chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 23 November 2009 from a consumer who is a physician. A 49-year-old male patient received a dose of H1N1 (lot number UP013AA) on 28 October 2009. The patient had no concurrent illnesses. Medical history includes allergy to celery, carrots, apples and tree nuts: but no known drug allergies. Concomitant medications include CRESTOR and LOVAZA. Approximately one week post-vaccination, the patient experienced itching all over his body especially in skin fold areas such as armpits and elbow areas, but also between legs and behind knees. He was so itchy in some spots that he scratched till he bled. No diagnostic tests or laboratory data were performed. As of 23 November 2009, the patient still had itching. Recovery status is unknown. Follow-up information received on 24 November 2009 from a patient who is a physician. Due to the following new information, the case was upgraded to serious. Per the reporter, a couple of days prior to vaccination, the patient changed his water softener. Testing of the water revealed water softness was better than before. One week post-vaccination, the patient developed severe pruritus accompanied by erythema and areas of fine maculopapular rash similar to contact dermatitis. The itching was so severe it resulted in bleeding in areas where he kept scratching. The pruritus worsened over time interrupting his sleep to where he was only getting about 2 hours of sleep a night. The patient tried changing soaps and detergents to no avail. Treatment with prednisone was started three weeks after vaccination, and at the time of this report, the pruritus had resolved; however it was not reported whether erythema and maculopapular rash had resolved. The patient had received influenza vaccine many times without any adverse events. Documents held by sender: None.
A report has been received from a Health Professional concerning a 7 month old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The health professional reported that they inadvertently gave a half dose of FLUMIST to seven month old on 13-Nov-2013. The outcome of the event of gave half dose of FLUMIST to seven month old is unknown. The report was considered to be non-serious.
Skin warm to touch, itching, redness and swollen start 48 hours post injection. Treatment Advil and ice. Redness 4 1/4 inches, Induration 6 1/2 inches.
low measles titer; This spontaneous report was received from a office manager regarding to a 20 year old female patient. The patient's medical history and concurrent condition were not reported. Concomitant medications included, during the time of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 3rd dose the patient was on birth control therapy (brand and manufacturer unknown) reported. On 06-FEB-1996, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) via subcutaneous, lot # 1181B has verified to be invalid and expiry date September 1997 (strength and dose were not reported) for prophylaxis and on 02-MAR-2000, the patient vaccinated 2nd dose (strength, dose, route, lot # and expiry date were not reported). The reporter stated that on 22-AUG-2015, the patient was performed a titer test that showed a low measles titer (viral titer decreased). Then the patient was vaccinated with third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # L007577 and expiry date 05-MAR-2017, (strength, dose, route were not reported) for prophylaxis. The outcome of viral titer decreased was unknown.
Information has been received from a pharmacist concerning a female who on approximately 10-AUG-2007 was vaccinated with a dose of Gardasil (lot # 653736/0014U).  On approximately 10-AUG-2007 the patient felt nauseous and fainted, "went straight down."  At the time of the report the outcome was unknown.  Additional information has been requested.
Flu like symptoms: weakness, fatigue, joint pain, hoarness, shortness of breath
got my period 15 days late; flow was all  is it affected by COVID-19 vaccine because is happened first time; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (got my period 15 days late) and MENSTRUAL DISORDER (flow was all  is it affected by COVID-19 vaccine because is happened first time) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (got my period 15 days late) and MENSTRUAL DISORDER (flow was all  is it affected by COVID-19 vaccine because is happened first time). At the time of the report, MENSTRUATION DELAYED (got my period 15 days late) and MENSTRUAL DISORDER (flow was all  is it affected by COVID-19 vaccine because is happened first time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patients' medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a doses of M-M-R II (lot number: L028273, expiration date: 28-JUL-2017, albumin status: RHA: lot number: L004658, expiration date: 11-FEB-2017, albumin status: RHA (dates, doses and routes not reported), that was improperly stored. The vaccine was stored in temperature of 1.7 Celsius degree (C) for two  hours and 5 minutes and in 1.7 C for 2 hours and 15 minutes. There was no previous temperature excursion. The excursion was captured with the use of Digital  Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
4 days after vaccination developed rash that spread from upper extremities through chest and abdomen and to lower extremities.  Was very itchy and took Benadryl and s/s resolved after 3-4 days.
Employee stated he began to experience left sided neck pain and swelling,  and headache. Presented to Urgent Care Center after neck pain persisted, was seen and given a muscle relaxer. Stated he took the medication for 4 days, alleviated neck pain. States he feels ok this week, no pain or swelling.
beginning 12/10/06, patient bagan getting diffuse spotty bumps over torso and spreading to neck. Prior to rash, Mom states patient ran fever up to 101.5 for 4-5days. Rash was observed and advised to use aveeno bath and/or acetaminophin for discomfort and fever.
stiffness in arm headache at the base of the skull tingly headache at the front of the skull feels heavy
Swelling of upper (R) lip 6/11 pm, 6/12 am poor sleep 6/11 pm.
8 hours after the shot I had body aches and fever and soreness on site.  This lasted for approximately 30 hours.     At about 50 hours after i had the second dose i got immense shooting pain up and down my left side (flank). It was centered near my hip/kidney area.  I was unable to stand.  The intense pain lasted about 2-3 hours i took Tylenol which helped.  The pain became manageable but continued and the following day - February 14 I went to the ER.
Pt came for yearly checkup 11/2/12. On 11/5/12 pt examined for hematuria. U/A, urine cx, CBC, Chem 7, urine creat/cal. ratio obtained. All labs WNL so far.
Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves 18 years old female patient where MENACTRA (lot U6015AA and Exp. Date: 06-Oct-2019) was used as a diluent for the MMR, dosage was slightly above 0.5ml via subcutaneous route in the left arm on 03-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to overdose, product preparation error and incorrect route of product administration. It was reported that she gave a MENACTRA as a diluent to mix with the MMR and gave it subcutaneously and the dosage was slightly above 0.5ml. No adverse reactions reported. 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 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. List of documents held by sender: none.
Patient has been admitted to the hospital on 4/15/21 with a right sigmoid sinus/jugular vein thrombus.
Headache, myalgia, papular lesion bilateral forearms flushed cheeks. Lesion firm, tender to touch. No fever no SOB, weakness, Sx occurred 24 hours after vaccines.
Pt is not experiencing any adverse events or side effects at this time. I was instructed to place this vaers report because she received her Covid-19 Vaccine on 15 Jan.
Patient was given COVID-19 booster 4 months post-primary series instead of 5 months after. No S/Sx of adverse reactions
pt recv vax 25JUN95 & @ the time of inj pt exp low grade fever, fatigue & an induration @ the inj site which were reported to have resolved;5wk p/vax exp low grade fever 99.2 to 100;induration @ inj site;
The patient was given the shot on Tues 3/12.The patient felt achy weds night.  On Thur she went to clinic for cough, congestion, sore throat, and low grade fever. Monday at 1 am she went to emergency room because her heart was racing. A blood test revealed she had mono. She was not given an antibiotic on either visit. On 3/21 she developed a bumpy rash on back that it itchy and tender. The rash has spread to her stomach. She is worried it may be shingles. I advised her to return to her doctor for further evaluation.
No weight bearing, pain, tender to touch, redness, swelling from groin to toes measuring upper thigh 25.5 cm. - middle thigh 28.3 cm. - lower thigh 23 cm. - lymph nodes x 2 swollen right groin.
Pain and tightness across the chest and back in pain down the left arm. Called EMS and they transported me to the hospital at midnight 35 2021 upon being put admitted into the hospital my liver enzymes and pancreas enzymes were elevated over 1000
Mild listlessness occurred approx. 7 hours, post vax. Pt had a fever of 102.1F, 24 hours after injection accompanied by continuous crying, sweating and apparent discomfort. Symptoms disappeared 36 hours, post vax. Pt had no prior history of fever or similar symptoms. Pt examined on 9/6/01 at 14:30 and was dx'd with fever. No other symptoms.
pt recvd vax & was screaming; would pull away from mom; could not stand up well; t 99.6 & Lt Leg had a 1/2 lump red, hives; hives disappeared by next day;
Information has been received from a physician concerning a female patient (age not reported) who  on an unspecified date was vaccinated with a dose of Gardasil. Concomitant medication was not reported. No illness was reported at the time of vaccination. On an unspecified date within 12-15 hours after receiving GARDASIL, the patient experienced nausea and vomiting. The patient recovered on an unspecified date. This is one of two reports received from the same source. Additional information is not expected.
Side effects/reactions similar to COVID symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) 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 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 VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms). At the time of the report, VACCINATION COMPLICATION (Side effects/reactions similar to COVID symptoms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-407006 (Patient Link).
PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A MIGRAINE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 189 pounds, and height was 64 inches. The patient's concurrent conditions included cancer, thyroid and other pre-existing medical conditions included patient receives steroid knee injection, left knee only every 3 months. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anastrozole for cancer, ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 22-MAR-2021, the subject experienced weakness. On 22-MAR-2021, the subject experienced headache so bad like a migraine. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. On 04-APR-2021, the subject experienced painful rash on right arm and hand, left arm, legs, head, back, face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness, and fever on 26-MAR-2021, and headache so bad like a migraine, and muscle ache on 25-MAR-2021, and was recovering from painful rash on right arm and hand, left arm, legs, head, back, face. This report was non-serious.
One month after MENACTRA, patient developed severe headache and developed optic neuritis, BELL'S PALSY, and left leg sensory monoparesis. Follow-up: Pt hospitalized on 4-17-06 with diagnosis of encephalitis - ADEM. 60 Day Follow-up Information 03-JUL-2006: Optic neuritis improving. Occasional nausea and vomitting. Pt also found to have mycoplasma on admission 4/17/2006.
anxiety, k pruritus, anorexia, loss of appetite, loss of smell Narrative:
18 hours after first pfizer covid vaccine developed redness / mild swelling of her cheeks / chin, hot. Improved with benadryl.
Day after receiving booster of Moderna, after waking from a nap on couch, she was extremely dizzy. Patients husband took her to ER and her heart was going crazy in A. Fib.  She said her husband told her she had passed out before leaving the house.  They then put her in ICU to get heart rate under control.  She had virtually no oxygen blood level and her memory  was non-existent. She spent several days in ICU.  Patient was already scheduled for heart ablation on Nov. 5.  Still going through with procedure. Dr. put her on Amiodarone to control heart in mean time.
Warmness to the injection site; Redness to the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warmness to the injection site) and VACCINATION SITE ERYTHEMA (Redness to the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 11-Feb-2021.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness to the injection site) and VACCINATION SITE ERYTHEMA (Redness to the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness to the injection site) and VACCINATION SITE ERYTHEMA (Redness to the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment details included.
2 month old given PCV/HIB (right thigh) DTaP #1/ IPV left thigh. Patient began to be irritable from 7 pm (2-19-04) till morning of 2-20-04 with excessive crying and irritability.
I had a papule on my right lateral nostril. It was removed once and biopsied twice. It was excised via Mohs surgery on November 21, 2022.
Dizzy, tachycardia, palpitations - HR 120-137. Sinus, joint pain, localized site erythema and pain.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported). On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (strength, dose and route of administration were not provided) (lot # L023588 expiry date 26-JUN-2017, L023594 expiry date 26-JUN-2016 and L027287 expiry date 27-JUL-2017). The Certified Medical Assistant (C.M.A) stated that VARIVAX (Merck) was exposed to the following temperature conditions: -14 degrees C for 93 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient's arm became red and hot, and started itching. The itching spread to her legs and she said she was having difficulty breathing. It happened within 30 mins after giving the shot.
Pt recv vax on 9/23/98; on 12/8/98 pt exp pox on face, back & neck
PT reported "I feel lightheaded "approximately 30 minutes into wait post vaccine. Also reported not having had breakfast.  Resp clear and easy. VS stable. Air turned on in vehicle, seat reclined, fluids given. Declined food due to nausea. Advised re stable vs. Within 10 - 20 minutes, pt reported no longer dizzy and "my chest is not tight now". Encouraged to eat prior to next vaccine. Rest and fluids this afternoon.
Dizzy, extreme nausea, vomiting, blacked out, tingling/numbness in both hands and part of left leg, fever, body aches, fatigue
My heart started racing uncontrollably Monday may . Still doing testing. I was put on propranolol and referred to cardiologist. Echo and stress test came back negative. Going to be doing another halter monitor in a few days. Cardiologist thinks it's PVC and might need an ablation.
stabbing pain in the opposite arm where shot was administered. The pain was in the upper arm in the same vacinity but on the other arm, a month later started to get stabbing pain in that same left arm, same location, and it is very painful; difficult to move and do things; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0151) via an unspecified route of administration in the right arm on 15Apr2021 at 12:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medications in two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 at 12:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. 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. Initially within a few days of the second shot, the patient experienced stabbing pain in the opposite arm where shot was administered and the pain was in the upper arm in the same vacinity but on the other arm and had no other side effects and the pain went away in a few days. On 15May2021 at 20:00, now a month later, the patient experienced to get stabbing pain in that same left arm, same location, and it was very painful and difficult to move and do things and had a very high tolerance for pain but the fact that this was surfacing over a month later and with more pain than before was concerning. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events stabbing pain in the opposite arm where shot was administered and the pain was in the upper arm in the same vacinity but on the other arm and had no other side effects and the pain went away in a few days. Now, a month later, started to get stabbing pain in that same left arm, same location, and it was very painful and was difficult to move and do things and had a very high tolerance for pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.