chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom reported diarrhea x 8 days. 10/16/06 Received medical records from PCP office which reveal patient developed watery green diarrhea for approx 11 days, completely resolved by 9/29/06 but GERD remained.  Treated w/zantac & formula change.  Dx: probable immunization reaction to Rotateq, resolved./ss This is in follow-up to report(s) previously submitted on 10/10/2006. Information has been received from a physician concerning an 8-week-old male with no medical history who on 30-AUG-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #654352/0410F). Concomitant vaccinations administered on that same day included the first IM dose of PEDIARIX (Lot #AC21B056AA), the first IM dose of ACTHIB (Lot #UE785AA) and the first IM dose of PREVNAR (Lot #B08653B). There was no illness at the time of vaccination. The physician reported that on 31-AUG-2006, the patient developed diarrhea characterized by 2-5 episodes per day. On 07-SEP-2006, the patient required an office visit. At that time, the patient afebrile and no blood was noted in his stools. No laboratory/diagnostic tests were performed. As os 11-SEP-2006, the patient's diarrhea persisted characterized by small volumous episodes occurring five times daily. Subsequently, the patient's diarrhea resolved. Additional information is not expected.
After 10 minutes of administration the patient fainted.  He was lowered to the floor and awakened almost immediately.  BP was 127/65, pulse was 63.  He was pale.  A physician was in attendance the entire time.  Once he was better he was transferred to a stretcher.  Mother stated he had been at an overnight sleep over, she had picked him up from there and came directly to the clinic.  He stated he had nothing to eat or drink that morning.  he was given water and some snacks..  MD released him when he appeared to be back to baseline.  He was seen in the pediatician's office on the 5/24/21 as a followup at the parent's request at which time no issues were found.  Patient's father had asked the pediatrician's office to see the patient following the innoculation that day which the office deferred as an MD was attending this patient in the clinic.
positive for covid; positive for covid; felt like she got hit by a truck; neck aches; back aches; Night sweat; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for covid"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt like she got hit by a truck"; NECK PAIN (non-serious), outcome "unknown", described as "neck aches"; BACK PAIN (non-serious), outcome "unknown", described as "back aches"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweat"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: The patient had the Pfizer covid vaccine but has not had her booster dose yet. The patient was positive for covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling. Cellulitis right thigh. Pain, tender and warm. Started on cephalexin.
This case was reported by a physician via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) stated that almost all of her patients complained of severe erythema and pain that last about 2 to 3 days.
1713: pt was anxious, BP:140/94, pt stated that normal BP range 120/80, pt states mild arm muscle weakness, pt resting and was observed for 15 min, left clinic 1730 because pt was feeling better 1830: patient returned to vaccine clinic, reported that both arms heavy and weak, fingers on both hands cold, left face check tingling sensation, no respiratory distress, pt referred to ED.
10 min after vaccines given -> itchy, dizzy, nausea, pain in thigh/buttocks. Became very flushed. Low diastolic BP, heart rate elevated. On exam, entire body flushed, warm esp over torso, bottom lip slightly swollen, eye injected. Seemed listless and confused. Pt given 25mg of BENADRYL and 10mg of DECADRON with good response. Within hour, flushing gone and pt feeling more like himself.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has PMH significant for COPD. Patient was 92 YO and received dose 2 of moderna on 2/16/2021. Per note, patient arrived to ER (Outside entity) pulseless and pronounced dead.
14FEB92 pt recvd 1st dose of Engerix-B & 16FEB92 devel fever, nausea, vomiting, abdominal pain & diarrhea; tx in ER; dx w/shigella infect;
rash on her collar bone; bad cold sore; burned underneath the cold sore; This case was reported by a consumer and described the occurrence of rash in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (had 3 strokes in 2018). Previously administered products included Zostavax (5 years ago from the reporting date), Xanax and statins. Concurrent medical conditions included drug hypersensitivity (sensitive to medications). Concomitant products included alprazolam (Xanax).   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, 34 days after receiving Shingrix, the patient experienced rash, cold sores and burning sensation. The patient was treated with medication unknown (Antipruritic (Unknown)). On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the cold sores and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the rash, cold sores and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received Shingrix shot and had symptoms for 1 day which were nothing major, similar to how she felt after a flu shot. Then within a month after vaccination, the patient developed a rash on her collar bone, she used an anti-itch cream which helped.  The patient also has a bad cold sore which had started blooming around 1st December 2020, and had not gone away. It was burned underneath the cold sore, the patient treats it with releive cream and also kept the area clean. The paient did not have a primary care physician at the time of reporting, she would try to get one around 20th January 2021. The patient takes a low dose of Xanax and reported years ago that Xanax from another pharmaceutical company did not work the same. The reporter mentioned that while taking a statin she threw up for 2 weeks and lost 30 pounds then was hospitalized. The reporter consented to follow-up. This case had been linked with US2020AMR248335, reported by the same reporter.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two brothers. This is the second of two reports. A male patient of unspecified age received the first single dose of TRUMENBA on an unknown date. Medical history and concomitant medications were not provided. After vaccination, on an unknown date, the patient experienced red, warm, swollen arms, vomiting and a high fever. Events outcome was unknown. Follow-up (22JAN2016): Follow-up attempts completed. No further information expected.
accidentally administered half a dose instead of a third full dose (for immunocompromised patient); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (accidentally administered half a dose instead of a third full dose (for immunocompromised patient)) 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 ACCIDENTAL UNDERDOSE (accidentally administered half a dose instead of a third full dose (for immunocompromised patient)). At the time of the report, ACCIDENTAL UNDERDOSE (accidentally administered half a dose instead of a third full dose (for immunocompromised patient)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Raised reddened area at injection site, observed 12 days after injection given.  08/26/03: .5 x .5 pink area-mom reports prior raised swollen.
Rash covered lower legs, back, arm, abdomen, was itching, patient noticed rash on Thursday night.
I was fine for the first day. When I woke up the following day, I was itchy and started breaking out into hives. This happened spontaneously over the course of about 2 weeks. The hives started to die down but seemed to be triggered by cold after the first few days. I have not had hives since the two weeks passed, but the weather also warmed up so the cold stimulus hasn't been present.
Dose administered after 30-day Use By Date/25Oct2021 19 booster doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/25Oct2021 19 booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/25Oct2021 19 booster doses). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/25Oct2021 19 booster doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
LEFT ARM KEEPS PULSATING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to iodine, and smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022,expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2019, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 14-MAR-2021, the subject experienced left arm keeps pulsating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm keeps pulsating. This report was non-serious.
Left arm sharp pain  Narrative:  Pain level increased from 5/10 to 10/10 pain level. He was seen at the local hospital with the diagnosis of"costochondritis". He is advised to f/u with his PCP to address ongoing pain. He requested to cancel his second vaccine appt.
Patient developed raspy cough and on itchy throat shortly after flu vaccine was given. He was given 7.5 ml of BENADRYL and observed for 20 minutes. Cough resolved.
Increased temperature, became cyanotic, and experienced apnea episodes. Taken to ER and is now on apnea monitor. This happened on 3/22/00 at noon. Questionable seizures, currently under the care of a pediatric neurologist.
NO ADVERSE REACTION WITHIN FIRST HOUR OF VACCINE ADMINISTRATION. PT. REPORTS LOSS OF SENSE OF TASTE WITHIN HOURS OF RECEIVING THE VACCINE.     PER PT. EMAIL REPORT, "I noticed when I got home yesterday while eating supper I could not TASTE anything. I was eating a really garlicy meal and I kept putting more garlic on it as I couldn?t figure out why I couldn?t taste it. I am still having the same problem today. I am sure it will go away, but you said to let you know of any symptoms."
Achilles tendon pain in both ankles starting the next day. One ankle improved over time while the other continues to get worse each day. Is worse with use. No period for two months. Random heart pain every two days since vaccination.
12/26/2021: Event occurred after 2nd vaccine.  Patient is a 61-year-old male past medical history significant for hepatitis C, possible recent HCC diagnosis presenting to the ED for vomiting bright red blood.  Denies fever, chills, chest pain, shortness of breath, weakness, numbness, vision changes, bruising, rash, dysuria. He is hypotensive, remaining vitals are stable.  Remains in hospital on Jan 5 2022.  GI Bleed
Patient began to feel throat tightness and dizziness after received vaccination. Vital signs stable, no respiratory complications assessed. Patient drank some juice and laid down and felt better after 15 minutes. Vitals checked again and once again were stable.
"I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again.; "I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again.; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 11Mar2021 (Lot number: unknown) at the age of 36 year(s) as dose 1, single for COVID-19 immunisation and bnt162b2 (COMIRNATY), administration date 01Apr2021 (Lot number: unknown) at the age of 36 year(s) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 22Mar2021, outcome "recovered" (an unknown date), MENSTRUATION IRREGULAR (non-serious) with onset an unknown date in Apr2021, outcome "recovered" (an unknown date) and all described as ""I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again". The event "I" had heavy non stop period/menstrual-cycle 21+ days consistently, one week off, then repeat of 21+ days of heavy bleeding again." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding and menstruation irregular.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Strange bumps/rash on uvala, uvala was swollen, breathing difficulty, lips swelled.
sore shoulder that started day after shot and still sore today - 2 weeks later. patient stated it has gotten worse, not better. explained SIRVA to patient and that he could reach out to his doctor.
Red rash, tender on the left thigh, cold/ cough, was very hot, and has been fussy.
Booster dose given.  Waited 15 minutes in lobby before leaving.  Family came back inside after getting her in the car to leave, for help. She was ash color with tongue protruding from mouth.  Opened her eyes upon shaking and breathing noted.  911 called and Oxygen applied via face mask.  Ambulance then arrived and transported to Hospital for medical treatment where she expired later the same afternoon.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 04-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Pt. accidentally given a MENACTRA instead of an MMR on 12/5/08, error discovered on 12/8/08. Called mom. Pt. doing well. No treatment needed.
pt recvd vax;high pitched persistent crying for more than 3 hrs p/ 1st set of immun; apap given for fussiness;
Case completed vaccine series in February 2021, then was hospitalized for Covid in November 2021
Expired dose administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Nov-2021 and was forwarded to Moderna on 03-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
severe headaches; This is a spontaneous report from a contactable consumer or other non hcp.  A 70-years-old non- pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9261; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 09:15 (at the age of 70 years)as dose 2, single for COVID-19 immunisation. The patient took the historical BNT162B2 vaccine on 11Feb2021 as dose 1, single (Lot number: Unknown; Expiration Date: Unknown) for COVID-19 immunisation. Medical history included embolism, anaemia. Concomitant medications included losartan; apixaban; simvastatin; tizanidine; meloxicam. The patient previously took lisinopril for product used for unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Mar2021, 07:00 the patient experienced severe headaches. The clinical course of the event includes Beginning on Friday, 05Mar2021, the day after my second vaccine, my severe headaches began, lasting 24 hours a day for a total of 15 days, ending on Friday, 19Mar21. Completely disappeared on Saturday, 20Mar21 and did not return. Therapeutic measures were taken as a result of severe headaches with Hydrocodone-acetaminophen 5-325MG for pain. The clinical outcome of the event was resolved on 20Mar2021.   No follow-up attempts are possible, no information is required.
sleepiness; bursitis in the arm and shoulder blade; quite a bit of chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), BURSITIS (bursitis in the arm and shoulder blade), CHILLS (quite a bit of chills) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced SOMNOLENCE (sleepiness), BURSITIS (bursitis in the arm and shoulder blade), CHILLS (quite a bit of chills) and FATIGUE (tired). At the time of the report, SOMNOLENCE (sleepiness), BURSITIS (bursitis in the arm and shoulder blade), CHILLS (quite a bit of chills) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9-102.1 (High) Result-99.9-102.1.         Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided bursitis in the arm and shoulder blade, so takes the pain medication