chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOST ABILITY TO PERSPIRE; ELEVATED INTERNAL BODY TEMPERATURE (INTERNAL BODY TEMPERATURE THROUGH THE ROOF); This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies or illicit use of drugs and usually sweats normally. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost ability to perspire. On APR-2021, the subject experienced elevated internal body temperature (internal body temperature through the roof). Laboratory data included: Body temperature (NR: not provided) 98-99 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.9 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from lost ability to perspire, and elevated internal body temperature (internal body temperature through the roof). This report was non-serious.
elevated fever 104; nausea, vomiting; unable to use arms; semicomatose; red, swollen, indurated;
This spontaneous report was received from a nurse and refers to a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Gave vaccine to pt. on left arm, pt. was sitting on the table after gave the vaccine pt. got down from the table seconds after pt. fell to floor and faint Dr. went in with pt. examined pt. to make sure everything is fine lay pt. on bed with legs up rechecked blood pressure and oxygen pt vitals normal per Dr. pt. to rest in room for 10 more minutes just to be safe.
Sore Throat; Sinus Congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) and SINUS CONGESTION (Sinus Congestion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant in 2004 and Back surgery in January 2021. Concurrent medical conditions included Seasonal allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Seasonal allergy.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and SINUS CONGESTION (Sinus Congestion). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) and SINUS CONGESTION (Sinus Congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She reported having allergy symptoms every spring and fall. Treatment information was not reported.
Patient received early administration of Pfizer booster (4 months after primary series completion). No adverse reactions documented.
Administered 40 days too soon.  Administered 4-12-2021.  She turns 18 later
Pt devel very sore arm @ inject site was seen by MD who dx sterile abscess @ inject site & lymphopharyngitis;
After > 12 years migraine free Got migraine lasting 4 days after second moderna shot 2/20/21
Around the vaccination site there is a red circle, it is firm and raised and itchy and tender to the touch. I noticed it a few days ago
I have typed up a long page, but this keeps timing out.  When I did it on pdf it would not upload and said i needed a death date.  I tried, retyping ever time.  4 days in enough and quite frankly my arm still hurts and it's worse every time after I am done.   My main problems was my arm and shoulder pain 6 months + at 10/10 pain. 6 doctors, O.T and P.T
patient called to complain of throbbing joints and heart palpitations. told patient to contact her physician
This is a spontaneous report received from a contactable consumer (patient). A 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 39, on Mar 3, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a headache, onset Mar 3, 2021, with outcome of recovered (Mar 2021). Additional Information: The patient had a headache for 12 hours after the first dose of the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021356359 same reporter, patient, and product; different events and dose.
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 17-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
VACCINE ERROR: DOSE GIVEN OVER 6 HOURS AFTER VIAL PUNCTURED.
kidney infections; scars; Bug bites; Burn like features in the neck/ Burn like features under breasts, arms, legs; severe diarrhea; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of KIDNEY INFECTION (kidney infections) and DIARRHOEA (severe diarrhea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078CZIA and 050CZIA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were not reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced BURNING SENSATION (Burn like features in the neck/ Burn like features under breasts, arms, legs). On an unknown date, the patient experienced KIDNEY INFECTION (kidney infections) (seriousness criterion medically significant), DIARRHOEA (severe diarrhea) (seriousness criterion medically significant), SCAR (scars) and ARTHROPOD BITE (Bug bites). At the time of the report, KIDNEY INFECTION (kidney infections), DIARRHOEA (severe diarrhea), SCAR (scars), ARTHROPOD BITE (Bug bites) and BURNING SENSATION (Burn like features in the neck/ Burn like features under breasts, arms, legs) outcome was unknown.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   After 1st dose patient had severe diarrhea for a month straight. So sick that felt like dying. Not able to eat or drink anything for a month. The rest could not remember. The patient could not do normal activities.  Patient did visit her dermatologist, but she mentioned that it was a waste of time. No laboratory done.  Treatment medication not reported. Company comment- This is a spontaneous case concerning a 45-year-old female patient with no medical history reported who experienced the unexpected and serious (medically significant) events of kidney infection and diarrhoea. Two doses of mRNA-1273 vaccine were administered in an appropriate schedule of vaccination as first and second doses of COVID-19 vaccine schedule. Onset date of the events were not provided, hence latency cannot be assessed. It was reported that after first dose patient experienced severe diarrhea for a month straight. She was so sick that felt like dying, she cannot eat or drink anything for a month. After the second dose she cannot do normal activities. She attracted bugs, bug bites. Other adverse events mentioned were kidney infections, white dots all over the body from scars and burn like features under breasts, arms, and legs. Patient did visit her dermatologist, but she mentioned that it was a waste of time. No laboratory was done, nor medication prescribed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint pain Fatigue
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 30-year-old. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Metallic taste in mouth within a few minutes that persists, then later headache, backache, malaise.
94 days post monoclonal antibody treatment for COVID infection on September 5 at ER.  Currently experiencing at about 20 hours after vaccination significant muscle cramps, fever, chills, body aches, moderately severe headache
Pt began crying about 4 hrs p/vax; cried steadily for 3-4 hrs; cry was unusual mom did not describe it as high-pitched, but did say it was not nl crying-no fever-no other sx;
Four siblings came with their mom to get the Pfizer 5-11 first dose. All four children sat on their moms lap while getting vaccinated. Daughter was the first child to get her shot and walked out of the booth to her siblings. It seemed like she was being silly and falling on her brother, but appears she may have fainted and quickly came to but not quite sure as The patient ran into the booth to her mother right after. She was a bit clammy and pale, so applied an ice pack to her face/forehead and nape of neck during observation time. The mom stated she was hungry and this had actually happened once before although during the screening she did not mention. I called the mom a few hours later and she said daughter had eaten lunch and was having ice cream and was doing just fine.
After 4 hours of the vaccine dose, but within 6 hours; the patient experienced: patient reported lethargy, "blood spots" in the hand (possibly petechiae), itchiness all over body; bruises on arms; fever and chills; headache; muscle pain. Received the 1st dose vaccine on 3/1/21. Then, on 3/3/21, patient reported fainting, and hospitalized (duration of hospital stay was about 12 hours). After hospital discharge; patient reported that felt all symptoms were resolving.
Patient had Influenza Vaccine administered, then second later stated she felt that she was going to pass out. Patients Body went tense and pt became unresponsive and was slowly allowed to fall to the floor (Rph had her By the arm) 40 seconds later pt Regained consciousness & Breathing was normal, Pt oriented, EMT arrived to assess. EMT assessed pt and determined pt passed out and was now fully responsive and did not need further treatment or to be taken to the hospital. Pt Reports she passes out / Faints each time she gets blood drawn & this type of event has occured many times previously, but not with a Flu shot.
Rash - Scattered vesicular papular eruption that dried to scabs over 1 wk.
Pt reports both hands swollen, headache, decreased appetite. ? nares edema/erythema neck and NT adenopathy on R side. DX: general viral syndrome
She also had another female patient of adolescent age that became light headed after receiving GARDASIL 9.; This spontaneous report was received from a physician via field representative, referring to a female adolescent patient of unknown age. The patient's pertinent medical history, previous drug allergies or reactions, and concomitant medications were unknown by the reporter.  On an unknown date in 2020 (also reported as "sometime in 2020"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number, and expiration date were unknown) as prophylaxis.   On an unknown date in 2020 (also reported as "sometime in 2020"), after receiving the vaccine, the patient became light headed (dizziness). It was unknown if the patient received treatment for the adverse event, if laboratory diagnostics or studies were performed, or if the patient sought medical attention.  The outcome of the event dizziness, and the causal relationship between the event dizziness and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA008637:
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 12-year-old male. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
pain left arm immediate, worse the day after, could barely lift arm left armpit pain starting 5  days later, also right armpit pain but milder
patient was given an expired dose of meningococcal group B vaccine (Bexsero) LOT abxb60aa, with expiration date of 09/01/2022
This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022), COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022), COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022). The patient did not have any adverse reactions from the 1st dose of Moderna. It was reported that the patient arm was tender and sore after receiving the Pfizer vaccine. Patient also felt warm that morning, but did not had a fever. No treatment information was reported.
Heart is racing/Feels palpitations; Heart hurts worse; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart is racing/Feels palpitations) and CARDIAC DISORDER (Heart hurts worse) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart is racing/Feels palpitations) and CARDIAC DISORDER (Heart hurts worse). At the time of the report, PALPITATIONS (Heart is racing/Feels palpitations) and CARDIAC DISORDER (Heart hurts worse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported the patient felt his heart racing and palpitations and his heart hurt more when he was doing manual labor. Patient visited urgent care where an electrocardiogram was performed which revealed normal results. Patient was encouraged to go to the emergency department but couldn't. He was scheduled for an appointment with his doctor and was told not to get the second dose.  No treatment medications were reported.
Headache, Fever, NauseaVomiting, fatigue  Narrative:  Other Relevant History:
Patient possibly inadvertently received 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State of MD was notified
pt states noc of inj-site began itching then devel 2 red marks about 1/4" from site; site was swollen & hot to the touch the next day;
Adverse event began at 31 weeks pregnant on the morning of 4/16/21 9 days after receiving vaccine. nausea, vomited once, had uterine contractions 2-3 minutes apart all day. Went to hospital at around 4 pm. Was very dehydrated. Treated with IV fluids and Nifedipine to stop contractions. Discharged at 7 pm. Had low grade fever and chills that night. Contractions stopped in response to treatment at the hospital. Next morning fever, chills, nausea and vomiting were gone. Currently feeling tired.
Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild
Spasms started Friday eve on October 30, 2021. First started with painful lines across from spine to each side. Then changed to bumps and advanced to large butterfly wing like raised sections from mid spine out. Pain is unbearable to which I have to sit down and not move. I am taking meds to stop spasms and pain. At one time when they first started pain was a 9 out of 10 being the worst my vision blurred. Over 2 months later I've been through MRI's, physical therapy, medications, target pain shots, and nerve block shots which have given me a quick temporary relief from spasms and pain. I am also out of work from and don't know when I'll be able to go back to work. My strength and mobility has been drastically limited. With simple walking and bending or lifting the spasms and pain come quickly, please help me.
pt recv vax 12NOV96 & arm became extremely sore 7PM;could not lift arm above shoulder height;approx 9PM pt became chilled;shivered uncontrollably for 4hr till fever came @ approx 1AM;violent h/a also during 9PM-1AM;
Systemic: mild rash on shoulder, upper back, and chest. and pt took benadryl herself-Medium, Additional Details: Rash developed after one hour recevived vaccine and took Benadryl and apply hydrocortisone topicall herself. itch and rash getting better but not resolved even till today. pt called md but md did not answer her call today.
Dry mouth, dizziness 30 minutes to 1 hour post MMR vaccine. Pt went to ER at pt preference, was given Benadryl and prednisone injection. Took BP and watched 1 hour. Pt doing well at present.
Nausea, diarrhea, muscle cramps, headache, chills, dehydration.  3 days after vaccine, I lost consciousness at work and was taken by ambulance to Hospital ER.  I was given IV fluids in the ambulance. I was in atrial fibrillation.   One possible complicating factor: I was on a clinical trial for Synpanemab (experimental Biogen monoclonal antibody) for 3 years, with the final dose given in mid January, 2 months before the vaccine.
Day 7-Pt ruptured the vaccination site blister during a shower, no bandage in place. Continued to dry off with the same towel. Papules appeared at day 9. Vesicles x4 at Day 10. She also c/o of eye itching and small red bumps on the lowere arm and leg, but they disappeared without progressing. She was given Zantac and Claritin for itching. No other treatment at this time.
Severe full body convulsions lasting 15 minutes, fever 101, moderate full body aches, headache, nausea, headache, fatigue
HIB vaccine  was not properly reconstituted, only the sterile diluent was administered.  No adverse reaction for the patient.
Lt arm cellulitis - severity 7/10 edema + pain from shoulder to elbow.  Immunizations given 9/23 5:45 PM.  Swelling noted 9 PM - increasing in severity until seen by PCP 9/24 9 AM.  Treated with AUGMENTIN 8.75-12.5 x 7 days.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 13-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Fever, nausea, scratchy throat, weakness. Constant cough, wheezing.
Approximately 5min post COVID vaccination, pt reported feeling light-headed.  Was initially tachycardic then went bardycardic.  Broke out in rash on neck, chest & upper back.  Benadryl 25mg po given & pt transported to ED for evaluation.  No SOB.   ED treated pt with an additional 25mg of po Benadryl & 40mg po Pepcid.  Pt responded well & was DC home.
Pt recvd 3 doses of Engerix-B & it was determined that vax did not develop titers; no treatment given;
The pt had a fever, chills, weakness. She felt faint but did not pass out.