chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14DEC98 pt mom called stated pt devel rash on chest p/vax;no itching, no resp problems;mom stated pt given DPH;still has rash on chest 14DEC98;
Patient came into store on 6/23/14 and complained of itching, redness, swelling around injection site. I told customer to check with physician.
Rapid heart rate and high blood pressure within exactly 24 hours of injection.  Called 911 and then went to emergency room for help.  Liquid ibuprofen was injected/given as treatment to slow/bring everything down.   Did not go to work the next day due to being very tired from this event.   Stayed home and rested.  Followed up with my doctor within the next few days.
This spontaneous report as received from a Licensed Practical Nurse refers to a 23 year old patient. on 15-APR-2013 the patient was vaccinated with the first dose of GARDASIL (lot # 668261/1397AA; expired date 09-APR-2013) (0.5 ml once, intramuscular) for HPV prevention. No adverse effects reported. The action taken and outcome were unknown. The causality was not provided at the time of report. It was unspecified if the patient sought any medical attention. Additional information has been requested.
she hurt a little bit more; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "she hurt a little bit more". Additional information: The patient states MD instructed her to pause xeljanz for one week around covid booster shot. Patient states at that time she noticed that she hurt a little bit more. States she is taking xeljanz again and is now feeling more normal. no further details given. MD not aware. No follow-up attempts are possible. No further information is expected.
Per Parent, Pt started on 06/26/2021 with headache, fatigue, and nausea at approx. 10 a.m..  Parent called our office on Monday 6/28/2021 at approx. 10:54 am and said symptoms continue.
Patient had pain in right thumb and ulnar aspect of wrist that started about a month after receiving injection in right deltoid. He now has pain in thumb and wrist with activity.
Fever, chills, muscle pain, tiredness, vomiting - ended up resolving within 36 hours after shot Dizziness and migraines still continue (not resolved)
Fever of 103.5 - 104 for 5 days .; Chills/Body aches; Chills/Body aches; This is a spontaneous report from a contactable consumer (parent) received via physician. A 15-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 14:00 (at the age of 15-Years-old) (Lot Number: EW0168) as dose 1, single for covid-19 immunisation. The patient's medical history included ADHD (attention deficit hyperactivity disorder) and asthma. Concomitant medication included oral dexmethylphenidate hydrochloride (FOCALIN XR ER) 15 mg daily taken for ADHD from an unspecified start date and ongoing for years. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination. No known allergies were reported. No known family history illness. On 14May2021, the patient experienced fever of 103.5 - 104 for 5 days started at 23:00. It go down to 101 with Tylenol or ibuprofen. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. On an unknown date in may2021, 24 hours after vaccination, the patient experienced chills/body aches. The patient was seen in the office 18May2021 and Felt to be either viral illness or immune response to vaccine. The patient underwent lab tests and procedures which included body temperature and showed result of 101 on an unknown date, body temperature was 103.5 -104 on 14May2021 and sars-cov-2 test (nasal swab) was negative on 19May2021. Therapeutic measures were taken as a result of fever of 103.5 -104 for 5 days. Therapeutic measures were not taken with to chills/body ache. At the time of this report the outcome of event fever of 103.5-104 for 5 days was recovered on 19May2021 and other events recovered on an unknown date in 2021.  The Physician considered the Pfizer product had a causal effect to the adverse event.   Follow-up attempts are completed. No further information is expected
Shortness of breath, fever, chills, body aches, headache. Pt reports symptoms were resolved 4/10/2021. Pt reported symptoms to this clinic 4/15/2021.
Patient is only 2 years old and vaccine is indicated for age 4 years and older, no adverse side effects noted at time of or after administration.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included heart racing (not regularly and the racing heart would usually occur when she was stressed). On 15th January 2019, the patient received the 1st dose of SHINGRIX. On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, feeling unwell and injection site induration. In January 2019, the patient experienced papular rash and itchy rash. On 17th January 2019, the patient experienced heart racing. On 18th January 2019, the patient experienced dizziness. On 17th January 2019, the outcome of the injection site pain, injection site swelling, feeling unwell and injection site induration were recovered/resolved. On 18th January 2019, the outcome of the heart racing was recovered/resolved. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the papular rash was unknown and the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling, feeling unwell, heart racing, dizziness, papular rash, injection site induration and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX left arm. The patient felt pain, swelling on her left arm at the injection site and the area was hurting and hard to touch. The patient felt sick and these symptoms started in the evening and continued the following day. The patient laid around for a while and then when she got back up and started to move around again after a few days, she experienced two episodes where her heart was racing. The patient experienced heart racing before but not regularly and the racing heart would usually occur when she was stressed. On 17th January 2019, 2 days after vaccination the patient experienced racing heart and continued the following day and then resolved. Three days after vaccination, the patient was also pretty dizzy for a couple of days on 18th January 2019 or 19th January 2019 but seemed ok after that. The patient reported a bump at the top of her chest close to her neck and another bump on her right arm with little tiny bumps that itch. The bumps were drying up but they started about a week after she received the SHINGRIX vaccination. The reporter consented to follow up.
Really bad cramping, like period but worse and through the lower back. Only a few days of spotting intermittently since - no full period but still pain. Enough to wake up in the middle of the night several nights
night of vaccination - headache, nosebleed two days post vaccination - muscle cramping in right leg, "Charlie horse" feeling. & left foot pain constant nosebleeds ever since & leg muscle cramping one month post vaccination - bruising on arms, legs, stomach august 18th primary care drs visit - dr noticed petechiae on head
Had 6 month shots and influenza on 12/2/11. That evening at 6pm went to the ER with fever of 104.3 and seizure, released a short while later, told to give Tylenol for fever.
pt recvd flu vax & 3 days later, devel redness of the lt eye;
This spontaneous report as received from a consumer refers to her son, a 4 month old male patient. The patient had no pertinent medical history. The patient had no drug allergies. On 27-SEP-2013 the patient was vaccinated with ROTATEQ (lot # not reported) (total daily dose not reported). There were no concomitant medications. On 27-SEP-2013, the patient developed a rash after receiving ROTATEQ. The patient sought for medical attention by speaking to physician. No treatment was given. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered. Additional information is not expected.
This spontaneous report was received from a registered nurse and refers to a 13 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-JAN-2017. On 07-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M038860 with expiration date of 13-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 21 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Pt recvd Engerix-B on the following dates 25JUL91; 22AUG91; 23JAN92; pt had a lack of seroconversion (low titers - less than therapeutic);
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) and ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5 ml and is not immunocompromised) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer vaccine (from lot FF2589) on 16-Sep-2021 and Pfizer vaccine (from lot FF8841) on 08-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) and ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5 ml and is not immunocompromised). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given more than 12 hour post-puncture) and ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5 ml and is not immunocompromised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Follow up contains patient identifiers.
No adverse event; Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday) 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 EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday).    This case contains information about patient 01 out of 02 patients. Concomitant medication details not reported by the reporter. Patient age group was reported as infant. Patients administered were from ages 6 months and above.  Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-737849 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737849:Patient 1
Lymph nodes on left side of neck, armpit, and ear are swollen and hurt.
The morning on 2-4-2021 he was walking across the yard and started to feel light headed and dizzy.  He fell injuring his right knee.  He is unable to bear any weight with significant swelling that is visibly enlarging.  He has decreased passive and active ROM and pain with any attempt at movement.
pt recv vax 18JUL96 130PM & had sz @ 230PM the same day;had 3 other sz that evening, 1 @ approx 6:30, 8PM & 1 in middle of noc;mom reports fever went to 101.7 2hr p/vax;told by MD sz d/t vax;
A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 03-Dec-2013. The Health professional reported that she inadvertently given an expired dose of FLUMIST to the patient on 03-Dec-2013. The outcome of the event of inadvertently gave an expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Development of 6-8 raised, erythematous, and painful nodule-like areas to bilateral axillae with aura-like sensation for 48 hours prior to visible changes noted. Writer/patient had stopped shaving and utilizing antiperspirant immediately once aura-like sensation developed. In addition, joint discomfort and general malaise noted. Writer/patient utilized APAP 1000 mg on 1/20 for pain management at hs. Workplace clinic visit attended on 1/21 with instruction to utilize prescription for triamcinolone 0.1% cream topically BID X10 days with diagnosis provided of ?dermatitis, unspecified ?. Prescription not filled as writer/patient disagreed with plan of care and instead continued to utilize APAP 1000mg Q12 hours x 2 doses for pain management. Presentation/eruption present for 36 hours prior to resolution. (*Per discussion with other healthcare COVID-19 vaccine recipients with similar presentations, writer/patient felt reaction mirrored that of others and chose not to introduce topical steroid). Presentation/eruption present for 36 hours prior to resolution.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL injection (strength, route and site of administration, dose, lot number and expiration date were not reported), which was administered late. No adverse effect was reported. Product quality complaint was not involved. Additional information is not expected as no consent for contact was reported.
Ten hours after my vaccine I had a low grade fever and a bad headache with aches and pains which went away. Two days later I had numbness in my legs, arms and face.
Swollen arm, red, hot to touch, rash around under arm and legs. Doctors refused to look at her. Had to find another doctor and was told in was an allergic reaction.
Fever headache sore throat body aches chills diarrhea Tylenol sleep day#2
HEPATITIS B SURFACE ANTIGEN POSITIVE. Information has been received from a registered nurse concerning a 64 year old female dialysis patient with a complicated medical history who on 19-may-2003 was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast) 40 mcg. On 21-may-2003, a lab test was drawn and revealed the patient was "hepatitis surface antigen positive, HBsAG". It was noted that the nurse did not know if the patient was core positive, and that she did not think the test was done for core". It was also noted that no treatment was required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Appx. 15-20 mins. after shot, hard headache, dizziness, flu-like symptoms onset. appx. 2 wks later my salivary glands closed up & my neck looked like I had a goiter it was so full.  Neck is still full today.  All blood tests, CT scans, etc. have proven to be normal.  The only foreign thing was the H1N1 shot.  My neck has never done this before.  I have been to 4 drs. to fix this, and no one can because no one can figure out how it happened; Administrator acknowledges it was probably the H1N1 shot.  It now needs to be fixed w/plastic surgery, which my insurance will not cover.
Next day post vax, the pt returned to physician's office with red, sore, swollen arm at injection site. Returns again on 10/13, entire arm red, warm, and swollen. Given Medrol dose pack.
Red blotches; rash; itching head, back, torso,a rm and thighs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching head, back, torso,a rm and thighs), RASH MACULAR (Red blotches) and RASH (rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included RISEDRONATE SODIUM for Osteoporosis.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itching head, back, torso,a rm and thighs). On an unknown date, the patient experienced RASH MACULAR (Red blotches) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching head, back, torso,a rm and thighs), RASH MACULAR (Red blotches) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included vitamins and calcium.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 55-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment currently. Also reported that no adverse reactions were experienced by any patients.
exteeme increase in fatigue, malaise, headaches, chronic upper resperatory congestion
Patient needed Shingrix vaccine and was given Menveo by mistake.  Patient suffered no ill effects from receiving this vaccine.  Will vaccinate with Shigrix ASAP.
Developed fever of 102 the day after immunization. Fever lasted 2 day, c/o body aches and  joint pain. Soreness at injection site but no redness or swelling. Arm felt heavy for 1 day. Patient's sx's resolved after 5 days.
- Dizziness / feeling of dis-ease within 15-30 mins following shot  - Some  face swelling and redness, hot to touch within first hour with itchiness - swelling and redness similar to a bad sunburn  - itchiness spread down neck and eventually to whole body and lasted for around 5-6 days - Nausea / general discomfort within first hour  - swelling feeling in my calves and feet like I was retaining water the first night after the shot, lasted a few days  - what felt like swelling / tightness in throat - felt like the back of my tongue was swelling a bit / harder to swallow  - extremely swollen lymph node at left collar bone  - noticeably swollen lymph node under left arm area
Sore, redness swelling - Rash on arm, arm hot and still itches.
2:15pm pt returned to clinic 10 mins after vac c/o stuffy, runny nose, itchy red watery eyes, had slight cough. 2:25pm 1 1/2 tsp Benadryl and 2ta Orepred given. 2:45pm better. Rx Orapred 15mg/5ml-2tab po bid x 2 days.
panic attacks; This is a spontaneous report from a Non-contactable physician.   A 30-year-old female patient received bnt162b2 (BNT162B2) at single dose on an unspecified date for immunisation.  Medical history included anaphylactic reaction, panic attack and 12 unspecified comorbid conditions. The patient's concomitant medications were not reported.  The patient experienced panic attacks on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. According to MD, they are not sure if was a true adverse reaction or a panic attack.  No follow-up attempts are possible, information about lot/batch cannot be obtained.