chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.; We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.) and PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm excursions.).    No concomitant medication was provided by the reporter  It was reported that Moderna product was stored in the fridge and experienced multiple warm excursions. Data shows the vaccine was above 46F for 27 hours. The max temperature reached was 49.658F. It was also reported that LOT was placed directly in the freezer and was moved to the fridge on 17-Nov-2022 and was not used after 26-Nov-2022 at 12pm EST. The vaccines were assumed to be administered on 25-Nov-2022, which would be more than 24 hours at room temperature. Temperature logs have been attached to the parent case NA22-00002036.  No treatment medication was provided by the reporter.
Not sure of the actual name/brand of each Vaccine. Not long after patient's shots, she started having spasms multiple times a day, almost every day. Mostly while falling asleep. Her eyes would roll back in head & her back would arch. She would start shaking/jerking in one arm, it would then move to her face, then the other arm. Sometimes her trunk would tremor as well as her legs. Lasting anywhere from 5-15 seconds if stopped. This would happen anytime of the day. Video proof available as well.
cellulitis; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient is taking Bactrim for cellulitis and is due for the second dose of the vaccine. Outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: The association between the event cellulitis with BNT162b2 can not be fully 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.
expired dose of Daptacel was inadvertently administered to a patient; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves an 18 months old female patient who was inadvertently vaccinated with an expired fourth dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (frequency once) lot C5202AA (expiry date: 16-May-2019) via intramuscular route in the right thigh on 12-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATIT A VACCIN (HEPATIT A VACCIN).  It is an actual medication error case due to expired vaccine used.  The patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Booster was given before prescreen paperwork was filled out. Pfizer vaccine was going to expire in 4 minutes. After the patient received the pfizer booster it was then realized that the patient just got Regen-COV on 8/28/21.
11/19/09 Developed shingles. Treated with Acyclovir tabs and ointment.
Moderna COVID?19 Vaccine EUA  Dizziness, Vomiting, Diarrhea, Muscle Aches, Fever, Headache ALL symptoms last 2 days
No other AE reported; administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 03-NOV-2021, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1821791, expiration date 26-JUL-2022, at a dose of 2 milliliter, orally for prophylaxis. No other adverse event reported.   The vaccine was stored in temperatures of below 36°F (34.7F) for 25 minutes; below 36°F (35.4F) for 5 hours; below 36°F (35.6F) for 3 hours and 20 minutes; below 36°F (35.9F) for 25 minutes; below 36°F (35.7F) for 25 minutes; below 36°F (35.2F) for 3 hours and 20 minutes; below 36°F (33.8F) for 18 hours and 20 minutes; below 36°F (32.1F) for 23 hours and 45 minutes and below 36°F (32.5F) for 9 hours and 35 minutes. There was no previous temperature excursion reported.
Neuro - reporting stocking/glove decreased sensation in hands and feet - to wrists in hands and feeling off still in forearms mand into upper arms and then from feet to knees with decreased sensation to touch, improved gait and not requiring husband to help transfer to exam table and no longer needing to use walker, positive romberg testitng and unable to balance on one leg without intense wobbling and nearly falling. Was dx from ER with dorsal cord syndrome from MRI C spine.
Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a six-month-old female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C4143AA received on 27 February 2012, lot number C4080AB received on 10 May 2012 and lot number C3080AB received on 09 July 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, five days  after the last dose. On 16 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR  and negative culture on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Fever, severe chills, nausea, vomiting, headache, night sweats on 3rd night
Patient received 0.3ml of Moderna vaccine rather than 0.5ml. Kept patient in observation for over 30 minutes. Spoke with patient about error however, does not recommend revaccinating since patient got over half the dose. No signs or symptoms observed.
This case was reported by a consumer and described the occurrence of injection site itching in a child female patient who received MENVEO (batch number M16130, expiry date 31st July 2018) for prophylaxis. On 15th May 2018, the patient received MENVEO. On 15th May 2018, immediately after receiving MENVEO, the patient experienced injection site itching. The patient was treated with PEPCID, TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site itching to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not provided. As soon as the patient had MENVEO she stated it itched. The reaction was not as bad as the May of 2015 reaction, the patient was brought to hospital. Records would be there.
233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 1:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not reported.
Drug ineffective; COVID-19; Bloody diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4377284-00 (AbbVie).  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day at the age of 76 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at unk, citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; Suspected COVID-19 (medically significant), outcome "recovering"; DIARRHOEA HAEMORRHAGIC (medically significant), outcome "recovering", described as "Bloody diarrhea". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "drug ineffective" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "Suspected covid-19" and "bloody diarrhea" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the information in the case provided and known drug temporal relationship, the causal association between the reported events with the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient stated on questionnaire that they had not received any previous vaccinations. J/J vaccine given.  No reaction noted during 15 minute wait time. When entering vaccine information into immunization registry, it was discovered that patient completed the two-shot series of Moderna about a month earlier. Called CDC for guidance, then  called patient and notified them to F/U with MD if they develop symptoms that las more than 3 days or to go to ER if they develop SOB, difficulty breathing, or chest pain.
Sore throat; Achy; bones hurt; Very weak; Itchy; sweats; Fatigued; Chills; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EPB955) via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Other medications received by the patient within two weeks prior to vaccination included levothyroxine sodium (MANUFACTURER UNKNOWN) and ibuprofen (MOTRIN). The patient had not received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 01:45, sixteen hours after vaccination, the patient experienced sore throat, achy, bones hurt, very weak, fatigued, itchy, chills and sweats. Therapeutic measures were not taken as a result of sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care.  The clinical outcome of the events sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Not feeling well; completely drenched; moving slow; had flu-like symptoms all night; fever; shivering; Feeling exhausted; chills; nausea; Had a swollen gland and hard; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FATIGUE (Feeling exhausted), BRADYKINESIA (moving slow), INFLUENZA LIKE ILLNESS (had flu-like symptoms all night) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MALAISE (Not feeling well), FATIGUE (Feeling exhausted), BRADYKINESIA (moving slow), INFLUENZA LIKE ILLNESS (had flu-like symptoms all night), PYREXIA (fever), CHILLS (shivering), HYPERHIDROSIS (completely drenched), CHILLS (chills), NAUSEA (nausea) and LYMPHADENOPATHY (Had a swollen gland and hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling well), FATIGUE (Feeling exhausted), BRADYKINESIA (moving slow), INFLUENZA LIKE ILLNESS (had flu-like symptoms all night), PYREXIA (fever), CHILLS (shivering), HYPERHIDROSIS (completely drenched), CHILLS (chills), NAUSEA (nausea) and LYMPHADENOPATHY (Had a swollen gland and hard) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.
Starting the evening after receiving the vaccine, I had some soreness at the injection site and developed body aches and fatigue. This progressively worsened over Saturday and Sunday. On Monday, the symptoms started to get better. As soon as I returned from work every day of the week, I had to go straight to bed due to the fatigue. On Saturday 06/18/2022, I developed significant chills, dry cough and the body aches/fatigue were worse than before. Also, I had a very severe headache and thought my head was going to explode. It got progressively worse until Tuesday where it has stabilized up until today where I am still experiencing symptoms. I have been alternating Tylenol and Ibuprofen every 4 hours since Saturday due to the severity of my symptoms. I have taken 3 COVID tests (one was a PCR test) and all were negative. My doctor has just prescribed me a Medrol dose pack and I am about to take my first dose now.
A physician reported the occurrence of an injection site reaction in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  There was no relevant medical history.  Concurrent conditions were not provided.  On 05/31/2002, the vaccinee received her fifth injection of Infanrix into her left leg.  On that date, she also received injectoins of inactivated poliomyelitis virus vaccine (IPOL) and measles, mumps and rubella virus vaccine (MMR II) into her right thigh.  On 06/01/2002, the vaccinee developed an injection site reaction at the site of Infanrix administration described as "red, hot, and enlarged," and itching of the "whole anterior left thigh." The vaccinee was seen by a physician and treated with unspecified antibiotics.  The most recent information, received on 09/17/2002, did not report the outcome of these events.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
All over body soreness (since injection), Fever (nightly), Extreme Chills (nightly), Arm Pain (since injection)
Leg swollen warm area about size of a golf ball hard & firm touch; Recd DT only rt leg;
On 11/10, pt had seizure (8-10 mins), swollen gland at neck, high fever 104.7 (and when he arrived at hosp), stiffness of neck & spine, difficulty breathing & pale, discolored complexion. On 11/19, had Measles rash & fever of 101.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/30/2021. PATIENT FULLY VACCINATED ON 02/26/2021.
No adverse effects. The employee was given a dose that was past the 10 week window as of 8/10/2023 at 0830 and dose was given 8/11/2023 at 0921. According to Pfizer Medical Information team regarding extended stability data, they do have data that provides a 2 day window after the initial 10 weeks approved by the FDA.
Patient presented to pharmacy for second dose Covid vaccine and was assisted by technician in the preparation of preliminary paperwork. Technician asked, "Pfizer vaccine, ma'am?", to which the patient responded affirmatively. A Pfizer vaccination was processed and administered. At the conclusion of the vaccination, patient asked, "So which vaccine did I get?"  This prompted discovery that patient's first dose was Moderna
Acute onset chest pain began 4/11/2021, he took NSAIDS and tried to sleep. The following day, 4/12/21 the chest pain was still present. He was admitted to hospital and diagnosed with acute myo-pericarditis. He was treated with Colchicine with improvement in his symptoms.
5 x 5 1/2 cms round/oval cellulitis on (L) ant thigh where HIB & PREVENAR 13 given. Placed on AUGMENTIN PO & warm compresses.
Sudden onset of flushing of the chest and upper extremities, subjective throat tightness and tongue swelling not evident on exam. Onset within 10 minutes of administration, provided 50 mg diphenhydramine, symptoms resolved within 1 hour completely. No wheezing, stridor, urticaria.
28 y/o female presents with c/o feeling dizzy, heaviness in the left arm in observation after receiving her second dose at 1635. Patient tolerated first dose without any adverse reaction. Symptoms then progressed to difficulty swallowing, throat swelling, hoarseness, full body rash. Patient was alert and oriented x 3. Patient denied difficulty breathing. EMS administered 0.3 mg IM Epinephrine (Right Deltoid) at 1711, 50 mg IV Benadryl at 1718. Blood Glucose was 116 at 1719. Patient was given IV fluids and IV Dexamethasone during transport to Hospital.
Thursday 1/14/21 5:30 PM began having chills and body aches.  Temperature of 102,  taken by ear.  Felt Strange just not well.  Ran a fever through the night into the next morning.,  Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided.   Began having a slight headache that lasted through Sunday.  Also had Nausea that started Friday and continued through today. Sunday.  Injection arm has been very sore.  I also have a very sore enlarged lymph node under my left arm pit.  Markedly swollen.
Patient arrived and accompanied by (mother).  Patient was given the Pfizer pediatric instead of the Pfizer Baby.  Exhibit no signs or symptoms while at the facility and monitored for thirty minutes after injection.  Mother was made aware of the situation.
ONE HOUR AFTER VACCINATION, VISION BECAME DIFFICULT TO FOCUS, WITH TUNNEL VISION,  WEAKNESS AND STRAIN IN EYE MUSCLES.  AS WELL AS WEAKNESS AND SLIGHT PAIN IN EXTREMETIES.  SYMPTOMS HAVE NOT RESOLVED IN 7 DAYS AND LITTLE TO NO IMPROVMENT HAS OCCURED.
My arm started with red sort of rash that spread around the top of my arm (the same arm that I received the vaccine).  About the 3rd day it covered the top of my arm but the middle was now lighter than the perimeter.   There was no pain or itching.  The rash is still present so I cannot answer 19 and 20.  I am assuming it will go away.