chrisvoncsefalvay/vaers-outcomes huggingface dataset:
26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant information was reported by the reporter. It was reported as on 08-OCT-2022, 09-OCT-2022 and 10-OCT-2022 they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. No treatment information was reported by the reporter. This case is of patient 24 out of 26 patients.
My shoulder remained in pain as the usual Covid Vaccine reactions.  From Day 5 and beyond my arm was extra soar, started losing sensation in my left hand and forearm. Sleeping became unbearable after 10 days. I was unable to tend to normal daily thing slike cooking, dressing myself, shampoo, putting on sunscreen (by that time I was on vacation in Florida). It did not get better. My arm hurt, shoulder, forearm  hand, weakness and pins and needs in my hand as well. I booked a doctors appointment for July 16.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-SEP-2015, the patient was vaccinated with (Oka/Merck) VARIVAX, the patient received MMR II (dose, route, lot# and expiration date were not reported). No adverse effects reported. Additional information had been requested.
Went to ER due to reddish/yellow discharge from left ear. Previous ear infection in 01/02. No fever, a few pox on face and body. Put on ear drops and amoxicillin. ER physician said it was a possible reaction to varicella. Had red hiving on external ear. Ear drum burst.
PREVNAR 13 Plus: On 1-30-2017 Dr. told me to get pneumonia shot booster with med added, so I'd never have to get the shot again. Only pharmacist give the shots. After 3 places I ended up at pharmacy. Had a script. After a while, they finally gave me the shot. Pharmacist told me if I notice anything different call her please - so when I 1st started with severe chills, for 2 hrs. could not get warm. Got into bed that has heated mattress pad and still could not get warm. After 2 hrs. got severe hot flashes etc. Tried calling pharmacy, left on hold 2 times, upset so I closed, stayed in bed. This continued for 2 days and nites. Anyway in a.m. called pharmacy, they didn't know who gave me shot, so I talked with pharmacist, said she can help. Told her all (the headache, chest etc) she said the med had nothing to do with it. She was gonna research and call me right back. 2 days after she calls and said yes the chills are the problem. I was upset and told her, "You're too late, I found out, you were wrong, cause all I was going through are the side effects and warnings. I had everything listed on the paper plus more. Blurred vision. Sending copies of sheet, underlined all I had. Severe headaches, dizzy bad, and could not sleep. Was in severe pain, right arm, ribs all R side where shot given severely painful. 2 mos. severely ill. Cyclobenzaprine - This was given to me on 3/3/17 to help relieve the pains all over. Severe constipated 5 days and on 6th day had diarrhea real bad for 30 1/2 hrs. Again all side effects and warning sides I got all. On sheet from pharmacy called Dr. and said take it all 30 pills. I did check, I'll never listen to anyone on taking meds. I'll only take Warfarin.
Approximately 3 days after the 1st dose vaccine developed diarrhea. Significant worsening of the symptoms after the 2nd dose which was given 2/17/2021. Began having severe blood diarrhea and abdominal pain
Blinding and debilitating migraine that?s light sensitive and unresponsive to pain medication.
Local reaction at site of injection tenderness, redness, swelling. No Rx- resolved less than 1 week.
Moderna Covid-19vaccine EUA  Side effects include severe joint pain all joints. Could   hardly walk.  Fever    100.7 degrees  inflamed chest wall  followed by fatigue.  in the space of 24 hours.
Resident developed uncontrolled coughing and vomiting. sent to ER resident tested positive for COVID-19 however resident originally tested positive  on 12/04/20
Pt states "feeling dizzy" for about 4 hours, 1-2 hours after immunizations. Pt laid down for a few hours and symptoms subsided. Husband monitored pt closely. Pt did not seek medical treatment (Attention: pt plans to still travel to Brazil 6/9 til 7/2/03.)
I was injected at my upper left arm, after about 24 hours I started feeling a needle sensation (as if I was injected) at about 12inches down from the site of the shot ( around the elbow) . 3 days later it developed into a swelling and each subsequent day I'm feeling a progression of lumps up and down arm as if my vein is calcifying.
Treatment of COVID-19 / the test was positive; Treatment of COVID-19 / the test was positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 19:00 as dose 3 (booster), single (Lot number: 301358A) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01May2022 at 08:00, outcome "unknown", COVID-19 (medically significant) with onset 01May2022 at 08:00, outcome "not recovered" and all described as "Treatment of COVID-19 / the test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Negative, notes: at 8:00 am; (01May2022) Positive, notes: at 8:00 am. Clinical course: Patient received any other medications within two weeks of vaccination was reported as no. Patient took a 5-day course of Paxlovid for treatment of COVID-19 with start date as 22Apr2022 and stop date as 27Apr2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took 975mg of Tylenol when I got home in the evening. But 12 hrs later after the vaccine shot, i woke up with severe body aches, chills, headache. Then i took another 975mg Tylenol but 3 hours later I started having fever that?s on and off. My fever even went up to 102.5F and the headache is very bad that is not relieved by Tylenol.
Pt recvd vax & went limp, then stiff, then white; took 1 breath & then did not breathe for 30 seconds; had a vasal vagal response during the time period was receiving an inject;
intermittent rapid heart rate, chest discomfort, short of breathe, dizzy spells; Seen at Urgent Care on 10/28/2021: had EKG, lab testing; Seen by Dr.  (Cardiologist) on 11/01/2021 EKG, Holter monitor for 48hours Seen: 11/11/2021
Had arm soreness and numbness from vaccine (left arm/hand) - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration
Blood pressure skyrocketting 3 days after receiving vaccine. Started having stabbing sensations and shortness of breathe, hurt to breathe in
Took Vivotif every day instead of every other day; Spontaneous report received on 21FEB2020.  A nurse reported that a consumer "took Vivotif every day instead of every other day" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that the consumer had taken Vivotif every day instead of every other day. The consumer will be travelling on 05MAR2020 as a onetime visit. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
This case was reported by a nurse via call center representative and described the occurrence of thirst in a 73-year-old female patient who received SHINGRIX (batch number JN25B, expiry date 11th September 2021) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In March 2019, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache, dizziness and flushing. On an unknown date, the outcome of the thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache and flushing were recovered/resolved and the outcome of the dizziness was unknown. It was unknown if the reporter considered the thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache, dizziness and flushing to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional case details were reported as follows: The patient received her first dose of SHINGRIX yesterday, along with an influenza vaccine. The patient woke in the middle of the night to get water because she was thirsty. She found that she had weakness in her legs, and was unable to stand or walk, her hands were cold, her body was sweaty, she had headache and dizziness and was flushed. The patient contacted the health care professional office around 8:30 in the morning of day of reporting and was already starting to feel better. It was reported that patient required emergency room visit. As per sales data sheet reported batch number was changed from JN258 to JN25B.
5/12 Cellulitis left thigh; Duricef 250/5ml BID for 7 days. 5/14 ER with increase in size of cellulitis.
Not feeling well; large lump under armpit; injection site was sore; High blood pressure 160/100; I feel pressure on my heart"; I hve an itchy hand; diarrhea; She states she had to take 2 days off from work; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Flu Seasonal QIV(FluLaval Quadrivalent 2022-2023 season) (batch number 437BK, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. In November 2022, several hours after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced feeling unwell, axillary lump, injection site pain, blood pressure high, heart pressure sensation of, itching both hands, diarrhea and activities of daily living impaired. On an unknown date, the outcome of the feeling unwell and activities of daily living impaired were unknown and the outcome of the axillary lump, injection site pain and diarrhea were recovered/resolved and the outcome of the blood pressure high, heart pressure sensation of and itching both hands were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, axillary lump, injection site pain, blood pressure high, heart pressure sensation of, itching both hands, diarrhea and activities of daily living impaired to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment: The reporter was the patient.  The patient received the flulaval vaccine and after an hours she experienced feeling unwell, injection site was sore, her blood pressure was high 160/100,cardiac disorder, axillary lump, itchy hand, diarrhea and had to take 2 days off from work. The reporter did not consent to follow-up. Note-clarification was raised but as per narrartive outcoem captured as recovering
02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours.  Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water.  02/03/2021 at 130am running nose and nausea started.  At 9am I took some alka seltzer cold tabs.  At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body.  02/04/20 swelling continues with some decreased visible; pain to right arm  pit continues and nausea continues.
Patient experiences severe flushing episodes, nausea, severe abdominal pain, back pain, difficulty breathing.  Several physicians and tests find nothing causing it.  Alls symptoms developed after the first Gardasil injection.  Symptoms still present two months later.  /24/09 Received vaccine records & PCP medical records of 12/1/08-2/17/2009. FINAL DX: likely dermatographism Records reveal patient experienced HA & dizziness intermittently x 2 yrs.  Meds had been d/c'd but HA & dizziness persisted.  Missed school due to HAs.  Allergy consult done 2/2/09 due to rash & flushing episodes since 12/29/08.  Allergy testing neg except for cedar pollen.  Tx w/antihistamine.  Had been hospitalized w/RLQ pain & dx w/constipation, treated w/enema & diet.  RTC 2/17/09 w/dizziness, flushing, abdominal pain.  Exam revealed orthostatic BP w/tachycardia.  Referred to known Neuro for additional w/u.  3/30/09 Received ER & Outpatient clinic records of 1/25/08-2/11/2009. FINAL DX: convulsive syncope Records reveal patient experienced continued dizziness, HA.  Had outside MRI considered to be abnormal & had been referred to Neuro.  RTC 9/08 off meds & mood markedly improved.  Continued w/HA, dizziness followed by syncope & tonic posturing w/some clonic jerks, last episode 8/08 & occurring approx q6mo, lasting approx 30-60 secs.  Seen in ER 1/13/09 for intermittent RUQ abdominal pain, right shoulder & shoulder blade pain; hot flashes & nausea x 1-2 wks. Dx w/acute gastroenteritis & constipation.  Tx w/fluids & enema.  Seen in GYN clinic 2/11/09 for recurring hot flashes, felt to be neurologic rather than GYN in origin as exam WNL.
Received the same dosage as the first two doses; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received the same dosage as the first two doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received the same dosage as the first two doses). At the time of the report, ACCIDENTAL OVERDOSE (Received the same dosage as the first two doses) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Injection sight swelling/rash, very itchy, red, hot, raised. Started 2 days after vaccination and continues to worse despite NSAIDS, ice, and movement.
This spontaneous report was received from a pharmacist refers to a 62 year old female patient. On 24-MAR-2014, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX and 15 minutes later the patient experienced redness and warmth at injection site. No treatment was given. No laboratory tests were performed. The outcome of redness and warmth at injection site was reported as not recovered. Causality was not reported. Additional information has been requested.
Within 5 days, fainted, husband called 911, taken to hospital, had to have a blood transfusion.  Went on for 4 months, doctors couldn't find the source of internal bleeding.  I was ready to quit all treatment,   A doctor finally repeated a test that had be done several times, found bleeding in small intestines.  At my age I don't want the second shot, I would rather die from the virus than go through that period of time again.  What I would like is a letter excusing me from the 2nd shot so I can go on with what life I have left  I would appreciate any help, other than a shot,  Thank you so much
Immediately after injection, pt felt numbness and tingling of the arm that resolved completely after 10 minutes.
Rash occurred approx 48 hrs after receiving vaccine.  Both arms, lower legs, feet, neck.; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) intramuscular at first dose on 17Dec2020 at single dose for covid-19 immunisation in left arm in hospital.  Medical history was not reported and no known allergy, no allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), atorvastatin, fish oil and 'women's 50+ MV'. The patient experienced rash occurred approximately 48 hours after receiving vaccine, both arms, lower legs, feet, neck on 19Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of event was resolving.
Erythema and edema at injection site ( 20 cm diameter ) fever/chills, headache, temp 98.9 degrees after treatment with tylenol
Received J&J vaccine on 03/17/21, then moderna on 11/22/21. Presented to ER on 1/10/22 due to sudden experience of left lower quadrant abdominal pain. Found to have perforated small abscess from diverticulitis. Incidentally found to be COVID positive, but without symptoms. Admitted due to diverticulitis. Discharged on 1/13/22.
Swollen lymph node in armpit of arm where shot was administered.  Lightheadedness, heart racing.
Pfizer-BioNTech Covid-19 Vaccine EUA Fever (varying from 100.5 to 101.5), achy joints
My arm began itching in the evening, 4 days after I got the second shot.  When I got up in the morning, my arm was REALLY itching and I rolled up my sleeve to find a red circle, about 2" in diameter around the site where I got my second COVID shot.  My arm was just sore initially after I got the shot and I've had no other side effects to either shot except this red, itching circular patch.  It hasn't gone away at the time of this report.
Patient became extremely tired after immunization. During observation time she slumped in the chair. She passed out, slipping out of the chair. We were able to lower her to the floor. She was conscious, but not coherent. BP was slightly elevated. Ambulance took her to the ER. 40 min total
This spontaneous report was received from an office manager via a company representative refers to a 68 year old female patient (also reported as patient's demographics were unknown). Patient's medical history and drug reactions or allergies were not reported. On 14-MAY-2014 the patient was vaccinated with ZOSTAVAX (strength, site of administration and lot number were not reported) dose 1 (reported as 1 single shot), subcutaneous. Concomitant medications were not reported. On 28-AUG-2014 the patient experienced pain after receiving ZOSTAVAX. It was reported that the patient went to a walk in clinic presenting with pain. 6 days later on 03-SEP-2014, the physician diagnosed the patient with shingles. The patient was treated with FAMVIR for the events. The patient had sought medical attention by visiting the clinic and consulting the physician. There was no product quality complaint (PQC) involved. The outcome of shingles and pain after receiving ZOSTAVAX was reported as recovering/resolving. The causality of the events was unknown. Additional information has been requested.
shaking like cold extreme; stomach ache; drowsy; felt like flu; typical mild fever; body got into chills /shivering; legs hurt, hands hurts; has a mild headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu) and PYREXIA (typical mild fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure and Epilepsy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu), PYREXIA (typical mild fever), CHILLS (body got into chills /shivering), PAIN IN EXTREMITY (legs hurt, hands hurts) and HEADACHE (has a mild headache). At the time of the report, NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu), PYREXIA (typical mild fever), CHILLS (body got into chills /shivering) and PAIN IN EXTREMITY (legs hurt, hands hurts) outcome was unknown and HEADACHE (has a mild headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The reporter stated that twin sister and her twin sister's husband also experienced same events. Chest hurt for a little bit, for a full week.  No treatment medication was reported.
Cold chills, body aches (flu like symptom) stomach pain, fatigue, sore arm.
Patient had swelling of left thigh as it was 25cm in circumference; 5cm above upper patella border while right thigh was 25cm at same spot.