chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 12 year old female patient with no drug allergies or medial history who on 9-MAR-2009 was vaccinated with her first and only dose of GARDASIL (lot # 661841/0653X) IM. Concomitant therapy included DIFFERIN. On 9-MAR-2009 the patient;s both eyes were swollen, bruised and sore after receiving the vaccine. The patient had called the office for medical attention. The outcome of the patient's adverse events was not reported. Additional information has been requested.  5/15/09 Medical records received DOS 3/9/09 to 5/5/9. FINAL DIAGNOSIS: Hypersensitivity to vaccine Post vaccination sore, swollen bruised eyes.
Information has been received from a physician concerning a male patient in his late 40's to late 50's with asthma and chronic obstructive pulmonary disease who was vaccinated with PNEUMOVAX (lot# 658449/0989U). Subsequently the patient experienced injection site reactions which included redness, induration and swelling. Physician states "It was almost like it was a cellulitis reaction". It is unspecified if the patient received PNEUMOVAX in the past because the patient could not recall their vaccination history. The patient was sent to the emergency room. No hospitalization required. Subsequently the patient recovered. This is one of two reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 16-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Throat tightness or thickening, difficulty swallowing - Denies any SOB or difficulty breathing. She was monitored over 30 mins with vitals taken multiple times. Patient felt better and vitals stabilized.
Immediately my left arm bleed at the injection site so much that the person administering  the injection stated "Oh Oh NO Oops a Daisy"  It took four ETOH swabs to clean the blood running down my arm.  A nodule welled up on my arm the size of 50 cent piece that was very painful.  The person who injected me was not a professional they were incompetent failed to meet the standard of care (competent nursing practice) as outlined in the nurse practice act & should be reported to the Board of Nursing.  The nodule stayed on my arm for 4 days.  It turned black/blue badly bruised.  The day after the injection I began to itch I had a raised red itchy rash on my back that lasted for 72 hours.  I immediately begin taking 25 mg of Benadryl  three times a day.
rash on arms and legs  concentrated on palms, soles and knees and elbows
Patient reports itchy rash that started at site of injection and has spread to other areas such as under breast.  I recommended that the patient call the Dr. so that the Dr. can evaluate and suggest treatments.
Information has been received from a licensed practical nurse concerning a 21 year old female patient with no allergies or medical history, who on 28-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot #656051/0244U).  There was no concomitant medication.  On 18-APR-2007, the patient experienced irregular menses.  It was reported that the patient was 2 weeks late on 18-APR-2007 and has had no menses after 18-APR-2007 or in May.  It was reported that after the first dose the patient had normal menses for the first month.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
p/vax lt arm was swollen, warm, reddened & hard to touch;c/o limited mobility & pain upon movement;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-DEC-2015 at 05:44, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.5 and 7.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
got it one time and got the flu; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via Digital Media.  This case involves a patient of unknown gender and age who experienced got it one time and got the flu while receiving vaccine influenza USP trival A-B vaccine - unspecified [Fluzone unsp].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza USP trival A-B vaccine - unspecified (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event got it one time and got the flu (influenza) (unknown latency) following the administration of influenza USP trival A-B vaccine - unspecified.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
bigger in size/; warm to touch; feeling ache; having real red arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), PAIN (feeling ache), VACCINATION SITE ERYTHEMA (having real red arm at injection site) and VACCINATION SITE SWELLING (bigger in size/) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), PAIN (feeling ache) and VACCINATION SITE ERYTHEMA (having real red arm at injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (bigger in size/). At the time of the report, VACCINATION SITE WARMTH (warm to touch), PAIN (feeling ache), VACCINATION SITE ERYTHEMA (having real red arm at injection site) and VACCINATION SITE SWELLING (bigger in size/) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
second dose which was scheduled for 14May2021 and so the patient did not take it yet.; flash of light in her right eye; temporary blindness followed by blurred vision and double vision in both eyes; dizziness; headache; "COVID arm"; arm had a bumpy rash on it and it was a little bit itchy.; rash spread up to her upper right arm.; fatigue; slightly sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (slightly sore arm), VACCINATION COMPLICATION ("COVID arm"), RASH PRURITIC (arm had a bumpy rash on it and it was a little bit itchy.), RASH PAPULAR (rash spread up to her upper right arm.) and DIZZINESS (dizziness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (slightly sore arm). On 21-Apr-2021, the patient experienced FATIGUE (fatigue). On 28-Apr-2021, the patient experienced VACCINATION COMPLICATION ("COVID arm"), RASH PRURITIC (arm had a bumpy rash on it and it was a little bit itchy.) and RASH PAPULAR (rash spread up to her upper right arm.). On 03-May-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). On 06-May-2021, the patient experienced PHOTOPSIA (flash of light in her right eye) and VISION BLURRED (temporary blindness followed by blurred vision and double vision in both eyes). On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose which was scheduled for 14May2021 and so the patient did not take it yet.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 16-Apr-2021, PAIN IN EXTREMITY (slightly sore arm) outcome was unknown. On 21-Apr-2021, FATIGUE (fatigue) had resolved. On 02-May-2021, VACCINATION COMPLICATION ("COVID arm"), RASH PRURITIC (arm had a bumpy rash on it and it was a little bit itchy.) and RASH PAPULAR (rash spread up to her upper right arm.) had resolved. On 12-May-2021, DIZZINESS (dizziness), PHOTOPSIA (flash of light in her right eye), VISION BLURRED (temporary blindness followed by blurred vision and double vision in both eyes) and HEADACHE (headache) had resolved. On 14-May-2021, PRODUCT DOSE OMISSION ISSUE (second dose which was scheduled for 14May2021 and so the patient did not take it yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information received and contains no new information.
Received Tdap tetanus shot on Wednesday, January 30, 2013 and developed a reddened area around injection site right deltoid area.
Chest pains, elevated Triponin levels  Treatmentand chest: xray, EKG, hearth cath, CT scan, heart monitoring,  bloodwork, blood thinner medicine,  aspirin, ibuprofen.   Hospitalization 2 nights  After two days, bloodwork levels returned to normal and chest pain decreased. RX for ibuprofen for symptoms.
Patient presented to me on Saturday, September 29, 2018 with red and swollen elbow and a pocket of pus on the bottom or upper arm. I recommeded that she see nurse practitioner immediately at Clinic.  Given antibiotic. She called me on Monday and said that she had gone to Dr. to follow-up.. He d/c antibiotic, started steroid and stated that he thought she had had an (allergic) reaction to the PNEUMOVAX vaccine. I saw her today (10/10/2018) and she is much better.. Some minor swelling in left elbow, but otherwise better.
This is a spontaneous report from a contactable nurse. A currently 58-year-old female patient of an unspecified ethnicity started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunisation. The patient's medical history, concomitant medications, and details regarding vaccinations were not reported. The patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date. The clinical outcome of event, allergy to vaccine, was unknown.
Pt developed a temperature of 103.7F on the eve after injection. Fever down to 100.1F at 14:00 the next day.
Continous headaches that come and go; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Continous headaches that come and go) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol and Weight above normal. Concomitant products included APIXABAN (ELIQUIS) and VITAMIN D3 for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, the patient experienced HEADACHE (Continous headaches that come and go). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Continous headaches that come and go) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications also included unspecified medicines for high blood pressure and high cholesterol.
Pt was alert and talking to the vaccine administrator, post vax, and when he went to stand up he fainted and fell. He had 45 stitches to his lip, head and chin. His top front 4 teeth were knocked loose and fractured the upper jaw.
Patient reports that after receiving vaccine she was feeling lightheaded. Per patient, she ate prior to arrival. Pt denied chest pain, SOB, n/v, feeling of throat closing. Pt given oral fluids.  Patients vitals remained stable throughout her time in observation
Blurred vision in the left eye as in the form of two dots as if they were mosquitoes. If it were a clock, one pointing at noon and the other at 7:00 pm, 2 to 3 inches apart. Next day April 1 there are already 3 points, several lines as if they were hairs lengthwise and many black dots.
R57.0 CARDIOGENIC SHOCK 9/30/2022 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 9/30/2022 CARDIOMYOPATHY, UNSPECIFIED
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 25-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Tinnitus in left ear. Continuous. Not pulsatile. Unchanged in these 26 days since it began
Case previously recorded as MA2009-4630. Case report received from a nurse, on 17 NOV 2009. 3 year-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 1008142P) i.m. on 13 NOV 2009, an off-label use. No adverse event was reported. Reference no.: NA09-008410.
The day following the vaccination noticed rash on the face which gradually became bigger and redder. In clinic today noticed maculopapular rash over forehead, nose neck and sparingly on trunk. Possibly viral exanthema or allergic reaction. Benadryl prescribed.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 84-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 16th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. The reporter considered the injection site pain and pain in arm to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 83 or 84 years. The patient was a hospital employee. The patient did not have any previous vaccination with ZOSTAVAX. The patient experienced pain at the site of injection and arm. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
PATIENT RECIEVED FIRST DOSE AT OTHER LOCATION ON 4/8/21. RECIEVED 2ND DOSE AT OUR LOCATION ON 7/21/21.
Severe urticaria that comes and goes all over body. At 19 days, as of filing this report, symptoms have lessened with the ongoing use of cetirizine, but still flare up. Began with itching in palms midday on November 28th, progressing into itchiness that night. By the night of the 29th, welts we're forming and I was anxious enough that I visited an urgent care facility, but was told hives wouldn't cause me any permanent harm and I could treat with cetirizine. I thought I'd just 'ride it out' and didn't take anything until it got extremely intense with huge welts in many locations and unbearable itching the night of 11/30. Since then, I've taken 10 mg of cetirizine most days to manage symptoms.
This is a spontaneous report from a contactable medical assistant and a contactable other HCP who reported for a patient. A 68 years old  male patient received PREVNAR13, (lot # J23867, expires: JAN2016) on 04DEC2014 at 16:08, at 0.5 ml single dose, intramuscular on left deltoid. Medical history included diabetes mellitus. Medical assistant mentioned that patient is taking several other medications. On 04DEC2014 directly after vaccination the patient started  having pain in his joints. The outcome of the event was not recovered. The physician consider the vaccine had no causal effect to the adverse event. Follow-up (26JAN2015): Additional information received from a contactable other HCP incldues route of administration and anatomical location of the vaccine. Assessment provided. Company Clinical Evaluation comment: The reported event might be compatible with the known adverse event  profile of PREVNAR13; a causal relationship therefore cannot be excluded.
FEVER, CHILS, ACHES AND PAINS THROUGHOUT BODY.   OCCURED FOR THE REST OF THE EVENING AFTER RECIEVEING SHOT AND MOST OF ENTIRE NEXT DAY INTO EVENING.
2/23 1:15 pm injection 2/24 2:30 am headache, injection site pain and chills 2/24 headache, chills, hot flashes, fatigue pretty much all day 2/25 nausea & diarrhea for a few hours with some fatigue
pt recv vax; 15-20 mins later, exp chills sensation;fever; sent to hosp
6/24/15-late afternoon itching, swollen, red. 6/25/15-woke up in morning and was the size of a baseball, fever and headache. 6/26/15-went to the hospital, swollen and red to pt. elbow, hot to touch and very painful.
Headache started small then blinding pain for 12-14hrs then faded away after 1 day: fever 99-100 degrees for 2 days: body aches for 3 days: slept for 4 days.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with a prior history of warts on the face and hands (also reported as "no medical history") who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot# and dose not reported), intramuscularly. On an unknown date the patient experienced after receiving her 2nd injection of GARDASIL warts had returned to her face and hands. The patient sought medical attention by her mother calling to the pharmacist. At the time of reporting, the patient had not recovered. Additional information has been requested.
10/27/10 Pt. called he had a temperature of 102-103 degrees F 3-4 hours after he received influenza high dose vaccination on 10/25/10. Pt. took THERAFLU, ADVIL for fever. Was given an alcohol rub down by his wife. Fever broke around 0200 (am) on 10/26/10. Felt tired, weak, dragged out on 10/26/10. Feeling fine today, 10/27/10. Denies SOB, skin rashes.
Pt. developed fever (Tmax 103.4) 12 hours post administration, fever persits approx. 48 hours later. (L) upper arm developed localized erythema tenderness & warmth to touch, area increased to 3 1/2 x 2 1/2". Recommended warm compress, Benedryl topical hydrocortisone, ibuprofen/Tylenol as directed
DTAP shot given in left arm deltoid area on 8/9/01. Pt developed local reaction with mild induration and swelling. Movements of arm were normal.
20 min, c/o slight burning and itching to R arm, declined vital signs. Sx resolved and requested to leave.
Pt developed fever, arm felt warm/burning sensation. Pt does not know what tx was given b/c she was diagnosed w/meningitis, in the hospital, when injection site reaction was discovered.
Hardness (L) deltoid, fever per mom. Advised cold compress, Ibuprofen, massage area, encourage movement. Call if not improving or new symptoms occur.
The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I went to bed. I started having generalized pain, all my muscles became  achy and my R arm was so sore I could not move it. About 1 am the next morning, I became nauseated and retching. I stared sweating and chilling, my body was shaking so bad I could not hold my thermometer. That lasted possibly 5 minutes, fever 100.8. Episodes of sweating alternating with cold chills occurred the remainder of the night. Exhaustion set in and I could not get out of bed. I was on bedrest all morning and I began to feel better around 4-5pm the next day.
I had the COVID vaccine on 3/4/21 was sick beginning the next morning. on 3/6/21 began having difficulty with breathing.  went to urgent care on 3/7/21 due to difficulty breathing.
HYPOXIA 4/5/2023 ACUTE EXACERBATION OF COPD
The pt had left-sided seizure activity on 11/7/01 (twitching of left arm) then was limp for a few minutes and emesis. The pt was admitted to the hospital. She was discharged on phenobarbital. The pt developed episodes compatible with infantile spasms. Evaluation and treatment ongoing. Per 1 year follow up: Pt did not recover. Persistent seizures. Diagnosis of infantile spasms.
chest tightened, glands became swollen, fever of 100, sinuses clogged, ear ringing, felt like going to pass out when stood up;
Headache & NauseaVomiting Narrative:  Employee reported headache approximately 15 mins after initial vaccine admin. BP at 15 min check 145/86. BP recheck ten minutes later 145/81. She also reported moderate nausea at this time. Employee escorted to ED for further eval. BP WNL on arrival to ED and no further intervention performed. She was discharged home.
No additional AEs were reported; patient received an expired VAQTA; This spontaneous report was received from a licensed practical nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 05-MAY-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter once, lot #T037788, expiration date: 30-APR-2022 (strength, anatomical location and route of administration were not provided) for prophylaxis (Expired product administered). No additional adverse events were reported (No adverse event).
Patient received Pfizer COVID Vaccine for ages 5-11 at the Pharmacy. Patient was seated in chair with mother and received the vaccine in the left arm.  After receiving the vaccine, the patient stood up, fell forward onto the desk, forehead struck desk and patient fell to the floor.  After patient fell, mother and pharmacist laid the patient in supine position, pharmacy manager was alerted, who called for MD and nurse from clinic for examination.  Patient was examined by MD, provided with apple juice, cookies, water and ice pack for bump on head.  Patient was subsequently monitored for an additional 20 minutes before being released.