chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in the arm achness around injection site itchy around the ears, in ears and itchy spots in throat around lips and face body felt numb
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of improperly stored ROTATEQ (orally, lot # M006111 with expiration date 18-NOV-2017, lot # M019706 with expiration date 24-OCT-2017, lot # M019707 with expiration date 18-NOV-2017, lot # M004508 with expiration date 29-JUN-2017; dose was not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in 34.71F for 24 hours and previously in 32.28 F for 8 hours and 46 minutes as well as 29.29 F for 96 hours. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1612USA013574: US-009507513-1612USA008513.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information reported. Date of Refrigeration5/7/2021.
T- 102.4, with TYLENOL & MOTRIN (max doses) sponging with cool water, vomiting & diarrhea for over 12 hours.
Chills,body ache,extreme tiredness,pain in vaccine arm,and nausea
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-JUL-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX (lot # L045953, dose and route of administration were not reported). Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  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.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   ).
First vaccine was Pfizer on 1-15-21 and 2nd dose was Moderna on 2-5-21
febrile convuls for 20 mins; taken to ER by ambulance; adm to hosp, no other sz while in hosp; 22OCT93 f/u EEG nl;
Spoke with the patient noting emesis starting 12 hours after the injections. Noting 13 episodes between today and yesterday. She is not able to keep any fluids down. Noting she urinated yesterday afternoon and then the next time was 7PM tonight. Noting she is very weak and sleeping most of the day along with feeling dizzy.
1633 - patient c/o dizziness and tingling to lips. 1641 - BP 167/63, pulse 80, anxious, Benadryl 25 mg PO administered. Requested water, 2 bottles given. 1643 - BP - 142/91, pulse 75. RN continue to monitor. 1700 - States feels much better.  No further complaints voiced, continue to closely monitor. 1707 - Discharged to home in stable condition.
LOSS OF TASTE; LOSS OF SMELL; DEEP COUGH; This spontaneous report received from a patient concerned a 64 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 (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-SEP-2021, the patient experienced loss of taste. On 06-SEP-2021, the patient experienced loss of smell. On 06-SEP-2021, the patient experienced deep cough.  On 17-SEP-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from loss of taste, loss of smell, and deep cough. This report was non-serious.
This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 58-year-old male patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 9th January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicular rash and skin lesion. On an unknown date, the outcome of the vesicular rash and skin lesion were not recovered/not resolved. It was unknown if the reporter considered the vesicular rash and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The patient experienced multiple shingles like lesions on extremities after second dose of SHINGRIX vaccine. The SHINGRIX batch number was reported as 3Z53, however based on a batch number review, the batch number was corrected to 3Z53C. No further information provided.
Rash across abdomen  and neck with raised bumps.  2days of moderate rash following 1 days of body aches.  Days of rash subsided..several bumps had scabs.  Non itchy rash..so there was no scratched.
Information has been received from a licensed practical nurse concerning her 12 year old granddaughter with no pertinent medical history and no known drug allergies who was vaccinated with the first dose of GARDASIL "2-3 weeks ago" (approximately 28-JUL-2009) (dose, route, and lot# not reported). There was no concomitant medication. The nurse reported that the patient was experiencing depression and mood swings. The nurse did not think this was related to GARDASIL and thought her granddaughter might be getting her monthly cycle. No lab diagnostics study was performed. The patient sought medical attention through a telephone call to the nurse. At the time of the report, the patient's outcome was unknown. No further information is available.
Redness on injection site; Swelling on injection site; Chills; Fever of 101; Body Aches; Swelling in the arm pit; Rash in the thigh area.; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness on injection site), injection site swelling (Verbatim: Swelling on injection site), chills (Verbatim: Chills), fever (Verbatim: Fever of 101), general body pain (Verbatim: Body Aches), local swelling (Verbatim: Swelling in the arm pit) and rash (Verbatim: Rash in the thigh area.). The outcome of the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash were not reported.   It was unknown if the reporter considered the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, chills, fever, general body pain, local swelling and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2023 The patient (nurse) was the reporter. The patient received the1st dose of Shingrix recently. After the vaccination the patient experienced chills, fever of 101, body aches, redness and swelling on injecting site, swelling in the arm pit, then a rash in the thigh area. The patient consented to follow up.
Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
severe migraine; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored program.  A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot unknown), at single dose via an unspecified route of administration on 22Feb2021 for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications.  The patient experienced severe migraine which she never felt before on an unspecified date in Feb2021 with outcome of unknown.  Took Tylenol already, and asked if she can still take some more. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with GARDASIL, COMVAX, PNEUMOVAX 23, or ROTATEQ stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Additional information has been requested.
positive side effect that I have had from the booster; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (positive side effect that I have had from the booster) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (positive side effect that I have had from the booster). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (positive side effect that I have had from the booster) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Patient was just curious if other people with my condition have had the same.
The day of vaccine given Ampicillin and Tramadol/acetaminophen for sore throat and earache. Right  away by the afternoon problems began. Felt very weak so went to bed. Right away paralyzed, lots of pain, headache, all joints very sensitive. Massaged arm until sensation came back. Symptoms continued, had fever 100 degrees-102 degrees before going to ER. On 1/10 went to ER. On ER they ran scan/x-rays. The discharge summary mentions angina, gallstone, tension headache. In the ER they gave her 2 aspirins for heart, TYLENOL X - 500mg, also received metoclopramide and acetaminophen and nitroglycerin. Came home rested because would get dizzy. Went to the doctor on 1/18 as follow-up to ER. By then felt better and was able to move more. Today still dizzy, tired a lot but on her way to recovery.
Headaches, Nausea, Could not look at screens (computer, television, projector-for college teaching). Symptoms were EXACTLY the same as those I had with a very mild case of shingles (January 2021). These symptoms were much more intense and longer lasting (symptomes lasted 6 weeks).   Prescribed Ondansetron (4 mg) 3 times a day with Dramamine. Advil for headaches.  NO POSITI VE OUTCOMES for 6 weeks. Symptoms gradually subsided after that.
@ time of vax hurt going in, like a bee sting which has never occurred before;by 9PM site was red & uncomfortable;next morning fever, red about 2" diameter;following day redness gone;mild h/a;
Had Flu High Dose vaccine in L deltoid. Presented to Health Department 10/17/2012 @ 4:30 p.m with c/o soreness, redness and pain of L arm. States better today.  "Just wanted to get arm loooked at today."  Public Health Nurse noted redness @ top of elbow to mid deltoid.  No redness @ injection site.
Erythema and tenderness of 20x20cm area of (L) thigh which was indurated, warm and tender. Augmentin and cold compress were prescribed.
Case number PHEH2014US017807, is an initial spontaneous report from a nurse received on 03 Sep 2014 with a follow-up from a health care professional received on 07 Oct 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. Past vaccination included administration of MENVEO (batch number: unknown) on 24 Jul 2014 which was tolerated. On 02 Sep 2014, at 5:13 pm, the patient was vaccinated an intramuscular dose of MENVEO (batch number: A13058) into left deltoid where MenA lyophilized conjugate component reconstituted with a sterile diluent (other than MenCWY). No adverse event was reported following this administration error (wrong solution used in drug reconstitution). Follow-up from a health care professional received on 08 Oct 2014: Patient's demographics (height and weight), reporter details, vaccination history, site and time of vaccination were updated.
Very large area on arm, much larger than injection site has become red, inflamed and warm to the touch. I advised to patient to contact her doctor
Heart palpitations have been consistent starting days after my second dose, this happens every couple of minutes. I have mild chest pain over my heart that comes with a sharp pain.
red spot on left hand; white pustules on left hand; painful to touch, left hand; Painful rash on left hand and small rash patch on right hand; Lymph node on underarm on left side swollen; Swollen lymph nodes on both sides of neck; tingling in both hands; Numbness in both hands; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in both hands), LYMPHADENOPATHY (Swollen lymph nodes on both sides of neck), PARAESTHESIA (tingling in both hands), ERYTHEMA (red spot on left hand) and RASH PUSTULAR (white pustules on left hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE for Contraception.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (Body aches). On 13-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in both hands) and PARAESTHESIA (tingling in both hands). On 14-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on both sides of neck). On 15-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph node on underarm on left side swollen). On 19-Feb-2021, the patient experienced ERYTHEMA (red spot on left hand), RASH PUSTULAR (white pustules on left hand), PAIN IN EXTREMITY (painful to touch, left hand) and RASH (Painful rash on left hand and small rash patch on right hand). At the time of the report, HYPOAESTHESIA (Numbness in both hands), LYMPHADENOPATHY (Swollen lymph nodes on both sides of neck), PARAESTHESIA (tingling in both hands), ERYTHEMA (red spot on left hand), RASH PUSTULAR (white pustules on left hand), PAIN IN EXTREMITY (painful to touch, left hand), RASH (Painful rash on left hand and small rash patch on right hand), VACCINATION SITE LYMPHADENOPATHY (Lymph node on underarm on left side swollen) and MYALGIA (Body aches) outcome was unknown.            The patient did not take any treatment.
Became weak and lethargic. Racing heart rate high fever and extreme night sweats. One day after injection, still very weak beginning to feel nauseous.
Toward end of dose pt went limp and became lethargic. no choking. Pt had been alert prior to vaccine and was sleepy after the episode, observed for 30 minutes. Pt was sleeping comfortable, but aroused. The rest of his vaccines were differed to another time.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (unknown strength and route). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a approximately 72 year old female patient who is also a registered nurse regarding herself. Patient's current conditions included decreased kidney function, high blood pressure, arthritis, Dermerol allergy (causes nausea), codeine allergy (causes headache), sulfur allergy ( causes ringing in the ears), Levoquin allergy (causes lockjaw), Morphine allergy and Lamisil allergy (reaction unspecified). On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). Concomitant medications included Tylenol. On an unknown date in 2013, the patient experienced shingles which caused the patient pain in her trigeminal nerve and jaw. Patient had a test for temporal arthritis (results unspecified). Patient sought medical attention spoke with nurse practitioner. The patient took a Maxalt for this pain and it went away (MARRS# 1309USA012420). The patient continues to use Maxalt to relieve pain in her trigeminal nerve and jaw. The outcome of shingles was reported as not recovered. The outcome of pain in her trigeminal nerve and jaw was reported as recovered. This is one of 2 reports regarding the same patient. Additional information has been requested.
Patient had redness at the injection site with some swelling, non-tender, temp of 102.3 on 03/02/2018. Patient seen in the office on 03/03/2018-injection site was warm, swelling, pink to the skin of the outer are blanches but firm. Did not look like a cellulitis. Give TYLENOL and cold compresses to injection site.
3 days after the covid 19 vaccine was administered my Dysautonomia worsened. My blood pressure and heart rate are all over the place from 150/96 to 87/ 52 for BP. Hear rate is from 49 bpm to 130 bpm. It has caused my whole autonomic system to worsen when I have been stabilized for many years.
Nausea, emesis, lightheaded, dizzy - Provided self-care measures for about 30 minutes and symptoms subsided. Client left with family.
Heplisav-B stored at -8°C for 38 hours; Initial Report Received on 26-Sep-2022  This is a spontaneous report, received from a pharmacist regarding a female patient, aged 40 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 19-Sep-2022, dose 1 of HEPLISAV B (Lot #935845, expiration date 06-Nov-2022, NDC #43528-0003-05), route and site not specified, was administered for hepatitis B immunisation.   The vaccine administered was reported as being stored at -8° C for 38 hours.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
11:15am Post vaccination reports feeling dizzy w/no associated symptoms reported / none noted; medical monitoring w/vitals assessment: BP 107/58 P67 RR 14 O2 sat 98% RA; rest, juice offered. 11:30am symptoms improve BP 113/88 P82 RR 14 O2 sat 99% RA; released from facility w/aunt
This is a spontaneous report from a contactable health care professional reporting on her daughter. A female patient of an unspecified age and ethnicity received fourth dose of PREVENAR (Lot number D81705) on 12Feb2010. The patient received the first dose (Lot number D21053) on 16Feb2009, the second dose (Lot number D21053) on 27Apr2009 and the third dose (Lot number D33245) on 29Jun2009. The patient has a history of sinus infections. The patient's concomitant medications were not reported. On unspecified dates, the patient continued to get sinus infections after receiving the fours doses of PREVNAR 7. On an unspecified date, the patient had titers done and was found to be deficient in protection against serotypes 1,3,8 and 9N. The clinical outcome of the sinus infections was unknown. The physician reported that the patient did not provide information regarding the reported adverse event with the use of the product. The physician cannot confirm the occurrence of the events reported by the patient. Follow up (14Nov2012): New information received from a contactable physician includes: medical confirmation (not medically confirmed). Follow-up attempts completed. No further information expected. Follow-up (21NOV2012): Follow-up attempts completed. No further information expected.
After sitting for 20 minutes I went to get up and felt dizzy, light headed and almost passed out. BP was slightly elevated and slight nausea. I felt a little ?foggy?   I went home and went to bed , I woke up at 3am with a severe headache and nothing helped it. It felt like a jackhammer  was pounding in my head. I felt very fatigued the next day. The headache lasted about 16 hours. I woke up 1/7/21 feeling better.
Left arm upper muscle, red swollen. Length of swelling shoulder to 1 inch above elbow.