chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congestion/Congestion nasal; Sinusitis; Sore throat; Coughing; Sneezing; This is a spontaneous report from a contactable pharmacist. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0171; expiry date: Aug2021), via an unspecified route of administration, administered at the right deltoid on 17May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included allergy and amoxycillin allergy, both from an unknown date and unknown if ongoing. He has allergies, the only medicine that allergy was reported for is amoxycillin and for his other allergies he takes antihistamine everyday (further details unknown). Concomitant medications included cetirizine and cetirizine hydrochloride (ZYRTEC), both taken for an unspecified indication, start and stop date were not reported. The patient experienced congestion, sinusitis, sore throat, coughing and sneezing on an unspecified date in May2021. It was reported that the patient was administered a BioNTech Covid Pfizer vaccine on 17May2021 and the patient's mom said about 36 hours later, the patient developed some congestion and build sinusitis, sore throat, coughing and sneezing and they went to the doctor and doctor was not blaming of the vaccine, they gave the patient like methylprednisolone some kind of steroid antibiotic albuterol (clarified as treatment), if it has been reported or it was not related to the vaccine. The mom told that the doctor gave him antibiotic, inhaler and steroids. When asked about causality, the pharmacist stated, they don't know that's why they were calling you to see if we can see if we have report like that. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Rash began Saturday 3/8/03 am on face continued to worsen on Sunday 3/9/03 and Monday 3/10/03-covering entire body with majority on arms, legs and face. Temp from 3/8 through 3/9 ranged from 100.7 to 101.5. Saw MD on Monday AM who felt it was an adverse reaction to vaccine and told her to call H-taking Benadryl now per MD. Also reports hands swollen.
Wife called to report the left upper arm of husband had red spots the night after the vaccine. No rash, hives, or anaphylaxis was reported.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-JAN-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius)for 1584 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Shot was at 11am 6/25/22, and nothing noted at bed time, but by 8am a large red hive was noticed on his chest.  It was a light read with splotchy edges.  It extended over the sternum and over to the right nipple.  My son did not report any pain, ache or pain.  He had no fever and no other symptoms.  The red intensity increased over the day but began to diminish by evening. It was nearly 100% gone 24 hours later.
This spontaneous report was received from a physician via company representative and refers to a 15 year old female patient. The patient had a history of anxiety and did experience three fainting episodes for reason unspecified in the past. The patient drug reactions and allergies and concomitant therapy were not reported. On 24-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 for herpesvirus (HPV) prevention (dose, units, route of administration, lot # and expiration date were not reported) without incident. On the subsequent visit on 13-MAR-2018, the patient was vaccinated with the second dose of GARDASIL 9 for HPV prevention (dose, units, route of administration, lot # and expiration date were not reported). On the same day, the patient experienced vasospasm syncope with convulsion. An emergency medical technician (EMT) was called to the office and the patient was taken to an Emergency Room. An urine test was performed, but the results were not available. The patient was treated with "rest and fluid hydration" and was recommended to follow up with a cardiologist. The physician reported that GARDASIL 9 would be discontinued and the patient would not receive the third dose. It was unknown by representative if the patient was admitted to the hospital once she was in the Emergency Room. On an unknown date in 2018, the patient recovered from vasospasm syncope with convulsion. The relatedness between vasospasm syncope with convulsion and GARDASIL 9 was not reported. The event of convulsion was considered by the physician to be life threatening. Upon internal review, the event of convulsion was determined to be medically significant.
Came to office for Hives.  No work of breathing.  Had COVID vaccine 1 week prior.  Could be vaccine, environmental allergy or viral rash
accine administration staff did not follow Moderna vaccine instructions for handling leftover vaccine doses. Specifically, Moderna handling instructions state that vaccines should be used within 6 hours of the first puncture or be discarded after 6 hours. We administered this patient Moderna dose that was from punctured of longer than 6 hours. Of note, although the vials have been out of the fridge past 6 hours, they were stored in the fridge at the recommended storage temperature of 2-8 degrees Celsius.
Pain; sick; feel pain in the site of injection; Very tired; Headache; feeling pain on his body; injected the 1st dose on the wrong place where it was all the way up of his shoulder; not able to sleep due to pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INSOMNIA (not able to sleep due to pain), ILLNESS (sick), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) and VACCINATION SITE PAIN (feel pain in the site of injection) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced INSOMNIA (not able to sleep due to pain), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) and MYALGIA (feeling pain on his body). On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (feel pain in the site of injection), FATIGUE (Very tired) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Pain) and ILLNESS (sick). On 08-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) had resolved. At the time of the report, PAIN (Pain), INSOMNIA (not able to sleep due to pain), ILLNESS (sick), VACCINATION SITE PAIN (feel pain in the site of injection), FATIGUE (Very tired), HEADACHE (Headache) and MYALGIA (feeling pain on his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Myalgia, Insomnia and Incorrect route of product administration events added.
pain at the injection site; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.   It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2023 The doctor mentioned that the patient had significant pain at the injection site following a dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
I was 7 weeks pregnant when I received the flu combo vaccine on approximately 10/13/2010 or 10/14/2010. One week later on 10/21/10, I started bleeding and cramping, vaginal ultrasound the next morning showed a fetus dating just under 7 weeks (when I received the vaccine) and a heartrate of only 98. Within the next hour I miscarried the baby!
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: The reporter called to report an expired dose of Havrix was administered to a patient. The lot number for the vaccine was asked but declined. The reporter consented to follow up via email. Additional Supportive Information: The reporter called to report an expired dose of Havrix was administered to a patient, which led to expired vaccine used.
pins and needles sensation of tingling in her hands and feet; allergic reaction/rash on arm that went up to her chest and face; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 26Apr2021 (Lot number: EW0164, Expiration Date: Aug2021) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st single dose; Lot number: ER8732, expiration date: Jul2021), administration date: 05Apr2021, when the patient was 22 years old, for Covid-19 immunization, reaction: "didn't have anything from the first one". The following information was reported: RASH (medically significant) with onset 26Apr2021, outcome "recovered", described as "allergic reaction/rash on arm that went up to her chest and face"; PARAESTHESIA (medically significant) with onset 27Apr2021, outcome "unknown", described as "pins and needles sensation of tingling in her hands and feet". The events "allergic reaction/rash on arm that went up to her chest and face" and "pins and needles sensation of tingling in her hands and feet" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: unknown results. Therapeutic measures were taken as a result of rash, paraesthesia. Clinical course: Patient had what she stated her allergist stated was likely an allergic reaction after receiving 2nd vaccination. Ten minutes after receipt of vaccine, patient had rash on arm that went up to her chest and face; this was treated with diphenhydramine hydrochloride (BENADRYL) and a steroid injection and resolved. On 27Apr2021 the patient awoke with pins and needles sensation of tingling in her hands and feet. Patient got a dose of BENADRYL in urgent care and then had a steroid injection, she didn't know what steroid it was in urgent care as well then in ER in the next day she thought they gave a dose of magnesium and did some blood work. Patient didn't have the allergic reaction to the first one, and just confused because she didn't have anything from the first one but with the second one she did and ended up in ER next day so it might be an inactive ingredient that have something to do.  Follow-up attempts are completed. No further information is expected.
Rash of itchy, small bumps across the back of my neck, ears, shoulders and scalp.  I have started taking Benadryl to soothe the itch.
chest tightness; systemic itching; This is a spontaneous report from a contactable other health care professional (Nurse). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient's relevant medical history included anaphylactic response to vinegar from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, after getting the first dose of the bnt162b2 vaccine, the patient had developed chest tightness and systemic itching 30 minutes after. Therapeutic measures were taken which was given herself with Benadryl and Albuterol for her reactions experienced. Patient wanted to know if the Pfizer COVID-19 vaccine has vinegar components in it. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was admitted for hypoxia and shortness of breath due to COVID-19.  He is a HCF resident.
Initial report received on 02 August 2011 from a company representative who had received the original information from a physician. This is a cluster of two 13-year-old twin patients (dates of birth and genders not identified) with the same reporter, same vaccine (ADACEL), same lot number (C2888AA) and same event of suspected pertussis. This case represents one of the 13-year-old twins. Information regarding the other twin is captured in case number 2011-06235. A 13-year-old patient, who has a twin sibling, was vaccinations at age 11 in November 2008 with a dose of ADACEL (lot number C2888AA) and subsequently was found to have a suspected case of pertussis. The patient had been coughing and showing URI (upper respiratory symptoms) for a very long time (onset date not reported) and her physician treated her for suspected pertussis, but never performed any lab testing to confirm the diagnosis. Treatments received were not reported. The physician eventually referred the patient to a pulmonologist who agreed with the diagnosis of pertussis, but who also did not test for pertussis since a prolonged period of time had elapsed. It was not reported whether the patient recovered. Documents held by sender: None.
Information has been received from a physician concerning a 14 year old female patient who on 22-MAY-1997 was vaccinated with the first dose of MMR II.  On 17-JUL-2001 the patient was vaccinated with the second dose of MMR II.  There was no lot number reported.  On 03-JAN-2010 the patient experienced mumps.  The patient was diagnosed on 23-NOV-2009.  The patient was afebrile and had parotitis on both sides.  On 23-NOV-2009, the patient's IgM <1:10, IgG was 6.55 and the serum amylase was 255.  Follow-up information was received which reported that the patient was diagnosed on 03-JAN-2010 (previously reported as 23-NOV-2009.  This is one of several reports from the same source.  Additional information is not expected.
Blood Clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE (LOT NUMBER: 3246)), administration date: 10Jan2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "Blood Clots"; BNT162b2 (DOSE 1, SINGLE (Lot Number: 1141)), administration date: 21Dec2020, when the patient was 69-year-old, for Covid-19 Immunization.  The following information was reported: THROMBOSIS (hospitalization, life threatening), outcome "unknown", described as "Blood Clots". The patient was hospitalized for thrombosis (hospitalization duration: 3 day(s)). The event "blood clots" required physician office visit and emergency room visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101244668 Same patient and drug, event separated in time;
The day after getting my vaccine, I had what I would think is a typical reaction. I had a fever and was tired and slept basically all day. The next day, I was feeling better. I was a little bit tired, but I expected that. On 11/10/2022 though, I started to feel a bunch of cold sores developing in the crease of the left side of my mouth and as the day went on it just began to spread all over my mouth. I've had the occasional cold sore, but this was just an intense number of cold sores. That night, my gums were feeling swollen and my lymph nodes around my jaw were swollen. That night, I woke up to feed my baby and it was difficult to sleep after because there were sores all over and in my mouth. The next day, I went to an urgent care to see if they could tell what was going on or if I could get on a medication. As soon as they saw what was happening, they were also surprised and prescribed me an antiviral. I have been on the medication ever since then. I have been able to take care of my kids, but it has been difficult because I have still been experiencing some fatigue. It has been difficult to eat due to the pain. They also prescribed me something to help with that but yesterday, it was painful to even drink water. Today, I'm feeling a bit better, but the whole experience has left me anxious. Although, I am still a proponent of vaccines.
Child began coughing after leaving office.  Became nauseous & arm became red.  Mom brought back to office.  Pulse ox 92%, pt wheezing.  Urticaria shoulder to elbow on L.  Given 30mg PRELONE, 25mg BENADRYL, & 0.5ml albuterol per MD.
Within 12 hours of receiving GARDASIL # 1 pt. describes : headache, lightheaded, lasting for 24 hrs. Swollen lymph nodes both sides for 3 days. Fever of 101.5 for 5 days. Both arms from shoulders to elbows a rash "pores were red and open". Rash lasted 24 hrs. No urticaria. No other s/sx described.
Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported had received an intramuscular, right arm injection of Daptacel, lot number number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report the patient had recovered from the event. The reporter in this case is the same as for 2006-00694, 2006-00695, 2006-00696, 2006-00697, 2006-00693, 2006-00699, and 2006-00700.
Approximately 3? round, red, slightly raised, warm and very itchy area at injection site that appeared approx 2 days after 2nd injection and lasted approx 3 days
Pain at injection within hours of administration. 15 min minor (L) chest pain, about 24 hrs after shot. Itching rash (L) elbow 3/19. Rash noted (R) elbow and hand 3/20. Pustular lesions noted extensor (B) elbows and dorsal (R) hand. No SOB/Fever/chills/sweats/cough/headache.
This spontaneous report was received from an approximately 46 year old male patient concerning himself. Pertinent medical history included: high blood pressure, kidney transplant. Drug reactions/allergies includes shellfish. On 14-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 0.5ml/one dose, intramuscular (lot # K008409; 04-MAR-2016). Concomitant therapies included unspecified HIP B vaccine and unspecified blood pressure medication. On 15-JUN-2015, the patient experienced his arm swelling up, stated that it felt like a loose bag of water, and was warm to the touch after receiving PNEUMOVAX 23. Lab diagnostics studies included unspecified blood work (details unknown). No treatment given for the events. The outcome of skin warm and swelling arm was reported as not resolved. Causality assessment was not reported. Additional information has been requested.
Patient presents to the emergency department less than 20 minutes after getting her first COVID-19 vaccine, feels like there is a tickle in her throat, patient has some blotchy erythema on the front of her neck and chest. Patient very hypertensive on arrival here to the ED.    Patient was given IM epi 300 mcg, was also given Solu-Medrol 125 mg IV, Pepcid 20 mg IV, and Benadryl 50 mg IV. Patient reexamined at 9:45 AM, states that symptoms are better. Blood pressure actually has improved down to 172/91. She no longer has the erythema edema on the front of her neck and chest, feels as though symptoms are improving.   We will continue to observe patient here for the next 2 hours after epi.  Pt. asymptomatic by 1230.  Discharged to home and advised to not get the second COVID-19 vaccine shot in three weeks.
Husband had the 2 dose Vaccine 4 yrs ago and is suffering with shingles/ Suspected vaccination failure; Shingles on his face, head, and eyelid; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: This case was reported by patient's wife via interactive digital media. The patient received 2 doses of Shingles vaccine 4 years ago from reporting and was experiencing shingles on his face, head and eyelid. The reporter questioned about the vaccine being good for 10 years. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up was not possible as no contact details were available.
redness, itching at injection site for two weeks. Felt ill the first 3 days
Administration Error: ?         Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. ?         1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. ?         This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml. ?         The dose given out of this vial was 0.3 ml. ?         The children (age 5-11) received 0.3ml x 41.9 mcg/ml = 12.6 mcg.