chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 480 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient experienced fever, seizure the same night vaccines given. Tylenol prescribed and advised to take Diastat if seizure occurs.
Left arm red and swollen from elbow to neck and ached all over for 4 days. Pt is better now.
weakness, dizziness, difficulty walking, feeling faint, fall due to dizziness , chest pain, nausea, swelling, and redness at injection site, headache.  Started night of vaccination and is still having symptoms as of 4/1/2021
Per mom pt had a seizure like event around 11 the night after receiving injections. Had fever of 101.5 at ER. Diagnosed with ear infection and given Rocephin. Pt also received H1N1 vaccines at local Health Dept along with other vaccines. Pt was fine the next day with no fever or complaint.
instead of using the liquid conjugate component/ they used a diluent instead / had been improperly reconstituted with non-GSK approved diluent; Menveo, second dose to patient / administered only one vial of Menveo vaccine to a 16 year old male patient, mentioned it vaccine number 2 in the series; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA415A, expiry date 20th September 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The preparing of the vaccine ended up being in error as instead of using the liquid conjugate component of the vaccine to mix both vials, they used a diluent instead, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Centers for Disease Control and Prevention (CDC) recommended meningococcal vaccination for all preteens and teens - all 11 to 12 years old should receive a single dose of a MenACWY vaccine. Since protection decreases over time, CDC recommends a booster at age 16 years and as this patient was 16 years old, and therefore receiving the second dose (booster) in the series as recommended by the CDC in this case as reported by the customer. The reporter did not consent to follow-up.   Follow up information received via nurse on 8th July 2021: The age at vaccination was updated as 16 years. On 7th July 2021, Menveo injection had been improperly reconstituted with non-GSK approved diluent.  The nurse reported that a diluent from MMR vaccine was used and so the patient only received the lyophilized portion of Menveo and only one vial of Menveo vaccine was given. The batch number and expiry date were updated. The VAERS details was updated. The reporter consented to follow up.  No further information was available.
migraine headaches; Ringing in the ears since after 1st dose and has not stopped and not getting migraine headaches; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an intramuscular route of administration in the arm left on 29Dec2020 as a single dose for COVID-19 immunisation. Medical history included contrast dye allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL) and pantoprazole sodium sesquihydrate (PROTONIX); all on an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020, the patient experienced ringing in the ears since after 1st dose and has not stopped and now started getting migraine headaches. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in the ears and migraine headaches was not recovered at the time of this report. The patient received second dose of BNT162b2 (COMIRNATY; Lot number: EL3246), via an unspecified route of administration in the arm left on an unknown date as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Pt felt nauseous. Did not vomit. Allergy to sulfa.  Stats @ 11:34pm: BP: 95/61 HR: 75  O2: 99 RR: 16  Stats @ 11:42pm: BP: 108/60 O2: 100 Pt feeling better. Has not lost consciousness & has not vomited. Symptoms resolved.
12/21/21 presents to ED for "altered mental status" "urinary frequency" "congestion, cough, shortness of breath, headache, diarrhea".   PMHx of "CVA & TIA, BPH, DVT, OSA
9 hours after injection, symptoms began: chills, fever, fatigue, aches/pain
About 36-48 hours after receiving these vaccines, patient reports swelling and itching at the injection site for SHINGRIX (left upper arm). She said that one day after this reaction, she noted a diffuse rash on both lower arms. She reports that it does not itch.
Pt came to our Walk-In clinic for a raised red area over injection site on right glute. Pt denies any itching. Pt states it is tender and also states she feels a small lump on the anterior aspect of her hip. A NP assessed her and traced the borders of the reddened area. She palpated a swollen lymph node on the anterior hip. Dr. prescribed oral antibiotics for possible cellulitis.
Information has been received from a physician concerning a 68 yr old female pt with inflammatory polyarthritis, rheumatoid arthritis and some allergies who on 01Feb05 was vaccinated into the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P). Concomitant therapies included levothyroxine sodium (Synthroid), risedronate sodium (Actonel), prednisone, and OTC vitamins (unspecified). On 03Feb05, the pt experienced redness, warmth, and tenderness at the injection site. Unspecified medical attention was sought. She was treated with an antibiotic. On 05Feb05, the pt recovered. No product quality complaint was involved. No further information is expected. It was also reported that an additional pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P) and experienced adverse events (WAES0502USA01151).
Pt woke up the next day with a red rash on arms and trunk. Mother put A + D ointment on rash. Upon presentation to HCP same day, only 1 tiny pink bump scan on L wrist.
nausea, headache, muscle ache, fever, chills lasting 24 hours red splotches around injection shot, warm to the touch and itchy lasting 3-4 days
This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. A 78-year-old, female patient of an unknown race was received immunization of PREVNAR 13 vaccine 0.5 ml single intramuscularly in the left arm in 12Nov2016 for pneumonia. The lot number was reported as N97935, expiration date was Dec2017 and NDC number was 00005-1971-02. "Alternatively it was reported that the site of administration was right" (R). Her relevant medical history included high blood pressure (HBP) and allergic to guanabana on an unknown date. The concomitant medication and past drug history were unknown. On 12Nov2016, the patient developed inflammation on the injection site. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 05Dec2016, the clinical outcome of the event inflammation on the injection site was unknown.
uncontrollable crying 1230PM-4PM p/immun sporadic crying 4PM-1030PM;
6 hours, post vax, the right deltoid became sore and was unable to lift arm. Applied ice, heat and took ibuprofen with some relief but states "it is better today".
I developed severe anxiety and panic after being on the same drug for 7 years all of a sudden i became allergic to it and started having palpatations and the very servere anxiety and panic in which i was regulated and fine prior to the injection, i did not get my second dose because of the issues i have been dealing with after the shot i literally became a different person and i had to stop taking the pristiq cause it was making me sweat and heart palpitations and my anxiety and panic became worse does not make sense because before that shot i was fine in nature and controlled
Patient noticed red welt on site of injection the following day. In the afternoon around 3 pm. she experienced slight itch on left arm. The red welt on right arm grew to the size of a tennis ball in a few days. Ice was applied during this time. Left arm became very itchy and Pt saw a dermatologist on 4/1/09 and doctor confirmed she has shingles. Pt was given a week course of VALTREX and cream to apply. Symptoms resolved. Pt has no other complaints
pt recv vax 3JUN97 & approx 10hr later pt exp the development of ulcer on upper lip & end of tongue;became painful;area were the area were the size of a small pea & appeared deeper than a nl viral ulcer;pt recovered;
Swelling over injection site on left arm, about 2cmx 2cm in size, erythematous and itching.
Patient presented to the ED and was subsequently hospitalized for encephalopathy within 6 weeks of receiving covid vaccination.
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before.  On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5  bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future.  1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine.  1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged.  1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
blood vessel issues in my foot,dark, blood looking area; like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (blood vessel issues in my foot,dark, blood looking area) and CONTUSION (like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FISH OIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE BESYLATE, TELMISARTAN and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced VASCULAR INJURY (blood vessel issues in my foot,dark, blood looking area) and CONTUSION (like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot). At the time of the report, VASCULAR INJURY (blood vessel issues in my foot,dark, blood looking area) and CONTUSION (like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot) outcome was unknown.            Treatment information was not provided.  Patient walk around in the field for 3.5 hours and noticed a bruise-like discoloration on the inside of his left ankle. Two days later, he was walking for several hours at the mall with his wife and saw that the left side of his foot had a dark, bloody looking area.   He said that this bruise-like discoloration was only on his left foot and was about the size of a half dollar. It looks like blood vessel issues on his left foot. He says that it's on the sole of his foot and runs about 3 inches along the side of his foot. He has never had any situation like this in his legs or ankles before. Patient has stopped the baby aspirin since this issue started.
while in school c/o h/a, stomachache & vomited once; spoke to teacher who sent school office;school office personnel called mom;APAP was given;p/napping pt stated felt better;
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 29th June 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site muscle pain. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, injection site muscle pain and pruritus were unchanged. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, injection site muscle pain and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm. Within 2 hours after getting the vaccine the patient experienced redness, heat, swelling, raised area, and muscle pain at the injection site. In 2018, less than a week after receiving SHINGRIX, the patient experienced itching. The patient had denied permission to contact their physician. No further details were provided by the patient. Advised patient to follow up with her health care provider.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that a 0.5 mL vial of PROQUAD (Merck) was reconstituted with 0.7 mL of sterile water and drawn into a syringe. The syringe with the reconstituted PROQUAD (Merck) was then injected into another un-reconstituted 0.5 mL vial of PROQUAD (Merck) and was then re-drawn into a syringe. Nurse stated this "double dose" of PROQUAD (Merck) (indication, route and lot # unknown) was then administered to a patient on 20-DEC-2013. No adverse effects reported. Additional information is not expected.
arm greatly swollen; fever; Itchy; injection site redness; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (arm greatly swollen), PYREXIA (fever), PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm greatly swollen), PYREXIA (fever), PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, PERIPHERAL SWELLING (arm greatly swollen), PYREXIA (fever), PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter,
fever 103  06/11/2019 02:00 and 06/12/2019 03:30 Fevers throughout 06/11/2019 Loss of appetite, fussy and tired,  vomiting 06/12/2019 04:30  screaming fit 6/11/2019 02:00-04:00
Patient received vaccine on 7/19/19, returned on Monday, 7/22/19, and reported the following to us: on evening of 7/19/19 (day of vaccination), she experienced a sore arm. By the next day (7/20/19), it had spread to her neck and side of abdomen. She also experienced a strong migraine.  By the next day though (7/21/19), she was back to normal.
April 18, 2021 ER visit- Dizziness, back pain, chest pain,  Nausea, fatigue over the week previous to the ER visit. I came to the ER on the advice of the advice nurse because of chest pain. May 21- swelling of ankles and feet. I was unable to stand and went home from work. The swelling is increasing and continues to make standing and sitting difficult. The pain is radiating up the legs to the knees.
mental confusion; difficulty speaking; severe headache; This is a spontaneous report from a contactable other hcp.   A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 11:00 hr (at the age of 64-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included Rheumatoid arthritis, gastro-oesophageal reflux disease (GERD) and drug hypersensitivity to penicillin (allergies with PCN) from an unknown date and unknown if ongoing. Concomitant medication included methotrexate (METHOTREXATE), hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); omeprazole (OMEPRAZOLE); pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced mental confusion, difficulty speaking, severe headache on 04Mar2021 23:00 hr. Lingering feeling of not being completely back to normal after another additional day. No treatment received. The outcome of the events was recovering at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sore arm all the way down to my fingertips. Sore body. Tender to the touch. Headache and fever.
Tiny little bumps; Warm to the touch; Red circle; Swollen; Horrific migraine; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Horrific migraine), PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Tiny little bumps) and INJECTION SITE WARMTH (Warm to the touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 02SL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension, Atrial fibrillation and Arthritis.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Feb-2021, the patient experienced MIGRAINE (Horrific migraine) and CHILLS (Chills). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen), ERYTHEMA (Tiny little bumps), INJECTION SITE WARMTH (Warm to the touch) and ERYTHEMA (Red circle). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, MIGRAINE (Horrific migraine) had resolved. On 27-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Tiny little bumps), INJECTION SITE WARMTH (Warm to the touch) and ERYTHEMA (Red circle) outcome was unknown.            Concomitant medications included high blood pressure medicine and blood thinner.   This case was linked to MOD-2021-030349, MOD-2021-030349 (Patient Link).
Injection was painful and remained painful.  Next day arm very sore, red and warm.  Went to family physician.  Put on Z-pack and steroids.  Finished Z-pack and had several large red raised areas around injection site on Rt. arm.  Put on additional antibiotics and problem resolved.  Follow-up phone call on 11/10/10.  Arm is fine now.
On 10/25/17, it was reported by caregiver/mother that patient developed Guillain-Barre Syndrome after receiving FLUARIX QUADRIVALENT in August.
34 hours post vaccine, my ears started ringing loudly. It is now  two days later and they are still ringing, same level.   This has been my only side effect other than a sore arm.