chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very red around the injection site; tenderness around the injection site; swelling around the injection site; warm to the touch; hardness around the injection site; her arm inside of the elbow was itchy, it looked like a mosquito bite; little bit sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (her arm inside of the elbow was itchy, it looked like a mosquito bite), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (hardness around the injection site), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (very red around the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy on 27-Jan-2021. Concurrent medical conditions included Cancer. Concomitant products included GEMCITABINE, CARBOPLATIN, BEVACIZUMAB, METFORMIN, APIXABAN (ELIQUIS), LEVOTHYROXINE SODIUM (LEVOTHYROXIN), SIMVASTATIN, LISINOPRIL, VITAMIN B12 [VITAMIN B12 NOS] and GABAPENTIN for an unknown indication.  On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PRURITUS (her arm inside of the elbow was itchy, it looked like a mosquito bite) and MYALGIA (little bit sore arm). In January 2021, the patient experienced HEADACHE (headache). On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (hardness around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE PAIN (tenderness around the injection site) and VACCINATION SITE SWELLING (swelling around the injection site). On 14-Jan-2021, PRURITUS (her arm inside of the elbow was itchy, it looked like a mosquito bite) and MYALGIA (little bit sore arm) had resolved.   At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INDURATION (hardness around the injection site), HEADACHE (headache), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE PAIN (tenderness around the injection site) and VACCINATION SITE SWELLING (swelling around the injection site) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient did not receive any treatment. No treatment medications were reported.
this vaccine was administered to a 3-year old; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 3-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 1, 0.2 ml single (Lot number: FL8095, Expiration Date: 31Aug2022) at the age of 3 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (medically significant) with onset 22Jun2022, described as "this vaccine was administered to a 3-year old".  Additional information: She mentioned that this vaccine was administered to a 3-year-old. She wants to know what they should do or should they wait longer before giving another dose. Agent has a pharmacist on hold, who reports that there was an administration error with the Covid-19 vaccine, orange cap. It was administered to a 3-year-old.
Right thigh at site of MMR has blister (2cm x 2xm) oozing clearfluid surrounded by bright red 3cm x 3cm with surrounding area of erythema approx 10cm x 10cm. Hot to touch and tender. Gave Benadryl and oral antibiotics.
Pt recvd flu vax & 7 days later exp an exacerbation of COPD; arterial blood gas determination demonstrated a po2 of 52 & pco2 of 68; pt marked wheezing; pt adm to hosp;
started with Nausea, had person lay down. Progressively got worse and advanced to a migraine.  Transported via on site EMS for observation
Information has been received from a physician concerning a 27 year old female who on 04-NOV-2008 was vaccinated with the first and only dose of GARDASIL 0.5ml/once IM.  One week after the vaccination, the patient developed rash from head to toe.  The patient was given ATARAX and BENADRYL for the treatment.  The patient's rash from head to toe was not recovered.  Additional information has been requested. Follow-up information was received on 17-FEB-2009 from the physician via medical records indicating the patient was a certified nursing assistant (CMA) who worked in a hospital. On 04-NOV-2006, at 09:00, the patient with no pre-existing allergies, birth defects or medical conditions was vaccinated in the right uper arm with a first dose of GARDASIL (lot# 659184/0843X). There was no illness at time of vaccination. On 11-NOV-2008 the patient was seen by the physician complaining of hives spreading in bilaterial arm which lasted "2 days", from 09-NOV-2009, at 09:00, She also complained of pruritus. Physical examination  showed there were "round oval" macules and papules in her neck, trunk and extremities. There was no lesions on her hands. The patient had taken Benadryl, OTC for symptoms. The patient was diagnosed with allergic reaction and was treated with ATARAX, 25mg, three times a day. No diagnostic or laboratory tests were performed. Subsequently, on an unspecified date, the patient recovered. Additional information is not expectede.
patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail) 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 VACCINATION COMPLICATION (patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail). At the time of the report, VACCINATION COMPLICATION (patient call to report that had an appoint the previous day and woke up feeling something that is indistinguishable in the recording of the voicemail) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Fatigue - day after only Swollen lymph node - left arm (below elbow) began 1 week after, ongoing
Fever all day of 101.7 Body aches Tired Nausea Sensitive to light
Felt rapid heart rate, headache and dizziness a few hours after the shot. Went to doctor the next day and the nurse took my blood pressure which was normal. Also no fever at the time. Nurse told me to monitor. Still feel lethargic.
Localized reaction approximately 5cm circumference. Hot to touch. Client state is allergic to latex(could possibly be allergic reaction from that)
Redness, swelling, tenderness, around site of injection. Informed pt to give Tylenol or Motrin and ice pack compress to site area.
Saturday, 3/6 11:00 p.m.  - Left arm began to hurt Sunday 3/7 - 3:00 a.m. - Woke with chills and body aches Entire day - Fever from 101 to 102.7, chills, body aches, headaches, nausea, diarrhea Monday - Temp 100.7.  Felt much better. Diarrhea continued Tuesday - Much better.
This study case was received from the investigator on 27 September 2012. A 21 year-old male subject with no reported medical history was found to have unspecified disease of pericardium 13 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 03 March 2012. Relevant laboratory data included: not available Troponin I, not available ECG, not available Echocardiogram, not available MRI (brain, spinal cord, heart) and a not available lumbar puncture. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Arm pain/persistent pain in arm; This is a spontaneous case, initially received on 25-Sep-2018 (combinedly processed), reported by other non-health professional, concerning a 25-year-old, adult, female patient.  On an unspecified date in 2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml (reported as full dose administered), route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date not reported) for influenza prophylaxis.  On an unspecified date in 2018 after the vaccination, the patient experienced prolonged arm pain (more than the normal 24 to 48 hours) with no warmth, swelling or redness for 10 days. The patient had no systemic, anaphylactic, nor local swelling and redness, just the persistent pain in arm. The pain was not extreme, nor life style altering.  On an unspecified date in 2018, the patient was treated with Advil (ibuprofen) which made a little difference in reducing or eliminating the degree of pain nor the length of time it had persisted.  At the time of the report, the time length of the pain was reported as greater than 10 days, and hence the patient had not recovered from the event.  The reporter assessed the case as non-serious.  This case was considered as lost to follow up, since the reported had not given the consent to follow up.; Reporter's Comments: A 25-year-old female patient developed persisting arm pain on an unspecified day after receiving the suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event as related due to the plausible temporal relationship.
Patient  presents to the ED with a Chief Complaint of Facial Droop, Numbness, after receiving his first dose of vaccine 12/31/21. Per guidelines, all hospitalization are reported.
I came down with strep throat over the weekend of 5/20/23. It began with an achy throat and a low grade temperature and body aches. I was diagnosed with it on Monday, 5/22/23. I was prescribed 10 days of penicillin.  I finished the course of medication. Then in the evening of 6/14/23 I began to feel an achy throat again. Overnight on 6/14/23 and on 6/15/23 I also had a low temperature, chills, and body aches. I was diagnosed with strep throat again on 6/15/23 and prescribed 10 days of amoxicillin.
Breakthrough case admission after 3 vaccines  Pfizer 3/2/21 lot# EN6202;  Pfizer 4/13/21 lot# ER8733;  Pfizer 10/20/21 lot# FF2589
Breakthrough case admission after 2 vaccines Moderna 3/27/21 lot# 017B21A;  Moderna 4/24/21 lot# 048B21A;
Papilledema diagnosed 8/15/02 post exam by doctor. Pt.. has appointment scheduled with neurologisst today, MRI done 87/15/02-reported as normal sudden onset of vomiting  without nausea 8/15/02. August 17,2002 papilledema diagnosed by opthamologist- screening for glaucoma.
Approx 12 hr after receiving 12's child became febrile (103 R) and irritable x 13 hrs and again the next night. Parent gave Advil gtts Q6H. Afebrile during daytime.
swollen mass in left axila. started feeling anaphylaxis-like symptoms, including swollen throat, face/jaw numbness, inner ear swelling. the symptoms appear random with varying intensities, no apparent trigger
pt claims that pt recvd DTP vax on 30NOV79, 25JAN80 & 28MAR80; in MAY80 parents noted "lumps" @ inject sites; on 16JUN80 pt underwent surgery to drain abscesses on both hips; Pt suffers deformation (indentation) @ the surgical sites;
Multiple health problems following receipt of anthrax vaccines December 1998 through January 1999; chronology of symptom onset as follows:  2001 - Bilateral arm paresthesias, hand numbness, neck pain, headaches.  2006 - Joint pain, intermittent diarrhea, fatigue.  2007 - Leg paresthesias, muscle spasms, hand tremors, depression, short term memory loss, hair loss.  2008 - Low back pain.
Arm pain, decrease range of motion started happening day after vaccine. Has had imaging. No signs of damage. Starting physical therapy.
Spoke with patient's mother on 12/7/2021.  She informed me that had not experienced any adverse effects.
Received MMR vaccine on 11-26-12; came to office on 12/6/12 with rash-diagnosed with chickenpox, patient & mother went to clinic on ? dare & diagnosed with Rubella.
Neck felt hot and swollen within day. Noticed this when reading and reading phone. Sore throat got worse over few days.    At first thought it might be GERD but was severe and realized it may be from vaccine. Had slight mucous discharge, in throat and slight change in swallowing. Had for full week; feels like it is resolving. No difficulty breathing, O2 level 97 plus.
did have more persistent myalgias than 1-2 days. vaccine given 9 days ago and patient still with aching and pain. also with new LUQ pain- likely unrelated and possible gastritis. planning PPI with f/u with me.
Slight fatigue and sleepiness the next day, 3/30. On Tue 4/6 the shot site became red, itchy, and swollen, and became worse overnight. Nose bled out of the blue on the evening of 4/6 but stopped within a few minutes. Experienced insomnia nights of 4/5 and 4/6 so of course I feel fatigue today 4/7. Sore throat on the morning of 4/7 has improved after gargling with salt water.
Symptoms of shooting pain in left arm. Progressively worsening until doctor visit. Was prescribed VICODIN and Prednisone treatment by doctor.
Developed tenderness and mild swelling left axillary lymph nodes 24 hours post TDAP left deltoid.
Client complained of numbness of tongue, itching on (L) arm, left arm tight/numb/redness, swelling.
Information has been received via the Merck pregnancy registry, from a licensed practical nurse (LPN), concerning a 23 year old female patient, with a history of miscarriage at 13 weeks, who on 04-OCT-2007 was vaccinated with the first dose of Gardasil (lot # 655849/0263U).  On 20-NOV-2007 the patient experienced her last menstrual period, and became pregnant on approximately 04-DEC-2007.  On 04-DEC-2007, she was vaccinated with the second dose of Gardasil (lot # 655154/1210U).  On 08-JAN-2008, prenatal vitamins were initiated for the pregnancy.  On approximately 17-JAN-2008 the patient developed spotting and cramping; an ultrasound was performed, and the original estimated date of delivery of 26-AUG-2008 was changed to 01-SEP-2008.  The outcome of spotting and cramping was not specified.  No further details were provided.  This is one of several reports received from the same source.  Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, fatigue, painful/swollen, red/hard to touch injection  site
This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (FEVER) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included FISH OIL for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (FEVER). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (FEVER) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received. Narrative updated,
Left arm very swollen, hot, tender, erythematous with nausea, no vomiting.
fever; adverse reaction; A spontaneous report was received from a male patient who received Moderna's COVID-19 Vaccine and experienced adverse reaction and fever.   The patient's medical history was not provided. No concomitant medications were reported.   On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 for COVID-19 for infection prophylaxis.  On an unknown date, the patient began having an adverse reaction. He reported that he had a fever and some other symptoms. Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, adverse reaction and fever, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event pyrexia, a causal relationship cannot be excluded.  Further information has been requested regarding the unnamed 'adverse reaction' event.
This case was reported by a consumer via out of hour services and described the occurrence of fatigue in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, shivering, muscle pain, headache and fever. On an unknown date, the outcome of the fatigue, shivering, muscle pain, headache and fever were unknown. It was unknown if the reporter considered the fatigue, shivering, muscle pain, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The call was presented as an Ad hoc Virtual Meeting (AHVM). The age at vaccination was not reported. The patient was called back, but got voice message and was provided a reference number if the patient wished to call back to ask additional questions, such as date of birth, date, onset timing, and lot number.
roughly 22 hours after the injections, patient (who has a known seizure disorder) had about a 2 minute "grand mal seizure" per parent ; she then had about an 8 minute post-ictal state while she "comes out of it" per parent she recovered and rested at home; did not present to doctor office
No adverse effect; received expired dose M-M-R II on 23-MAY-2019; This spontaneous report as received from medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition were unknown.Concomitant medications included sterile diluent. On 23-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type: RHA, lot # N013866, expiration date: 04-MAY-2019 (strength, dose, dose number and anatomical location unknown) via subcutaneously for prophylaxis (expired product administered). The lot number and expiration dates were not known for the properly stored sterile diluent, which was used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse effects were reported. No product quality complaints(PQC) was involved.     This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1905USA012962:
Reaction swelling and pink discoloration to right thigh. Able to walk without difficulty. Lungs CTA. Heart RRR. Treated with Orapred.
Red Rash at vaccination site 1.5" x 1.5" and bilateral red swelling of hands with itching as well as associated pain/discomfort especially when using hand sanitizer. Five days later rash and swelling improving but hands still very sensitive and painful when disinfecting.
Feeling quite ill.  Did not sleep  night before trip to hospital.  Terrible taste in mouth. Taken to hospital emergency room  morning of April 18, 2021.  Admitted to hospital by ER physician.   Reason:  blood c lots in both lungs.
product was given to 17 month old; three doses of DTaP and this was their fourth dose with no reported adverse event; Initial information received on 28-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old unknown gender patient who was given three doses of dtap and this was their fourth dose with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE dose, frequency,strength, lot number expiry date unknown)with unknown indication.  On an unknown date the patient  was given three doses of dtap and this was their fourth dose with no reported adverse event (off label use) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (product was given to 17 month old; three doses of DTaP and this was their fourth dose with no reported adverse event).  At time of reporting, the outcome was Unknown for the event product was given to 17 month old; three doses of dtap and this was their fourth dose with no reported adverse event.