chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ALLERGIC REACTION; DOWN FOR THREE DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: unknown) 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 subject experienced allergic reaction, and down for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and down for three days was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
About 10 days, I broke out in hives. They were big red, itchy lumps. I also came down with Vertigo. The hives lasted about 5 days and the Vertigo lasted about 10 weeks. I went to doctor about this. They just prescribed some cream for the rash.
Patient reported that vaccine was administered via IM injection to the dorsogluteal region two months ago and has resulted in a "hole" or depression of the tissue at the injection site.
pt recv vax & w/in 24 to 48hr devel pneumatosis intestinalis;the reporter stated that the pt may have been hosp. Discharge summary states diagnosis: milk protein intolerance. Pt treated with a 15-day course of ampicillin, gentamicin, and clindamycin. The rotavaccine was reported as an adverse reaction, although it is likely that the two are not related.
HANGOVER; CHILLS (SHAKING); FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, high cholesterol, low vitamin d, seasonal allergy, and walnut allergy, and other pre-existing medical conditions included the patient had no drug abuse. the patient had no history of hospitalization in last 30 days with cause and no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 18:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, ascorbic acid/biotin/calcium pantothenate/calcium phosphate dibasic/cyanocobalamin/ferrous fumarate/folic acid/magnesium oxide/manganese sulfate/nicotinamide/potassium sulfate/pyridoxine hydrochloride/riboflavin/thiamine mononitrate/tocopheryl acid succinate/zinc sulfate for general health, and ergocalciferol for low vitamin d. On 21-MAR-2021, the subject experienced hangover. On 21-MAR-2021, the subject experienced chills (shaking). On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 23-MAR-2021, had not recovered from headache, nausea, and hangover, and the outcome of chills (shaking) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210341912.
Severe muscle spasms in injection arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 13:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included quadriplegia from an unknown date. The patient previously took sulfonamide for an unknown indication on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 28Mar2021, the patient experienced severe muscle spasms in injection arm. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event of muscle spasms was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with bruises easily and none drug reactions or allergies. On 20-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX, injection (strength, douse route, lot number and expiration date not provided). Other suspected therapies included influenza virus vaccine reported as flu shot in the same arm administered on an unspecified date. In November 2013 reported as few days after receiving ZOSTAVAX, the patient experienced an injections site reaction described as: two separate sited the shape of a ring, one is larger the size of a half dollar, the other much smaller. The center of both sites are red, hard, raised and slightly warm with little hard bumps. The patient sought medical attention  visited pharmacy. No treatment was ginve for adverse event. None lab diagnostics studies were performed. The outcome of events was reported as not recovered. The relatedness between vaccinations with ZOSTAVAX and events was not reported. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 31-JAN-2017). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24,34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 47 and R; 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
-Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird".  I honestly didn't even consider it could be a reaction, I thought the way I was breathing through my mask must have been drying my eyes out. -Left clinic after 15 mins, only symptom at this point was dry eyes -about 5 mins in to our drive home my face was feeling very funny and kind of numb.  I was feeling worse and worse. -looked in mirror and noticed face was bright red and swelling up.  Also my throat was fire red. -it was getting worse and worse, also was starting to get itchy.   -My entire face was bright red -Stopped at Sister-in-law's house (cause it was on the way home and she is a nurse) and took two benadryl.  Was observed for another 20 mins there and the reaction started to calm down.  The redness was still there, but the swelling seemed to have stopped. -went home and kept a close eye on it the rest of the night. -became itchy, but no rash.  The bright redness went away after about 20 mins, but my face stayed red (like a sunburn) most of the evening.  Throat was red as well.  -felt fine when waking up on 4/9 and no other instances of these symptoms -sore arm 4/8-4/10
Information has been received from a physician concerning a female patient who on 23-APR-2010 was vaccinated with a dose of GARDASIL. Right after getting the vaccine, the patient became dizzy, and called the physician next day still experiencing dizziness. At the time of the report, the patient's status was unknown. Additional information has been requested.
Starting on the day of the 2nd dose vaccine,  later in the evening with low grade fever and fatigue.  I took some Tylenol the next morning and call out of work and stayed in bed for about 1 and 1/2 days.  I felt fine after that.  About 1-2 weeks later, I started to get pain  in my hands.  The pain and stiffness got so bad I went to my doctor and was referred to an orthopedic hand specialist.  I  got x-ray , blood work and was referred to a rheumatologist who ran more blood work and I got a diagnosed with limited scleroderma arthritis.  I was put on hydroxychloroquine 200mg once daily.  I have been taking that for 3 months so far and have been very effective. The pain  has improved drastically.
DEATH; .This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date; Unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On SEP-2021, the patient experienced death from unknown cause. Reporter stated that "attending a funeral this Saturday for a fully vaccinated man". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210946753-covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
pt recvd vax; Rt brachial nerve inflammation; weakness of Rt hand musculature & sensory loss;
Cold symptoms, swollen face and neck, periorbital edema, flushed skin, rash on chest, fatigue, weakness. Lasted for 2 + weeks. Prescribed BENADRYL. Symptoms started on 4/1/16. Reported to Emp Hlth on 5/4/16, not observed.
Hospitalized with abdominal pain, diarrhea, nausea, vomiting, rhinorrhea, chills. COVID 19 positive
Syncope during observation time approximately 5min after receiving the injection. Unconsciousness for  10-15 seconds then returned to observation chair. until paramedics arrived. He was cleared to leave on his on recognizance. He remained seated for 1 to 2 hours then left the store.
Date of Admission:  1/15/2022   Chief Complaint:  Acute hypoxic respiratory failure   Source of Information:  Available medical record   History of Present Illness:  Patient is a 72-year-old female with a past medical history of asthma, hyperlipidemia, hypertension, presented to the hospital on 1/15/2022 for altered mental status.  Patient is accompanied by her husband and daughter.  Entirety of history is obtained from chart review as well as conversation with the daughter and husband as the patient is currently sedated and on the ventilator.  Patient was noted to arrive to the ED with an SPO2 of 77% on room air.  She was noted to be alert and oriented x0, nonverbal.  Husband tells me that in the last 2 months the patient has had intermittent episodes where she "stares off into space".  The daughter states that the patient also starting 2 months ago has had lapses in memory.  This morning at approximately 4 AM, the husband woke up and noted that the patient was nonverbal. Family denies any head trauma or recent falls with the patient.  She does not have a history of strokes or seizures.   In the ED the patient presented with a blood pressure 200/105, HR 102, temp 98, RR 17, SPO2 77% on room air.  She was noted to be positive for COVID 19.  Imaging was obtained showing a new left lateral ventricle effacement with 9 mm rightward midline shift.  Was admitted to ICU for further evaluation with consults made to neurology and neurosurgery.
Flu-like Symptoms-- Severe body aches, extreme fatigue, lack of appetite.
Female patient experiencing chills 30 minutes after Pfizer vaccine administered. No other symptoms reported. Vitals 140/90, HR 70, SPO2 100% on room air, Respirations 22, Temp 97.3  axillary. Patient appears anxious but states she is not. Emergency response activated/ 911 called.  Benadryl administered via  IM on right deltoid. Paramedics arrive at 1054hrs. Takes patient via gurney to further assess in ambulance. Patient is vitally stable. Refused further care. Left AMA.
Patient was inadvertently given a 0.5ml dose (instead of the authorized 0.25ml dose) for her booster dose.
The morning after the vaccination, there was swelling in the left axillary lymph nodes and axilla. There was also a pain radiating from the left shoulder and axilla all the way down my side, hip and into the lower left buttock. I was not able to put excessive weight (from standing or sitting) on my left side.
pt recv vax 18MAY95 & evening of 18MAy95 pt devel chicken pox; nurse felt pt's exp was not related to vax but from exposure to natural varicella virus
My cheeks were very red and hot; My cheeks were very red and hot; Above my upper lip is itchy.; Sensation in the back of my left cheek in front of my ear; My eyes are very red and irritated; My eyes are very red and irritated; The rest of my face especially my checks and beneath my nose also feel like they are swelling; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 30Apr2021 at 11:30 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE (at the age of 64 years old) for covid-19 immunisation.  Medical history included allergy to pencillin, and mold/seasonal allergies from an unknown date. Concomitant medication(s) included trazodone hydrochloride (TRAZODON) taken for an unspecified indication, start and stop date were not reported, sleep aid, and multi vitamin.  The patient previously took first dose of BNT162B2, lot number ER8729, for covid-19 immunisation on 09Apr2021 at 12:00PM in the right arm and stated the day after her first shot her upper lip felt like it was swelling. For the next two weeks her lips continued to feel swollen but then would sting.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced eyes are very red and irritated (ocular hyperaemia) (medically significant) on 2021 with outcome of not recovered, the rest of her face especially her checks and beneath her nose also feel like they are swelling on 2021 with outcome of not recovered, her cheeks were very red and hot on 26May2021 with outcome of not recovered, above her upper lip is itchy on 2021 with outcome of not recovered, and sensation in the back of her left cheek in front of her ear on 2021 with outcome of not recovered. Therapeutic measures were taken as a result of eyes are very red and irritated, the rest of her face especially her checks and beneath her nose also feel like they are swelling, her cheeks were very red and hot, above her upper lip is itchy, and sensation in the back of her left cheek in front of her ear. The events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are needed. further information has been requested.
mom reported that pt had a large, swollen area @ inject site w/rash & c/o malaise/fever treated w/APAP & cold compress;
Initial report received from a health care professional on 24 May 2010. A neonate, with no medical history reported, received transplacental ADACEL at the end of July 2009 when the mother was vaccinated with ADACEL, lot number unknown. The mother had no health risks, no pregnancy complications and was healthy during pregnancy. A prenatal ultrasound was normal and Alphafetoprotein (AFP) testing was negative (dates not provided). The neonate experienced complication of shoulder dystocia during labor and/or delivery. The patient was delivered live vaginally on 26 March 2010 with no congenital anomaly and weighing 8.5 pounds (3.8 kilograms) with a one minute Apgar score of 8 and a 5 minute Apgar score of 9. The reporter for this case is the same as for case number 2009- 03908 (mother case, no adverse event). Follow-up information was received on 14 July 2010 from a healthcare professional. The neonate recovered from the previously reported shoulder dystocia on an unspecified date. Documents held by sender: None.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age (also reported as about 45 years old). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On an unknown date, the patient experienced cold sores after administering with ZOSTAVAX. It was reported that the patient was not sought any medical attention. It was also reported that the patient had not received any treatment. The pharmacist also reported that developing cold sores happens frequently to the patient. The outcome of the event cold sores was unknown. This case is linked to the cases 1401USA014549 and 1401USA014550 (same reporter link). Additional information has been requested.
Progressive bilateral weakness of lower and upper extremities. Fever of 102. She had severe fatigue as well.
Several months after the vaccine, starting on May 26th, my wife got a headache and has body heaviness. She still has those conditions to this day.
itch two days after vaccine was administered.  Benadryl did not help, patient is not just started to try a topical cream prescribed by a provider to see if it will help.
mouth sores; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (mouth sores) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced STOMATITIS (mouth sores). At the time of the report, STOMATITIS (mouth sores) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Pt presented to the clinic today for concerns for a vaccine reaction that he received on 11/18/2022. Pt. Brought to an exam room to discuss concerns. Pt. States that he received a shingles vaccine on 11/18/2022 at the pharmacy and developed side effects of rash, chills, body aches but then later he developed headaches on and off and a sore neck and has concerns that he may be getting sick or getting COVID. Per system record no recent shingles vaccination was documented. Pt. Educated on the common side effects of the shingles vaccine and what an adverse reaction to a vaccination is. Pt. Informed that we are not able to test for COVID here and that he will need to go to his PCP, urgent care, or he can get a home COVID test. Pt. Verbalized understanding. Pt. Concerns where discussed with Nursing Supervisor. Supervising nurse stated that pt. Should follow up with entity that administered vaccine to report concerns and side effects and that patient can also file a VAERS report on behalf of himself. She also recommended that pt seek medical care and evaluation for symptoms experienced if they worsen or persist. This nurse returned to exam room to re-educate pt. Based on conversation with Nurse Supervisor. Before all education could be provided, pt. Injected that I dont know how shingles got into the conversation because I received a COVID vaccination. This nurse informed pt. That he told her that he got a shingles vaccination and that he received it at the Pharmacy. Pt. States that he got a COVID vaccination and that it was done her. Due to pt. Receiving a COVID vaccination, he was informed that we will file a VARES report but if he feels like he is getting sick he will need evaluation with PCP or at urgent care. Pt. Verbalized understanding. VARES report was filed. BSN, RN.
Body aches, fever 101 F, chills, diarrhoea, loss of taste and smell, followed by shortness of breath, turned out that I became positive with COVID-19 virus and all my family including my mother who is 70+ and my pregnant wife got infected with active virus.
This 32 yr old female presents with a cough and wheeze.  She has some shortness of breath, chills, sneezing, stuffiness and slight ear pain.  she is achy as well and gagging from the cough.  She has a low grade fever as well. She was diagnosed with H1N1 virus based on a positive rapid influenza swab in the office. She was treated with tamiflu and a proair inhaler. 11/2/09 Primary Care Records received for date of service 10/29/09.  DX:  H1N1 Assessment:  Pregnant female presented with cough and wheezing x 1 day.  Also some SOB, chills, sneezing, stuffiness, runny nose, low grade fever and slight ear pain as well as achy feeling and gagging on cough.  Mucosa of pharynx inflammed.  Instructed to increase PO fluids and given Tamiflu, Guiatuss with Codeine and Pro Air HFA.
11/2/12 Patient reported itching at injection site and a swollen red area 2.5 in x 3.5 in surrounding injection site, 24 hours after vaccine administration she used cetirizine 10mg and Diphenhydramine for 3-4 days. All itching and swelling resolved by day 5.
Individual returned to the clinic to receive dose two in his Pfizer series. He was inadvertently administered Janssen vaccine instead of the Pfizer vaccine.
This spontaneous report was received from a nurse concerning a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose ZOSTAVAX, lot # N025570, expiration date: 19-DEC-2018, for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported.
woke up @ 5AM 5SEP94 w/high pitched, shrieking cry, temp 104.6, pt now has autistic synd
This case was reported by a physician and described the occurrence of pruritus body rash in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included wheezing. On 23 October 2008, the subject received a dose of FLULAVAL (unknown). On 25 October 2008, two days after vaccination with FLULAVAL, the subject experienced pruritus body rash and vesicular lesions. On 03 November 2008, eleven days after vaccination with FLULAVAL, the subject experienced eosinophil infiltration of skin. At an unspecified time after vaccination with FLULAVAL, the subject experienced wheezing. The physician stated a subject received FLULAVAL on 23 October 2008 and presented with a pruritic severe rash all over her body that was diffuse, contained vesicular lesions on 25 October 2008. She saw a dermatologist on 03 November 2008 who performed a skin biopsy and showed eosinophilic infiltrates in the rash. The subject also experienced wheezing flare-ups that correspond to flare ups of the rash. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.