chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching in right arm; Right Arm Rash; Swollen in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Right Arm Rash), PERIPHERAL SWELLING (Swollen in right arm) and PRURITUS (Itching in right arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical records).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE RASH (Right Arm Rash) and PERIPHERAL SWELLING (Swollen in right arm). On an unknown date, the patient experienced PRURITUS (Itching in right arm). At the time of the report, INJECTION SITE RASH (Right Arm Rash), PERIPHERAL SWELLING (Swollen in right arm) and PRURITUS (Itching in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
After the second size of the vaccine Modena I developed a skin rash. I never had issues until this.
Reporting that a 15 year old individual received both a Moderna and a Pfizer COVID-19 vaccine. This individual received Pfizer on 8/31/2021 and Moderna on 9/25/2021.
Information has been received from a physician concerning a 19 year old female with no pertinent medical history or drug reactions allergies, who on 11/9/06 was vaccinated at her OB/GYN's office with HPV vaccine. Concomitant therapy included Zyrtec and oral hormonal contraceptives (unspecified). On 11/19/06 the pt developed a rash on the injection site arm, but not at the injections site. On 11/19/06 the pt also experienced extreme myalgia in all four extremities and her hand was discolored (purple). On 11/20/06 lab testing revealed a positive Rapid streptococcal test and the pt was placed on unspecified antibiotics. Other lab findings revealed a neg medical panel, a complete blood count revealed an elevated WBC count with a shift to the left, and a urinalysis was neg but with a trace hemoglobin. At the time of this report, the pt was recovering. The physician felt that one or more of the events were disabling. Additional information has been requested.
Progressive lethargy - now sleeps approximately 14-16 hrs/day, worsens with greater activity. Also, hypotension.
fell down; brain bleed; fracture; More than 42 days since first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (fell down), HAEMORRHAGE INTRACRANIAL (brain bleed) and FRACTURE (fracture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell down) (seriousness criterion hospitalization), HAEMORRHAGE INTRACRANIAL (brain bleed) (seriousness criteria hospitalization and medically significant), FRACTURE (fracture) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (More than 42 days since first dose). At the time of the report, FALL (fell down), HAEMORRHAGE INTRACRANIAL (brain bleed) and FRACTURE (fracture) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 42 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not provided..  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.   Reporter did not allow further contact; 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.
Mother reports pt fell asleep at noon after receiving vaccine and slept all day, Mom had to wake to feed not easily aroused and only took 4oz of formula, had voided. early OM - TM red.
Patient was unintentionally given an expired Moderna booster vaccine on 11/5/2021. Expiration date was 11/3/2021 per the 30 day rule once in the fridge. Moderna vial used was placed in fridge on 10/04/2021. No known adverse events have occured at the time of reporting.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No information reported regarding medical history and concurrent conditions. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneus (lot#, dose number, anatomical location  not reported). No concomitant medications reported. The pharmacist reported that she has seen an unspecified amount of patients develop unspecified rashes around the injection site and rashes around other unspecified areas after receiving ZOSTAVAX. The outcome of unspecified amount of patients develop unspecified rashes around the injection site and rashes around other unspecified areas after receiving ZOSTAVAX was unknown. This is one of the two report received from the same reporter. Additional information has been requested.
On 4/30/2021 @1423 DOB 7/24/1954 received his first dose of the Pfizer Vaccine Lot Number EW0173 Expiration Date 5/2/2021 to Left arm. Per , RN she administered the vaccine and the patient and his wife were laughing and joking and the pt walked over to the observation area in no apparent signs of distress. 1430- Pt was sitting in observation area with his wife and him and his wife signaled to EMT's for help. Per nurse, EMT pt was diaphoretic, complaining of being tired, rapid increasing in lethargy, and frequent yawning, vitals were SpO2 97% @RA, 108/60 BP, 90 pulse, A&O to person and place. Per pt's wife pt doesn't have a history of impaired memory. Lead Nurse and  Co-lead nurse instructed EMT to call 911. 1438- Pt continues to decline as evidenced by SpO2 96% @ RA, pulse-47, BP 90/unable to assess, A&Ox1 to person. Pt's wife stated ?he's diabetic and I don't think he has eaten much?.1440- Co lead nurse assisted pt with oral glucose gel. 1447- Paramedics arrive and assess pt. Pt stated ?I feel much better now that I had the gel?I didn't remember anything that happened. I think I just need to eat?. Per paramedics VS were SpO2 96% @ RA, Pulse 77, BP127/82, Pt A&Ox3, no longer sweating, lethargy resolved, RBS via finger stick 144mg/dL. Paramedics instructed pt that a hospital visit is warranted and pt refused. Paramedics instructed pt to finish the oral glucose gel and he did. Pt was observed by paramedics and paramedics educated pt that a ER visit is warranted and pt refused again. Paramedics gave AMA form and pt signed the form. Pt was educated by Lead Nurse, Co-Lead Nurse and Paramedics that he could not drive home. Pt's nephew came to a lady with his wife, who is also a nurse. They said they would drive the pt to their house and follow up with PCP. Final vital signs: SpO2 96% @ RA, Pulse -75, BP 128/82, Temp 97.6, A&Ox3, pt calm and stable Negative for signs and symptoms of distress. Pt and family were instructed when to seek emergency intervention, all parties verbalized 100% understanding. Pt left ambulatory @ 1515.
Got sick after 1st primary shot/Got sick after 2nd primary shot/Got sick after 1st Booster shot/Got sick  after 2nd Booster shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Got sick after 1st primary shot/Got sick after 2nd primary shot/Got sick after 1st Booster shot/Got sick  after 2nd Booster shot) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced ILLNESS (Got sick after 1st primary shot/Got sick after 2nd primary shot/Got sick after 1st Booster shot/Got sick  after 2nd Booster shot). At the time of the report, ILLNESS (Got sick after 1st primary shot/Got sick after 2nd primary shot/Got sick after 1st Booster shot/Got sick  after 2nd Booster shot) outcome was unknown.            Concomitant medication information was not provided by the reporter.  He stated that he received 4 doses of Monovalent Moderna COVID-19 vaccine already.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
5 inch diameter erythematous, warm, circular area/mil swelling at site of Varivax injection L arm.
brief dizziness followed by onset of chills and muscle aches that lasted for approximately 2 hours.  Now, approximately 22 hours later, I am experiencing fatigue, light nausea, headache, and hot flashes.
9-21-2021.  Covid vaccination 10-02-2021. Shortness of breath,  extremely tiered, head ache 10-05-2021 covid test (negative) 10/10  shortness of breath, worse 1st thing in the morning  10/11/2021 increase shortness of breath, chest pain, mental fog, pulse ox 77%, called 911 EMS performed ekg breathing treatment,  then proceeded to hospital EG performed, proceeded to the hospital, labs, ekg, chest x-ray, chest CT, ephashagram,  IV, overnight stay. 10-21-2021 urgent care shortness of breath, chest pain. Chest x-ray, EKG, lab work performed sent to hospital for elevated d-dimer, more lab work, ekg, chest ct scan. 10-27-2021continued issues  dr visit  steroids, antibiotics  11-10-2021 increased chest pain elevated HR, BP and frequent drops in BP and Hr, labs, referral for echocardiogram and heart monitor 11-17-2021 48 hour heart monitor placed 11-24-2021 Emergency room, chest pain, headache, elevated heart rate and BP. Chest c-ray lab. Follow up with cardiologist .  12-01-2021 echocardiogram. 12-02-2021 slurred speech, confusion, loss of use of right sided extremities, pupil change, right sided involvement resolved within 30min. Difficulty concentrating and speech for several hours.  12-07-2021   Cardiologist appointment, chest pain, shortness of breath on exertion, edema in bilateral hands and feet. Stress test and head ct performed.  12-09-2021 ct head
Pt was inpatient in the hospital for non COVID reasons, screening swab was positive COVID.  Pt asymptomatic
pt recv vax 12NOV97 & 25NOV devel urticaria, itching & joint pain & swelling (moderate);taken to MD 26NOV joints swollen;
initial urgent care visit due to blurred vision- dx as corneal scratch Follow up with Eye physician- DX with Central Retinal Vein OcclusionI continue to get eye shots Bevacizmab  to minimize sx from this occlusion
Developed massive Pulmonary Blood Clots in both lungs.  First symptom was shortness of breath and feeling I would faint.  Went to Hospital Emergency room and was admitted immediately  spent 2 1/2 days in ICU for treatment to dissolve blood clots (TPA) Was discharged on third day as oxygen level, heart beat, breathing and blood pressure appeared normal. Took second COVID19 (Pfizer-BioNTec) shot on Monday, March 29, 2021 at 1:00 p.m. (Lot ER8732)  No adverse reaction to second shot except some muscle paid in left leg (calf).
Respiratory issues; This serious case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced respiratory disorder (Verbatim: Respiratory issues) (serious criteria hospitalization). The outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Arexvy.     It was unknown if the company considered the respiratory disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-NOV-2023 An GSK sales representative called on behalf of healthcare professional (MD). The healthcare professional reported that a couple of patients were hospitalized with respiratory issues after receiving the RSV vaccine (Unknown manufacturer). Adverse event filed with limited information. The reporter did not consent to follow-up. The healthcare professional provided very limited information. The reporter did not know which RSV vaccine the patients received (GSK or Pfizer). The healthcare professional did not wish to follow up with Safety.
Within 48 hours, the pt experienced a rash on his chest. He experienced 4 days of skin burning, diarrhea, an increase in eczema to cover all of body. He then experienced a spotted rash all over his face from day 8-14 post vax. No measles were determined. Doctor stated he was reacting to the vaccine and building antibodies.
Patient sitting in chair, father holding her up and her head was back with eyes open rolled back. Pt became alert and oriented and was placed on cot for safety. No injury to patient. No head injury. Paramedics responded. Vitals stable. Blood sugar 94mg/dL
Arthralgia arm sore for month, brain fog for 1st + 2nd days post-admin Narrative:
improperly stored medication given to patient; This spontaneous report was received from a healthcare professional and refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 04-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # S035100, expiration date 03-MAY-2021, subcutaneously (exact dose was not reported) for routine immunization. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 7.9 degrees of C for 2 hours. It is unknown if there was a previous temperature excursion.
Pt recvd 3 doses of Engerix-B 5DEC90, 8JAN91 & 3JUN91 & 12SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
IPOL for a total of 13 hrs, with a maximum warm temperature of 9.9 C with no reported adverse event; IPOL was administered to a patient post excursion with no reported adverse event; Initial information received on 11-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 year old male patient to whom IPV (VERO) [IPOL] was administered post excursion total of 13 hours, with a maximum warm temperature of 9.9 c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Jul-2023, the patient received a dose 0.5 ml of suspect IPV (VERO) Suspension for injection strength, expiry date: not reported lot W1A191M via intramuscular route in unknown administration site for immunization and was exposed to a total of 13 hours, with a maximum warm temperature of 9.9 c with no reported adverse event (product storage error)(same day latency).  On 24-JUL-2023 IPOL was administered to a patient post excursion with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event ipol for a total of 13 hrs, with a maximum warm temperature of 9.9 c with no reported adverse event and ipol was administered to a patient post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Muscle aches and weakness progressing over several months since vaccination.  Patient is undergoing extensive workup to determine if symptoms are related to myasthenia gravis or polymyalgia rheumatica.
12/2 Awoke in AM with inability to smile and close right eyelid. Went to ER and diagnosed with Bell's Palsy. Rx with Acyclovir and Prednisone. Lyme titer done - no results yet. CT scan of head negative.
T104-105.9 20DEC91 & 21DEC91; childrens' Advil prescribed along w/Tylenol; Amantadine given for 5 days; leg remains stiff; now has cough; dx: influenza A - probably Beijing;
Slight headache. Offered patient water and extended observation to 30 minutes. Symptom subsided and patient was released.
Pt revd 1st dose of Hep B vax w/no adverse rxn; On 30APR91 pt recvd 2nd dose of Hep B & the next day pt devel a fever of 101; 2 days p/vax pt exp joint pain; pt fever resolved several days later;
Body aches, nausea, feverish, right ankle burning pain, red, warm to touch.
Mother called, child complaining left arm hurts.  3" x 5" erythemateous area, mid deltoid.  Slight nodule underneath.  Very warm to touch and painful.  Doctor stated a mild reaction from the preservative.
5/7/2021 Extremely painful cramp in left calf and fasiculations. Has bloodwork and US, all normal. 6/1 fasiculations in both calves. Followed by many more symptoms  Bulging and blue looking shin, pain and aching below the knee and feet. Electrical shock from top of head to toes (1x). Tingling and fizzy sensations in legs and feet, heavy legs, parasthesia in leg, popping and cracking joints, stabbing pains in random places, flushing, pain and tingling in toes, extremely tight Achilles? tendon and muscle spasms.   I am scheduled for EMG, MRI and more bloodwork.  I was a heathy person for my age until the vaccine. Although, I am better than when this all started, I still have a lot of the same symptoms. Constant fasiculations. Is this permanent?
Seizure followed by Acute encephalopathy  a few hours after receiving 2nd dose of Pfizer COVId-19 vaccine.  COPVID-19 PCR testing positive on admission.  Ongoing encephalopathy and patient made Comfort care.  EEG showed no overt siezures.
About 17 hr after Imm, pt had indurated, eryth left arm, spreading in size through the day. 4 x6 cm redness, 2 x 2cm induration, mild tenderness, mild itching. Tx: Ice, MOTRIN, BENADRYL, monitor.
Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness  Symptoms gradually subsided over 24 hours.  Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever.   Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.
Bexsero 2nd late dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose of bexsero when the patient was 16 years old).   On an unknown date, the patient did not receive the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment:  The patient went to the facility for administration with the second dose of Bexsero, but physician did not administer the vaccine as the patient declared once in the facility that she was not sure about first or second doses of Bexsero received in the past.  The physician called GlaxoSmithKline to request medical information on three doses of Bexsero, but at the moment of the communication did not administer the patient with a bexsero vaccine dose. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sore upper arm to start.  Then the next morning, black and blue bruise continued to get worse as the days went on.  Eventually was approximately a bruise with a radius of about 5 inches, all discolored, and lasted for 3 weeks, until today.  Today it finally has all disappeared except for very small remnants.
feeling tired sometimes; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 15:00 (Lot number: EW0150) at the age of 64 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 23Apr2021, outcome "recovering", described as "feeling tired sometimes".  Additional information: patient had no prior vaccinations within 4 weeks and no adverse events following prior vaccinations. Patient was due for his second COVID 19 vaccine in 2 weeks. He reported everything was going ok, other than him feeling tired sometimes. But he had a different question. He wanted to make sure he stayed in compliance with the regimen until he received his second COVID-19 vaccine. He was asking if it was ok for him to have a beer or glass of wine. He hadn't drunk any beer or wine and it was just a thought he had and thought he'd ask. The first day after receiving the COVID-19 vaccine or the second day (as reported), he just felt a little tired and he slept a little bit. He was a little tired the day before the present report, 29Apr2021, maybe from running around. He was feeling better the day of the present report, 30Apr2021.  No follow-up attempts are needed. No further information is expected.