chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; felt like she was running a fever; chills; nausea; headache (felt like her eyes were being taken out with a spoon); high blood sugar level readings; couldn't eat; clammy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), DYSPNOEA (shortness of breath) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021 and Hysterectomy. Concurrent medical conditions included Diabetic (Patient is a newly diagnosed diabetic, taking Metformin once a day, not insulin-dependent.), Leukemia (in remission), Benign lymphoma, Drug allergy, Dust allergy, Pollen allergy and Allergy to animal (The patient is allergic to bees and needed EpiPen due to bees.). Concomitant products included BENAZEPRIL for Hypertension, METHOCARBAMOL (ROBAXIN), GABAPENTIN, SUCRALFATE (CARAFATE) and MELOXICAM for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), NAUSEA (nausea) and HEADACHE (headache (felt like her eyes were being taken out with a spoon)). On 13-Jul-2021, the patient experienced DYSPNOEA (shortness of breath), PYREXIA (felt like she was running a fever) and CHILLS (chills). The patient was treated with METFORMIN at an unspecified dose and frequency; INSULIN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and BUDESONIDE, LEVOSALBUTAMOL HYDROCHLORIDE (NEBULAIR) at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), DYSPNOEA (shortness of breath), NAUSEA (nausea), HEADACHE (headache (felt like her eyes were being taken out with a spoon)), PYREXIA (felt like she was running a fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: other (abnormal) 378, other (abnormal) 400, other (abnormal) 518 and other (abnormal) 270.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initially the patient experienced flu like symptoms for several days that has progressed to more serious issues.  Patient states that she has developed severe pain, swelling in head, neck, back, hamstrings and shins, as well as nerve inflammation.  Patient is being treated by her physician with steriods.  Patient has had an MRI and being treated by a Chiropractor as well.  All of this started after the second dose of Moderna Covid 19 vaccine per patient.
Four days post 2nd dose of COVID-19 (Pfizer-BioNTech), patient had severe bilateral chest pain with rest or activity. Came in for evaluation 10 days post vaccine, EKG showed he has diffuse ST elevations c/w acute pericarditis. OU Pediatric Cardiologist wanted patient to be seen in ER.
Symptoms: scracthy throat, headache, fever, stuffy head, lack of energy Time course: 2 days from symptoms until fever broke and symptoms began to go away Treatment: Dr. prescribed 5 days of Paxlovid and treatment completed Note: Symptoms were already diminishing greatly by time I was able to meet with Dr. and began Paxlovid treatment
temperature excursion due to opening and closing the door to perform an inventory check, the highest temperature reached 9.1 C and the total excursion lasted 64 minutes with no reported adverse event; IPOL has been administered post excursion with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old male patient and reporter reported temperature excursion due to opening and closing the door to perform an inventory check, the highest temperature reached 9.1 c and the total excursion lasted 64 minutes with no reported adverse event and IPV (VERO) [IPOL] has been administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  Caller reported temperature excursion for IPOL due to opening and closing the door to perform an inventory check, the highest temperature reached 9.1 c and the total excursion lasted 64 minutes with no reported adverse event(product storage error) (unknown latency) and then On 10-Jul-2023, the patient received a standard total dose 1 of punctured IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot V1A021M, expiry date- 17-FEB-2024) via subcutaneous route in the left arm for Immunization, post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, No previous temperature excursions to report. The possible excursion was due to human error. The caller was also not aware of any adverse reactions post administration  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the guidelines. 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.
She denied further adverse event; patient was administered GARDASIL 9 that expired; This spontaneous report as received from a nurse health professional refers to a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 28-MAY-2021 the patient was vaccinated with  an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, lot # R025155, expired dose: 23-MAY-2021 for prophylaxis  (dose, and route of administration was unknown).   The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had not had any temperature excursions. She was verbally provided the supported disclaimer. No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025155; expirationdate: 23-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for Rheumatoid arthritis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medical also include Orencia by infusion .  Treatment information was not provided.   unknown; 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
Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management.  Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction.  Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.
Fever (102), Clear runny nose, Headache, muscle aches, very irritable
Information has been received from a pharmacist concerning a currently 70 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014127: US-009507513-1611USA014128.
States nothing happened immediately after receiving vaccination "just hurt like a normal shot". Reports that one week later her muscle and shoulder joint felt "tight", states "felt like a pulled muscle." Reported that after about 3 more weeks it got worse and "felt really tight" and "as if someone was putting a knife in my shoulder joint."  She reports still having pain. Has been taking ibuprofen 800 and using a heating pad. Reports "there was a yellowish bruise (sic) on the back of my shoulder". States pain is unbearable at times, feeling tingling and numbness and "hot to touch in the spot the shot was given" as of 11/9/2017. Has not been seen or evaluated by a physician.
3 days p/HIB given pt had febrile reaction; t105 R; pt was hallucinating unable to find any cause for fever;
Patient given Pfizer ages 5-11, not Pfizer 6mo-5yr.
In March I was having chest pains and they would come and go and they would be strong. They would last 5-10 minutes. If I laid down on my L side, it would hurt more and pulsate. So I would do breathing exercises to try and calm the pain. It didn't matter what I was doing, the pain would randomly come. I would try to wait for it to go away. I did eventually go see a cardiologist and he did an EKG and he said it was normal and that if I was still having pain he would do more tests. He offered to do another follow up cardio exam. In a few weeks the pain stopped so I didn't get the test done. I did go see Dr. and everything is fine and have follow up every 3-6 months. 2 months ago, If I laid down I would get very light headed and dizzy. That lasted maybe 3 weeks and that went away. I haven't had any of those spells lately. When I had the itchiness in March, I had a rash on my face and my stomach and right across my abdomen ? little bumps that were itchy. And I saw a dermatologist. She gave me medication for rash and itchiness and she gave me medication for the lightheadedness and dizziness as well.
Patient received her vaccination on Wednesday, April 21. Her arm became itchy and she scratched it. It then became red, swollen, hard, and hot below and to the side of the injection site on Monday, April 26. Patient presented to the pharmacy on Friday, April 30. She said it was getting worse and asked if it was normal. She was referred to a doctor. Patient went to the clinic and was diagnosed with a skin infection that the doctor thought was related to the vaccination.
double ear infection; double ear infection; sinus infection; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: DJ7721, expiration date 31Jul2022), via an unspecified route of administration on 29Oct2020 at 0.5 mL, single for immunization. There were no medical history and concomitant medications. On 12Nov2020, two weeks later the patient developed the double ear infection and also experienced sinus infection on Nov2020. She had to go to the Emergency room for the double ear infection. So, the pharmacist said it was serious in her opinion. The sinus infection went away, but then she got the second double ear infection. The patient got the Prevnar 13 vaccine because she was getting a cochlear implant, and it was recommended by the surgeon. The patient said nothing else had changed except that she got the vaccine two weeks to the day of the side effects. The outcome of the event sinus infection was recovered while not recovered for the double ear infection.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The association between the event lack of effect (ear infection) with PREVNAR 13 can not be fully excluded.
Initial information received on 03-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had got very sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got flu shot once, got very sick. never again".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
A couple weeks after the vaccine I noticed my cycle was delayed and hadn't begun as it usually does. I previously had my cycle in May but didn't receive another cycle until 7/1.
This spontaneous report as received from approximately 71 year old male consumer refers to himself. The patient's relevant medical history included ulcerative colitis, immunosuppression and stroke in September 2013. The consumer had experienced shortness of breath after taking LEVAQUIN and a stomach ache after taking AUGMENTIN. On 30-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (dosage, lot# and expiry date not provided). Concomitant therapies included promethazine, ascorbic acid (Vitamin C), OMEGA-3, eicosapentaenoic acid (OMEGA-5), oleic acid (OMEGA-9), steroids (unspecified), codeine, allopurinol, cyanocobalamin, folic acid, FOLGARD, SYNTHROID, iron pills (unspecified), multivitamins (unspecified), natural factors COENZYME Q10 (also reported as Q10), fenofibrate and niacin. The consumer stated that he suffered from ulcerative colitis and immunosuppression but his physician gave him the ZOSTAVAX vaccine anyway. After receiving the ZOSTAVAX vaccine, he had experienced diarrhea and an increase in bowel movements from three a day to eight to ten a day approximately on 01-JAN-2014 (also reported as about two or three days after receiving the vaccine). Consumer had also experienced a cold since getting the vaccination. No product quality complaint (PQC) was filed. No treatment received for the events, no lab diagnostic studies performed and no medical attention sought. The outcome of the events was unknown. Reporter's causality was not provided. Additional information has been requested.
Woke up with severe vertigo 2 days after being vaccinated. Called pharmacist and he said it was a side effect from the vaccination. Advised me to take motion sickness medicine. It got a little better each day and was gone after 3 days.
prolonged muscle spasms, SOB not requiring oxygen or hospitalization, dizziness, foggy thinking for 7 days and not resolved at this time.
This was my second shot, some of it was outside my arm; This was my second shot, some of it was outside my arm; This spontaneous case was reported by an other and describes the occurrence of UNDERDOSE (This was my second shot, some of it was outside my arm) and DEVICE CONNECTION ISSUE (This was my second shot, some of it was outside my arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (This was my second shot, some of it was outside my arm) and DEVICE CONNECTION ISSUE (This was my second shot, some of it was outside my arm). At the time of the report, UNDERDOSE (This was my second shot, some of it was outside my arm) and DEVICE CONNECTION ISSUE (This was my second shot, some of it was outside my arm) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up document received 16-jun-2021 has No New Information.
This spontaneous report was received from a pharmacy intern and refers to an adult patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On JUL-2018 (reported as 3 months ago), the patient was vaccinated with the first dose of VAQTA for prophylaxis (dose, strength, frequency, route of administration, lo# and expiration date were unknown). On JUL-2018 (reported as a few days ago), the patient was vaccinated with a second dose of VAQTA 0.5/1.0 U/ml, intramuscularly, for prophylaxis, lot # R000180 and expiration date 31-MAR-2019. No adverse effects were reported.
Complained of very sore vaccine location (slightly red) and spiked a fever of 103.6 (oral) approximately 12 hours after the vaccination (3rd HPV vaccine in set). Fever treated with Motrin, came down fairly quickly. No fever as of noon today, and fever has not recurred as of yet.
Pt. received DTaP for ages less than 7 instead of Tdap for his age of 12 on 7-19-10. Parent advised and questioned regarding any adverse reactions or side effects noted. Denies any redness, warmth or swelling at site. Parent states child states shot site is still a little tender when touched. Advised that dosage did not need to be repeated and is a valid dosage per CDC. No injury noted.
Information has been received from a registered nurse concerning two patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650454/0751P). Subsequently, the patients developed injection site swelling and fever. The patients are being treated with acetaminophen Tylenol and application of ice pack. No other information was available regarding the adverse event or the patients outcomes. There was no product quality complaint reported. The reporter considered the patients adverse experiences to be other important medical events (OMIC). No further information is available.
Moderna COVID-19 Vaccine  Developed some blotchy bruising on the bottom half of both legs within 12 hours of receiving the vaccine
Same day as administered left arm started feeling like muscle had been knuckle-punched. Pain progressed that evening to be significant level up into left side of neck and down left side of abdomen to approx hip area. Woke up the next morning with fluctuating fever, switching from sweating to chills, highest temp recorded was 99.9 and my average is 97.4. Fever persisted for approx 30 hours. Day after administered I had significant full body aches and headache. It was difficult to get comfortable in any position. Body aches persisted approx 24 hours (starting 6:30am day after administered). Since administered, I have had a noticeable increase in eye aches/fatigue, not constant but every since vaccine administered, at this point approx 9 days.
A COVID 19 Pfizer Bivalent vaccine was accidentally given as the first dose of a primary series. No adverse events have been reported at this time.
Urticaria over full torso, neck, inside elbows, underarms for 10 days so far.
Severe muscle spasms in the lower extremities lasting at least 3 to 5 minutes.
flu like symptoms; swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and LIP SWELLING (swollen lips) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NA) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and LIP SWELLING (swollen lips). On 28-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. On 29-Apr-2021, LIP SWELLING (swollen lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided. treatment medication include ibuprofen, benadryl
This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a female subject aged between 50 and 59 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL, intradermally. At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site inflammation (the inflammation was described as big). The subject also experienced inappropriate route of vaccination. The nurse was looking to give the subject the TB test intradermally, but accidentally administered FLULAVAL. No further details are expected.