chrisvoncsefalvay/vaers-outcomes huggingface dataset:
38.0 C fever; malaise; generalized fatigue; muscle cramps; chills; headache; general myalgia; injection site pain; mild exacerbation of underlying allergic asthma; mild exacerbation of underlying allergic asthma; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received BNT162B2, (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included allergic asthma. The patient had no concomitant medications. Historical vaccine included BNT162B2 (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced 38.0 c fever, malaise, generalized fatigue, muscle cramps, chills, headache, general myalgia, injection site pain, mild exacerbation of underlying allergic asthma on an unspecified date and all resolved within 48 hours. The patient underwent lab tests and procedures which included pyrexia: 38.0 c on resolved within 48 hours. The outcome of the events was recovered on unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Info has been received from a medical assistant concerning a pt who in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641116/1160L). Approx 24 hours later, the pt presented to the doctor's office with a large red welt at the injection site that extended across the arm. A similar adverse experience occurred in a second pt (WAES #0210USA01132) and the reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Pt was asymptomatic, was swabbed for COVID for transfer to SNF. Pt came into to hospital for AKI.
The pt experienced screaming for 6 hours after receiving vax. The screaming started 1 hour post injections. The MD has stated that the Pertussis vax should not be given.
Injection site swelling, bruising and warm to touch with red streaks going down right arm to wrist with sharp pain radiating to neck with right ear ringing.
Patient received 2 vials of liquid adjuvant; Patient received 2 vials of liquid adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 24LA3, expiry date July 2023) for prophylaxis.   On 11th May 2022, the patient received Shingrix. On 11th May 2022, 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: 11-MAY-2022 Reporters comment: The patient was administered 2 vials of liquid adjuvant instead of 1 adjuvant and 1 powder. No side effects were reported at the time of reporting. Additional supportive information: The patient was administered 2 vials of liquid adjuvant instead of 1 adjuvant and 1 powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness at the injection site) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified, Arthritis and Drug allergy. Concomitant products included POTASSIUM, VITAMINS NOS, VITAMIN D NOS, POLYCARBOPHIL CALCIUM (FIBER) and PARACETAMOL (TYLENOL) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (mild soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (mild soreness at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unknown heart medications, unknown water pill and fiber.
At or around 7 pm, patient was getting ready to eat so beforehand I checked her temperature it was 101.4 (by ear) at that time I gave her 1.25mg of infants Tylenol and then started feeding her, while feeding her she cut her eyes to the right and wouldn't move them so I wiped her face off and tried to get her to look at me, her eyes went crossed and she wouldn't uncross them and then clenched her mouth shut and balled up both fists out to the sides of her body and got really stiff. Then she seemingly came right out of it.
Diaphoretic, tachycardia - observed by fire rescue for 30 minutes, returned to normal, cleared to go.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 78.92 years.  Concomitant products were not provided.  On 09-Feb-2021, vaccines with batch number 031L20A were moved to the fridge. On 12-Feb-2021, three vials were moved to clinic. On the same day at 09 AM, vials underwent temperature excursion with temperature 29 degrees Fahrenheit and between 10 AM to 11 AM vials underwent temperature excursion with temperature 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
PE and pneumonia  hospitalization, Heparin Drip X 2 days,  Eliquis 5 mg BID  outcome favorable Symptoms: fainting, pain in left side under the rib cage, fever shortness of breath, fatigue
Today, one week to the day after receiving my first dose of the Moderna Covid-19 vaccine, I have a red welt at the injection site.  It is hard and warm to the touch, and it does not hurt to be pressed on, but is very itchy.  It is approximately 1.5 - 2 inches in diameter.  I grew up in a rural area and it reminds me of a horse fly bite.
Complained of rash, raised welts on back of right upper thigh, itchy. Symptoms began approx. 12 hours after receiving injection.
-(RT) arm red & swollen, tender & indurated - rec'd DTaP 2 days prior to onset of s/s. - ? reaction to DTaP - vs - infection R/T late response. Tx: ibuprofen q 6 hours with food & OMNICEF (250/5) 6 ml/qd x 10d.
pt moved from LTC to SNF (Rehab Center) due to testing positive for COVID; diarrhea and confusion; moved to isolation for treatment on 1/8/22; 1/17/22 pt became more lethargic, chest congestion, cough, decreasing O2 sats; general decline in condition; family declined hospitalization transfer; pt given O2 supplementation and IV ABX; pt passed away in the SNF; death certificate and med records sent per VAERS request
When pt returned on 9/2/03 for a physical exam, she reported that she lost consciousness while in the shower at home the evening following her tetanus (Td) booster. No witnesses. No memory of event after loss of consciousness until regaining consciousness. Sustained a bruise on her right side. No other effects known or reported. Previous seizure Jan 2003.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On 14-JUL-2015, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB 0.5 ml once intramuscular (Lot # L002867 and expiry date 04-NOV-2017, lot # K025002 with expiry date of 20-JUL-2017, lot # L002866 with expiry date of 10-NOV-2017 and lot # K015464 with expiry date of 09-JUL-2017). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning a friend of the family's child who on an unspecified date was vaccinated with MMR II, and developed autism. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
did not have immunity; did not have immunity; Intramuscular; she originally received the series in 1995/She got a booster after that; This spontaneous report was received from the 31-year-old female patient, who refers to herself. The patient's medical history was not reported. The patient's concurrent conditions included drug reactions/ allergies to cefaclor (CECLOR). Historical drugs, and concomitant therapies were not provided.  On an unknown date in 1995, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered intramuscularly (incorrect route of product administration)(strength, lot #, expiry date, and indication were not provided).  However, in 2009, she received a titer test for work and was told that she did not have immunity (antibody test negative). She got a booster (extra dose administered) after that. However, she took another titer test in 2016, and which showed again, that she did not have immunity (antibody test negative). It is unknown, when she received her booster. No further information was provided. No additional adverse event reported.  The reporter considered antibody tests negative to be related to varicella virus vaccine live (oka/merck) (VARIVAX).
Patient informed us that he has had a dull intermittent pain at about 3/10 on the pain scale since his first vaccination 04/16/2021 in his left arm. He denies having any restrictions in mobility, he states that the pain comes intermittently with activity. He denies having any restrictions in mobility or any numbness. He takes no current medications and has no allergies.  Denies having any current medical diagnoses. Patient requested to take the vaccine in his right arm today 3/25/22 and patient was okayed for his Pfizer(comirnaty) booster by MD.
Injection site reaction, redness and swelling 2 inches up and down from injection site.
Information has been received from a physician concerning a 24 month old female child, who was a full-tern, third child and was well at the time of vaccination, with a history of language delay prior to receiving the MMR II vaccine. In June 2002, the pt was vaccinated with a dose of MMR II. The physician reported that the child did not appear autistic at the time of vaccination but within weeks of receiving the vaccine the child began to avert her eyes and her language regressed. The child was seen by a pediatric neurologist who diagnosed her with autism in July 2002. Subsequently, the child started a "heavy duty" interventional program. As of 2/4/03 it was reported that the child was doing better with making eye contact and that her language was a little better. The physician stated that overall there was some improvement. Upon internal review, autism was considered to be an other important medical event (OMIC). The physician also reported another pt experienced trouble with word retrieval, being slower in language and slower in movement (WAES0301USA03157). Additional info has been requested.
Fever to 102 for 5 days after MMR and Hep B vax. Then fine. Maculopapular rash over face, trunk and ear
Patient received vaccine in the afternoon on 9/27/11. About 18 hours later started 'itching from head to toe". Had an appointment 9/28 with Dr. to discuss new diagnosis with Lymphoma. He wasn't concerned - told her to try HC cream. Seemed to help. Trying BENADRYL.
103 fever, chills, nausea, dizziness, body aches (felt like it had activated my RA that has been in remission for over 15 years), migraine headache
This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 and 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Immediately after injection patient became lightheaded and weak.  States her vision became white and she felt very tired.  Patient was sitting, no fall. Patient does not believe she lost consciousness.  Initial BP was 77/57, HR 64, O2 sat 98%, resp 14.  Patient was given water and apple juice to drink over the course of approx. 1/2 hour. BP slowly improved during that time and final BP was 101/69, HR 76, O2 sat 99%, resp 14.  Patient states sxs resolved and was able to ambulate across the hall to restroom on own.  Patient continued denying sxs and ambulated out of clinic on own.
Increased bleeding during period. The timing of my period is the same, however it started, and instantly was very heavy. Also, not only is this the heaviest flow I?ve ever experienced, but the blood is severely clotted, which I have never experienced before.
hardness, itching, redness and swelling; hardness, itching, redness and swelling; hardness, itching, redness and swelling; hardness, itching, redness and swelling; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (hardness, itching, redness and swelling), PRURITUS (hardness, itching, redness and swelling), ERYTHEMA (hardness, itching, redness and swelling) and SWELLING (hardness, itching, redness and swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INDURATION (hardness, itching, redness and swelling), PRURITUS (hardness, itching, redness and swelling), ERYTHEMA (hardness, itching, redness and swelling) and SWELLING (hardness, itching, redness and swelling). At the time of the report, INDURATION (hardness, itching, redness and swelling), PRURITUS (hardness, itching, redness and swelling), ERYTHEMA (hardness, itching, redness and swelling) and SWELLING (hardness, itching, redness and swelling) outcome was unknown.            No Concomitant medications was reported Treatment information was not provided
This spontaneous report was received from a consumer and refers to her 68 years old husband with high blood pressure. Concomitant therapies included blood pressure medicine. There were no known drug allergies. On 30-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot #, dose and frequency not specified) subcutaneously. On 17-JUL-2015 the patient began to experience pain and on 19-JUL-2015 developed shingles rash. The reporter stated that the rash was on the chest wall under the arms, across the back and ended at the spine. The shingles was treated with an unspecified antiviral, prednisone and unspecified pain medication. The rash stopped spreading as of 23-JUL-2015. The patient sought medical attention by calling the doctor's office. There were no laboratory tests performed. The outcome of the event was reported as not recovered/not resolved, also reported as the patient was doing slightly better. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Immediate: rash, fever, crying, no sleep, sounds of distress, diarrhea. The same week of vaccine: lower muscle tone, regression of development, lost skills, lost speech, staring, flapping of hands, spinning, no longer responded when called by name, fixation on objects
woke at 6am on 2/7 with chills and cold sweats, some minor body aches.  started vomiting at approximately 8am and continued to vomit every hour or two until about 4pm.  heartburn and nausea throughout the day.  could not even keep sips of water down.  feeling a little better as I type this at approximately 5:30pm
felt a little tingling after the injection; couldn't lift up her arm; arm was sore; massive pain in arm not just injection site, whole shoulder area; lots of vomiting; 2 lymph nodes in the left armpit; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (felt a little tingling after the injection), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (couldn't lift up her arm), PAIN IN EXTREMITY (arm was sore; massive pain in arm not just injection site, whole shoulder area), VOMITING (lots of vomiting) and LYMPHADENOPATHY (2 lymph nodes in the left armpit) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (felt a little tingling after the injection), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (couldn't lift up her arm), PAIN IN EXTREMITY (arm was sore; massive pain in arm not just injection site, whole shoulder area), VOMITING (lots of vomiting), LYMPHADENOPATHY (2 lymph nodes in the left armpit) and MYALGIA (body aches). At the time of the report, PARAESTHESIA (felt a little tingling after the injection), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (couldn't lift up her arm), PAIN IN EXTREMITY (arm was sore; massive pain in arm not just injection site, whole shoulder area), VOMITING (lots of vomiting), LYMPHADENOPATHY (2 lymph nodes in the left armpit) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: pending result (Inconclusive) pending result (to rule out breast cancer). On an unknown date, Ultrasound scan: lymph node (Inconclusive) lymph node. On an unknown date, X-ray: lymph node (Inconclusive) lymph node.     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 medication was not reported. After 5 hours, the patient had such massive pain in her arm, not just the injection site, it was the whole shoulder area. She couldn't lift up her arm to put on her bra; she was guessing it was because the lymph nodes swelling up so bad.
Sclerotic right eye; Severe headache; This case was reported by a nurse via call center representative and described the occurrence of scleritis in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number C7EX2, expiry date unknown) for prophylaxis.   On 20th July 2020, the patient received the 1st dose of Shingrix. On 23rd July 2020, 3 days after receiving Shingrix, the patient experienced scleritis (serious criteria GSK medically significant) and headache. The patient was treated with indometacin (Indomethacin). On an unknown date, the outcome of the scleritis and headache were unknown.   It was unknown if the reporter considered the scleritis and headache to be related to Shingrix.  Additional details were reported as follows: The patient developed an sclerotic eye (right eye) and severe headache 3 days after vaccination. On 27th July 2020, she attended a walk in urgent care facility due to the adverse event. The patient then attended an emergency room on 30th July 2020 and again on 31st July 2020. The patient was derived to an ophthalmologist on 31st July 2020 and was prescribed with indomethacin.  The reporter consented to follow up. The batch number was reported as C7EY2 however it was updated to C7EX2 as per sales data sheet.