chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event- however, this was an administration error. Patient had previously received Covid19 Johnson and Johnson vaccine on 03/19/21 which was not known by pharmacy at time of administration.
Within 1 hour after administration patient called her PCP office with complaints of severe muscle pain, swelling over her entire deltoid, redness, blotchy raised rash, and temp 100.8.
Rhabdomyolysis/his muscles are deteriorating and he has high levels of protein that are developing into his body and are seeping into his bloodstream; Got a cola colored urine/his pee was the color of Pepsi- Cola; Excruciating pain/his body was achy but he thought that maybe that was possibly a regular side effect; At some time during that night he had pain and aches but they said that he might feel that in his arm; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 23-year-old male patient (reporter' son).   A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 24Aug2021 (age at the time of vaccination was 23-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that at some time during that night on 24Aug2021, the patient had pain and aches, but they said that the patient might feel that in his arm, that was Tuesday. Then on Wednesday, 25Aug2021, the patient body was achy, but the patient thought that maybe that was possibly a regular side effect and then by Thursday, 26Aug2021, the patient was having excruciating pain. On Friday, 27Aug2021, the patient thought that he had blood in his urine because his pee was the color of Pepsi- Cola but he still had the pain. The patient was told that this was a result of the COVID vaccine and that he had rhabdomyolysis on 28Aug2021. Then on Saturday, 28Aug2021, the patient went to the emergency room and was hospitalized on 28Aug2021. The patient was an otherwise healthy young man and now the patient muscles were deteriorating, and the patient had high levels of protein that were developed into his body and were seeping into the patient bloodstream. The patient was told that this could have caused renal failure if the patient had not gone to the emergency room when he did. They were currently flushing the patient. They said that the numbers were so high, they were like 300 something either in the millions or the thousands. It was reported that the patient was kept in the hospital and he now had circumstance that the patient did not have before he took the COVID vaccine.The patient had his own apartment, the patient worked every day, and his baby was due in November. The patient insurance just kicked in with his job, but the caller (patient's mother) was unsure about any long-term care for him. The patient IVs had been changed and were flushing this stuff out of the patient system. The doctor said that the numbers were not going higher, but they were also not going down fast. The patient was recommended for her son to not take the second dose. Outcome of all the events was reported as Unknown at this time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
ACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 fatigue, and ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and ache. This report was non-serious. This case, involving the same patient is linked to 20211151493.
Extreme chills with chattering teeth. Muscle aches. Lasted 6 hours.
At the time of the injection, I felt that the injection was painful and remarked to the pharmacists that it hurt way more than usual. When being given the shot I felt a shooting sensation down my arm. After being given the shot, my arm still felt sore for the following days - the pain never went away but wasn't too sever, just somewhat annoying. After about five days (Saturday night, October 8, 2022), my arm was hurting during the night and was affecting my sleep and the pain was getting noticeably worse. My arm and shoulder were hurting throughout the day on Sunday, October 9, 2022. Before going to sleep on Sunday night, I took 2 Tylenol to try to help with the pain. ON Sunday night the pain was no longer just in my arm  but also in my shoulder. It became impossible to sleep through the night on Sunday night because of the pain and I awoke at about 1:30 am after 5 hours of sleep (I need 8 hours). I took another 2 Tylenol and lay in bed for another hour and a half trying to go back to sleep but the pain was so bad no matter what position I low on that I couldn't find any position that would allow me to sleep so I got up. By about 4:30 am this morning the pain continued to get worse in my shoulder and my arm feels slightly tingly.
Information has been received from a physician concerning a 9 year old female who was vaccinated with subcutaneous Varivax. On 07-MAR-2006, the patient experienced mild breakthrough varicella. Subsequently, the patient recovered from mild breakthrough varicella. Additional information has been requested.
swelling and tenderness at injection site; swelling and tenderness at injection site; swelling of lymph nodes in armpit on the side of injection site; joint pain; headache; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 10Mar2021 16:30 (at the age of 31-year-old) as single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypertension, anxiety and depression. Concomitant medications included sertraline, buspirone, lotensin and nortriptyline taken for an unspecified indication and start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 17Feb2021 at 09:30 at single dose for COVID-19 immunisation. On 11Mar2021 at 10:00 AM, the patient experienced swelling and tenderness at injection site, swelling of lymph nodes in armpit on the side of injection site, joint pain and headache. Facility type vaccine was reported as Doctor office/urgent care. The patient did not receive treatment for the events. The clinical outcome of events was recovering at the time of report.  No follow-up attempts are possible. No further information is expected
Case number PHEH2013US021651 is an initial spontaneous report from physician received on 16 OCT 2013 with a follow-up received fr om the physician on 08  NOV 2013. This case refers to 2-year-old female patient. She received FLUVIRIN 2013/2014 (batch number: 1308801 and expiry date: APR 2014) intramuscularly on an unknown date. The physician stated that patient received FLUVIRIN that had been pre-dawn from multidose vials into syringes and left at room temperature. No specific dates of occurrence provided. The seriousness and causality of event was not reported.   Follow-up received from the physician on 08 NOV 2013. Updated batch number and expiry date of FLUVIRIN.
Patient said, she had redness/fever/headaches and a golf ball-size lump - She took Apap 500mg and ice packs.
Day 1 Night:  Sleeplessness Day 2:  Muscle aches in left arm, left shoulder, neck.  Fullness in ear, dizziness.
15FEB92 onset of rash, red & heavy x 2-3 days;resolved by 22FEB92;21FEB-25FEB92 onset of swelling & pain in rt knee/ankle;lt knee/ankle/fingers/elbow/wrists;Improvement started 26FEB basically all swelling & pain gone by 4MAR92;
BLOOD CLOT; BELLY BUTTON PAIN; LOWER LEG PAIN; STOMACH PROBLEMS; This spontaneous report received from a patient concerned a 57 year old white(Not Hispanic or Latino) female. The patient's height, and weight were not reported. No past medical history was reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025,expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the patient experienced stomach problems(pain, cramping, bloating). On an unspecified date, the patient experienced blood clot, belly button pain, and lower leg pain. The patient did not made any changes to diet and no new medications took since getting the vaccine. The patient had tried yogurt and probiotic. Treatment medications (dates unspecified) included: bismuth subsalicylate for unknown indication. On 28-May-2021, she started taking turmeric, but so far nothing had resolved the issues. The patient had a tele visit with family doctor of medicine and would go next week wednesday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot, and lower leg pain, and had not recovered from stomach problems, and belly button pain. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210556734.; Sender's Comments: V0 20210556510- COVID-19 VACCINE AD26.COV2.S- blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Baby was given varicella vaccine and was seen in office on 04-08-13 for a rash diagnosed by two M.D.'s as shingles (herpes zoster).
Developed diaphoresis, weakness, headache, muscle soreness and back pain.Could be described as flu-like symptoms. Was febrile(100). Symptoms worsened with 2nd injection on 8/22/05 of Imovax Rabies Vaccine
MIGRAINE HEADACHES; TWITCHING OF FACE; This spontaneous report received from a patient via a company representative concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced migraine headaches, and twitching of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine headaches and twitching of face was not reported. This report was non-serious.
I felt significant  arm pain immediately upon injection, worse than a typical vaccine, prompting me to looks at the needle and note that the injection was placed too high on the arm, above the proper landmarks. Pain in shoulder was severe for several days, then was noted exclusively in the shoulder joint for several weeks. Was prescribed meloxicam from healthcare provider and instructed to apply Voltaren cream to shoulder. Several weeks have passed with no improvement in pain. Pain is a sharp severe pain when lifting the arm above shoulder height affecting ADLs, and pain with pressure and turning over, affecting sleep.
pt normally has an issue with her heart skipping beats but the day after taking the vax she noticed her heart was not skipping any beats which is very unusual for her.  Pt was very tired the day following the vax until in the early evening.  Pt says her BP is up higher than usual stating it is normally 160/85 and is now 186/111.  Pt has an appt w/ her cardiologist on 5/26/21 to give her a Holter monitor and to check BP.
sneezing, cough, puffy eyes, watery eyes, wheezing, skin turned red from head to toe, hives, lathargy
Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not recover immediately . Became nauseous and shaky then began vomitting. Pt remained lightheaded and near syncopal whenever brought to a sitting position or standing position. Pt. refused Benadryl . Pt. admitted having nausea and diarrhea for past 1-2 days intractable vomitting 5 yrs ago Agreed to EMS transport to  ED
Diffuse vesicular/scabbing rash that starts 10 days after 12 month vaccines. Looked similar to chickenpox yet no known exposure.
Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022; No adverse event; Dose administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     It was unknown if the patient had ever tested or diagnosed with COVID-19 It was unknown whether patient Allergies to medications, food and other products.     On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 6Jul2022 and administered on 8Aug2022).    Patient was not under any concomitant or regular medication.  Reporter reported that the vaccine had expired on 5Aug2022. No adverse events were reported post vaccine administration. Vaccine was initially stored in refrigerator on 6Jul2022. It was confirmed that the product had not undergone any temperature excursion issue.  No treatment drug information was provided.
2 days after receiving PNEUMOVAX patient developed about 4 red areas - not at the injection site but surround the site.
blurred vision, new floaters  DX with Branch Retinal Vein Occlusion With Macular Edema, Frosted Branch Angiitis - left eye.  Treated with intravitreal Ozurdez. and 450 mg Valganciclovir po
pt woke up on 1JUL93 had a hive on rt cheek; then devel hive on rt arm 7 then lt arm & leg; no temp seen by MD & placed on DPh; 2JUL mom reports no hives;
COVID-19; COVID-19; 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-163-4510312-00.  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular 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), COVID-19 (medically significant) all with onset 02Aug2022, outcome "recovered" (Aug2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter's causality for the event(s) of COVID and GI upset with Humira (Adalimumab) was a reasonable possibility.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
lightheaded/dizzy; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), first dose via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated yesterday with the Pfizer COVID-19. The patient felt lightheaded/dizzy after the injection and for many hours after in Dec2020. The patient felt these events before with other vaccines. The outcome of the event was unknown.
terrible shakes; chills; nausea; pain; headache; Fever; Very tired; sick; This is a spontaneous report from a contactable other hcp (patient).  A 51-years-old (Age group: Adult 18-64 Years) non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Feb2021 08:30 (age at vaccination 51 years) as dose number unknown, single for covid-19 immunisation.  Medical history included Ulcerative colitis, prior covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included mesalazine (ASACOL); probiotics (PROBIOTICS); diphenhydramine hydrochloride (BENADRYL); paracetamol (TYLENOL); ibuprofen (MOTRIN [IBUPROFEN]). Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021 17:00 the patient experienced the first night after vaccine terrible shakes, chills, nausea, pain, headache, Day after she continued being sick, fever, very tired in feb2021. Second night still had fever. Second day after shot still fever and very tired. The patient received treatment of Took Vicodin for reported events. The outcome of fever was not recovered rest of all events was recovering.  No follow-up attempts are needed. No further information is expected.
Pt recv vax on 2/22/99; 1 hr post vax pt exp non-stop crying x 4 hr, fever, poor feeding
THIS PATIENT WAS GIVEN A HEPATITIS A IMMUNIZATION AND HAD AN ABRUPT EPISODE OF NAUSEA, VOMITING AND LIGHT HEADACHE.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site mass (developed a knot like a lump under the skin) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site mass (developed a knot like a lump under the skin). At the time of the report, vaccination site mass (developed a knot like a lump under the skin) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Not feeling well several days after the first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well several days after the first Moderna Covid-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well several days after the first Moderna Covid-19 vaccine). At the time of the report, MALAISE (Not feeling well several days after the first Moderna Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
One month post vax, the pt was dx with multiple sclerosis which was reportedly confirmed by three physicians.
Ran a fever of about 101.4 and the area around where the shot was administered is swelled. Now running a slight fever of about 100 and the area is still swelled.
My first shot was on 4/7/2021 and my second shot was on 4/28/2021.   Around 6AM on 4/29/2021, my skin was very sensitive to touch. I pushed the sheets covering me off of my body because they felt rough and painful. I checked my temperature and it was 102 F. I had to work for a few hours. Around 10AM, I got back into bed because I could not remain upright. I took 3 Advil liquid gels. I could not move all day. I drank some water. I do not remember much, just that I had fevers all day into the night. The fever would break for about an hour during which time I would sleep, and then come back again. I did not check my temperature again, but I knew what I was feeling was consistent with a high fever. I did not eat and drank only lime flavored La Croix seltzer water. I was extremely nauseous. Every four hours, I would take two Advil liquid gels to keep the fever down.  I slept from about 3am to 6am on 4/30/2021. I tried drinking weak black tea when I woke and threw it up. My temperature was 103 F. I took three Advil liquid gels. This day continued much the same as the previous one. I ate two cups of plain brown rice. I did not check my temperature again, but was certain I had a very high fever, because I was very cold and shaking in between bouts of sweating. Again, I took 2 Advil liquid gels at intervals.  When I woke up around 8am on 5/1/2021, I ate some plain, dry cereal. I checked my temperature and it was 101 F. I took 3 Advil liquid gels. I slept for the full day. I was very weak on 5/2/201 and in the days after. I felt back to normal by 5/5/2021.
Pt came in on 10/18 and stated that a couple hours after the vaccine was administerd she developed a 3 to 4 inch in diameter raised, itchy, red, warm to touch rash.  She said that the area is still red but not as bothersome as it was originally.
I develop Bell's Palsey on the left side of my face starting Sunday 12/5/2021.