chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. Concurrent medical conditions included pertussis immunisation. On 18th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th August 2018, 11 days after receiving SHINGRIX, the patient experienced injection site erythema, joint pain, burning hip, fever, feeling hot and injection site swelling. On an unknown date, the outcome of the injection site erythema, joint pain and fever were recovered/resolved and the outcome of the burning hip, feeling hot and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, joint pain, burning hip, fever, feeling hot and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The caller was a nurse from healthcare professional office relaying information on behalf of provider. The caller relayed that the patient received SHINGRIX on left deltoid. The caller relayed that the patient complained of fever (the patient's body temperature was recorded as 103 degrees F), joints aching, joints burning in her knees, elbows, and hips that felt flaming hot. The caller relayed that the patient complained of injection site being red and the size of baseball. The caller relayed that the patient was feeling better on the day of reporting. The caller relayed that the patient stated that the injection site was still red but the swelling, aches, and burning were relieved and the fever subsided. The caller relayed that the patient also stated that she had a similar reaction to TDAP vaccine but is not aware of which product and patient also allergy listed for pertussis vaccine. No further information provided. This is 1 of the 3 linked cases, reported by the same reporter. This case has been linked with US2018GSK161565 (same patient).
DIFFUSE PAPULA RASH ON SHOULDER AND SPREAD OVER BACK WITH PRURITIS. ZERO VESICLES/ULCERS. C/W HEAT RASH AND MILD TAPE DERMATITIS.
Patient contracted COVID after being fully vaccinated 9/12/2021 start of symptoms - shortness of breath, fever, diarrhea, fatigue, cough Admitted to the hospital on 9/16/2021
By the evening of the first day: Severe headache, face pain, neck pain( both muscle and nerve), neck tension, left and right arm pain and tingling, pain and tingling in left leg( mild). Talking hurt my face, smiling hurt my face. Being in any position where my arms hung down at my sides hurt everything above my mid back. Took 200 mg of Gabapentin. This allowed me to sleep.  At noon on Mar 21, starting taking Ibuprofen, 800 mg 3x daily. After most of a week of doing little other than sitting and reading, the pain seemed to subside somewhat.  Sat Mar 27th evening : increase of upper body pain after small amount of light work with arms followed by nausea and vomiting.  Visited Emergency room. Blood tests were taken. The tests were normal. Vomiting subsided after doses mof anti-nausea medication for 24 hours. Nausea has not returned. Started taking 500 mg of Methocarbamol nightly.   Started taking Tylenol 3 x daily on Mar 28 Presently: The pain in my left leg has gone except for the foot pain that I have lived with for 2 years. The left leg tingles mildly once in a while.  All other pain is nearly the same. I am unable to do much more than type or sit and read. If I look down to do a task, after a few minutes, I get a sharp nerve pain in my face, head, and neck. The skin on the back of my neck has been mildly numb for several days.
Fainting & abnormal EKG at time of vaccination. Day after- low grade fever & pain at site of injection
Several weeks after the vaccine on 3/27 I started experiencing cold symptoms, lost my sense of smell and taste and developed a cough so I reached out to my PCP who advised I take a COVID test and on 3/30 I tested positive for COVID-19 via the rapid test.
On 6-20-9, child complained of rt cheek/jaw hurting, small amt. of swelling below rt ear/jaw. Called CDC to see if mumps was a possibility - CDC confirmed incubation period up to 25 days for mumps. 6-21-9, swelling & pain progressed. On 6-22-9, rt side swelled horribly with pain. Took to Drs. at 830AM, Dr confirmed mumps with exam and quarantined my son for 1 week - we live in a community. By 6-24-9, my son was much better - no visual signs of illness on 6-25-9.
PT STATED SHE WAS VERY HOT, STARTED SHAKING, HAD CHEST PAIN WHEN BREATHING. WE GAVE PT WATER AND COLD PACK AND OBSERVED FOR 30 MINUTES AT WHICH TIME THE PATIENT SAID SHE FELT SHE NEEDED TO GO TO THE ER. PARAMEDICS WERE CALLED AND EKG/BLOOD PRESSURE TAKEN. PARAMEDICS ADVISED PT TO BE EVALUATED AT HOSPITAL.
The patient states that two days after receiving the vaccine she started having diarrhea and that this has continued off and on since then. She states cramping above her waist.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a non-health professional (office staff). This case is linked to cases 2019SA071131, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155, 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE (prefilled syringes) lot UJ043AB (expiry date: 22-May-2019) via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date (during the 2018 - 2019 Flu Season) given during Well Child Check Ups or Vaccine visits. The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided. It was an actual medication error case due to wrong vaccine administered, inappropriate age of vaccine administration and overdose. No side effects had been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On 2/8/2023, I began to feel very tired and have muscle aches. The symptoms worsened throughout the day, so I decided to go to the doctor on 2/9/2023. I underwent a PCR test and got a positive result. The doctor prescribed me Paxlovid, which I began taking that afternoon. I began to feel better pretty quickly. I isolated for either ten days or two weeks. I never developed any other symptoms besides the muscle aches and fatigue, and I had those only maybe two or three days. After I recovered, I felt fine and didn't have any residual symptoms. In fact, after the first two or three days, I felt well enough to go outside and walk for exercise.
TINGLING OF THE TONGUE APPROX 5 MIN AFTER VACCINE WAS ADMINISTERED.
0.5 mL booster instead of 0.25 mL; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (0.5 mL booster instead of 0.25 mL) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 047B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Jul-2022. On 28-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (0.5 mL booster instead of 0.25 mL) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 28-Feb-2022, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (0.5 mL booster instead of 0.25 mL) outcome was unknown.            No treatment information provided No concomitant medication information provided
Patient had Fluarix Influenza vaccine on 10/17/2022.  On patient's office visit 3/22/2023, patient requested his flu vaccine and a Fluarix vaccine was administered.  No adverse effects observed and patient denied any adverse reactions.
pt recv vax 10JAN97 & devel a rash on arms & legs;pt was treated w/DPH;
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 12:11 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 28-Oct-2021 at 12:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-Oct-2021 at 12:11 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.  The vaccine facility placed the vaccines into the freezer the same day they were delivered. They only removed a vial from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
Client received vaccine in school Tdap clinic.  He complained of feeling nauseated and was noted to have pale lips 30 min after receiving vaccine.  Client was sent home; he returned to school the following day without any complaints of discomfort.
Information has been received from a nurse practitioner (N.P.) concerning a 0 day old baby who was conceived to a 31 year old female with sulfonamide allergy and no medical history who on 14-SEP-2010, was vaccinated intramuscularly the first 0.5 mL dose of GARDASIL (663561/1498Y) in her left arm. Concomitant therapy included vitamins. It was reported that on unknown date, the mother performed the follow lab diagnostics: ultrasound normal (USN); positive fetal heart rate (+FHR); single intrauterine pregnancy (SIUP); size less than dates by LMP. At the time of the report, the outcome was unknown. It was unknown if the patient sought an medical attention. The mother's experience was previously reported in WAES 1009USA03286. Additional information has been requested.
Experiencing hypoxemia; A spontaneous report  was received from a consumer concerning a 78-year-old male patient who received  Moderna's Covid-19 vaccine (mRNA1273) and experienced hypoxemia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned dose of mRNA-1273 (Lot: 031L20A) intramuscularly on 02-FEB-2021 for prophylaxis of Covid-19 infection.  On an unknown date, the patient experienced hypoxemia. The blood oxygen level of the patient went between 80-90% for a short time and then would recover. The patient reported "it was getting a little tiring." At the time of this report, the patient was still experiencing symptoms. The patient had not taken any treatment for the events.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, hypoxemia, was considered not resolved.; Reporter's Comments: This case concerns a 78 year old male patient, who was on hospice care experienced a fatal event of death, 4 to 5 days after receiving second dose of mRNA- 1273 (Lot# 031L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
Patient was very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient was very sleepy) in a 74-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced SOMNOLENCE (Patient was very sleepy). At the time of the report, SOMNOLENCE (Patient was very sleepy) outcome was unknown.            No Concomitant and  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable. .   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: TCR: nonsafety info
Patient had syncopal event 3-5 minutes following administration of the HPV vaccine. He was standing at the time. Mom reports he began to look pale, and he fell on his face. He appeared to stiffen. In the floor. When I examined him, he was noted to be pale. He was sitting up in a chair. There was a superficial mucosal laceration to lower lip and an abrasion to mucosa of top lip. He responded to questions appropriately. His vitals were stable. Several minutes later, he became pale again and vomited several times. HR was in the 40?s prior to vomiting, but rebounded after the episode. He recovered after 30 minutes and tolerated a pedialyte popsicle.  He was observed in clinic for around 1 hour following syncopal event.
Mild generalized, erythematous rash noted on patient's abdomen and back. The rash is pruritus.
Day of injection  & day after swelling and fever below injection site.  03/31/2021 swelling and fever came back into arm below injection site; approximately 1" x 1.5"
mother of Patient brought Patient on 09/21/2020 stating Patient had vomiting and seizure at 9:30pm, 09/18/2020. Seizure lasted about  1 1/2 minute.
Approximately 10 minutes after vaccination patient complained of substernal chest pain.  No associated symptoms.  No anaphylactic symptoms.  Usually takes sublingual nitro but did not bring to vaccination site.
Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; Jynneos had a temperature excursion; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-002028 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communication (reference number: USBAV22-1123) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 18-Aug-2022, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) had a temperature excursion (explicitly coded as 'product storage error').  On the same date, the patient was vaccinated with the affected Jynneos vaccine (batch number: FDP00003), at dose reported as 0.1 mL, administered intradermally (explicitly coded as 'underdose', 'inappropriate route of vaccination' and 'product administration error'), for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 23-Aug-2022 included the local BN case ID.  The case is linked to cases US-BN-2022-002030, US-BN-2022-002045, US-BN-2022-002046, US-BN-2022-002047, US-BN-2022-002048 and US-BN-2022-002049, concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, inappropriate route of vaccination, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
This spontaneous report as received from a nurse refers to an unspecified gender patient of unknown age. On 19-APR-2012, the patient was vaccinated with the first dose of GARDASIL, (lot#, indication and anatomical location not reported), 0.5ml, intramuscular. On 26-JUL-2013, the patient was vaccinated with the second dose of GARDASIL, (lot#, dose, strength, indication and anatomical location not reported). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
very swollen; very red; felt a lot of sleepiness; a lot of itching; red mark around; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (very swollen), ERYTHEMA (very red), SOMNOLENCE (felt a lot of sleepiness), PRURITUS (a lot of itching) and ERYTHEMA (red mark around) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (NO MEDICAL HSTORY REPORTED).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (very swollen), ERYTHEMA (very red), SOMNOLENCE (felt a lot of sleepiness), PRURITUS (a lot of itching) and ERYTHEMA (red mark around). At the time of the report, SWELLING (very swollen), ERYTHEMA (very red), SOMNOLENCE (felt a lot of sleepiness), PRURITUS (a lot of itching) and ERYTHEMA (red mark around) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
ON the site of the flu shot there is a 5cm areA of macular erythema with multiple  confluent vesicles . Across the mid chest large patches of macular erythem with  vesicle.
patient's wife reports when patient got home, he had fever, chills that his teeth were clattering, nausea, and high bloog glucose.  they called 911 and paramedics came and checked his blood pressure.
Date and Time of Arrival: 01-Dec-2021 16:00   Diagnosis:  COVID/hypoxia   Mode of Arrival: Wheelchair   Admitted From: ER   Patient is being discharged from HOSPITAL Unit today DEC 02, 2021.
Pt reported difficulty breathing - extreme, heart beat racing - extremely fast, severe rash, weak, shakening - bad, still having difficulty breathing - tired, 2/13/01.
I was sick for three months now, very ill from the Pfizer shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was sick for three months now, very ill from the Pfizer shot".  Additional information: The patient stated to have already sent a report from a terrible reaction patient had with the shot (Unspecified shot) what patient want the copy of the report that patient sent him in case they remain the booster for patient who don't want to get the booster. So patient wrote a big report to you guys till everything out nobody did following up with me. Well patient like the copy of what patient sent."  When probed to confirm the product as COVID-19 Booster, patient stated, "I don't want the booster. I didn't get the booster. I got the Pfizer shot (Unspecified shot). Yes, Pfizer." Consumer was informed about role Pfizer Drug Safety. Consumer stated, "Ma'am, this language is very hard for me to understand. You have to spoke slower I only talk somebody for another country and I don't understand when they talk. Could you please start over again what you are saying slowly?" Patient was again informed role of Pfizer Drug Safety and informed to contact the facility, patient stated, "I need to talk what? I don't want to talk anyone ma'am. I want the copy of the report what I sent to Pfizer mailed to me. I should made a copy. I already told all the reactions I had to the shot. I was sick for three months now, very ill from the Pfizer shot. I sent Pfizer a big report. I required to mail me the copy of the report I have sent." Patient stated, "I don't have my card handy. Wait a minute, Let me check. No, I feel I have handy but I don't. I don't have that handy." Further probing could not be done as consumer was unwilling to complete the report and hung up the call abruptly. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Overall feeling unwell, self-treated with ibuprofen for muscle aches and Benadryl for sleep aid due to insomnia from feeling sick
Swollen injection site area 8 days after the injection. Red, slight pain, slight itch, bigger in size each day.
Phone call from family at 2/18/11 at 4:25 pm reporting that child had started with fever (102 degrees) (highest) on Wed. 2/16/11. Also had rash and had vomited x 1. Instructed to take child to urgent care or ER. Spoke with family on 2/22/11. Child not taken to doctor & fully recovered.
Fever (100 F).  Tachycardia. Heart rate measured at around 110 beats/minute for 10 hours after onset of fever.  Both fever and tachycardia subsided after two days.
pt vaxed 10JAN94 & 21JAN94 c/o h/a;next morning told wife feet tingling, speech slurred,brain stem infarct;3AM on Sunday morning awoke in severe pain & asked to go to ER;exp high BP, & rapid HR;dx bells palsy;GBS,muscle weakness;resp arrest
warm to the touch (no fever), rosy cheeks, body aches and felt like scalp was itching for about an hour