chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syringe/Needle malfunctioned during injection.  Pt. was given a half dose as the syringe/needle did not make a good connection and only half the dose went into the patient arm.  (The syringe and needle kept spinning).   An 11th dose was able to be pulled from the vial, and the patient was given another half dose to complete her vaccination series.
TERRIBLY SICK AFTER THE JAB AND WERE STILL NOT OVER IT; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced terribly sick after the jab and were still not over it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terribly sick after the jab and were still not over it. This report was non-serious.
fever; chills; This is a spontaneous report from a contactable pharmacist (patient). A 42-years-old patient of an unspecified gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 02Mar2021 at 11:00 hours as dose 1, single (at the age of 42-years-old) for covid-19 immunisation. Patient had no known allergies and medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 02Mar2021, at around 18:00 hours, patient began getting some fever and chills. These symptoms were gone by next morning when patient woke up. Patient received no treatment for the events. Patient reported these symptoms on 03Mar2021 once patient felt much better. The outcome of the events was recovered on 03Mar2021.  No follow-up attempts are needed. No further information is expected.
Within 4 hours of injection, rapid pulse, elevating blood pressures which peaked at over 200/100.  This was verified by nursing staff as I had a podiatry appointment the same day as the injection.  Eight hours after injection blood pressures lowering to 174/90.  Took several days to get all the way back to normal range.  No headaches, no dizziness.  I was monitored in ER for several hours before being released.  I was told by the Pharmacist not to repeat (with booster) the Moderna or Pfizer covid vaccine due to adverse reaction.  I might possible be able to do a booster with J&J as this is a different type of vaccine.
racing heart; thin pulse; moody; passed out/loss all color went black under his eyes; crying; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In December 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In December 2020, an unknown time after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced passed out (serious criteria GSK medically significant), heart racing, low pulse rate, crying and mood change. On an unknown date, the outcome of the passed out and crying were recovered/resolved and the outcome of the heart racing, low pulse rate and mood change were unknown.   It was unknown if the reporter considered the passed out, heart racing, low pulse rate, crying and mood change to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported.  The patient received vaccine a week over the flu shot passed out 5 minutes later his mom had to catch him before he hit the ground was out for 15 minutes lost all color went black under his eyes racing heart thin pulse they had to stay at the flu clinic for hours to make sure he was okay when he woke up. This week so moody and one minute crying the next. He never had trouble with the flu vaccine before.
autoimmune hepatitis is triggered; autoimmune hepatitis is triggered/might have triggered the reactivation of the autoimmune hepatitis; liver enzyme are way out of site, very high; welt; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; A spontaneous report was received  from a consumer concerning a 73 year old, female patient who experienced good palm size red hot on her arm but way below the shot, hotness itched, 10 days after vaccine welt returned, liver enzyme way out of site, very high. Doctors say that autoimmune hepatitis is triggered.    The patient's medical history was autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one.  Concomitant product use Estratest, Gabapentin, Omeprazole, Zinc, B50, CoQ10, Coconut oil, and Magnesium.  The patient received their first of two planned doses of mRNA-1273 Batch number [(0 o6)31L20A] on 12Feb2021,  intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient stated she had a reaction to first Moderna vaccine shot and I didn't think it was too bad but she had autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one. On 14Feb2021, second day after vaccine she got a good palm size red hot on her arm but way below the shot. Where shot admin it looked okay. Kind of hot itchy and that lasted one and a half day. Tenth day after vaccine shot this welt came back again and lasted a couple of days.So then when she went to have blood test on Tuesday and mentioned lady taking blood that this red area and told her what happened, and asked her if she had seen this happen and lady mentioned that no. And now she is concerned because she had her blood report back last night, and her liver enzyme are way out of site, very high. Doctors said that autoimmune hepatitis is triggered. Phone with liver doctor. We don't know yet, they suspect that vaccine as autoimmune system is supposed to attack Covid, in fact it might have triggered the reactivation of the autoimmune hepatitis.  Treatment for the event none provided.  The outcome of the events were not resolved.  Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain) a causal relationship cannot be excluded. However, a very limited information has been provided for the events-Autoimmune hepatitis, condition aggravated, and hepatic enzyme increased, at this time. Further information has been requested.
Pain and swelling to injection site. temperature 100.8 on 2/23/07. Nurse at health dept notified. 2/23/07 spoke to mother at 1:30pm. child is doing fine. Mother decided not to go to the Dr.
During the night after receiving the injection I experienced sleeplessness and a dull headache at the base of my neck.  Day following injection I experienced a gradual increasing feeling of weakness and lightheadedness along with the aforementioned headache.    I felt like the environment around me was spinning.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, dose and route not reported). The patient was vaccinated with ZOSTAVAX that the pharmacist predrew in a syringe and stored in a refrigerator for 2 hours before administering. No adverse symptoms reported. Additional information has been requested.
Dizziness, pallor, hungry-small breakfast. Stable and released with mother after significant improvement.
Week of 1/11/2010 she started showing symptoms of "jiggley" eyes and a roaring in her ears and problems with stumbling. Confirmed all symptoms were in effect on 1/13/2010.  Symptoms worsened until she fell on 1/23/2010 at which time she was taken to the ER. She reported to the ER that she had numbness running up from her big toe to her inner thighs.  They dismissed all symptoms as result of a sinus infection based on a CT scan. (The CT scan was later read by another ENT doctor, the CT was rerun and the diagnosis was put aside).  On Monday 1/25/2010, she fell in the home around 2:30PM and we had her transported to hospital by ambulance. She has not walked since. She was admitted and diagnosed with Guillaine-Barre Syndrome (GBS) and treated with IGIV.  When she did not improve she was transferred to another hospital on 1/29/2010.  The ultimate diagnosis was Transverse Myelitis.  She has been treated there ever since and is now in rehab (since 2/19/2010), but still wheelchair bound.
Hospitalization from COVID-19 Reported per Janssen COVID-19 Vaccine EUA
My arm was quite sore from the shot which was not surprising. However, It has continued to hurt for 7 weeks now. If I take Advil, it hurts less. But it continues to bother me every day and night. If I wake at night, it usually hurts more, probably from moving it or laying on it.
Information has been received from a physician concerning his 10 year old granddaughter who has no known allergies or pertinent medical history, who on 08-AUG-1997 was vaccinated with a dose of Varivax. There was no concomitant medication. ON 23-AUG-2006 the patient developed a breakthrough case of chickenpox. The rash was described by the patient's mother to be at least 20 pox, which progressed from papular to vesicular mostly on the torso (groin are) and scalp. The patient complained of itching, developed a low grade fever, was tired, and "did not eat". The patient presented to the physician's office and was prescribed ATARAX which was not needed, topical hydrocortisone cream and 4 teaspoons qid for 5 days of acyclovir suspension. The patient was also advised to use AVEENO bath. On 06-SEP-2006 the patient recovered. It was also reported that both the patient's father and grandfather are physicians. There was no product quality complaint involved. The patient's sister (WAES # 0609USA00973) had a similar experience after vaccination with Varivax. Additional information from the nurse indicated that no further information is available.
Headache, stomach pain, chills, tiredness, general body ache. Rash on the skin (the itch lasted more than a week). Since the vaccine I have felt inflammations in the body in general.
The facility did not have a prior history of COVID vaccinations on this patient so a primary series was to be started. The patient's form was originally marked for a booster dose so a half dose was given in the right arm and then it was determined the patient needed a 1st dose so the patient was given another half dose in the left arm. Based on the state database this was the 3rd dose and should of been a booster dose.
3/10,2020 at approx. 4:30pm at Pharmacy, rec?d initial Shingrex vaccine in left deltoid.  Remained in discussion with the pharmacist for approximately 15 minutes.  I was without any adverse issues when I went to bed at 10:30. 12:30am awakened, urinated. Burning pain all of perineal area. Back in bed, sore mouth and tongue, as if burnt with hot liquid. Tongue, lips, cheeks had pins and needles tingling. I had a metallic taste in my mouth.  Skin over entire body felt very hot, though cool to touch on outside. Had pulse throbbing in head and the sensation of near to losing consciousness (This felt as I have experienced in the few seconds after pre-op anesthesia, only this time sensation cont?d and I did not lose consciousness) My pulse remained  near the usual 70bpm, but stronger throbbing.  1:25 am I phoned local ER spoke with triage RN. Temp 96.2   She advised call my personal physician, MD.  1:35am  Spoke with after-hours triage RN. After report, she advised me to go to ER. Since my husband was awake with me, I decided to avoid ER if possible, and wait to see if symptoms changed.  About 2:20am symptoms subsiding. 3am generally comfortable without symptoms. Slept from approx. 3:30am until 8am.  Generally feeling bruised sore all over. Injection site normal color, but moderately swollen, sore and quite tender to pressure. Took Advil 600mg. By 9am  tenderness of arm only discomfort.
Mild cough; Shortness of breath; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath) and COUGH (Mild cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072M204) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE and CARISOPRODOL (SOMA [CARISOPRODOL]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). On 06-Feb-2021, the patient experienced COUGH (Mild cough). At the time of the report, DYSPNOEA (Shortness of breath) and COUGH (Mild cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes inhaler fovent
Patient was given rx for hepatitis B vaccine 5/22. Vaccine (ENGERIX-B) was administered Weds 5/28/14. On Saturday 5/31 pt called to report possible allergic reaction - red, swollen feet. Legs red with white patches. Localised to legs only. Rph advised her to go to ER.
first dose on 2/19/2018, second dose today; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th February 2018).   On 6th June 2022, the patient received the 2nd dose of Shingrix. On 6th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date:  06-JUN-2022 Reporter's Comments: The patient received the second dose of the Shingrix vaccine on the day of reporting. The reporter consented to follow-up Additional Supportive Information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening vaccination schedule.
Information has been received from a physician concerning a 16 year old female who was vaccinated with Hep B vaccine. On approximately 8/23/98, the pt fainted. The pt was seen in the ER. On approximately 9/1/98 the pt experienced daily headaches, dizziness, and fatigue. A strep culture was negative on 9/4/98. Around the end of September 1998, the pt recovered.
SWOLLEN LYMPH NODES; DIZZY; VOMITING; NAUSEA; FEVER; DON'T FEEL 100% CORRECT; COULD NOT WALK; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to MIR contrast, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse, illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, 1802070 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 11:30 to left arm for prophylactic vaccination. Concomitant medications included diet formulations for treatment of obesity for diet pill, and spironolactone for diuretic.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 17-MAR-2021, the subject experienced swollen lymph nodes. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced vomiting. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced could not walk, and don't feel 100% correct. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 17-MAR-2021, was recovering from dizzy, had not recovered from swollen lymph nodes, and fever, and the outcome of could not walk and don't feel 100% correct was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non-serious.
Prescribed paxlovid after vaccination; Prescribed paxlovid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 08Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 14May2022, outcome "recovered" (19May2022), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Prescribed paxlovid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.
Not sure when blood clots formed in my left lower leg. No history or family history of blood clots. I am up to date with all my screenings and in good health.. Upon rising on morning of 8/5/2021 I had shortness of breath. That was my only symptom. Went to doctor. D-Dimer blood test came back at 7000, norm is 500. CAT SCANshowed A MULTITUDE OF PULMONARY embolisms with a saddle embolism as well. Ultrasound showed multiple blood clots in my leg. Hospitalized on heparin for two days. On Eliquis now. I am not pointing the finger at Moderna, I am simply reporting for your data base as we do not know what caused the clots in my leg that subsequently went to my lungs.
TOLD TO REMOVE FROM INVENTORY AS THIS LOT WAS SHORT DATED AND ACTUALLY EXPIRED ON 9/30/22 INSTEAD OF PREDICTED SHELF LIFE TO LAST UNTIL 11/4/22
They thought I had pulmonary embolism, constant stress/I had to go into the hospital, they had me on a heart monitor as they thought I was dying; I am really sick; Have lesions from my head to my toe bilateral on my body like lesions and sores and holes; Have lesions from my head to my toe bilateral on my body like lesions and sores and holes; My legs were so swollen that I have like there were blisters forming in; My legs were so swollen that I have like there were blisters forming in; They thought I had pulmonary embolism, constant stress; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date  as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had pulmonary embolism, constant stress had to go into the hospital, had on a heart monitor as patient was dying, really sick, have lesions from head to toe bilateral on body like lesions and sores and holes and legs were so swollen that have like there were blisters forming in. Patient stated, patient just found online or whatever about adverse reaction to the Covid vaccine and patient have had one. Patient have been hospitalized over this (further hospitalization details were unknown), patient really sick, patient very sick and don't know what to do. It got patient hospitalized and they are trying to get patient better but patient not getting better. Patient have lesions, from head to toe bilateral on body like lesions and sores and holes and legs were so swollen that patient have like there were blisters forming in and it is really keeping out of patient way (not clear). Patient had to go into the hospital, they had patient on a heart monitor as they thought patient was dying. They thought patient had pulmonary embolism, constant stress (further clarification unknown) patient was very sick. Patient further stated, cannot we go where patient need to speak with? So, patient can get some help because patient do feel like dying. It can probably be anything, patient cannot even picture themself at the time of report. The outcome of the events was unknown.  Information about batch/Lot number Is requested.
Patient received Pfizer vaccine with 1st dose on 01/20/2021 and 2nd dose on 02/12/2021. Covid + on 10/04/2021 and hospitalized Per ED Note: Patient is a pleasant 77year old male presented today to emergency department for evaluation of shortness of breath.  He has been feeling this way for the past 2 days.  He does admit to fevers and cough at home.  He took Tylenol prior to coming in.  Patient denies any chest pain, abdominal pain, vomiting, focal paresthesias or weakness, headache, change in bowel or bladder habits, dizziness, leg pain or edema or history of blood clots, or changes in medications. He denies any other modifying precipitating or relieving factors.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 13-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N025718, expiry date 17-MAR-2019 (exact dose and route of administration were not reported) for prophylaxis. The sterile diluent (manufacturer unknown) with lot# N016189, expiry date 13-AUG-2019 used was stored properly. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported.
pt experienced rash on both arms and armpits. Pt expressed itchiness and swollen skin after receiving third dose of pfizer 2 days after
Patient stated about 7 hours after vaccination he started to feel sick and he's been feeling the same way ever since vaccination date. He stated that he visited medical facility for treatment, but the treatment did not help much