chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got vaccinated & still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected 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 details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got vaccinated with the Shingles and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
This spontaneous prospective pregnancy report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. The patient became pregnant with a last menstrual period (LMP) calculated of 19-SEP-2018 and an estimated date of delivery (EDD) of 26-JUN-2019. On an unspecified date in October 2018, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route, frequency, lot# and expiration date were not provided) for prophylaxis (vaccine exposure during pregnancy). The reporter received more information from the physician, who stated that the patient was 11 weeks pregnant by the time of reporting. The pregnancy outcome was pending.
she accidently administered a dose of MMR II via intramuscular route instead of subcutaneous route. Date of administration was Mar 1, 2023. No further information provided. No additional AE reported. No PQC reported.; she accidently administered a dose of MMR II via intramuscular route instead of subcutaneous route. Date of administration was Mar 1, 2023. No further information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from a pharmacist 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 01-MAR-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U039548 with expiration date of 14-DEC-2023, via intramuscular route instead of subcutaneous route (incorrect route of product administration), for prophylaxis. No additional event reported.        No further information provided.
Patient's arm was very sore; Patient felt that the vaccine was incorrectly administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient's arm was very sore) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient felt that the vaccine was incorrectly administered) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN IN EXTREMITY (Patient's arm was very sore) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient felt that the vaccine was incorrectly administered). On 10-Nov-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient felt that the vaccine was incorrectly administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Patient's arm was very sore) outcome was unknown.        Patient's mother reported that patient received her booster on 10-Nov-2021. She also stated that the patient received booster shot above where vaccination provider sanitized her left arm.  She was concerned about getting an infection and went to Urgent care.   No concomitant medications were reported.  No treatment medications were reported.
calling because they gave Pfizer covid-19 vaccines for the age group of 5 to after the expiration date; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "calling because they gave Pfizer covid-19 vaccines for the age group of 5 to after the expiration date".  Additional information: Gave Pfizer covid-19 vaccines for the age group of 5 to after the expiration date, six days at the expiration date to be exact (withheld), Reporter wants to know if they have some guidance to see.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Health compromised with COPD; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Health compromised with COPD) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Severe COPD).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Health compromised with COPD). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Health compromised with COPD) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown   Concomitant medications were not provided. Treatment information was not provided. No lab data provided by reporter.
Woke up with fever under 100 degrees, nausea, dizziness and headache. Woke up 3/20/15 with stiff neck as well. By 10 AM on 3/20/15 symptoms resolved.
Patient developed an instant at perc - injection site of erythema - no other rash or symptoms. Injection given on left thigh -Rx noted just interior to injection of MMR - 2 X 2cm area - treated with cool compress - Rx resolved fairly quickly.
body aches; had a fever of 102.2F; severe in the legs; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: 5318) via an unspecified route of administration in Arm Right on 18Feb2021 14:30 (age at vaccination: 46 Years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't have covid prior to vaccination. The patient medical history and patient's concomitant medications were not reported. patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: 5318) via unspecified route of administration in Arm right on 27Jan2021 14:30(age at vaccination:46 years) as DOSE 1, SINGLE for covid-19 immunisation. On 18Feb2021 12:00 the patient experienced body aches, had a fever of 102.2f, severe in the legs. The patient underwent lab tests and procedures which included pyrexia: 102.2 fahrenheit on 18Feb2021. Therapeutic measures were taken as a result of body aches, had a fever of 102.2f, severe in the legs was Tylenol. Patient was not tested with covid to post vaccination. The outcome of the events pain, pyrexia, pain in extremity was recovering.  No follow-up attempts are possible. No further information is expected.
reconstituted with diluent other than the supplied diluent.; reconstituted with diluent other than the supplied diluent.; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 49-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA591A, expiry date 31st August 2022) for prophylaxis.   On 18th February 2022, the patient received Menveo. On 18th February 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter reconstituted Menveo with diluent other than the supplied diluent and was unsure if the used diluent was normal saline or sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Healthcare professional gave permission for safety to follow up.
This morning he is diabetic. His sugar it was elevated, it was up to 300 which is he said much higher than normal; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program Pfizer First Connect. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. He has his first dose of the COVID Vaccine yesterday and this morning he is diabetic. When he woke up this morning to test his sugar it was elevated, it was up to 300 which is he said much higher than normal and wants to know if that would be a symptom. Outcome of event was unknown.   Information on the lot/batch number has been requested.
Macular papular rash on arms, chest and back appeared 4 days after vaccination and still present 10 days later. Non pruritic. No fever or other symptoms. No treatment given told to return if no improvement in 3 days.
Patient received Moderna Booster but Moderna Booster is not currently approved for this age group.
Painful nerve issue in her neck and arm for 6 weeks; This is a spontaneous report from a contactable consumer reported for a female patient (twin sister). A female patient of unspecified age received second dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection), via an unspecified route on an unspecified date in Dec2020 (age at vaccination: 62-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection), as a single dose for covid-19 immunization. On an unknown date, after the second dose patient experienced a painful nerve issue in her neck and arm for 6 weeks. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a phlebotomist concerning to a male patient of unknown age.  The patient's concurrent conditions, medical history, drug reaction/allergies, and concomitant therapies were not reported. On 14-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L035687, (expiration date 16-FEB-2017) for prophylaxis (the route, dose, frequency, and strength were not reported). No adverse effects were reported in the patient.  There was no product quality complaint involved. Additional information has been requested.
Fever, fatigue, headache, muscle pain, chills, pain at the injection site.  Still have some side effects 6 days later. Sleep for 10 to 13 hours each night. Totally exhausted.
Hospitalization for left lung collapse and large decubitus ulcer (tested positive for COVID-19 upon admission) on dates 9/2/22-9/15/22.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 19 March 2010 an elevated Troponin, central laboratory level of 0.13 ng/mL (draw date 18 March 2010). The subject had a rapid Troponin I level on 18 March 2010 that was within normal limits (negative). The subject was asymptomatic according to the investigator. An ECG on 23 March 2010 was "abnormal:NCS", ectopic supraventricular rhythm. A repeat Troponin on 23 March 2010 was <0.10 ng/mL. The subject had no concomitant medications. No treatments were reported. No further information was available at the time of the report. The subject's outcome was recovered, no residual effects on 24 March 2010. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Received one of the vials of Shingrix; Received one of the vials of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The pharmacist believed that 20 other patients over time received one of the vials of shingrix, either adjuvant alone or antigen mixed with other diluent.  The reporter did not knew what was given. No other details was available. The reporter consented to follow up. Additional Supportive Information: The unspecified number of patients received one of the vials of shingrix, either adjuvant alone or antigen mixed with other diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a nurse concerning an 11year old female patient who was vaccinated IM in the left deltoid with a first dose of Gardasil. Subsequently the patient experienced pain while receiving the injection. The nurse indicated that it seemed as if the needle was "too big for girls with small arms and it almost feels as if the needle is hitting the bone in the child patients." The nurse said that they have to switch to a 5/8 inch needle when administering the vaccine to patients. Unspecified medical attention was sought. the patient recovered from the arm pain. No product quality complaint was involved. Additional information is not expected.
9 days p/receiving MMR/HIB had t103.3 elevation & seizures was seen in ER @ hosp;
Lupus butterfly rash on his face; he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line; That night his arm swelled and hurt; he couldn't use his arm; That night his arm swelled and hurt.; The arm was rock hard; he didn't feel right until 4 pm; brain fog; his face turned plum red; test for Lupus came back as potential positive; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Scleroderma.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face) (seriousness criterion medically significant), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard) and MALAISE (he didn't feel right until 4 pm). 11-Apr-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS RASH (Lupus butterfly rash on his face), ERYTHEMA (his face turned plum red), MUSCLE TIGHTNESS (he felt tightening of the muscles in his face, particularly in the T zone and upper jaw line), PERIPHERAL SWELLING (That night his arm swelled and hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (he couldn't use his arm), PAIN IN EXTREMITY (That night his arm swelled and hurt.), LIMB DISCOMFORT (The arm was rock hard), MALAISE (he didn't feel right until 4 pm) and FEELING ABNORMAL (brain fog) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received the smallpox vaccine on 4 JAN 2020 and had problems with pain, nausea and vomiting about 6-7 days later. He went to the ER at Hospital on 13 JAN 2020 and saw his PCP for follow up on 17 JAN 2020. He took 2 days off work; 14-15 JAN 2020. I spoke with him and he is fully recovered and should not need any more follow up care.
took the flu shot it gave him the flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who took the Influenza Vaccine shot it gave him the flu.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s),and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, frequency, formulation, lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient took the flu shot it gave him the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.   The outcome was Unknown.
patient felt little nausea, tingling on both arms, cold sweat, vomiting.
Case number PHEH2013US025308 is an initial spontaneous report from a nurse received on 04 DEC 2013. This report refers to a 14-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13012/X13012) subcutaneously on 04 DEC 2013. No adverse event was reported following this administration error.  No other information was available.
Slight headache; Chills; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8738) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis c. The patient had known allergies to bee stings. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: paa165469) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:00, the patient experienced slight headache, chills and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight headache, chills and tiredness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 13-SEP-2016, the patients were vaccination with improperly stored PROQUAD lot # M011664/ expiration date- 08-SEP-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored GARDASIL 9 (lot # M011840 with expiration date 01-FEB-2018, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA009010: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009013: US-009507513-1707USA009014.
Pt recvd 3 doses of Engerix-B & was found to have a neg titer; pt recvd 4th dose of Engerix-B 19FEB92 & now has a pos titer;
pt recv vax 22DEC95 & 12hr p/vax 23DEC95 pt devel cold sores @ corner of mouth which persisted for 2 days;the nurse reported that the vesicles were quite painful & indicated that the pt reported that never had anything like that a/;
I started experiencing some sharp chest pain on the left side that started around a week or less after the shot. I?ve been stubborn and pushing it off (not currently insured so I didn?t want to get checked up). I?ve been experiencing the sharp pain on the left side of my chest off and on a few times a week at least. I?ve never experienced this but figured it would go away eventually.   Last Sunday (July 11,2021) The chest pain was more severe than usual and I was very lightheaded and nausea and it didn?t get any better so I visited the ER. The EKG, chest x-rays, troponin levels, and other tests came back normal according to the physician assistant.
pt recv vax 21MAY97 & pt noted a dime size, red, hard spot @ inj site 27MAy97;this area grow to tennis ball size w/in 24hr;seen in office on 28MAY97 w/red area the size of tennis ball;