chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts). At the time of the report, PAIN IN EXTREMITY (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Fever (low-grade) and vomiting within 24 hours of vaccines, followed by redness, warmth of leg just distal to site of DTaP and IPV.
ABOUT 30 SECONDS AFTER THE SHOT WAS ADMINISTERED THE PATIENT HAD A SEIZURE WHILE SITTING IN THE CHAIR IN THE WAITING ROOM.  FULL BODY TWITCHING AND EYES ROLLING FOR 15 SECONDES OR SO.  LEFT ARM WAS ALSO SWOLLEN AT THE ELBOW WHICH WAS OPPOSITE ARM OF THE IMMUNIZATION.  PARAMEDICS WERE CALLED AND PATIENT WAS EVALUATED IN THE AMBULANCE BUT CHOSE NOT TO GO TO THE HOSPITAL AND TOLD THE PARAMEDICS HE WOULD GO ON HIS OWN.  STILL HAS NOT BEEN SEEN PER PATIENT.
Two weeks after getting the second doze i started getting sever joint pain. It has persisted and never changed since the shot.
Left arm very sore, with some nausea (so far I haven?t thrown up).
PATIENT CAME TODAY WITH  SOUND LIKE SHE BEEN HAVING BURING SENSATION  HARD TO TOUCH  SENSITIVE TO CLOTHING FROM SHOULDER TO FINGER IN LEFT HAND WICH SHE HAD INJECTION .  SHE DIDNOT USE ANY MED  ITS BEEN   1 WEEK  PT SAID SHE WILL MAKE APPOINTMENT WITH DR IF IT CONTINUED
This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. The patients' medical history, concurrent conditions and concomitant medications were not reported. In approximately 2013 (reported as 3 to 4 years ago), the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient complained that her whole arm swelled up (peripheral swelling), was red (erythema) and uncomfortable (limb discomfort). The patient recovered from erythema, limb discomfort and peripheral swelling on an unknown date. The causality between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Expired doses were administered to 12 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses were administered to 12 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses were administered to 12 patients). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses were administered to 12 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided.
The fist vaccine on May 22nd, about 40 minutes after I took the vaccine and walked upstairs and in my home, I felt light headed and a little dizzy. I drank some water,  laid down and felt better with soreness in my arm. About 3 days later my arm began itching only in the injection area.  On June 3rd, I woke up with my eyes stuck together.  I stopped taking my allergy medicine a few days before May 25th and didn't start taking Clariton again until June 3rd to alleviate the itchy, watery,, and stuck together eyes. That lasted about 2 and half days while still taking Clariton. I had allergy systems before the vaccine but haven't had this reaction in a few years. I took the second vaccine today,  June 22nd a few minutes after 6:30pm. I'm writing this to inform others in case this issue occurs in other people too.
LOCAL REACTION ON RIGHT UPPER ARM. RED SWOLLEN 3-4 INCHES IN DIAMETER. TO DO WARM OR COLD COMPRESSES.
contracted covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (contracted covid) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (contracted covid). At the time of the report, SARS-COV-2 TEST POSITIVE (contracted covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown; Reporter's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273. The event of COVID-19 virus test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
PFIZER COVID VACCINE #3 GIVE 1/6/22, LOT #330258D; 12/23/21 pt admitted to hospital with increasing generalized weakness, mild cough, and falls at home throughout the week; 12/25/22 pt c/o epigastric pain; TTR amyloidosis, was to receive treatment once discharged; Echocardiogram revealed left ventricular ejection fraction of 40% with grade II diastolic dysfunction; pt experienced increase in confusion and hallucinations; potassium levels had dropped; uric acid levels were high; medications given; 1/20/22 pt requiring more O2 supplementation; found to be positive for COVID; Infectious Disease consulted; pt had a cardiac arrest the next day and passed away in the hospital
Fatigue and sexual dysfunction. Fatigue started in January,2001, sexual problems also.
Pt c/o right arm pain started 24 hours after immunization with MENACTRA. Pt stated his arm was difficult to move and "felt heavy" for a day or so. Pt seen 5 days post immunization had full ROM, no erythema, ecchymosis, infection at site of injection, no masses. Pt Afebrile. No findings at that time.
Felt achy 6 hours after getting Tdap and flu shots (Tuesday); left arm warm and sore, by the next day (Wednesday) felt body aches and warmth progressing to fever by evening, 100.4 - 101 F, took Ibuprofen for fever and on Thursday had redness and induration on left upper arm.
pt recv vax 29MAR96 & 7MAY97 pt presented to MD office w/chickenpox;
Rash; Itchy; Swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
headache, stomachache, malaise, temp 99.3 this morning (oral), Nausea last evening, no vomiting. Acetaminophen 650 mg po x 1, rest x 15 mins in clinic this am
1205 throat started tingling cold feeling on arms.  1214 BP 150/92, O2 99%, BL lungs clear. 1232 130/80, )2 98%, HR 106, T 98.6  @ 1236 Pt states she is feeling better. 1253 BP 102/80, 02 99%, HR 99.  Pt has a ride home.  Will monitor for another 10 min and per MD. she is good to go home with a friend who drove her.  @ 1258 Pt swallow normally.  @ 1308 Pt left the room stating feeling better and confident to go home.  This nurse advised pt to call PCP and call 911 in case of worsening vital signs.
(I'm unsure if flu vaccine I selected is the correct one.) body aches, sensitive skin, headaches on and off since morning of 9/11/2022 (about 15 hours after vaccines were administered) side effects still ongoing at 1:15pm 9/11/2022 (about 22 hours after vaccines administered)
within a short time of injection throat started to swell, took Benadryl. In less than 1.5 hours Nausea and fatigue began. Benadryl  caused me to sleep woke @ 1 am with internal shaking/quivering/sharp pains and the feeling of a blow torch heating up my insides. Cramping in female organs similar to body prepping for cycle when it is not time.  No fever. Took more Benadryl.  Went to physician this morning, 2 days post shot with now constant internal vibrations/shaking and fatigue
severe h/a, photophobia, neck stiffness, irritable meningitis; Annual follow-up dated 11/27/00 states the pt also experienced fatigue and occasional neck pain.
ADMINISTRATIVE REPORT: Patient stated on his form that the received the vaccine on 20210309 but the actual date was 20210316.  Received shot #2 on 20210408 based on his misreported dates listed on his Vaccine Screening and Immunization Document.  He had NO ADVERSE REACTION.
Racing heartbeat; Dizzy; This is a spontaneous report from a contactable consumer (parent). A 12-year-old female patient received first dose of BNT162B2 (COVID-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/lot number: EW0161, NDC/UPC number/Expiry Date: Unknown) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced racing heartbeat and dizzy. Reporter stated, "her daughter had the COVID Vaccine, she was 12 years and 10 months old and she was supposed to be having her second dose today but she had a problem, she had a lot of tachycardia and had the racing heartbeat, it was racing very fast, she was very dizzy and was having for the last week we passed like a very bad time, contacted her primary doctor and he had ordered to ask for X-Ray to check the chest and check the thyroid gland". Reporter stated, "patient was having her second dose appointment today but I am very concerned about her dizziness and her fast, racing heart and if like recommend getting the dosage or to wait because she was very worried about that". Reporter was provided with the number of Pfizer Medical Information Department. Reporter further stated, "she did not know what to do, it was so scary the doctor sent her daughter to the cardiologist". Product details (Expiration Date, NDC number and UPC number) and purchase details could not be probed over the call as the reporter hung up abruptly. Hence, limited information was available over the call. The events were assessed as non-serious. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
No additional AE information; administered both VARlVAX and PROQUAD on 2/4/2020; administered both VARlV AX and PROQUAD on 2/4/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 04-FEB-2020, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S025610, expiration date 18-AUG-2021 (exact dose, route of administration were not reported) and 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S027464, expiration date 02-MAR-2021 (exact dose, route of administration were not reported). It was reported that the vaccines were administered with sterile diluent (STERILE DILUENT). No additional adverse event information were reported.
patient received fluzone quadrivalent (np) instead of the fluzone high-dose quadrivalent, with no reported adverse event; Initial information was received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 87 years old male patient who experienced patient received fluzone quadrivalent (np) instead of the fluzone high-dose quadrivalent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-SEP-2022, the patient received 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot- UT7701KA) instead of the fluzone high-dose quadrivalent (lot- Unknown) (wrong vaccine administered) (latency same day) (dose, formulation, strength, and expiry date: unknown) via unknown route in an unknown administration site for prophylaxis vaccination.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received fluzone quadrivalent (np) instead of the fluzone high-dose quadrivalent, with no reported adverse event.  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.
Information has been received from a certified medical assistant concerning her son who on 18-MAY-2005 was vaccinated with a dose of hepatitis A virus vaccine inactivated. On 19-MAY-2005, she reported that her son had since developed hives all over his entire body and has a low fever. He is being treated with over the counter diphenhydramine hydrochloride (BENADRYL). Unspecified medical attention was sought. At the time of this report, her son was recovering. No product quality complaint was involved. Additional information has been requested.
Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 6th  out of 19 adult patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
The patient presented with a mild case of chicken pox in 1999 and again on 11/13/2000. No further information is expected. This patient was also mentioned in WAES 01010774.
ON HER CONSENT FORM SHE SAID SHE RECEIVED THE 1ST DOSE ON 5/28/21. SHE RECEIVED HER 2ND DOSE EARLY.
This is the 3rd time filling out the form and having it be automatically deleted- so I will rush to fill out before deleted again automatically. After receiving the Moderna COVID-19 vaccinations on January 6, 2021 and February 3, 2021, I experienced at least moderate joint pain, muscle stiffness and spasms, acute migraines, pain, acute spasming and stiffness in my spine; particularly my neck, middle and upper back, pain in my arms, hands, hips, buttocks, knees and feet and connective tissues. I also experienced insensitivity to cold.  I had blood work done at Quest Labs on 2/19/21, 3/8/21, and 4/2/21 due to the acute inflammation in my body post COVID-19 vaccinations. I also saw multiple doctors/ specialists including Primary Care Physician, Rheumatologist, Ear Nose and Throat Doctor, Neurologist and 3 Neurosurgeons/ Spine Surgeons. I had MRIs of the Brain and Cervical Spine on 4/22/2021. I also underwent Acupuncture, Chiropractic Treatment, Physical Therapy and a Cervical Epidural Injection to attempt to decrease the inflammation in my spine, middle and upper back, neck, arms, hands.  I am still in Chiropractic treatment.
In less than an hour after injections, got sudden chills, severe headache, muscle ache, nausea. Tried to relieve headache with cold compresses and Alleve.  Finally took codeine after 6 hours and got relief.   Headache and body aches continued in the morning, relieved with Alleve but right breast continued to be exceptionally sore and rashed.  This breast had radiation in 2015. The initial questionnaire asked if I had undergone radiation.  Is this an adverse effect?  Why is the question on the sheet?
TEMPERATURE LITTLE ON THE LOW SIDE; HEADACHE; FATIGUE; MUSCLE ACHES; This spontaneous report received from a consumer concerned an 80 year old male. The patient's weight was 170 pounds, and height was 69 inches. The patient's past medical history included: infectious hepatitis as a child/teenager, and concurrent conditions included: non alcoholic, non smoker, hives with exposure to mosquito bites or certain foods (rarely), exposure to mosquito bites, and hives with exposure to certain foods (rarely), and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient was previously treated with acetylsalicylic acid. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A /205AZ1A expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced fatigue/feeling very tired. On JUL-2021, the patient experienced muscle ache. On an unspecified date, the patient experienced temperature little on the low side, and headache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Between 60 to 70 bpm, Body temperature (NR: not provided) Normal or a little on the low side, and Oxygen saturation (NR: not provided) 98 %. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fatigue, muscle aches, and headache, and the outcome of temperature little on the low side was not reported. This report was non-serious.
Cellulitis on left upper arm approx 1 inch to the right of injection site on Sun 11/21/21 area red warm approx 6x7 in size.  Started abx.  Nausea and rash Thurs evening 11/18/21 that resolved with Tylenol pm (50mg of Benadryl)
9/29/2021  Severe dizziness, blurred vision, lasted ~3 min, no treatment (TIA?) 11/06/2022  Severe dizziness, blurred vision, lasted ~3 min, no treatment (TIA?); occurred after 7 days of vascillating blood presssure. 11/13/2022  Left hand went totally numb, 9 am, lasted ~1 min.  While driving, 9:30 am, left hand went totally numb again, feeling didn't return. Arrived, reported to ER. Blood pressure was 189/98, CT scan, EKG, blood work. Hospitalized overnight with heart monitor. 11/14/2022 MRI showed mild stroke in area that controls left hand & prior TIAs (9-29-21 & 11-06-22?). 12/21/2022 Saw neurologist. 12/28/2022 Saw cardiologist.
Epididymitis, fatigue after 2 days. Chest pain requiring hospitalization after 10 days. ER physician stated vaccine likely cause of chest pain.
pulmonary embolism, treated with blood thinners (heparin for first week and eliquis thereafter).  Must continue eliquis for six months and then have another CT scan to determine if it has dissolved
irregular tremor like movements that started the day after vaccination and worsened a few days later. They responded to benzodiazepines and he was discharged from the hospital.  The clinical impression was that these movements were psychogenic.
Very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 14:30 hours (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced very sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very sore arm was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan was provided, issue resolved in about two hours.