chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching at injection site, red patch about 5 inches oblong pattern   went away for a few days - then returned to itching/red patch today (3/31 - 11 days post injection)
This spontaneous report as received from a physician assistant refers to a 49 year old female patient. On 29-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # H015780, expiration date 11-JUN-2014, 0.5 ml in the left deltoid for pneumococcal challenge. The physician assistant did not specify reason for challenge. On 30-APR-2013, 2 days after onset of therapy, the patient experienced cellulitis and on an unknown date, the patient was admitted to the hospital with cellulitis, fever of 102 degrees F and induration at injection site after receiving PNEUMOVAX 23. Unspecified lab test resulted in white blood cell count of 26000 (unspecified unit of measurement). Physician assistant stated the patient could not use that arm. At the time of the report, the patient was recovering. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated subcutaneously with 0.65 ml expired ZOSTAVAX (lot number 0693AA, expiration date 11-AUG-2012) on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
patient was administered an expired dose of VARIVAX which had a temperature excursion.; No additional adverse effect reported.; patient was administered an expired dose of VARIVAX which had a temperature excursion.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 19-MAY-2020, the patient was vaccinated with an improper stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R013566 with expiration date of 13-MAY-2020, for prophylaxis (route of administration and frequency were not reported), the varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with proper storage sterile diluent(STERILE DILUENT MRK).     No adverse effects were reported.  It was stated that the vaccines underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (8.24F) for 35 minutes. No previous temperature excursion was done. The call was because of a "data logger".
ON THE MORNING OF 01/22/2021 PT WOKE UP AND HAD RIGHT SIDED FACIAL DROOPING. PT DID NOT TELL ANYONE UNTIL THE MORNING OF 01/25 AND WAS SEEN BY HER PRIMARY. PT PRESENTED TO PRIMARY VISIT WITH RIGHT SIDED FACIAL DROOPING, PT ABLE TO OPEN AND CLOSE RIGHT EYE, TONGUE GOES TO LEFT SIDE, NO SWALLOWING ISSUES.
severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; This is a spontaneous report from a non contactable   physician reporting for herself.  A 28-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 19Dec2020 17:00 at  single dose for Covid-19 immunisation .  The patient medical history  and concomitant medications were not reported.  The patient experienced severe chills, fatigue, fever 100.7°F, nausea on an unknown date with outcome of recovering.  The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on an unspecified.  Unspecified therapeutic measures were taken as a result of the reported events.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
I get the Shingles shot. I had them a couple times/Suspected vaccination failure; I had shingles a couple times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-JUN-2022 Reporter's Comments: This case was reported patient via interactive digital media. The patient got the Shingles shot and experienced  shingles a couple times. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
it seems like it is getting worse; today i had numbness (in her eyes); blurring in my eyes; leg is sore and stuff; had a reaction to the vaccine; weakness in the left leg; leg has been swollen; really bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the vaccine), MUSCULAR WEAKNESS (weakness in the left leg), PERIPHERAL SWELLING (leg has been swollen), HYPOAESTHESIA EYE (today i had numbness (in her eyes)) and VISION BLURRED (blurring in my eyes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O3OA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION COMPLICATION (had a reaction to the vaccine), MUSCULAR WEAKNESS (weakness in the left leg), PERIPHERAL SWELLING (leg has been swollen), PAIN IN EXTREMITY (leg is sore and stuff) and HEADACHE (really bad headaches). On 02-Apr-2021, the patient experienced HYPOAESTHESIA EYE (today i had numbness (in her eyes)) and VISION BLURRED (blurring in my eyes). On an unknown date, the patient experienced CONDITION AGGRAVATED (it seems like it is getting worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of 1 UNK. At the time of the report, VACCINATION COMPLICATION (had a reaction to the vaccine), MUSCULAR WEAKNESS (weakness in the left leg), PERIPHERAL SWELLING (leg has been swollen), HYPOAESTHESIA EYE (today i had numbness (in her eyes)), VISION BLURRED (blurring in my eyes), PAIN IN EXTREMITY (leg is sore and stuff), CONDITION AGGRAVATED (it seems like it is getting worse) and HEADACHE (really bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported include high blood pressure medication,high cholesterol medication.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter Contact information updated.
The symptoms were approximately on February 1st I developed extreme bloating and gas on my stomach that I was unable to expel. After about 3 weeks I went to the doctor and they ran a series of tests and everything came out within the normal range. He prescribed something that did seem to help, XIFAXAN. Upon taking that, the symptoms have definitely alleviated. I have a follow up with a gastroenterologist next week for a more extensive look.
Pt complained of SOB, itching, throat swelling and coughing, Pt was given, epi injection, Benadryl and  supplemental O2. Vital signs remained stable.
Burning initially then, red hot raised circle about 1 1/2" from injection for 3 days. Now muscle pain in arm when extending out.
lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe
Morbilliform rash globally 9 days post vaccine 2 in Pfizer series, with pruritus, ongoing past 4 days from onset. Rash waxes and wanes, worse at night, also affecting hands and feet with papules, no lesion sin mouth and no injection site reaction or enlarged lymph nodes. Treated with Benadryl and transitioned to daily zyrtec.  No fever, no vomiting, no shortness of breath, and no recent illness within month.
Information has been received from a health professional concerning a 10 year old female who, on 9/20/1995 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccinations. On 12/31/2004 the patient presented in the office with a rash described as skin rash in various stages of vesicles lesions. There were no laboratory or diagnostic tests performed. Follow up information from a health professional indicated that on 12/31/2004 the physician examined the patient at the office with a skin rash, that began on 12/29/2004, that was in various stages with elongated vesicles. The physician diagnosed the rash as varicella. It was reported that the patient recovered in approximately 2 weeks, on approximately 1/11/2005. Additional information is not expected.
This is a spontaneous report from a contactable physician received via a sales representative. A 20-year-old female patient started to receive TRUMENBA, via an unspecified route of administration from 20Sep2016 to 20Sep2016 at a single dose for meningitis B vaccine. The patient's medical history and concomitant medications were not reported. The patient experienced pain and swelling and redness in her left arm for about one week after the patient's first dose of meningococcal group b rlp2086 on 20Sep2016. The outcome of the events was recovered.
Diffuse, generalized MAC/Papular rash with fine papules and surrounding clearing over entire body.  No large lesions
Administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 20-Oct-2021 and the expiration date of the vial was on 10-Oct-2021.  No concomitant medication was reported. No treatment information was reported.
Patient, 10/31/44 was admitted Sunday night for confusion, weakness, and a fall at home. Patient had his Covid-19 vaccine here on 4/9 through the clinic. Per patient?s step-grandson (which is the most involved family member) patient had his first vaccine on March 4th at our clinic. On March 6th patient became extremely weak and step-grandson went to check on him and was unable to get into the house because patient was too weak to get off the couch. A window AC unit had to be removed for step-grandson to get access to patient. They did not seek medical attention at that time and patient improved within a few days back to baseline. Family was unaware that he was getting the second covid shot on 4/9. Patient was seen in grocery store the evening of 4/9 but family was unable to get ahold of patient on Saturday 4/10 and on Sunday (4/11) step-grandson went to his home and found patient on the floor. Patient has been a poor historian but states that he became weak and fell out of a chair. We think he may have been laying on his right side for about 36 hours at home. Patient was found to have blisters on his right forearm and right chest, liver enzymes were elevated on labs and he had dehydration. Patient has also had hallucinations and confusion but everything seems to be slowly improving with supportive care. He is still incontinent which is very unusual for him per family. He was negative for rhabdomyolysis, stroke, C-spine injury, negative for hepatitis, urine drug screen was negative. We are continuing to provide wound care for his blisters and PT/OT. Just a strange case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Paxlovid was taken as therapeutic measures as a result of Drug ineffective, Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300278988 Same patient, different product, different dose/event;
Started period two weeks early, severe cramps, heavy bleeding. Began 8 hours after receiving injection. Flu like symptoms started at the same time. Still experiencing severe cramps. I?ve never had an early period before.
accidentally administering a pediatric dose of Engerix B to an adult; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 21-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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: 30-JUN-2022 Reporter's comments:  The nurse reported accidentally administered a pediatric dose of Engerix B to an adult. The reporter consented to follow up. Additional supportive information: The adult patient was accidentally administered with a pediatric dose of Engerix B which led to accidental underdose.
Slight facial numbness mostly on the left side of the face (the same side I was vaccinated on)
This spontaneous report as received from a registered pharmacist refers to a 73 year old female patient. Drug reactions and allergies were reported as none. On 05-OCT-2012, the patient was vaccinated with ZOSTAVAX (dosing details and route was not reported). Lot number was reported as H012577 and expiry date as 28-SEP-2013. No concomitant medications were reported. The patient had called the pharmacy the next day on 06-OCT-2102 and complained of rash around injection site that was 5 inch in diameter and itching. The patient reported to the pharmacist that itching was not just around injection site but all over the body and the pharmacist recommended BENADRYL. On 07-OCT-2012, the pharmacist followed up with the patient and the patient stated that the itching was better and was reduced to just around the injection site. The outcome of rash around injection site that was 5 inch in diameter and itching was reported as recovering/resolving. The patient experienced similar adverse events with PNEUMOVAX 23 and AFLURIA: 1210USA004393 and 1210USA004394. Additional information has been requested.
As pt was waiting 15 minutes after vaccine, tech looked out and noticed pt had head between legs and was breathing heavy.  Mother was paged overhead.  I went out to see if she was okay and when I brought a water to pt.  Seemed like an anxiety type of reaction but mom noticed pts fist where clinched and request we call 911.  EMTs thought this was more of a reaction from anxiety .  Pt was pale but seemed ok when EMTs arrived.  They took her to hospital just in case.
No additional AE; a patient was administered an improperly stored VARIVAX vaccine.; This spontaneous report was received from a consumer referring to a patient of unknown age and gender.     The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-AUG-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # W039689, expiration date on 13-DEC-2024, for prophylaxis (dosage, frequency, route, anatomical location were not reported). No additional adverse event was reported.
Diagnosed with genital warts approximately 15 days after receiving Gardasil vaccine. Cryotherapy treatment by physician.
This spontaneous report as received from a nurse refers to an 18 years old nursing student. The patient was vaccinated with 3 dose of 0.25 ml hepatitis b vaccine (recombinant) (manufacturer unspecified and RECOMBIVAX HB could not be ruled out) (Lot number unspecified) (vaccination site unknown) in 1994 and not seroconverted. No other co-suspects were reported. No concomitant medications were reported. On 20-AUG-2012 the patient received a forth dose of hepatitis b vaccine (manufacturer unknown but RECOMBIVAX HB could not be ruled out). No treatment information was reported. The outcome was unknown. The patient had sought unspecified medical attention. This is one of three reports from the same reporter. All telephone attempt to obtain follow-up information have been unsuccessful. Additional information has been requested.
Top lip tingling, swelling, itching all over body, rapid heart rate, throat felt "thick" had to keep clearing throat or drinking
15mins post vaccination, pt c/o dizziness and "feeling anxious".  @13:40 BP 146/99, HR 108, RR 20 Sat 100% on RA; @13:50 120/94; @14:00 128/96; @14:10 124/92, 96, 99% on RA.  Pt symptoms resolved and pt released from the vaccination site @14:30.  Pt w/ PMH of Genital Herpes, hx of abnormal Pap Smear, C-section x3 and appendectomy. Pt is currently using Nexplanon.
Patient developed two red areas near the injection site. Both warm to the touch and slightly raised and painful. After three days redness reduced and pain reduced and swelling gone. No treatment, symptoms appear to be resolving.
Vaccine error. Provider inadvertently administered Influenza vaccine to patient. Pt received influenza vaccine in 08/2023 and not due to receive another flu shot until Fall of 2024. Pt's mother requested COVID-19 vaccination, not influenza. Appropriate COVID-19 vaccine administered per Mother's request after inadvertent influenza vaccination.
Pt. states that after receiving the 2nd dose of Phizer 04/13/2021, started experiencing symptoms 05/03/2021 of redness, swelling at the injection site. Developed into raised "bumpy" area in and around the injection site, still experiencing symptoms of itchiness. Primary/ Dermatologist visit 09/2021 with Follow-Up with Steroid Cream (Triamcinolone Acetonide).
pt to hosp with inferior STEMI; 10 dys before, had a positive COVID test; emergent CATH lab for LHC; underwent successful PCL to distal RCA and mLAD with excellent results; after procedure, pt arrested and there was no return of ROSC
booster shot - severe headache, pain at injection location; intense muscle aches, stiff joints
Patient hospitalized for Induction of labor, normal spontaneous vaginal delivery. Per doctor's notes: She had a 5# 9oz, female. This was within 6 weeks of receiving COVID vaccination.
Disseminated: hands, head, legs warts resolved; HPV vaccine for disseminated: hands, head, legs warts; This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 36 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, candida albicans and curertage. The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for disseminated hands, head and legs warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unspecified date, the patient's disseminated hands, head and legs warts resolved (drug effective for unapproved indication).  The outcome of drug effective for unapproved indication was unknown.  The causal relationship between the vaccination with quadrivalent human papillomavirs (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomarivus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Fainting; Swelling of arm; no taste; headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:30 as a single dose for COVID-19 immunization.  Medical history included narcolepsy from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took Cymbalta and experienced allergies. The patient was not tested for COVID post vaccination. On 13Apr2021 at 05:30 PM, the patient experienced fainting, swelling of arm, no taste and headache. The patient did not receive treatment for the events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Dizziness, Headache, first weakness, tireness, and progressed to chills lasting all night; the 2am woke up with headache; all resolved with Tylenol Narrative:
A report was received from a health care professional on 11/14/03 concerning a 75 year old female vaccinee who inadvertently received expired Fluvirin SC on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
I experienced vitreous detachment in my left eye, starting about three days after the vaccine.  At first my eye was very irritated and sore. Then a large floater appeared in my visual field. A few weeks later, I started seeing flashes when I moved my eye.