chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed out but when she awoke she was no longer in the kitchen; Crawled to bed and stayed there for an hour; Bruised big toe; Started feeling bad nauseous for a moment; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out but when she awoke she was no longer in the kitchen), BED REST (Crawled to bed and stayed there for an hour), CONTUSION (Bruised big toe) and NAUSEA (Started feeling bad nauseous for a moment) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076CZ1A, 015M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included CALCIUM and CALENDULA OFFICINALIS, GINKGO BILOBA, SOLANUM LYCOPERSICUM, VACCINIUM MYRTILLUS (EYE HEALTH) for Supplementation therapy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out but when she awoke she was no longer in the kitchen), BED REST (Crawled to bed and stayed there for an hour), CONTUSION (Bruised big toe) and NAUSEA (Started feeling bad nauseous for a moment). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out but when she awoke she was no longer in the kitchen), BED REST (Crawled to bed and stayed there for an hour), CONTUSION (Bruised big toe) and NAUSEA (Started feeling bad nauseous for a moment) outcome was unknown.            Concomitant medications included Cholesterol medication along with above mentioned medications. No treatment details were reported.   This case was linked to MOD-2021-403391 (Patient Link).
Pt. mother called and stated Pt. began having, Headache, Nausea, and numbing of Lower extremities.
Sever abdominal pain extending up center of chest to ears and down center of back.  Sever pain if trying to lay flat. Initial occurrence March 31,2021 approximately two weeks after 2nd Pfizer vaccination,   Released from hospital same day but unable to lay flat for four days.  Same symptoms reoccurred on May 26, 2021 and was admitted to the hospital for three days and it was determined my condition was  pericarditis.
The client reported being bit by a bat on 12/16/2022. She was referred to ER and MD evaluated and began Rabies PEP.  Per the client: "she reports starting on 12/26/2022 she has had no control over her emotions and the smallest issues bother her that normally don't bother her. She has been lashing out at others in her family. Tossing items and crying and yelling. She reports having a history of depression/mental health issues. She is under the care of a psychologist and therapist and has been able to control her emotions inside. Today 12/30/2022 is the first time she has reported having depression/mental health issues. She also reports that over the Christmas weekend she felt like she wanted to harm herself and had a knife in her hand but, put the knife down and called someone. Her mom is in the room while pt. is explaining this. Today she denies any suicidal thoughts and declines to go to the ER.  Client and her mom are convinced that the rabies vaccines and immune globulin are attaching to the receptors of her mental health medications and interacting with the rabies vaccines/immune globulin and causing these side effects and requested nurse report this."
Had severe pain rt upper arm when received the injection. Pain persisted and 2 days later developed pain in the left area same exact area as right arm. Has not gotten any better. Difficulty raising arms without pain
Information has been received from a health professional concerning a 9 year old female pt with no past medical history and no known allergies who on 04/14/1997 was vaccinated with a first dose of varicella vaccine in the left arm. There was no concomitant medication. On 10/25/2001, the pt presented to a physician's office with approximately 15 chicken pox and a fever of 101.7 deg F. The pox were dispersed over her trunk and extremities. It was noted that the pt was not on any medication at the time of the office visit. The pt subsequently had a fever of 103 deg F and had approximately 14-18 chicken pox lesions on her face, chest, and back. The pt recovered. No additional info is expected.
11:50 AM the patient was syncope, clammy , and nausea Blood Pressure  on the Right Arm 76/46.  Patient was given Ammonia Inhalants followed by a cup of water and some crackers. Patient Blood Pressure taken again at 11:55 am and was 76/49 on the left arm HR 100 Sp02 99. Patient was taken into exam room to lie down and elevate feet. 12:00 pm Patient Blood Pressure 96/64 lying down left arm.  Patient sat up and walked out of exam no complaints.
Began scratching itchy arms and torso around midnight. Itchiness gradually became more unbearable and widespread to whole body over an hour, and face became warm and filled with rashes. Went to the bathroom and noticed hives and redness all over body. Took Benedryl and took a warm shower and symptoms wore off after approx. 1 hour.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients, of unknown ages and gender. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of PEDVAXHIB (Lot # L002867, expiry date on 11-NOV-2017) were inadvertently administration to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Diffuse lesions to anterior aspect of trunk.  Appear to be self inoculation sites of smallpox patient had received on 29 May 2013.
3 weeks after varicella/Hep A were given in right leg. Pt had unexplained tenderness, pain to leg.
Fever, chills, headache, nausea, vomiting, dizziness like I was going to pass out.  Sensitive to lightens arm pain near injection sight.
Patient notified me about a little bruising and warmth that showed up at the injection site.  She was not sure when it started to come about.  She also stated that she had some general body soreness recently as well.
a little sore; tenderness; a little bit off; it affected her glucose numbers/numbers have been running high in the 170s; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little sore), TENDERNESS (tenderness), VACCINATION COMPLICATION (a little bit off) and BLOOD GLUCOSE INCREASED (it affected her glucose numbers/numbers have been running high in the 170s) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (a little sore), TENDERNESS (tenderness), VACCINATION COMPLICATION (a little bit off) and BLOOD GLUCOSE INCREASED (it affected her glucose numbers/numbers have been running high in the 170s). At the time of the report, PAIN (a little sore), TENDERNESS (tenderness), VACCINATION COMPLICATION (a little bit off) and BLOOD GLUCOSE INCREASED (it affected her glucose numbers/numbers have been running high in the 170s) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 170 High. On an unknown date, Body temperature: 98.3 (Inconclusive) degrees Fahrenheit (patient noted following vaccination).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In response to the increase in her glucose numbers (running high, in the 170s), the patient had to increase her units of insulin. No additional treatment for the events was reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Pruritic blister like bumps on left shoulder/back, symptoms have lasted 3 days still ongoing
found to have trivial pericardial effuion 5/25/2021 (incidental finding)  Narrative: employee found to have incidental small pericardia effusion on imaging; per echo, trivial size. She was asymptomatic until 6/18th when she went to ER for cp (ruled out for ACS/neg stress test). Denies any viral symptoms; no hx of autoimmune (though she was seen once by rheum for possible Sjogrens')
Hospitalization - COVID-19 infection, hyperglycemia, hypomagnesemia, acute kidney injury
Site: Swelling at Injection Site-Mild, Additional Details: Patient received the vaccination and then immediately developed a hard knot at the site of the injection, it was slightly bigger then a marble. The patient had no other symptoms and felt mild discomfort at the site. He stayed at the store for roughly 45 minutes after the shot with no change.
About 2 hours after injection, patient felt a big lump on throat to the point of it almost closing. Pt got over the counter benedryl and took some on her way home from work where she received the vaccine. Had chills during the night. Patient still has lump on throat but it is about 50% recovered. Throat is sore also and voice changed a bit.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, injection site warmth and swelling. On an unknown date, the outcome of the erythema, injection site warmth and swelling were recovered/resolved. It was unknown if the reporter considered the erythema, injection site warmth and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced adverse events of swelling, redness, and injection site was hot to the touch. The HCP was unable to provide lot number or expiry date or patient demographics at the time of reporting but would follow up once they were found. This case was linked with US2018GSK180378, reported by the same reporter.
dose of Infanrix/ nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect product storage in a 4-year-old male patient who received DTPa (Infanrix) (batch number KGFM4, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 25th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received a dose of Infanrix on 25th June 2021, that was deemed nonviable after a temperature excursion, which led to incorrect product storage. No symptoms reported. The reporter consented to follow up. This was 5th of the 6 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142813:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter US-GLAXOSMITHKLINE-US2021142818:Same reporter
Patient reports itching and aches all over the body for 1 day. Reports feeling tired all week.
On day 5 after booster vaccination, and 7 days after onset of symptoms of minor sore throat, low-grade fever, chronic productive cough, shortness of breath, sought urgent care follow-up.  Home Covid test was negative on day 5 after the onset of symptoms.  Urgent care PA tested for Covid and Flu.  Both negative.  Indicated she would treat as if an acute bronchitis.  Ordered Doxycycline for 10 days and one time Decadron injection.  Felt better in 2 days, much improved within the week and finished 10  days antibiotics.
Fever=102.9, 103.2, throughout night, chills,  Severe body aches, severe fatigue, headache,  nausea
couldn't  walk; got very ill; pounding headache/could not pick her head; body aches; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient of unknown age who couldn't  walk (gait disturbance), got very ill (malaise), pounding headache/could not pick her head (headache) and body aches (pain), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ223AA via unknown route.  On an unknown date, The patient developed a non-serious couldn't  walk (gait disturbance), got very ill (malaise), pounding headache/could not pick her head (headache) and body aches (pain) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  No lab test reported.   Final diagnosis was body aches, pounding headache/could not pick her head, got very ill and couldn't  walk.   It was not reported if the patient received a corrective treatment.  The patient's event outcome was not reported..
Was napping the day after receiving the vaccine and woke up about 3:00 pm to severe chest pain on the right side radiating deep into the shoulder blade.  It would last about 5 - 10 min., stop for the same amount of time, then start up again.... on & off until close to 11:00 pm.   Since someone else I know had the same thing happen the day after her shot, I assumed I had the same symptom, tho' it was very frightening.  A week later after going to bed on Friday night, I woke at 2:00 a.m. to the same pain only this time on my left side.  Thinking I could be having a heart attack, I went to the hospital where I was admitted after having a series of tests.  I was there for 2 days during which time I also began to have un-controllable diarrhea.  Altho' they could find nothing wrong with my heart,  after scans, x-rays, a stress test, numerous blood tests etc., they cannot say positively whether or not it was from the Covid vaccine.  I tho't it best to report this in case others have similar events.  I had the MODERNA vaccine
Left shoulder kind of itchy near an older BCG vaccine scar; Left shoulder looks like she got a mosquito bite; Left shoulder redness near an older BCG vaccine scar; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Left shoulder redness near an older BCG vaccine scar), PRURITUS (Left shoulder kind of itchy near an older BCG vaccine scar) and ERYTHEMA (Left shoulder looks like she got a mosquito bite) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: BCG VACCINE AJV.   On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced ERYTHEMA (Left shoulder redness near an older BCG vaccine scar). On 17-May-2021, the patient experienced PRURITUS (Left shoulder kind of itchy near an older BCG vaccine scar) and ERYTHEMA (Left shoulder looks like she got a mosquito bite). At the time of the report, ERYTHEMA (Left shoulder redness near an older BCG vaccine scar), PRURITUS (Left shoulder kind of itchy near an older BCG vaccine scar) and ERYTHEMA (Left shoulder looks like she got a mosquito bite) outcome was unknown.            No concomitant products were reported. No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 at 13:00 as dose 1, single (Lot number: ER8734), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 25Jun2022 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 12Jan2023. No follow-up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient admitted for another diagnosis and found to have COVID-19 infection two days after vaccination. Vital signs on admission stable except blood pressure slightly elevated. Patient reported shortness of breath with exertion, dry cough, and mild dyspnea at rest. Received cough suppressants and supportive care. Patient discharged medically stable two days later.
Initial and follow up information has been received from a physician concerning a 15 year old female patient with a seizure disorder of petit mal convulsions, who was vaccinated on 23-JUL-2007, with her first dose of Gardasil (lot# 655620/0171U).  Concomitant therapy included LAMICTAL.  On 04-SEP-2007, at 10:10 am, the patient experienced flu-like symptoms and myalgia.  The patient sought medical treatment, and a lumbar puncture was performed (results not specified).  Treatment included MOTRIN, 800mg, STAT, diazepam and LORTAB.  On 18-OCT-2007, the events resolved.  Physician decided to discontinue the series with Gardasil.  The physician considered the events serious as persistent/significant disability or incapacity.  Additional information is not expected.  Additional information has been requested.
Patient presented to our ED on 3/30/21 @ 1149 with complaints of SOB and chest pain. D-Dimer was elevated > 3 times upper normal limit so CTA was performed. CTA showed bilateral lower lobe PE with moderate thrombus burden. Patient was given Lovenox 1mg/kg (90 mg) x 1, pain medication, and home medications he had not yet taken at home on 3/30. He was then transferred to a higher level of care. Course at transfer hospital unknown at this time.
3 asthma attacks evening of 1st injection which is very abnormal. 2 days later i started menstruating and it was a week early. I have not stopped bleeding as of yet so it has been 10 days. My normal menstruation is 5 days. I am 44 but have not had any symptoms of menopause until this. I read over the weekend several women had reported issues so I decided to report as well. Not finding much information on expectation of stopping. Waiting to get in with my OBGYN.
Possible pustular skin reaction over lower extremities. Patient reported this started after GARDASIL injection. No other new medications or changes. Seen by Dr. in office today. Rash/bumps noted in various stages of healing. Patient reported they were "bumps with white stuff coming out of them". No pain or itching. Darkened skin changes noted. 6/11/2019: Follow up received: Specific reaction date and time are not available. Patient presented to office on 4/4/19 for 2nd GARDASIL injection and reported "blistered" bumps that started "after 1st GARDASIL". Patient saw physician for office visit and assessment on 4/16/19 (declined visit on 4/4/19) and bumps were noted "in varying degrees of healing" per MD.
Arthralgia, Fever Diarrhea, CHILLS; FATIGUE Narrative:
Left arm erythema/swelling at 24 hours after administration w/development of rash (macular: blanchable) on left arm, back, and knees. Improvement noted at 72 hours.
PATIENT PRESENTED ON 07/13/2017 AND SAID THE SITE WAS RED AND SORE AND FELT A LITTLE  HOT BUT WAS GETTING BETTER. LOOKED AT AREA AND TOLD THE PATIENT TO APPLY ICE PACK FOR 15 MINUTES AND TAKE SOME IBUPROFEN AND TO CALL PHARMACY IF STARTED TO GET WORSE.
Vaccine administration site was left deltoid.  Patient states that later that day she experienced pain radiating up left side of neck and to left TMJ. Also felt that her hearing in her left ear was temporarily muffled.  These symptoms resolved completely by the time she returned to the Employee Health clinic on 10/21/16. Now states the only lingering effect is some pain under left shoulder blade.
Caller is a consumer. Caller stated that she experience a severe reaction from the PNEUMOVAX 23 vaccine. Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the v; stated that she experienced a metallic taste in her mouth; severe chest pain; thinking in short sentences,; general discomfort; nausea; light headedness/dizziness; high heart rate; Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the vaccine for the second time on 5/25/2022; Caller stated that she received this vaccine for the first time in April of 2020 and didn't experience any symptoms. However, she received the vaccine for the second time on 5/25/2022; This spontaneous report was received from the consumer and refers to a 68-year-old female patient.  The patient's concurrent conditions included drug hypersensitivity to penicillin. The patient's medical history was not reported. Concomitant medications included diphenhydramine hydrochloride (BENADRYL).   On an unknown date in April 2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On 25-MAY-2022 the patient received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly into the left upper arm as pneumococcal disease prevention, NDC number: 00006-4837-03 (dose, lot number and expiry date were not provided) (extra dose administered) (inappropriate schedule of administration).  On 25-MAY-2022, the patient experienced severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea, light headedness, dizziness and high heart rate.  The outcome of the events of severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea and high heart rate was resolved on an unknown date in 2022. At the time of reporting, the patient had not recovered from the event of light headedness/dizziness.   The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not applicable.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events of severe reaction, metallic taste in her mouth, severe chest pain, thinking in short sentences, general discomfort, nausea, light headedness, dizziness and high heart rate was considered to be related.