chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes zoster/vesicular eruption; This spontaneous report regarding a potential litigation was received from a physician regarding a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) indicated for shingles vaccine (prophylaxis) (route of administration, vaccination scheme, dose, lot number, and expiration date were not provided).   On an unknown date, the physician reported that the patient who received Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine) developed herpes zoster afterwards. The physician stated he did not want to provided any further information since this was a legal case but said the vesicular eruption (herpes zoster), had resolved.   The outcome of the event herpes zoster was reported as resolved.  The causality assessment between the event herpes zoster and therapy with Zoster Vaccine Live (ZOSTAVAX) was not provided.
2/9 vaccine; 2/17-erythema,edema ,and hard welts at injection site to elbow and including inner arm area accompanied by intense itching. Treated with hydrocortisone cream, benedryl cream and OTC diphenhydramine 25 mg tab q 6 hrs. 2/23- resolved. 2/26- developed floater in right eye; 2/28- developed edema, erythema with burning, itching rash on upper chest, anterior neck and bilateral lateral face. Treated as above for arm, 3/4- resolved.    3/9- 2nd dose followed by mild rash at injection site, severe chills, headache and left arm pain from evening until morning followed by fatigue until following day when it resolved.  3/24 developed erythema, edema, burning, itching, painful to touch rash on entire face, neck and upper chest more intense than previous instance  worsening over next several days to include very edematous eyes and bruising of right eyelids and painful rash continued. Treated as above but self treated with additional 5 day course of prednisone 10 mg already on hand as well as oral diphenhydramine tabs due to severity of symptoms. 3/30-Resolved.. Concern whether to accept booster or additional future vaccines.
Patient woke up on Feb 28, 2021 with fatigue, headache and nausea. It has been ongoing x 17 days. She has been taking zofran as needed for nausea. She was covid-19 antigen tested (which was negative) on 3/17/2021
Neuralgia left groin area to left buttock on October 2, 2021.  On October 5, 2021 morning red, itchy, hot, rash on left groin, mons pubis, and left buttock. Diagnosed with Shingles.
no additional adverse events; patient was intended to receive MMRII and VARIVAX, but was inadvertently administered PROQUAD and VARIVAX; inadvertently administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse and referred to a 12-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 08-MAR-2023, the patient was intended to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), but was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD), 0.5 milliliter subcutaneous injection, lot #W002784, expiration date: 24-JUL-2023; and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter subcutaneous injection, lot #W012167, expiration date: 12-APR-2024 (both administered for prophylaxis: dose 0.5 milliliter, quantity 1, route of administration was not provided) (wrong product administered, accidental overdose). No additional adverse events reported.
the patient was got infected with COVID/again the last one was about three weeks ago; the patient was got infected with COVID/again the last one was about three weeks ago; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "the patient was got infected with COVID/again the last one was about three weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: last one was about three weeks ago. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has had 4 COVID-19 vaccines from Pfizer. Then, the patient was got infected with COVID and took antiviral treatment for 5 days (could not confirm the identity of this treatment). Caller wanted to know how long after the treatment, the patient should wait to get the fifth dose of the vaccine. The patient has had four vaccine from Pfizer and then the patient has been exposed to COVID and the patient got infected so, the patient has took the anti-viral treatment for five days. The patient was exposed twice to COVID and he got very sick so, once was about Dec2021 and again the last one was about three weeks ago. The patient has the symptoms very very very bad symptoms, somehow that medication did not do the effect, did not work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect products  BNT162B2,BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
This spontaneous report was received from an administrator and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of M-M-R II (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided), were administered to an unspecified number of patients on an unspecified date, for prophylaxis. The vaccine had multiple unspecified excursions due to a data logger issue. The reporter provided information relevant to the temperature at which the vaccines were maintained, however it was explicitly stated that such vaccines were not administered to any patient. There was no product quality complaint involved. This is one of three reports received from the same source. Additional information is not expected as there was no information and consent to contact the physician.
Arm soreness immediately. After 6 hours, headache, fatigue, tiredness and nausea continues for 36hours.
Patient was inadvertently given the 6m-4 yr (3mcg/0.2ml) Pfizer vaccine instead of the intended Pfizer 12+ bivalent booster.
on morning after 2nd vaccination, 6/7/21, episode of acute hemorrhagic rectal bleeding.  Presented to ED with hypotension requiring pressors, fluids, blood transfusion and ICU admission.  Treated empirically for sepsis but more likely hemorrhagic vs hypovolemic shock and cardiogenic shock.  Recovered quickly and discharged on 6/11/21
Diagnosed with moderate to severe asthma and VCD (vocal cord dysfunction) I have progressively been having issues with breathing while exercising.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm and erythema. On an unknown date, the outcome of the swelling arm and erythema were recovered/resolved. It was unknown if the reporter considered the swelling arm and erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that several patients had received BEXSERO and had a red swollen arm for approximately 36 hours.
Swelling, face swelling, arm red to elbow along with swelling, disorientation.
HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 65 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: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced headache. On 11-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from headache. This report was non-serious.
Patient was given a Tdap vaccine on 8/31/21 which had expired on 8/8/21.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The pharmacist reported that on an unknown date, the patient received an improperly stored dose of ZOSTAVAX lot # N020943 with expiration date 26-OCT-2018, or lot # N021170 with expiration date 27-OCT-2018 (also reported as 18-OCT-2018) (dosage and route of administration were not reported) for prophylaxis, which was exposed to a temperature of 6 Farenheit (F) to 14 F, for a time frame of 1 hour because of data logger. The vaccine had a previous temperature excursion of 6 F to 14 F for 19 hours and 30 minutes on an unknown date. A properly stored sterile diluent (manufacturer unknown) was used. No adverse effects reported.
Information has been received from a medical assistant concerning an 11 months female patient. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patient was vaccinated with doses of improperly stored ROTATEQ lot # M045545 and expiration date of 10-JUN-2018, orally (anatomical location was not reported) for prophylaxis, which were stored in the range of 47 Fahrenheit degrees to 77 Fahrenheit degrees (75 Fahrenheit degrees) for 6 hours and 46 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA011911.
the administration of a product that was no longer suitable for use post excursion, with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid  non-serious case received from  other health professional via call center.  This case involves an unknown age and unknown gender patient who experienced the administration of a product that was no longer suitable for use post excursion, with no reported adverse event while receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] and hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and hib (prp/t) vaccine (unknown dosage, strength, formulation, batch lot number and expiry date for both vaccines) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of the administration of a product that was no longer suitable for use post excursion, with no reported adverse event (product storage error) (unknown latency)  following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and hib (prp/t) vaccine.  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 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.
Information has been received from a physician concerning a 44 month old Hispanic female who was born at 34 weeks (premature) with no pertinent medical history and no known drug allergies who on 28MAR2001, also reported as "approximately one year ago", was vaccinated SC, also reported as IM, in the left thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant therapy included a first dose of measles- mumps-rubella vaccine administered SC in the right thigh, a first dose of tuberculin purified protein derivative administered in intradermally in the left forearm, a fourth dose of Hib conj vaccine (tet toxoid) administered IM in the left thigh, a third dose of poliovirus vaccine inactivated administered IM in he left thigh, a a fourth dose of diphtheria toxoid + pertussis acellular Biken vaccine+ tetanus toxoid administered IM in the right thigh. There were no other concomitant medications. On 03SEP2003 the patient developed shingles. The blisters were noted to be on the child's scalp and forehead, ad have been crusted over without any treatments. No lab diagnostic studies were performed. Unspecified medical atttention was sought. There was no product quality complaint. There were no adverse events following prior vaccinations. It was noted that the patient recovered. Follow up information from the physician indicated that the eruption "followed perfectly along the dermatome." Additional follow up information indicated that on 03SEP2003, the blister appeared anteriorly on the right side of the patient's forehead/scalp. It was noted that there were approximately 2 dozen lesions form the patient's right forehead into the scalp area, abruptly stopping at the midline. It was reported as itchy. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. No fever was noted. The pain was noted to be a 2 (with 0 being the least and 10 being the most). There were no other systemic symptoms. The outcome was reported as recovered. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations. There was no history of chickenpox. There was no recent exposure to chickenpox or herpes zoster. No direct flourescent antibody was done. No specimen was collect for PCR. No photo was taken. No further information is expected.
felt like she had had the flu for 2 weeks; in a fog; very fatigued & run down; vomiting; diarrhea; nausea; chills; arm was sore clear to elbow; headache; vaccination struck the shoulder bone; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had had the flu for 2 weeks), FEELING ABNORMAL (in a fog), DIARRHOEA (diarrhea), PRODUCT ADMINISTRATION ERROR (vaccination struck the shoulder bone) and VACCINATION SITE PAIN (arm was sore clear to elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (vaccination struck the shoulder bone). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore clear to elbow), HEADACHE (headache) and CHILLS (chills). On 18-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). On 19-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had had the flu for 2 weeks), FEELING ABNORMAL (in a fog) and FATIGUE (very fatigued & run down). On 16-Mar-2021, PRODUCT ADMINISTRATION ERROR (vaccination struck the shoulder bone) had resolved. On 20-Mar-2021, INFLUENZA LIKE ILLNESS (felt like she had had the flu for 2 weeks), FEELING ABNORMAL (in a fog), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (arm was sore clear to elbow), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills) and VOMITING (vomiting) had resolved. At the time of the report, FATIGUE (very fatigued & run down) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17 June -2021 and does not contain significant information
3/22/2021 5pm- Received shot ~10pm- adverse events started.As I was falling asleep, it started with restless legs. Quickly, I was shaking so violently I couldn't control my body. I made it to the shower to try and relax my muscles. My heart was uncontrollable and I had difficulty breathing.   4/4/2021- 4/5/2021 Woke up at night shaking similar to the first time, but not as terribly  Low-key nausea and shortness of breath, fatigue, dizziness and weakness have been constant.
8 days after injection, itchy, raised rash. Arm is sore, feels warm and is red
shingles 3 times / 2nd time I received the vaccine plus 2 boosters / got shingles the 3rd time / Suspected vaccination failure; shingles; nerve pain was so excruciating that I actually wanted to die; received the vaccine plus 2 boosters 6 month apart; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, nerve pain and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had shingles 3 times. A vaccine was not available the 1st time. The 2nd time patient received the vaccine plus 2 boosters 6 month apart, which led to extra dose administered. When patient got shingles the 3rd time, the nerve pain was so excruciating that he/she actually wanted to die. The reporter mentioned that, the shingles vaccine did not help him/her. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Information has been received from a nurse concerning her granddaughter who on approximatley 20AUG2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed "one reddened area on her back, no lesion or pox-like area, and has been irritable since then". The child was treated with acetaminophen, Tylenol. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that her daughter, the patient's mother, was diagnosed with singles on 05SEP2003. Additional information has been requested.
needle leaked during administration; did not receive the full dose; This case was reported by a nurse via call center representative and described the occurrence of syringe issue in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA584A, expiry date 31st August 2022) for prophylaxis.   On 11th October 2021, the patient received Menveo. On 11th October 2021, unknown after receiving Menveo, the patient experienced syringe issue and accidental underdose. On an unknown date, the outcome of the syringe issue and accidental underdose were unknown.  Additional details were reported as follows: This case was reported by the nurse. The nurse stated that the needle leaked during administration of Menveo and the patient did not receive the full dose, which led to syringe issue and accidental underdose. The reporter consented to follow-up.
Patient went to ophthalmologist who diagnosed herpes zoster in eye. S/P Zostavax administration.
Arm swollen to over twice it's size, was hot, hard and started developing bleeding blisters around the vaccination site. Took her to the doctor on Thursday the 23rd and she was diagnosed with cellulitis at the vaccination site. She was administer Clindamycin for 10 days and is still on her meds. She still has a hard lump under her skin and a brown patch the size of an orange around the vaccination site.
Deathly sick; Diarrhea; Weak; Throwing up; Running a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever). At the time of the report, MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever) outcome was unknown.            No concomitant medications were provided. No treatment details pertained to the events were provided.  The action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-092650 (Patient Link).
Post vaccine pt. C/o severe HA dizzy, light headed, vertigo no SOB or CP; No notes from ED Pt went to ED!