chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: KESIMPTA, start date: 30Apr2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on antigen test; Unknown results, notes: Indication=Treatment of COVID-19; Positive, notes: tested positive through day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The antiviral drug paxlovid was started on 13Jun2022 for the treatment of COVID-19 and stop on 17Jun2022. Paxlovid Rebound. Felt fine and tested negative on antigen test on days 6 - 9 from original positive test. Have felt mildly ill and tested positive through day 13 and showing no signs of letting up. The patient was on a B cell depleting drug - Kesimpta. The patient has no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3 days after vaccine, I got really rapid heart rate, high heart rate, muscle spasms, fatigue, chest pain, shortness of breath. Over the next 4 days it increased dramatically. I visited my PCP and I had blood work done and that is when I was diagnosed with graves disease. I was back in normal range and  got my second dose and then it raised my labs, about April 22nd, 2021 2 weeks after my second vaccine, my labs showed my levels to have increased again. May 11th and June 4th I visited Endocrinologist. On Jan 13th diagnosed with Graves Disease.
Mom states patient had high fever and was lathargic/inactive. Physician called, Motrin given. On 3/13/2013 follow up phone call to mom she states pt is feeling better and fever is 99.8 degrees. No Motrin has been given since 03/12/2013 PM dose.
Pt RECEIVED IMCORRECT COVID FORMULATION FOR AGE-GROUP.  Pt 5 YO AT TIME OF VACCINATION. SHOULD'VE RECEIVED PFIZER 5-11Y ORAGER CAP.
Pt recvd 1st dose of Hep B vax in OCT91 & 3 to 4 hrs later exp pain throughout arm; also had a bried episode of dysarthria; w/in 12 hrs noted some swelling of arm, primarily in distal portion;
The injection area of the left arm with redness and swollen. It's the 8th day after receiving the vaccine.  No treatment.
Information has been received from an immunization technician. She heard from a patient who heard from an occupational therapist who heard from another person that one patient was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced seizure and was hospitalized. It was reported that "the patient was diagnosed with epilepsy". Therapy with GARDASIL was discontinued. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. The Immunization Technician stated that she did not remember the patient's name or contact information who reported that she heard about a patient that was diagnosed with epilepsy after receiving GARDASIL. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information is not expected.
Soon after receiving her vaccination, the patient reported a red rash around her neck and chest, which was moderately itchy.  She never developed other signs of reaction and was monitored for 30 minutes.  Vitals remained within normal limits throughout the observation time.  She was instructed monitor the rash for progression, take antihistamines at home, and to seek help for worsening symptoms.
Fever 99 degrees; Fatigue feel asleep without provocation; mild injection site irritation; body aches; bone ache; This is spontaneous report from a contactable 69-year-old female consumer (patient).  A 69-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration in right arm on 03Feb2021 at 14:15 (at the age of 69-year-old) as a 2nd dose, single for COVID-19 immunization. Medical history included hypothyroidism, hashimotos, allergies to medications, food, or other products was none. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm right on 12Jan2021 14:15 PM at a 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 04Feb2021 at 16:00, the patient experienced fever 99 degrees, fatigue feel asleep without provocation, mild injection site irritation, body aches / bone ache. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature was fever 99 degrees on 04Feb2021. The events were reported as non-serious. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
#1 post vaccine low BP in post 30 minutes 48 hs of pain local, tired/headache/aches  #2 Internal local pain followed by 48-72 of tired, HA, chills fever- continued fatigue since then. congestion for past 10 day- onset Dyspnea at activity/rest since 4/16/2021.  sent to emergency room.  T= 97.7 PO=100% BP 110/64 P= 72 R= 18
On April 27th, I had a detached retina of my right eye. I had emergency surgery scheduled on April 28th for the detached retina. On April 29th, post operation follow up, the doctors seen that the retina was not fully attached, so they injected a gas bubble in my eye. Follow up for gas bubble was on May 3rd. My retina was still not attached so I was scheduled for 2nd surgery on May 4th. Post follow up was on May 5th and the retina was fully attached. I was out of work from April 28th - May 20th.
Had been perspiring profusely in my sleep; That night I had a mild night sweat again but very slight.; Soreness at injection site; Felt somewhat listless at work; Before bedtime felt slight chill. My clothing being damp from work.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to pollen, mold and plants and some mild food allergies. 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 26Feb2021, patient felt slight chill before bedtime and patient's clothes were damp from work. The patient had no problem sleeping. On 27Feb2021 at 03:00, the patient was perspiring profusely in sleep. The patient checked temperature and was quite normal so changed clothes and went back to sleep. On 27Feb2021, patient experienced normal soreness at injection site and felt somewhat listless at work. That night patient had a mild night sweat again but very slight. The patient had nothing like that currently and felt great. Since the vaccination, the patient had not been tested for COVID-19. 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 event. The clinical outcome of the events slight chill, perspiring profusely in sleep/ mild night sweat again but very slight, soreness at injection site and felt somewhat listless at work was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
pt had subjective fevers p/vax, treated w/APAP & pediaprofen alternately; 29NOV pt had episode of fever, stiffening & unresponsiveness last about 2 mins; mom called 911; ambulance took t104 then taken to ER-t106 R: dx w/febrile seizures;
The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the patient called complaining of right eye drooping, right facial tingling, mild shortness of breath, facial flushing and new onset headache. She arrived at ED at 2:06 pm presenting with facial swelling, tingling and shortness of breath. At that time, she stated her shortness of breath had actually improved and stated "probably just nerves". She still had a funny sensation in her face. She denied any focal numbness or weakness in her extremities. She stated she felt a little lightheaded. She had no sensation of throat swelling, difficulty swallowing. Physical Exam in ED: Constitutional: She appears well-developed and well-nourished.  HENT:  Head: Normocephalic and atraumatic.  Eyes: EOM are normal.  Neck: Normal range of motion.  Cardiovascular: Normal rate and regular rhythm.  Pulmonary/Chest: Breath sounds normal. No respiratory distress.  Abdominal: Soft. There is no abdominal tenderness.  Musculoskeletal: Normal range of motion.  Neurological: She is alert and oriented to person, place, and time.  Patient has symmetric facial numbness, she has right periorbital swelling causing what appears to be a facial droop however her mouth seems symmetric, she has negative Romberg's, she has full strength and symmetric sensation throughout  Skin: Skin is warm and dry.  Psychiatric: She has a normal mood and affect.
She got her vaccine, a couple of weeks later she found that she was unable to walk without feeling confused.  She normally walks with her neighbor and when they would return she would mix up her name and the dogs name, had mental confusion.   Was doing nothing strenuous.  She went to the doctor and her BP was 80/50, so she had to stop going on walks.  She was dizzy all of the time, low BP, couldn't take in enough fluid, chronically dehydrated, headaches.  Because of the dehydration she was in the ER 6 times in May, June and July and had a really bad UTI due to the dehydration.  From May to August she had very bad hemorrhoids to the point where she could not sit and had to have a hemorrhoidectomy and could not complete it due to low BP during the procedure.  She has continued to see doctors due to this.  She has seen multiple neurologists to get 2nd opinions, and they feel that she has dysautonomia, which they feel is related to the vaccine as she did not have any issues with her BP or other issues since then.  She biweekly sees a neurologist, cardiologist, endocrinologist, PCP and sometimes biweekly sees her, nephrologist, gastroenterologist, and they went through every single option to rule out what she had before they came to a diagnosis.  Her nephrologist said that she has treated at least 4 people with similar issues since getting the vaccine.  She saw another neurologist yesterday for movement disorder and they believe that she has functional gait disorder, this also since the vaccine.  She cannot walk straight and her balance is off.  She is sending her for PT and feels that it can be reversed, but her walking is not normal.  She cannot stand without her legs giving out.   She has depression and anxiety due to what she is going through.  She has had it in the past, but it is extremely exacerbated since this condition.  Her doctors told her that if she doesn't get treatment then she only has 5-10 years to live.  They want to give her medication to increase her BP which will increase the pressure in her brain and/or cause blindness.  She has a 5 and a 9 year old and she thought that she was doing the right thing.  There is a dysautonomia center at  but when she calls they only take Medicare.    She is not working and does not qualify for Medicaid and only take Medicare, and she has to pay out of pocket for any treatment that she is going to need and feels that she is going to die and if she does not get treated she will die.
Pt came in today stating she developed pain radiating from injection site down to thumb 3 days after vaccine. Still experiencing numbness in arm. States she has Dr appointment on 11/12/19 and will bring it up to physician.
Chills, lightheadedness, nausea, low blood pressure 90/65, fever 101.6  My shot was given yesterday morning at 9:30 AM. It is now almost 3:30 PM the day after. I no longer feel lightheaded or faint but I?m still running fever and just have a general feeling of nausea.
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.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient's concomitant medications were not reported. Past drug history included: Malarone, reaction(s): "Known allergies: Malarone"; Synthroid, reaction(s): "Known allergies: Synthroid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Positive, notes: Positive COVID test 5 days after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received, other medication in 2 weeks was reported as no. Paxlovid was started on 03Oct2022 and stopped on 08Oct2022 for the treatment of COVID-19. Vaccine lot unknown reason: Misplaced/discarded  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.
I did a booster shot with Moderna on 1/12/22 and got a side reaction: swollen area around lips, including lower lip, chin and partially lower cheeks. At the evening on 1/14 the symptoms started developing, I massaged the area a bit, drank some water and went to bed. At night I woke up as the aforementioned area got worse (pain, more swollen). I took a pill of Benadryl, applied some Hydrocortisone ointment and went to bed. I could sleep till morning as symptoms pertained. In the morning I scheduled a call with my medical provider (1:50 pm PST) and took one more antihistamine pill (Claritin). I still have one part of my face (left one) bigger than other. Some mild side effects I got on a second day after booster: pain in left under armpit (lymph knot), weakness.
Varicella Vaccine breakthrough.  Had varivax on 3/10/05 and 4/8/08.  Diagnosed in our office on 7/6/09 with varicella.  Fever for 72 hrs starting on 6/30/09.  Had over 50 lesions.
A report has been received from a health professional concerning a 6 year old female patient. No relevant history or concomitant medications were provided. The patient received nasal FLUMIST QUADRIVALENT, 0.2 millilitres, once/single administration. The patient experienced flu like symptoms two and half week after vaccination. The outcome of the event of flu symptoms was unknown. The report was considered to be non-serious by company physician.
Breakthrough case admission after 4 vaccines Moderna 1/13/21 Lot# 037K20A;  Moderna 2/10/21 Lot# 037K20A;  Moderna 12/22/21 Lot# 034F21A;  Moderna 6/1/22 Lot# 004M21A
pt recv vax & 1 day post vax pt described lt arm to be red from shoulder to elbow, hot & swollen;pt stated had a fever & arm ached;pt was seen by PMD & given ATB for cellulitis;c/o lt shoulder pain on exertion eg. lifting arm or using arm;
The patient was mistakenly given a dose of Pfizer vaccine intended for a person 12 years or older when she should have been given a pediatric dose.
Paralysis bilateral lower extremities 3 weeks after vaccinations. Hospitalized special care unit for 6 days. Underwent plasmapheresis x 5 treatments. Outpatient rehab at a rehab hospital for 6 weeks. Continues rehab 4 days a week at his school.
evening of injection (4/18) patient also experienced shorntess of breath without increased work of breathing (retractions, accessory muscle use, head bobbing, tripod positioning etc.)- an unexpected reaction.
Employee received vaccine at 10am, by 8pm that evening employee experienced achiness, tiredness, had headache, joint ache, fever, cramping, can't sleep, no appetite.
Information has been received from a healthcare worker (Medical assistant) concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L023387 with expire date 22-JUN-2017)(dosage and route not reported). The improper conditions of storage was 9 degree centigrade for 2 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
My forearms are itchy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 16:00 (Lot number: EL9263) as dose 1, single for covid-19 immunisation. The patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 08:00 (Lot number: EN6198) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amox, notes: Amox. The following information was reported: PRURITUS (non-serious) with onset 01Mar2021 18:00, outcome "not recovered", described as "My forearms are itchy.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus.  Additional information: He noticed this when he was unoccupied, particularly in the evening and night. Patient did not have covid prior vaccination. Patient tested for covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
On 10/22/02 at babysitter-who noted a 7 minute episode of cyanosis, eye rolling and generalized shaking. Lethargic afterwards for a period of time then started acting normally. Seen at center high temp 102.1. Questionable pneumonia tx'd Rocephen IV po dose.
fever 102 degrees, chills, body aches, fatigue starting at 4 pm. Took tylenol around midnight and able to fall asleep. Called into work the next day and was instructed by caregiver health to get COVID test and schedule appt. before coming back to work due to fever over 100. Felt ok the next day.
Information has been received from a consumer concerning a female who on an unspecified date was vaccinated with one dose of Zostavax. Subsequently the patient experienced dizziness and illness for over a month after receiving the vaccine. The patient also experienced a fever a couple months after receiving the vaccine. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Bell's Palsy Narrative:  The patient was present for his second vaccine. He reported that he felt he developed Bell's Palsy 21 days after his first vaccine. He stated his second vaccine appointment was 3/5 but was not feeling well and rescheduled for 3/12. Screener consulted with one of the Nurses in the vaccine tent, and knowing that Bell's Palsy is not a contraindication for getting the vaccine, both felt he would benefit from receiving it considering his cardiac history that he reported. As well he reported his PCC and Cardiologist did not express any reservations for him receiving the vaccine. However, reviewing records does not support the care for the Bell's Palsy from his PCC. As well, he reported he spoke with his Cardiologist via telephone about the shot and this is also not documented in chart at the present. Considering the literature has not been solidified for the vaccine causing Bell's Palsy, I informed him of his options of waiting another two weeks to completely recover from the symptoms of Bell's Palsy or to receive the vaccine today with a possible risk of reoccurring Bell's Palsy. After the nurse had a lengthy conversation with him and his daughter he decided to take the vaccine, for he felt the health risk of not receiving the vaccine far outweighed a reoccurrence of Bell's Palsy. Nurse followed up with him via a phone call same afternoon (at 3:30 pm) jut to see how he was feeling. He said he felt great. She informed him that she would follow up with him net week. He expressed appreciation for the call.