chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient had a "really strong" seizure [...] the patient had another seizure when the ambulance was on the way and a third seizure when the ambulance finally arrived; his arm hurt at the injection site of the vaccine; developed a fever; he could not sleep during the night after receiving the vaccine; This spontaneous report was received from a patient's mother, referring to a 12-year-old male patient. The patient's medical history, concomitant medications, concurrent conditions, historical drugs and drug allergies were not reported.  On 09-APR-2021, the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARASIL 9) (dose, route and site of administration, lot number and expiration date were not reported) for prophylaxis. On 14-MAY-2021, the patient received his second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot# 1659422, expiration date not reported but upon internal validation established as 04-SEP-2022 (dose, route and site of administration were not reported) for prophylaxis.  On 14-MAY-2021, after administration of the second dose, the patient's arm was hurting at the injection site of the vaccine and he developed a fever. It was also reported that he could not sleep during the night after receiving the vaccine (insomnia) and the fever did not go down. On 15-MAY-2021, the patient experienced a "really strong" seizure. He had another seizure when the ambulance was on the way and a third one when the ambulance arrived. The patient was taken to the emergency room but was not admitted to the hospital. On an unknown date, the patient recovered from the events.  The relatedness between the events and the suspect vaccine was not reported.  Upon internal review, the event of seizures was determined to be medically significant.
seizures; stroke; kidney failure; diabetes onset when never had prior; Altered mental status; This is a spontaneous report from a contactable other HCP. A 66-year-old male patient received an unknown dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included high blood pressure. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was unknown. The patient didn't received other vaccine in four weeks. Concomitant medication include regular prescriptions of high blood pressure medication and water pills. On 15Jul2021, the patient experienced altered mental status, seizures, stroke, kidney failure and diabetes onset when never had prior. The events caused in hospitalization 7 days. Treatment was received . The outcome of events was not recovered.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition(hypertension) which is not related to the suspected drug. The case will be reassessed if additional information becomes available.
Pt states her arm is red and swollen and she feels nodules under the skin she rubs her arm.
1130AM - HAD 2 SHOTS GIVEN AT MD OFFICE. 4PM - COMPLAINED LEG HURT AND COULD NOT WALK FOR THE REST OF THE EVENING WITHOUT EXTREME PAIN. 130AM - WOKE UP WITH FEVER OF 104.2.  LEG STILL HURT TO MUCH TO WALK. 7AM - WOKE UP STILL WITH FEVER OF 104 AND STILL COULD NOT WALK BECAUSE OF THE PAIN IN INJECTION LEG. 10AM - STARTED VOMITING, FEVER NOW AT 103.
Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still there at 5 days after vaccination.
anaphylaxis; This is a spontaneous report received from a contactable nurse. A 66-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), 1st dose via intramuscular route of administration, on 02Apr2021 09:30 AM (at the age of 66-years-old) as single dose for COVID-19 immunisation. Patient's medical history included asthma, GERD. Concomitant medications were not reported. The patient previously took keflex, peanut, fentanyl, pcn ms and experienced known allergies. On 02Apr2021 09:30 AM, the patient experienced anaphylaxix chest/throat tightness, which resulted in emergency room visit. Treatment received for the adverse events included epi, albuterol, and Benadryl. It was unknown that the patient was diagnosed with COVID-19, prior to vaccination and whether the patient had been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylaxis and the suspect drug BNT162B2.
Shot made my arm feel very heavy and was sore for several days.  Within 24 hours, I experienced flu-like symptoms--Body aches, fever, headache, fatigue. The fever and body aches are mostly at night; I feel better though tired during the day. (Also, coughing at night but that may just be coincidental rather than causal. ) I took Tylenol as needed to reduce aches and fever which helps temporarily but after 2 nights, I'm still not completely well.  I also use Flovent inhaler and saline nasal spray for coughing as needed.
WITHIN HOURS THE AREA BECAME PUFFY,RED, AND ITCHY.FEVERISH TO THE TOUCH. PATIENT WAS STARTED ON OMNICEF 300MG 1-BID FOR 7 DAYS AND GIVEN CLARINEX SUSP. 2 TSP BID FOR ITCHING.
Exactly 3 weeks after my son's first Covid Vaccine he had his first ever Febrile Seizure at 3:25 am on Thursday, July 28th 2022. I thought he felt warm around midnight when I was rocking him in the glider but when I took his temperature the head thermometer gave me different readings ranging from normal 98.6 degrees to 99 - 100 degrees Fahrenheit. I did not give him any fever reducing medications. At 3:25 am when he was sleeping with me in my bed I woke up to him having a full body convulsion, fists clenched and eyes rolling around. I called his name and he did not respond therefore I immediately called 911. The seizure lasted about 20 seconds (from the time I woke up and saw him). After the convulsions stopped he immediately regained conscience and started calling out to me "mama, mama" he seemed tired and would open and close his eyes. When the paramedics arrived about 10 minutes later (I stayed on the phone with the 911 operator until they arrived) they undressed him and got a reading of 100.7 degrees Fahrenheit. The ambulance took him to hospital.
Information has been received on 10-MAY-2017 from a licensed practical nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 10-MAY-2017 the patient inadvertently received an expired dose of M-M-R II lot # M032153 expiration 22-APR-2017 subcutaneous for prophylaxis. Concomitant therapies included reconstituted with sterile diluent (STERILE DILUENT) lot # M022416 expiration 17-DEC-2018. No adverse effects reported. No further information available. Additional information has been requested.
Weakness, muscle pain, severe nausea, shivering, fever, headache, loss of hearing in right ear for several hours. Laid on the bathroom floor and waited it out..... Symptoms subsided about 12:00 a.m. 3/21/22.
This spontaneous report was received from a nurse and refers to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 31-JUL-2017, the patient was vaccinated with a first dose of improperly stored GARDASIL 9 lot # N001533, expiry date: 16-OCT-2019, intramuscularly in left deltoid for prophylaxis. Concomitant therapies included VARIVAX. The dose of GARDASIL 9 was stored at a temperature between 47 degree Fahrenheit to 77 degree Fahrenheit for 10 minutes. No adverse effects were reported. The call was because of a data logger. No product quality complaint was involved. This is one of two reports form the same reporter. Sender's Comments: US-009507513-1708USA000698.
mild headache towards back of head on the right side; ringing in both ears; mild body ache; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in both ears), PAIN (mild body ache), FATIGUE (fatigue) and HEADACHE (mild headache towards back of head on the right side) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to Ampicillin) and Allergy to chemicals (Allergic to sulphur). Concomitant products included VITAMIN B COMPLEX (VIT B COMPLEX), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MAGNESIUM CITRATE, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) for Routine health maintenance.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (mild body ache) and FATIGUE (fatigue). On 03-Mar-2021, the patient experienced HEADACHE (mild headache towards back of head on the right side). In March 2021, the patient experienced TINNITUS (ringing in both ears). The patient was treated with IBUPROFEN for Headache, at a dose of 2 tablets once a day, 2 times a week. On 16-Feb-2021, PAIN (mild body ache) and FATIGUE (fatigue) had resolved. At the time of the report, TINNITUS (ringing in both ears) had not resolved and HEADACHE (mild headache towards back of head on the right side) had resolved.            Physician recommend patient to take breaks from computer screen, doing shoulder exercises and getting nightguard for headaches.  As per audiologist and ENT specialist, patient's ears are fine.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Updated medical history, concomitant medications, ethnicity, reporter causality and event outcome.
accidentally received a dose of Kinrix instead of Pediarix; inappropriate age at vaccine administered; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 69N2M, expiry date 14-APR-2024) for prophylaxis.   On 06-JUL-2023, the patient received Kinrix. On 06-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: accidentally received a dose of Kinrix instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administered). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 6 July 2023: A physician called in to reported that a patient accidentally received a dose of Kinrix instead of Pediarix and wished to know if there was any information available. Information about the patient, vaccines and event given. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The 5 month patient accidentally received a dose of Kinrix instead of Pediarix which led to wrong vaccine administered and inappropriate age at vaccine administration.
My son was given the FLUZONE flu shot on 12-7-10. Two or three days later he started having flu symptoms, temperature shot up to 103. A week after the flu shot he had a febrile seizure. Happened again after his second dose.
No symptoms until 9 p.m.-chills and a sensation of internal shaking at intervals of every other second; could not get warm; unable to relax or sleep; aches in joints; headache; weakness; slept after taking Tylenol about 1 a.m.  In morning at 6.a.m. temp was 101 degrees with continuing weakness, joint aches, headache; and a sensation of nausea (which did not happen); no chills that morning; Tylenol was effective for fever; extremely fatigued,achey, and thirsty all day and evening.  Symptoms were gone by 9 p.m. on 9/13/2008. Time of vaccination was at 3:45 p.m. on Friday, Sept. 12, 2008
Mom reports raised red area/rash and spreading on Saturday AM, Zyrtec taken.  Sunday no rash noted, Monday 10/13/14 noted area slight reddness and raised rash, c/o of itchiness, but decreased throughout the day.
Immunizations given on 9/19/08. Onset on 9/21/08 with rt deltoid region red swollen and hot to touch.  9/22/08 Water blister formed on rt deltoid region.  Pt was seen at Health Department on 9/22/08 with 20mmx20mm water blister 1 inch below Im injection site.
Diarrhea, refusing solids and only wanting to nurse, fussy, fever started around 7pm lasting until 4am. Highest temp was at 2am 102 taken by armpit. 9 bm diapers in 12hrs. Nursed almost constantly. Baby finally slept 6am to 840am. Baby warm 11/24 but much better. Instable walking and fussy. Refusing solids and nursing every 45mins for about 10mins. 5 bm diapers during the day. Refusing to nap...up 14hrs before sleeping finally and only being held. Restless all night with frequent crying and nursing. 11/25 still unstable walking, fevers gone but mild rash on trunk. Still not eating much solids. 3 bms cranky and wanting to be held a lot. 11/26. Cries while standing still. Refusing to walk or crying until picked up. Still few solids. 2 bms rash on neck, trunk and limbs. Cheeks flushed.
hives; trouble breathing; throat swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling). At the time of the report, URTICARIA (hives), DYSPNOEA (trouble breathing) and PHARYNGEAL SWELLING (throat swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
itching/burning around eyes (2 days p/vax);rash on back & both forearms (4 days p/vax);paresth4sia in lower extremities & hands (7wk p/vax);soreness/pain around inj site;joint pain discomfort (8wk p/vax);infectious disease;
Arthus type reaction. Pain, redness and swelling at injection site that lasted for 5 days after time of injection.
muscle aches; fever; headache; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, fever, headache and feeling unwell. On an unknown date, the outcome of the muscle pain, fever, headache and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fever, headache and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The caller was a consumer. The age at vaccination was not reported. The caller stated that the patient who was his personal trainer received the 1st dose of Shingrix.  After receiving the vaccine, the patient experienced muscle aches, fever, headache and did not feel well. The caller did not had time to provide any additional details regarding the patient or this event during the call. He had to get off of the phone and get to work. There is discrepancy in the reported event outcome in system and in narrative. However it is captured as per system.
By the end of the day after I received the vaccine I felt exhausted and extreme fatigue similar to the extreme fatigue I experienced when I contracted Covid. Since the vaccination I experience constant fatigue and brain fog.
No patient side effects; HCP calling to report AE for MMRII and VARIVAX. MMRII was stored within recommended range. VARIVAX was improperly stored and experienced a supported temperature excursion. No patient side effects reported. HCP consent to contact obtained. No Addition; This spontaneous report was received from a medical assistant and to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-JUL-2023, the patient was vaccinated with a dose  of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W016747, expiration date reported as 23-MAY-2024,  but upon internal review  stablished as 23-APR-2024) (dose, route of administration, anatomical location not provided) as prophylaxis, that was improperly stored and experienced a supported temperature excursion (product storage error) at 12.43 Fahrenheit (F) for 11 hours and 30 minutes, and at 18.43 F for 2 hours and 20 minutes, which was recorded by data logger. No side effects were reported for the patient. Additionally, it was also mentioned the vaccine measles, mumps, rubella virus vaccine live (M-M-R II) with lot # U039548, expiration date: 14-DEC-2023) but it was stated that it was stored within the recommended range.
Shortness of breath; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
A few days after the vaccination on 1/5  I starting having chills, severe body aches which eventually a fever arose and I developed a cough.  I felt a little foggy in the head so I  asked my facility to perform a COVID test on me on 1/5 and on 1/7 was diagnosed with COVID .
Blurred and distorted vision that has progressed; Blurred and distorted vision that has progressed; Full bloom pain and spasms in left arm in muscle; Arm pain in muscle; This case was received via  Medicines Agency (Reference number: US-irms-MOD21-124942) on 30-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Blurred and distorted vision that has progressed), VISION BLURRED (Blurred and distorted vision that has progressed), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle) and MYALGIA (Arm pain in muscle) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A2A1 and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced METAMORPHOPSIA (Blurred and distorted vision that has progressed), VISION BLURRED (Blurred and distorted vision that has progressed), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle) and MYALGIA (Arm pain in muscle). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, METAMORPHOPSIA (Blurred and distorted vision that has progressed), VISION BLURRED (Blurred and distorted vision that has progressed), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle) and MYALGIA (Arm pain in muscle) had not resolved.            Patient reported that between the 1st and 2nd dose she started having distorted and blurred vision that has now progressed and states that she does not wear glasses. She had pain in both arms in the muscle of which right arm has gotten better but her left arm is still in pain. No concomitant medications were mentioned.  Treatment medications included using ointments   This case was linked to MOD-2021-271794 (Patient Link).
Patient received vaccine on Tuesday evening. She began seeing rash on her leg that she attributes to this vaccine on Friday night. Rash is currently improving as of this morning. No longer itchy.
After receiving my flu shot 5 hours I became symptomatic. Cough, sore throat, body chills, muscle aches, pains, eyes swelled and leaked puss, fever 101.
Bad headache, arm pain, fever, nauseous, vomiting, diarrhea, extreme fatigue, dizziness, period came 6 days early
Swelling at site of injection. Redness, Skin is hard. Skin is hot. Fever, nausea and pain at site of injection. These symptoms occurred within 24 hours and today is day three after the injections. Symptoms remain. I did contact the doctor on the day after injections to let him know about the reactions. He said next year they will give them in separate sites as these were given in the same site. And perhaps on different days.
Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesday the 9th I noticed drooping to the right side of my face. Went to the ER and was told it was bells palsy
From initial information received on 8/30/04 from the patient regarding an adverse event occurring in the USA, it was reported that the 38 year old female received a booster dose of TD ADS ADULT, lot number U1186AA, administered in the left deltoid on 7/22/04. Several days post-vaccination (exact date not reported), the patient experienced an unusual burning sensation in her body. Her recovery status was not reported. From additional information received on 11/1/04 from a health care professional, it was reported that the route of administration for the TD ADS ADULT product was not documented and the nurse administered the vaccine is no longer employed at the facility due to retirement. The adverse event onset date was reported as 7/24/04 at 11:10 AM. The patient required an emergency room or doctor's visit due to the symptoms. It was not reported whether the patient recovered from this event.
Fever, full body aches, dizziness, sore throat, large amount of mucus that made me gag, excessive deep nonstop coughing, nausea, chills started about  24 hours after injection and lasted for about 24 hours. Then 24 hours later after these symptoms stopped I had a rash circling my neck that spread to my upper chest throughout the day. By evening there was still a full rash but also a small lump on my throat. Some itching, but no pain.
We were notified 02/02/2021 of patient's death. Unknown cause at this time.
Dose given to patient from vial kept in refrigerator 35 days after taken from ultra cold storage