chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; no apatite; soreness in her arm; -2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness), DECREASED APPETITE (no apatite), PAIN IN EXTREMITY (soreness in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (-2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013f21a, 026a21a and 031m20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy and Allergy to antibiotic (Antibiotic for sinus infection). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (-2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a). On an unknown date, the patient experienced ERYTHEMA (redness), DECREASED APPETITE (no apatite) and PAIN IN EXTREMITY (soreness in her arm). At the time of the report, ERYTHEMA (redness), DECREASED APPETITE (no apatite), PAIN IN EXTREMITY (soreness in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (-2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a) outcome was unknown.            Patient had no history relating to mentioned adverse event. Patient had no acute and chronic illnesses at the time of vaccination. Patient did not test positive for COVID-19 or diagnosed with it. Patient did not seek medical care . Patient did not have similar event in the past. Patient was told to consume more water and hot tea. Patient was unable to take aspirin.   This case was linked to US-MODERNATX, INC.-MOD-2022-653962 (E2B Linked Report). This case was linked to MOD-2022-654032, MOD-2022-654068, MOD-2022-654100 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653962:Same reporter
Pt said her arm hurt a bit after immunization (9:23 AM). She said it itched a little. She went to bed that day but woke up around 3 AM the next day and part of her right lower jaw and lower lip were a bit swollen. She states that she didn't do or eat anything differently from her usual routine/food. She believes that the swelling is caused by the shot. She came to the pharmacy just before noon the day after shot was given. Pt stating the arm feels the same (not worse), just FYI - pt had flu shot in 2016 and 2017 (different brands), had no reaction. Pt advised to get antihistamine. Pharmacy contacted PCP, no further instructions given. Pt told to report back to pharmacy if the issue worsens.
Chills, nauseous, fever over 100°, throwing up. Heart rate exceeded 148 beats per minute while sleeping.  Continued for 2 days.  Still hasn?t returned back down to normal 12 days later. Headache. Lethargic.
Began having itching 6/17/2008 on left hand; progressed to left arm, then chest and face. Having some facial swelling. Also have rash on hips and abdomen mostly on the left side. Right hand began with rash and itching in a.m. 6/18/2008.
1ST SHOT 3-5-2021. 2ND SHOT 3-26-2021 C/O ARM BEING ACHY & STILL TENDER TO THE TOUCH AFTER THE 2ND SHOT. NO ISSUES WITH THE 1ST. STATED HE HAS FULL ROM. JUST C/O OF STILL BEING SORE AFTER 2 MONTHS. ENCOURAGED HIM TO F/U WITH HIS PCP.
heretic rash on left outer thigh and back; This case was reported by a nurse via sales rep and described the occurrence of rash herpetiform in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash herpetiform. On an unknown date, the outcome of the rash herpetiform was recovered/resolved.   It was unknown if the reporter considered the rash herpetiform to be related to Shingrix.  Additional details were provided as follows: The patient presented to the physician's office at the time of reporting with a heretic rash on his left outer thigh and back. The rash has been present for a week.  The reporter stated that they have not done testing to confirm herpes zoster, but it has a dermatology distribution from the lumbar. The patient received Shingrix on unknown date. However, the prescription to receive at the pharmacy was written on 19th March 2019. The reporter stated that the rash was not blistered and she attributed this mild presentation to the fact that the patient had received Shingrix.  The patient received Zostavax. The patient was otherwise healthy with no immunocompromising medication and condition. The reporter agreed to follow up from GlaxoSmithKline.
lost over 40 lbs; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost over 40 lbs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced WEIGHT DECREASED (lost over 40 lbs). At the time of the report, WEIGHT DECREASED (lost over 40 lbs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated the first and second dose went "really smooth". patient mentioned that he has Type O negative blood.  No concomitant medication was reported.  No treatment medication use was reported.    Reporter did not allow further contact
Lower left back pain; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 10:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. On 08Apr2021, the patient experienced lower left back pain, headache and fatigue. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lower left back pain, headache and fatigue were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Provider ordered 12 month shots and one of the vaccination names was Vaqta and MA's and vaccination providers both stated they thought the order said "Rotataq", 2 person check policy is in place for vaccinations but did not occur correctly and incident report will be sent to corporate company and also discussed internally and changes to be made to avoid this error in future.
Eye puffiness day after vaccine, then 10 days after that and most recently 28 days after vaccines.  relieved with Benadryl dose.  some eye pain/headache associated with the puffiness.
Fever, chills, muscle aches, headache first couple of days.  Continued symptoms minus fever for at least 2 more weeks.  My hands would become ice cold and numb.  Moving forward I still have the headache, very intense at times, plus brain fog, joint and muscle aches more than usual, heart fluttering waking me at night, vision blurred and double vision, fatigue, feeling like my legs are so heavy I can?t move forward, dizzy when bending over and winded when walking a short distance.    I am normally an active, healthy senior who manages a small farm on my own and prior to the pandemic, I was a part time stock clerk.
Odd coating feeling in the back of the throat ten to fifteen minutes after injection. Coming up from the lungs? Not feeling sliding up, just appearing as a coat.  The next day a HUGE problem that knocked me out of commission for the entire day (around 20 hours). Blood pooled and painfully hardened in my brain and could no longer flow properly. Veins around the outer perimeter felt stiff and hard. The blood felt pooled in the limbic system, like a half-scab. Painful. I could barely speak at a normal tone to my lover by the time I was falling asleep.     Love and peace,
Pfizer 2nd dose administered at 1030am and immediately patient reported feeling difficulty breathing. 911 was called at 1030am. 0.3mg of Epinephrine was administered on right vastus lateralis and patient expressed slight relief. Patient had tachycardia with weak pulses and hypotension. Second dose of 0.3mg epinephrine given at 1036am. Paramedics arrived at 1037am.
2nd Shingrix vaccine at a 1 month interval rather than the 2 to 6 month interval.; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd Shingrix vaccine at a 1 month interval rather than the 2 to 6 month interval.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that they had an immune competent patient who received their 2nd shingrix vaccine at a 1 month interval rather than the 2 to 6 month interval, which led to shortening of vaccine schedule. No other information was provided. The reporter did not consent to follow up.
Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, obesity and penicillin allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), spironolactone (MANUFACTURER UNKNOWN) and trazodone (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and valaciclovir (VALACYCLOVIR) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the patient experienced dizziness 5 days after first dose. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event dizziness was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a headache and arm soreness that evening - 12 hours later. At night - fight flu-like symptoms - nauseous, chills, and achy feeling. I didn't take me temp but think I had one probably - didn't sleep well. And in the morning was tired the next morning. These were mild to moderate symptoms. Two weeks, in routine visit -  I was diagnosed with gestational diabetes - no symptoms but was tested for pregnancy.  Pregnancy history - 2nd pregnancy; first pregnancy was full term; Estimated date of delivery: June 22, 2021
63 yom developed (L) eye pruritis, dryness and vesicular rash of (L) eyelid accompanied by local edema about 2 weeks after ZOSTAVAX.
DIED; This spontaneous report received from a consumer via media via a company representative concerned a patient of unspecified (senior) age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died. The cause of death was unknown. The date of death was not reported. It was unknown whether an autopsy was performed. Reporter stated that, "I knew healthy people, one senior who died shortly after the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221152742, 20221152749 and 20221152816.; Sender's Comments: V0: 20221152669- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
another red area next to the injection site; Red area on arm at injection site; rash on neck, chest and arms,; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (another red area next to the injection site), RASH (rash on neck, chest and arms,) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drug). Concomitant products included LOVASTATIN for Cholesterol.   On 23-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on neck, chest and arms,). On an unknown date, the patient experienced ERYTHEMA (another red area next to the injection site) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 22-Apr-2021 at a dose of 1 dosage form once a day; CETIRIZINE HYDROCHLORIDE (ZYRTEK) on 22-Apr-2021 at a dose of 1 dosage form once a day; MONTELUKAST SODIUM (SINGULAIR) on 22-Apr-2021 at a dose of 1 dosage form once a day and PREDNISONE from 27-Mar-2021 to 12-May-2021 at an unspecified dose and frequency. At the time of the report, ERYTHEMA (another red area next to the injection site), RASH (rash on neck, chest and arms,) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood pressure measurement: 175-98 mmHg. On 27-Mar-2021, Body temperature: 97.8 degree Fahrenheit. On 27-Mar-2021, Heart rate: 86 beats per minute.         On 22-Apr-2021 lab test, Mast cell tryptase  was done. Other treatment medication include Benedryl.   This case was linked to MOD-2021-263012 (Patient Link).
Had  previously received one dose vaccine  7-8-2000 but series not completed.  Second dose given 4-30-19.  EE noted soreness & rash 5/1/19, returned to Occupational Health  1140 5/2/19  with slight swelling  & central redness 2-3 cm at injection site, with penumbra rash of lighter redness extending to 12-15 cm circularly around  site.  No significant distress-referred to worker's comp nurse for eval at 1415 5/2/19.
Hydronephrosis with renal and ureteral calculous obstruction BACK PAIN VOMITING NAUSEA
Pt devel scattered, red macules on abdomen, lt wrist, lt arm near armpit, few on neck 15min post vax; Observed closely no other signs of anaphylaxis-alert & happy; MD notified advised DPH & be brought to office for further observation;
Very low heart rate during night, was very cold and fidgety during night with arm and neck pain.  Fainted when I was fixing breakfast at 7:00 am.  Activity tracker said my pulse was 48 when I came around.
minor burning/stinging rash on shoulder-duration 12 hours enlarged lymph nodes around collar bone and neck on the left side. Painful to touch, warm and swollen.  Started after rash subsided.  pain in shoulder that radiates down arm and around to the shoulder blade.
Acute allergies; Little dizzy; Feels like a bruise; Delayed reactions sore arm, red, swollen, itchy, feels like a bruise, and hurts to touch it; Red; Fatigue; Back ache; Headache; Nausea; Sore arm; Woke up drenched; Vertigo; Diarrhea; Achy; Got very itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Acute allergies), DIZZINESS (Little dizzy), PRURITUS (Got very itchy), DIARRHOEA (Diarrhea) and PAIN (Achy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Got very itchy). On 27-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Achy), PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Woke up drenched), VERTIGO (Vertigo), BACK PAIN (Back ache), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced HYPERSENSITIVITY (Acute allergies), DIZZINESS (Little dizzy), CONTUSION (Feels like a bruise), VACCINATION SITE REACTION (Delayed reactions sore arm, red, swollen, itchy, feels like a bruise, and hurts to touch it), ERYTHEMA (Red) and FATIGUE (Fatigue). At the time of the report, HYPERSENSITIVITY (Acute allergies), DIZZINESS (Little dizzy), PRURITUS (Got very itchy), DIARRHOEA (Diarrhea), PAIN (Achy), CONTUSION (Feels like a bruise), PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Woke up drenched), VERTIGO (Vertigo), VACCINATION SITE REACTION (Delayed reactions sore arm, red, swollen, itchy, feels like a bruise, and hurts to touch it), ERYTHEMA (Red), BACK PAIN (Back ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Dizziness with 24 hours of taking vaccine. Currently day 7 and  still experiencing vertigo, nausea, lethargy, and cold chills.
This spontaneous report was received from a physician via company representative who provided the media report concerning 15037 female patients of unknown age, whose concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patients were vaccinated with unknown number of doses of GARDASIL (details not known). It was reported that "so far 15037 girls had reported adverse events from the vaccine which include: Guillain Barre Syndrome (paralysis lasting for years, or permanently- sometimes eventually causing suffocation), lupus, seizures, blood clots, and brain inflammation. It was also reported that 44 girls who were officially known to have died from GARDASIL. (Case reported in MARRS # 1608USA012148). Upon internal review, all of the events, besides blood clots were considered to be medically significant. This is one of the several reports received from the same reporter. Additional information is not expected as the physician does not want to be contacted.
Fussy, increased frequency stool, abnormal odor to looser stool, green, some sloughing outer anus and brown flecks in stool (? sloughed mucosa), (-) blood.
Red circle, 3 1/2-4 inches in diameter noticed on arm in location injection was given, 2 weeks after the injection was given.  It isn?t painful, red and hit to the touch with a thickened feeling of the skin in that area.  I contacted my family doctor and she recommended I report the incident and treat at home with ibuprofen, diphenhydramine and warm compresses.
Pt vaccinated with MMR/HIB/OPV developed febrile seizure requiring hospital admission approx 24 hrs after vax. /w HIB, MMR, & oral Polio. Released next day & only treament was observation.
DEVELOPED BRAIN BLEED; CERIBRAL VENOUSTHROMBOCIOUS; This serious case was reported by a nurse via sales rep and described the occurrence of hemorrhage brain in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR VACCINE) for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis.   On 11-JUL-2023, the patient received Pediarix, Hiberix, PREVNAR VACCINE and ROTATEQ. In JUL-2023, less than 3 weeks after receiving Pediarix and Hiberix, the patient experienced hemorrhage brain (Verbatim: DEVELOPED BRAIN BLEED) (serious criteria GSK medically significant) and cerebral venous thrombosis (Verbatim: CERIBRAL VENOUSTHROMBOCIOUS) (serious criteria GSK medically significant). The outcome of the hemorrhage brain and cerebral venous thrombosis were not reported.   It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix.     It was unknown if the company considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix.   Additional Information: GSK receipt date: 14-AUG-2023 The patient received 2 month vaccines on and went to emergency room on 26th July 2023 and  developed brain bleed and ceribral venousthrombocious. In JUL-2023, less than 3 weeks after receiving PREVNAR VACCINE and ROTATEQ, the patient experienced hemorrhage brain and cerebral venous thrombosis. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to hemorrhage brain and cerebral venous thrombosis. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Flu vaccine. 10/31/20 - known Mast Cell Activation Syndrome Hives started later that evening. Over the course of the next week some difficulty breathing felt to be an issue with her vocal cords and/or throat. Admitted to hosp 11/6/20