chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Like burning chest; Chills; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Like burning chest), CHILLS (Chills) and OROPHARYNGEAL PAIN (Sore throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for COPD.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Like burning chest), CHILLS (Chills) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, CHEST PAIN (Like burning chest), CHILLS (Chills) and OROPHARYNGEAL PAIN (Sore throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shingles; Rash on the lower abdomen that then extended to the back and itches; Sensitive pains; Rash on the lower abdomen that then extended to the back; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), PRURITUS (Rash on the lower abdomen that then extended to the back and itches), PAIN (Sensitive pains) and RASH (Rash on the lower abdomen that then extended to the back) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HERPES ZOSTER (Shingles), PRURITUS (Rash on the lower abdomen that then extended to the back and itches), PAIN (Sensitive pains) and RASH (Rash on the lower abdomen that then extended to the back). At the time of the report, HERPES ZOSTER (Shingles), PRURITUS (Rash on the lower abdomen that then extended to the back and itches), PAIN (Sensitive pains) and RASH (Rash on the lower abdomen that then extended to the back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-261735 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added reporter's email id and address
SM noted raised red, mildly pruritic bumps on his feet in the AM and later in the day, the bumps were on his upper body as well.
After receiving the Prevnar 13 shot at around 11am, patient immediately felt lightheadedness, sweating, and increased in heart beat.
Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------- G47.30 SLEEP APNEA 3/29/2023 AORTIC VALVE STENOSIS G47.30 SLEEP APNEA 3/29/2023 CELLULITIS G47.30 SLEEP APNEA 3/29/2023 HX OF HEMORRHAGIC STROKE W UNSPECIFIED RESIDUAL DEFICITS
sore arm; injection site started to get rash; Redness; Bumpy; Mild headache; It was sore for 1st 2 days of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (It was sore for 1st 2 days of injection). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and HEADACHE (Mild headache). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy), VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) and HEADACHE (Mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were provided.  Reportedly, it was sore (at injection site) for first 2 days of injection as well but then again it started getting red, bumpy, mild headache, sore from 19-Feb-2021. No treatment was taken by the patient for the symptoms.  The patient's 2nd shot scheduled on 05 Mar 2021. Lot number: 012M20A.
pt devel erythematous macular, papular rash on back, arms, abd, legs & buttocks 11 days p/vax;
Dizziness began the day following the flu vacination and irregular and fast heart beats.  Just did not feel good.  Was dizzy sitting chair but tolerable.  Was much worse standing up and walking making me unsteady and bumping into walls and furniture.  Gathered all my medications into a paper bag in case I passed out or something and my husband might have to take me to the emergency room.  In evening before bed finally took a Dramamine to see if that would help the dizziness and help me sleep.  The next day I was still dizzy.  This is two days after the flu shot and I am still dizzy, but my heart has calmed down.
Soreness in arm within 1 hour; fatigue and body aches within 5 hours and persisting at 20 hours; stomach cramps at 12 hours until 18 hours; stomach cramps and body aches diminished with 400mg of ibuprofen at 5 hours, 13 hours, and 18 hours.
HEADACHE; FEVER; AROUND 3:30 AM, THE PATIENT EXPERIENCED SHAKING; AROUND 3:30 AM, THE PATIENT EXPERIENCED COLD AND HOT FLASHES; VOMITING WHICH WAS CONSISTENT TILL 3 AM; NAUSEA WHICH WAS CONSISTENT TILL 3 AM; ACHE DESCRIBED AS ACHENESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 10005022, and batch number: 10005022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 05:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced ache described as acheness. On 06-MAR-2021 11:00, the subject experienced vomiting which was consistent till 3 am. On 06-MAR-2021 11:00, the subject experienced nausea which was consistent till 3 am. On 07-MAR-2021, the subject experienced around 3:30 am, the subject experienced shaking. On 07-MAR-2021, the subject experienced around 3:30 am, the subject experienced shaking cold and hot flashes. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting which was consistent till 3 am on 07-MAR-2021, was recovering from fever, had not recovered from around 3:30 am, the patient experienced shaking cold and hot flashes, and ache described as acheness, and the outcome of around 3:30 am, the patient experienced shaking, headache and nausea which was consistent till 3 am was not reported. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of headache in a 26-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 21 August 2007, the subject also underwent a PPD skin test.  On 21 August 2007 the subject received the first dose of Engerix B (1 ml, unknown).  On 21 August 2007, 1 hour after vaccination with Engerix B, the subject experienced headache, chills, nausea and myalgia.  Approximately five hours later, the subject took Aleve, followed by improvement of symptoms.  On 22 August 2007, approximately 24 hours following vaccination, the events were resolved.  The healthcare professional considered the events were probably related to vaccination with Engerix B.
Child received vaccines at 0938. Fell asleep until 12:00. Woke, fed, then began crying/screaming uncontrollably. Mom gave dose of TYLENOL at 1230 & checked babies legs. (Rt) leg swollen. Child screams when moving it. 1430 mom states TYLENOL has not helped. Advised mom to try ice pack & return to clinic if not better in 4-6 hrs. 6/11/12 1445 Child's leg remained swollen throughout weekend & child remained fussy, per mom Swelling resolved in 48 hours & child returned to normal disposition. No fever noted throughout course of reaction.
my arm was sore a little bit; Reports headaches every day; Case reference number MOD-2021-013708 is a spontaneous case report sent by a Non-Health Professional on 27-JAN-2021, which refers to a Male patient aged 78 Years .  Patient received the dose for Moderna covid-19 vaccine on 21JAN2021.Later  the patient developed headache every other day. After certain days his cardiologist identified isosorbide as the cause for headaches which he stated to be resolved and developed little bit  sore in his and nothing else."  No treatment medication information was provided.   The patient was recovered without any treatment medication for headache .The action taken  for Moderna COVID-19 Vaccine for sore arm  and its outcome was unknown.   The Non-Health Professional cited in the report considered the event headache as not related to Moderna COVID-19 Vaccine. The Non-Health Professional did not declare any relatedness between headache and Moderna COVID-19 Vaccine In their opinion.   .
Malaise, myalgia, flu-like symptoms with out GI distress, shaking chills.
Additional booster: administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date. Vial was initially stored in the refrigerator on October 24, 2022 and administered to patient November 29, 2022. No symptoms.
No adverse event; expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine for their first primary series dose of the Moderna Covid-19 vaccine).    Concomitant medications were not reported.  The patient reports no other adverse events. Treatment medications were not reported.
Information has been received from a physician concerning a 13 1/2 month old patient who at 12 months of age, received a single dose of varicella virus vaccine live (Oka/Merck). On an unspecified date while the patient was 13 1/2 months old, the patient developed chicken pox. It was reported that he had developed over 50 but less than 300 lesions and a fever for 4 to 5 days. It was reported that unspecified medical attention was sought. At the time of this report, the patient on an unspecified date had recovered. A quality complaint was not reported. Additional information has been requested.
PT described arm as turning purple. Stated no pain, no issues, but arm with flu vaccine site turned slightly purple. She stated it went away after a few days but that she was concerned I may have hit a vein or something.
Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) in a 62-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 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.  Reporter stated that on 24-May-2021 vaccines were received and immediately placed vaccines into refrigerated storage and they administered this vaccine to patients after this 30 day mark. That vaccine vials were never punched until use.  Reporter also stated that patient did not report any adverse events and symptoms. And also stated that they performed an antibody test on all of the patients and antibody numbers were in the 800-900 range.
Patient stated that on July 30th he started feeling bad. His wife took him to the Er. He had an inflammation around his heart that was stopping him from breathing. The only thing that he could say was that he could not breathe. He was told it could take 4 or 6 months to recover.
thought it might be a heart attack; Sharp pain in center of chest. Noticed mild pain first; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Apr2021 09:30 (Batch/Lot Number: ew0167) (at the age of 51 years old) as 2nd dose, single dose for COVID-19 immunization. Medical history included T1 diabetic. Concomitant medications included insulin lispro (HUMALOG) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient received the first dose of BNT162B2 in left arm on 02Apr2021 09:30 (lot: er8734) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 22:30, the patient experienced sharp pain in center of chest. Patient noticed mild pain first, he considered going to hospital at peak, thought it might be a heart attack. Patient didn't have any other symptoms and it subsided so he didn't think to do anything. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on unspecified date in Apr2021.
This case was considered medically important. Additional information has been received pertaining to the reported product, patient demographics, medical history, additional adverse events, laboratory tests, immunizations and dates of administration. Information regarding Hib-Titer Vaccine was received from an attorney regarding an 18-month-old male patient who experienced bruxism, pica, PDD, autism, neurodevelopmental disorder, developmental incapacity, mental  and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The patient also received the fourth of DTaP on 29-Mar-1996. On 06-Nov-1997 the patient developed PDD, bruxism and pica. On unknown dates the patient also experienced neurodevelopmental disorder, developmental incapacity, autism, mental and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The outcome is unknown. DNA test for fragile X (results: negative) was done on 07-Jul-1997. No additional information was available at the time of this report.
Swelling and redness at injection site. Patient came back to the pharmacy, arm was red, swollen and sore according to patient.  He stated that the swelling was getting worse,  I suggested that he try taking  some benadryl  to see if that might help if it was an allergic reaction. Or if it continues to get worse to go to the MD.
tiny bumps/light pink rash that appeared on neck. itchy, but not enough to take antihistamine or report to doctor. is minor nuisance. still present 5 days after vaccination
Information has been received from a nurse practitioner for GARDASIL, a pregnancy registry product, concerning a 26 year old female with no pertinent medical history, drug reaction and allergies,  who on 21-OCT-2009 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # no reported). On 22-DEC-2009 received the second dose of GARDASIL (Lot # and route no reported) and on 08-SEP-2010 was vaccinated with the third dose of GARDASIL (Lot # and route no reported). Concomitant therapy included prenatal vitamins. The nurse reported that on 01-AUG-2010 a pregnancy test was performed which was negative. On 08-SEP-2010 another pregnancy test was performed after receiving the third dose and it was positive. No adverse events were reported. The patient last menstrual period (LMP) was on 06-JUN-2010 and the estimated delivery date is on 13-MAR-2011. Follow up information has been received from a triage nurse who reported that on approximately 20-MAR-2011 the patient delivered a healthy female neonate. Gestational age was 41 weeks. The neonate weighed 7 pounds, 15 ounces and American Pediatric Gross Assessment Record (APGAR) scores were 9/9. There were no congenital anomalies reported in OB/delivery record. Follow up information has been received from the nurse practitioner and a health professional concerning the female patient with polycystic ovarian syndrome (PCOS) and with no significant past medical history and with no previous pregnancy who was vaccinated with GARDASIL (lot # of the third dose: 0318Z). On 22-SEP-2010 ultrasound for pregnancy revealed 5 weeks and 5 days. On 19-APR-2011 ultrasound was performed (result not reported). The health professional reported that there were no complication during pregnancy and no diagnostic test during pregnancy. On 29-MAR-2011 the patient had a cesarean section due to failure to progress and delivered a normal female baby (previously reported as approximately 20-MAR-2011, gestational age was 41 week). There were no congenital anomalies and no other complications or abnormalities. Upon internal review, cesarean section/failure to progress was considered to be an other important medical event. Additional information is not expected.
Pt recvd vax & w/in 2 hrs of the inject exp 5 "herpetic type" vesicular lesions;
passed out; This case was reported by a physician via sales rep and described the occurrence of passed out in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, less than an hour after receiving Menveo, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patients fainted after receiving Menveo. The reporter stated that they encourage the patients to wait for 15 minutes after vaccination but the patients did not always wait. The patient fainted at check out window. This case was 1 of the 3 cases, reported by same reporter.
This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 68-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (received 1st dose and experienced muscle soreness, refer case US2019GSK100301). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and dermatitis (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and dermatitis were unknown. It was unknown if the reporter considered the guillain barre syndrome and dermatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 68 years old at the time of reporting. The patient experienced severe dermatitis, possible Guillain barre syndrome (GBS). The patient was in Intensive Care Unit (ICU) for 3 days and was hospitalized for 10 days. The reporter agreed for the follow up.
Extreme fatigue, rapid heartbeat (92/min laying down, 120/min standing, elevated blood pressure (156/92 laying down), feeling pressure on chest, alternating chills and feeling feverish, arm sore at injection site.
Information has been received from a health professional concerning a 9 year old female who on 02 NOV 1996 was vaccinated with one dose of varicella virus vaccine live (site unknown) (lot #617912/0782D). Subsequently it was reported that on 04 JUN 2001 the patient was diagnosed with a mild case of chicken pox. Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that the vaccine lot numbers were not similar in the other cases reported. Subsequently, the patient recovered. No further information is available.
Increasing pain and spasms in back of neck and upper shoulders. Limitation in neck rotation to the right side due to pain.  Began approximately 3 days after shot and increasing for past 11 days
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity needed to protect against covid 19 on date vaccine was administered. Also patient did not call in to advise of adverse event  This is administrative error without adverse event.
Headache, muscle pain, joint pain, fever 100.6, fatigue,chills
little bumps (swelling) on the body;(not on back & face) for few hours;pt fine;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was specified.