications included vitamins. The patient stated she took medications for her thyroid and cholesterol, and vitamins. On 08Feb2021 at 19:30 the patient had cramping "real bad." The patient was sick all night, had chills, stayed in the bathroom, "you know I was just dribbling sometimes and hurting." The patient could not keep the Tylenol down, it came back up. There was no investigational assessment. The reporter stated she had her first dose of vaccine "yesterday" about 11. The patient was told that the second dose would probably make her sick, but "last night" at about 7:30 she started cramping "real bad," was sick all night, had chills, and just "now" really feeling quite normal. The patient asked if "this in anyway could have affected her kidneys." The patient stayed in the bathroom and "was just dribbling sometimes, was getting normal then she just dribbling and tried Tylenol (taken as treatment) but could not keep the Tylenol." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
severe, prolonged crying w/emesis (10-12X) no fever-occured w/in 30-45" p/vax;seen in MD office approx 6hr p/vax;given APAP crying stopped 10-15" p/calm;took 20z formula w/o emesis;
Patient was at local church receiving second covid vaccine when he had a vasovagal event. Patient was brought to our hospital. CBC and CMP drawn. Patients wife states that he hasn't been drinking at home and it was determined that patient was dehydrated. APRN, doesn't feel that this is a true reaction to the vaccine but rather a vasovagal response.
Vomiting 4 times, diarrhea, headache, body aches, joint pain, chills.
Extreme fatigue, muscle pain all over even hair follicles hurt, Entirely snuffed up nose
Nerve pain started in left  lower  lateral leg, jumped to medial thigh. Debilitating , could not drive or sit (for work) or walk. Also interrupted sleep.  Started in lower left leg, then to whole leg, then went to right leg.  And one day felt in elbow.
?Moderna COVID-19 Vaccine  Swollen gland or lymph node in left armpit area. Slightly painful if touched or arm raise. Letter arm is where I got the shot.
3 days after receiving SHINGRIX, the patient developed a rash on his left forehead "cluster of vesicles", dx'ed with possible shingles and rx'ed valacyclovir. The rash spread, as well as developed white heads. The left side of his face was swollen. Advised to see dermatology to r/u bacterial cellulitis vs shingles. Dermatologist saw the patient 6 days post-vaccine. Dx'ed with Herpes Zoster, rx'ed triamcinolone cream as well as the valacyclovir that was already rx'ed. Rash cleared within a few weeks. Patient had some mild residual tenderness and redness as the skin healed.
light headed; Chills; Nausea; Pain/Soreness at injection site; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6206,) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included Atorvastatin (MANUFACTURER: UNKNOWN) for an unknown indication, Metoprolol (MANUFACTURER: UNKNOWN) for an unknown indication, Lisinopril (MANUFACTURER: UNKNOWN) for an unknown indication and Tamsulosin (FLOMAX) for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Mar2021, the patient experienced chills, nausea, pain/soreness at injection site, tiredness and light headed. The clinical outcome of the chills, nausea, pain/soreness at injection site, tiredness and light headed were recovering at the time of report. No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot #: K010215, expiration date on 05-MAY-2017 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 45 days. No previous temperature excursion was reported. Other suspect therapies included an sterile diluent (lot #: K026419, expiration date: 19-OCT-2017, Lot : L041248, expiration date: 27-JAN-2018), which were exposed with the same conditions. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
dx erythema mult dx on 8FEB98;recheck 9FEB97 rx DPH for itching;
Pt  received shot at 8 am and started to have a rash and itching all over the body at 9:30 am.  Advised to take Benadryl or apply Benadryl cream and call doctor or go to ER if s/s get worse.
Pt noticed difficulty swallowing. Numbness throughout her mouth w/ swelling at injection site. Lasted 2-3 days. Pt only expressed this 3 weeks later at her next appt.
FEELING UNWELL WITH NEGATIVE COVID TESTING AND NEGATIVE FLU; SEVERE HAIR LOSS; HEADACHES THAT DON'T REALLY EVER GO AWAY; SPIKE IN BLOOD PRESSURE FOR NO REASON  RECENTLY DONE AN EKG TO SEE IF THERE'S ARRHYTHMIA AND THERE WAS NONE. IT WAS NORMAL. SCHEDULED TO HAVE A ECHO AND STRESS TEST IN THE NEXT MONTH.   THE SEVERE HEADACHES AND BLOOD PRESSURE SPIKES ARE ALL NEW AND ONLY HAPPENED AFTER THE BOOSTER. 12/21/2021
Chills, fever 101.1, fatigue for 2 days. Took tylenol 1G and ibuprofen 400mg every 6-8hr for symptoms
Tested positive for COVID-19 on 7/17/22. Experienced fever of 103-104 for full 24 hours. (Tylenol and Ibuprofen brought it down to 102 degrees.) Next two days temperature was 100-102. Want to make it clear - the vaccine did NOT cause COVID-19 or the fever. V-safe asked for report to be submitted.
headache; achy; weak; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 14:00 at single dose on the left arm as COVID-19 vaccine. Medical history included allergies to penicillin; allergies, ITP. Concomitant medication was noted as other vaccine in four weeks reported as allergy shots on 08Dec2020 (advance ENT). The patient also had other medications in two weeks such as zinc 50mg, 5000 Vit D, venlafaxine 225, levothyroxine sodium (SYNTHROID) 100, spironolactone 100. The patient experienced headache, achy, and weak, all on 17Dec2020 21:00. Treatment was not received for the adverse events. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Got shot on Wed 11/13/13, reported blister at site of injection with minor pain and redness. Also reported flu-like symptoms and headache.
02/23/22 presents as transfer from hospital for "hematemesis" "evaluation for TIPS procedure" "Covid positive". PMHx of "nonalcoholic steatohepatitis complicated by cirrhosis of the liver and portal hypertension with splenomegaly and ascites"
expired adacel was administered to a patient, no adverse event; Initial information was received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a non-health care professional.  This case involves an 11 year old male patient who was vaccinated with a 0.5 ml expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5829BA and expiration date 24-Nov-2019) via intramuscular route in the right deltoid on 26-Nov-2019.  Concomitant medications included HPV VACCINE (HPV VACCINE) and MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for unknown indication.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Feeling of impending doom for about 20 minutes, loss of consciousness, vomiting and diarrhea, fever/chills and shaking. It resolved after 1 hour total. Didn't get worse after loss of consciousness or I would have gone to the ER.
4 days after injection, the injection site is red, itchy, swollen, hard, and warm to the touch, the redness is spreading down the arm, patient is taking Bendaryl 25 mg twice daily and using hydrocortisone 1% cream.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness) and FEEDING DISORDER (unable to eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event from 05-Apr-2021 to 18-Mar-2021. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness), FEEDING DISORDER (unable to eat), HEADACHE (Headache), NAUSEA (nauseous), MYALGIA (muscle aches and pains/whole body ached) and CHILLS (SHIVERS). On 28-Feb-2021, DIARRHEA (Diaarhea), ASTHENIA (weakness), GAIT INABILITY (unable to walk), DIZZINESS (Dizziness), FEEDING DISORDER (unable to eat), HEADACHE (Headache), MYALGIA (muscle aches and pains/whole body ached) and CHILLS (SHIVERS) had resolved. At the time of the report, NAUSEA (nauseous) had resolved.  This case was linked to MOD-2021-101676.
patient administered an expired Ipol, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a physician via Global Medical Information (GMI) (Reference number- 00558086) and transmitted to Sanofi on 12-Apr-2021.  This case involves a 14-year old male patient who administered an expired IPV (VERO) [IPOL] (lot number: R1B251M and expiration date: 13-Mar-2021] at 0.5 ml dose via intramuscular route in the right deltoid for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used (latency: unknown).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Intense low back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 10:30 (Lot number: ER8732) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herniated disc in lower back years ago" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 17Apr2021 16:00, outcome "not recovered", described as "Intense low back pain". The event "intense low back pain" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of back pain.  Additional Information: Intense low back pain. Patient had intermittent issues with back, his first shot was on a Thursday, and woke up Sunday morning with back pain that she could not associate with anything. No heavy lifting or twisting that usually causes bouts. Patient went to primary, received a prescription for a methylprednisolone pak, and felt better within 24-48 hours. No known allergies. No covid prior vaccination. Covid not tested post vaccination. No other vaccine in four weeks and no other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
03/23/21 Redness of face, neck, anxiety, rapid heart rate.  03/24/21 Vomiting,  red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
Information has been received from a consumer concerning her daughter with a history of poison ivy allergy who "6 to 8 weeks ago", was vaccinated 0.5mL with the 1st dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). Within a week of receiving the vaccination the patient experienced a marble sized knot under her skin at the injection site and the area is still tender. The patient's marble sized knot under skin at injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Client was in parking lot being monitored after injection.  Reported to attendant that she felt her throat was tightening.  RN's x 2  arrived to assess. At 3:30 BP was 106/62, HR 78.  Was administered Benadryl 50 mg po at 3:35 pm.   At 3:45 pm BP was 100/78 and  HR 72.  After approx. 10 more minutes pt reported she no longer felt sensation of throat tightening.  RN's  continued to stand by.  After 10-15 more minutes pt stated she felt fine, did not have far to drive to her home.  Was instructed to continue to monitor symptoms.  If began to experience throat tightening again, or any other symptoms to seek medical attention immediately; call 911.  Client voiced understanding.
Pt vaccinated with DTP developed Fever 102.6R, irritable, local swelling & erythema.
Rt upper thigh injection site with 9 cm x 7 cm oval area of firm redness. (KINRIX injection site). Treated with BENADRYL every 6-8 hrs.
Soreness at injection site beginning evening of administration (3/14/23).  Burning/electric shock pain behind left knee and waistline that extended to her back were reported on 3/17/23 by husband.  Upon follow-up on 3/19/23, the burning/electric shock symptoms had subsided.
Information has been received from a 66 year old female with allergy to flu vaccine who on approximately 12-AUG-2010, "2 weeks ago", was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included vitamins (unspecified). The patient said that she developed a rash on the injection site 2 days later (on approximately 14-AUG-2010) after getting ZOSTAVAX (Merck). The patient stated that her rash was approximately 1.5 inches and that it was getting bigger as time progresses. The patient was recovering at the time of reporting. It was not specified if the patient sought medical attention or not. Additional information has been requested.
Patient called office on 11-3-16 in AM stating she has swelling in the arm in which she received her flu shot. Arm also red. Pt. denies visit to see the doctor recommended warm compress, TYLENOL. patient to call office for fever, increase in swelling, redness, pain.
A non-serious spontaneous report of administration of expired product to a 44-month-old female was received from a clinic administrator concerning a 44-month-old female, subsequent to the administration of FLUMIST. The patient's medical history and concomitant medications were not reported. On 25-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this administration; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
About 12 hours after the vaccine I had chills, low energy, headache, body aches which lasted about 7 hours. I improved and was able to go about my day for most part, energy still low. The next day, 11/7 I worked and was fine until around 4:30pm I became nauseous and was close to vomiting and broke out in chills. I stayed in bed from 5pm to 9 am next day with chills, headache, body ache (entire body), nausea. When I got out of bed I broke out into a sweat and nearly passed out. I had light sensitivity. The chills ended by around 9:30am. The rest of the day I was tired and could not do normal activities. I could not stand in the morning to pack my daughter's lunch or even remember my password to my work computer. I stared feeling more normal by the evening of 11/8. It's 11/9 at 8:20pm mow and I've been feeling fine all day except I still don't have my full appetite back yet even though nausea has subsided.
This spontaneous report was received from a healthcare professional and refers to a currently 2 years old, male patient. The patient's medical history and concurrent conditions were not reported. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse in the USA concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up received 17-Oct-2008. no adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
I woke up on the morning of Nov 8th with lots of raised hives covering my shoulders and upper and lower arm as well as upper and lower legs.  This was a similar reaction to the J&J COVID vaccine I got in early April.  The hives slowly dissipate upon waking up and then occasionally reappear at decreasing size and intensity over the next several weeks and months.  My experience with the J&J lasted several months but tapered off.  So far this Moderna vaccination is behaving somewhat similarly, with a burst of hives and gradual dissipating reappearance.
Information received on 21MAR2014 from an Investigator. A 28 year old female (gravida 1, para 0) experienced a spontaneous abortion. On an unspecified date in November 2013, the female received a second dose 2 of BIOTHRAX (Lot FAV324), 10 days prior to her last menstrual period (LMP), and 24 days prior to her estimated date of conception. It was noted that no other medications were administered on the same date as BIOTHRAX, but 10 days later on the first day of her last menstrual period, in December 2013, she received a primary dose of smallpox (Lot VV04-003A) and Yellow Fever (Lot UH347AA) vaccines. In January 2014, the subject was determined to be pregnant (48 days after vaccination with BIOTHRAX). Subsequently, she was contacted by the Investigator for possible enrollment in an ongoing pregnancy registry. Self referral was received in MAR2014 and it was determined that she was vaccinated prior to LMP and was therefore ineligible for the registry. At the same time the subject self-reported a spontaneous miscarriage which occurred in FEB2014 at estimated gestation age by LMP of 10+4 weeks, but an ultrasound at that time revealed the loss occurred at EGA 6+0 weeks based on pregnancy measurements. She was treated with PERCOCET for pain. Concomitant medications included TRINESSA and Prenatal vitamins. The Investigator/Reporter felt that the event was unlikely related to the administration of BIOTHRAX. No further information is expected.
Three days post-vaccination #1, patient developed chest tightness and shortness of breath, has continued for past 3 weeks. Had syncopal episode on 5/26/21 and presented to Emergency Department at facility.  Was found to be COVID positive with result on 5/26/21.  Admitted to facility on 5/26/21, and diagnosed with pericarditis.  Hospitalist suspects that pericarditis could be result of Moderna vaccine, as patient was previously young and healthy with no chronic conditions, with symptom onset 3 days post-vaccination.  Patient also had expected post-vaccination symptoms, including  flu-like symptoms, fever, chills.
Covid arm-swelling, itchiness red blotch about  4 inches big. Warm to touch. Appeared a week after vaccination.
0833, Patient reports muffled hearing and "feeling hot". Cold pack applied to neck, providing some comfort. No itching, hives, SOB, pain, weakness. Pulse strong at 84.  0846 BP 110/79, 84 Pulse, 18 Resp, 94% O2 Sat, Additional complaint of generalized  body 'itching' at 5/10, without erythema, urticaria. Lungs clear bilaterally.  Per protocol, 25 mg PO diphenhydramine. 250 ml water PO 0856 Rapid increase in 'itching' to 8/10 with desire to stand and scratch most of her body.  Per protocol, 25 mg PO diphenhydramine 0900 BP 112/68 'itching' improving 6/10 0920 'Itching' at 2/10, O2 Sat 99%, 79 HR, 18 R, BP 108/78. Hearing with return to normal.  0939 Itching at 1/10 1000 Itching at 0/10, all other signs and symptoms  1015 BP 106/76, P 78, O2 Sat 98
Headache, Myalgia, Fever, Diarrhea, Pain @ injection site, Gastric Reflux Narrative: