chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing), notes: PCOS; "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Quinine, reaction(s): "Allergy_Quinine"; Sucralose, reaction(s): "Allergy_Sucralose". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported that, COVID-19 treatment Paxlovid was started on unspecified date in Dec2022. Last dose was on Saturday, 10Dec2022. After taking Paxlovid, Patient had rebound of COVID. Rebound COVID symptoms returned on Friday 16Dec2022 and patient took an at home test that was positive. Patient was recovering from COVID symptoms and no treatment received for symptoms. Patient was taking other medications or products within 2 weeks of starting COVID-19 treatment included Nyquil (started and stopped on 04Dec2022).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recv vax;soft ball sized local swelling & redness, red rash w/ itching at site; warm to touch; no fever; aching w/ ambulation;
DTAP or IPV site developed a dime-sized vesicle associated with pain approx. 30 hrs after injection. Vesicle size improved by next morning but has still 1/2cm 48 hrs after. No redness, itch or hives. Pain relieved with Motrin.
Presented to Clinic on 8/17/06 with c/o fever on 8/14/06 which resolved with OTC Tylenol. Fever was again present on 8/16/06, following up on continues systemic symptoms s/p smallpox vaccination. Smallpox vaccination site assessed and noted to be with increased erythema around vaccination site and extending to axilla. Positive axillary lymphadenopathy. Diagnosed with Cellulitis with systemic s/sx. Orders received for Keflex 500mg bid, Motrin 800mg 1 po q 6 hours prn, Tylenol 325mg alternate with motrin. Quarters ordered.
Patient presented from home after a fall, work up indicated stroke. Patient hospitalized for 27 days (10/8-11/4/2021) and discharged to a facility.
Headache, arm ache, leg ache, nausea, dizziness  all lasting 3 days Unable to eat anything or else it comes right out of my body this has  started 2 days after getting vaccine and has lasted 4 days and still ongoing
Four days after influenza injection had two days of Right red and painful eye with watery discharge, also associated with headache with movement.
Sleeplessness, insomnia, fatigue on day 1, severe fatigue the next day, aches,  sore arm at injection site
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (strength, dose# and route of administration were not reported) for prophylaxis. Properly stored sterile diluent (MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature between 15 and 46 Fahrenheit for 2 hours and 50 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1710USA007380: US-009507513-1709USA007245: US-009507513-1710USA007379: US-009507513-1710USA007382: US-009507513-1710USA007383.
I am flat on my back in bed. I feel like I have a massive case of the flu. Aching joints, feverish, lethargic, muscle pain.
Nausea, diarrhea, headache. Injection site red, sore, swollen - size of egg.
Extreme pain throughout like lighting up like a Christmas tree. Still happening, even after anti viral and steroid script. Systemic pain throughout lower back and legs especially. Then, 18 days later,, Bells Palsy
Breakthrough case admission after three vaccines Pfizer 3/18/21 Lot# EN6207;  Pfizer 4/8/21 Lot# Ew0150;  Pfizer 10/19/21 Lot3 Ff2593
@ site of injection L arm - enlarged, red, raised mass, itching, peeling - still with pale rash on 11/16
About ten minutes after receiving my vaccine, I was talking to a friend and I started feeling light headed. I started to get up to go talk to the nurse and I about passed out. I hit the pillar that I was standing next to. They had me sit. The first responder checked me out. My blood sugar was a little high, my bp was 50/70 and my heart rate was low. They took me to Hospital where I was given an IV, but I'm not sure what was in it. They drew blood and could not find anything. About three hours later, I started feeling normal. I have not had any other episodes since.
Both thighs instantly developed erythema in 6 in patch @ shot site. Right cheek became erythematous. Gave 4ml of 12.5/5 Benadryl. Pt was improved after 20 min waiting period.
No adverse events. Patient received his 2nd dose of the vaccine at 21 days instead of 28. Our staff member was unable to log into the portal at the time of vaccination. Per staff, patient stated it had been 28 days since his last dose. He did not have his hard copy with vaccination dates with him.  Caught the error when reviewing March data for billing.
Fever, chills, myalgia, diarrhea - started following AM after vaccine given.
1 1/2hr p/vax on 30APR96 pt suddenly turned pale, limp & unresponsive about 15-20min, recovering completely afterwards spontaneously;
17 year old patient presented to clinic with parent for first Covid vaccine, patient was administered Moderna instead of Phizer. Parent was notified and no additional adverse signs and symptoms reported by parent.
After giving Covid19 immunization to patient, technician attempted to recap syringe, resulting in a poke to her left hand.
FELT SHE IS GOING TO DIE; GAGGED ALL OVER HERSELF; VOMITING; COULDN'T WALK/TRIED TO DRAG HERSELF TO BATHROOM; CHILLS; FEVER; FEELING WEAK AND CAN'T DO ANYTHING; TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, lupus, non alcohol user and non smoker and other pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A-HR, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 at 09:15 on right arm for prophylactic vaccination. The concomitant medications included immuno-suppressant medications. On 30-MAR-2021, the patient started experiencing chills which kept getting worse and got fever then started with vomiting and could not walk. The patient Gagged all over herself.  The patient felt like she was going die and can't do anything so she called an ambulance. She was hospitalized on 30-Mar-2021 for all night. At hospital patient treated with medication for vomiting and was put on IV and blood test was performed. On 31-Mar-2021, At 13:00 , the patient was discharged from hospital but patient still experience weak, tired and can't do anything. The patient was hospitalized for 1 day. Hospital stated note for visit was Adverse Drug Reaction and instructed for follow up with treating physician in 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt she is going to die, and vomiting, couldn't walk/tried to drag herself to bathroom, chills, and fever on 31-MAR-2021, had not recovered from feeling weak and can't do anything, and tired, and the outcome of gagged all over herself was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210404324-covid-19 vaccine ad26.cov2.s -Vomiting, couldn't walk and tried to drag herself to the bathroom, gagged all over herself, felt like she is going to die. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210404324-covid-19 vaccine ad26.cov2.s -Fever, chills. These events are labeled per Agency and are therefore considered potentially related.
Information has been received from a physician concerning a 40 year old female acquaintance who in approximately 1996 was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced antibody levels that were either seronegative or low seropositive. Medical attention was sought. Additional information has been requested.
Patient developed what I though was Raynaud's in right hand. Later that day began having pain. I advised her to go to ED. Evaluated in ED and felt to have Raynaud's as well. Approximately 36 hours later developed severe pain in right arm. Went back to ED and CT scan showed thrombus extending from Aortic arch to subclavian artery and down brachial artery. Underwent emergency surgery to remove thrombus.
Couldn't get out of bed the next day. Achy, headache, body aches, chills, fever. This lasted throughout the entire day.
I was called at bedside because pt had a grand mal sz which lasted for a few seconds. Pt woke up alert and oriented right away. No posttictal episode. Pt stated that he felt pain and started to feel dizzy. Pt was pale, cool to touch, diaphoretic. No injuries noted. Pt was leaning against mother. C/O weakness. Assisted to gurney by 2 person assist. Tol well. Pt felt better being placed on supine. Color slowly coming back. Per mother, pt has a history of syncopal episode. Pt had a finger fracture before, got reinjured. Pt blanked out and passed out. Pt was brought to the ED then and was cleared. 1138 92/41 (58) 51 99% RA 16; 1140 89/39 (54) 50 99% RA 16; 1143 95/46 (62) 54 100% RA 18; 1153 92/55 (65) 55 100%RA 16; Pt is now placed on semi fowlers position. Pt is tolerating positioning well. Tolerating crackers and fluids. Mother at bedside, assisting patient. Doctor on call, Dr.  made aware of pt's situation and current condition. Per MD, to observe patient for 30 mins and to let him know pt's condition then. Per MD, to introduce PO intake as tolerated. @1208 Pt ate 3 packets of crackers and on the second box juice. Made mother aware that doctor on call was notified and discussed plan of care. Mother and patient verbalized understanding. Instructed mother to make appointment with pediatrician for follow up. Instructed pt and mother that pt should rest, increase PO intake today. Pt and mother verbalized understanding. @1205 98/53 (71) 56 100%RA 16 Pt sat up in a high fowlers position. Tolerating well. Denies dizziness, nausea. Pt ambulated. Tol well. No problems.  Made Dr. aware. Pt is cleared to go home with PMD follow up and ED precaution instructions. Pt and mother aware. Mother is confident of taking pt home.
Patient states she has a large lump underneath her right arm and it's sore, swollen and hurts.
12/7/11 - (R) deltoid area, Influenza vaccine site, red, sore, mild swelling, warm to touch. C/O N/V following Influenza vaccine. Onset 12/7/11.
So on July the 13th I was getting ready to go for an appointment for a massage and I started hurting mid-chest, just below the breast bone. I thought at first that maybe it was indigestion or something. I took tums. After that my arm was hurting and I got my husband to take me to the ER. I was monitored and they called in a cardiologist, I stayed overnight and had a cardiac cath the next day. The pain lasted about 50 minutes after I arrived at the ER by the way, so they had kept me there. They wanted to watch me because my troponin levels were high. I also got a severe migraine for about 8 hours and they had given me something to go to sleep. They let me go home on July 14th 2021. After that, I followed up with my PCD and the cardiologist. The cardiologist thought it was a coronary artery spasm but they are unsure. They put me on a calcium channel blocker.
Hives over entire body started Sunday night (01/03/2021). No change in hives, worsening with heat and at night. Was seen in urgent care (on 01/05/2021) and given a topical cream (Triamcinolone Acetonide) that did nothing. Seen by dermatologist (1/07/2021) and given IM steroid injection and a methylprednisone pack for 6 days. Symptoms improved with IM injection. But still in the process of completing the steroid pack.
Tired; Nauseated; Sneezing; Runny nose; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 09Sep2021 at 12:15 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included anemic and heart murmur. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 09Sep2021 at 19:00, the patient experienced tired, nauseated, sneezing, runny nose and sore throat. 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 event tired, nauseated, sneezing, runny nose and sore throat was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. This 75-year-old female patient of unknown race received PREVNAR 13 at single dose for immunization in Oct2015. Relevant medical history included breast cancer, diverticulitis, abdominal discomfort, she has a leaky valve in her heart which started about 5 years ago, pulmonary embolism, treated with Zpack and so the patient was fine. The patient experienced sepsis and multiple episodes of pneumonia from Jun2017. It was reported that in Jun2017 the patient experienced a small bout of pneumonia with outcome of recovered, in Nov2017 cough and short of breath and she did not know if they are symptom of cold, the patient was on the cruise ship and was treated in their ship hospital with antibiotics in IV form and inhaler. Then she was on the plane and there was a guy sitting next to her and he was really sick and coughing and hacking. She started with a cough and coughed a lot. She took a lot of Zinc and Vitamin C to try to cut it short. Then she got to the point, she needed to get some oxygen and went to emergency and sent her to ICU. She ended up in the hospital for 9 days. They knew that I would have IV antibiotics. After that she developed Steven Johnson Syndrome when she had the antibiotics. The last time she was in hospital after a trip and her daughter had to explain to them that she could get Steven Johnson syndrome again and no one in that hospital knew about this condition and her daughter was adamant about getting a doctor who knew how to take care of her. She did prednisone again and the doctor was wonderful. I also was sepsis. The outcome of the event pneumonia reported as recovered while the outcome of the event sepsis was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
pt exp h/a so severe that was unable to play basketball;pt was seen by MD on 15MAR96 who felt poss hay fever;also exp intermittent sore throat & yellowing of white part of eye & devel a lump on testicle dx cyst or poss missing liver enzyme;
Short of Breath, Dizzy, Pale, Low BP and Heart Rate, Syncope, Nausea.
Fever 100.5 for 2 days Fatigue 2 days Nausea 2 days Body aches 2 days  Headache 3 days Extremely heavy menstrual flow
devel fever 1wk p/vax;devel extensive bruising & petechiae; 3wk p/vax;ITP dx 1FEB99 w/platelet count 11K;completed 2wk oral steroids;platelet count dropped to 7K despite this;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 4:33 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 78.90. No concomitant medications were reported. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Shingles that started 3 days following the 1st vaccine administration.; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: ER8732), via an unspecified route of administration on 30Mar2021 at 14:30(at the age of 52-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at hospital. Medical history included allergies: Sulfa from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021 at 16:30, the patient experienced Shingles that started 3 days following the 1st vaccine administration. Therapeutic measures were taken as a result of shingles and treatment included 7-day course of Valtrex. The adverse event did result Doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.
Patient became unusually fussy and could not be consoled easily. Wasn't nursing well. Fell asleep around 10pm and woke up around 1am with 101-102 fever. Treated with infant ibuprofen. Fever went down to 99-100. Fever/treatment continued for next day. That evening (12/29) noticed three areas of red blood in stool. Called PCP and was told it was likely an anal tear. Patient is breastfed so no straining to have movement, and movements had been normal. Continued fussy for next day. On 1/1 developed dry cough and some chest congestion. Eating normally, and having regular wet/soiled diapers. Was not ill prior to shots (Prevnar 13 and Hib), does not attend daycare and has not been exposed to sick people.
Rash (non-indurated) slight erythematous swelling on the RUE, fairly round (6-7 cm) 2nd similar patch of erythema that is less round, more medial, tender.
This spontaneous report was received from an office manager referring to an 11 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 02-NOV-2017, the patient was vaccinated with an adult dose of VAQTA lot number M039055 and expiration date of 22-JUL-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Patient stopped by pharmacy on 7/23/21 to show the rash on her body and face. She stated that she experienced body ache, chill, and soreness at site of injection in the evening of the vaccine administration. These symptoms persisted for about 3 days and her arm was sore for about 7 days. She started to develop a scatter, spotting rash over body (more concentrated in the chest area) and several spots on her face. The rash was itchy and turned into blisters. She mentioned that she had outdoor activity in the yard several days after her vaccination. She didn't know for sure whether her body and face rash was related to the Shingrix vaccine or pollen allergies. She went to see her doctor on 7/22/21 and was prescribed Prednisone, Cephalexin, and otc Benadryl for her rash. The blisters from her rash started to scab over and she said she still has some itching and rash was improved and got better.
Pt received 1st dose of Janssen vaccine.  Pt was visibly very nervous before receiving vaccine.  After administration, pt felt dizzy, lethargic, complained of blurry vision, and almost passed out.  EMS dispatched to store as a precaution.  After sitting and drinking some water, pt was feeling better within 5-10 minutes.  He was checked out by EMS, but he waived any further care.  Left store after parents picked him up.