chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe hives; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient who experienced severe hives (urticaria), while she received vaccine INFLUENZA VACCINE..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing corn allergies.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious severe hives (urticaria) (Unknown latency) following the administration of INFLUENZA VACCINE. It was reported that, The reaction drives her crazy and therefore she did not receive another flu shot.  No lab data was reported.  Final diagnosis was urticarial.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for urticarial.  Information on the batch number was requested.
Every night is a low grade fever AND Massive Hives on thighs, arms, hips, back.  Go away overnight, come back at night.  Now been 15 day.  Took photos.  Chest/neck area are breakout itchy hives, now scabs.  Tookk photos. Minor sore throat has ended.
Hot spot at injection site. Infrared thermometer measured the spot as 100.4?F
12 days after second shot, Fever 100F, 13 days after second shot, Fever 99.9; Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the arm left on 06Apr2021 at 12:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207) via an unspecified route of administration in the arm left on 16Mar2021 at 12:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 14:30, 10 days after second shot, the patient experienced moderate fatigue. On17Apr2021, 11 days after second shot, the patient had moderate fatigue. On18Apr2021, 12 days after second shot, the patient experienced  fever of 100 F, fatigue moderate and body aches. On 19Apr2021,13 days after second shot, the patient had fever of 99.9 and fatigue moderate. It was reported that all the symptoms were resolved with Tylenol and rest. On 18Apr2021, the patient underwent lab tests and procedures which included body temperature test and the result was 100 F and on 19Apr2021, the result was 99.9 (unspecified unit).Therapeutic measures included treatment with Tylenol. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, fever 100F, 99.9 and body aches was resolved on an unknown date of Apr2021.    No follow-up attempts are needed. No further information is expected.
Subject BIT010024, a 58 year old female with a medical history of allergy to sulfa drugs, received the 5th dose of Anthrax vaccine (lot FAV048B) on 02/08/2001. No other vaccines were given on this date. Concomitant medications at the time of the event included Estrogen, Provers, and dailty multiple vitamins. The pt did not have an illness at the time of vaccination and has no history of reactions to previous vaccinations. Two days post vaccination, the pt experienced a red, swollen, hot to touch area on the upper arm, five and one half to six inches in diameter. The redness continued for six days. Dizziness occurred on the third and fourth day post immunization. Ringing in he ears occurred on the third and fourth day, which was the most severe. While the ringing continued as of 02/22/2001, it is improving. The pt also experienced headaches that were treated with Tylenol from 02/11/2001 to 02/17/2001. While mild headaches continued as of 02/22/2001, the pt had discontinued the use of Tylenol to treat them. The pt noted increased sinus secretions associated with the headaches. Additional info received on 03/08/2001 indicated the headaches resolved b 03/02/2001. The outcome of the other events is unknown.
Lethargic; Fever 102.7 degrees Fahrenheit; Tired after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PYREXIA (Fever 102.7 degrees Fahrenheit) and FATIGUE (Tired after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hemochromatosis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced LETHARGY (Lethargic), PYREXIA (Fever 102.7 degrees Fahrenheit) and FATIGUE (Tired after 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 02-Apr-2021, LETHARGY (Lethargic), PYREXIA (Fever 102.7 degrees Fahrenheit) and FATIGUE (Tired after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102.7 (High) 102.7 degrees Fahrenheit.         Relevant concomitant medications included unspecified medications for blood pressure and Hemochromatosis.   This case was linked to MOD-2021-218679 (Patient Link).
had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, SPIRONOLACTONE, ACETYLSALICYLIC ACID (ASPIRIN ACTIV), CARVEDILOL, LISINOPRIL, MIRTAZAPINE, ATORVASTATIN and OMEPRAZOLE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced HAEMORRHAGIC STROKE (had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Mar-2021 to 05-Apr-2021 due to HAEMORRHAGIC STROKE. The patient was treated with Rehabilitation therapy (had to learn to talk and work with his hands again, He couldn't eat or swallow food and had to re-le) for Haemorrhagic stroke. At the time of the report, HAEMORRHAGIC STROKE (had a stroke, haemorrhagic stroke/ bleeding at the brain, bleeding at the brain, had to learn to talk again, couldn't eat or swallow food and still has trouble with his right hand) had resolved with sequelae.            patient experienced hemorrhagic stroke, with bleeding in the brain. Patient was hospitalized and  put on a ventilator for 2-3 days to make blood pressure down to stop the bleeding. Patient was in rehab at the hospital for 20 days and was discharged around 5APR2021.  Patient has doing better now but still had trouble talking and right hand still has some trouble doing things.   The treatment history was not reported. Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.
Very Strong shoulder pain.  Nothing alleviated it.  Lasted for about 1 week although pain lessened after about 4 days.
Rash developed on back of hands two days after injection and has lasted for three days (still present at time of this report). The rash is comprised of small reddish blisters/bumps that became itchy on the second day.  On the worst day (Saturday), both hands had a tingling sensation. The rash is more pronounced on the left hand (injection was on left arm), as was the tingling (which has since stopped). The rash seems to be responding to an antihistamine.  I will visit the dermatologist if it does not clear up by next week.
Patient was given an expired dose of moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose of moderna vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia and Hypertension.    On 23-Mar-2022 at 1:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2022 at 1:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose of moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose of moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  The patient had not experienced an adverse event to the knowledge of clinical staff. Patient did not received any other vaccine. No known drug allergy was reported. The vial did not undergone any temperature excursion issue.  No treatment medication reported by reporter.   This case was linked to MOD-2022-543908 (Patient Link).
The pt was given vaccines on 9/8/01. Approx. 4-6 hours, post vax, the infant had an episode of atonia and eye deviation, lasting about 1 minute, after which she was lethargic for about 15 minutes. The mother checked temperature at that time and pt was not febrile. Exam, shortly after in the hospital ER was normal.
Information has been received from a physician concerning a 54 year old female consumer with diabetes and rheumatoid arthritis who on 07-FEB-2008 was vaccinated IM with 0.65 mL  of zoster vaccine live (Oka/Merck). On 10-APR-2008, the patient was seen in the physician's office with a rash on T3 dermatome. It was unspecified if lab studies were performed. The patient was diagnosed with shingles. The patient was treated with VALTREX 1000 mg three times a day for 10 days. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the physician indicated that the patient also had neuritis. At the time the report the patient had not recovered. Additional information has been requested.
This spontaneous report as received from a 59 year old male consumer with type II diabetes and high blood pressure who refers to himself. Then patient had none drug reactions/allergies. On 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, strength, site, lot #, route of administration not reported). Concomitant therapies included QNASL (80 mg). On 25-JUL-2013 the patient experienced wheezing, sore throat and coughing. Consumer did not seek any medical attention. No treatment was given for adverse event and no lab test performed. The outcome of wheezing, sore throat and coughing was reported as not recovered/not resolved. The relatedness between PNEUMOVAX23 and adverse events was not reported. Additional information is not expected.
Pt received flu vaccine at her employer and within 20-30 minutes felt lightheaded and fainted hitting her head on the floor. When pharmacist arrived she was conscious, alert, aware. BP was normal, no sign of allergic reaction. 911 had been called and arrived.
Full body hives beginning about 36 hours after vaccination. Angioedema in the hands, feet, and lips beginning about 48 hours after vaccination. Hives did not improve with Benadryl so doctor prescribed prednisone. No severe reaction such as anaphylaxis, but reaction was moderate enough to make daily life difficult.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/21/2021 and 02/18/2021. They presented to emergency department on 01/11/2022 with a primary concern of shortness of breath. They tested positive for COVID-19 via PCR test on 01/11/2022 and died on 01/11/2022.
No symptoms or additional adverse effects reported; unspecified dose in ROTATEQ immunization series inadvertently administered past its expiry; This spontaneous report was received from a medical assistant referring to a 8 weeks old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.     On 09-JUN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) inadvertently past its expiry (lot # R034104, expiration date 08-JUN-2020; strength, dose, route of administration not reported) for prophylaxis ( expired product administered).
About 24 hours after receiving the first dose of the the vaccine, patient experienced decreased fetal movement and severe uterine cramping with no bleeding that lasted approximately 10 hours.  This is the patients first pregnancy, with zero complications prior to receiving the vaccine.  At the time of the vaccine the patient was 21w2d with and estimated date of delivery as 02/14/2022.  Patient was instructed to rest and stay hydrated. If fetal movement was not detected that night or following morning, patient was instructed to call the clinic for a visit with the Nurse Practitioner.
It was after my 2nd shot which I had in june.  I got to feelibg light headed and dizzy......off in September after cardio. Went to the ER.l and was told my potassium was extremely low. Was given fluids and reported to my primary doctor. Was placed on potassium tablets 2 a day but not quite there. I get tired easily and short of breath. Chest feels funny at times.
Hospital Course and Significant Findings: 73-year-old woman, presenting with subjective fevers and confusion (symptoms that were attributed to COVID). Patient has history of bipolar disorder, diabetes, CKD, hypothyroidism, hypertension, patient also presented with cough but no shortness of breath.   Patient was treated with IV remdesivir, her mental status quickly improved and she is now back to her baseline, she is not confused and is alert and oriented x3.  She does not have COVID symptoms at the present time, denies cough, shortness of breath, chest pain, fever, chills, nausea, vomiting.
After patient got the Janssen vaccine, patient was told to sit and wait for 15 minutes. While waiting patient was walking around and felt fine. After about 10 minutes, patient said she felt dizzy and fell. She got back up right away. She looked pale. Told her to sit down and gave her water and power bar. Patient didn't eat anything beforehand. After sitting and drinking water patient felt better. Out of precaution we called 911 and when EMT came to check her vital signs. Her blood sugar and blood pressure were low. She also said she was feeling dizzy again. EMT took her to hospital for further monitoring.
Anticipated/expected Muscle soreness for two days after injection. One week after injection I started to experience intermittent Nerve pain, weakness, numbness in the shoulder joint. I kept thinking it would improve, it has not. The pain has increased over the past two weeks and is now limiting ADL and job performance because of restricted movements and strength in left arm.
A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a seven-year-old female. The product expired on 12-Dec-2010. On 12/13/2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 14-Feb-2011: Reporter confirmed that there was no late occurrence of adverse events.
Patient was seen in office and dx'd with Varicella. Rec'd vaccine 1/4/10.
sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Immunocompromised. Concomitant products included METHOTREXATE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not reported. Patient received his flu shot at the same time he received his 3rd dose of Moderna vaccine.   This case was linked to MOD-2021-339391, MOD-2021-339390 (Patient Link).
Patient received Tdap, HPV and Meningococcal immunizations - 15 minutes after, had erythema, edema (periorbital) & conjunctival infection. Fading & resolving within 10 minutes and resolved after 30 minutes.
Patient reports 104 degree fever night of vaccine. Patient presents to the office on 7/20/2018 with redness, warmth, and swelling at site of 5 cm x 10 cm. Patient complains of pain under arm and in armpit.
4/3 started experiencing tingling and numbness on left side of body leg and arm initially it was intermittent but has progressed to daily occurring.  On  4/6 called doctor and advised them of my symptoms and the doctor ordered full blood work up. On 4/9 called and scheduled video app to speak to my regular PCP she stated that if blood work came back normal and symptoms persisted then would refer to neurologist. 4/13 experienced ocular issues along with continued tingling and numbness called doctor and they told me to go to ER. ER doctor thought I was having a migraine.  4/21 started experiencing pressure in my chest. 4/29 had video call with neurologist who requested that I get an MRI.  Both PCP and Neurologist stated that I should still get 2nd dose of vaccine which I did on 5/6/21  next day started to experience waves of pressure and feeling like I was going to pass out. This occurred intermittently and then on 5/17 it last several hours along with hands and feet being very cold to the touch and throbbing in my left calf I went to the ER by the time I was seen in the ER the feeling of passing out had subsided.
Rash and progressive abdominal discomfort...subsequent visit to my office where diagnosed with Henoch-Schonlein Purpura (HSP) on 1/14/2010.
Began getting sore throat, runny nose, and by later that night had a fever which spiked to 103.5 on 12/5. Had body aches, headache, fever, dizziness, sore throat, runny nose until 12/6. Improved on 12/06, and much better on 12/07.
Supraclavicular lymph nodes swollen. 10 days later is still swollen.
immunizing pharmacist reported that patient's vein "spasmed" when she inserted the needle, after which the patient experienced an acute syncopal episode with a clammy-like skin and visual "clouds" prodrome.  This pharmacist (reporter) came to check on immunizing pharmacist and patient after returning from break and was informed of this siutation. Patient was monitored for 10-15 mins and noted that he has a slight sore throat. No difficulty breathing but continued to have sensation of passing out again. Patient did not loose conscious again and did report a history of similar events when younger and a fear of needles. Out of precaution, this pharmacist reported the event to the hospital emergency response team that responded with EMS to escort patient to the emergency room for further evaluation given throat complaint. The patient reported improvement back to baseline before leaving pharmacy and never received a dose of epinephrine.
And got a large bruise (at the COVID-19 Vaccine injection site); This is a spontaneous report from a contactable nurse. An 80-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: ELV0158), dose 1 in the left arm on 13Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 80-year-old). The patient medical included she had COPD, Sinusitis, Bronchial infection and Doxycycline. The patient said she was a bad smoker. The patient reported that she got her first Shingles Vaccine in 2017. XARELTO was reported as concomitant medication. The patient reported that a couple years ago her Xarelto dose was upped from 15mg to 20mg. The patient had not visited emergency room or physician office due to the event and patient had not received any other vaccinations within 4 weeks. On 13-APR-2021 the patient got a large bruise (at the COVID-19 Vaccine injection site). She had her first COVID-19 shot on Tuesday (13Apr2021) and got a large bruise at the COVID-19 Vaccine injection site. She said she never had a bruise from a vaccination before. She said the bruise was over 2" in diameter, and there was no redness, or swelling. She said the bruising didn't hurt, and she did not even have to take Tylenol.  She said her left arm did not hurt. She said the COVID-19 Vaccine injection site bruising was dissipating now. She said she just had a large bruise on her left arm. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Patient experienced  measles-like, pruritic rash on head, chest, and back with fever (TMAX 100.5F) lasting for several days, this started 9 days following vaccination.  Other symptoms included coryza, difficulty sleeping, fussiness.  Pt had phone consult during COVID19 with provider.  At that time we took a watch and wait approach with conservative, comfort management: hydration, rest, antipyretics prn.  Pt used oatmeal baths, castor oil, and essential oils to help soothe rash.  Pt made full recovery with in a week.  Duration of symptoms was about 5-7 days from onset to resolution.