chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper arm hurt unusually badly / too painful to lift arm / pain / migrated down my arm to my forearm / Weirdest most painful reaction ive ever experienced before / awful pain from left forearm / dangling it is very painful; pain also migrated / up my neck to the base of my left jaw / Weirdest most painful reaction ive ever experienced before /awful pain / up neck to base of jaw; pain also migrated / up my shoulder, across the top of the shoulder / Weirdest most painful reaction ive ever experienced before /awful pain / top of shldr, across top of clavicle; Pain in base of my left; too painful to lift arm but pain; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date). Concurrent medical conditions included osteoarthritis.   On 2nd July 2021 09:00, the patient received Shingles vaccine. On 2nd July 2021 05:30, 8 hrs 30 min after receiving Shingles vaccine, the patient experienced injected limb mobility decreased, neck pain, shoulder pain and jaw pain. On 2nd July 2021 16:00, the patient experienced pain in arm. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, neck pain, shoulder pain and jaw pain were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, neck pain, shoulder pain and jaw pain to be related to Shingles vaccine.  Additional case details were reported as follows: Age at vaccination was not reported but it could be 64 years or 65 years. On the day of vaccination by 4 pm, the patient's upper arm hurt unusually badly.  By 5:30 pm it was too painful to lift arm but pain also migrated down to forearm and up to shoulder, across the top of the shoulder and up the neck to the base of left jaw. Ice had not helped thus far. The patient said that, this was the weirdest most painful reaction ever experienced before. The patient's current situation nearing 23 hrs post injection was, awful pain from left forearm, up over injection site of arm, top of shoulder, across top of clavicle and up neck to base of jaw.  The patient's arm was propped up on a pillow as dangling it was very painful.  Over the counter (OTC) pain medicine ineffective. waiting this out.
I passed out about 30 seconds (according to physician) after the injection. 911 was called and arrived on site to take my vitals and check to see if I needed to be taken to the hospital.
Day 1: Immediately after administration arm was extremely painful. Unable to sleep on my arm that night. Chills and dizziness. Day 2: Chills. Unable to lift my arm higher than 45 degrees. Injection site: redness of 1.5-inch diameter, warm to touch, burning/itchy sensation, painful. Day 4: Injection site was normal Day 8: Constant muscle twitching in right bicep for about 30 minutes. Day 9: Constant muscle twitching in right upper thigh for about 30 minutes, and random muscle twitching from head to toe.   Injection site signs and symptoms reappeared: redness of 3-inch x 1.5-inch diameter, warm to touch, burning/itchy sensation
This spontaneous report was received from an office manager, concerning multiple unspecified patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the GARDASIL 9 was 29 °F for a time frame of 1 hour; it was unknown if a previous temperature excursion occurred. No adverse effects were reported and no product quality complaint (PQC) or data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as no consent to contact the reporter was granted. Sender's Comments: US-009507513-1704USA003989.
Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022; No Adverse event; Patient was given vaccine beyound 30 day use by date; 1st dose on 11-07-2022 and  2nd dose on 26-09-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 dosage form. On 26-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-07-2022 and  2nd dose on 26-09-2022).    No concomitant medication was reported.  Route and body site of first vaccination was mentioned as LO. It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date (22-Sep-2022). There were unbroken cartons. Vial size for 6 months to 5 years. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date. Vial sizes were reported as 2.5 mL or 5.5 mL For six months to five-year-old patient vial size was reported as 2.5 ml For adult patient Vial size was reported as 5.5 ml. The vial did not undergo any temperature excursions.  No treatment medication was reported.
pain in the thigh muscle; terrible pain in her leg and in her thigh/arm was feeling a little sore/ache in arm; a lot of pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Jan2021 to Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient stated that she got the Pfizer Vaccine on Tuesday and she have now a terrible pain in her leg and in her thigh, pain in the thigh muscle, it is very, very painful. She had a little ache in arm, nothing terrible. She also stated that She felt fine except her arm was feeling a little sore. Last night, she got terrific pain in her thigh muscle and she is in a lot of pain. Outcome of the events was unknown.   Information on lot/batch number has been requested..
Ringing in right ear.  It gets louder then softer throughout the day.  It started about 9 or 10 days after the vaccine and has not subsided.
At approximately 9:05 am, child returned to vaccination area c/o not feeling well and runny nose. Shortly thereafter, child complained of abdominal pain/nausea and vomited. Increased redness around mouth and above eyebrows noted. Child c/o funny feeling in his mouth and itching in his fingers. Benadryl 0.5 ml (25 mg) adminstered IM at 9:15 am. Child re-assessed at 9:20 am, showing no resolution of above symptoms and noted bilateral anterior inspiratory wheezing. 0.2 ml 1:1000 Epinephrine administered SQ at 9:22 am. Re-assessment at 9:27 am showed resolution of wheezing and child reported feeling better. 911 notified and child transported to ER via ambulance for observation at 9:35 am.
Triggered  my Neuropathy two days later in my mid section. Thighs to chest area. It?s so bad I can barely move. I have to go to my neurologist to get checked out as they thing it may have something to do with my spine.
On 5/11/21 at a routine growth ultrasound, my baby was diagnosed with hydrops with pericardial effusion, swelling and fluid around the scalp and an abdominal mass that measured estimately 6cmx6cm. EDD: 8/1/21. 2nd pregnancy, no complications with first except spontaneous rupture of membranes at 35w4d. Amniocentesis shows no genetic or chromosomal defects or infections present. No true diagnosis for the occurrence of hydrops fetalis. Diagnosed with polyhydramnios and preeclampsia related secondary to hydrops.
Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 17-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021) outcome was unknown.            Reportedly, the patient did not received any other  medications or products within 2 weeks of starting COVID-19 treatment and patient  previously received a COVID-19 Vaccine. Patient had received unspecified drug for allergy. Concomitant medications details were not reported by the reporter.  Patient had took third dose of Moderna vaccine on 11-Nov-2021 at 02:00 PM on left arm (Batch number unknown). Treatment details were not reported by the reporter.   This case was linked to MOD-2022-581177 (Patient Link).
3inch by 3inch circle of swelling, redness, tenderness, and bruising.
Within 12-18 hours of receiving my 1st dose of the Moderna vaccine, I experienced a severe migraine; fever & chills; nausea; vomiting episodes; GI/upset stomach episodes & fatigue. These side effects subsided after 4 hours, except for the migraine which lasted the remainder of the day. I also experienced intermittent headaches 72-96 hours after my 1st vaccine but the headaches were far less severe & painful.
Heart palpitations started around 1-2 hours after injections, lasted a few hours. Fever, chills, full body hives and headache , fatigue and swelling at injection started 9 hours later. Vomiting and diarrhea started approximately 20 hours after injection. All lasting 48 hours .
Chills beginning approximately 3 hrs after immunization. Temperature unknown. Developed sore throat during night. Throat still sore on 11/13/02, but no chills. Still with chills and "head cold" as of 11/15/02.
Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she "couldn't feel her hands" shortly after receiving her vaccine.  She was highly anxious and stated "I never should have done this".  On arrival to med obvs, her hands were in a contracted position and her arms/legs were shaking.  Patient repeatedly asked if she was going to be paralyzed.  The patient began to feel better after several deep, relaxed breaths.  Patient was given water, apple juice, and crackers.  Pt requested to use the restroom around 11:10.  She was transferred there via wheelchair where she was able to urinate, and reported feeling better after doing so. On discharge, patient reported slight light headedness and "off" feeling, but was otherwise better.  Vitals as follows: 10:50- BP 151/84, HR 144, RR 22, O2 97 10:52- BP 146/78, HR 144, RR 22, O2 97 11:00- BP 148/85, HR 125, RR 20, O2 100 11:07- BP 139/78, HR 116, RR 20, O2 100 11:26 (sitting)- BP 135/70, HR 104, RR 18, O2 100 11:36 (sitting)- BP 128/73, HR 98, RR 18, O2 100
Doctor gave vaccine in June and again in July from same opened vial. Did not realize use-by was 12 hour after puncturing.
Lost Appetite; took a couple naps during the day; Cough; Felt like Punching in the ribs; Aches; Tiredness; Chills; My left arm was sore around the area of injection site; my entire body being sore; head pain; Skin Discoloration on the injection area; injection site was red; Waffle skin on the injection area felt like a bump; Lingering pain on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Lingering pain on the left arm), DECREASED APPETITE (Lost Appetite), SOMNOLENCE (took a couple naps during the day), COUGH (Cough) and MUSCULOSKELETAL CHEST PAIN (Felt like Punching in the ribs) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (Lingering pain on the left arm), INJECTION SITE MASS (Waffle skin on the injection area felt like a bump) and VACCINATION SITE ERYTHEMA (injection site was red). On 05-May-2021, the patient experienced INJECTION SITE DISCOLORATION (Skin Discoloration on the injection area). On an unknown date, the patient experienced DECREASED APPETITE (Lost Appetite), SOMNOLENCE (took a couple naps during the day), COUGH (Cough), MUSCULOSKELETAL CHEST PAIN (Felt like Punching in the ribs), PAIN (Aches), FATIGUE (Tiredness), CHILLS (Chills), VACCINATION SITE PAIN (My left arm was sore around the area of injection site), MYALGIA (my entire body being sore) and HEADACHE (head pain). On 08-May-2021, PAIN IN EXTREMITY (Lingering pain on the left arm), DECREASED APPETITE (Lost Appetite), COUGH (Cough), MUSCULOSKELETAL CHEST PAIN (Felt like Punching in the ribs), INJECTION SITE DISCOLORATION (Skin Discoloration on the injection area), PAIN (Aches), INJECTION SITE MASS (Waffle skin on the injection area felt like a bump), FATIGUE (Tiredness) and CHILLS (Chills) had resolved. At the time of the report, SOMNOLENCE (took a couple naps during the day), VACCINATION SITE ERYTHEMA (injection site was red), MYALGIA (my entire body being sore) and HEADACHE (head pain) had resolved and VACCINATION SITE PAIN (My left arm was sore around the area of injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that all the reported events was gone (recovered) within a week of second vaccination. No concomitant information was reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Significant follow up appended to agency. First dose information was provided. All the events of second dose was reported to be gone (recovered)
This is a literature report for the following literature source(s): "EARLY DIAGNOSIS OF EOSINOPHILIC FASCIITIS IN A 16 YEAR-OLD FEMALE", Annals of Allergy, Asthma and Immunology., 2021; Vol:127 (5 Suppl.), pgs:S119, DOI:10.1016/j.anai.2021.08.378. A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing); "food allergies" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EOSINOPHILIC FASCIITIS (medically significant), outcome "recovering", described as "Eosinophilic fasciitis". The patient underwent the following laboratory tests and procedures: aldolase: 15.6 IU/l, notes: elevated, biopsy muscle: demonstrated inflammatory myofasciitis consistent, notes: with EF; blood creatine phosphokinase: normal; blood immunoglobulin g: positive, notes: positive Toxocara serology; eosinophil count: 2130 cells/uL, notes: eosinophilia; investigation: was unremarkable; laboratory test: remarkable for eosinophilia, notes: (2130 cells/uL), elevated aldolase (15.6 U/L), and normal creatinine kinase; magnetic resonance imaging: showed fasciitis. Therapeutic measures were taken as a result of eosinophilic fasciitis. Sender's Comments: Based on the currently available information the possibility of causal association between the event Eosinophilic fasciitis and the suspect drug BNT162B2 cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Accidently Drew the 0.5 ML instead of the Child  0.25 ML.
when giving the shot, the vaccination leaked from the syringe and the patient did not receive the dose and therefore it had to be readministered.
Tinnitus in my ear started about 3 days after my first vaccine and continued after my second vaccine. I saw and was examined by my family doctor on April 14,2021. There is no treatment available for tinnitus.
(R) hip 8"x4" local red, hot, very hard, painful reaction.
This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 22-JUN-2017, the patient was vaccinated with an expired VAQTA (lot # M034893, expiration date 26-MAY-2017) for prophylaxis (dose, frequency and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
according to pt's father pt became paralyzed from the waist down p/receving Td & TOPV;23AUG95 pt treated by MD & hospitalized;pt remains weak & c/o back pain
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing), notes: high triglycerides; "Known allergies:Mollusks" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "Known allergies: Neosporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2023) Negative, notes: On the evenings of 20Mar and 22Mar, at-home tests had shown negative results and patient had no symptoms; (22Mar2023) Negative, notes: On the evenings of 20Mar and 22Mar, at-home tests had shown negative results and patient had no symptoms; (23Mar2023) Positive, notes: Two at-home tests on the evening of 23Mar showed positive results for COVID-19; (23Mar2023) Positive, notes: Two at-home tests on the evening of 23Mar showed positive results for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
No unusual side effects.  However, I have an autoimmune condition and am on immunosuppressants.  My husband came down with COVID right before he was eligible for the vaccine so he brought it home in early April.  We have 2 young kids under 5 so were unable to isolate from each other realistically in the home.  I tested positive on 4/12 and had a very mild COVID illness compared with my husband, only had low grade temp 99-100, loss of smell with bloody sinus discharge, mild brief headache.  However about 10-14 days later, I became very short of breath, had tachycardia to 115 just walking around my house (usually I'm pretty fit), chest pressure, palpitations.  Talking for prolonged periods of time left me very winded.  I lost time from work.  About 3 weeks after initially test, I went to the ER and my EKG and lab tests were normal EXCEPT my D-dimer was elevated to 870 so I got a CT scan to rule out pulmonary embolism.  My CT was normal, but CTs cannot see the microemboli (small clots) seen on autopsies of COVID patients.
Swelling of right hand including sore joints in wrist and fingers.  This resolved by 3/1/2021.  Hot flashes including drenching sweat , red neck and face and raised blood pressure.  This occurred randomly.  It was an almost daily event until 3/5/2021.  This then reduced to 1 event every 2-3 days until the present.  Last occurred on 3/18/2021.
Flu-like symptoms. Headache, slight fever, body aches, loss of appetite. Began approximately 7hrs post injection, peaked in intensity approximately 15hrs post injection, then declined in intensity until fully dissipated approximately 48hrs post injection.
"[S]hortness of breath, neck pain, headache, muscle spasms and weakness, nausea and vomiting, that the reaction lasted about 6 hours, then after she was able to fall asleep, she felt normal when she woke up."