chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's were reported and no additional AE details were provided.; was supposed to receive a dose of MMR-II and VARIVAX but received a dose of PROQUAD instead; PROQUAD administered to a 31-year-old woman; This spontaneous report was received from a medical assistance and refers to a 31-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, allergies and drug reactions were not provided.  On 03-OCT-2022 (at the age of 31 years), the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered subcutaneously, lot #U039259, expiration date: 09-JUN-2023, (strength and anatomical site of vaccination were not provided) for prophylaxis (product administered to patient of inappropriate age). The patient was supposed to be vaccinated with a dose of rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, but received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead (wrong product administered). The patient had not any side effects from the vaccine which she received. No additional adverse events (AEs) were reported (no adverse event) and no additional adverse event (AE) details were provided.
It began on the evening of the shot with first my upper arm becoming sore, sorer as the hours passed and then into my left shoulder. I went to bed and tossed and turned beginning a short time later with body aches and upset stomach feeling like I was getting a bad flu. By 4 - 5 AM I just got up and tried to go downstairs but had to keep sitting down on the steps because I felt like I was going to pass out. I laid on the couch under a blanket the entire day with severe headaches, upset stomach and body aches. By evening I had to hide under blankets upstairs not to smell any cooking food. I was hoping it would pass quickly but by the next very early morning I got up once again and came down. My headache which settled now on the right side, right eye and ear hurt so bad I felt like I was going to stroke out. My eyelid corners were swollen. I called the pharmacy finally to see if I could at least take TYLENOL and she said she thought that would be okay. I needed something for the pain and she said Ibuprofen but I asked her "isn't that what causes adverse effects if you have the flu and wouldn't TYLENOL be better". She told me to report the effects to the CDC. So I decided on the TYLENOL but after 3 double doses correctly timed and no difference I decided to put an ice pack straight on my head, eye and ear and take Ibuprofen. The symptoms started easing up a bit as I continued the ibuprofen and slept with ice packs. I tried ginger ale and bouillon and then some chicken soup for the upset stomach. Day 4 was better with still some headache and stomach symptoms. My legs felt like extreme noodles. By Day 5 in the evening I felt like I had a bit of energy and proceeded to do a few things then quickly wore out. Day 6 I wasn't sure if I was getting sick again or if now it was going into a cold or what. I took some SUDAFED as my head felt congested but still didn't feel quite right. I do not have a cold as of yet but still feel like I could be coming down with one. Nothing other than coughing now and then, a little bit of swelling on the eyelid corners and sneezing have developed.
On July 10, 2021 I went to the ER. I experienced a lost of platelets. I crashed with 0 platelets. I was diagnosed with ITP. The doctor gave me two doses of platelet infusions.
I developed some small areas of rashes all over my body I had a rather large patch behind my right knee and lots of small rashes everywhere concentrated on my arms and lower back. They were all over. I am allergic to penicillin, I don't know and the rash that I got it looked like the one that I get from when I get penicillin. I looked up the ingredients and it seems they have a polyethoglycol like penicillin. I consulted with the nurse at the vaccine station and she suggested cold showers,  not get overheated it is not life threatening but it is still going on and some have started scabbing over but they are still here and they are itchy. The nurse also recommended OTC hydrocortisone cream and Benadryl but it has not really effective. I am thinking about going to see my PCP to se of something else can be done about it.
Fever 101.6 per pt/aches - took one 325 mg TYLENOL T = 97.6 in office arm swollen/erythematous & extremely tender normal CBC.
6 months pregnant. Due date of 12/12/19  Left shoulder is locking up as a reaction.
On 8/2/12 I received a vaccine of ZOSTAVAX, 0.65 ml dose in my Rt arm. On 8/4/13 I noted a "bug bite", that was quickly joined by more itchy - painful spots. In about 4-5 days blisters erupted. My physician said it looked like shingles and prescribed Valacyclovir hCL - 1 gram tablets.
PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA AND EYES BURNING.
BODY ACHES; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and as per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, low grade fever and body aches was not reported. This report was non-serious.
migraine; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 30's received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 4 decade as dose 1, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: patient get migraines when patient have anxiety and when about to get my period; "migraine" (unspecified if ongoing), notes: but it's not related to that, it is related to my feminine cycle. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "migraine"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "sore arm".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
42 yo male with history of congenital kidney disease s/p renal transplant in 1990; stable on myfortic, Neoral, and prednisone. He developed COVID symptoms on 7/15 and tested positive that day with cough, fevers, but no hypoxia or work of breathing. He completed his full Pfizer COVID-19 vaccination:first dose 2/18/21, second dose 3/11/21. He presented and was admitted to the hospital on 7/20 for abdomen tenderness and AKI. Due to his immunocompromised state, he was started on remdesivir for COVID-19.
about 4hr p/vax lt deltoid area became red & swollen no temp;presented today no temp sl redness-small amount of swelling approx 4" in diameter;sore to touch-hurts on movement;
Nauseous; Muscle pain; No appetite; Most painful on shot arm; Crash naps 3 times on first day; Vision disruption; Chest pain; Dizzy; Pain in lymph under armpitsand neck; Exhaustion all day; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch number: ER 2613), via an unspecified route of administration, administered in arm left on 23Mar2021 at 10:00 as a single dose (at the age of vaccination 42-years) for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch number: ER 6205), via an unspecified route of administration, administered at left arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was allergic to keflex, bractrum. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent dose of COVID-19 vaccine in a clinic. On 23Mar2021, the patient experienced vision disruption, dizzy non-stop for first 4 hrs that impacted vision and stability, pain in lymph under armpits and neck, most painful on shot arm, crash naps 3 times on first day, exhaustion all day, no appetite, nauseous. muscle pain and chest pain for 3 days. The patient did not receive any therapeutic measures for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events most painful on shot arm, dizzy, crash naps 3 times on first day, exhaustion, nauseous, pain in lymph, vision disruption and no appetite were recovering. The clinical outcome of the events muscle pain and chest pain was recovered on unknown date. No follow-up attempts are possible. No further information is expected.
Guillain Barre syndrome; paralyzed after taking a flu shot; Initial information was received on 17-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case is linked to cases 2020SA331005 and 2020SA331006 (same reporter).  This case involves a male patient (age unspecified) who had Guillain Barre syndrome (GBS) and become paralyzed (paralysis), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [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 had Guillain Barre syndrome (GBS) and become paralyzed (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a male patient (age unspecified) who experienced Guillain Barre Syndrome and paralysis after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
self injurous behavior, tantrums, regression incontinence when previously potty trained,bowel pain,loss of functional language,
According to the patient's daughter, patient started with a rash on her hand the day following her second dose of Moderna. It progressed to cover almost her entire body. She was prescribed a course of oral steroids which minimized the rash, but it returned after the course was completed. Her primary doctor referred her to a dermatologist, who at the time this form was submitted had not yet been seen, but based on the description suspected Stevens-Johnson Syndrome(SJS).
Timing ERROR only, 2nd dose given 83 days after 1st Narrative: Timing ERROR only, 2nd dose given 8 days after 1st.
Unable to move arm/shoulder. Body rash from neck to hips. Reaction 4 hrs. after vaccination.
high blood pressure; Anxiety disorder attacks; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and ANXIETY DISORDER (Anxiety disorder attacks) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant) and ANXIETY DISORDER (Anxiety disorder attacks) (seriousness criterion medically significant). At the time of the report, HYPERTENSION (high blood pressure) and ANXIETY DISORDER (Anxiety disorder attacks) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Live Follow-up received on 20-JUN-2021 does not contain any new information.; Sender's Comments: 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.
Day of injection patient noticed increased redness at injection site, over the next few days the redness spread, became hot to touch.  Patient was seen in the clinic and given keflex.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with a doses of improperly stored GARDASIL 9 lot # M020103 and expiration date: 15-FEB-2018; (strength, dosage and route unspecified). No adverse effect reported. No product quality complaint involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received injections of Engerix B on 5/1/98, 6/12/98, and 10/20/98. He also received diphtheria and tetanus toxoids and acellular pertussis vaccine, Haemophilus influenzae type B conjugate vaccine, inactivated poliomyelitis virus vaccine, oral poliomyelitis virus vaccine, and MMR. He also received a tuberculin test. The subject's attorney alleged that, as a result of the vaccines administered, the subject suffers from the effects of mercury poisoning. The mercury poisoning in this report is considered medically serious.
Patient developed moderate-Covid-19 48 hours after receiving the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset 01Nov2023, outcome "unknown", described as "Patient developed moderate-Covid-19 48 hours after receiving the vaccine". The event "patient developed moderate-covid-19 48 hours after receiving the vaccine" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient did not received other vaccine in four weeks. No covid prior vaccination and covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed common cold-like symptoms which did not go away and have developed into persistent mucus/allergy problem.
Injection site was very sore and red for five days. Hurt to lift my arm and took Aleve.  Nine days after injection, I noticed that the injection site was becoming red, warm and itching. On the tenth day the affected area had increased in size by three inches. I have never had a vaccine have such a delayed reaction. I have read articles that call this Covid Arm, but nobody knows why it is happening. This makes me very nervous to get the second dose.
Red, itchy, bumpy, swollen  rash on right shoulder extending to right  breast. Swelling of left hand, stiffness, hard to move fingers,  same rash as above between fingers.
5-8-07 seen in clinic 24 hours after vaccinations L upper arm - deltoid muscle - swollen, red, tender, warm to touch. Tx with Keflex TZD X 10D 2 cellulitis.
weakness; felt ill; low fever; chills; arm hurt; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic fatigue syndrome (has Chronic Fatigue syndrome).   On 14th February 2019, the patient received the 1st dose of Shingrix 50 µg. On 14th February 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell, fever, chills and pain in arm. On 24th February 2019, the patient experienced weakness. On an unknown date, the outcome of the feeling unwell, fever, chills, pain in arm and weakness were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fever, chills, pain in arm and weakness to be related to Shingrix.  Additional details were provided as follows: The caller stated the weakness she experienced 10 days after her 1st dose of Shingrix was what it felt like.  She states it lasted for months.  She noted she also felt ill the night of the shot.  She states she had a low lever and chills that resolved after three days.   Her arm hurt for 2 weeks, which started the same day as the vaccination.  She was concerned about getting the 2nd dose after the experience of the 1st. The reporter consented to follow up. The caller was offered for health care professional to call management information system to obtain information on 1st dose efficacy if data was available. There is discrepancy between the outcome reported in the structured field (recovered) and the outcome reported in the source document (recovered with sequel).
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender, who on an unknown date in 2014 was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not provided). On an unknown date, in 2014, the patient developed itching and redness on unspecified area(s) of the body. The pharmacist stated that it was little red bumps on the patient's body. The rash had been present for the past two to three weeks starting on an unspecified date in 2014 after the administration of the ZOSTAVAX. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Swelling on arm near injection site. Swelling looks like red bruise that has grown in side. Started out at 2 inches wide by 1 inch high on Tuesday. Currently on Thursday it is 6 inches wide by 4 includes high covering much of the inside bicep area. Also there are red blotches. The red swelling and blotches hurt when touched. Entire upper arm is painful to move an files like very sore muscles. Some numbness and tingling experience in the fingers on the same arm.
Death  Patient was being prepared for discharge. Found pulseless in room around 1845 which was roughly 3 hours post vaccination. Additional therapies given during ED stay were IV fluids and IV acetaminophen.  ACLS initiated and continued for ~45 minutes. Time of death called at 1928
Within 5 minutes post vaccination patient c/o SOB, mid chest pain, no radiation, itchy skin, hives presented on (R) face, (R) back. VSS BP 110/70, HR 80, RR 18. Transported via medic to emergency room.
dose administered > 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post puncture) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Number of doses/vials was one. The vial was initially stored in the refrigerator on 13-Sep-2021. Date(s) and time(S) vial was first punctured on 13-Sep-2021. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions.
fever of 101.5 w/flu-like sx;off work w day;back @ work on 26OCT95 still expressing dull ache in back of head;
Day after receiving COVID 19 vaccine dose 1 admitted to hospital with fall and weakness, tested positive for COVID 19.
Fever 102.2, Headache, Body aches, chills, weak, a little nauseas
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Flu like symptoms (very achy and cold) 12 hours post injection.   Headache, neck pain, achy ness began 24 hours post injection.  Significant tiredness and weakness throughout  at least 48 hours post injection.  Still have mild neck pain 48 hours post injection.
09/09/2021 hospitalized with DX Covid19, Pneumonia r/t corona virus disease 2019, Acute respiratory failure with hypoxia, hypoxemia, LLE DVT 09/24/2021 rehospitalized with hypoxia, pneumonia, sepsis
Pt c/o Dizziness then "passed out" while leaving the clinic. Pt was outside lying on side-walk when assistance arrived. Pt's eyes were closed but responded verbally & oriented x3. Pt was transported inside clinic via w/c and vital taken x 3; All normal. Pt c/o nausea but was released after 30 minutes and stated she felt "fine"