chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 95-year-old female patient who received mRNA-1273 for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture).    Concomitant drugs were not reported.  It was reported that patient received second booster dose.  It was reported that the vial was initially stored in refrigerator on 04-Aug-2022. The vial was stored at room temperature post puncture for 25 hours and did not undergo any temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-633797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-633797:
10 minutes post vaccination - 0945am - child c/o dizziness, nausea, no difficulty walking. Assisted child to lying position. Oriented x 3. Provided juice. Tolerated juice. Vital signs stable: HR 82, BP 106/66, PR 16, Temp 97.2. C/O blurred vision. Cont. to monitor child for 2 hours until parent picked up. Child ate lunch, walked and stated felt better at 11:30am
Documented Hypersensitivity to administered product; Didn't like outcome; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included egg allergy.   In 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In 2019, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced adverse event. On an unknown date, the patient experienced documented hypersensitivity to administered product. On an unknown date, the outcome of the adverse event and documented hypersensitivity to administered product were unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient with egg allergy received a Influenza vaccine Quadrivalent 2019-2020 season (unknown brand) and did not like the outcome. No more details were provided to the pharmacist by the patient, and the vaccine was not given at the pharmacy so additional details were not available. This was a medication error with adverse event. Consent to follow up was provided.
This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always' received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Began local redness about 1/2 dollar size. Then after 1 day possibly after scratching increased to 4.5 x 2.5 in redness/warmth with discomfort. No fever, some bruising.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
While outside I got lightheaded and leaned on the garage. I then had a sharp pain in my toe. I then passed out and after I woke up I passed out again. I passed out once more. I went to the emergency department. I had a broken toe from when I passed out the first time. I was diagnosed with vasovagal syncope after seeing the neurologist and cardiologist. My blood pressure had now become very low for months, 80/50 and began taking medicine to bring it back up to normal range of 110/70.
Body aches; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 06Apr2021 at 11:00 in left arm (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol high, breast cancer, gluten intolerance(gluten allergy) and latex allergy. The patient previously received morphine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, at 11:00, the patient experienced fever that ran for 2 days, body aches, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of fever, body aches and fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
After the patient received the second vaccine, he stood up and appeared to become dizzy. He was advised to sit down  and began to shake uncontrollably, similar to heat stroke shaking. The pharmacist at the time felt it was necessary to administer an EpiPen. He called family and after about 40 minutes family arrived to take him home. Patient declined emergency care.
Patient got a rash and bump at injection site. She also had chills but no fever. She also experienced pain at injection site from 10/29/20 when she received the vaccine and is still experiencing that pain 11/9/20
Pfizer COVID-19 vaccine (5-11yrs) manufacturer expiration date is 8/31/2022. However, vaccine expiration date after being transferred from freezer to refrigerator is 5/17/22. Vaccine was administered on 5/27/22.
Fever, 99.4 to 99.5 , cough , URI symptoms,  generalized body aches  one pustule present on left forearm,
IRRITABLE, VOMITING, LOW GRADE TEMP, WENT TO ER AND NEEDED IV FLUIDS
This is a spontaneous report from a contactable consumer (the patient). A 82-year-old female patient received PREVNAR 13, NDC number 00005-1971-02, intramuscular in left arm on 13Oct2016 13:15 at 1 ml one shot, for immunisation. Medical history included atrial fibrillation from 1975 and ongoing, cerebrovascular accident in 15Feb2004, thyroidectomy in 1970, clostridium difficile infection in Jul2015, hysterectomy in 1971, shoulder operation in Feb2015, rotator cuff syndrome, joint dislocation, depression, thrombosis. The patient had no illness at vaccination time. Concomitant medication included FLUZONE administered on 13Oct2016 intramuscular in the right arm, citalopram for at least 4 years and ongoing for depression, levothyroxine from 1970 and ongoing for thyroidectomy, warfarin sodium from 15Feb2004 and ongoing for blood clot, DILTIAZEM CD ongoing for atrial fibrillation, and probiotics nos from Jul2015 and ongoing for Clostridium difficile. The patient previously took pneumococcal vaccine ten years ago, and Fluzone in 2015. The patient experienced very limited movement of the left arm, pain inside the arm/ if she extends the arm it is painful between the shoulder and elbow, and if the patient holds her arm up to her shoulder it is uncomfortable in Oct2016 after vaccination. The patient experienced soreness at injection site on 14Oct2016. The outcome of the events experienced very limited movement of the left arm, pain inside the arm/ if she extends the arm it is painful between the shoulder and elbow and if the patient holds her arm up to her shoulder it is uncomfortable was not recovered. The outcome of the event soreness at injection site was recovered on unspecified date.  The patient underwent lab tests and procedures which included clostridium test positive on Jul2015.
This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (suffered from neuropathy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced NEUROPATHY PERIPHERAL (suffered from neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (suffered from neuropathy) was resolving. It was reported that, patient suffered from neuropathy since Apr-2021 following a second Moderna vaccine. Patient had been to numerous doctors including a neurologist. Symptoms were lessening but not totally gone. Patient was advised not to get a booster due to adverse reactions. Patient stated that it had been a very long and miserable 10 months. Attempts to reach patient for additional details were unsuccessful. No additional details available at the time of report. No concomitant and treatment medications were provided. Company comment: This spontaneous case concerns patient of unknown age and gender with no reported medical history, who experienced unexpected serious event of Neuropathy peripheral (seriousness criterion Medically significant) which occurred unknown dates after the second dose of mRNA-1273 vaccine. It was reported that, patient suffered from neuropathy since Apr-2021 following a second mRNA1273 vaccine. Patient had been to numerous doctors including a neurologist. Symptoms were lessening but stated that it had been a very long and miserable 10 months. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns patient of unknown age and gender with no reported medical history, who experienced unexpected serious event of Neuropathy peripheral (seriousness criterion Medically significant) which occurred unknown dates after the second dose of mRNA-1273 vaccine. It was reported that, patient suffered from neuropathy since Apr-2021 following a second mRNA1273 vaccine. Patient had been to numerous doctors including a neurologist. Symptoms were lessening but stated that it had been a very long and miserable 10 months. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
PANIC ATTACK; SWEATING; DID NOT LOOK SO GOOD; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced panic attack, sweating, and did not look so good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack, sweating, and did not look so good. This report was non-serious.
A near miss occurred whereby an RN administering vaccines affixed a high-dose Fluzone vaccine syringe to the vial containing lyophilized RSV vaccine. On review, it was observed that the pre-filled syringes of high-dose Fluzone and the pre-filled sterile water diluent to reconstitute the RSV vaccine look very similar and have the same (interchangeable) connector system. In high-volume vaccine clinic settings where both vaccines are stored, there is a risk for inadvertent co-mingling of flu vaccine and RSV diluent. (photos attached). Note, this was caught prior to incorrect administration; no harm done.
SORE JOINTS; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore joints, and low fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore joints and low fever was not reported. This report was non-serious.
hyaluronic acid fillers in her face have reacted; face ached; areas of filler are swollen; areas of filler are tender; areas of filler are a little irritated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (hyaluronic acid fillers in her face have reacted), FACIAL PAIN (face ached), SWELLING (areas of filler are swollen), TENDERNESS (areas of filler are tender) and SKIN IRRITATION (areas of filler are a little irritated) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced VACCINATION COMPLICATION (hyaluronic acid fillers in her face have reacted), FACIAL PAIN (face ached), SWELLING (areas of filler are swollen), TENDERNESS (areas of filler are tender) and SKIN IRRITATION (areas of filler are a little irritated). At the time of the report, VACCINATION COMPLICATION (hyaluronic acid fillers in her face have reacted), FACIAL PAIN (face ached), SWELLING (areas of filler are swollen), TENDERNESS (areas of filler are tender) and SKIN IRRITATION (areas of filler are a little irritated) outcome was unknown.        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.   No concomitant medications were provided by reporter. No treatment details were provided by reporter.
I have had Mirena IUDs since 2012.  I never have a period when I have the Mirena IUD.  After I received the COVID-19 vaccine, I had a period for the first time in nine years.  I thought maybe it was a one-time event, but since having the COVID-19 vaccine, I have continued to have monthly periods.  This side effect is not going away.  This is extremely unusual for me because I have had Mirena IUDs several times in my adult life, and I NEVER have a period when I have the Mirena IUD, no matter what else has changed in my life.  Since being vaccinated in April 2021, I now have monthly periods.
pt recvd vax;4-5 hrs later,mom noted some breath holding 10-15 secs;no signs of fever,limpness or unusual positioning;pt adm to hosp for 23 hrs for observation;thighs not sore or tender at site of injection;
The employee/patient attended seasonal flu clinic for healthcare worker vaccination. She reported symptoms starting around 1700-1900 later that same evening. The patient reported being evaluated at hospital campus. She reported being evaluated by Dr. for arm pain and swelling at site. She stated she was treated with NAPROSYN and ruled out for tendonitis and diagnosed with likely flu reaction. In Aug. 2018 She reported having lower leg swelling and hives when she had her hepatitis B series in August 2017 she approximated around the 17th to the 21st as the time frame.
Red area about 3 inches across on arm.  Pt had also had elevated blood sugars since vaccinations, 200-300. Mom will be taking pt to urgent care to be evaluated.
left periorbital and eyeball swelling; left periorbital and eyeball swelling; left side facial swelling; This is a spontaneous report from a contactable nurse (patient herself). A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en9581), via intramuscular route, administered in left arm on 17Feb2021 13:00 (Age at vaccination: 40 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included asthma, Wilms tumor and anxiety. The patient was allergic to clindamycin and adhesive. Concomitant medication(s) included salbutamol (ALBUTEROL) inhaler. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: en5318) via intramuscular route in left arm on an unknown date as DOSE 1, SINGLE. The patient did not have any other vaccine in four weeks. On 18Feb2021 08:00, the patient experienced left side facial swelling. On 22Feb2021 08:00, the patient experienced left periorbital and eyeball swelling. The patient did not receive any treatment for the adverse event. The patient did not have covid before vaccination nor was tested since vaccination. The outcome of all the events was recovered on an unknown date in 2021.   Follow-up attempts completed. No further information expected.
1st day after Vaccine, soreness on injection sight. 3rd day  Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine.   I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning.  Hope I don't have to report anything on the 2nd.
I had a 5in x3in bright red, hot, itchy rash on my left arm below injection site that appeared 7 days after I had received the shot. It has now been 2 weeks since I received the shot and I still have the rash. I reached out to my doctor's office, but have not been able to talk to my PCP yet. The rash remains the same size, hot, itchy and red.
chills; achiness; not feeling well; Right arm slightly sore; This is a spontaneous report from a contactable Nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02Apr2021 (Lot Number: EW0151) (at the age of 68-year-old) as dose 2, single; received the third dose via an unspecified route of administration, administered in right arm on 13Oct2021 11:00 AM (Lot Number: 59267-1000-02) as dose 3 (booster), single for COVID-19 immunisation. The patient was no pregnant on the vaccination. She previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6207) (at the age of 68-year-old) on the left arm for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), hypertension. No COVID prior vaccination, no COVID tested post vaccination. The patient's concomitant medications included flu shot (influenza vaccine) on 08Oct2021 for immunisation. The patient previously took ketamine and experienced drug allergy, took lisinopril and experienced drug allergy. On 14Oct2021 11:00 AM, 24 hours after receiving booster shot, had chills, achiness, not feeling well. Right arm slightly sore. Similar adverse events after receiving 2nd COVID shot but was a little more severe (on 2021), the patient did not report this. No treatment received for events. The patient was recovered from events on 2021.  Follow-up attempts are completed. No further information is expected.
patient was assessed at 8:00, Patient is accompanied by parent/Guardian, History obtained from Parent/guradian. Patient appears comfortable, Patient is cooperative, alert and oriented as age appropriate, interactive, consolable, well hydrates. Patient has good muscle tone. Patient immunizations up to date was a normal vaginal delivery without complication was delivered with no complications, Pt received immunizations 10 days ago. Respiratory; no complaint of pain, Breath sounds clear bilaterally. No acute respiratory distress, intercostal retractions, supracivicular retractions, sternal retractions, Equal chest expansion, No nasal flaring, cough, vigorous cry, small amount of clear nasal drainage. Abdomen; Patient denies abdominal pain. Abdomen is soft to palpation, non tender, non distended, positive bowel sounds in 4 quads. Patient denies nausea, vomiting, diarrhea, constipation, flank tenderness, no pulsatile masses noted to abdomen. Patient assessed at 10:10 few scattered pox noted to arms and legs. Large rash appearing to left arm that mom states is a birth mark. Diagnosis: Varicella Zoster in recently vaccinated Child.