chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA   In addition to arm soreness and headache (which I also experienced following my first dose of the Moderna Covid-19 vaccine), I have a raised, firm, very warm, and  red area around the injection site (4inches in diameter). Though the red area is not exactly a circle, the diameter of the red area has steadily increased over the past few days. The area is not itchy. My arm is most painful when I move it (attempting to abduct at the shoulder feels impossible) and I cannot apply pressure (leaning or laying on that arm is also tremendously painful, as is the weight of a blanket touching the arm).    My arm soreness after the first dose I received resolved after 5-6 days. My arm was firm and warm around the injection site for that dose, but did not have this red area surrounding the injection site.
there was an issue with the attached needle product where the needle hub popped off the safety part of it, and it was secure (not too tight or too loose) and upon removal of needle from deltoid the needle/hub stayed in the 15 month old's arm - patient did not move and no injury occurred but there was risk for it so we are removing the stock from use and notified distributor who is contacting manufacturing company
HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 43 year old female. 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 not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 13-APR-2021, and headache on 20-APR-2021. This report was non-serious.
The vial was initially stored in the refrigerator on 20-MAR-2023; No adverse event; Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an elderly 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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-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 21-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-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 (Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-2023).    Concomitant medication was not provided.  Reporter reported that the vial was individual vial and size was 2.5 ml. The vial did not undergo any temperature excursion. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721044 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721044:1st patient case (Master case)
pt recvd vax & next AM devel raised rash bilat sides from underarm to hips; sl itching; rx DPH
cold chills; light headache; rashy feeling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (cold chills), HEADACHE (light headache) and RASH (rashy feeling) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (cold chills), HEADACHE (light headache) and RASH (rashy feeling). At the time of the report, CHILLS (cold chills), HEADACHE (light headache) and RASH (rashy feeling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment drugs were Tylenol, Advil, Steroid injection. Patient has been using a heat pad in the middle of his back.   2 days after receiving the second dose of the vaccine, patient came down with cold chills and a light, dull headache which have continued intermittently until today. Patient has consulted his doctor twice for his symptoms.
breathing diff w/wheezing;rash on neck, upper chest lt arm, puffy eye;epi given;
Temperature of 102.5 - r/arm edematous shoulder to elbow, erythematous and warm to touch.
Information has been received from a medical assistant concerning an 8 week male patient with no medical history or drug/allergies reported, who on 02-NOV-2010 was vaccinated with a dose of ROTATEQ (Lot # not provided), 2 mL, orally. There was no concomitant medication. It was reported that the patient regurgitated immediately after receiving a dose of ROTATEQ. The child had just been fed prior to being seen by the doctor. There were no laboratories diagnostics performed. The patient recovered on the same day. Follow up information has been received from the medical assistant who stated that the patient spit up entire dose of ROTATEQ in October, 2010 (previously reported as 02-NOV-2010). Additional information has been requested.
ON 6-12-2020, INJECTION SITE TO BACK OF RIGHT ARM STARTED WITH FLUID FILLED VESICLES. APPROXIMATELY 3 INCHES IN DIAMETER. NO PAIN OR ITCHING AT SITE. ITCHY RED BUMPS BEGAN TO TORSO ON 6-12-2020
Blindness: Devel seizures, fainting, and fevers after each vax. Has attributed legal blindness "residual seizure syndrome" and worsening muscular & joint problems to combined effects of DTP administration.
itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
After vaccination my had started aching and swelling, the next day it got worse, a few days later it got worse and I couldn't make a fist, I then had a huge flair up and I couldn't walk. From the knees down there were shingles red spots, blisters. I got Benadryl that helped a little so that I could drive, and I had to take 4 of them every four hours. I saw my doctor and was given Prednisone and another drug that's an anti-inflammatory but it didn't help. The flare up are random and last from a few days to a week. Since then, my hands will hurt from like the pinky down to the palm, then it'll be my thumb, then it'll be one hand and sometimes both hands.  The last flare up was both hands with sever itching and lasted a week. I also had it on my inner thigh from the crotch down to the knees and it took a week but it was all hurting.  The doctor gave me a new medication and it helped some.  I also get cold sores in my mouth and I never had this before. Also, the flare up always seem to start after 7pm.
Tiredness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Mar2021 12:30 (Lot Number: ER8730) as dose 1, single for COVID-19 immunization at the age of 41-year-old. The vaccine was administered at pharmacy/drug store. Medical history included smoking from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had SARS-CoV-2 test (nasal swab) on 14Apr2021 and result was negative. The patient experienced tiredness on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021778305 Same patient/drug, different dose/event.
Patient had shingles/ suspected vaccination failure; Shingles; Nerve soreness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: Nerve soreness). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received shingles vaccine and still experienced shingles. The patient still have nerve soreness where he or she had shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst.  Started about 7:00 pm and pain and symptoms  lasted about  24 hrs
Absence spells or seizures x3 20 seconds day #3 after, seen day 4 and OK.
Hives on body began one day after immunizations. Hive would appear with contact and last about 20 minutes.  Parent did preventative things like switch to mild detergent, lotion and soap.  Mom breastfeeding switched to an elimination diet.  Plan to vaccinate at 4 months with observation.
Small bumps covering both legs front and back.   Painless.  Colorless with some mild itching.
Information has been received from a physician and a healthcare worker (also reported as "practice administrator") referring to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 24-JUN-2015 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # J007349, expired date 13-JUN-2015; dose and route were not reported). Information regarding concomitant medications was not reported. No adverse effect was reported. Additional information has been requested.
Unexplained Tachycardia, Radiating chest pain, Presyncope episodes, unexplained syncope,  elevated d-Dimer, Shortness of breath, Leg pain, swelling, pain at the injection site.
This spontaneous report has been received from a certified registered nurse prescriber, referring to a patient of an unknown age and gender.  The information regarding the patient's medical history, drug and allergy history, current condition and concomitant therapies was not provided. It was reported that on an unknown date, the patient was vaccinated intramusculary instead of subcutaneously with M-M-R II, (dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported. Additional information has been requested.
Significant erythema and swelling of (R) upper extremity with tenderness from shoulder to mid forearm which began a couple of hours after PPSV23 injection on 12/18/19. Symptoms continue 48 hours after injection with little to no improvement. Patient seen in clinic 12/20/19 for further evaluation. Benadryl 50mg IM administered and ACE bandage compression applied to (R) arm.   Pt ordered to keep ACE in place 12 hours on/ 12 hours off for the next 2 days. PCV13 vaccine completed 11/2018 with no adverse effects. Pharmacy contacted regarding adverse event.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On 09-FEB-2016, the patient received the second dose of GARDASIL 9 (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On 10-MAR-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L045711, expiration date: 08-MAY-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Additional information has been requested.
I had nothing wrong with my heart until I decided to take one of Pfizer little shots.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: CARDIAC DISORDER (hospitalization), outcome "unknown", described as "I had nothing wrong with my heart until I decided to take one of Pfizer little shots.". The patient was hospitalized for cardiac disorder (hospitalization duration: 14 days). Clinical Course: Caller called in with questions about the medication Estring. During the call caller stated." It's the only one I can use I don't have any insides left I don't have anything because of having children. patient later stated on the call. I had nothing wrong with my heart until I decided to take one of Pfizer little shots. And I'm not the only one it's other people have gotten heart problems from these damn shots. I spent 2 weeks in the hospital a year after I had 2 shots."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness at injection site for two days.  Redness around injection site on day 14 after shot received
Pt recvd 3 doses of Engerix-B & 9NOV91 it was determined that pt did not respond to the vax series;
Patient mistakenly received 2 high dose influenza vaccines, first 10/17/18 and the second 10/30/18.
Nausea - dizzy - pale - lightheaded B/P 82/60 - 10 minutes after receiving vaccine. Patient in supine position for 10 minutes - sitting for 10 minutes.
woke from sleep to completely SOAKED night shirt, bed sheet, mattress cover and thru the mattress.  Hair was completely dry just body wet and big rectangular wet spot in bed.  Tossed clothing off and moved to the other side of the bed to continue sleep.  Nothing else happened
pt recv vax;seen at md's ofc & tx for urticaria hives;md feels rxn to MMR & should not recv any oth MMR;
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 4 month old male patient. Patient had no history of chickenpox. On 30-OCT-2014, the patient was vaccinated with first dose of ROTATEQ (dose: 2 ml, orally) (lot # J013589, expiration date: 06-JUN-2015) which was incorrectly stored. Concomitant therapies included DTAPHBIP (default manufacturer GlaxoSmithKline reported as "GSK"), HIB (default manufacturer: Sanofi reported as "AVP") and PCV 13 (default manufacturer: Pfizer reported as "PFI"). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Just can't go to sleep; Area of the injection hurts, really painful; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Just can't go to sleep) and VACCINATION SITE PAIN (Area of the injection hurts, really painful) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 013AZ1A and 141LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INSOMNIA (Just can't go to sleep) and VACCINATION SITE PAIN (Area of the injection hurts, really painful). At the time of the report, INSOMNIA (Just can't go to sleep) and VACCINATION SITE PAIN (Area of the injection hurts, really painful) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
This spontaneous reported as received from a consumer refers to 4 children patients (gender and exact age not provided). The consumer stated, that heard about four children, who on an unknown date, were vaccinated with GARDASIL (dose, batch/lot #, expiration date not reported), and experienced behavior changes. Action taken and outcome of adverse event was unknown. The relatedness between adverse event and therapy with GARDASIL was not reported. This is one of several received from the same reporter. Additional information has been requested.
p/vax pt broke out w//what was thought to be chickenpox;it was determined @ MD office that pt had sustained spider bites, not chickenpox, as originally reported;
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a 28 year old female medical assistant referring to herself. There was no concomitant medication, pertinent medical history or drug reaction/allergy. On 03-OCT-2018, she was reconstituting VARIVAX (lot# R017635 with expiration date 20-JUN-2020) with sterile diluent(MERCK STERILE DILUENT) (lot# reported as R022411 with expiration date 10-NOV-2019), and the mixture came up thru the stopper splashing the Medical Assistant (Product quality issue and Occupational exposure while preparing product for administration). No adverse effect was reported. There was no treatment for the events. No lab diagnostics or studies were performed. The outcome of product quality issue was reported as recovered. The causality was not provided.
From phone correspondence received at manufacturer on 8/14/02, it was reported that a college-age female administered with Menomune A/C/Y/W-135. The PT was admitted to the hospital ER where, due to her Sx's of severe headache, and neck stiffness, a spinal tap was done (no results were provided). No date of vax or other vax info was provided. It was not reported whether PT recovered from these events. The info was reported by the PT's mother.
Patient complained of pain at injection site, nausea and vomiting and numbness of extremity of right arm.
signs and symptoms:  dx COVID; SOB and dry cough. His chest x-ray showed a left base subsegmental atelectasis with minimal blunting suggestive of small effusion, cardiomegaly.  Lactic acid 1.0, troponin 0.03.  Procalcitonin 0.17.  White count 6.8. D-dimer 600. Treatment:  Decadron and Lovenox and he received a full course of remdesivir.