chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy, red rash started about 1 wk. after receiving MMR vaccine. Prednisone Dose Pk prescribed, MEDROL injection given.
Immediately after receiving the vaccine, he developed pain on the top and bottom of his feet, on his shins, on the front and back of his knees, on the front and back of his thighs, and on his hips which lasted for a few days. We called his pediatrician the day after he got the vaccine and they were not sure. Then, it got better. Since then, it appears intermittently at varying intensities and we are currently trying to look at things that may exacerbate it. Sometimes when he exercises a lot, it is worse, but it is always there. He has had the second dose (07/28/2021) and the booster (01/17/2022) since. Each shot seemed to exacerbate it. We have an appointment this coming friday (02/11/2022) to try to determine the root cause.
Cough  Shortness of Breath  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Congestion or running nose
No immediate reaction. 24h later, pain in left shoulder from elbow to left chin, swelling in same area, nausea, some flu-like symptoms but no documented fever. Pain when moving fingers. As of 20OCT2020, 95% improved per patient.
p/2nd inject 3 wks sign of shingles began; a month of fatigue, chronic pharyngitis, & now cough; signs of arthritis surfaced;
Patient stated that he has a pink area about 2 inches by 3 inches at the site of the injection. I advised him to seek medical attention if it worsens or does not improve in a day or two. At the time of the vaccination he stated he had not received Pneumovax before, but then yesterday or today realized that in fact he had received the vaccine in 2012 (and not Prevnar as he had indicated). Counseled patient to get Prevnar in 12 months.
Redness/induration of R upper arm at inj site minimally tender to palpation. Dx IM immunization reaction (local).
Child screamed (high-pitched) for 4 hours and then shook/tremored starting approximately 4 hours after he received a Comvax vaccine. Parents elected to discontinue all vaccines for the child after this event, and he is now a healthy neurotypical 6-year old boy.
Started with tingling in the right of tongue which later extreme tingling all over body. Itching in body especially face and scalp.   Side effects lasted for 4 days.
Received Moderna covied vaccine @ 8:05 am then 20 minutes after the injection i developed Palpitations HR=130,redness on neck, chest & forehead area, Petechiae rashes on both arms.BP 200/109.was sent to ER for further evaluation.EKG was done,NS 500c given IV ,blood drawn & sent to laboratory for CBC & BMP. released from ER @ 12.30 when my BP  & HR was normal.redness on my neck & chest was less but Petechiae rashes subsided in the evening of same day.Early morning Friday Jan.8,2021 temp was 100.2.felt bodyaches & headache. when i checked my temp i noticed a lymph node in my left armpit.
2 weeks after second dose=dizziness, nausea, weakness in legs, high bp, heart palpitations, severe weight loss( 14 lbs in first 10 days) , vertigo, left ear pain, diarrhea constant at first, feeling faint, left side of face tingling, palpitations, skipped beats, now, after 7 months=vibrating in head, torso with heat in feet/back of hands and twitching random places every night like clock work. Feels like a seizure sometimes when the vibrating is on my left side of my head. This has been consistent for 4 months now and replaced the ?wave of motion, followed by nauseating ? in middle of the night. Tingling, heat in random areas, fatigue twitching and fatigue is still keeping me from living my life. I have no insurance and the hospital bills and ER, specialists have left me deep in debt without helping me
Patient received booster shot of Moderna one and half month after second dose. The recommended time is 5 month after second dose.
TENIVAC had an excursion at temperature -1.07C for 2 days and 13 hours with no adverse event; TENIVAC administered after an excursion with no adverse event.; Initial information received on 07-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA111249.  This case involves a 40 years old male patient to whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered after an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that on an unknown date the tenivac had an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event (product storage error) (unknown latency). The refrigerator door was left open and excursion occurred due to a human error.  On 09-Feb-2023, the patient was administered unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection, (lot LU7189AA; strength and expiry date not reported) via unknown route in unknown administration site for Immunization after an excursion with no adverse event (poor quality product administered) (latency; on same day).  Action taken: not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
fatigue; fever; scratchy throat; Chills/chills have gotten worse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in right arm on 08Mar2021 15:00 (age at vaccination was 35 years) as dose 1, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that on 08Mar201 at evening, he experienced fatigue that transformed into a fever and scratchy throat. The patient also reported that his side effects were still present at the day of reporting. The patient reported that the chills had gotten worse, and he did have a thermometer to check it, but he was pretty sure he had a fever that afternoon. He would like to know if these side effects were normal and if he could take Tylenol for treatment to relieve them. The patient did not take anything yet for his treatment. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 20 minutes: Heart beating faster or louder. I Felt like I got paralysis on my middle finger. Feeling numb.  20 - 30mins: Felt a little drowsy, dizzy? Heart beating faster or louder.  1hour: Tiredness and drowsy.  1st day - 2nd~3rd day: Muscle pain (pretty bad on the arm) and all over the body. Middle finger feeling numb.  Evening, April 13th - 16th: Slight shortness of breath. It got much better, but I still feel very very minor shortness of breath.  Evening, April  15 - April 17th (until 6am): Hives on neck, under eyes(Right side), Between front of my left eye and nose, near mouth, Forehead. Very itchy. Hives keep appearing and disappearing. It gets better and then all the sudden gets bad.  April 17th  evening (8:00pm): Face and neck itchy. I had 1 pill of Benadryl after seeing a doctor. I had fever and chills.  April 18th: Nose bleeding. Having a little chest pain.
Pt received two doses of the flu vaccine instead of one dose of the Pfizer Booster vaccine.
General Body aches; Pain in arm; Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General Body aches), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and HEADACHE (Headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C31A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 06-May-2021, the patient experienced PAIN (General Body aches), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and HEADACHE (Headaches). At the time of the report, PAIN (General Body aches), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and HEADACHE (Headaches) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was reported.
Site red, swollen, burning, itching, sore with pressure over area of approximately 4 x 6 inches.
Patient went through a drive through food restaurant and could not lift her arm to hand payment to attendant.
A Spontaneous report was received from a Consumer concerning a male patient of unknown age who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) Myalgia, Pyrexia, Chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown but said 20A) for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient reports she received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills, fever going from 99 to 100 and back down again. Laboratory details were not provided. Treatment details were not provided. Action taken with mRNA-1273 in response to the events was not reported. On date of this report, the outcome of the events of patient receiving a dose of vaccine and experienced events Myalgia, Pyrexia, Chills were unknown/ not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient/family made vaccination appointment for dose #1 on 5/20/2021 using with the date of birth listed as . Actual date of birth is . Patient received dose #1 on 5/20/2021 at age 11 years. Patient was born at  and the actual age was noted when the medical records were merged. Patient received dose #2 on 6/10/2021 at age 11.
This spontaneous report as received from a registered nurse via company representative refers to a 4 months old infant patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Skin irritation of face, mostly around eyes and eyelids.  Dry, itchy and scaly eyelids, similar to eczema, and eventual swelling. I believe the side effect (my immune response) is connected to the vaccine because I had the exact same skin issues arise about two weeks after a positive COVID test (mid Sept 2020).  The symptoms lasted a little over two months (early January 2021) after COVID.
Fever, chills, diarrhea, muscle and joint pain, headache, fatigue all started at 10 pm after shot at 11:50 am.  Continued until about 12pm the next day.  Took Tylenol and Ibuprofen ever 6 hours and stayed in bed.  After 12 pm I still had headache and fatigue up to today...almost 48 hours after shot.  Still taking Tylenol and Ibuprofen.
Vaccinated 2/20. At that time, had symptoms of incarcerated hernia, went to ED for evaluation. Not felt to warrant hospital admission. Returned two days later with agitation, altered mental status, and incarceration. Went to OR, uncomplicated hernia repair. Postoperatively, did not recover mental status. Went into arrythmias POD 4, hypotension ensued, had multiple interventions and evaluations without satisfying answers for clinical course.
Pt developed redness at site 1" x 3" area, not hard or swollen, warm to touch.
Patient was vaccinated with Pfizer #1 (lot EN6202). She received a second invitation for vaccine in error, signed up, and was vaccinated a second time with Moderna #2 on 4/5/2021.  No adverse outcomes or symptoms reported;  counseled by doctor that she does not need additional vaccine. Troubleshooting: The patient did not present her vaccine card at the time of vaccine; scribe did not access the computer screen where it said what vaccine was given; screeners at the beginning of the process did not ask or turn her away on a Moderna-only day
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M049125 and N007930 for prophylaxis with sterile diluent (STERILE DILUENT). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: 1708USA002826-1708USA002091:
headache; Total bodyache; fatigue; feeling unwell; fever; Chills; Joint pain; Fogginess of mind; This is a spontaneous report received from Pfizer-sponsored program. A contactable female consumer(patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/lot no: EK5730) second dose via an intramuscular administered in left arm 19Jan202 0.3ml as single dose for COVID-19 immunization. The patient family medical history Father- Deceased was Diabetic, HPN, Kidney Transplant, Dialysis. Mother- Alive-Osteoporosis, Mild Dementia. Sister-Diabetic, HPN. The patient concomitant medications were not reported. The patient experienced with second dose - 19Jan2021 - 1st Day foolness of mind,2nd day -Chills, joint pain,3rd day- Fever, 4th day- feeling unwell,5th day fatigue total body ache, 6th day -feeling unwell' 7th day then 11th day Headaches-pain score-4-5,12th day feeling back to normal about 50-90, 13th day-back to normal. First dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. 1st Dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
high fever, worse shivering (convulsive) ever experienced, tired and lethargic for about a month, feeling off for about a month, site of injection sore, raised, red, and unable to move freely for a week and a half
Decreased sense of taste and smell, stuffy/runny nose, cough, and chills
Chills; fever (38 C); weakness; muscle pain; mild diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 18Feb2021 13:00 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history was reported none. The patient had no allergies to medications, food, or other products. The patient was not pregnant at time of vaccination. Prior to vaccination,  the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered in workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium  taken for supplement, start and stop date were not reported.  The patient previously received the first dose of BNT162B2, via an unspecified route of administration, administered in arm right on 27Jan2021 12:00 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for COVID-19 immunisation. On 19Feb2021, the patient experienced chills, fever (38 C), weakness, muscle pain, mild diarrhea, lasted for one day following the vaccination. The patient started experiencing the symptoms on Friday 19Feb2021, and reported on Monday 22Feb2021, when she had no more symptoms and could conclude that the adverse effects were finished. Treatment was not received for the adverse events. The outcome of the event was recovered on unspecified date in Feb2021.  Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Suddenly deaf on 07/21/2021 and not recovered since then. Probably nerve connection issues?
Vaccine was placed into fridge on 12/1/21 and was administered on 1/6/22.
pt recv vax; devel ecchymosis;lab eval showed anti HBs less than 10; pt recv 4th & 5th dose of Hep B;by dec94 pt recovered;
This case was reported by a nurse via sales rep and described the occurrence of malaise in a 54-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain (redness and swelling after receiving 1st dose, see case US2018GSK078814). In April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced malaise, exhaustion and chills. In April 2018, the outcome of the malaise, exhaustion and child were recovered/resolved. It was unknown if the reporter considered the malaise, exhaustion and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the week of 16th April 2018 and experienced extreme exhaustion, malaise and moderate or severe chills which lasted for 2 to 3 days. The 1st dose of SHINGRIX was systemically better tolerated compared to 2nd dose. The reporter agreed to contact on follow up, if necessary. This case had been linked with case US2018GSK078814, reported by the same reporter for the same patient (for the 1st dose).
Patient received two vaccines in the office; from the chart notes, it appears he received his flu vaccine prior to the provider seeing him, but they discussed the HPV vaccine.  Approximately 5 minutes after he received the HPV vaccine, he was leaving the clinic.  While leaving through the waiting room (accompanied by his mother), his mother noticed he became pale, started to take another step and immediately fell to the floor (syncope) and hit his head on a doorjam.  Pt. was brought back to an exam room where the physician examined him; patient rested for 15 minutes until he felt well enough to leave.  Provider gave follow-up instructions to patient/mother of concerns to report.  Pt reported to provider no problems with vaccines in the past other than some mild soreness.
I felt arm pain and i had an extremely sore throat and cough. everything else has gone away but i still have a bad cough.
Patient presents to clinic on 10/8/2020 for another reason and mentioned to me that he has a tennis ball size lump in his left armpit after receiving the shinrix vaccine on 10/1/2020.  He also notes that he felt unwell for a couple of days, but was warned that he may feel unwell, the lump was unexpected and he wonders if it is normal.  He notes that it became large on the day the vaccine was given, but has not changed since then.  It is no longer getting bigger and is only painful if he uses the arm too much or pushes on it.
vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, 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 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    The case contains information of patient 19th Male patient out of 100 patients.  Concomitant medications were not reported.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11-Jan-2023, lot numbers unknown to the HCP. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Case
weird dizziness; headache; her bp spikes significantly; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 16Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient mentioned that she is a healthy person but in the morning, on 20Apr2021, she experienced weird dizziness, headache and her blood pressure (BP) spikes significantly. She asked if these are normal side effects and if it is something that she needs to consult. Outcome of all the events was unknown. Second dose will be on 07May2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Left arm above and below Covid Pfizer Vaccination Booster injection site from top of shoulder to elbow is dark red, swollen and hard to touch and painful.  This began 72 hours after receiving the booster injection.  This same exact thing happened, same arm & same injection site after the second Pfizer vaccination in February 2021, which resolved slowly over two weeks time in February.