chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, GARDASIL 9 was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; and 38.6  F for 20 minutes on 27-DEC-2016, at 07:51 hours. They were called out because of a digital data logger. On 27-DEC-2016, at 15:08 hours, the patient was vaccinated with the second, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M021407 with an expiration date of 30-APR-2018), intramuscularly, in the left arm, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA010731: US-009507513-1703USA011161: US-009507513-1703USA011162: US-009507513-1703USA011158: US-009507513-1703USA011159.
1/14/21 early a.m. woke with severe itch at injection site. Lasted all day. Did not scratch, Checked throughout day, no redness or swelling. After work around 4:30 p.m. noticed red areas at the site, 2 small hard areas. remains itchy. Applied cold to area. Itchy through the night. Woke up 4 a.m.entire area completely red oval , warm to touch and itchy. Picked up Zyrtec on way to work, it took away itch, alternated Extra Strength Tylenol and Advil through the day. No fever or pain. Red area remains at this time Saturday 10:30 a.m. and has gotten larger. Another Zyrtec taken.
36 y F, patient present with allergic type reaction s/p receiving a Moderna booster vaccination. Immediately after pt began feeling itching in her throat and difficulty swallowing. Pt assessed and noted to have mild facial swelling and what appears to be urticarial on skin. Pt given epinephrine and EMS activated. Pt did not require any other treatments and was felt better after epi. The following is the RA Report:  ARRIVED TO FIND PT. SITTING IN CHAIR AT OFFICE. PT. A/OX3, GCS 15, AMBULATORY ONSCENE. C/C: ANAPHYLAXIS SECONDARY TO MODERNA BOOSTER SHOT. PT. STATES SHE HAD COVID PNEUMONIA LAST YEAR AND STARTED TO BECOME ALLERGIC TO MULTIPLE THINGS AFTER RECOVERING. PT. RECEIVED BOTH FIRST AND SECOND DOSES OF MODERNA VACCINE EARLIER THIS YEAR AND HAD MILD ALLERGIC REACTIONS TO BOTH OF THEM. PT. ALSO STATES SHE WENT INTO ANAPHYLAXIS A MONTH AGO AFTER A MOSQUITO BITE. PT. PRESCRIBED AN EPI PEN BUT DOESN'T CARRY IT. APPROX 5 MIN AFTER ADMINISTRATION OF BOOSTER, PT. STARTED TO DEVELOP HIVES AND ANGIOEDEMA IN LIPS AND TONGUE.  ADMINISTERED 0.5MG EPI TO PT. SYMPTOMS BEGAN TO RESOLVE AND PT. FELT BETTER UPON ARRIVAL. NO CP, NO MORE SOB, HIVES RESOLVED. LUNGS CBL. PT. TSP HSP 343 PER PT. REQUEST. NO CHANGES ENROUTE.   A: Allergic reaction with high probability of anaphylaxis if left untreated   P: Actions were deemed appropriate given the situation and history of the patient. Pt remained stable after treatment. Unclear if patient had any other symptoms such as hypotension, tachycardia or other identifying criteria for anaphylaxis. Pt appears to be stable on report and transport was the best disposition given history and symptoms. Pt most likely will be monitored with the possibility of further medications such as Benadryl and/or steroids. Pt tsp to 343 by RA 10 per pt request and w/o incident.
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves Four years old female who was vaccinated with 0.5ml dose of vaccine PENTACEL (lot number C5576AB (Expiry date unknown) via intramuscular route in the right deltoid instead of KINRIX. Patient had earlier received three dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR, VARICELLA VACCINE, and FLUZONE QUADRIVALENT. It was an actual medication error case due Wrong vaccine administered. (It was reported that KINRIX vaccine was ordered and PENTACEL was given to a 4 year old patient by mistake). It was reported that the patient did not experience any adverse event. 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.
pt was not sleeping well, fussy during noc-awake p/temp taken-105; MD notified by phone; Ordered cool bath & APAP by mouth; reaction reported 5MAR92 @ 1130am, t102 @ this time;
My underarm area and the length of my arm began to feel tight and hurt when I lifted it or stretched it out. The following morning, there was extreme swelling in my armpit shaped like an oblong water balloon and much pain was associated with it whenever I stretched my arm. I could not lift my arm over my head without pain. This swelling lasted 7 days, and is now subsided almost entirely. I applied heat for comfort and then ice for the swelling. I took Aleve every 8 hours for pain and discomfort.
Patient arm becames swollen and hot later in the day after she got the flu shot. She went to urgent care and was diagnosed with cellulitis and was given IV abx while admitted and discharged home with clindamycin and prednisone.  After 2.5 days of taking oral antibiotics, the injection site seem to have reduced in swelling but and no longer hot (patient also had no fever or other symptoms) but infection site seem to be spreading. She went back to urgent care and was prescribed Keflex to take on top of clindamycin. Pt had a fever on  the night of 9/20 and the fever broke the morning of 9/21.  She will be seeing her PCP today 9/22/21
Information has been received from a physician concerning a 2 year old male who on 8/6/97, was vaccinated with MMRII (lot 1537H and 0872B). The physician reported that in 1998, at age 2, the pt was seen for autism. The physician indicated that the pt was developing normally while in his care (last seen in 12/97). The physician also indicated that he is unsure which lot # of MMRII the pt received as both were documented in the pt's medical report. Upon internal review, autism was considered serious due to an "Other Important Medical Event". Additional information has been requested.
headache / My headaches were severe; arm and muscle soreness; arm and muscle soreness; extreme fatigue; cramps; cramps, and started menstruating mid cycle; Pain went from left arm up through neck and back; Pain went from left arm up through neck and back; Pain went from left arm up through neck and back; Dose number: 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 14:00 (Lot number: 330308D) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 11Nov2021. Vaccination history included: Bnt162b2 (dose 2, lot number: ER8731), administration date: 13Apr2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (dose 1, lot number: ER8727, Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 14:00, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "headache / My headaches were severe"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 03Dec2021 20:00, outcome "recovering" and all described as "arm and muscle soreness"; FATIGUE (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "extreme fatigue"; MUSCLE SPASMS (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "cramps"; MENSTRUAL DISORDER (non-serious) with onset 03Dec2021 20:00, outcome "recovering", described as "cramps, and started menstruating mid cycle"; VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 03Dec2021 20:00, outcome "recovering" and all described as "Pain went from left arm up through neck and back". Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of pain in extremity, myalgia, fatigue, muscle spasms, menstrual disorder, vaccination site pain, neck pain, back pain.
HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 to Left Arm for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced headache and pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and pain at injection site. This report was non-serious.
Patient visited the doctor's office one week after the vaccination (8/2/17), reported a red, itching, burning rash from the top of her shoulder to mid arm. Doctor wrote a prescription for Triamcinolone 0.5% Cream and pt picked it up 8/2/17.
Pox-like bumps all over, especially near joints--hands, knees feet. Itchy and painful. Fingers swollen.
Post 2nd vax, the client developed, rash, clammy skin, respiratory, shallow, hypotensive (60/30). He remained verbal; no pain, and responsive. With- in 2-3 min, BP 100/60, pulse 80, Resp. 16-20.
Chills, fever, weakness, aching for about 36 hours,  Sore, painful arm, then  3 days post injection, swollen area covering a 2-3 inch on arm with severe itching, redness  lasted about 2 days.
The pharmacist administered 1 mL instead of 0.5 mL on accident. The pharmacy receives the Pfizer shot syringes (1 mL) and the Moderna syringes (3mL). The pharmacy received new syringe products for 5mL and the labeling and color looked nearly identical to the 3mL syringe. Unfortunately, in a chaotically busy retail pharmacy, where patients want their vaccines and medications quickly. I was trying to be quick and administered the vaccine in a 5 mL syringe. The graduations in the 5 mL syringe are by 1 mL, so 1,2,3,4,5 mL. Each mL increases in increments of 0.2 mL, so 0.2, 0.4, 0.6, 0.8 and 1 mL. In the usual syringe, the first bold graduation is 0.5 mL (for the 3mL syringe). In the 5mL syringe, the first bold graduation is 1mL. I have been administering covid vaccines since February 2021. By habit, I drew up the vaccine to the first bold mark, but regretfully, this was 1mL instead of 0.5mL. My pharmacy manager and I are working on eliminating all syringes that are not suitable for measuring volume for the covid vaccine. We receive Pfizer and Moderna shot supplies via a large box that is automatically sent from corporate/CDC (to my knowledge). My pharmacy manager and I are both confused on why we would be sent vaccine supplies that are not suitable for covid vaccinations to begin with. It is almost like they are trying to create a situation for a pharmacist to measure an incorrect dose. Although it is ultimately my fault, I was placed in a hazardous situation, both with the work environment (due to short staffing and unrealistic expectations) and with the incorrect syringe supplies.
Symptoms began  8-10 hours post vaccine (second Moderna dose only).  I experienced major fatigue, muscle soreness, sweating, strong chills, body aches, headache.  Every symptom listed was experienced for up to 16-20 hours when the initial onset of symptoms began.
- Numbness in bottoms of feet, toes, legs (entirety), waist, hands, face (both sides, lips, and throat) - neurological: brain fog, acting out of character, impulse control gone, memory loss, headache, tingles in head, blurred vision (seeing black dots), slowed movements with extremities, thought process is slowed, stumbling over words, confusion, feeling uneasy, eyes drooping, spacing out, random twitching, and couldn't hold a conversation - physical symptoms: flushed face, sweating profusely, feeling hot, swollen hands (red hue), fast heart rate (up to 134 bpm), chest pain, shaky hands (morning and night), physically feel (energized on caffeine) body more than mentally, pulsing pain in neck while sleeping, puffy face, sensory issue, restlessness, hard to breath, high blood pressure
Temperature & chills - 99.4F,  tiredness, large red hard lump, sore to touch or to move however I exercised the muscle because the pharmacy told me that would cause the pain to dissipate faster.  The soreness has diminished - though now it itches and the lump has moved down my arm so it is now below the injection site.
Yes symptoms began around 11am on Oct 10, 2009 continued until Sunday Oct 11, 2009 about 12 pm. Dizziness, vertigo, imbalance. General weakness through body all over. Lethargic similar to Meniere's symptom. Blurred vision. Everything cleared by Monday. 10-12-09
68 y/o male who received influenza vaccine on 11/8/17 in clinic who developed malaise, retrosternal burning, burping, nonbloody emesis, diaphoresis and 8/10 chest discomfort for which he presented to an hospital for on 11/9/17 where EKG was reported to show inferior Q waves and slight ST elevation, with 1 mm ST elevation with inferior leads. Underwent cardiac catheterization and PCI on 11/9/17. Per hospital report, on 11/9/17, initial lab work was as follows: troponin I 130, CMP WNL, AST 262, ALT 52. On 11/10/17 troponin I was 61.90 and then 38.60. On 11/10/17, CK MB 143.3 and 64. Patient was initiated on atorvastatin 80mg daily (previously on simvastatin 20mg daily), metoprolol tartrate 12.5mg BID, ticagrelor 90 mg BID and was discharged from the hospital the following day. Aspirin 325 mg once, Metoprolol 12.5 mg bid, Ticagrelor 90 mg BID.
Excessive heart rate, chest pain, entire body trembling,  joint pain enough to enable walking.
no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 01-APR-2021 the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), 1 dosage form (lot number T013546 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 28-OCT-2021), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001385: US-009507513-2104USA001384: US-009507513-2104USA001383: US-009507513-2104USA001386: US-009507513-2104USA001382:
Standard side effects ( headache, fever, chills). Lymphnodes started to enlarge, and side effects continued to worsen. Eventually a blood test confirmed I had Mono.
Immunizations on 07/22/04: Was seen in ER 07/23 for swelling from elbow to shoulder. Diagnosed cellulitis and treated with Augmentin.
Standard influenza shot caused severe, nearly disabling  muscle and joint pain starting about 30 hours after injection. Injection site red, swollen, hot and hard.
30 years old patient has a script from a doctor to receive the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 30-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles on an unknown date last year).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that this 30-year-old patient had a script from a doctor to receive the 1st dose of Shingrix as to the patient got shingles last year, which led to intercepted drug prescribing error. Till the time of reporting, the patient had not received any dose. The reporter did not consent to follow up.
Fever-off and on. Red streak on arm day after and lasted a day. Rash on arm-day after lasting 2 days and again 2 wks later lasting a day. Burning sensation in entire arm-2 weeks after lasting 2 days. Yellowish skin color in arm-3 weeks later lasting a day. Headaches off and on. Arm hurt for 4 1/2 weeks after stating 6 hrs after shot.
Over 24 hours after getting the vaccines, 11:30AM on May 1, 2020, Patient's temperature spiked to 102.6 degrees, gave her Motrin, but she was acting normal. We continued to monitor her, at 12:30PM she was eating a peanut butter jelly sandwich and ended up vomiting that up right after. Patient then took a nap. She woke up at 5:15PM, crying, like she was uncomfortable and she was hot to the touch. We took her temperature at that time and it was 104.6 degrees, we immediately got in the car and went to Urgent Care. The urgent care took her temperature and it was 103 degrees. While at the urgent care patient vomited the Up & Up brand of Pedialyte that she was drinking, we let them know that she did have a well visit yesterday at her PCP and was given the routine vaccines for the two and half year old appointment, the doctor came in and informed me that there are no routine vaccines at two and half years old. The urgent care did a flu, step & COVID-19 test. The flu and strep test came back negative, the doctor there did want to send the strep test off to do a culture test on it also. We left the urgent care with no answers but to give her Tylenol every six hours for the fever, do our best to keep her hydrated and if any new symptoms arise to go to Hospital. We continued to monitor her and last took her temperature that day at 9:45PM and it was 101 degrees.  May 2, 2020 patient's fever continued, we gave her Tylenol throughout the day to help with the fever. She vomited about five times throughout the day. We did luke warm bath?s to help her fever. Kept working on getting her to drink Up & Up brand Pedialyte. For the second day patient was unable to keep anything in her stomach. No word from the urgent care yet about her test results.  May 3, 2020 patient's fever continued, it did start to stay down for longer periods of time, we did continue with Tylenol. She was able to keep liquids down today and she ate some crackers. Heard from the urgent care office today that the strep culture test was negative.  May 4, 2020 patient had a high fever twice throughout the day. We gave her Tylenol to control, she was drinking and eating more than yesterday. I called and left a message for patient's PCP asking them why they gave her a Dtap & Polio shot on Thursday April 30, 2020 when it wasn?t needed. A medical assistant called me back and explained to me that her transferred shot records from over a year ago were imputed into their system properly and they thought she had missed those two vaccines. I let her know that I was not informed they were ?catch up? vaccines or I would have questioned before she got them. The medical assistant did apologize and let me know there shouldn?t be any long term damage.  May 5, 2020 Urgent Care called in the evening letting us know that the COVID-19 test was negative. Patient was 90% back to her normal self.
This spontaneous report as received from a male physician who is patient currently refers to a 58 year old male patient. The patient's medical history included whitlow and the current condition are not reported. On 20-AUG-2014 the patient was vaccinated with (oka/merck) VARIVAX. It was reported that a day later on 21-AUG-2014, he developed pain in his fingers. Then, 24 hours after onset of pain on his fingers, he developed vesicles on fingers which the reporter described as whitlow, herpes simplex infection. Also reported that he had experienced whitlow 30 years ago on the same fingers and he found it amazing that whitlow recurred after 30 years on the same spot, 2 days after receiving (oka/merck) VARIVAX (which is same herpes family of virus). Product quality complaint was not involved. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
1.  A little tired 2. Aches all day 3. Aches and flu like feelings, chills   December 21 started symptoms of Covid, positive test came back on Dec 31.  Also, I had a positive sample for Haemophilus Influenza B infection, sick for 3 weeks
first dose in fall of 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19. Previously administered products included Shingrix (received 1st dose of Shingrix in fall of 2021) and Monoclonal antibody infusion (received Monoclonal antibody infusion one after the Shingrix vaccination for Covid-19).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Jun-2022 Reporter's comment: Pharmacist reported that a patient received the first dose of Shingrix in fall of 2021.  In 2021, the patient received a monoclonal antibody infusion the one day after the Shingrix vaccination for COVID-19. The date of the first dose was unknown.  The monoclonal antibody was unknown as well.  The vaccine was administered elsewhere. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Swollen area at injection site. Rash on injection site and above it towards my neck. Low grade fever. Chills. Severe headache. Fatigue. Received shot on Monday and still suffering from listed reaction today Wednesday.