chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 14Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FP4774) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: tested negative Day 6; (12May2022) Positive, notes: Day 11 stuffy nose, tested positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Antiviral details product COVID 19 Treatment Paxlovid, treatment start date on 02May2022 and treatment stop date on 07May2022, 5 Day course of Paxlovid, tested negative Day 6, felt great, symptoms gone. Day 11 stuffy nose, tested positive.  No follow-up attempts are possible. No further information was expected.  Follow-Up (17May2022): Follow-up attempts are completed. No further information is expected.
No additional AEs or PQC reported.; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided.  On 24-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), dose of 0.5 mL, administered subcutaneously, lot number: U019906, expiration date: 24-JUN-2023 (dose number was not provided) for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaint (PQC) was reported (no adverse event).  The administered dose of the vaccine experienced temperature excursion of 6.8 degrees Fahrenheit (F) for 1 hour and 36 minutes and 6.0 F for 36 minutes. There were no previous reported temperature excursions. It was unknown if a digital data logger was involved.
Headache, Myalgia, Fever, NauseaVomiting, T-max 104 degrees Narrative:  Other Relevant History:
Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: The reporter stated that there was inappropriate reconstitution technique happened. The patient received only the liquid component. The reporter give consent to follow up. Additional supportive Information: The patient received only the liquid component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Patient came into office for an annual well child check, patient was due for three vaccines: Hep A, MMR, and VAR. MA pulled MMRV instead of MMR and was administered to patient as well as HAVRIX. Patient received two doses of varicella on 12/27/22. Since the administration, MA contacted manager and provider to make them aware of the situation. Patient will be monitored closely by mother.
Developed an ugly reaction on left arm below vaccine site that doesn't go away or keeps returning, and itches morE that scabies!!! Hot , red and inflamed
Breakthrough case admission after 2 vaccines Moderna 2/17/21 lot# 006M20A;  Moderna 3/17/21 Lot# 001B21A
perioral numbness and tingling 15-25 min after vaccination. epi-pen administered 25-30 min after vaccination.
Information has been received from a patient's mother concerning her 15 month old son with hypersensitivity to Amoxicillin who on 31-JAN-2006 was vaccinated with a first dose of MMR II. Concomitant therapy included VARIVAX and PROQUAD. On approximately 15-FEB-2006, "two weeks after receiving MMR II", the patient was shaking for about fifteen minutes. The patient was not hospitalized but went to the hospital to have a test done to monitor the patient's brain activity. The test showed that the patient did not have a seizure and it could have been that the patient had a fever. On an unspecified date, the patient recovered. The patient was not going to get the booster. No further adverse effect information was provided. No additional information is available.
dime size red area 4hr post inj;cont to worsen to 5x4 erythema;also had fever & painful achiness down to finger for 4 days;unable to recall when had last tetanus vax;
Arm itchy; Swollen arm; Hard arm; Hot to touch; COVID arm; other pain; fatigue; chills; headache; muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm), FEELING HOT (Hot to touch) and VACCINATION SITE REACTION (COVID arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm) and FEELING HOT (Hot to touch). In June 2021, the patient experienced VACCINATION SITE REACTION (COVID arm), PAIN (other pain), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches and pains). At the time of the report, PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm), FEELING HOT (Hot to touch), VACCINATION SITE REACTION (COVID arm), PAIN (other pain), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches and pains) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications were reported.  Patient was not taking any treatment medications for events- itchy, swollen, hard and hot to touch.
Patient marked on consent form that he had received 2 Pfizer doses at least 6 months ago.  It was later discovered his first 2 doses were Moderna and his 2nd Moderna dose was in April.
two days after vaccination shoulder ache, cough, 4 days after RT calf upper muscle pain which moved into RT ankle, 5 days later previous symptoms gone, 8 days later same calf pain again but in LT, pt also noticed heart arrhythmia's occurring, pt took a beta blocker and symptom subsided
Right leg/knee pain the morning after receiving Pfizer vaccine.   Pain worsened and leg swelled over the following week.  Ultrasound shows a DVT in the right peroneal vein.  Treatment:  Eliquis and follow up with hematology
Pt had her vaccine at 1835 and then proceeded to the monitoring area for her 30 minutes of monitoring due to allergy hx. At 1800 pt reported itchiness over her chest and left leg to monitoring RN. RN noted no other symptoms. Pt provided with diphenhydramine 25mg PO. RN continued to monitor. No added complaints and pt discharged home at 1850 feeling better.
Woke up on January 8th with pain in lower back, pain progressed, on January 10th I went to urgent care for the pain. They did EKG and chest x-ray and decided I needed to go to the hospital. The hospital did blood work and sent me on my way with muscle relaxers saying it was a sore muscle. The pain was not getting better so I saw another doctor at my primary care Wednesday January 12th. She did a urine analysis and also thought it was sore muscles. That night, I noticed a blistery rash on my left side. The next day I sent a picture to my primary care and they  diagnosed it as shingles. I took antivirals and it eventually cleared up. I am unclear if this was an immune response from the booster or just a coincidence. I did have a miscarriage at 5 weeks in October and was more stressed than average.
inner ear not able to find my balance feeling; off balance; numbness turned into pins and needles; my numb legs began twitching uncontrollable; I was not able to walk or lift my legs; my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks; my tongue became heavy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 14:15 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old.  Medical history included Congenital deafness/hard of hearing. Sensory processing disorder and allergic to Septra (co-timoxazole). There were no concomitant medications.  The consumer reported about 10 minutes after the shot, my feet began going numb. The numbness climbed up my legs to where my legs attach to my torso. I also experienced numbness in my hands and arm, cheeks, and my tongue became heavy. About 25 minutes after the shot, I was not able to walk or lift my legs. This was extremely scary. About 40 minutes after the shot, my numb legs began twitching uncontrollable. The twitching lasted about 10 minutes. About 2 hours after my shot I was able to walk again and the numbness turned into pins and needles. At about 7 hours after the shot the pins and needles subsided. The next morning I felt like I was on a ship. It was not a dizzy feeling, but more of an inner ear not able to find my balance feeling. I am still off balance. The pins and needles comes and goes. The events resulted in doctor or other healthcare professional office/clinic visit and prolonged hospitalization. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is requested.
Allergic reaction; cheek on the right side of his face was swollen like a golf ball; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (cheek on the right side of his face was swollen like a golf ball), HYPERSENSITIVITY (Allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced SWELLING FACE (cheek on the right side of his face was swollen like a golf ball). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, SWELLING FACE (cheek on the right side of his face was swollen like a golf ball) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Additional events.
pt recv vax 13MAY96 & 17MAy96 pt devel rash around inj site;by 22MAY96 rash spread to larger areas of the body;it was noted that rash did not have lesions assoc w/varicella & was not felt to be varicella-like
This spontaneous report as received from a 55 year old male consumer regarding himself. The patient did not have any pertinent medical history or allergies. On 18-JUL-2017, the patient was vaccinated with ZOSTAVAX, 1 DF in the triceps area of left arm for prophylaxis. Concomitant therapies included escitalopram. On 18-JUL-2017, the patient experienced injection site swelling and injection site warmth. Treatment was given for the events and no medical attention was sought. The outcome of injection site swelling and injection site warmth was reported as not recovered. Causality was not reported. No further information was provided.        Additional information is not expected as there are contact details .
Several hours after receiving vaccine got very restless legs (that she couldn't hold still) followed by muscle cramping that spread from legs up through trunk, arms and neck.  Resolved during sleep at night.  Muscles tender to touch in legs and various parts of body the next day.
Pressure headache; Chills; Had 99 degrees temperature on Saturday (21Aug2021)/On Sunday (22Aug2021), caller's temperature was at 101+ degrees/Today (23Aug2021), her temperature was still at around 101 degrees; Arm was hurting a little; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pressure headache on 23Aug2021, chills on 22Aug2021, arm was hurting a little on Aug2021, had 99 degrees temperature on Saturday (21aug2021)/on Sunday (22aug2021), caller's temperature was at 101+ degrees/today (23aug2021), her temperature was still at around 101 degrees on 21Aug2021. The patient underwent lab tests and procedures which included body temperature: 99 degrees on 21Aug2021, body temperature: 101+ degrees on 22Aug2021, body temperature: around 101 degrees on 23Aug2021. The outcome of the event pyrexia was not recovered, the outcome of the events headache, chills, pain in extremity was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient developed sore right arm the day she received the vaccine. Bothers her most at night rolling over in bed. Difficult to put deodorant on. No fever or redness.
patient returned to office today to receive thrid dose of GARDASIL 9, received first dose November 2020; patient returned to office today to receive thrid dose of GARDASIL 9, received first dose November 2020; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unknown day in November 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown day in February 2021, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On 24-NOV-2021 (reported as today), the patient returned to the office to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis (inappropriate schedule of product administration, circumstance or information capable of leading to medication error). The reporter was unable to provide the patient information as she was at another office location.
1 hour after receiving the second vaccination i started having an increased heart rate, high blood pressure, lips where tingling, and tongue felt as if it was swelling, flushing sensation throughout my body and shaking in my hands.
Hypothermia; I had a horrible headache; This is a spontaneous report from a contactable consumer. A 26-year-old male consumer received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6208) via an unspecified route of administration in left arm on 11Mar2021 at 05:30 PM (at the age of 26-year-old) for COVID-19 immunisation. Relevant medical history included asthma and hypertension. Concomitant medications were not reported. On 12Mar2021, 24 hours after vaccination (also reported at 01:00AM), the patient had a horrible headache and temperature was 94F (hypothermia). The patient was treated with hot water baths. He had no COVID prior vaccination and was not tested post vaccination. The event resolved on an unspecified date.
Vaccine was expired on 11/27/22- 1 day prior to admission. Contacted mom and explained what happened, mom declined wanting to repeat dose again for this flu season.
I had the expected side effects of fever and chills that evening around 8pm on the evening of the vaccine (3/13/21) and it went away by 1am. The next morning (3/14) I felt a bit tired but still had enough energy to go on my usual 8-mile run.  Just when I thought the side effects had passed, I was woken up that night by chest tightness and shortness of breath. I had to go to the ER on the evening of 3/14/21and got discharged around 2am of 3/15/21. They did and EKG and they said my heart and lungs are all in great shape and that this is probably just a vaccine side effect. They said they see it more often in Moderna but I guess it can happen with this one too. I just hope I?m not one of the rare cases that ends up in death.  I do have a history of allergies and asthma. I?m feeling better though, though I still feel something different in my chest.
Mom stated child developed rash and swelling to injection sites  after receving vaccines on June 8, 2021.  Soon after hives spread about body.  Mom admits  child has "bad" allergies.  Has Epi pen. . Mom administered  Benadryl  & tylenol every four hours  for 2 days.  She indicated that child  normally takes benaryl for allergies.   6/11/21 seen by allergist. Labs ordered.   Hx. Ecema since age  2 months of age. Has been on steriod meds 3 years for severe ezema. Denied swelilng to face or difficulty breathing.
No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 9-week-old patient of unspecified age. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 08-NOV-2022 at 12:54, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter (ml) oral liquid, 2 ml, lot #1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000032: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000037: US-009507513-2212USA000038: US-009507513-2211USA004171:
A week after getting it, I went into the clinic with hives and full body rash. The initially diagnosed it as a food allergy and sent me home with hydrocortisone and epinephrine. It did not improve so I went back. I was placed on oral Allegra with hydrocortisone cream to be taken twice daily until the symptoms improved. I am currently down to 1 every other day.
Sore Arm; He stated he lost 30% used in his right arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (He stated he lost 30% used in his right arm) and PAIN IN EXTREMITY (Sore Arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 037F01A, 026A21A and 013L20A) for COVID-19 vaccination.     Patient had no tested positive or diagnosed. Patient had not taken any other vaccines within 1 month prior to Moderna covid-19 vaccine.  The patient's past medical history included Cardiac operation (7 years ago). Concurrent medical conditions included Drug addict. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore Arm). In April 2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (He stated he lost 30% used in his right arm). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (He stated he lost 30% used in his right arm) and PAIN IN EXTREMITY (Sore Arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Negative.         Post vaccination patient's arm was sore and got worse. Patient lost 30% used in right arm. Patient went to see a general practitioner, had a blood test, Lyme and rheumatoid arthritis test done, and they all came back negative. The general practitioner stated that the side effects were common. Patient randomly mention yelling at wife. Patient went to see at a rheumatologist, and rheumatologist try to put patient on prednisone again. Patient went to see a bone doctor and bone doctor explained that side effects were not skeletal it was in the muscle in the arm. Patient was not mad and was a high risk patient . Patient also reported that his doctor want him to take 5 th dose.