chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILLS; WEAKNESS; LEFT ARM PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcoholic. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced stomach hurt. On 21-MAY-2021, the subject experienced vomiting /threw up brown liquid. On 21-MAY-2021, the subject experienced can't eat or drink anything. On 21-MAY-2021, the subject experienced feeling cold. On 21-MAY-2021, the subject experienced body chills. On 21-MAY-2021, the subject experienced weakness. On 21-MAY-2021, the subject experienced left arm pain. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting /threw up brown liquid, left arm pain, and nausea on 21-MAY-2021, had not recovered from headache, body chills, stomach hurt, weakness, and feeling cold, and the outcome of can't eat or drink anything was not reported. This report was non-serious.
Severe full body ache and fatigue starting around 11pm, fever of 102°, and migraine continuing for about 36 hours. Full body fatigue for about 12 hours following resolution of body aches. Minor and herpetiform vulvar aphthous sores beginning ~60 hours post injection and resolving 7 days after first appearance.
Dose given beyond 30-day expiration date; Dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date).    Concomitant products were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov. The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  The vial did not undergo any temperature excursions.  Treatment medications were not reported.
Rash on the left side of the neck; This case was reported by a pharmacist and described the occurrence of neck rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   On 11th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 14th January 2021, 3 days after receiving Shingrix, the patient experienced neck rash. On an unknown date, the outcome of the neck rash was not recovered/not resolved.   It was unknown if the reporter considered the neck rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient received Shingrix in the left deltoid. The batch number of Shingrix was reported as ZLH9L, which was corrected to 2LH9L as per sales data sheet. The patient developed rash on the left side of the neck and was ongoing at the time of call. The reporter consented to follow up.
Allergic reaction - swelling in upper arm near injection site, some swelling, some redness, some itching, site warm to touch
I started with left sided chest pain, which was worse when I was laying down or taking deep breaths.  I was out of the county when I experience it.  We came home early.  Motrin helped a little.  I keep getting worse I went to my doctor, and they did an x-ray and EKG which both came back normal.  Those were done on May 20th.  By the 23rd I couldn't walk with chest pain.  The cardiologist did a scan of my heart, and they found a small left sided pleural effusion.  They still do not know why I have that pleural effusion.  They check my labs which I had a small elevated inflammatory lab.  Over the next few days after that it went way, and I was able to go back to my normal activities.   I have not had problems since.
No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; arthritis; she can't go to sleep until 1 am/unable to sleep/She can go to sleep at the drop of the hat in the afternoon which is not usual; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 15Jan2021 14:15 at single dose on the left deltoid (also reported as "left arm") for COVID-19 immunization (reported as "Prevention"). Vaccination facility type was retirement community, not a military facility. Medical history included "blood pressure", reflux (her esophageal flapper bottom is deteriorated), blood disorder (reported as indication of aspirin: "blood thinner") and depression. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID) as a blood thinner, citalopram hydrobromide (CELEXA) for depression, hydrochlorothiazide for blood pressure, omeprazole for reflux (It is because her esophageal flapper bottom is deteriorated) and multivitamin; patient reported that she was taking all prior to the vaccine and did not think any were relevant to the report.  There were no previous vaccine (reported as "Additional Vaccines Administered on Same Date of the Pfizer Suspect. None"). The patient reported that she got the injection last Friday (15Jan2021). She was still feeling the symptoms of everything with the exception of injection site pain and swelling and redness. She did not have any swelling of lymph nodes or nausea. With the exception of those items listed, she had all the other side effects. On 16Jan2021, the patient experienced tiredness, headache, muscle pain, chills, joint pain and feeling unwell. The patient stated that muscle pain and joint pain could also be attributed to arthritis. Patient mentioned that chills could have been Sunday, but she thought Saturday (16Jan2021). Patient did not have a fever. Patient also mentioned that unable to sleep was a chronic problem. She can go to sleep at the drop of the hat in the afternoon which was not usual. Then at night, she could not go to sleep until 1 am. She did not wish to list this as a side effect and did not feel it was attributed to the vaccine. No energy has been really bad today (19Jan2021), but she still thinks it was persistent. Patient will get another dose in 3 weeks. No emergency room (ER) or physician's office required. Patient wanted to know if it was common to get these side effects. Outcome of the events tiredness, headache, muscle pain, chills, joint pain, feeling unwell and No energy was not recovered while for other events was unknown. There was no investigation assessment.  Information on the lot/batch number has been requested.; Sender's Comments: The reported insomnia is considered unrelated to BNT162B2 administration since mentioned as a pre-existing condition
Headache, NauseaVomiting, dizziness Narrative: severe migraine
Nurse calling to request information on voluntary recall of PNEUMOV AX 23 / she had vaccines from the affected batch that were administered to 30 patients after 12Aug2020.; This spontaneous non-valid report was received from a registered nurse and refers to 30 unknown patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 12-AUG-2020 (also reported as after this date), voluntary recalled doses of pneumococcal vaccines, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml (lot # S036495, expiration date not reported, but upon internal validation established as: 13-SEP-2021) (route of administration and anatomical location were not reported) were administered to 30 patients for prophylaxis.   This case is considered non-valid due to no patients' identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Day 1. All the common side effects.  Headache, chills, tiredness, fever 101.6   Day 2 tiredness. Fever 100 for short time, bad headache.   Problem day 3. Woke up to the room spinning around.  This subsided in about 5-10 minutes but was dizzy with any head movement most of the day.  Also headache     Day 4  tiredness  slight dizziness.   Day 5.  Headache gone. Still tired and dizziness not gone, but not near as bad as day 3.  I am hydrating also
ADMINISTERED TO A 16 YEAR OLD MODERNA VACCINE WHICH IS ONLY INDICATED FOR 18 AND OVER. I DIDN'T REALIZED THE MISTAKE UNTIL I HAD ALREADY ADMINISTERED IT. I TRIED TO CALL THE PATIENT HOWEVER I WASN'T ABLE TO GET AHOLD OF THEM. I WILL FOLLOW UP TOMORROW WITH THE PATIENT AND SEEK GUIDANCE FROM OUR IMMUNIZER COORDINATOR.
Information has been received from a registered nurse (R.N.) concerning her 15-year-old daughter who on an unspecified date was vaccinated subcutaneously with a second 0.5 ml dose of Varivax. Subsequently, the patient experienced chickenpox two weeks after vaccination. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. It was reported that the patient recovered after 5 days. No product quality complaint was involved. The patient's siblings also had adverse experiences following vaccination (WAES# 0609USA04120 and 0609USA04903). Additional information has been requested.
less than 24hr post vax pt arm became swollen, red & hard-area 6" in diameter;rx ice sx increased dx possible cellulitis;after several days sx resolved;
Had diarrhea briefly, soreness body aches could not walk muscle pain and lack of use. Husband tried to put her in the car and she fell. Felt like the flu x 100. Today, she is able to walk.
pt states that within a couple of hours after receiving the covid vax she got nauseated, had a headache, stomach pain, dry heaves.  Her balance is off and she is having trouble walking.  On 2/21/2021 she went to Hospital ER.  She was given IV fluids and a shot of Reglan to settle her stomach.  Her blood pressure was 250/97.  She was discharged w/ instructions to keep drinking fluids, eat when she could and to come back if necessary.  Pt has not contacted her PCP at this time. These symptoms have been going on a week now.
According to the system, patient was given  initial Moderna dose on 2/1/2021. He received a  first Pfizer dose on 2/16/2021 and the system did not display the location as it was invalid. Then patient showed up as a walk-in who was due for his second dose at clinic on 3/9/2021. After administering the vaccines, the information was input in the system after the patient had been observed for 15 min in the observation/recovery room. Since his first dose Pfizer was considered invalid, the system does not show where he got his first dose. This is how we discovered the situation. . Patient did not have any adverse reactions and went home.
Developed low grade fever immediately p/vax; Con't to rise to 106 over next 3-4 days, very listless. No other sx.
rash(injection site); Inflamed lymph node a week after receiving the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (rash(injection site)) and VACCINATION SITE LYMPHADENOPATHY (Inflamed lymph node a week after receiving the first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash(injection site)) and VACCINATION SITE LYMPHADENOPATHY (Inflamed lymph node a week after receiving the first dose). At the time of the report, VACCINATION SITE RASH (rash(injection site)) 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 details were not provided.   Reporter did not allow further contact
Client received 2nd dose of Moderna vaccine at 1405 and began with dizziness and lightheadedness at 1420. Client was provided water and VS were assessed. Client's blood pressure was 130/70, P 85,  and 02 97%. Client's dizziness and lightheadedness resolved at 1447 and client left facility at 1450 with her husband. Writer followed up with client via phone on 3/4/21 at 0943. Client reports no episodes of dizziness since initial episode following vaccination. Client is now experiencing expected effects of vaccination such as headache, sore arm, and body aches. Client encouraged to call health department with any questions and to seek medical care in the event of emergency.
pt states about 4 days after he took the vax the underside of his right arm became sore and developed a red rash.  It is about 6 inches from the middle of the arm and ends about a foot above his wrist.  he is using magnalife pain and inflammation foam.  he said it helps with the pain but the rash is still present.  He is having severe pain in his right shoulder down about 6 inches of the right arm.  he is using absorbing plus junior pain relieving liquid to help with this pain.  The back of his neck is swollen, sore and painful.  His symptoms are not getting any better and he does not have a PCP to call for medical advice.
Boosted on 2/16/22. Woke up 2/17/22 at 10:00 AM with severe body pain. Too weak to get out of bed. Took pain medication. Experienced severe fatigue. Woke up by extreme crushing vulvar pain at 1:00 AM 2/18/22. I thought I had a UTI although I never get them. Took cranberry tablets, vitamin C. Monday 2/21/22 called Doctor. Got tele appt Thursday. She gave me Fluconazole for possible yeast infection. Felt slightly better initially, then got worse. Saw Doctor on Thursday March 3rd, she saw nothing and referred me to gyn. Refilled Fluconazole. March 10th saw OBGyn, she saw ?white spots? and vulva was ?inflamed and red?. OBGyn scheduled me for a biopsy May 3rd. Pain was out of control ? was put on 24 hour pain management ? 100mg of tramadol ER 2xday, compounded vaginal cream consisting of ketamine, gabapentin, cyclobenzaprine, and lidocaine, 400 mg Gabapentin 4xday. I began have erosions on March 27th. I began researching vulvar problems after vaccination out of desperation. I came across a support group. This looked like what was happening to me. Joined support group to get any help at all as doctors were doing nothing. I was encouraged to find a vulvar dermatologist. Thank God I live near one ?Dr. saw me on Wednesday April 13th. She diagnosed me. Did biopsy to confirm on Monday April 18th. Friday April 22nd Diagnosis was confirmed - Erosive Vulvar Lichen Planus. Started on Clobetasol ointment 3xdaily. Prednisone was prescribed but I could not tolerate it. Follow up appt, on May 16th.
When pt woke up on 11/30/17, 21 hours after having the flu vaccine, he was unable to walk. It was his right leg that was giving him the issue. This went on for 1 hour 45 minutes. Patient was then able to walk but with a very noticeable limp and his right foot turned slightly outward. Patient did not seem to be in pain but was very distress because he was unable to walk. When he could walk he was still in distress because he could not walk without the limp. Patient went to urgent care at 8:15 on 11/30/17 but was told by the doctor that the symptoms could possible be caused by rheumatoid arthritis and that I, the patients mother, was to keep a log of when symptoms happen so that if continued, testing could be performed. The limp continued throughout the day and evening. Patient saw chiropractor at 6:00pm 11/29/17 for an adjustment. On 12/1/17 patient woke up with slight limp again. Patient was given 1 teaspoon ibuprofen in hopes to calm any inflammation. Slight limp continued and patient was given 1 teaspoon ibuprofen before bed at 8pm. Patient woke up on 12/2/17 less of a limp than previous day and was given 1 teaspoon ibuprofen for any additional inflammation. That takes us to right now where patient still isn't waking like normal but is much better than day prior.
Pt vaccinated with DTP 3 hrs later developed fever to 101, irritability, several apneic episodes, vomited once. Admitted to hosp, placed on oxygen. A few brief bradycardic episodes noted. Child afebrile, doing well next morning.
Pt received ZOSTAVAX on Dec. 12 - 11 - 13 or Fri 12 - 13 - 13 he says he developed a 5 cm, red, swollen rash at injection site, on left deltoid. He immediately began taking, dicloxacillin. The rash resolved. He believes it was an injection.
Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: tingling, dizzy, lightheaded, pale, anxiety, called 911, left with paramedics -Mild
Began screaming p/immun for a long time; screaming episodes recurred @ intervals x 3 days; appetite dec spontaneous recovery;
Leukocytoclastic vasculitis; This is a spontaneous report from a contactable other hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, in arm right on 23Feb2021 (Batch/Lot Number: EN6201) and dose 2 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported); both as single dose for Covid-19 immunisation (age at vaccination was 83 years). It was unknown if other vaccine was received in four weeks. The patient medical history and concomitant medications were not reported. She was not pregnant. On an unspecified date in year 2021, the patient had leukocytoclastic vasculitis after each of the 2 vaccines. No treatment was received. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether patient had Covid prior vaccination or not and whether patient tested for Covid post vaccination or not. Outcome for leukocytoclastic vasculitis was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported event leukocytoclastic vasculitis cannot be excluded. Case will be reassessed upon receipt of additional information. 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.
Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  The Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.The Pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24-Jan-2022.
Started to get muscle aches and INTENSE chills at 11:30 pm. Arm was also quite painful around this time. Woke up at 0300 with nausea and a fever of 100.9. Also had a mild cough, SOB, fatigue, and low appetite.  I called out of work that morning due to illness. I was instructed to get a COVID test that day. Results were negative. All symptoms resolved the following day with the exception of malaise which lasted until 2/5/21.
Patient is a 66 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/18/2021. The patient experienced the following reaction(s) during the immediate of observation: 10:35am Patient c/o redness to bilateral hands. Denies numbness and tingling to hands or difficulty breathing. Patient reports feeling fine. Patient was treated/managed as follows:  VS BP 116/78 HR 63, RR 16, O2 sat 98% on room air. Redness to hands subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 10:43am Patient escorted to door.
first dose of Shingrix in december 2019 and has not received a second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The medical assistant reported the case. Till the time of reporting patient not received second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.