chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the vaccine on Dec 28.  I had some expected arm pain in the left arm where I had received the vaccine.  About 1 week later, I noticed the upper left arm was itchy and continued to itch throughout the week.  On Jan 10, I noticed a large red area on the side and back of the left upper arm.  The area was warm and felt slightly swollen.  The center of the area was clear and the edge was red.  The area continues to be itchy, but there is no pain or decreased in function of the left upper arm.  Since January 10, I have been using over the counter Cortisone cream, which helps the itching temporarily.
This spontaneous report as received from nurse refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients was received improperly stored ROTATEQ (lot# K022990 and expiry date: 26-JUN-2016; lot# K023537 and expiry date: 22-JUN-2016; lot# L004466 and expiry date: 02-AUG-2016). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB lot # J011112, expiration date 12-JUN-2016 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 8AUG90 had temp elevation & sz in Hospital 24 hrs; On 16OCT90 had another sz in hosp 1 wk home on apnea monitor;
At 12:44pm patient complained of Tinnitus, patient vitals were taken, BP: 120/90, HR: 86, RR: 14, Pulse: 68, O2: 93%.  Patient denied s/s of hearing loss, dizziness, vision changes, difficulty breathing, and said he felt fine other than the ringing in his ears. Waited 15 minutes and Patient reported no improvement with Tinnitus. Rechecked vitals at 01:10pm BP: 120/90, HR: 89, RR: 12, O2: 93%, Patient still denies any s/s of hearing loss, dizziness, vision changes, difficulty breathing. Patient was alert and oriented no signs of confusion, skin looked normal no pallor or sweat visible. Patient education on Tinnitus and encouraged to see Primary Provider ASAP.
Initial unsolicited report received from a pharmacist on 10-Nov-2017. This case involves 73-year-old female patient, who was vaccinated with 0.5ml dose of FLUZONE HIGH-DOSE (batch number, expiry date and dose in series, site of administartion were not reported) via intramuscular route once, on 11-Oct-2017. The patient's medical history included allergy to codeine and heart issue and concomitant medication was not reported. On an unknown day, the day after following the vaccination, the patient experienced a cough, hoarsness, fever, headache, dizziness, tachycardia, racing heartbeat, irregular heartbeat and increased BP. Laboratory investigation and corrective treatment was not reported. Outcome of all the events were resolved on an unspecified day. List of documents held by sender: none.
85 y/o M admitted for malaise and fever found to have leukocytosis. Given only sig. event in pt's recent hx was PNEUMOVAX 2 days prior, rxn to vaccine seemed most likely. Pt improved w/o additional tx and was d/c'ed home with close outpt f/u.
pt recvd vax; w/in 24 hrs, exp pink urine;low grade fever & irritability;no findings on exam;adm to hosp x 24 hrs;dx:myoglobinuria, etiology unk;urine clear on discharge;12dec urine oink again;no fam h/o myoglobinuria;
Caller then mentions her voice is hoarse; Date of start of drug:12May2021/Date of last administration:25May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 25May2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Smoking" (unspecified if ongoing), notes: Smoking. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical location: Left arm, Lot number: 675, Time the Vaccination Was Given: in the evening), administration date: 12May2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25May2021, outcome "unknown", described as "Date of start of drug:12May2021/Date of last administration:25May2021"; DYSPHONIA (non-serious), outcome "unknown", described as "Caller then mentions her voice is hoarse". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Infant had lethargy and possible ALTE. 6 mo shots, 12/7/15; mom went into patient's room and found pt crying, she picked patient up and noted his head was floppy, she placed patient back on crib and patient's eyes rolled back. Patient is a 6 month old otherwise healthy male who presented for evaluation of an ALTE. On the evening of admission patient awoke from sleep about an hour after eating screaming as if in pain. Parents went to him and when mom picked him up he was limp and not focusing on them. They noticed his eyes appeared to be open and rolling up into his head (straight, no deviation). No jerking or rhythmic movements. No cyanosis. No apnea but some snorting, grunting, and gasps as the event was resolving. Muscle tone slowly returned to normal with the entire event lasting about 3 minutes. No sick contacts. Parent deny patient having any fever, cough, congestion, vomiting or diarrhea prior to this episode.
0955 SEEN BY DOCTOR FOR CHECK-UP 1040 SEEN AT IMMUNIZATIONS FOR SHOTS 1140 GIVEN IMMUNIZATIONS (SEE BELOW) 1210 STABLE UPON DISCHARGE FROM WELLNESS CLINIC 1345 MOTHER BROUGHT BABY BACK TO PRIMARY CARE CLINIC FOR FEBRILE SEIZURES 1500 AIR EVAC TO HOSP.
became sick within 7-9 days of getting the vaccine and currently in rehab center; unable to get their 2nd dose within the 42 day window; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (became sick within 7-9 days of getting the vaccine and currently in rehab center) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became sick within 7-9 days of getting the vaccine and currently in rehab center) and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window). At the time of the report, ILLNESS (became sick within 7-9 days of getting the vaccine and currently in rehab center) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose within the 42 day window) had resolved.        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.   No concomitant medications were provided No treatment medications were provided
12/19 - fever, congestion, headache, cough 12/24 -  body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension
Hospitalized with COVID-19, tested +7/17/21. Pt has a cough, SOB, CP.
after the  patient received the vaccine she waited approx 20 minutes in our waiting area and then went around the store to do some shopping.  I did notice that when she arrived to the pharmacy and when she went into to the vaccine area that she was limping and favoring her right leg.  roughly 30 min after she left, one of our  associates came to the pharmacy asking for me aid about this patient.  When I arrived to the patient she was clutching a a display end cap and stating that her right knee was in extreme pain and crying.  I called the patients PCP and told them what had happened to our mutual patient.  the patients daughter in law arrived shortly after and took her to her PCP.
Employee mandated to have the vaccination as a nurse. Delayed reaction, 03/01/2021 was the first incident after receiving the vaccination. Vision was going in and out and could not see. Loss vision in the right eye March of 2020 vision was stable and had not been getting worse. Every since the vaccination vision has been deteriorating. New diagnose of Rental Migram 03/01/2021. 12 Days later, right side of body was feeling numb, pupils was blow and right side of body was numb and and facial drop, she called 911. 03/13/2022, Went to ER and was diagnosed as a headache. Doctor said the pupil was fine. Memory issues, Facial drop and new heart issues since vaccination as new health issue after vaccination. ER multiple times and still having issues. TIA Hospitalization for new diagnosis heart condition with heart rate fluctuating up to 220, was admitted to hospital with a stay of three days.
Developed fever, chills, aches, fatigue approximately 12 hours post vaccine.  unable to report to work the day after vaccine administered
Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was 84 and receiving palliative care for metastatic prostate cancer. Comorbidities include T2DM, HTN, MI s/p PCI, and CKD.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.90  Concomitant products were not provided.  On 07-Jan-2021 vials were moved to clinic. On 05-Jan-2021 the vaccines were moved to fridge. On 07-Jan-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34 and at 10 AM temperature was 34  The vaccine beyond use date was reported as 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient said he was light headed and dizzy. No signs of respiratory distress, but he said his lips were puffy. An epi-pen was given and the paramedics were called. The patient's wife met him and agreed to take him to the emergency room
The pt developed urticaria over left arm and lower legs following the 3rd dose of Anthrax.
Vaccine given 11 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days post expiry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Patient said that the same night while sleeping he woke up with "convulsions"/shaking/chill and had a fever of 101 (his usual is 97) - he was scared enough to almost call the ambulance but did not. He was fine when he woke up in the morning.
AT APPROXIMATELY 11PM ON 1-25-21, I EXPERIENCED CHILLS, HEADACHE, AND BODY ACHES AND PAIN. AT AROUND 2AM, I STARTED EXPERIENCING NAUSEA. THE SYMPTOMS PERSISTED THROUGH THE NEXT DAY UNTIL ABOUT 6PM. THE FOLLOWING DAY, I HAD VERTIGO AND CONTINUED STOMACH UPSET.
12/9/2013 visit to Dr. for nausea, dizziness, abdominal pain, visual floaters and blurry, subtle symptoms added on - panic attacks 3/14, light and color sensitivity, fatigue, brain fog, headaches, neuropathy 1/14. The GI specialist only could explain constipation....the nausea was from the POTS which we did not know about in 12/2013....she saw the GI doctor on 12/10/2013, and we only knew she was nauseous. It did not make sense then but does now since we know her autonomic nervous system deregulated. This started within days of the 2nd GARDASIL (12/3/2013) and to Primary care doc on 12/9/2013. The POTS symptoms built....professionals never tied in the BP and HR to this until Neurologist took her BP sitting and then standing and the same with the heart rate...We first got in to see Neurologist on 7/10/2014. He said it was POTS somewhere between 7/10 and 9/24/2014...by 12/2014, the POTS was so bad, the nurses at her high school had me pick her up and take her to the ER on 12/8/2014...We had the official TTT done on 2/20/2014 which confirmed POTS. She also had some nerve conduction testing that same day which confirmed CIDP. Today we know that patient has PANS, POTS, chronic Lyme that came forth after the GARDASIL....the 2nd GARDASIL vaccine triggered an inflammatory/autoimmune response within her causing many complaints: headaches came before the fatigue, neuropathy started in Jan. 2014, swallowing issues 8/14....4/14 POTS symptoms and continued worsening into Fall and Winter 2014....tunnel vision Kw/presyncope, chest pain, cognitive decline, anxiety, OCD, depression, self-harm, separation anxiety noted 4/2014, the dizziness progressed to constant vertigo, and the nausea continues consistently to this day. Meds only take it away briefly....ZOFRAN = 2 hours. Insomnia, nightmares, twitches, tics, pain legs-neck-knees, shoulders. She started in January, 2015 with seizure like episodes (they may be focal or partial complicated seizures)....they are more frequent now (8/5/2015). She missed a great deal of school since 12/3/2013 and was unable to go to school since 1/2015 when she was changed to homebound and received 9 hours of one on one tutoring. She has had extensive blood work drawn. The Cunningham Panel drawn on 11/20/2014 supports Neurologist's PANS diagnosis. She had a SPECT-scan on 1/2/2015. She has fainted and fallen.
Patient's spouse described patient having swollen arm, fatigue, dizziness, cold sweats, shortness of breath.
immediately after the shot her arm started to ache, pain became on and off depending on how she moves
patient got the flu and died; Initial information received on 29-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves male patient of unknown age who got the flu and died (influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date (reported as in September of 88), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (reported as in December 88), the patient got the flu and died (influenza) (serious event), approximately 3 months (exact latency unknown) following the administration of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient was receiving any corrective treatment.  It was unknown at the time of reporting if an autopsy was done and the cause of death was captured as influenza.  Information on the batch number to be requested.; Sender's Comments: This poorly documented social media case concerns a male patient of unknown age who had influenza and died after receiving INFLUENZA VACCINE. Time to onset is compatible. Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient got flu and died
Patient reports twitching in left arm throughout day at vaccine site in tricep each day since first covid Pfizer vaccine. Patient reports twitching is getting better.
stroke; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lupus" (ongoing), notes: has a history of lupus. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". Clinical Course: patient got the vaccine, Name of Product: Pfizer bivalent vaccine and had a stroke 2.5 weeks later. Event took place after use of product. Patient also had a history of lupus.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Feels like heart beating faster. Tongue a little "swollen". Evaluated by EMS-Cleared.
This spontaneous report was received from a pharmacist regarding a 53 year old female patient with no pertinent medical history reported and no known allergies. On 24-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number reported as J001693, expiration date 08-MAY-2014) (dose and route not reported0. Concomitant medications included furosemide (manufacturer unknown), fluticasone nasal, norethindrone and hydrocodone with acetaminophen. The pharmacist reported that approximately in June 2013 the patient developed a single spot (like a bug bite) on the right elbow, another single spot on the left arm (site unspecified) and swelling and redness on the neck, following vaccination with ZOSTAVAX. The patient went to the physician yesterday (also reported as 27-JUN-2013). The outcome for the above mentioned events was reported as Not recovered. Treatment with Caladryl topically and BENADRYL orally was given. It was reported that the patient sought medical attention by contacting pharmacy and physician. The reporter did not assess the causality between ZOSTAVAX and the above mentioned events. Additional information has been requested.
4 hours after vaccine I started noticing a slight headache and slept for 5 hours which was weird because I usually don't do that. I did go to work the next day though. It was fine the next day. It only lasted that night.
Imm on Thurs 10/30/03. Began chills on Fri-localized  swelling at injection site-general malaise and weakness-called this clinic on Tuesday 11/4/03 advised to seek medical attn. Mom called here to inform pt admitted to hospital. Generalized rash also mom said abscess on buttock x 2-sent home with Bactrim x 10 days post 4 day hospital stay. The discharge summary received on 3/23/04 states cellulitis and MRSA.
Pain, itching, red welt appeared on arm at vaccination site the day after vaccine, as typical.  Also had body aches for two days, again typical.  However, 5 days after the vaccine, redness and itching on arm WORSENED and began SPREADING DOWN THE ARM, well past the injection site.  On day 6, redness and itching continued to spread & worsen.  On day 7, I contacted the pharmacist, who advised me to take oral antihistimes (benedryl).  The benedryl seemed to help and on day 8 the redness and itching finally started to lessen and go away.
shingles; I got my second shot this morning. It hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 1st dose on an unknown date and had shingles, refer case US2023AMR038408).   On 03-JUL-2023, the patient received the 2nd dose of Shingles vaccine. On 03-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles) and pain (Verbatim: I got my second shot this morning. It hurts). Rechallenge with Shingles vaccine was positive. The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038408   Additional Information: GSK receipt date: 03-JUL-2023 The case was received from the patient via interactive digital media. The patient got the second shot this morning (on the day of reporting) and it hurts, but not as much as shingles. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR038408:1st dose case