chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:11 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered 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 reported as 53.08.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.   On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM:42.  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.
Headaches / sore stiff neck starting Sep. 28 AM. Treated for migraine at urgent care on 10.8.12.
Seizure activity of brief duration, she turned pale, blue lips & passed out for 2-3 min. Ambulance was called and transported to ER. Was released from ER after a couple hours. ER assumed vasovagal .
arms, shoulders, upper spine became weak, heaviness, aching.  but resolved later in day
24 hours after 2 m vaccines administered in bilateral thigh, she developed erythematous papules at injection sites which spread diffusely over her body. Seen in ER, Tx with BENADRYL, 40sec. resp. symptom no fever.
Wellness check up 830 am. 8pm bed time felt slightly warm given tylenol   10 pm convulsions and vomiting. Called ambulance taken to E.R.. Seen Dr.  Around 1030 temp check at er was 103.5 given motrin. Doc diagnosis was febrile siezure temp check 101 discharged follow up with primary dr   Aug 26 and 1130.  No fever present still irritable sleepy and not normal appetite but is coming back. And becoming good natured again. Dr. checked nose and ears double check for signs of infections listened to tummy and lungs all is good.
weakness; headaches; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) for COVID-19 immunization. The patient's concomitant medications were not reported. It was reported that, missing 2-3 days of Xeljanz due to running out of refills on her script (prescription) but also skipping one day of Xeljanz for the first dose of the COVID-19 vaccine on an unspecified date patient experienced weakness after the first dose and then experienced major headaches and body weakness after the second COVID-19 (vaccine) dose. Patient advised to notify MD. Patient's abdominal test finding was white fatty liver and some bladder stones. The patient underwent lab tests and procedures which included blood test; her blood work being just fine 2 months ago. The outcome of both the events was unknown.   Information on the lot/batch number has been requested.
5 YO wasgiven  adult dose; 5 YO wasgiven  adult dose; 5 YO wasgiven 4th dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 5-year-old male patient who received HBV (Engerix B adult) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received the 4th dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose, adult product administered to child and extra dose administered. On an unknown date, the outcome of the accidental overdose, adult product administered to child and extra dose administered were unknown.   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: 3-Aug-2022 Reporter's comment: The patient was accidentally given an adult dose of Engerix-B for his fourth dose at age of 5 years. The reporter did'nt had anything else to report. The reporter consented to follow up. Additional supportive information: The patient received an adult dose of Engerix B at age of 5 years, which led to the accidental overdose and adult product administered to child. The patient received fourth dose of Engerix B at age of 5 years, which led to Extra dose administered.
dizzy with vertigo; could not walk; and slurred speech; This spontaneous case was reported by a consumer and describes the occurrence in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) and experienced events very dizzy with vertigo and could not walk and slurred speech.        The patient's medical history not provided.  On 14th JAN 2021, onset of the events, the patient received their one of two planned doses of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.   The patient was treated with BARIUM SULFATE (FLUID) 14-Jan-2021 for Fluid and electrolyte imbalance in the emergency room.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  On 14th JAN 2021, the outcome of the events dizziness, vertigo and speech resolved and  Walking difficulty not resolved.     Treatment given 1-bag of fluid and medicine for dizziness.  Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: Upon internal review on 26 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Has thumbprint sized red area at immunization site on right thigh. Area is swollen and tender to touch. No fever or streaking. Will treat with cool compresses and TYLENOL.
Covid test positive.; Covid test positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6200), in left arm and on 08Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 43 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.   The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2023, outcome "unknown" and all described as "Covid test positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any Other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had tested for COVID-19.Patient did not have any known allergies and no other medical history.  No follow-up attempts are possible. No further information is expected.
Chills/sweets, headache, body ache and loss of appetite. Strong pain in left arm.
After my first dose of Moderna on 3/19/21 (046A21A) I started having ringing in my right ear and having facial pain while still waiting in the 15 minute holding area after the shot.  The attendants said they hadn't heard of that side effect and I left when my time was up.  I had my second shot on 4/15/21 and didn't experience the same reaction.  Two weeks later on 5/2/21 I woke up with the right side of my face feeling numb and heavy with a drooping eyelid.  At the ER, the ruled out a stroke with a CT scan, diagnosed it as Bell's Palsy and gave me 20 mg Prednisone 2x per day for 5 days.  The symptoms subside and return, unlike a typical case of Bell's Palsy.   I also experienced muffled hearing on the same side of my face, vision changes that come and go, and eye pain.  A referral was put in to see a neurologist, but was unable to see them due to the distance, cost, and time
Had tolerable off and on body aches, fatigue and tachycardia for months  before the vaccine.  I could go a month or more without symptoms.  vaccine 3/15  Fatigue, body aches and tachycardia got much worse and intolerable after vaccine 3/15  8 days later at physical doctor gave me thorough exam and I become much sicker which escalated (I couldn?t do anything including work) Got to the point I was in constant horrible pain Severe body aches and fatigue  Increased HR especially when upright  Very dizzy  SOB Some Headaches  Nauseas almost always when I am upright  Terrible Brain fog  Body ache Symptoms improved some with  prednisone but have gotten worse again since being off prednisone  Struggling to function / work Left / middle Chest pain Tingling lips, finger tips and toes  Weak  Shaky
swelling of my lips and nose; sensation of having an allergic reaction; my lips are red and feel as if they are burning; This is a spontaneous report from a contactable consumer (patient)  A 55 year old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730) on 13Feb2021 at 12:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included venlafaxine, levothyroxine sodium and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient received first dose of BNT162B2 on 23Jan2021 on left arm. On 15Feb2021 at 09:30 the patient experienced  had slight swelling of her lips and nose. She had the sensation of having an allergic reaction but can breath fine. The edge of her lips were red and feel as if they were burning as does the skin adjacent to the lips. Consumption of most foods makes it feel as if her lips are on fire (as reported). At the time of the reporting the patient had not yet recovered from reported events.
One hr following administration developed injection site pain, swelling, erythema. Also shortness of breath with chest pain. Nausea, fever and chills.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
headache, chest tightness fever to 101.4 with chills x 2 days. 24 hrs post vaccination
Left arm swollen, hot red, sore, an area of 6"x8" was itchy,raised about 1/2 inch.
"Pain like a torn rotator cuff, i couldn't lift my arm.  After about 2 weeks i was back to 80% mobility.  on 1/7/21 i am almost back to 100%.  No other symptoms"
Information was received on 14-MAR-2017 from a health care worker concerning and unknown number of unspecified patients. No medical history, concomitant medications or patient demographics were reported. The unspecified patients were administered improperly stored vaccines on unknown dates, starting after 01-JUN-2015. There were several different sets of excursion conditions with different vaccines involved. The nurse confirmed that while many of the vaccines lots are now expired, all improperly stored doses were not expired at the time of administration. No adverse effects were reported. The lot of RECOMBIVAX HB involved in the temperature excursion was lot J009374, expired 11-JUN-2016. Other vaccines involved in the temperature excursion were PNEUMOVAX 23 (MARRS# 1703USA014563), GARDASIL 9 (MARRS# 1703USA014565), PEDVAXHIB (MARRS# 1703USA014567) and VARIVAX (MARRS# 1703USA014566), GARDASIL (MARRS# 1703USA007376). Follow-up information was received on 20-MAR-2017 from the reporter. It was reported that RECOMBIVAX lot J009374, expired 11-JUN-2016 (dose and sites not reported) doses were administered on 29-JUN-2015, 16-JUL-2015, 22-JUL-2015, 27-JUL-2015, 28-JUL-2015, 29-JUL-2015, 30-JUL-2015, 31-JUL-2015, 12-AUG-2015, 13-AUG-2015, 14-AUG-2015, 17-AUG-2015, 02-SEP-2015 and 02-FEB-2016. No patient identifiers provided. Additional information has been requested. This is one of several reports by the same reporter.
On the night of 9/14/2022, I got a sore throat. On the morning of 9/15/2022, I underwent a PCR test and got a positive result. The sore throat lasted for about two days, but I had persistent, nonproductive cough that lasted for about six to eight weeks. Towards the end of the six to eight weeks, when I thought I was getting better, I went out to eat one day. I developed a coughing spell that was so severe that I had to leave the restaurant. I almost passed out, and someone at the restaurant actually asked me if he needed to call the rescue squad. I never took an antiviral. I took NYQUIL and MOTRIN to manage the symptoms I had, but they weren't really effective. I work at a hospital, and I was off from work for only five days after I was diagnosed. Shortly after the coughing subsided, I began to have Nocturia in late November or early December 2022. I went to my PCP sometime in early December 2022, and he put me on tamsulosin and told me to follow up with him. Unfortunately, the Nocturia became even worse. I then saw a urologist in early January 2023, and he told me my prostate was just fine after he conducted a digital rectal exam. He then doubled my dose of tamsulosin. Two weeks later, I went to the urgent care. I underwent a urinalysis and another digital rectal exam. I was then diagnosed with prostatitis and put on doxycycline. I then followed up with my PCP. I underwent a pelvic CT scan, and the results were normal with regard to the benign prostatic hyperplasia. The Nocturia continued, though. I am currently under the care of a NP at a urologist's office. I have gone through three rounds of different antibiotics (doxycycline, ciprofloxacin, and BACTRIM). My condition has improved. I no longer have any issues with nighttime urination beyond the ordinary at this point. I am due to see the NP for a follow-up in the next month.
acute chest pain; Myocarditis; Pericardial effusion; This is a literature report.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis"; PERICARDIAL EFFUSION (hospitalization, medically significant), outcome "recovering", described as "Pericardial effusion"; CHEST PAIN (hospitalization), outcome "recovering", described as "acute chest pain". The patient was hospitalized for myocarditis, pericardial effusion (hospitalization duration: 3 day(s)). The events "myocarditis" and "pericardial effusion" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: c-reactive protein: 18.00 mg/dl; echocardiogram: biventricular size: normal, notes: Biventricular function: Normal Additional findings: Hyperechoic septum; ejection fraction: 60 %; 58 %; electrocardiogram: diffuse st elevation; electrocardiogram qrs complex abnormal: normal; investigation: negative; laboratory test: normal; 5, 6, and 12; 71, notes: mL/m2; 69, notes: mL/m2; magnetic resonance imaging heart: interval between vaccination and mri (d): 5, notes: LVEF (left ventricular ejection fraction): 60% RVEF (right ventricular ejection fraction): 58%; LVEDV (left ventricular end-diastolic volume) /BSA: 71 mL/m2; RVEDV (right ventricular end-diastolic volume): 69 mL/m2; Early gadolinium enhancement: Yes; Late gadolinium enhancement: Yes; Distribution of enhancement: 5, 6, and 12; Myocardial edema: No; Pericardial effusion: Trace; yes; yes; respiratory viral panel: igg ebv antibodies; troponin i: 4.91 ng/ml. Therapeutic measures were taken as a result of myocarditis, pericardial effusion.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events Myocarditis , Pericardial effusion, Chest pain cannot be completely excluded. 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.,Linked Report(s) : US-PFIZER INC-202200355287 Same article/ drug/event and different patient
Left arm feels numb like asleep, lasts for minutes 10-12 times a day.  dorsal arm, multiple denuatunes treatments wait & watch
I experienced chills late at night. My teeth were chattering and I was shaking very hard. I felt cold and I was freezing. It lasted 8 hours. When I woke up, I was fine.
A nurse with a history of varicella, who while administering varicella virus vaccine live to a pt, inadvertently spilled some of the vaccine on her finger. A couple of days later, she developed a pox mark on her finger in the same spot. She was concerned with a greater risk of shingles outbreak due to close and frequent contact with the vaccine.
ON 2/27/10 Pt. recv'd the H1N1 on 2/28/10, while pt. was getting ready for wk. she was very sore. She went to work and began to have a sore throat and felt feverish. Pt left work at 5pm, muscle aches had gotten severe. When she got home her temp was 103.5. Went to doctor had strep test done, was negative.
Low grade infection for a month now; Sore throat; Really stiff neck; Gland swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Low grade infection for a month now), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL STIFFNESS (Really stiff neck) and LYMPHADENOPATHY (Gland swelling) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 040A21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergic sinusitis, Heart disease, unspecified, Chronic lung disease, Renal failure chronic, Heart failure and Pain. Concomitant products included TADALAFIL (CIALIS) for Heart failure, OXYCODONE for Pain, LISINOPRIL, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), FUROSEMIDE (LASIX [FUROSEMIDE]) and POTASSIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (Low grade infection for a month now), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL STIFFNESS (Really stiff neck) and LYMPHADENOPATHY (Gland swelling). At the time of the report, INFECTION (Low grade infection for a month now), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL STIFFNESS (Really stiff neck) and LYMPHADENOPATHY (Gland swelling) had not resolved.            Other concomitant medications included steroid nasal spray for sinus allergy.  Patient started having the reported events for a month now.  No treatment medication was provided.   This case was linked to MOD-2021-041085 (Patient Link).
the covid 19 vaccination was improperly diluted. Patient was made aware of the situation and that the manufacture recommends getting revaccinated.
No adverse reaction was reported.  It was discovered o n 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered.  Baby received 2 doses of Hib in error.  Mother/guardian of child was telephoned on 6/1/2022, at number provided in patient's record, but message "not accepting calls" was received.  Her voice mail box was full, so no message was left.