chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient reported feeling tired and "spacey" 2 hours after the immunization. She also reported the following day, bumps (possible oozing, she indicated they feel wet but cannot see it) that itch on her back; right of her spine  about an inch below her bra strap. She was unable to see the reaction site but said they feel like her shingle flare ups. She believes this to be another flare, possibly triggered by the immunization.
It was reported that a 30 year old woman was vaccinated with a Fluzone SV '00-'01 vaccination on 13 Oct 2000. Reportedly the same day the patient experienced local pain, burning, and a red, itching rash from the shoulder to elbow. On 17 Oct 2000, the pt was starting to improve. Further info is being requested. From add. info received 01 Feb 2001, pt has recovered.
Temp 103, red surrounding shot site 5cm x 8cm, Axillary and chin
Pain, numbness and tingling from injection site on left arm all the way to fingers of left hand.  Lasted about 36 hours.  Pain was significant enough to wake me.   This happened with my first or second Covid Moderna vaccine as well.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients (unknown age and gender). On unknown dates these patients received doses of PROQUAD (lot#, dose, route not reported) that were exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of two reports received from the same reporter (other MARRS# 1411USA003487). Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE RESPIRATORY FAILURE  1/17/2023 &  3/18/2023  --  RECURRENCE OF SAME SYMPTOMS
Rash and bumps on both arms and both legs. Reoccurring minor joint pain in both hands
This non-valid spontaneous report was received from a registered nurse and refers to an unspecified number of patients that were shown in a documentary. No information regarding the patients' medical histories, concurrent conditions or concomitant medications was provided. On unknown dates, the patient were vaccinated with doses of M-M-R II injection (dose, route of administration, lot number and expiration date were not reported). On unknown dates, the patients could not walk. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported.
Patient felt faint, hot, weak, had to sit down upon trying to leave the facility after observation period. Vital signs stable, blood glucose measured = 89 Orthostatics conducted, negative for orthostatic hypotension Patient given crackers, water. Evaluated by nurse practitioner, advised to take deep breathes, patient felt better and left facility with daughter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks was reported as no. The patient received anti viral COVID-19 Treatment Paxlovid from 28Feb2023 to 05Mar2023. The patient known allergies and other medical history was reported as none.
Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided.
injection site got red and was about size of a hand print; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site got red and was about size of a hand print) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included TESTOSTERONE, ATORVASTATIN CALCIUM (LIPITOR), LEUPRORELIN ACETATE (LUPRON), BICALUTAMIDE (CASODEX), RIVAROXABAN (XARELTO) and FINASTERIDE (PROSCAR) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site got red and was about size of a hand print). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, INJECTION SITE ERYTHEMA (injection site got red and was about size of a hand print) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non significant follow up
7/18/08 injection site became red, swollen and began to hurt.  7/19/08 Pt returned. started on Motrin childrens tablets 100mg Q6hPRN x 10 days for pain.  Cool compresses to site.  no fever, no rash, no hives, no SOB and no itching.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 18-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A2IA expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Extensive redness, pain and swelling as well as bruising near the injection site. Redness measures approximately 10.5cm x 14 cm on 6/10/2016.
Dose 1, Fever, chills, body aches, dizziness, couldn't walk, lack of appetite, weak  Dose 2, High Fever 103, chills body aches, dizziness, nauseous, fainted twice, had to call 911, disoriented, couldn't answer questions early on
Day 1 after injection-numbness of left arm for 1 day Day 7 after injection-runny/stuffy nose, chest congestion, headache, numbness of left arm returned
No Adverse event; Temperature excursion; This spontaneous report was received from a medical assistant and refers to a 13-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 23-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W006412, expiration date: 23-FEB-2024, administered intramuscularly (IM) in right thigh for prophylaxis (strength, dose, and frequency were not provided). It was reported that the vaccine had undergone temperature excursion and it was stored in the temperature range -14 to -10 degree Celsius by 1 hour on 20-JAN-2023 (product storage error). No additional adverse event (AE) reported.; Sender's Comments:  US-009507513-2303USA002114:MSD
Information has been received form a 62 year old female physician with osteoporosis who on 08-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Lot # and expire date not reported), intramuscularly. Physician stated that immediately after ZOSTAVAX administration on 08-JAN-2011, she experienced pain and itching in her upper arm near the injection site specially the dorsal side. The next day on 09-JAN-2011, her entire arm was involved. During the next 3-4 weeks she had lessening of the injection site pain and more triceps pain with swelling and tenderness. Physician stated that at the time of the report, some pain and swelling continued. On 08-FEB-2011, physician developed a non-traditional shingles-like rash across her abdomen. Physician was treated with acyclovir and mentioned that a private physician ordered "testing" of the rash immediately after it developed, but she had not received the results. Physician sought unspecified medical attention. At the time of the report, physician was recovering. Follow-up information was received form a questionnaire and the female physician and informatics with allergy to sulfa, osteoarthritis, no illness at the time of vaccination, no recent exposure to chickenpox or herpes zoster and a history of chickenpox at the age 5 year who on 08-JAN-2011 at 9:30 a.m was vaccinated with the first dose of ZOSTAVAX (Lot # 669406/13572 and expire date not reported), 0.65 ml, intramuscularly in the lower border of the left deltoid. Physician stated that on 08-JAN-2011, shortly after ZOSTAVAX administration at 9:30 a.m, she experienced severe left arm, dorsal and ventral pain (deep ache) that lasted 4 weeks, unremitting. The pain gradually became more focal over the triceps and at the first week on approximately 15-JAN-2011, she was unable to lift her arm with the 2 degree pain. By 6 weeks on approximately 18-FEB-2011, the pain was completely resolved. On 08-FEB-2011, a typical zoster rash appeared (vesicles on an erythematous base) on the abdomen, the dermatome had a T10 distribution of 4 patches but there was no pain and no systemic symptoms. At the time of this report, the rash was primarily macular, the vesicles had always been more papular, there was no fluid and patient was a 90% recovered since her skin remains hyperpigmented in the 4 areas but papulas had resolved. There was no a recent exposure to chickenpox or herpes zoster. The maximum temperature was 97F degree. No fluid for culture was collected but a swab of maculopapular area was taken, negative for Polymerase chain reaction (PCR), direct fluorescent antibody (DFA) was none. No photo was taken. The physician sought medical attention by a doctor visit. Additional information is not expected.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION APPROVED FOR AGES 5-11YO. CLIENT SHOULD'VE RECEIVED PFIZER GRAY CAP FORMULATION OF 0.3ML DUE TO BEING 12YO.
Patient arrived at clinic requesting a COVID booster vaccine.  The vaccine administer/healthcare professional informed the patient that they only had the Janssen Vaccine (Johnson & Johnson), which the patient replied that it was fine.  After the healthcare professional completed the questionnaire with the patient they then administered the Janssen Vaccine.  It wasn't until the patient had left the clinic that the healthcare professional realized the the patient was only 15 years old.  No immediate symptoms were noted at the time of the vaccine.  Patients parents were immediately notified of the event that had occurred, in which five hours later the parents have reported that the school nurse stated the patient was having body aches.
LEFT THIGH 1.5CM INDURATION AT SHOT SIGHT,  RED AND PURPLE BRUSE INNER L THIGH
Pt devel persistent crying w/in 2 hrs p/DTP/OPV/HIB which lasted > 3hrs; Pt was seen in ER no tests done;
Within 5 minutes of having vaccine administration both times , my right arm experienced pins and needles as well as burning sensation. ( my L was the vaccine site. ) Accompanied by  right arm feeling weak and slight slurred speech.  This stopped after 10-15 minutes. Since 1/7 though I have had daily sensations of pins and needles in bilateral lower extremities as well as upper extremities that is not constant but intermittent throughout the day , there  is also daily joint pain or discomfort and muscle weakness. I have intermittent episodes of extreme fatigue, slurred speech, weak heavy right arm, cognitive brain fog issues with word recall .  My heart rates have been as low as 40's daily since january which is new as im usually mid to high 50's and 60's.  GI distress daily, abd pain or discomfort , loose stools
Morning after receiving vaccine, the area in axilla of R arm, same side vaccine was given, is inflamed but tissue is soft, no lumps noted. States is painful and seems to be getting bigger.
Induration and erythema at injection site, started 1 day after injection, and increasing in size on day 4. No cellulitis.
Menstrual period after menopause; Pain; inflammation; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Menstrual period after menopause) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN for an unknown indication.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Menstrual period after menopause) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain), INFLAMMATION (inflammation) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Menstrual period after menopause), PAIN IN EXTREMITY (Pain), INFLAMMATION (inflammation) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear cervix normal: normal (normal) it was normal to try to discard cancer.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took a vaccine after 2 week later had menstruation after being menopause and one week later had another episode of menstruation. She did not have menstruation again.  Company Comment  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.; 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.
This was a cluster of eight patients who experienced adverse events after administration of intradermal FLUZONE (lot number not reported) instead of a TB test. One patient had been identified and captured in this case. The other seven patients were captured in case number 2012-03923. Initial report was received from a health care professional, who was also the patient, on 12 April 2012 which also involved a case of misuse (wrong route of administration and wrong drug administered). A female patient (age and date of birth not reported) had received a 0.5ml intradermal injection of FLUZONE (lot number not reported) instead of a TB test in March of 2012. In March of 2012, the patient experienced immediate burning and itching, cellulitis at some degree, pain from the axillary area down arm to hands, numbness and tingling into arms and hands which is intermittent and a lump at the injection site. The patient had no illness at the time of vaccination. Concomitant medications and past medical history were not reported. Out of the eight total patients, three patients were still having symptoms and five patients symptoms had resolved. This patient's outcome was not reported. Documents held by sender: None.
chills, achy bones, stomach pain between ribs, esophagus raw;hospitalized d/t severe pain
Condition aggravated; Vaccination site pruritus; Vaccination site erythema; hives; Skin nodule; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Skin nodule), URTICARIA (hives), CONDITION AGGRAVATED (Condition aggravated), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced SKIN MASS (Skin nodule). On 12-Mar-2021, the patient experienced URTICARIA (hives) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 13-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PRURITUS (Vaccination site pruritus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]) at a dose of 25 mg at bedtime and LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form once a day. On 12-Mar-2021, SKIN MASS (Skin nodule) had resolved. On 15-Mar-2021, VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. At the time of the report, URTICARIA (hives), CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up information received contains Significant follow up - updated Gender of the patient.
Pt reported feeling new onset dizziness 10 minutes following administration of second dose of the Pfizer vaccine. Clinical staff requested assistance from on site EMS. VS taken and were reported WNL. Pt condition improved with administration of H2O, candy and rest. Patient able to leave independently following  period of observation.
This is a spontaneous report from a contactable physician communicated to a Pfizer representative. The physician informed that another physician's patient (age, gender unknown) received PREVNAR 13 on an unknown date. On an unknown date, the patient required hospitalization due to high fever after immunization. Outcome of the event is unknown.
pt admitted to hosp after a syncopal spell with facial trauma; found to be positive for COVID; O2 supplementation; given remdesivir, dexamethasone; respiratory status worsened; transferred to ICU; found to have bilateral occlusive DVTs; given Lovenox; changed status to DNR/comfort care; pt passed away in the hospital
fever; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications. The patient experienced fever on an unspecified. The reporter reported that her son who was fine yesterday but woke up this morning with a little fever. She added his COVID-19 test came back "inconclusive" and they are waiting for the PCR. She said his doctor specified that her son wouldn't have been contagious yesterday, since his symptoms began today. She asked if her mother could get her second dose as scheduled given this potential exposure to COIVD-19date with. She asked if she can be around her son who may have COVID-19, since she has received both doses of the COVID-19 vaccine around 3 weeks ago. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive. Outcome of the event was unknown.   No Follow-up attempts are possible: information about lot/batch number cannot be obtained.
Dull ache, numbness and weakness of left arm (injection arm). Numbness and weakness resolved after 2 days. Achiness lasted 3 days. All symptoms resolved.
No adverse effect, but I am reporting because she was erroneously given vaccine for ages 3 and up, and she is only 2 years 10 months old.
Information has been received from a health professional concerning a 31 month old male who on 12-AUG-2005, at 4:05 p.m., was vaccinated with a first dose in the left arm of Varivax (Oka/Merck) (Lot# 649261/0587P). On 22-MAR-2006 the patient broke out with less than 50 lesions. It was reported that the patient recovered. Additional information is not expected.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 2-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536: