chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 10:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 50.47.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Feb-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Janssen COVID-19 Vaccine EUA  I received the Janssen COVID-19 Vaccine EUA on 03/09/21 at 6:20AM. My arm started to ache maybe 15 minutes after and lasted throughout the whole day. Around 4:30:PM I started to feel more aches and chills. Then, by 7:00PM I had a  fever. My temperature was 100  degrees. By the next day, 03/10/21 my fever and chills were gone, however, I felt very achy all over the body. It was not until the next day, 03/11/21 that I didn't feel achy anymore.
pt recv vax 6JAN97 & in the PM pt devel a rash on the legs & back w/itching which was not relieved w/DPh;
Moderna 1st shot, left arm.    Left arm pit swelled lymph node with soreness.  It?s been 3 days, it is getting better.
right arm pain that continued up until next vaccine date. pain was with use of arm . Some swelling and alot of discomfort
Patient got Dtap, instead of Tdap.  No adverse reaction/symptoms from vaccination was reported
2nd dose was similar as 1st afterwards, but on 03/22/21 my quadricep muscles were paralyzed and I had to drag my feet and I couldn't lift my legs. I went to my chiropractor because I have back issues and she did a thorough check and said it has nothing to do with my back and to see my Doctor. I saw my Doctor 2 days later and she sent me for an MRI of brain and spine and did labs and everything came back negative. I didn't know what to do and no one could diagnose what was wrong. I dealt with the basic paralysis for about a week and kept walking as much as I could and tried to be as active as much as I could. A week later I was able to walk normally. I missed two weeks of work and I couldn't function and I was slow. Since that and within that time and November, I had a 10 pound weight loss with no effort to lose weight, and the interesting thing is I had been lifting weights and exercising and with doing that I lost muscle and it was visible and noticeable and very rapid. I've had difficulty ever since with maintaining my weight and the Doctor said I was underweight and I can't gain any fat or muscle weight of any substance. It was very unusual circumstances for me and it was profound and immediately after leg issues. I've been evaluated for MS and have had my spine looked at with MRI and everything came back negative. My neurologist said my Vitamin D was low so I've been taking that and my labs are back to normal. I can function normally and muscles seem to be working but I've been having issues with maintaining weight and muscle even with dietary changes. I've had a nerve conduction test of my whole body done and Doctor said I have carpal tunnel but no leg problems, but I'll go see him again and have more testing.
Side effects:  Mild chills, headache, joint pain, nausea, feeling unwell, rash and itching, muscle pain, and difficulty breathing.
Received vaccine on 3/2 called 3/4 with itching, pain, swelling, and redness to injection site. Saw Dr. 3/5 dx cellulitis. Pt went to Urgent Care 3/5 at 1:11 and referred to ER. Seen again in office 3/7 for ER. f/u cellulitis.
BEFORE GIVING THE JANSSEN COVID VACCINE (LOT # 1805025 EXP 5/25/21), THE PATIENT HAD STATED THAT THE LAST FEW TIMES HE GOT A SHOT OR HAD A BLOOD DRAW HE GOT REALLY SICK AND EVEN PASSED OUT. THE VACCINE WAS GIVEN WITHOUT INCIDENT AND PATIENT SAID HE FELT OK. HE TRADED PLACES WITH HIS GIRLFRIEND AND SAT IN A CHAIR IN THE EXAM ROOM. IT WAS NOT UNTIL AFTER I HAD ALREADY GIVEN HIS GIRLFRIEND HER VACCINE THAT HE SAID THAT HE WAS FEELING FUNNY. HIS COLORING CHANGED AND HE WAS DIAPHORETIC. I GOT A PAPERTOWEL WITH COOL WATER ON IT AND PLACED ON HIS NECK AND ANOTHER ONE FOR HIS FOREHEAD. AFTER A MINUTE OR SO, HE DID PASS OUT WHILE IN THE CHAIR. HE WAS OUT FOR ABOUT 30 SECONDS AND THEN CAME BACK TO AND WAS ALERT AND ORIENTED X 4 BUT STILL FELT VERY WEAK. I GAVE HIM A WATER TO SIP ON. HIS GIRLFRIEND STAYED AT HIS SIDE THE WHOLE TIME. HIS O2 WAS 100% AND HIS PULSE 53. HE SAID THAT HE HAD EATEN SHORTLY BEFORE COMING TO GET HIS VACCINE BUT THEN LATER ASKED FOR AN APPLE BECAUSE HE WAS ON A CLEANSE DIET AND REALLY HAD NOT EATTEN MUCH. THE PCT WENT TO GET HIM AN APPLE. AFTER EATING THE APPLE AND SITTING FOR AN ADDITIONAL 20 MIN HE FELT WELL ENOUGH TO LEAVE. STILL WITH HIS GIRLFRIEND AND HIS GIRLFRIEND COMMITTED TO DRIVING HIM SO HE DID NOT HAVE TO. HE LEFT WITH NO ASSISTANCE.
Hives all over body including some that formed raised welts or blisters.  Treated with topical steroids.
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the arm left on 30Mar2021 at 16:30 as a single dose for COVID-19 immunisation. Medical history included diabetes, rectal cancer treated and in remission, appendectomy, facial bones fracture from a car accident. The patient previously took Metformin and experienced drug allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN), sitagliptin phosphate (JANUVIA) and pioglitazone hydrochloride (PIOGLI) all from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021 at 16:30 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site redness, nausea and feeling unwell. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills. joint pain, fever, injection site redness, nausea and feeling unwell were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
pt recv vax; broke out in 15 pox;pt's brother broke out in approx 50 lesions;
A lot of pain; bad headache; tiredness; Arm soreness; achy; This is a spontaneous report from a Pfizer-sponsored program. A female contactable consumer reported for herself.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number: Not reported Expiration Date: Unknown) via an unspecified route of administration on 21Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number: Not reported Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On 21Feb2021 after the second dose of vaccination, the patient experienced a lot of pain, bad headache, tiredness, arm soreness, achy.  Patient took Excedrin Migraine and Tramadol after she went home. The outcome of events was unknown.  Follow-up attempts have been completed and no further information is expected. information about batch/lot number is not available despite the follow-up attempts made.
Approximately 3-4 days after her first immunization, patient became ill.  She contacted our triage line 6 days after immunization with report of chills and weakness.  She presented to Medical Center Emergency Room where she was admitted for hypoxia.  She was subsequently diagnosed with COVID by PCR.  She developed respiratory failure, worsening kidney failure necessitating dialysis, c diff colitis, GI bleed, and acute heart failure.  Despite maximal efforts by the ICU/hospitalist team and specialists her conditioned worsened.  She was made comfort care and died on 2.26.21
brought in by EMS due to code.  Started as CP and proceeded to cardiac arrest. Went into Vtach twice in the field.  No cardiac issues other than HTN & afib.         Per ED note, received COVID vaccine yesterday
came down with the stomach bug/stomach virus; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (came down with the stomach bug/stomach virus) in a patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (came down with the stomach bug/stomach virus). At the time of the report, GASTROENTERITIS VIRAL (came down with the stomach bug/stomach virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.   Reporter did not allow further contact
1-2 minute episode turning blue, apnea with stiffness of upper extremities. Not responsive; no tonic-clonic activity, no fever, no choking. Did not require CPR. Normal activity since admitted two hours to event and CXR; patchy infiltrates. Discharge summary states diarrhea, apnea. msv
This spontaneous report as received from an approximately currently 68 year old patient of unknown gender, reporting on him/herself. In 2011 the patient was vaccinated with ZOSTAVAX (route, dosage, dose no, and lot no. unknown). In September 2013 (reported as: this past September) the patient got the shingles. The outcome of got the shingles was unknown. Additional information has been requested.
pt acquired the customary patch @ inj site w/vesicles;pt father came in w/varicella zoster (shingles) on side where holds baby;
After receiving vaccine, pt reported rash on both legs and burning itching sensation on back. Blister underneath upper lip. Went to see MD  a few days after incident.
Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) 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. AR5186C) for COVID-19 prophylaxis.     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 (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) 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 (Pediatric dose was given to adults mistakenly).    This case included information of patient 35 out of 104 patients.  No concomitant product reported by reporter.  051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and each patient received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  No treatment medication reported by reporter.
both legs are cold; right leg cannot be lifted; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (both legs are cold) and MOBILITY DECREASED (right leg cannot be lifted) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULINE) for Diabetes mellitus, CLONAZEPAM and SERTRALINE for Schizophrenia.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (both legs are cold) and MOBILITY DECREASED (right leg cannot be lifted). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL COLDNESS (both legs are cold) and MOBILITY DECREASED (right leg cannot be lifted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dosing details, anatomical locations, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Received 2nd dose of Pfizer COVID vaccine. On 4/30/2021 patient developed body aches, chills, fatigue. Tested positive for COVID. Treated with bamlanivimab/etesevimab on 5/7/2021.
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1709USA007014:  US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054:
A nurse reported the occurrence of an injection site reaction in a child of unspecified ate and gender who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. In March 2002, the vaccinee received the fifth injection of Infanrix. Six days later, the vaccinee developed an injection site reaction characterized by a rash, swelling, and a welt. Additionally, the injection site became black and blue. The reporter stated that these events were probably related to Infanrix administration. As of 3/27/02, the outcomes of the events were unknown.
Myalgia, Diarrhea & NauseaVomiting Narrative:  Employee claimed that she had mild fever at the evening of the 1/4/20. This continued till 1/5/2021. On 1/6/2021, she related to worsening body ache, nausea, and diarrhea. She stated that she took Tylenol and drink a lot fluid, she did not seek medical advice She could not come to work on the 1//6,1/7,1/8 because of the diarrhea now completely resolved.
Pt. felt dizzy immediately after vaccine.  Sweating profusely and was not able to speak. Vitals: HR 78, BP/105, O2 98 and EKG heart seemed to have prolonged QT but EMT used pump to stimulate heart.  Pt. transferred to hospital.
Prior to immunization child was able to run, walk, crawl and play without support. Post- immunization child had fever with cold like symptoms for 7 days. Child to be supported in order to walk. Legs give out on child when standing, walking, and crawling. Child does not complain of pain. Mobility is decreasing as the days go by. Child visited PCP on 9/1/11. Exam was done no medication administered.
12/3 arm began getting sore, on 12/24 an area approximately 3" x 5" became red, hot and inflamed.
p/vax pt was painful that noc a little swollen, 2 days later inner arm red, feels hot to touch, sore from inner elbow to below shoulder inj site sore;erythema down lt anterior arm;
Fever of 101.5  Left arm where injection was issued starting severe pain and swelling. By morning could not move arm.  Fever continued for two days. Arm is still sore and swollen starting to bruise. Fever comes and goes now on the third day, extremely tired and weak.  Called doctor, recp told me to call store where I got the shots at. Doctor never returned my call to have her call me back.
mild cough with throat irritation for about 3 weeks; mild cough with throat irritation for about 3 weeks; This is a spontaneous report from a contactable other health care professional (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route, administered in right arm on 23Dec2021 at 08:00 (at the age of 30-year-old), as first dose, single, for COVID-19 immunization at hospital. Medical history included rheumatoid arthritis. Concomitant medications included ibuprofen (IBUPROFEN) and certolizumab pegol (CIMZIA). The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild cough with throat irritation for about 3 weeks on an unspecified date. The outcome was reported as recovered on an unknown date of 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021576704 same patient, different event, different dose of vaccine
This case was reported by a nurse via sales rep and described the occurrence of injection site hives in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT2018-2019 season, the patient experienced injection site hives, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site hives, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site hives, injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient experienced oversized, raised redness and hives at the injection site and beyond. The reporter did not agree to be followed up.
had a subdural hematoma to his head; stated that he was on floor; This is a spontaneous report from a contactable consumer (patient's son). An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9269), via an unspecified route of administration, administered through his left arm on 09Feb2021 13:00 (also reported as 09Apr2021) at the age of 86-years-old as single dose for COVID-19 immunization at a hospital. There were no additional vaccines administered on the same date of BNT162B2. The patient had no medical history and no family medical history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) through the arm on 19Jan2021 at the age of 86-years-old for COVID-19 immunization and did not experience adverse events. The patient's son reported that the patient got the second vaccine on 09Feb2021. He reported that the patient was healthy. On Friday night (12Feb2021 at 24:00, as reported) at midnight, his mom heard a thump and stated that he was on the floor. The reporter stated that he had a subdural hematoma to his head on 12Feb2021 at 24:00, as reported (also reported as 12Apr2021). The reporter stated that the patient thinks that since he had the vaccine and no other health issues that they needed to call and make Pfizer aware. The patient was hospitalized due to a subdural hematoma to his head from 13Feb2021 to 12Mar2021. The patient had to have craniotomy on 21Feb2021 at 13:00. The events required a visit to emergency room. It was reported that there were relevant tests and no investigation assessment. The outcome of the event "stated that he was on floor" was recovered on 12Feb2021. The outcome of the event subdural hematoma to his head was recovering.