chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red right arm; warm right arm; itchy right arm; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red right arm), FEELING HOT (warm right arm), PRURITUS (itchy right arm) and PAIN IN EXTREMITY (sore right arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (itchy right arm) and PAIN IN EXTREMITY (sore right arm). On 28-Mar-2021, the patient experienced ERYTHEMA (red right arm) and FEELING HOT (warm right arm). At the time of the report, ERYTHEMA (red right arm), FEELING HOT (warm right arm), PRURITUS (itchy right arm) and PAIN IN EXTREMITY (sore right arm) outcome was unknown.        No concomitant medications were reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 1st October 2018, the patient received SHINGRIX .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced injection site burning and burning sensation. On an unknown date, the outcome of the injection site burning and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the injection site burning and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced burning at the injection site a couple days after getting SHINGRIX. The burning had spread throughout her shoulder and into her neck.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. and treated with Paxlovid. Follow-up attempts are completed. No further information is expected.
Intercepted medication error; No adverse event; HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird; This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird), INTERCEPTED MEDICATION ERROR (Intercepted medication error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird). On an unknown date, the patient experienced INTERCEPTED MEDICATION ERROR (Intercepted medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird), INTERCEPTED MEDICATION ERROR (Intercepted medication error) 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 LIQUID PRODUCT PHYSICAL ISSUE (HCP just received shipment of Moderna COVID19 vaccine monovalent which doesn't look as translucent and a little more cloudy than the bivalent almost white looking. Caller mentioned that it doesn't expire until 03/31/23, it looks kind of weird) and INTERCEPTED MEDICATION ERROR (Intercepted medication error).    No concomitant medications was provided. It was repoted that, HCP stated that she first noticed that the product looked separated but after a while it didn't anymore. Dosage text was reported as unknown for suspect. No treatment medications was provided.   Reporter did not allow further contact
pneumonia; blood clots; exposed to COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), 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 (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE: 3; unknown manufacturer), for Covid-19 Immunization. The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: My wife was also exposed to COVID, had 4th shot end of June. She tested negative. Clinical course: The patient was also exposed to COVID, had 4th shot end of June. She tested negative but had pneumonia. Also got blood clots in right leg most likely from COVID and flying.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 05-AUG-2016 or 12-AUG-2016, the patients were vaccinated with doses of improperly stored PROQUAD (therapy type rHA, lot # M017335, expiration date 05-OCT-2017; strength, dose, frequency and route were unknown). The vaccines were exposed to temperature excursion of -14.7 degree centigrade for 15 minutes; -13.0 degree centigrade for 15 minutes; -11.6 degree centigrade for 15 minutes; -10.2 degree centigrade for 15 minutes; -8.9 degree centigrade for 15 minutes; -7.9 degree for 15 minutes; -6.7 degree centigrade for 15 minutes; -5.8 degree centigrade for 30 minutes; -9.8 degree centigrade for 15 minutes and -13.5 degree centigrade for 15 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects 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.
Extensive DVT(blood clots) involving both legs-- initially with tachycardia dyspnea. Now on 10a meds. Likely to have disability or permanent damage.     History of post-op DVT with PEs following sholder surgery, subsequent placement of IVC filter.
Moderately increased temperature, edema, pain and  erythema,  at injection site beginning 17 hours after administration with progressive increase of severity.
Fever since evening of 5/6/02, Irritable crying, Temperature 104.8 rectally at noon 5/9/02, Has been treated w/Tylenol, Directed pt to other facility on 5/9/02
Awakened in middle of night with fever of 102.4 (taken in ear), severe back pain, headache, feeling lousy. Temperature normalized within 24 hours and shooting pains throughout body ended within two days. Two days after vaccination had a lot of sneezing, a runny nose, and sore throat (cold-like symptoms).
Pt was given #2 HPV and left area went to pharmacy, we had a Fire Drill pt walking out to car and fainted. Hit head, LOC, was taken to Hospital found to have a skull fracture was airlifted to another hospital for treatment.  4/2/09 ER report received for DOS 2/18/09  with Final dx:  Syncope. Head bleed. Shortly (~5 min) after receiving vax pt had a syncopal episode where pt fell backwards and hit head on sidewalk. LOC x several minutes. One episode of vomiting en route to ER. PE (+) for hemotypanum of the R ear, vomiting and pain at C4. Transfered to higher level of care for subarachnoid bleed.  5/11/09 MR received from transfer facility for DOS 2/18-19/2009 with dx: R occipital skull fx, L frontal contusion with presentation c/w vasovagal syncope. Cardiac and ENT consults. Systolic murmer noted on PE. Neuro exam WNL. ENT notes conductive hearing loss  and possible R temporal bone fx on R. Will f/u on hearing loss as outpt.
Patient reports pain at injection site months after receiving the injection. Temporarily relief with creams given by her dermatologist, but it still lingers. Weakness in her right arm as well.
Fever of 103 Extreme chills and shaking  Horrible headache  Severe body aches
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant product use was not provider by the reporter.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  Treatment information was not provided.  This case contains information for the 182 of 190 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Pt recvd vax & devel pruritic skin rash following vax; no further details were provided;
Pink Rash on her legs; Blotches on her legs; is uncomfortable for her to sleep; pain when bending down; confirmed with a case of Shingles; pain in her left leg; nerve pain and her leg; feels like burning sensation; dots on her left side of the back.; Redness at injection site; Soreness at injection site; bad bruise under the left arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's and immunocompromised (on immunosupresants). Concomitant products included mercaptopurine.   On 11th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 13th January 2020, the patient experienced contusion. In January 2020, the patient experienced shingles, leg pain, nerve pain, burning sensation and rash. On an unknown date, the patient experienced red rash, blotchy, sleep disorder and pain. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site erythema, injection site pain and contusion were recovered/resolved and the outcome of the leg pain and nerve pain were not recovered/not resolved and the outcome of the burning sensation, rash, red rash, blotchy, sleep disorder and pain were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site pain, contusion, leg pain, nerve pain, burning sensation, rash, red rash, blotchy, sleep disorder and pain to be related to Shingrix.  Additional information was provided as follows: The patient received the vaccine on her left arm. The same day of vaccination she experienced redness and soreness at injection site that lasted for 3 days. On the third day she experienced a bad bruise under the left arm which took 5 days to resolve.  About a week later from the day of vaccination she started to experience pain in her left leg. At the same time she experienced dots on her left side of the back.  She visited her physician and was confirmed with a case of Shingles. About 2 weeks after vaccination she started to experience pink rash and blotches on her legs, and from knee to groin area.  The Shingles on her back and legs got better and lighter.  The pain in her legs was ongoing and she described it as nerve pain and her leg feels like burning sensation.  It is uncomfortable for her to sleep and she had pain when bending down. The patient used calamine lotion on the affected area.  The patient experienced all the adverse events on the left side of the body. The reporter did not consented to follow up. This is 1 of the 5 cases reported by the same reporter.
On 3/28/2022, I started with a bad chest cold, runny nose, a headache, and congestion. The next day I tested positive for COVID-19. I was really tired that whole week. I felt stuffy and ran down. When I called the doctor, they prescribed me with prednisone and benzonatate. Those symptoms lasted for almost 3 weeks. I would be feeling better, and then I would start feeling tired and lousy again. This week I felt tired, run down, and lousy. Each time when I start feeling bad again, I would test negative for COVID-19. Off and on I feel good and then bad again.
Rash generalized starting on 05/16/2002. Highest temp 100.6. Rash disappearing by 05/20/02. Throat culture swab done on 05/20/02. No cough, coryza or conjunctivitis. Rash on trunk, back, face, and back of throat.
Fever 104.7, loss of consciousness, high heart rate, low sodium, cardiac ischemia
Developed severe Jaundice with elevated liver enzymes and required hospital admission.; Developed severe Jaundice with elevated liver enzymes and required hospital admission.; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), second dose via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:00 (at the age of 25 -years-old), single dose for covid-19 immunisation. Medical history included Migraine headaches from an unknown date. The patient's concomitant medications were not reported.  The patient had the fist dose of BNT162B2 vaccine on 20Jan2021 (at the age of 25 -years-old) for COVID-19 immunisation. Lot number=EL9261,on right arm. On 10Mar2021, patient developed severe Jaundice with elevated liver enzymes and required hospital admission. Patient required three days of hospitalization. Ae treatment were IVF, Hepatic biopsy, CT imaging, MRCP, U/S. The events outcome was not recovered. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Jaundice with elevated liver enzymes cannot be excluded.  The case will be reassessed if additional information becomes 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.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 14-JUL-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. NO adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012657, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
LOWER BACK PAIN IN BOTH SIDES; BLOATING; COUGH; THROAT TICKLISH; MUCOUS; SWOLLEN ANKLE IN RIGHT LEG; NUMB TONGUE; LOSS OF TASTE; WHITE COAT ON THE TONGUE; RIGHT ARM SWOLLEN; CHILLS; TIRED; HOT FLUSHES; THIRSTY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hot flushes. On 31-MAR-2021, the subject experienced thirsty. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced lower back pain in both sides. On APR-2021, the subject experienced bloating. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced throat ticklish. On APR-2021, the subject experienced mucous. On APR-2021, the subject experienced swollen ankle in right leg. On APR-2021, the subject experienced numb tongue. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced white coat on the tongue. On APR-2021, the subject experienced right arm swollen. Laboratory data included: Chest X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes, thirsty, throat ticklish, chills, and tired on APR-2021, was recovering from numb tongue, and loss of taste, had not recovered from lower back pain in both sides, bloating, cough, mucous, swollen ankle in right leg, and white coat on the tongue, and the outcome of right arm swollen was not reported. This report was non-serious.
pt c/o throat irritation. denied chest pain. denied dyspnea. respirations unlabored. BP 173/86, HR 103, RR 20, 99%O2sat RA
With my first vaccine shot on 2/1/21 I developed a small itchy spot on my neck immediately following injection.  The doctor on site recommended waiting there at the hospital to monitor it for a few minutes, and I did, and the spot went away.  My second vaccination was 2/24/21 and the next day, around noon, I started to have a back ache.  Late afternoon I became a little light headed and slightly queasy.  That night the pain started in my joints - neck, shoulders, all down my back.  They became rather intense, and at one point during the night, after I had managed to fall asleep, I was awoken with burning pain in both elbows, and random sharp pains in toes and fingers.  I took Tylenol through the afternoon and night.   The following day I was still sore, but not in pain.  Then all symptoms disappeared. Not severe enough to seek medical attention but thought I ought to report symptoms for medical research reasons.
Several days after injection I noticed some redness and itching.  By Day 8 redness was about 3 inches in diameter.  By Day 9 (today) redness is about 6 X 8 inches.  Moderate to severe itching.