chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4-Apr, 20:00 - pain at injection site, numbness in right ring and pinkie fingers.  Numbness cleared after vigorous flexing of hand.  Repeated symptom and solution throughout night. Treatment: see above 5-Apr, 02:30 - pronounced pain at injection site and right hip (site of existing injury) radiating to groin, nausea (without vomiting), alternating hot flashes and chills, generalized muscular discomfort.  Treatment: OTC painkiller (Tylenol) 5-Apr, 04:00 - Headache, sound of rushing blood in right ear.  Treatment: none
pt recvd vax; cellulitis, lump at site; tx w/ warm compressed & benadryl;
Nausea; vomiting about 3-4 days after vaccination; Fatigue; This is a spontaneous report received from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 13:00 (at the age of 21-years-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included Aller-Zyr (as reported), diphenhydramine (Benadryl), fluoxetine (MANUFACTURER UNKNOWN) for an unknown indication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 15Mar2021 at 22:00, the patient had experienced nausea, vomiting about 3-4 days after vaccination and fatigue as well. The patient did not receive any treatment for the reported events. Adverse events resulted in in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events nausea, vomiting about 3-4 days after vaccination and fatigue was resolved on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
Nurse reporting 3cm x 3cm raised area below injection site warm to touch itches, nurse contacted Dr. Patient was given Benadryl.
Had sore arm days 1-5; day 7-12 COVID arm; day 14 started to have tight muscle around mid section and back; then started to have partial loss of taste and smell up to this time.  I had a COVID test and tested negative. I do not have any other kind of infection or cold.
Fainted. Placed supine, initially hypotensive 110/62 & recovered quickly (120/70).
Extremely bad muscle and joint pains for approximately 16hours. feverish, weak, headache approximately 16 hours in duration. Blotchy type rash with itching developed at injection site and spread below site about an inch or more. This developed or was noted about 14 hours after injection done on the 23rd. Area still sore,silghtly swollen and itchy today 10/26.
Information has been received from a registered nurse concerning a 64-year-old male, with no pertinent medical history or allergies, who on 27-SEP-2007 was vaccinated subcutaneous with a "single dose" of zoster vaccine live (Oka/Merck) (lot # 658081/0743U). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 31-MAR-2008 the patient developed shingles. The rash appeared on the patient's hip and buttocks and because of the pain and tenderness around the rash he has a hard time walking. The patient was seen by the physician. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Child has Dravet's Syndrome. Physician provided script requesting child receive his immunizations, except Dtap. He is to receive Dt instead. He has history of seizures, almost monthly. Had been seizure free since 9-25-07. Mom reported on 11/21/07 that child had a total of 7 seizures the evening after his immunizations. Mom states he didn't have a fever until the following evening, but started seizing.. was taken by squad to hospital and intubated. He spent 2 days in the hospital and was released. 4/7/08-records received for DOS 11/15/07 and 12/22/07-Short stay for increased seizure activity most likely due to AFI.  Presented to ED with 24 hour history of acute febrile illness.
This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. The patient's pertinent medical history and current conditions were not reported. On 02-MAY-2016 the patient was vaccinated with first dose of VARIVAX (lot # L023588, expiry date not reported) (dose, route of administration were not reported). No other vaccine was administered on 02-MAY-2016. The reporter stated that as per patient's mother on an unknown date in May 2016, one to two days post vaccination, patient experienced a fall and had a cut finger (fall and injury). The patient was taken to unspecified emergency visit on 05-MAY-2016 for suturing of cut on finger at which time unspecified blood work was taken from patient. The reporter stated that patient's platelet count was not elevated, it was decreased to 67 (units not reported) (platelet count decreased). The reporter stated that the patient is due to come into office for repeat blood work. The outcome of the events was not reported. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Pain, redness, swelling. The patient iced the injection site and took acetaminophen and is feeling better.
The patient passed out approximately 5 minutes after receiving the Fluvirin vaccination. The patient fell slowly to the ground. He experienced minor spastic convulsions but remained conscious. His blood pressure and heart rate returned to normal within a few minutes. Paramedics were called and arrived within 5 minutes but the patient was stable and was given permission to return home.
Felt severe hot flushes  after the covid-19 vaccination, which lasted for about 2-3 days.
No additional AE; expired MMRII was administered to a patient on 11/3/2023, and it expired on 10/15/2023; This spontaneous report was received from a nurse referring to a 21-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditio9ns and concomitant medications were not reported.       On 03-NOV-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 mL/once, recombinant Human albumin (rHA) lot # W034714 expiration date reported as "15-OCT-2023", but upon internal determination established as 18-OCT-2023, for prophylaxis (strength, route of administration and anatomical location were not reported) (expired product administered). It was confirmed that no temperature excursion on this product. It was also confirmed that no side effects symptoms were reported and no additional adverse event (AE).
Patient stated that her entire upper left arm was swollen and hot to the touch starting on Friday April 22, 2022.  She said she applied ice but used no other treatment.  Her arm was swollen today Monday April 25,  2022 when she presented back at the pharmacy.  I suggested she try taking some Benadryl, Tylenol, and use hydrocortisone cream for the itching and to follow up with a medical provider if no relief.  Patient was from out of town and did not want to see a provider.
I would like to report an error that occurred in our facility in our NICU. We had an order that read HBIG 0.5 ml IM x 1. The pharmacist entered HIB or Hib titer (H Influenza), The baby received the incorrect vaccine with no adverse outcome. There was no harm to the pt, and the correct vaccine was given. However, it was written as the same abbreviation. I am sure the error was due to abbreviation confusion. The nurse taking over care of the baby discovered the error. She found it in the trash at the babies bedside. I have educated the NICU staff and physician about using this abbreviation. I know it is not on the list of unacceptable abbreviations, but would like to get this information out to others as a learning tool. I believe that abbreviations should be avoided in most instances.
Information has been received from a registered nurse concerning a 16 week old patient who was vaccinated PO with the first dose of ROTATEQ (no lot# provided). No adverse event was involved. There was no product quality complaint. Additional information has been requested.
I?ve had dizziness in the morning and at bed time. The room spins. Today, 4/19, I couldn?t even take my kids to school/daycare in the morning because the dizziness was so bad.
Patient became anxious, c/o throat irritation, throat and chest tightness.  Patient monitored for longer period of time and permitted to go home once symptoms resolved.
101.5F fever; Arm soreness; injection site hardness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm soreness), INJECTION SITE DISCOMFORT (injection site hardness) and PYREXIA (101.5F fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21B) for COVID-19 vaccination. Concomitant products included VITAMIN D3 for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Arm soreness) and INJECTION SITE DISCOMFORT (injection site hardness). On 21-Mar-2021, the patient experienced PYREXIA (101.5F fever). At the time of the report, MYALGIA (Arm soreness), INJECTION SITE DISCOMFORT (injection site hardness) and PYREXIA (101.5F fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment was provided. Reporter did not allow further contact.
After 1 min of receiving  Pfzier COVID Vaccine pt was dizzy. Then sweaty and calmy. Pt sat and drank water and after a few minutes cold pack on back of the neck helped the dizziness and sweatiness.  Pt was in vaccination room for about 5 mins and then felt better.  She sat outside for another 5 mins.  She felt better and was up and shopping. Called in late afternoon to follow up, left message for patient and to take APAP for muscle soreness and any flu like symptoms
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.55.  No concomitant medications were reported.  On 11-JAN-2021 Excursion time was reported at 02:00 P.M with  temperature as 35  degrees. Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-JAN-2021, vial was moved to clinic on 11-JAN-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. No treatment information was provided.
Patient had an allergic reaction to the ZOSTAVAX. Pt. developed a red oval area 3x4 long. It was also swollen. Pt. complained of Hx of fever which was relieved by TYLENOL. Will follow up w/pt. - to take BENADRYL for allergic reaction. Pt will also f/u w/Dr. I contacted Dr. in regards with no other concerns.
heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     It was reported that a patient had a heart attack after taking the Moderna COVID-19 vaccine.   No treatment medications were reported.  Company Comment :This is a spontaneous case concerns an adult female patient of unspecified age, with no relevant medical history reported, who experienced the expected serious (medically significant) AESI event of Myocardial infarction that occurred on unspecified day after a dose of mRNA-1273 bivalent BA4-5 vaccine. Vaccination dose number and vaccination schedule not disclosed. The event outcome was reported unknown. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 bivalent BA4-5 vaccine is not affected by this report.
This spontaneous report as received from a health professional refers to a 13-month-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning an about 5 months old patient who was vaccinated with the second dose of ROTATEQ. A couple of months ago, in 2008, the patient experienced intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. Intussusception was considered to be an other important medical event by the physician, as the patient underwent an enema. Additional information has been requested.
Received vaccine 1:45pm. Because of her known allergies, she was set for a 30 minute Observation. Symptoms began 1:55pm. Pt began wheezing, complaining of shortness of breath. At 1:56 she was given 3 puffs from an Albuterol inhaler.  At 1:58 she was given 0.3mg Epinephrine. Symptoms started to improve. An ambulance was called. By 2:20 her symptoms were gone, ambulance took her to ED.
Patient had Gross hematuria after BOTH his first and second vaccination.  Onset was 24 hours.  Hematuria was confirmed in lab.  Patient underwent a complete hematuria work-up including CT with and without Contrast abdomen and pelvis and cystoscopy without other cause found
Injection site swelling, erythema, bruising & itching at left shoulder. Vaccine given 1-4-12 & symptoms still present at discharge 1-6-12.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech,vaccine dose number=4; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2022 as dose 4 (booster), single (Lot number: Git9702) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 015M20A), in right arm, on 24Mar2021 as dose 2, single (Lot number: 031A21A), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: 032H21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing), notes: Breast cancer survivor; "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meperghan, reaction: "known allergies: Meperghan"; Reglan, reaction: "known allergies: Reglan"; Ketek, reaction: "known allergies: Ketek". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2022, outcome "unknown", described as "vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech,vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2023) Positive; (08Feb2023) Positive; (14Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Fever of 101.1. Baseball sized red lump at injection site, extreme fatigue, hives.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 26-JUN-2018, the patient was vaccinated with a properly stored but expired RECOMBIVAX HB injection, lot # M008551 and expiry date 02-JUN-2018 (strength, dose, route and frequency were not reported) (Expired product administered) for prophylaxis. No adverse effects were reported. This case was determined to be non-valid due to the lack of patient's identifier. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow-up information was received from physician on 06-JUL-2018 refers to a 21-year-old male patient. Patient had a nonreactive result for hepatitis B surface antibody despite 3 dose series given in first year of life. The patient needed to be given another 3 dose series from medical school. On 26-JUN-2018, the patient was administered two 0.5 ml vials of RECOMBIVAX HB (to administer vaccine as 1 injection) at left deltoid by intramuscular route from lot M008551 (expiration date 02-JUN-2018) and lot N002914 (expiration date 04-NOV-2019). Concomitant therapy included testosterone. Expiration date was checked on 1 vial prior to administration but not on second one. After administering vaccine, noticed that the second vial had a different lot # and expiration date. Internal studies indicated that vaccine still effective as on date given. Patient will be having repeat hepatitis B surface antibody titer drawn after 3 dose series. Office that supplied vaccine notified of expired stock. Patient also informed of event.
ONE WEEK AFTER 1ST VAX (IM,DELT)SHE DEVELPD HIGH FEVER,ACHINESS,HEADACHES. PHYSYCIAN TREATMENT UNSPECIFIC. OUTCOME:UNKNOWN. PHYSICIAN DECIDED PT WILL NOT RECEIVE FURTHER DOSES OF ENGERIX-B. EVENTS CLEARED ON 3-17-90.
Patient had severe pain in the shoulder and arm. She was unable to move her arm soon after getting the shot because of the pain. She also had bruising halfway down the inside of her arm (4 to 5 bruises) Pain started to subside about 36 hours after getting the shot
Initial unsolicited report received from a Nurse manager on 27 September 2016. This case involves a female patient (age not reported) who was vaccinated with a dose FLUZONE QIV (batch number: UI643AE, expiration date: 30 June 2017 and dose were not reported) intramuscularly in left deltoid on 22 September 2016. Patient had no Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 22 September 2016, within two hours and fifteen minutes following the vaccination, the patient developed a severe anaphylactic reaction and symptoms of difficulty breathing, widespread hives and tongue swelling. On 22 September 2016, patient was taken to the emergency room visit and was admitted to the ICU (intensive care unit). Lab data was not provided. Patient's corrective treatment was not reported. On an unknown date, patient recovered from the events. It was reported that patient was discharged (next day) on 23 September 2016. List of documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Onset of chills, then progressed to sore throat, headache, then 3 days later vomiting, then followed for a sore throat and cough for 3 more days, for a total of 5 days total illness.
Vaccination 2-12-21 chest pains 2-12-21 evening heart attack 2-13-21 Flown from first hospital to second hospital 2-13-21 night stent applied, breakout in rash and hives on 2-17 severe.
Pt had an appointment with her cardiologist 4/15/2021 and no changes in patient's health noted states daughter.  Patient performed yard work at noon 4/16/2021 and developed chest tightness that was relieved by rest. After patient's nap at noon no more chest discomfort occurred. Patient went to bed that night and husband noted she was sleeping comfortbly with no breathing difficulties at midnight.  At 3 am husband found patient cold and she had expired.
Pruritus erythematous hives  on all extremities, back, butt, underarms, and abdomen within 8 hours following the pfizer vaccination.