chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/24/2021 I woke up with pain in my lower right leg, that progressed to pain and pins and needles in all of my limbs, especially my hands and feet. The pins and needles progressed to loss of sensation and weakness. By 2/29/21 I woke up feeling weak in my limbs with difficulty walking and with balance. MRI of neck and head reveal not issues. Lumbar puncture showed no signs of infection or autoimmune markers but white blood cells and lymphocytes were elevated in spinal fluid. I began to experience increased fatigue and debilitating headaches 3/30/21 for about 1 week. I was prescribed 50mg Predsidone for aseptic meningitis. My symptoms subsided while on medication but have since returned. I experience pain, and pins and needles in my limbs and back, particularly in my hands, feet, and buttock when any amount of pressure is applied for an extended period of time.
Fluid around heart again; Moderate swelling all over my body; This case was initially received via another Manufacturer (Reference number: PVIUS2021001073) on 19-Jun-2021. The most recent information was received on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. The license partner had received the report from VAERS (Reference number: 1435708).    This regulatory authority case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (Fluid around heart again) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Fibromyalgia, Bipolar affective disorder and Allergy to antibiotic (Ceflosporin).   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDIAL EFFUSION (Fluid around heart again) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Moderate swelling all over my body). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERICARDIAL EFFUSION (Fluid around heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERICARDIAL EFFUSION (Fluid around heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) to be possibly related.    The patient had right arm, leg back and left leg are all swollen and starting to get fluid around heart again. Treating with ibuprofen right now did the same after first vaccine. No concomitant medication information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document received on 13 Jul 2021 updated report type as Regulatory authority case. Secondary reporter details added.; 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.
Hives noted around mouth, chin, forehead, cheeks and arms. Pt scratching. Admin. epinephrine 0.15 mL LD @ 1135 am. Rash improved at 1138, pt transported to ER by EMS.
Patient was vaccinated at Pharmacy.  Patient had COVID vaccine on 03/29/2021- Janssen vax, was administered at Pharmacy at 11:20 am.  He had headache "almost migraine like" and nausea started 03/30/2021 lasted about 24 hrs.  He states that he was just calling to report HA since he has heard the news about the Janssen vaccine.    I informed him that I would take down this information and that most likely he was having side effects to vaccine which is pretty common for those symptoms.  I also informed him of the adverse effects that would require immediate medical attention (severe HA, abd pain, leg pain and SOB).  He states that currently he feels fine and does not have any symptoms.  I informed him that would document this information for him and if he started with any other symptoms to come into clinic.
pt recvd vax 08SEP95 9-10AM & called clinic c/o feeling flushed & neck & face red; states had temp (did not know degree) & has taken APAP;stated heart felt a little fluttery; MD suggested go to ER if any problems breathing or any swelling;
Information has been received from a nurse practitioner concerning a 48 year old female pt with no known allergies who on 05/12/2000 was vaccinated with a first dose of hep B vaccine recombinant. On 06/12/2000 and 11/14/2000 the pt was vaccinated with the second and third dose respectively of hep B vaccine recombinant. There were no concomitant medications. On approximately 05/13/2000, the pt experienced vomiting, swelling of the lips, and swelling of the tongue. On aprox. 06/13/2000, the pt experienced vomiting, swelling of the lips, and swelling of the tongue. On approx. 11/15/2000 the pt again experienced swelling of the lips, swelling of the tongue, and vomiting. The nurse reorted that the pt's experience started about 24 hours after each vaccination and lasted about 24 hours. On approximately 11/15/2000, after the third vaccination, the pt also developed area specified "puritis," an injection site induration (12x20mm), and 2 small nodules at the injection site. The pt sought unspecified medical attention. It was reported in follow-up that as of 03/16/2001 the pt was experiencing "persistent puritis" of a nodule, 12x7mm, on her right deltoid. Additional info is not expected.
TIRED; HEADACHE; SHAKING; CANNOT STAND UP WITHOUT FALLING; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced shaking, tired, headache, and cannot stand up without falling. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, tired, headache and cannot stand up without falling was not reported. This report was non-serious.
sore arm; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date after vaccination administered. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt describes flu sx's (severe) since immunization on 12/15/99. Was not seen until 1/14/00 & diagnosed with viral syndrome. No evidence of allergic reaction.
Patient states that the vaccine administration caused her excruciating pain. This pain lasted a few days and then dissipated. She states that the pain then came back a few days later in the same spot and has not subsided since. She is having difficulty using her arm in her daily living activities. She has notified her primary care provider of the incident and pain she is experiencing and the doctor told her that he thinks the pharmacist may have hit a nerve during the administration. The patient then notified the pharmacy of the issue 10/13/18.
Flu-like aches, pain at joints, headache, nausea, syncope.
Pt had a temp 106, began crying unconsolable for at least 3 hrs; Was listless for about 10 days p/immun; PMD called & consulted w/parent over phone;
arm red and swollen; Tenderness and swelling of the lymph nodes; swelling of the lymph nodes in the same arm of the injection; i fell like a ball; cramps on my legs \ cramps; very bad body aches; knots in the legs \ in the thigh above the knee \ in the foot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm red and swollen), LYMPH NODE PAIN (Tenderness and swelling of the lymph nodes), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection), FEELING ABNORMAL (i fell like a ball) and MYALGIA (very bad body aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.     On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced MYALGIA (very bad body aches) and MASS (knots in the legs \ in the thigh above the knee \ in the foot). On 27-Apr-2021, the patient experienced MUSCLE SPASMS (cramps on my legs \ cramps). On 28-Apr-2021, the patient experienced FEELING ABNORMAL (i fell like a ball). On an unknown date, the patient experienced ERYTHEMA (arm red and swollen), LYMPH NODE PAIN (Tenderness and swelling of the lymph nodes) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection). At the time of the report, ERYTHEMA (arm red and swollen), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection), FEELING ABNORMAL (i fell like a ball), MYALGIA (very bad body aches), MASS (knots in the legs \ in the thigh above the knee \ in the foot) and MUSCLE SPASMS (cramps on my legs \ cramps) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment with Ibuprofen on 25 an 26 April 2021 ,pertained to the events , were provided.   This case was linked to MOD-2021-095235 (E2B Linked Report).; Sender's Comments:  MOD-2021-095235:First dose
16 days after having the booster I have experience Urticaria. I went to hospital thrice. They administered Epinephrine, Iv Fluid and Solu-Cortef 100mg. It subside the allergic reaction. However, only after 2 hours I developed another severe allergic reaction. So I went to the hospital again, they administered Penegran, Iv Fluid, Dexamethasome 8mg. It subside the allergic reaction. Thought within the day I developed a severe allergic reaction. And up until now even I?m taking Telfast, Prednisolone and Pantactive the urticaria never goes away. The allergy I have now is come and go. I?ve been experiencing this for 3 days now. It?s all over my face and body.
pt recv vax 8OCT97 & immed p/vax pt exp a large, red area @ the site of inj;pt recv cholera & Meningitis vax on 8OCT97;
a patient under 10 years of age was administered ADACEL instead of her first dose of PENTACEL (with no reported adverse event); Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 2 months old female patient who was under 10 years of age was administered adacel instead of her first dose of pentacel (with no reported adverse event) while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13); and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) both for Prophylactic vaccination.  On 24-May-2022, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine lot U7093AA, Expiry date: 18-Jun-2023, frequency: once, strength unknown via intramuscular route in the left thigh as immunization.  On 24-MAY-2022 the patient developed a non-serious event a patient under 10 years of age was administered adacel instead of her first dose of pentacel (with no reported adverse event) (wrong product administered) latency: same day following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (wrong product administered)  At time of reporting, the outcome was Unknown for the event a wrong product administered.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is 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 has contributed to or is to be held liable for the occurrence of this medication error.
Tdap Boostrix was given on 10/13/2022.  Noted it had expired 10/08/22.  CDC recommended repeating the dose at that time. Provider and parent notified. Parent declined child to have an additional dose.  No adverse reaction noted
Day after vaccine I developed sever jaundice including yellowing eyes.  One week after vaccine I had blood work done and my liver enzymes and bilirubin levels were.  On 3/23 I admitted myself to ER with jaundice and vomiting.  My liver levels were normal but bilirubin was still high.  At this point I had lost 30 pounds since my shot.   I was in the hospital for 5 days where the ran UT, CT, and MRI on my abdomen with none showing issues.   Jaundice and itchiness/jaundice got progressively worse.   The hospital ran multitude of blood tests to pin point the issue and even did a liver biopsy.  No tests showed anything abnormal but biopsy isn?t back yet.  At this point 4/1/21, I am still jaundiced, extremely itchiness, lethargy and a total of 33 pounds weigh loss.
Sore arm at injection site; This is a spontaneous report from contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: 3247), via an unspecified route of administration on 02Mar2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Prior to 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 4 weeks prior to the COVID vaccine. It was queried you have reported about an adverse regarding covid-19 vaccine, please help the first awareness date of this report. You filled PRD as 03Mar2021, however the adverse event start date 02Mar2021, it seemed that you know these on 02Mar2021, could you please help confirm the correct first awareness date for the events. In response, yes, I received my shot on 02Mar2021 at 08:00 PM when I began experiencing the sore arm at injection site (the day I received my vaccine) and reported it on 03Mar2021. No treatment was received for the adverse event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse referring to a 29 year old female patient. The patient was allergy to morphine, VICODIN and penicillin. The patient's concurrent condition included arthritis of the knees. The patient's medical history included gastric bypass surgery. Concomitant therapies included ZOCOR and aspirin. On unspecified dates in "late 1996 or early 1997", the patient was administered with three-dose series of an unspecified hepatitis B vaccine (manufacturer unknown) (lot#, dose and route were not reported) which were not documented in the patient's medical record and it could not be determined whether the unspecified hepatitis B vaccine was RECOMBIVAX HB. On 19-SEP-1997, the patient had blood tests for hepatitis B surface antigen, which was negative; patient also had hepatitis B antibody titers drawn on this date, which were undetectable. As a result, patient was administered a two-dose series of ENGERIX-B (both doses from lot# 2429A4, expiry date unspecified): one dose on 25-NOV-1997 and one dose on 13-JAN-1998, which were her fourth and fifth doses of hepatitis B vaccine. When patient began working at a new facility, she had repeat hepatitis B antibody titers drawn on 17-APR-2015, which were also undetectable, described as "less than 3.0". As a result, patient was administered two 0.5 mL doses of RECOMBIVAX HB (both doses from lot # K010535, expiry date 27-AUG-2016) on 22-APR-2015 to equal one 1 ml dose. Patient had repeat hepatitis B antibody titers drawn on 26-MAY-2015, which were also undetectable, described as "less than 3.0". No treatment was given for the adverse events. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
pt c/o pain w/walking from site for 48 hrs, high pitched screaming & uncontrollable crying, t100.4;
Developed SHINGLESON TRIGEMINAL NERVE, OPHTHALMIC BRANCH, RIGHT SIDE OF FACE AND EPI-RETINAL MEMBRANE IN LEFT EYE REQUIRING VITRECTOMY
Headache, sore throat, tingling of feet and hands, blood sugar unusually fluctuated. Patient had paralysis earlier in the day on day of death.
Varivax administered in office on 11/14/00. Patient presented to office on 11/19/2002 with s/s of varicella. Dx with varicella zoster.
Flushed, urticaria, lightheaded in 1/2 hr. Took BENADRYL last evening - better - has rash. Received vaccine last year as 2-step. Received single dose this year.
I am not sure what adverse event I reported to the VAERS system, but I think it was extreme dizziness.  I had my first dose of Pfizer vaccine on 1/28/2021 and second dose on 2/19/2021.  My dizziness event was about 5 weeks later.  I woke up on 3/28/2021, did my daily stretches lying on the floor; when I stood up, my head was swimming and I felt like my eyes were rolling around in my head.  The dizziness came and went over the next week.  I also had migraine headaches at bridge of my nose for about a week.  On 3/29/2021, P.A. diagnosed me with Orthostatic hypotension due to unusual blood pressure numbers when I was in various positions; he also said it could be benign paroxysmal positional vertigo (BPPB). Additional information for Item 18: Saw Doctor about 10 days later.  Had follow-up treatment by a Physical Therapist for 3 weeks.
Diarrhea, fever, chills, nausea, vomiting, body aches, bone pain, abdominal pain.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 04-MAY-2015 the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (lot # K019102, expiration date 15-APR-2015, 0.5 ml/once), subcutaneously. No adverse effects were reported. Additional information has been requested.
Got the shot on Wednesday afternoon by Wednesday evening I wasn't feeling good.  I was achy all over running and fever this continued on I home tested for covid on Saturday and was positive for covid.
Fever, irritable, erythematous urticaria, multiple macular lesions on abdomen and upper right thigh. Knot on right leg 4-4-07.
Systemic; chills, tiredness Local: (L) upper arm, blushed, swollen, tender to palpation, limited range of motion.
Subcutaneous boil on left shoulder, 2 weeks, received cloxacillan as treatment.
ARM TO TOUCH IS STILL SORE 10 DAYS  LATER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced arm to touch is still sore 10 days later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm to touch is still sore 10 days later was not reported. This report was non-serious.
Tingling all over the body,  nausea, pale-looking, hot/cold, clammy, duration approx. 2 hours but not as severe.
Sore arm for first 2 days post-vaccine, but on evening of 3rd night (1/30) also developed chills, muscle and body aches, heart racing.
pt ran temp 102-105 approx 2 days p/vax was given; pt seen in ER on 31JAN93; On 1FEB93 pt broke out in rash & cont to have fever of 102 off & on; on 4FEB93 (1 wk p/vax) pt is free from rash & fever, but mom plans to have pt checked by MD;
Dizzy, light headed, flu like symptoms,bad cough; Dizzy, light headed, flu like symptoms,bad cough; Dizzy, light headed, flu like symptoms,bad cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy, light headed, flu like symptoms,bad cough), INFLUENZA LIKE ILLNESS (Dizzy, light headed, flu like symptoms,bad cough) and COUGH (Dizzy, light headed, flu like symptoms,bad cough) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Dizzy, light headed, flu like symptoms,bad cough), INFLUENZA LIKE ILLNESS (Dizzy, light headed, flu like symptoms,bad cough) and COUGH (Dizzy, light headed, flu like symptoms,bad cough). At the time of the report, DIZZINESS (Dizzy, light headed, flu like symptoms,bad cough), INFLUENZA LIKE ILLNESS (Dizzy, light headed, flu like symptoms,bad cough) and COUGH (Dizzy, light headed, flu like symptoms,bad cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Admit 6/14. Vaccine 1/26, 2/20. H/O COPD, Type II DM, CAD, HTN. Admit for SOB. CXR showed COVID PNA. Treated with abx, steroid, remdesivir, Vit C and supplemental O2. Requested to be DC'd. DC'd to SNF on 2L O2.
The nurse incorrectly injected me. She injected my arm too low. She stabbed me through my arm rupturing my deltoid tendon.
Patient says that immediately after receiving the vaccine for almost 4 hours her face was numb.  Patient says since then on and off the right side of her face will go numb for a short period of time.  She also states that she noticed sun sensitivity yesterday on her right side and stated that she has never had that before only noticed after receiving the vaccine.
Parent reported at 3:55 that patient with c/o right arm swollen and full feeling without redness.
Fever between 99.5 and 102 for 43 hours, and ongoing. Muscle pain, bone pain, headache, pain at injection site ongoing. Mild nausea first day.