chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's arm began hurting and swelling Friday evening (1/29/10). Due to continued pain and swelling, patient went to urgent care on Saturday but was referred to ER. Seen Sunday morning, admin'd IV antibiotics and morphine then discharged on BACTRIM DS, KEFLEX, ibuprofen and PERCOCET (generics) for cellulitis. ER doctor thought immunizer stuck vein/artery or perhaps did not swab site satisfactorily or just unknown reason.
Still to this day severe pain in my right arm. Can not stretch up and also use my right arm to carry anything heavy.
Deep Vein Thrombosis- occlusive and non-occlusive in R axial and R brachial veins at level of PICC line. Pt admitted to hospital on 4/18/21 with acute basal ganglia hemorrhagic CVA, with PICC line placement on admission. DVTs identified on 4/21 via ultrasound.   Pt currently admitted to Hospital
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 03-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated).    Concomitant Medication use information was not provided by reporter. Patient did not receive second dose. Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master Case
red bumps on right side of forehead.  No itching.  No other adverse effects.
Patient stated she had a mild reaction 15 to 20 minutes after she received the vaccine that lasted a few hours. She complained of a thickness in the throat and flushing in the vaginal area.
24hrs after his vaccine got hives on his arms and legs, it lasted around 12hrs and resolved on its own.  Had some fatigue aferwords and some sensation of low grade fever those resolved within another 12hrs.  Denies any other symptoms or concerns.   He thinks he had covid in December. His friend dx with covid and they were together w/o masks and he got respiratory symptoms but did not get a confirmatory test.
chills, low grade fever, nausea, diarrhea, muscle aches,  soreness at injection site
DIZZINESS; DEBILITATING HEAD PRESSURE; STRUGGLES TO FALL ASLEEP; TERRIBLE THROBBING HEADACHE; BURNING IN LEGS VEINS; THROBBING IN LEGS VEINS; BRUISING IN LEGS; RADIATING PAIN THROUGH HIPS; INJECTION SITE BRUISING; INJECTION SITE KNOT; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) Did not find anything abnormal, and MRI (NR: not provided) Did not find anything abnormal. On 30-MAR-2021, the subject experienced injection site bruising. On 30-MAR-2021, the subject experienced injection site knot. On 04-APR-2021, the subject experienced radiating pain through hips. On 10-APR-2021, the subject experienced bruising in legs. On 12-APR-2021, the subject experienced burning in legs veins. On 12-APR-2021, the subject experienced throbbing in legs veins. On 26-APR-2021, the subject experienced dizziness. On 26-APR-2021, the subject experienced debilitating head pressure. On 26-APR-2021, the subject experienced struggles to fall asleep. On 26-APR-2021, the subject experienced terrible throbbing headache. Treatment medications (dates unspecified) included: pseudoephedrine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 13-APR-2021, injection site knot on 31-MAR-2021, bruising in legs on 11-APR-2021, burning in legs veins, and throbbing in legs veins on 19-APR-2021, and radiating pain through hips on 08-APR-2021, was recovering from terrible throbbing headache, and had not recovered from dizziness, debilitating head pressure, and struggles to fall asleep. This report was non-serious.
The nurse from dr requested a copy of the VAR. They have sent a sample from the injection off to be tested for cancer.
Inner arm very inflamed, swollen and red. The area was approximately 12 inch long and 3-4 inches wide.
The morning after (8 April) the vaccine I had sever muscle aches that started from the arms, shoulders, back and legs. It seemed to be getting better but today (10 April) I felt dizzy and had symptoms of almost fainting. I did go running this morning, had breakfast, and then around 12:00, I had the dizzy spell.
Extremely weak, extremely tired, slight headache, nausea, chills, pain on the inside of my face, sore joints (shoulders, knees, ankles, feet and toes),  sore muscles, minor soreness on injection site, eye pain/soreness
From initial information received on 09Oct2003 from a physician regarding an adverse event occurring, it was reported that a 45 year old male pt received a dose of Tetanus Toxoid ADS USP, lot number U1044AA, given intra-muscularly in the left deltoid, a dose of MMR, manufacturer, lot number 021N, given in either the right leg or right arm (extremity not specified) and Tubersol 5 TU, lot number C1260AA, route and site not reported, on 21Jul03. Sometime after the vaccinations were given, the pt complained of pain with certain sudden movements of his left arm, briefly but recurrent. No episodes of swelling, redness or fever were reported after the vaccination. Reportedly, the events still persist and the pt has not recovered.
Had swelling, redness, small red dots at site. Still have muscle soreness ( 9th. day) at site.
Severe Achyness  Fever 100.2 Headache  Stomach ache
Syncope with head injury from fall, followed by loc and tonic seizure activity 1-2 minutes resolved with O2 and stimulation/Trendelenberg.
This case was reported in a literature article and described the occurrence of Kikuchi's disease in a 45-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Soon after vaccination with Influenza vaccine (unspecified), the subject noted repeated spikes in fever with chills. Approximately 6 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced fever, night sweats and poor oral intake. The subject was treated with ibuprofen, ACETAMINOPHEN and azithromycin. Two weeks later, the subject was hospitalised. Approximately 2 days prior to admission, the subject complained about swelling in the left axilla. A physical exam did not reveal any hepatosplenomegaly nor tenderness in the left axilla. CT scan of the chest with contrast revealed multiple enlarged lymph nodes (LN) measuring up to 3 cm, localized in the left axilla. She underwent excisional LN biopsy. The pathology report of the LN revealed lymphoid tissue with extensive geographic necrosis suggestive of Kikuchi's disease. She was discharged home and initially felt better after excisional biopsy, only to note recurrence of fevers and chills within a week. She was treated with low dose prednisone with dramatic improvement in symptoms and no recurrence.
Pt. taken to hospital via EMS. "Turning blue and stopped breathing" arrived @ 1206. Diagnosed at hospital : Febrile Seizures. Temp of 102. Discharged with 1/2 hrs in ER. Patient afebrile and taking fluids well.
Patient became dizzy and had a syncopal event at school on 9/18/18. This occured about 24 hours after receiving the meningococcal and Tdap vaccinations on 9/17/18 (I am not sure which brand name vaccinations these were). She was brought to the ER where she was hypotensive (88/42).  She received three 1 liter normal saline boluses and her hypotension resolved. She had associated headache and low grade fever of 100.4 F, so symptoms may have been related to an accompanying viral illness. She was admitted for observtion and sent home in less than 24 hours.
lightheadedness immediately after injection, 6:30pm 02/02/21 periods of dizziness 02/04/21 til present severe vertigo on laying down 02/06/21 - no repeat since site of injection still red 10 days later, but not still sore. Soreness dissipated by the 2nd or 3rd day dizziness and vertigo could possible be a result of a physical activity, but because of the lightheadedness at the time of the vaccine, I thought I should report as possible vaccine adverse event.
I had a 2nd dose on 3/23. On 4/9, I had irregular rhythm associated with atrial fibrillation. This lasted until I was cardioverted on 4/23. I had a change in rhythm again after that and I had to be cardioverted a second time. On 6/8, in the evening, I palpated an irregular pulse associated with atrial fibrillation. This continued until I was cardioverted in the afternoon of 6/14. Since then I have not experienced an irregular pulse. I am scheduled a follow up on 8/5 with my cardiologist. I have had 2 ablations in the hopes they would give a cure, but they have not.
The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022; Patient received expired Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 012A21A and 027B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Number of doses or vials includes 4 doses.  On 29-Mar, the patient received vaccine (unspecified) (unknown route), batch number was reported as 016B21A (expiration date was 13-Sep-2021). The patient received vaccine in right arm.  On 21-Jul-2022, the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
Low fever, fatigue, headache, chills, imbalance, and weakness  that lasted from early A.M. 3/9/21 to P.M. 3/10/21.
COLD; SHAKY; PAIN IN HIS RIGHT SIDE; DISORIENTED; CHILLS; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced cold. On 04-APR-2021, the subject experienced shaky. On 04-APR-2021, the subject experienced pain in his right side. On 04-APR-2021, the subject experienced disoriented. On 04-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cold, shaky, pain in his right side, and disoriented. This report was non-serious.
This spontaneous report as received from a physician refers to a patient of unknown demographics. On an unspecified date, the patient was inadvertently vaccinated with 0.5 milliliter (ml) VARIVAX (merck) who was indicated to receive ZOSTAVAX. Lot number and dosing details were not specified. No concomitant medications were reported. The physician stated that this was due to human error and not product confusion. No adverse effect was reported. Additional information has been requested.
After the first shot, my lymph node under left arm was quite swollen and painful for a week.  Had 100 fever, chills, severe aches - for two days, then felt fine.  (I had Covid in Dec 2020, so first vaccine shot was only 3 months after my infection)  After the second shot,  again had 100 fever and chills and severe body aches for 2 days, then felt fine. Lymph node under right arm was swollen and painful for several days.   AND I suddenly had a metallic taste in my mouth, and my smell was weird - less able to clearly delineate what I was smelling.  This has lasted two weeks now....
Patient received less than a full Moderna Covid-19 vaccine dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received less than a full Moderna Covid-19 vaccine dose) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced UNDERDOSE (Patient received less than a full Moderna Covid-19 vaccine dose). On 21-May-2021, UNDERDOSE (Patient received less than a full Moderna Covid-19 vaccine dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Patient demographics and patient taken 2nd dose was updated
This child's arm was swollen from shoulder to elbow. Had vaccination in the morning, swelling noted in the afternoon and redness noted with elevated temp of 105. Given Tylenol which brought fever decreased, also given ice to swollen area.
Pt was administered Havrix, Proquad  and Varicella on 7/27/23 @ age 15 months  .  Merck notified as well   manufacturer for ProQuad.
PT states he began feeling tired the afternoon of the vaccination, approx 1500.  He rested and woke during the night at 2am with temp of 103.0 and headache, muscle aches.  Temp at 3 am  was 100.7 and headache/muscle aches.  Temp 0900 was 100.0 with headache/muscle aches.   Pt denies nausea, vomiting, sore throat.   will continue to monitor
Welt; lump on left breast (same side as vaccination= left arm); under arm and breast pain; sleepiness  Welt when subsided became itchy
I developed COVID symptoms - cough, fever, sore throat - July 25, 2022.
This case was reported by a healthcare professional via a sales representative and described the occurrence of seizure in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included a history of seizures.  On an unspecified date the subject received 1st dose of ENGERIX B (unknown).  At an unspecified time after vaccination with ENGERIX B, the subject experienced seizure.  This case was assessed as medically serious by GSK.  At the time of reporting the event was resolved.  At the time of event, the seizure was not thought to be related to vaccination with ENGERIX B because of the subject's history of seizures.  Then after the second dose on 17 October 2008, the subject experienced another seizure.  For details regarding the 2nd seizure, refer to suffix case A0754680B.  The sales representative reported that she was almost sure the nurse said ENGERIX B, but the drug could have been TWINRIX.
No side effects from second Pfizer Vaccine. However, shortly after a Endoscopy in late July when my immune system was weakened I was subsequently diagnosed with Shingles. As a 57 year old male, I have never had Shingles. The outbreak was on the left side of my head only. Is it coincidental that 2 months after receiving my second Pfizer vaccine and post routine  GI Procedure when my immune system is weakened or adjusted to fight off COVID, that in turn the chicken pox virus that was dormant for some 50 plus years in my body releases? Now I have Shingles. I?ll be getting the Shingle shot as soon as I recover, but I believe other males over 50 should be aware.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who experienced pain, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI985AC, expiry date: 22-Mar-2019 via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also the case of actual medication error due to overdose and Inappropriate age at vaccine administration. Other relevant tests included no lab data. Final diagnosis was pain. It was unknown if the patient received a corrective treatment. The outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Local pain which started at 4 pm and worsened by 6 pm and peaked by 8 pm and was rated as severe. He experienced swelling of the vaccinated right upper extremity by that evening. The swelling is slowly resolving but he has some mild redness. The discomfort is resolving.
This spontaneous report was received from a 77-year-old male patient who was also a resident physician via GlaxoSmithKline (US2021240625) referring to himself a 77-year-old male patient. The patient's concurrent condition was not reported. Medical history included herpes zoster. Concomitant therapies included fluticasone propionate (+) salmeterol xinafoate (ADVAIR), ipratropium bromide (+) salbutamol sulfate (DUONEB), metoprolol tartrate (LOPRESSOR), morniflumate (FLOMAX), varenicline tartrate (CHANTIX), atorvastatin calcium (LIPITOR) and apoaequorin (+) colecalciferol (PREVAGEN). On 21-FEB-2011, 03-MAR-2011 and 21-FEB-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) dose 1, 2 and 3 (strength, dose, route, lot #, expiration date and anatomical location not reported) for prophylaxis. On 27-MAR-2019, he was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX) (strength, dose, route, lot #, expiration date and anatomical location not reported) for prophylaxis; and the second dose of varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 ml was vaccinated intramuscularly in deltoid (strength, lot # and expiration date not reported) on 17-JUL-2019 (also reported as about 3 to 4 years ago from reporting date). In November 2021, more than 2 years after receiving varicella zoster vaccine rge (cho) (SHINGRIX), the patient experienced shingles, post herpetic trigeminal neuralgia and suspected vaccination failure. It was reported that sometime last week, he came down with shingles. It was also stated that the symptom dermatomal pain without rash started on 10-NOV-2021. The outcome of shingles and post herpetic trigeminal neuralgia was reported as not recovered. The outcome of suspected vaccination failure was unknown. The causality between the events shingles and post herpetic trigeminal neuralgia with both suspect vaccines were not reported. The causality between suspected vaccination failure with zoster vaccine live (ZOSTAVAX) was considered as related. The causality between suspected vaccination failure with varicella zoster vaccine rge (cho) (SHINGRIX) was not reported.