chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials; Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival; Accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at time of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided Total duration of the excursion refrigerated temperature for maximum of 4 hour. On 01Dec2021 Vial was moved to fridge. The facility thought that the vials are received frozen from  Moderna so they had unpacked them and put them back into the facility freezer. They just recently found out that the vials are received in refrigerated temperatures and not frozen. They have been accidentally administering refrozen vials to their patients. Vaccine administered post 30 days from the initial storage at 2 degree C to 8 degree C Treatment information was not provided
Redness pain swelling L upper arm stated the might be received vaccination (1/29/15) complains of headache, subjective fever, neck pain. All improving on 2/2/15.
About 20 or 25 minutes after vaccine, pt asked for a benadryl tablet because her throat felt funny, like she had a lump in her throat.  She had no visible swelling, no rash, no hives, no breathing difficulty. We provider her with a benadryl as permitted per standing order.  Pt stayed at the pharmacy for probably another 20 minutes and then elected to leave. We followed up with her later, pt said most likely her reaction was anxiety. Pt says she took a xanax and felt better.
According to patient he was suffering from fever, headache, joint pains, nausea, rashes, and diarrhea on the 15 Feb 2009. Seen by Medical Provider yesterday and found some vesicles and postules on chest and a few on the back. Prescribed with Motrin and cough medication.
limp episode x2; floppy; hard to arouse evening p/having DTP/OPV;
Post vax, child slumped forward in chair, mother grabbed her from behind around her waist. Her arms and legs stiffened and began to jerk in rhythmic motion, she had a blank stare but within seconds, she focused and sat up in her chair. She was dazed in appearance, she moved to another chair with help from her mom and layed her head down on the table and rested. After about 5 minutes, she was feeling alright and left our office.
Patient was given an extra dose of flu vaccine for this season, per provider there is no harm to patient. Moving forward only one dose per season
pt recv vax 17NOV98 & 19NOV98 pt devel watery diarrhea which persisted for 7 days;
On 6/30/20 patient developed an erythematous papular rash starting at 9am over left & right clavicle, shoulder area and chest. 15-20 lesions total. Began itching around 3pm on 6/30/20. Evaluated via telehealth. Advised to use calamine lotion and keep covered.
Multiple neurological symptoms after multiple vaccines and exacerbation after Hep B #3. Head bobbing, gait abnormality (loss of balance at times), memory loss short term, tremors, paresthesia, sensation decrease (in feet), cognitive deficiency, weakness, joint pain isolated (back pain), fatigue/malaise >60 days, burred vision, diplopia, depression, hoarseness. Follow up on 8/01/05: Member has probable diagnosis of dopamine dependent dystonia and cervical dystonia and has responded to sinemet. Has to take sinemet regularly to function normally. Will be medically separated from military. Total reaction was a conversion disorder, no adverse event at all!
This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 64, via an unspecified route of administration, left arm, on Apr 13, 2021, at 00:00, single dose for COVID-19, immunisation. Medical history included COVID-19. Prior to the vaccination, patient diagnosed with COVID-19. Concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 13, 2021, at 00:00, patient experienced underarm pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of the underarm pain and swelling: not recovered (at the time of this report). No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Very sore shot site.  Tired lack of energy.  Went to bed immediately after dinner only 7pm slept til 7am the next day feeling weak, sore arm still, chills, skin hurt like with dengue fever, lack of appetite but mostly dead tired!
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on 25-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 inj (lot # J006921, expiration date 09-AUF-2014), 0.5 ml, intramuscular. No adverse effects were reported. This case is linked to case MARRS # 1408USA015595 (same reporter link). Additional information has been requested.
Administered 1st dose of vaccine to a 17 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 4:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old). On 20-Jan-2022 at 4:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided. I t was reported that patient did not have any reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up received contains significant information, patient demographics, suspect vaccine administration time and information on events were updated.
Headache within first 4 hours.  Chills after 8 hours.  Fever and body aches after 10 hours.  Fever of 102 degrees Fahrenheit lasting for one day.  Severe bilateral buttock and thigh pain lasting for one day.  Cramps and vaginal/pelvic pain lasting one day.  Moderate swelling and redness at injection site 2 days after injection.
Patient collapsed at cheerleading. She collapsed again four days later. She passed out at our home two days later. She was admitted to hospital and has subsequently been diagnosed with POTS syndrome. She has episodes of extreme weakness, fatigue, dizziness, digestive problems, body pains and numbness, low blood pressure, high heart rate, irregular heart beat, chest pains, shortness of breath, migraines, and hair loss. She is currently seeing a neurologist and a cardiologist. She takes Florinef, Elavil, and Lexapro to help with her symptoms. She has episodes approximately every 2 weeks even with medication. These episodes leave her unable to function and she misses school frequently. Her school schedule will be abbreviated beginning in January.
This spontaneous report as received from a health professional refers to an 8 year old patient. On 14-JUL-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J013905, EXP 30-OCT-2015, dose and route not reported) which was stored improperly. On 29-MAY-2014 M-M-R II (HSA, lot # J003785, EXP 28-MAR-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
low grade fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MYALGIA (Body ache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], FISH OIL, Claritin for allergies, labetalol for blood pressure, metformin diabetes and insulin for diabetes for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (low grade fever) and MYALGIA (Body ache). On 05-May-2021, PYREXIA (low grade fever) and MYALGIA (Body ache) 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.
Worsening Tinnitus.  I am not 100% sure when it exactly started because it is often masked by other sounds or mental.  However, within a couple of weeks of getting the vaccine, the tinnitus was definitely worse than it was prior to getting the vaccine.
04/29/2021 - optic nerve swelling dx annual exam 1 week prior - OD pain Dr.  saw pt 07/23/2021 - pt c/o eye aches as of 07/22/2021. DX with papilledema. Sent to ER and in hospital for 2 days. DX with syphillis in blood not in CFS; prescribed with vicillin.  11/23/2021 - COVID booster Moderna. C/o same eye pain within 8 hours of getting booster. Seeing a different doctor
No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985; This spontaneous report was received from an other health professional (HCP) and referred to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions/allergies were not reported.  On unknown dates, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacture unknown) oral liquid, lot #W026137, expiration date: 05-FEB-2024 (dose, frequency, strength, route of administration were unknown) for prophylaxis.   It was reported that rotavirus vaccine, live, oral, pentavalent (manufacture unknown) experienced a temperature excursion, the temperature was 8.74 C, and time frame was 35 Minutes (Product storage error). No side effects reported (No adverse event). No other medical information known. See additional adverse event (AE) cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985.
about 9 days after vaccine, patient had a mild fever (99-100 degrees); this resolved itself within 48 hours and never was above 100.5 . About 10 days after the vaccine, patient developed a very mild rash - he had about 10 pimple looking blemishes across his body. This resolved itself within 48 hours - the bumps looked like pimples or clogged pores - he had one on his cheek and then 9-ish across his body (stomach, butt, arms)
I had a headache, fever, chills, sweats, cough, and body aches. I tested positive for COVID-19. I already had Paxlovid on hand. So, I took that and Tylenol. I contacted my doctor afterwards because it was the holidays. He said that it was fine. After taking Paxlovid I tested negative on day 5 and on day 6 I was symptomatic again and tested positive for COVID-19. I had the same symptoms and just as bad. I took Tylenol to manage the fever and body aches.
Soreness at and around injection site about a soft ball area, feels swollen. Whole body aches and soreness with exhaustion, slight headache, dimished taste of food
pt recvd vax & had 9 cm X 7cm area of redness; t 102 X 2, hot & tender; cellulitis;
Today arm & upper left side of body aches. Remembered hearing about metal items sticking to people, I laughed at them, was sure was a joke for social media.  It's not. Right before lunch I though hmm, let me just see, not expecting anything. I have pics & coworker witnesses of a large binder, penny, paper clip & large nail file, all sticking to my arm & neck area. I am a mom, gramma, paralegal & HATE conspiracy theories!! I want to know what is going on please. Why do these objects stick to me like I am a magnet? Please tell me a reasonable explanation. I googled, nothing, everyone says it's a lie. Please let me know asap and thank you.
Patient was given a .5 dose and should have only gotten the .25 dose. Per Dr if you had already received dose last year and got 2 then you would get a .5 dose. We did not realize the brand that we have in office was to only get a .25 dose and gave 2 to equal the .5 dose.
PAIN IN BACK LOWER SPINE UNABLE TO WALK FOR 24 HOURS.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), on 29Jan2021 at 13:00 as dose 1, single (Lot number: EL92965), in left arm, on 20Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in left arm and on 28Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: Tested positive for COVID with antigen test 3 days after fifth day of taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: patient experienced a recurrence of COVID symptoms (a little milder than initial symptoms) and tested positive for COVID with antigen test 3 days after fifth day of taking Paxlovid. Patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received covid-19 vaccine.  No follow up attempts are possible, no further information expected.
Initial misuse report received from a healthcare professional on 25 November 2013. A patient (no information was provided regarding the patient) had received an intramuscular dose of FLUZONE about a week ago, and FLUMIST on an unspecified date, and no adverse event was reported, i.e. extra dose administered. List of documents held by sender: none.
This spontaneous report received from a patient concerned a 73-year-old white and non-Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 19-SEP-2021) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included chewable airborne. Ascorbicacid/herbalnos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc).  On an unspecified date, laboratory data included: Blood pressure 105/60 millimetres of mercury. On 07-APR-2021, the patient did not feel well within minutes after vaccination. The patient asked a nurse to check her after the 15-minute wait. The emergency medical technician checked blood pressure of patient and it was elevated to 190/80 millimetres of mercury. The emergency medical technician checked blood pressure of patient again, after about 15 minutes and it was 180/70 millimetres of mercury at 17:20. When patient was walking to her car to leave her nostrils closed, lips itched, eyeballs felt funny. The patient was still trying to get home with her special needs child. The patient did not feel it effect lungs. The feeling wore off in approximately five hours. Blood pressure of patient was 137/68 millimetres of mercury at 23:00 that night. Next morning (08-DEC-2021) patient felt wobbly, shaky and felt like she was coming down with something. The patient lost her zip lock bag with all the cards and could not find it in the car, so she drove back to the vaccination site to try and find the bag with the cards. Did not find them there. Patient then drove home, and, in the morning, patient called the vaccination site gymnasium to try and locate the cards. The patient found the cards at the vaccination site. The patient recovered from blood pressure increased, nostrils closed, lips itched, eyeballs felt funny, shaky, wobbly, felt like coming down with something, and did not feel well on 09-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260647-COVID-19 VACCINE blood pressure increased. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Begin with headache, shortness of breath followed, ended up in ICU on ventilator on 11/08/09, doing very poor at this time.  12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Deceased Diagnosis: Acute respiratory failure secondary to bilateral pneumonia, hemoptysis, AIDS, history of coronary artery disease, status post coronary stent, previous history of myocardial infarction, history of chronic obstructive pulmonary disease.  Patient had ingested 18 Percocet, called EMS because of fever, coughing, shortness of breath and pain in back. Presented at ED complaining of shortness of breath and hemoptytsis. Intubated, ICU. Bilateral pneumonia, hypoxic. Placed on ventilator and IV antibiotics. DNR order signed, consent for tracheostomy denied, placed on morphine drip. Stopped breathing, heart rate dropped to flat line. No muscle tone, pupils dilated, pronounced dead.
Mother reported left thigh was red and swollen at site of injection; he had trouble breathing on the 4th day, post vax, though the 6th day; hives starting on 5th day, post vax and continuing through to the 6th day; vomiting and loss of appetite from the 4th to 6th day, post vax. Took to health center on day 6, 1/11/01.
Swollen Lymph Nodes at clavicle and under arm; Headache; Chills; Fatigue; Body Aches; Vomiting; This is a spontaneous report from a contactable other hcp. A 44-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 10:00 AM (at the age of 44-years-old) as dose 2, single dose for covid-19 immunisation. Medical history included allergies to sulfa drugs from an unknown date. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) via unknown route of administration on 15Jan2021 at 1.00 PM administered on right arm, dose 1, single for Covid-19 immunisation. Prior to vaccination, the patient was not affected with covid. Post vaccination the patient was not tested for covid. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). It was reported that on 05Feb2021 at 22:00, the patient experienced swollen lymph nodes at clavicle and under arm, headache, chills, fatigue, body aches and vomiting. The did not receive any treatment for events. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist referring to an 83 year old patient of unknown gender. The patient was incorrectly vaccinated with two doses of PNEUMOVAX23 (dose, strength, lot #, expiry date and route were not reported) within a 24-hour period respectively on 31-AUG-2015 and 01-SEP-2015 (extra dose administered). This error was identified when a charge was returned from an insurance company, which questioned a double charge. The patient did not experience an adverse effect. Additional information has been requeted.
About 1 hour after receiving Td (b), MMR (2), she called to complain of "trouble breathing", known asthmatic. Ventolin inhaler not giving relief, advised she be seen in ER or with PMD.
Day 1- fever, body aches, headache  Day 2- sinus symptoms, headache, ?drunk? feeling Day 3- 9- headache and severe cough   Tried nebulizer for cough with no relief.
Around seven hours after receiving the vaccination I was very fatigued. Nine hours post vaccine I had chills and a fever. Upon waking up the next morning I was nauseas, had a mild headache, a fever and chills, and very sore and stiff joints. Tylenol has been helping with the fever and the joint pain.
very sick; vomiting; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) 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 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). At the time of the report, ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  No treatment medications were reported.