chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose 1 on Jan 2020. Any guidance on 2nd dose?; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist inquired that if patient received 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No other details were provided. The reporter consented to follow up.
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In July 2014, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a physician. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Case number PHEH2014US003675, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 10-year-old patient of unknown gender. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years might have vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on an unknown date in NOV 2013. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 20 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Janssen vaccine that expired 12/11/21 given on 12/13/21 in error. No adverse effects noted.  Contacted Manufacturer and state regarding the incident. Manufacturer supports stability up to 6 weeks post expiration and does not recommend a repeat dose.
Red raised soft ball sized rash that was hot to the touch and painful. Started itching two days after appearance. High fever day after injection (102) very bad body aches, and overall weakness.
Fatigue, chest pressure, cough when lay flat, chest pain worse when flat and also exercise.
the morning after IMZ, patient noticed a red, swollen area on arm, took some tylenol and put a cool compress on area. Area continued to be warm, swollen and tender to touch and went to Urgent Care on 11/5/2023
Patient received vaccine 20 hours after puncture; Patient received vaccine 20 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 20 hours after puncture) and PRODUCT STORAGE ERROR (Patient received vaccine 20 hours after puncture) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 939904, 017B21A and 040A21A) for COVID-19 vaccination.     The patient has ever had COVID + test or diagnosis from greater then 6 months. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose no) .  The patient's past medical history included Anemia. Concurrent medical conditions included Diabetes, Heart disorder, Kidney disorder and Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 20 hours after puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine 20 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 20 hours after puncture) and PRODUCT STORAGE ERROR (Patient received vaccine 20 hours after puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient is in a residential facility. Number of doses/vials: 1 Dose 1 vial. Date the vial was initially stored in the refrigerator was 21-Jun-2021. Date(s) and time(S) vial was first punctured was 21-Jun-2021 around 9 am. The vial was stored post puncture in Fridge. The vial did not undergo any temperature excursions. The vaccine was never at room temperature.  No treatment medications were reported.
pt states unvaccinated; presented with cough/congestion; previous loss of taste & smell; dx Covid PNA; treated with steroids; Vit C, Vit D, Zinc, antibiotics, remdesivir, supplemental O2; weaned to room air prior to dc; dc home
pain in Arm.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced pain in arm on an unspecified date. The outcome of the event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Initial information received from a healthcare professional (physician) on 18 September 2013. An 82 year old male patient was administered FLUZONE HD, lot U4714AA on 15 September 2013. In the evening on 15 September 2013, the patient developed intractable nausea and vomiting as well as a fever of 101.2. The patient was taken to the hospital, date not reported and was found to be hypoglycemic, bradycardic with unspecified mental status changes. The patient had a history of Addisons' and Brittle Diabetes. During hospitalization the patient developed a seizure and was transferred to a critical care unit. He remains in the hospital at the time of the report. Concomitant medications and laboratory reports were not reported. No further details were available at the time of this report. Documents held by sender: None.
Male patient 18 years of age, came into the clinic to receive vaccines. He was registered and verified. When patient arrived to the nurse to receive multiple vaccines; nurse asked patient if he had any shot record; patient stated no. Nurse asked patient had he ever received any vaccines before he stated yes but had no proof. Patient was vaccinated with MCV4 and HPV. After being vaccinated the school nurse produced shot records that were not provided prior. After reviewing records, patient was explained that he did not need to receive MCV4 because he had received a previous dose. Explain the side effects and allergic reactions. Advised patient if he has any problems please seek medical attention immediately.
Soreness at injection site, especially when extending arm forward and when lifting arm. Shot was administered high in shoulder and burned per pt. Pain developed w/in 30 mins of administration. Soreness is slightly better as of 3/24/06.
Numbness and weakness and pain in low ext and hands.  Loss of hearing dx with Guillain Barre syndrome  Pt was hospitalized
Developed a blister on left side of  mouth and inside left nostril, fatigue.  These would not have alarmed me except that my friend had the same shot at the same pharmacy two days earlier than I did and was just diagnosed by his physician today wth Shingles, likely reactivated after vaccine, which I know is rare.
Pt says muscle in arm as just been achy since he's gotten the Fluzone HD. Still having that achy till this date 9/25/15.
Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness, lying on floor felt better. PMH of vascular response, taking beta blocker had juice felt better. Vss. 115/76 bp pulse 65. Recheck b/p 103/69 65 pulse, 101/68 pulse 69 oxygen sats room aire were 100. initial pulse was 43 b/p 115/76. Resolved after rest elevated legs, and fluids. Employee left about after and hour walking well, with no further c/o symptoms all seemed to resolved She was instructed to go the emergency room any further symptoms. She verbalized back the plan.
PATIENT RECEIVED 2ND BOOSTER (4TH SHOT) BEFORE THE RECCOMENDED TIME FRAME. 1ST DOSE MODERNA, 05/15/2021. 2ND DOSE MODERNA, 02/12/2021. 1ST BOOSTER (3RD SHOT) MODERNA 02/24/2022. AND THEN THE 4TH SHOT OF MODERNA ON 05/17/2022.
Pt recvd vax & 1 wk later exp sore throat, could hardly talk, fever; seen by MD 12OCT who said was not related to flu vax; given a prescription for Emycin, Demacol; exp aching, cough, fever 101.5;
vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration; vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Amoxicillin) and Hyperlipidemia. Concomitant products included SIMVASTATIN for an unknown indication.    On 20-Apr-2022 at 9:10 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 9:10 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo temperature excursion. it was reported that the patient was vaccinated post 30 day use period. The patient did not experience any side effects.  No treatment details were reported.
presented to ER with weakness, increase confusion, hallucinations and decreased mobility. Patient has hx of  frequent hospitalization since he had cardiac arrest/MI. Tested positive for COVID, was hyoxic. Started on IV abx, steroids, Vit C, vibramycin, zinc.  Had AKI on CKD IV. Renal status worsened. Had poor prognosis. Family and patient wanted HD. quinton was placed amd HD initiated. Had metabolic encephalopathy, CT head was neg. Likely due to pneumonia and AKI. Patient is DNR; patient went in to asystole and passed away.  Pt up to NRB mask near end of hospitalization
Patient lost consciousness for approximately 5 seconds. She was awoken, given water, offered a snack, and left the waiting area approximately 15 minutes later.
Patient said that she has a red rash, itching, headache and a knot (at the injection site). She also reports sweating. I recommended diphenhydramine orally and topically for the itching and Tylenol or ibuprofen for headache and pain.
throat started to swell; arm pain; lymph node swelling; left cheek was itchy; chills; fever; arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of   in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), MIRTAZAPINE, MONTELUKAST SODIUM (SINGULAIR), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), OMEPRAZOLE, AMLODIPINE and ACETYLSALICYLIC ACID (ASPIRIN 1000).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hives covering body,Benadryl 1 tsp every 406 hours
2 days post vaccine I developed significant vertigo.  Now, 4 days later, I have not improved.  It does get better as the day goes on.  Audiology test suggests a possible central cause or at least not Benign Paroxysmal Postural Vertigo. .  MRI of the brain with contrast shows not central lesions.  Working diagnosis is post vaccine vestibular neuritis.
I got breakthrough COVID despite having the COVID omicron bivalent booster. Tested positive 19Oct2022 after traveling for work; I got breakthrough COVID despite having the COVID omicron bivalent booster. Tested positive 19Oct2022 after traveling for work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2022, outcome "unknown" and all described as "I got breakthrough COVID despite having the COVID omicron bivalent booster. Tested positive 19Oct2022 after traveling for work". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive, notes: Tested positive 19Oct2022 after traveling for work. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This is a 71y.o. male with significant past medical history of HTN, T2DM, CAD, IHD, chronic systolic HF, and S/P AICD that presented to the hospital from clinic with chief complaint of shortness of breath. He was noted by clinic staff to be in mild respiratory distress with complaints of dyspnea. He was found to be 91% on room air and transferred to the ED for further evaluation.    In the ED, patient normotensive, afebrile, stable SPO2 on 2 L nasal cannula  COVID positive. Elevated acute phase level reactants. He has been admitted for further evaluation and management with ID consultation.    Patient seen and examined only by the attending physician; NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.
Moderate fatigue starting 12 hours after vaccine.  Severe myalgias, fever, chills, rigors, neck stiffness, joint pain, flu-like symptoms
SEVERE JOINT PAIN MOSTLY IN LEGS AND ARMS AND SEVERE NIGHT SWEATS AFTER DAY 1 AND HAS CONTINUED TO PRESENT. UPPER DIGESTIVE PROBLEMS DEVELOPED AFTER 9 MONTHS AND CONTINUE TO PRESENT. CHEST PAIN RELATED TO DIGESTIVE ISSUES.
2-24-20 Child injured L hand with nail outside of home in the morning. Visited Health Department, received vaccinations as listed above.   2-25-20 child noted both hand at puncture site and L deltoid were sore and warm/red, applied ice packs 2-26-20 visited medical clinic per medical note: " Musculoskeletal: Normal range of motion and strength. Left deltoid has area of erythema surrounding injection site 8cm x 10cm. Warm to the touch, Left thenar eminence puncture site has surrounding erythema 3x4cm in size. Tender to the touch. Skin is warm, dry and pink, no rashes or lesions, no edema." Treatment: Vaccination reaction: cool packs to the site of injection. Benadryl 25mg at HS. Monitor site for worsening, Report to clinic if worsening.  Cellulitis of left hand: Keflex PO BID x 10 days. Report any further swelling, pain, drainage or worsening to the area. Follow up 2-28-20 if no improvement
PATIENT WAS GIVEN PFIZER ADULT 0.3ML AS SECOND DOSE, PATIENT HAD RECEIVED MODERNA AS FIRST DOSE. PPATIENT NEEDED TO COMPLETE SERIES FOR WORK AND WAS INFORMED THE CLINIC DID NOT HAVE ANY MODERNA VACCINES . PATIENT EXPRESSED WANTING THE VACCINE TODAY REGARDLESS OF CDC GUEDILINES.  NO SIDE EFFECTS OR REACTIONS REPORTED.
PT RECEIVED SMALLPOX VACCINE ON 25FEB04.  ON 02MAR04, PT ARRIVED WITH A LESION ON RIGHT NOSTRIL.  LESION RUPTURED ON 02MAR04.  PT EDUCATED ON PROPER PERSONAL HYGIENE.
Right arm became a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right arm became a little sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A31A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Right arm became a little sore). At the time of the report, VACCINATION SITE PAIN (Right arm became a little sore) outcome was unknown.            No concomitant medications are provided. No treatment medications are provided   This case was linked to MOD-2021-368757, MOD-2021-368775 (Patient Link).
Productive cough x 3 with generalized malaise. Denies fever, or sick contacts. Also c/o post tussive chest pain.
Patient given HPV vaccine when provider asked MA to "add HPV". Confusion arose as the patient was having her pnuemo vaccine that day but had also had a pap and the provider had really meant to add HPV to the pap as opposed to the vaccine. Provider aware of issue and patient contacted by provider so the situation could be explained and patient assessed. No adverse reactions noted.
Information has been received from a physician concerning a 38 year old male who on 04-MAY-2009 was vaccinated with VARIVAX (Merck) (dose, route and lot number unspecified).  The physician reported the patient developed a varicella rash on the face, neck and abdomen, about 18 days after vaccination (approximately 22-MAY-2009).  The patient also had myalgia.  The outcome of the patient was not recovered.  The patient sought medical attention at the physician's office.  Additional information has been requested.
Pregnancy history: 1 previous pregnancy with healthy full term vaginal delivery. No complications.  Estimated due date: Sept, 23, 2021. Symptoms: vaginal bleeding starting Jan 26th. Progressing to miscarriage on 1/29/21
accidentally received another full course in 2023.; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a infant female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 2019 received 1st dose) and Shingrix (on 2019 received 2nd dose).   On an unknown date, the patient received the 4th dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced extra dose administered (Verbatim: accidentally received another full course in 2023.).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2023 The Patient was vaccinated with a full course of Shingrix in 2019 and then accidentally received another full course in 2023.  No further information available. Caller did not give any information other than her name.   Call abandoned before any other information could be obtained. The patient accidentally received another full course, which led to extra dose administration. The reporter did not consent to follow-up.
[Pfizer-BioNTech] treatment under Emergency Use Authorization(EUA): New (195 vial count size) box from Lot: EL3249 opened and one vial less than expected.
Vasovagal syncope (bp 70/30) onset ~ 5 minutes after vaccine administration; recovered without intervention beyond lying down. Chronic fatigue also exacerbated and lasted for ~ 3 weeks. Approximately 10 days after vaccine had head to toe hives from a couple of bug bites. Doctor thinks that it was the inflammatory response from the vaccine that contributed to the inflammatory response of the bites (had never had hives before). Used benadryl on a schedule to treat. Hives resolved in ~ 4 days. Had c-reactive protein tested 14 days after first dose. While typically in the 3-6 range, the cardiac CRP had elevated to 17.  Second dose delayed to 5 weeks from first, to 4/23/2021 at 1:30 pm. Second form completed for this.