chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 60+ year old pt (gender and age not reported), who was vaccinated (date not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P; also reported lot 649988/0692P). There were no other concomitant vaccinations at the same time. Subsequently, the pt experienced redness, heat and swelling in the injection arm from the injection site down. It was reported that warm compresses, acetaminophen (Tylenol) and ibuprofen (Motrin) were recommended as treatment for the pt. It was also reported that this pt was revaccinated with pneumococcal 23v polysaccharide vaccine within 2 yrs. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
On 9/1/2021 I was unable to get out of car/put weight on my legs and had to crawl into my home/bed.  On 9/2/2021 I could not put weight on my legs and my daughter/son-in-law transported me to Hospital ER.  I presented with a fever, abdominal pain, leg weakness and was admitted on 9/3/21. It was determined that my fever was related to possible UTI and antibiotics given. I also had abdominal/lumbar scans and neurologist did not know what to attribute my leg weakness to.  On 9/9/21, I was discharged to acute rehab facility.  Ten days later on 9/19/21, my family and I agreed that I was not improving and after consultation with doctor, it was recommended that I go to Neurological ER for neurological evaluation. Within four hours, I was diagnosed with Guillain-Barre Syndrome and began receiving 3 IVIG treatments.  Three days later on 9/22/21, I was admitted to inpatient rehab where I received OT/PT for 20 days and am currently using a walker and receiving home health care.
w/in 30 minutes of vax pt started; vomiting then became lethargic & seemed to have difficulty breathing; instructed to see MD in ER; nausea & vomiting had lessened & by next AM had only vomited once & was playing;
Substantial muscular soreness lasting several days. Diarrhea lasting 7 days. Fatigue lasting 5 days.
Sore at injection spot and muscles surrounding.  Rash on side of upper arm xs 4 days
14FEB98 onset rash;16FEB98 onset arthralgias;18FEB98 rash & arthralgias resolving;
Arm felt fine originally, but, at that point, felt more like how I would imagine a gun shot to feel.  Very painful and could not lay on it at all.  Had bad chills and fevers and sweats.  Extremely painful headache.  Very sleepy.  Slept constantly on 10/24/2009.  Would go to sleep for an hour or two wake up, then go right back to sleep again.  No energy.  Very weak (it was somewhat difficult just to stand to take a shower). Redness developed around the entire shoulder area of my arm where the shot was given.  Developed a slight earache.  Most symptoms relented on 10/25/2009.  Was still very tired and had very low energy.
Interval between the first and second dose more than one year; no other reported AE; This spontaneous report was received from a nurse referring to a 14 year old female patient.  Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.      On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 milliliter for prophylaxis, and over a year later she return for her second dose (inappropriate schedule of product administration). No adverse events were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06May2021 as dose 3 (booster), single (Lot number: FI4989), in left arm and on 19Nov2021 as dose 4 (booster), single (Lot number: FG3527) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lactose intolerant" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: YASMIN; FLONASE [FLUTICASONE PROPIONATE]; WELLBUTRIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive, notes: COVID 19 Treatment; (27Aug2022) Positive, notes: COVID rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 15Aug2022 to 19Aug2022 for treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-SEP-2014, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 18-DEC-2014, she was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and prednisone for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
9/26/12 Itching swelling of (L) upper arm continued to get increasingly worse. 10/1/12 Blisters formed on and around site of injection 60mm diameter.
PT REPORTED BLOOD CLOTS, LYPHADEMA, AND WORSENING DIABETIES.
Two doses of improperly stored vaccine were administered to two separate uspecified patients; The total volume used of the sterile diluent used to reconstitute the vaccine was 0.7 ml; No adverse effects reported; This spontaneous report has been received from a medical assistant regarding a 12-month-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, Lot number S007069, expiration date reported as 06-SEP-2020, for prophylaxis (strength and anatomical location not reported) which were reconstituted with properly stored sterile diluent (DILUENT MRK) lot number R014176 and expiration date reported as 23-JAN-2021. The total volume of sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was reported to be 0.7 ml (Product preparation issue).   The vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of 15°F for the time frame of 40 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-1911USA009979:
Chest pain, sweating, discomfort. Began decrease after ibuprofen and 3hrs.  Also, day 2&3 after second dose had fever (100-101.2 peak), aches, chills, shivering, sore, reduced appetite, headache. These all subsided in the 12-18hrs before the onset on chest pain.
4 hours later, subjective SOB and chest tightness. Worsened by the next morning, slowly eased off. No other symptoms.
Patient received TDAP, MENACTRA, and HPV vaccine today. HPV was administered last. Almost immediately after the injection, he became pale, had a fixed gaze, and his arms an upper body shook. The episode lasted approximately 2 seconds. There was no LOC. His BP went down from 99/60 to 76/33, but after resting for 5 min and drinking 2 cups of water it went up to 96/63, HR 55 - all NNL
Dose1: Approximately 24-30 hours after injection got severe chills and sweats for the following 24 hours Dose2: Approximately 24 hours after injection got severe chills and sweats for the following 24 hours Dose3: Approximately 12 hours after injection got severe chills, went to bed, woke up 2 hours later very dizzy and nauseated, used the bathroom then passed out on the way back to bed falling to the floor. My wife woke up when she heard me hit the floor, she saw me lying on the floor passed out, eyes rolled back in my head. I started to wake up then was barely able to make my way to the toilet because I felt like I was going to vomit. I did not vomit so I tried to head to bed. As I was heading back to bed my wife said I passed out again vomiting as I was passing out then landed on the floor on my back still vomiting and choking on my vomit. She rolled me over because I was asphyxiating. I was then able to clean up and get to bed still dizzy. I had severe chills and sweats for approximately 24 to 30 hours afterwords. I felt weak, run down and had a headache for the next 3 days along with diarrhea. My head, neck, back and left side were in pain from passing out and hitting the floor for approximately a week. When I passed out I must have hit my elbow hard on the floor, it was in pain afterwords and still is to this day.
This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). ZOSTAVAX was exposed to temperature up to 24F for 67 days (1608 hours) and it was determined not viable. Improperly stored ZOSTAVAX had been administered to the patient. No adverse effects reported. This is one of several reports received from the same source (same reporter link: 1304USA002220 and 1304USA002221). Additional information has been requested.
Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4269884-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1155481), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1; Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 62-year-old, for Covid-19 Vaccination, reaction(s): " Drug ineffective", "COVID-19", "Glaucoma", "Sarcoidosis". The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "recovered". The action taken for adalimumab was unknown. Additional information: It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of fatigue was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated the report type from Non-interventional study to spontaneous, added stimulated in classification.
Treatment of COVID-19 on 10-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Treatment of COVID-19 on 10-May-2022) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002m21a, 076c31a, 029l20A and 037k20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Motrim).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Treatment of COVID-19 on 10-May-2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, COVID-19 (Treatment of COVID-19 on 10-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The indication provided for Paxlovid was Treatment of COVID-19.  company comment: This spontaneous case concerns a 59-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred unspecified days after and after the fourth dose mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19 for 5 days. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred unspecified days after and after the fourth dose mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19 for 5 days. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
patient was scheduled before 21 days for the second vaccine; 102 fever; body aches; fatigue; chills/body tremors; sore arm; nausea; chills/body tremors; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL8982) via an unspecified route of administration, administered in left arm on 11Feb2021 at 09:45 (at the age of 39-years) as 2nd single dose for COVID-19 immunisation at Hospital. The patient had known allergies to sulfa drugs, gluten. The patient received no other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number EL3246) via an unspecified route of administration in left arm on 25Jan2021 at 09:30 for COVID-19 immunisation. On 12Feb2021 at 12:00, patient experienced 102 fever, body aches, fatigue, chills, body tremors, sore arm, nausea. The fatigue and body aches lasted 48 hours. Patient was wondering if the reaction was more severe because patient was scheduled before 21 days for the second vaccine. It was reported that no therapeutic measures were taken for the events experienced. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
No bad reactions.  The vaccine that the patient was supposed to receive was hepatitis B, NOT hepatitis A.  Therefore, the patient received an extra dose of hepatitis A
pt seen in office 14DEC92; t97.6 w/faint flat blanching maculopapular rash on trunk & extremities; Ryantan;
SEVERE DIZZYNESS,NAUSEA FROM THE DIZZYNESS. DAUGHTER HAD EXACT VAC. A COUPLE OF WEEKS PROIR WITH THE EXACT SAME SIDE EFFECTS. THIS IS THE REASON THAT THEY WERE ABLE TO PUT IT TOGETHER TO FIGURE OUT THAT IT WAS FROM THE VAC.
Thought  3rd dose of RotaTeq was being given when it was only the 1st dose and patient is 6 months old. No adverse effects noted at this time. Mother informed to monitor for side effects.
10/12/22: Covid Arm Rash (which I get after each vaccine/booster). 3" diameter. Red/itchy/warm. 10/24/22: Scalp to feet full body rash began.  Areas included scalp, face, eyelids, lips, ears (inside and outside) neck, back, chest, arms, waist, pubic area, groin, in between butt-cheeks, thighs, knees, shins, feet (tops/bottoms), hands (tops/bottoms, fingers). Everywhere.  Symptoms: red spots, pencil-like scratches, hive-like patches. These were inches long and wide. Itchy-ness level 7. Affected areas come and go within say 1 hour then re-appear in a different area. Can't wear earrings, bra, compression socks.  Did not work: benedryl, loratadine, hydrocortizone, triamcinolone. As of 12/12/22, symptoms are decreasing, As of 12/12/22, symptoms are decreasing, but still present. Important to note that these symptoms appear in one area for about an hour, disappear, then re-appear in another area.  Some of the affected areas ranged from 3"x3" to 4"x8" for patch of say 6 pencil like scratches on back or 4"x4" raised/bumpy area on butt. Hives seem to be more common in warm folds (inside elbows, groin, stomach, waist). I have photos if you need them.
Started out with a breakout of hives on arm of injection (left arm) Hives started spreading to all over the back area and down body. Was advised by doctor's office to start Benadryl. Benadryl did not help at all Woke up Thursday morning 4/1/21, with bottom lip swollen approximately 3 times it's normal size.  Saw doctor that afternoon and they prescribed Hydroxyzine and if that didn't work in a couple of days they also called in a prescription of steriods.   Hydroxyzine did not work so started the round of steriods that was given on Saturday 4/3/21
On 08/11 patient awoke with pain at 4am crying about his legs, buttocks,back and shoulders were hurting.  3 hours later he couldn't walk, I then take him to hospital ER the same day, they ran tests on him and sent us back home with hydrocodone for pain and told me if it worsens to bring him back. Thursday morning had to bring him back to the ER at Hospital and they had to admit him for a day, he had a fever and still in pain. They wanted to run more test on him and monitor him, so we stayed overnight until 08/14. We're back home with more pain medicine and he's still in the same condition. It hurts for him to walk, sit and lay down.
Patient complained of immediate burning pain in shoulder after infection, followed by persistent bruising at the injection site for some time. Patient stated that she still has chronic pain in the shoulder and muscle since the time of injection.
got covid even after 3 shots; got covid even after 3 shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid even after 3 shots".  Additional information: Thought about how she got covid even after 3 shots. But she still got the 4th shot (2nd booster) anyway.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A male pt, age unk, was treated with Oncotice (indication and treatment period not reported). Reportedly, he experienced urinary discomfort six hours after Oncotice instillation.
chills (6-8 hours post-vaccine), nausea (12 hours post-vaccine), headache (8-24 hours post-vaccine)
Information has been received from a physician, via a company rep, and a nurse concerning a male pt in his 40's to 50's, with unk medical history and unk drug reactions/allergies, who on approx 15Nov05 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (651523/0604R). On approx 16Nov05 (in the same week), the pt developed cellulitis. Information on the outcome was not known. The nurse could not provide additional details. However, she reported that the office would keep track of additional reactions involving pneumococcal 23v polysaccharide vaccine. The doctor also re-trained staff on how to store and administer the vaccine. Additional information has been requested.
Patient had red arm hot to the touch. Redness started at injection site went around deltoid/bicep and down to mid forearm.
A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving nasal FLUMIST QUADRIVALENT 0.2 Millilitres. FLUMIST QUADRIVALENT started on an unknown date. It was reported took expired FLUMIST-medication error which started on 18-Feb-2016. The outcome of the event of given expired FLUMIST-medication error is unknown. The report was considered to be non-serious.
Left arm swollen, hot, reddened (size of a soft ball) hard lump - VARIVAX. Right arm same but the size of an apple - MENACTRA.
mild discomfort Narrative: mild discomfort for 3 days with 1st and with 2nd dose
A couple of days after the vaccination, I developed a rash on both forearms that lasted about 4 days. I had a rash in the same place several weeks prior to the shot, but this was more extensive. It looked like Atopic Dermatitis.  I self treated with gold bond lotion. it was gone after a week.
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old male patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were unknown. It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was approximately 65 years old. The caller was a field based account manager who was doing an in-service on SHINGRIX. The patient received the SHINGRIX sometime in the previous week before the date of reporting. The events were reported to the physician the day after the shot was administered. The reporter had limited information. No additional details were available.