chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACUTE HEPATITIS; This case was reported by a consumer and described the occurrence of hepatitis acute in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hepatitis acute (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis acute was unknown.   It was unknown if the reporter considered the hepatitis acute to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter informed by the physician that he had seen at least two more patients with similar diagnoses of acute hepatitis following a Shingrix administration. The reporter consented to follow up. This case has been link with US2020153365, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter
Starting one week after first Moderna dose, experiencing low grade fever, chills, sweating, and myalgia. Still has not resolved after 7 days.
extreme skin rashes; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 05Feb2021 (lot number and expiry date not reported), then second dose on an unspecified date (lot number and expiry date not reported), both via unspecified routes of administration at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she already had the first and second dose. She developed extreme skin rashes after the first dose on an unspecified date and until the time of reporting. She said the rashes started on her arm even now on her back and thigh. Patient was asking what medication will be able to recommend to her. Outcome of extreme skin rashes was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Induration, erythema, swelling & warmth around injection site. 2nd pt to have same with this lot.
Fever of 101 for a few hours, severe aches and pains all over and especially in joints, severe headache, mild vertigo / dizziness,  severe chills,  difficulty breathing.
Patient had adverse reaction  to the first dose of pfizer. He was dizzy and lightheaded Vaccine given at 9:06 AM and reacted at 9:17 AM with dizziness and lightheaded. Also had tunnel vision, skin was clammy and was pale.  Was laid down at the time and lifted his feet with ice on head. Vitals signs every 15 minutes.  9:42 AM his vitals were good and he was released at 9:45 AM.
Both feet bottom of feet and top of feet extreme heat  started on April 15 and still happening now Since 4/15/21 had approximately 4 hrs of sleep. Not sleepy or tired.  Feeling heat sensation on a scale of 1 to 10  heat is about 10. Continuous have no relief And cannot sleep
2.5cm lump at injection site right arm redness 4-5cm wide extending to elbow evaluated by doctor. Diagnosed rule out cellulitis. Treatment: Benadryl, Keflex 250/5cc 1 tsp TID x 10 days.
Body aches, chills, heart racing, anxiety, fidgety-took Aleve lasted 2 days
Went for a Doctor's visit at 10:30am on April 21, 2023.  After consultations, I asked if I can be vaccinated against Shingles.  Dr. approved and requested nurse staff to administer the Zoster (Shingrix) vaccine right in the clinic room where I was.  This was done at about 12:30pm of the same day.  I waited awhile for any allergic reaction but was negative after 15 mins. wait.  I drove back home.  Inspected my skin while prepared for bed in the evening.  On April 22, no rash showing up around poke area and other parts of body.  By April 23, 2023, at about 9:30pm, I noticed reddish spots like "Hives" started appearing on my left and right arms, my neckline area and two armpits.  I immediately took a Benadryl 25mg as advised by the clinic.  Then today, April 24, more reddish spots or Hives have developed fast on both under the arm areas,  around neck and on both armpits.  No other reddish spots were noted on other parts of the body.  Took another Benadryl 25mg upon wakeup today.
The next day I had normal symptoms, but as part of that, I had lower back pain. I waited a month before I visited the doctor. Then I went to Primary Care Physician, she did not agree that it was a reaction to the vaccine. The pain got so intense, I am now going to physical therapy for treatment for the nerve.
Pfizer-BioNTech COVID-19 Vaccine EUA Fever (Tmax 101.3), generalized myalgia, chills, headache, fatigue - these symptoms began to occur about 18 hours after the 2nd injection in the series and last about 18 hours. Treated successfully with ibuprofen. Feeling much better by the following morning with only fatigue.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2015, the patient was vaccinated with the fourth dose of GARDASIL (dose: 0.5 ml, route intramuscular, lot number and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Patient reported, redness, tenderness, swelling, and heat at the site of the injection.
very severe joint and bone pain especially on her back and her spine area; very severe joint and bone pain especially on her back and her spine area; very severe joint and bone pain especially on her back and her spine area; very fragile health; wheelchair and her movements are limited; This is a spontaneous report from a contactable consumer (patients daughter) or other non-health care professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced very severe joint and bone pain especially on her back and her spine area, the pain was kind of on the bottom part near patient's tail area just a little bit above that. The reporter was just wondering if this was one of side effects of the COVID 19 vaccine. Patient was very fragile health, wheelchair and her movements were limited. when she was in pain she can't move at all, she has a hard time going to the bathroom. It was a hassle and it was very hard on her. Reporter stated that her mother said that there was no way she was going to get the second dose with all of that pain. The reporter just wanted to know what will happen if they dont get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
a little sluggish on the second day; arm sore; sore on top of his head appeared back which he observed after getting the shot; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on 06Apr2021 (Tuesday) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. On 07Apr2021, the patient started having arm sore and a little sluggish (on the second day about 24 hours after), and yesterday (09Apr2021) he was fine but the sore on top of his head appeared back which he observed after getting the shot. The outcome for all of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
0905 eye started to get watery. 1100 eyes started to swell and started feeling bad- sore throat. 1200pm went to Occ Health office and reported sore throat, release from work and followed up with my PCP. 200pm started to have shortness of breath and feeling worse.
At first it began with extreme fatigue, chills, and weakness. Then later it became impossible to take deep breaths and could hyperventilate.
stood up after injection and had probable vaso vagal response with full body tremor, lips turned pale, eyes rolled back, assisted to exam table tremors lasted a few seconds-less than a minute, vital signs taken WNL
No other AE occurred; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 14-JUN-2022, the patient vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose reported as 1 dose, lot # U039723 with expiration date on 15-DEC-2023, administered subcutaneously for prophylaxis (strength, vaccination scheme frequency and anatomical location were not provided) (product storage error). The administered dose of the vaccine experienced a temperature excursion at -2.5 degrees Celsius (C) for a time frame of 5 hours and 6 minutes. It was stated that there were not previous temperature excursions. Additionally, it was confirmed that no adverse events occurred.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005711: US-009507513-2206USA005588: US-009507513-2206USA005579: US-009507513-2206USA005817:
Initial unsolicited report received from healthcare professional on 12 December 2014. A male patient, whose medical history, age, gender, and concomitant medications were not reported, had received a dose of FLUZONE HD batch number- U5042AA, Expire date- 14-MAY-2015 (dose number, dose in series, route of administration, site of administration were not reported) also ADACEL batch number-U4963AA, Expire date- 30-Jan-2017 (dose number, dose in series, route of administration, site of administration were not reported) and PNEUMOVAX  (manufacturer-Merck, batch number, dose number, dose in series, route of administration, site of administration were not reported ) on unspecified date in December 2014. On unspecified date in December 2014 after vaccination the patient experienced a reaction which is not specific. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event is unknown. Documents held by sender: none. Follow-up report received from a health care professional on 1 July 2015. No new additional information was reported. Documents held by sender: none.
pt recv vax 15JAN99 & 17JAN99 mom noted to have rash on face/upper torso;19JAN99 office visit dx erythema multiforme rx pred/atarax;20JAN99 office f/u better dx erythema mult;
On the evening of the vaccine, I noticed that my body was red and splotchy.  The next day, I was very itchy and scratching was painful.  Yesterday - 2 days post injection - my head and entire torso was hot to the touch, extremely itchy and painful to scratch. I also noticed that where my bra was rubbing, it was extremely painful. Last evening, I took a Benadryl to help with itchiness.  This morning, I have small blister-like patches all over my torso.
Onset of pain, swelling, redness (4x2 cm area on exam) occurring 9 days after vaccine administration in left thigh with low-grade fevers. Treated with PO antibiotics (Bactrim DS, weight-based dosing) x 5 days, started today. Will follow up to await outcome of treatment.
Right upper arm profuse redness, warmth, and swelling posteriorly from shoulder to just above elbow
Child developed severe diarrhea, rotavirus positive and 2 weeks after the Rotateq was admitted to hospital for IV hydration and a bicarbonate of 16, so it was not just a poor judgement of his hydration status. Records received 5/15/07-Discharge Summary received for DOS 4/7-4/9/07-DX: Rotavirus positive diarrhea. Dehydration. Temp 103(R). IV fluids for 48 hours.
Temp spike to 103.8 - Advil given, generalized body aches. Unable to even get out of bed. Fever continued despite Advil, became dehydrated and needed IVF. Antibiotics and steroids started by MD.
Arm became warm, red, tender the evening after receiving a DTaP vaccine in her arm. The pt went to emergency department and received antibiotics. The pt improved. Father reported the arm was normal 07/10/02.
Thyroid eye disease; Did not feel good; Can't work,Can't live,Can't see, her life is a living ,ruined her life; Can't live,Can't see, her life is a living ,ruined her life; Can´t see; can't drive; This spontaneous case was reported by a consumer and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) and BLINDNESS (Can´t see) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease) (seriousness criterion medically significant), FEELING ABNORMAL (Did not feel good) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), BLINDNESS (Can´t see) (seriousness criterion medically significant) and IMPAIRED DRIVING ABILITY (can't drive). At the time of the report, ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life), BLINDNESS (Can´t see) and IMPAIRED DRIVING ABILITY (can't drive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: +23 (High) Thyroid level sky rocket high at +23.         No concomitant medication information was mentioned by reporter  Synthroid 1mg used as a treatment medication then dose of Synthroid  was changed it to 0.88mg.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a certified medical assistant (C.M.A.) concerning a 60 year old patient who was vaccinated subcutaneously with a dose of VARIVAX (Oka/Merck) (lot# 659250/1474U) in lieu of ZOSTAVAX (Oak/Merck) (MSD). The physician thought that that VARIVAX (Oka/Merck) was indicated to prevent Varicella and Zoster virus. No adverse experience was reported thus far. Follow-up information was received from the C.M.A. on 23-JUN-2008. She indicated that the doctor thought VARIVAX (Oka/Merck) was the vaccine to prevent shingles.
he also received a full dose as a Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (he also received a full dose as a Booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (he also received a full dose as a Booster dose). At the time of the report, ACCIDENTAL OVERDOSE (he also received a full dose as a Booster dose) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient recieved the covid 19 booster by pfizer today 9/8/22 at 12pm and then shortly after recieving the shot, patient felt dizzy, confusion and fainted shortly after. Emergency was called and paramedics came to check the patient.
nurse mistakenly gave a 7 month old FLUBLOK with no adverse event; Initial information regarding this unsolicited valid non-serious case received from other health professional transmitted to Sanofi on 16-Dec-2020.  This case was linked to case 2020SA362408 (3.5 year old patient).  This case involved a 7 month old patient who was mistakenly received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.  There would be no information available on the batch number for this case.
38 hours after the shot, at 10pm at night, after waking up from falling asleep on the couch, I saw what I thought was a softball size "swarm of gnats/flies" in the corner of the room with trailing flies.  After staring at it, it disppeared and disper; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0150) via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis b carrier. The patient previously received penicillin type medications (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced penicillin allergy. Concomitant medications included tenofovir disoproxil fumarate (TENOFOVIR) for unknown indication on an unknown date. 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. On 01Apr2021, 38 hours after the shot, at 22:00 in the night, the patient woke up from falling asleep on the couch, then what the patient saw was a softball size "swarm of gnats/flies" in the corner of the room with trailing flies.  After staring at it, it had disappeared and dispersed from her vision after about 40 seconds. No therapeutic measures were taken as a result of reported event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event optical illusion of a softball size "swarm of gnats/flies" in the corner of the room with trailing flies was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
I have lumps over my body that have been growing, but they are not abscesses. I have several in my forearm and several in my upper forearm. The ones in my armpits are very painful. In November 2021, I had noticed a lump in my breast. The doctor said that the lump was just an enlarged lymph node and nothing to worry about. The doctor also said that the vaccine is what caused the lumps to go crazy. I have a few on my thigh as well. It feels like someone is beating me with a bag of rocks constantly. This  has been overwhelming. It is a myasthenic thing. I'm not sure if they are ever going to go away. The exacerbation of my myasthenia gravis exacerbated in a myasthenia crisis. The first week I was running a low grade fever, and I felt like I was dying. My myasthenia gravis flared up that same day after the vaccine, but this one was the worst. I had a flare up after each covid vaccine. I'm better but not completely better. I'm not falling or having trouble breathing anymore, and my voice is getting better.
On 02/24/2023, I began to feel a headache around 06:00 or 07:00PM. I had been drinking alcohol, so I assumed it was due to that. However, it did not go away, and I had a difficult night sleeping. My wife had tested positive for COVID-19, so I had slept on the couch. By morning, I didn't sleep at all and was uncomfortable and achy. I took an at home COVID-19 test and was positive. As the day went on, I deteriorated. I had aches, fever, and bad chills. I was in bed for the next few days. I started PAXLOVID on 02/25/2023. My first dose was around 01:00PM. The 02/25/2023 was the worst. During the next few days, it got a bit better and I was able to get out. I was able to resume work around Tuesday or Wednesday, but I would get fatigued. I was feeling better by the following weekend. However, 03/08/2023, I woke up with a bad headache that felt like a sinus infection. I had a telehealth appointment with my doctor and was prescribed and antibiotic. In the past, when I've had sinus infections, the antibiotics helped very quickly, but that did not happen this time. I was able to work 03/08/2023 and 03/09/2023. My wife suggested I take another COVID-19 test and was positive again. I was out again for around 3 days. I was out for 03/08/2023-03/11/2023. By 03/12/2023, I was able to move around again and was able to work by the next day. So by the time it was all over, it took around a month for me to fully recover.
Pt recvd vax in 1990 through 1991; lab eval in FEB91 revealed anti-HBs pos; In SEP92 pt donated blood & was found to be pos for hep core antibody, & neg for anti-HBs;
This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a patient. On 17-Oct-2012 the patient received a partial dose of AFLURIA (batch number was not provided) injection intramuscularly due to a leaking AFLURIA prefilled syringe. The rest of the dose leaked out of the syringe onto the patient's arm. No known adverse effect was reported.
EMS was called to pt's house for SOB; was found in respiratory extremis; emergently intubated when brought to ED and mechanically ventilated; admitted to CCU; acute renal disease; positive for COVID; given dexamethasone; pt's condition worsened drastically; family consulted and pt was placed on comfort measures and on terminal weaning protocol; pt died in the CCU