chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose Dec2020, 2nd dose Aug2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2020).   On 22nd August 2022, the patient received the 2nd dose of Shingrix. On 22nd August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 23-AUG-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient had a 2nd Shingrix vaccine one day before reporting.  The patient had no immune problems. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up could not be possible as no contact details were available.
Pt noticed 'hives' on the administration arm approximately 1 inch below injection site to elbow arm felt warm to touch and tender. Pt went to MD, given BENADRYL and told not to get flu shots in future.
(1) Rt arm swollen from below vaccine site all the way to the elbow (2) Lt arm swollen tense about 8 cm x 8 cm
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and PRODUCT DOSE OMISSION ISSUE (did nto receive 2nd dose even after 3 months from the 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). On 05-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did nto receive 2nd dose even after 3 months from the 1st dose). On 05-Mar-2021, PRODUCT DOSE OMISSION ISSUE (did nto receive 2nd dose even after 3 months from the 1st dose) had resolved. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact.
This spontaneous report as received from a Registered Nurse (R.N.) refers to a patient of unknown age and unknown gender. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L048854, Expiration Date: 31-AUG-2017), oral. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt received PNEUMOVAX on 5/29/13. Woke up on 5/31/12 with pain and redness at site (L) deltoid) radiating to under arm. Deltoid region tender to palpation.
Pt recv vax on 11/2/98; on 11/12/98 pt exp rash from head to toe, fever (102) & uncontrollable crying > 2hr
sore at the injection site,  body ache(11am-01am) and fever (100.4 F, 6pm-9pm)
I felt like I had blood clots; because of the buzzing feeling going through my body.; my arm hurt very bad; my tongue swelled up; I was extremely ill; I was suicidal for the first time in my life; 10 days after first shot my arm swelled up; This is a spontaneous report from a contactable consumer (patient reported for herself). A 53-year-old no-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 at 12:00 (at the age of 53-year-old) as single for covid-19 immunisation. The patient medical history included asthma and osteoarthritis. The patient had no known allergies. Concomitant medications included Alprazolam (XANAX) and Fluticasone propionate (FLOVENT), all taken for an unspecified indication, start and stop date were not reported. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. 06May2021 20:00,10 days after first shot, patient arm swelled up and later that night she was suicidal for the first time in her life and had to call for help. She stated that she had photos and video of a magnet sticking to her arm on 27May2021, 03Jun2021 and 17Jun2021. After 17Jun2021, In Jun2021, the patient arm hurt very bad, her tongue swelled up and she was extremely ill. She stated that she would never do it again. She felt like she had blood clots on 17Jun2021 because of the buzzing feeling going through my body. No treatment was received to treat the events. The reporter assessed the event as non serious. It was reported that the events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient was resolved from all the events on an unspecified date in 2021.
Patient was given 2 Hep B vaccines after extern MA double checked doses with trainer MA. Mistake was noticed when they went to document the medication to the patients chart.
Prior to being deployed overseas, I received an Anthrax vaccination. I have had problems in the past with the pneumonia vaccine. I had sudden vomiting and was required to use an inhaler and also developed skin problems. While overseas, I contracted Salmonella, which led to the Reiter's Syndrome in which now I am in the process of a Medical Evaluation Board. I'm currently under Chemotherapy, monitoring and under going a lot of pharmaceutical treatment. While in a discussion of the events with a Major during my part 2 physical, we came to a relative conclusion that the vaccine lowers my immune system, making me susceptible to sickness. And also, the fact that 20 plus soldiers all got sick but I was the only 1 that came out with Salmonella and which lead to Reiter's Syndrome. It's beyond me.  Follow up:  Additional diagnosis noted on discharge summaries:  Dehydration, reactive arthritis, plantar fasciitis.
Mom reports rectal temp of 101.2. She is more fussy than usual, no rash, no site discomfort or redness.
Sore throat, nasal congestion, cough, nausea, vomited x3. Temp 98.9 (tympanic).
mom reports p/pt recv vax devel t104.2;that finally resolved p/12hr of alternating APAP & motrin w/cool baths;MD was contacted but did not exam pt;recv ped DT next dose;
Patient had pain to left arm, back, left side of neck and jaw. She became short of breath and pulse oximetry reading was in the low 80's. Called ED and she was taken via ambulance to local ED.
1 day following vaccinations, pt developed a 16 x 12 cm area of induration, edema and erythema on upper left arm. Pt was prescribed Claritin, cold packs and Bactrim today and will follow up as needed.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer COVID-19 vaccine on 01/05/2021 and 01/26/2021.   The individual became symptomatic for COVID-19 disease on 07/15/2021 with symptoms of fever, cough, and fatigue.   They seen in an emergency department on 07/15/2021 and admitted to hospital on the same day. They were diagnosed with a pulmonary embolism during their hospital stay. They remained hospitalized until their death on 07/24/2021.
pt fussy most of day; started approx 5-6PM up to 104; ? leg from knee up was 3x nl size, beet red & hot; mom called MD 8-9PM; APAP given;
received Covid-19 vaccine IM at 11:50 am on 12/29/20. After a few hours felt a localized chest tightness on the upper sternum area. It was not severe but constant for a few hours. Took Acetaminophen 500mg and seemed to help. Toward the evening had a little cough and sore throat. The next day had chills and felt the same symptoms all day long same as the day before. Acetaminophen seem to help. Not sure what tomorrow will bring but these symptoms were during the first two days. Chest tightness was complaint from a few other co-workers as well.
Patient had shot on 03/08/2021 and had no immediate effects. On 3/16/2021 she noticed some redness, itching, and warm feeling at the injection site. She plans to take tylenol and benadryl as needed until it self resolves or will contact her PCP if it doesn't self resolve.
Vaccine had expiration date of 3/15/22. Patient had no ASE since administration.
6/17/10 Received TDAP-48 hrs later redness swelling to left upper arm (injection site) headache dizziness x 4 days - dizziness.
I had chills and ended up going to the hospital.  I was diagnosed w/ a blood clot in my left lung.  I had covid in December and the doctor attributed it to that.  I was put on blood thinner.
Within 6 hours headache, body ache   By 8 hours chills  Severe persistent headache for about 48 hrs  Vomiting next day   Diarrhea 1.5 days later  Headache was constant
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours), PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2022 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours), PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours) and PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours). No concomitant medication information was provided. Pharmacist reports that they inadvertently administered one dose of the 6 months-5years Moderna vaccine which had been punctured for about 20 hours to a patient on 31-Aug-2022. Number of doses/vials administered 1 dose. The vial was initially stored in the refrigerator on 30-Aug-2022, around 10 or 11am. The vial was first punctured on 30-Aug-2022 at 5:00pm. The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70F. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius which is equal to 46 degree to 77 degree  Fahrenheit ) about 20 hours. No treatment medication were provided.
Was fighting to breathe. Rushed to the ER and was put on a nebulizer.
Last Friday (5 Aug 2022) I took Patient to a Pharmacy local to me for his first dose of the Pfizer COVID-19 vaccine for kids 4 and under. He complained of a tummy ache and threw up in the car about 20 minutes after his shot, so I took him to Urgent Care. The urgent care intake staff triaged him and recommended hydration and monitoring for any other symptoms. He initially had a temp of 99.6F, was able to sip water & a little bit of pedialite and fell asleep for about three hours (continued).
On 9/25/22 Experienced loss of consciousness while out on a hike, and upon regaining consciousness I realized my heart rate was extremely fast and I was struggling to breathe. Called 911, was found to have a resting heart rate of ~300bpm. Was air lifted to hospital. Received cardioversion which successfully restored normal sinus rhythm.  Received an angiogram with clear results. Received echocardiogram showing moderate paravalvular leak and EF of ~30% (EF thought to be a result of cardioversion) Received electrophysiology study which was able to reproduce atrial tachycardia, then received cardiac ablation, reported to be successful in preventing reporduction of atrial tachycardia.  Was released on 9/28/22
A small amount of vaccine appeared to leak out of patient's arm post booster vaccination. The patient received > 1/2 the recommended dose, so patient was not revaccinated per guidelines.
Breathing was fast; very weak; peeing straight blood; Second shot was just a lot tiredness; Feeling body aches; Feeling cold and shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness) and MYALGIA (Feeling body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 dosage form. At the time of the report, TACHYPNOEA (Breathing was fast), ASTHENIA (very weak), HAEMATURIA (peeing straight blood), FATIGUE (Second shot was just a lot tiredness), MYALGIA (Feeling body aches), CHILLS (Feeling cold and shaking) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood test: inconclusive (Inconclusive) Inconclusive. On an unknown date, Body temperature: 103.5 (High) 103.5, 101.5 (High) 101.5 and 101.1 (High) 101.1. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On an unknown date, Heart rate: 115 to 120 (High) 115 to 120. On an unknown date, X-ray: inconclusive (Inconclusive) Inconclusive.         Concomitant medication information was not reported by the reporter.  The patient was put on IV fluids at some point.  The action taken with m-RNA with the events was considered as not applicable.
Rt arm is swollen and red and has some vesicles looking infected. Sent for culture and patient was prescribed clindamycin and bactroban ointment.
Patient had 4-year vaccines on 04/25/2023. Mom reports some redness and swelling to left leg started on Wednesday, April 04/26/2023 evening where patient received Kinrix and MMR. Patients swelling and redness worsened on Thursday, April 27, 2023, after school. Patient is able to ambulate but complains of pain. Afebrile.
The FLUAD (over 65 dose) of flu vaccine was inadvertantly five to patient who is 56 years old.
The patient received an extra dose of Menactra; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11 years old female patient who received an extra dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6690AA  and expiration date: 31-Aug-2021) via intramuscular route in the right deltoid as prophylactic vaccination on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for prophylactic vaccination on an unknown date.  It was an actual medication error case due to extra dose administered.  No adverse event reported at the time of reporting.  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.
1. hives/ break out across shoulders delayed reaction  2.  Burning sensation in spine  (lasting 1 week, now occasionally appears)
The vaccine was administered approx. 2 weeks before it should have been. The last vaccination was given on 5/13/2022 and his next shot should have been 3 months from that date. When the pharmacist (who was not the one who administered the vaccine) realized the situation, he called the patient. the patient was not able to have the conversation with the pharmacist so the pharmacist spoke to his nurse. The nurse reported that the patient was not exhibiting any adverse reactions.
10 months old and is accompanied by the mother. Patient has a rash on his right thigh for one day. Patient was given his shots yesterday and was given Prevnar 13 immunization in the right thigh. The mother states patient started complaining of pain and was fussy last night and this morning the mother states that she saw the swelling and the patient is not moving his leg much.
Initial report was retrieved from a scientific literature on 12 September 2013. This case is linked to case numbers 2012-10777, 2013-09581, 2013-09582, 2013-09584, 2013-09585 and 2013-09603. A pregnant female patient (age range of 25-35 years) had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced seizures. Outcome was not reported. Documents held by sender: None.
Second dose, ~ 15 minutes post vaccine...left the building .  She experienced redness, warmth & weakness.  She was given oral benadryl at her clinic and  administered 0.3mg epi x 1 en route by EMS.
Tiredness; Muscle pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Tiredness"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakiness, and then a tightness in her throat associated with "gagging."
Altered taste - tastes too sweet or tastes too salty, tired she sleeps all the time/She has similar symptoms as when she had Covid 19; Altered taste - tastes too sweet or tastes too salty, tired she sleeps all the time/She has similar symptoms as when she had Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing), notes: she had Covid 19 first week of December.; "Hypertensive" (unspecified if ongoing), notes: About 20 years ago. There were no concomitant medications. Patient had no medical history (including any illness) at time of vaccination. No family history. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. Vaccination history included: Bnt162b2 (Batch/lot number - EP7534 , dose 1, Anatomical location: Left arm), administration date: 24Mar2021, for COVID-19 immunization. It was reported that after the first vaccine there was no problem at all.   The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2021, outcome "not recovered" and all described as "Altered taste - tastes too sweet or tastes too salty, tired she sleeps all the time/She has similar symptoms as when she had Covid 19". It was reported that symptoms were still persisting at the time of the report. This report was not related to a study or program. The events did not result in emergency room and/or physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I tested negative on the 20th but was suffering from a sore throat and body aches. I tested positive for COVID-19 on the 21st. I had a tele-visit w/ my doctor on the 22nd and received PAXLOVID. I took it for 5 days but was still suffering from wheezing. I contacted my doctor again and received an inhaler. I tested negative on 6/30 but still felt sick even till today.  According to my doctor, my lungs are clear. I just have a scratchy throat.
1-18-00 left deltoid red, swollen, tender sl. frim 'diffuse border'; 1-19-08 Rev'd much improved
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was reported. On multiple unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX, lot number L013067, expiration date: 14-APR-2017, lot number L015045, expiration date: 29-APR-2017, lot number reported as K015968, expiration date: 23-SEP-2016 and lot number K010437, expiration date: 22-JUL-2016, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -13.1 degrees Celsius for 40 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.