chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an expired Ipol was given to patient with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid non-serious case received from health professional (Medical assistant). (GMI number: 01233715)  This case involves a 15-year-old female patient who experienced an expired IPV (VERO) [IPOL] was given to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Aug-2022, the patient received 1st Dose of suspect IPOL at dose 0.5 ml once via intramuscular route in the right arm (Lot: T1D482M, Expiration Date: 25-JUL-2022) for Immunization (expired product administered) at latency same day. No adverse event was reported. It was the first-time product was used. Patient was no more using the product.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Administered an expired vaccine. The expiration date on the vaccine was dated 06/09/2022. Pt had no sxs after injection.
72 YOF pt with C/O erythematous and edematous wheal lesion of left upper arm at injection site after FLUZONE HIGH DOSE and PNEUMOVAX 23 vaccines were given on 10-25-18 at a pharmacy. Pt has had the symptoms x 4 days. Pt also has a C/O erythematous vesicular lesions on lower lip since this morning. No distress observed. PE unremarkable except as noted. Pt treated with valacyclovir for H/O herpes labialis and provided with topical steroid cream to apply on wheal site. I recommended re-assessment by PCP within the next 24 hrs and ER recommendations given. Pt verbalized understanding. Pt declined referral to PCP.
Severe diarrhea, abdominal cramps, weakness, weight loss, dizziness,occasional nausea/vomiting
I wake up with a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received Shingrix. On 14th December 2020, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On Saturday, the patient received Shingrix and on the day of reporting the patient woke up with a rash.
Very mild sore throat and sinus drainage initially on day 1. Day 2 - Sinus and sore throat, fatigue. Day 3 - Body aches, headache, severe nausea, stomach pains. Day 4: mild body aches, nausea, severe stomach pains, mild diarrhea.
Patient came to our pharmacy complaining of a swollen arm. She showed me her left arm and it was swollen with a red center and a light red surrounding.
TD vaccine was administered on the 11th of March 2013. She started having redness and swelling of the (Rt) arm by Tuesday the 12th of March 2013. Ran a low grade fever x1 day up to 100.8 (F).
approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sensation in my head, fullness in the ears, ringing associated with nausea, the following day it was worse, upon waking and walking my legs felt rubbery which spontaneously resolved after briefly walking, the nausea, supratentorial symptoms, fullness in the ears persisted, no vomiting, today is the 4th day post injection without improvement. Injection site pain lasted 2 days-not bothersome.  Consider my symptoms moderate and interfering with daily activities.
Skin: left leg thigh upper area red, flat, 5"X3" lesion, minimal pain upon palpation. Treatment continue allergy medications, and KEFLEX x 10 days. Per mom - flu shot given at site on 9/21/10.
No patients experienced symptoms; improperly stored doses administered; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9.4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005638: US-009507513-2006USA005637: US-009507513-2006USA005639: US-009507513-2006USA005635: US-009507513-2006USA005595:
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 18-FEB-2022) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Age at time of vaccination 30 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Headaches in the middle of the night; Muscle aches; Slight fever; Injections site sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches in the middle of the night), MYALGIA (Muscle aches), PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injections site sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Muscle aches), PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injections site sore). On 13-Feb-2021, the patient experienced HEADACHE (Headaches in the middle of the night). At the time of the report, HEADACHE (Headaches in the middle of the night), MYALGIA (Muscle aches), PYREXIA (Slight fever) and VACCINATION SITE PAIN (Injections site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included acetaminophen 250mg/ aspirin 250mg/ caffeine 65mg
APPROX 0700 ON 4 MAY 2004 MEMBER HAD BILATERAL BURNING AND ITCHING SENSATION FROM BICEP DOWN TO TIPS OF FINGERS.  MEMBER SPOKE WITH FLIGHT SURGEON, AND WAS TOLD CONTINUE TO MONITOR.  IF CONDITION WORSENS SEEK MEDICAL ATTENTION.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-APR-2016, the patient was vaccinated with VAQTA, lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
After being vaccinated with 0.5ml of influenza patient reactions were described as, swelling and redness at the injection site.
Hives on thighs, extending to lower extremities and lower torso. Treated with Benadryl.
Information has been received from a nurse concerning a female who on 30-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The nurse stated that the patient received a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse symptoms were reported. It was unknown whether medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I broke out in very itchy rash all over my body - shin, area between my pelvic area and navel, knees, scalp and upper arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I broke out in very itchy rash all over my body - shin, area between my pelvic area and navel, knees, scalp and upper arms". Additional information: The patient reported After I received a second Pfizer shot in Jun, I broke out in very itchy rash all over my body -shin, area between my pelvic area and navel, knees, scalp and upper arms. The most severe rash appeared on my right shin in Jul. To this day, 07Feb2022, I am still dealing with most of these rashes even though I apply steroid prescribed by my doctor.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This case was reported by a physician via sales rep and described the occurrence of chronic cough in a child male patient who received KINRIX. Co-suspect products included Varicella vaccine, FLUZONE, Albuterol nebulizer solution for drug use for unknown indication. On an unknown date, the patient received KINRIX at an unknown dose, Varicella Vaccine at an unknown dose, FLUZONE at an unknown dose and Albuterol (nebulizer) at an unknown dose and frequency. On an unknown date, several minutes  after receiving KINRIX and not applicable after starting Albuterol, the patient experienced chronic cough, hives, swelling of eyelid and lip swelling. The action taken with Albuterol was unknown. On an unknown date, the outcome of the chronic cough, hives, swelling of eyelid and lip swelling were unknown. The reporter considered the chronic cough and hives to be possibly related to KINRIX. The reporter considered the swelling of eyelid and lip swelling to possibly related to Albuterol. Additional details were provided as follows: The age at vaccination was not reported. The patient received KINRIX, MMR, Varicella and FLUZONE vaccines, several minutes after receiving vaccines, the patient experienced chronic cough and hives. The healthcare professional administered Albuterol by nebulizer and after that the patient's eye lids and lips began to swell. Then ambulance was called and patient was taken to the emergency room. No further information was known about the patient's condition. The sales representative had limited information. No product lot or expiry dates were provided. The healthcare professional wanted to be contacted about these adverse events by the safety department. The reporter considered the chronic cough and hives to be possible related to MMR, Varicella and FLUZONE vaccines as well.
During a flu vaccine clinic for employees at facility, this employee was inadvertently given expired influenza vaccine.  The vaccine administered was for the 2021-2022 season and expired on 6/30/2022.  The employee was made aware of the this mistake, did not present with any adverse clinical reaction, and will be administered the influenza vaccine for the 2022-2023 season as soon as clinically appropriate.
States developed fine itchy rash - generalized on 03/05/2006.  Was taking Benadryl when presented on 03/08/2006.  Given prescription for Zyrtec as needed.  Still has rash.
PT received Dtap #5 on 5-3-07.Came back to clinic 5-5-07 c/o redness, swelling and pain at injection site - L deltoid.
Patient received vaccine that may not be fully effective due to room temperature storage for more than 12 hours
Tightening in jaw and throat. Went to ER. Pain in right arm, chest and back, dizziness.
Information has been received from a published literature article. Rotavirus remains the leading cause of severe diarrhea in children under 5 years worldwide. ROTARIX (RV1) an ROTATEQ (RV5) have been associated with reductions in and severity of rotavirus disease. Studies have evaluated the impact of RV1 or RV5 but little is known about the impact of incomplete or mixed vaccination upon vaccine effectiveness. This is a case control study to examine association of combined RV1 and RV5 and rotavirus acute gastroenteritis, factoring severity of diarrheal disease. Children born after March 1, 2009 with acute gastroenteritis from three hospitals were approached for enrollment. Survey was administered, stool specimen was collected, and vaccination records were obtained. 89 of 1127 children with acute gastroenteritis were enrolled. Stool specimens were collected from 708 for rotavirus testing; 215 stool samples tested positively for rotavirus. Among the 215 patients, 7 patients received complete mixed dose of rotavirus vaccination, which was defined as receiving one dose of RV1 and two doses of RV5 by 8 months 0 days or one dose of RV1 and one dose of RV5 before 8 months of 0 days of age; 5 patients received incomplete mixed dose of rotavirus vaccination, which was defined as receiving only one dose of RV5 and one dose of RV1 after 8 months 0 days of age. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age referring on herself. On an unspecified date, approximately in 2009 (about 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot/batch number, expiration date, dose not reported). On approximately 07-MAY-2014 (beginning about 5 weeks ago), the patient developed shingles. The outcome of shingles at the time of the report was considered as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a child who experienced rash. The patient received a dose Prevnar, Pediarix and Hepatitis B vaccines (date not specified). Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect vaccines included Pediarix (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/hepatitis B vaccine). The reporter noted that that the rash was possibly  from vitamins or cereal not vaccines started at the time of vaccination. Concomitant medications were not reported. The patient experienced a rash two 2 days post vaccination (date not provided). The reporter stated that the child also started cereal and vitamins at the time of vaccination and that the rash is possibly from vitamins or cereal not vaccines. The mother reported to the pediatrician that her child is doing fine (recovery date unknown). Information regarding this event has been forwarded to the manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
No Adverse Event; administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in a 14-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: HPV, Tdap and Meningococci. Past adverse reactions to the above products included No adverse event with HPV, Meningococci and Tdap. Concurrent medical conditions included Penicillin allergy (Taking medicine for allergies: Penicillin, Sulfamethoxazole Trimethoprim), Drug allergy (Taking medicine for allergies: Penicillin, Sulfamethoxazole Trimethoprim) and Drug allergy (Taking medicine for allergies: Penicillin, Sulfamethoxazole Trimethoprim).    On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with 1 dose of Moderna COVID-19 Vaccine Bivalent on 19Jan2023 after 20 hours post puncture).    No concomitant medications were reported. Other historical vaccine included Flu. It was reported that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No COVID-19 diagnosis reported. No treatment information was reported.
Nine days after receiving the vaccine, my vaccine site on my arm started itching really bad, and when I went to scratch it, I felt a very large (~size of a tennis ball) bump on my arm that was also very hard and very red. Initially, I thought it must be a spider bite, though I haven?t noticed any spiders in my home, and I simply watched it for any sign of infection (which never happened). The next day I also noticed an unusually high degree of fatigue which limited my ability to do much of anything for three days, thus far! Throughout the day and night, without warning, my eyes become really heavy, and I feel like I?m going to immediately drop off to sleep. My eyes also begin to burn, and when I close them I simply fall asleep for about a half hour. This has been happening off and on all day for three days, so far. I have no idea if there?s any connection to the vaccine or to the sudden appearance of a hard, big, red, itchy bump at the vaccination site on my left arm.
Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009868: US-009507513-1707USA009866: US-009507513-1707USA009867: US-009507513-1707USA005581: US-009507513-1707USA009865.
pulmonary embolism; shortness of breath; dizziness; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Feb2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation; and apixaban (ELIQUIS), via an unspecified route of administration from Feb2021 (batch/lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization. On Feb2021, three weeks following the patient's TK (unspecified), patient experienced shortness of breath, dizziness (notable with exertion), and pulmonary embolism. The patient underwent lab test and procedure which included body mass index: 42.19 on Feb2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, the reported pulmonary embolism is likely an intercurrent medical condition in this 76 year old female patient and unrelated to BNT162B2. Of note, medical history and indication for apixaban were not provided to determine pre-existing risk factors that may have led to the event.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Cold sore; Swelling of the lymph nodes underneath her arm; Swelling at the injection site; Headache; Achiness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), ORAL HERPES (Cold sore), LYMPHADENOPATHY (Swelling of the lymph nodes underneath her arm), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included LISINOPRIL for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Achiness), LYMPHADENOPATHY (Swelling of the lymph nodes underneath her arm), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache). On an unknown date, the patient experienced ORAL HERPES (Cold sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achiness), ORAL HERPES (Cold sore), LYMPHADENOPATHY (Swelling of the lymph nodes underneath her arm), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I had sore throat, running nose, low-grade fever, headache, SOB, and fatigue that lasted for about 6 days. On July 27th, I tested positive for COVID-19. About 6 weeks later, I develop Atrial fibrillation. I went to the ER and they did EKG and Electronical Cardio version.