chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After first shot on 3/1/2021 all I had was a sore arm for a couple hours and nothing else a breeze but after 2nd shot on 3/29/2021 My arm was getting sore and sorer and by 6:00 p.m. I started to get hot sweats and chills for the next 24 hours. I became very weak and developed diarrhea badly running to the toilet all the time and that lasted for four days. I also developed on day two burning urination  for 3 days like a bad UTI which I have experienced being a diabetic. On day four hot sweats and chills stopped but burning urination continued but I was able to get diarrhea under control using some very good medicine I had on hand - The light green anti diarrhea medicine in the bottle -can't remember name  but I can get. I also got very bad headace and there is still some there to day on top of back of head
Raynaud's syndrome - painful tingling in hands and feet, changes in color, poor circulation, cold. Consistently occurring over last two weeks
I came down really sick; Nightmares; Headache; I was very weak; Nausea; I don't feel as good as I was before; Night sweats; Feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 85 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 25Dec2020 (unspecified if ongoing). Concomitant medication included: BABY ASPIRIN.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I came down really sick"; NIGHTMARE (non-serious), outcome "unknown", described as "Nightmares"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; ASTHENIA (non-serious), outcome "unknown", described as "I was very weak"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MALAISE (non-serious), outcome "unknown", described as "I don't feel as good as I was before"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweats"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad". Therapeutic measures were not taken as a result of illness, nightmare, headache, asthenia, nausea, malaise, night sweats, feeling abnormal.  No follow-up attempts are possible. No further information is expected.
Patient called our clinic today (12-01-2016) to report this adverse event. She states the problem is a result of the Tdap vaccine. Adverse Event: Leg pain. Pain has persisted off and on. Patient sought treatment at MD, Chiropractor and at hospital ER. Diagnosis: muscle spasms. Treatment has been muscle relaxers, physical therapy. Lumbar X-Ray was done.
WE HAVE CONTACTED PFIZER ABOUT THIS EVENT. THERE HAS NOT BEEN ANY SIDE EFFECTS NOTE BY THE PATIENT.
11 days after 2nd Shot - April 6, 2021 - woke up w/ joint pain in fingers, knuckles, wrist in right hand AND left thumb.  I have tried ICE and Ibuprofen / Advil and pain patches.  It hurts to open a bottle and write (examples of pain levels).  When I wake up in the morning, my right hand is very sore & painful.  Highly frustrating and concerning.  I was FINE before the Pfizer injection.
This spontaneous report received from a consumer via a company representative concerned a female 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got the latest variant/Covid-19. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got the latest variant/covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20220214903.
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
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 33-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 at 10:30 as dose 1, single (Lot number: ER8727), in left arm, on 18Apr2021 at 10:30 as dose 2, single (Lot number: EW0161), in left arm and on 06Dec2021 at 19:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was treated with Paxlovid for treatment of covid-19 from 11Oct2022 to 16Oct2022. Patient was taking other medications/products within two weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.
Rash (redness only) began 5 days after vaccine administered--back & much of torso. Itchy.  Prior to appearance of rash, but following vaccine receipt, took Cephalexin, 500mg (for possible finger infection);   Ambien; Vitamin D3. Stopped above once rash appeared, added Benadryl. It's now 48 hours since rash appeared, seems to be fading.
Began with pain to injection the same evening of injection on Sat 1/23/21, then 2 days later on Mon 1/25/21 with some redness around injection, no drainage or fevers.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history was not reported. In approximately 2016 (reported as on or after 19-JAN-2016), the patients were vaccinated with improperly stored doses of VARIVAX lot # L008270, expiration date reported as 11-MAR-2017, lot # L032396, expiration date reported as 26-AUG-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 5.1 Fahrenheit degrees for 8 hours 45 minutes. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
At the time I received my 1st Pfizer vaccine I was pregnant. I recently found out my unborn child has a birth defect called spina bifida. I am 18 weeks pregnant and my due date is 10/18/2021.
HEADACHE; BODY ACHES; CHILLS; TIREDNESS; STRANGE TASTE IN MOUTH; This spontaneous report received from a patient concerned a 66 year old. The patient's height, and weight were not reported. The patient's past medical history included family history of cholesterol, and concurrent conditions included chemical allergies, and petroleum byproducts allergy. The patient experienced drug allergy when treated with cefotetan.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced body aches. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced strange taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, body aches, chills, and tiredness on 07-MAR-2021, and was recovering from strange taste in mouth. This report was non-serious.
Case number PHEH2014US018223 is an initial spontaneous report from the health care professional (medical assistant) received on 09 Sep 2014. This report refers to a 16 year old male patient. He was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 02 Sep 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
It actually started out in 2021. I had a test that showed an abnormal liver result. We thought that it could be not much of anything. It was my AST and ALT and they were high. They were never high before. We waited 3 to 4 months and took another test and that was normal. Some other liver enzyme tests came back high - Mitochondrial M2 Antibody. The other two came back normal at that time. In 2021, I went to see a liver doctor. He noted that everything looks fine except for this. Everything else was normal in other tests. In January 2023, we ran another test and my AST and ALT were normal, the Mitochondrial M2 Antibody was still high, and now my immunoglobulin M, Qn serum is high and my antinuclear bodies are high. IFA was positive when it was negative a year ago. Homogenous pattern was also high.  I've had more autoimmune things that have shown up that weren't there before. I don't have any symptoms for Lupus or Cirrhosis of the Liver. I've had 5 of these vaccines and I was wondering if this could have caused this. The doctors noted that the vaccines couldn't be it. The tests pointed to something wrong, but we don't really know what it is. Nothing else has changed in my life. I've never had COVID-19. The only significant change has been receiving the vaccinations.
dizzy, nasal congestion, cough, has not eaten in 2 days, shortness of breath, lost of taste and smell since her shots on the spring, diarrhea, chest congestion, slight wheezing, starting 12/21/21
Hives on scalp initially, moving to body, hands and feet, dermatographia presenting in welts and scratches.
Went to cafeteria, had French fries, orange/pineapple juice. Complained of headaches, became pale, white lips, pulse 119, Lungs clear , no wheezing.
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with FLUVIRIN 2007/2008 (manufacturer unknown, batch number unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swab or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 160, 320, 320, and 2560 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
Severe muscle pain inside of gluteus maximus, difficulty walking & lying down did not alleviate the pain.
The itching started before the booster dose/ this has been going on for about 6 months; Regular side effects for the other doses; Chills; slight fever; Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (The itching started before the booster dose/ this has been going on for about 6 months), VACCINATION COMPLICATION (Sick for one day), VACCINATION COMPLICATION (Regular side effects for the other doses), CHILLS (Chills) and PYREXIA (slight fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (well maintained, she is not on any medications for it.), Constipation and Legal blindness, as defined in U.S.A. (So she needs to take dilation drops). Concomitant products included SENNOSIDE A+B (SENOKOT) for Constipation, CYCLOPENTOLATE HYDROCHLORIDE (CYCLOGEL) for Legal blindness, as defined in U.S.A..   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (The itching started before the booster dose/ this has been going on for about 6 months), VACCINATION COMPLICATION (Sick for one day), VACCINATION COMPLICATION (Regular side effects for the other doses), CHILLS (Chills) and PYREXIA (slight fever). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date for Itching, at a dose of UNK, qd. At the time of the report, PRURITUS (The itching started before the booster dose/ this has been going on for about 6 months) had not resolved, VACCINATION COMPLICATION (Sick for one day) had resolved and VACCINATION COMPLICATION (Regular side effects for the other doses), CHILLS (Chills) and PYREXIA (slight fever) outcome was unknown.            Patient had severe itching inside the body, it is not topical. The consumer reported that had been going on for about six months. She took a lot of labs and tests at her doctor's office, and she was concerned she could be allergic. She took Claritin every day, once the Claritin leaves its 24 hour cycle, the itching starts on the top of her feet, back, all over her body. The itching started before the booster dose.   This case was linked to MOD-2021-396227, MOD-2021-396265 (Patient Link).
Approximately 4 months after second vaccination on June 24th I developed tremendous chest pain and tightness.  After a couple days it passed.  About 2 weeks later it re-appeared and was so severe I went to Emergency department.   They diagnosed me with Gerd and put me on Prilosec.  It did not work and pain increased so I visited the emergency department again for a second over-night visit.  The prescribed me Sucralfate and Pantoprazole (neither helped)
Erythema on mid 1/3 of left upper arm (from site of injection down), mild swelling and warmness, temp 99.4 deg. F.
Delayed severe reaction to left deltoid S/P adm. vaccines IP and MMR    HC 170 - Benadryl
Absolutely terrible, incapacitating  period cramps, unlike I have had in many years, also a few days earlier than usual. Treatable by ibuprofen and rest, but I felt women?s issues need to be documented better.
Information was received on 28-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 16-JUN-2014, the patient received the ZOSTAVAX (lot number and expiration date unknown) unknown route for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 16-JAN-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious progressive permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a result of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses and other losses and damages. Shingles outbreak and chronic pain were considered to be disabling. Additional information has been requested.
Rash on arm of injection, runs from injection site to the elbow. Fever (102F), chills, headache, pain on affected arm and nausea.
16 years of age - Moderna vaccine.  Off label use, less than 18 years of age.  Phone call to client's mom.  Reports client is doing well, just fine.  Reports he had an achy arm and was tired for a couple of days, but that was it.  States, "he is just fine."
Information has been received from a nurse practitioner concerning a female who on approximately December 2006, was vaccinated IM with a first dose of Gardasil. On an unspecified date, the patient was vaccinated with a second dose of Gardasil. "About 2 weeks after the second vaccination" the patient developed "big bump on her upper arm". Unspecified medical attention was sought. Subsequently, after a few days the patient recovered from "big bump on her upper arm". 20-JUN-2007 when the patient came into the office for her third dose. It was at this visit that she notified the doctor of the "big bump on her upper arm" that was felt after receiving her second vaccination. On 20-JUN-2007, the patient was vaccinated with a third dose of Gardasil. Additional information has been requested.
vaccine given against FDA approval ages for 6 and older. Inadvertently given to a 5 year old
Patient states severe pain  in left  arm  radiating to  shoulder area.   Kept arm in sling then had pain in  wrist.    Spoke    with  patient  -  using gentile movement  and massage.  Doing much better per call to patient.
Approximately five minutes after the vaccination, patient became very light-headed and nauseated with loss of vision. She was offered water and hard candy while waiting for the paramedics to arrive. She took a small amount of each, but declined anything else from the store. She seemed to be in significant distress and had difficulty moving to the immunization room where she would be out of view from others in the store. Parmedics arrived and checked her vitals and said those looked ok, so they didn't seem concerned. Patient still seemed very unsteady when leaving, but did say that her vision had improved. Patients were advised to keep a very close eye on her.
WE WERE SUPPOSED TO GIVE MODERNA, ENDED UP GIVING PATIENT PFIZER VACCINE.
We had heard about the Measles outbreak, and we were headed back so my mother and I decided we would take him to get his MMR. Patient was fine receiving it, we noticed he was pretty out of it the following hours which we were told when we called that was completely normal. Excessive sleeping, fever, all normal is what we were told. A couple days later I noticed he wasn't looking at us in the eye anymore, we lost some eye contact and he also wasn't speaking with us even in babble form as he would typically do. A couple days after receiving it, that evening he was just inconsolable. High pitch screaming that's hard to forget, he cried for hours. We took him to an evaluation about a year later, where we were asked if he was up to date and was asked to explain what had happen and once there at that evaluation I was told it sounds like he was having an adverse reaction, but to continue vaccinating per Doctor. It wasn't till then did I realize that it was a adverse reaction, and did not realize reporting it was something I was able to do.
First pressure in area - 2 days later reports unable to lift or move arm - severe pain in area of left arm at injection site - we phone own PMD for following.
Low grade fever; aching; fatigue for a week; flu like symptoms that lasted for several days.
Extremely painful muscles , fever 103.8 - 102, extreme exhaustion, chills lasting 15 hours. Followed by low grade temp 100-101 and minor muscle pain and tiredness
Bleeding giant blood clots vagnially. She has never had that before the vaccine.  It lasted about 2 1/2 days and subsided and started again.
I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand. Later in the day i became extremely tired, had pain in my neck. The next day i was still very tired, arm pain, headache, body aches, vomiting. Day 4 i am still very tired with body aches.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had received Brand: Paxlovid as COVID 19 Treatment on 18Apr2022. Paxlovid rebound. Paxlovid completed on 22Apr2022. On Day 12 (26Apr2022) testing positive on RAT with mild symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Eyesight has significantly deteriorated after vaccination. First realized on Monday 05Apr2021 as other side affects such as muscle soreness, dizziness, and fevers prevented me from getting up. Eye sight has not deteriorated since Monday.