chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Pneumovax 23 in Left Deltoid on 10/15/20. Patient came back to clinic 10/23/20 stating she had a sore at the site of the injection. Seen by FNP-C. Upon examination, pt had a scabbed over area at injection site that was 1cm across. Under scab, hardened tissue was felt and measured to be 2cm across. No drainage was noted. Patient prescribed bactroban ointment to apply topically and instructed to return to clinic for follow up in 1 week or sooner if site worsens.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive; (04Jun2022) positive, notes: after symptoms recurred, tested positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Antiviral details: product- COVID 19 treatment, treatment start date: 23May2022, treatment stop date: 27May2022. Adverse event: Possible case of rebound. Symptoms subsided but then recurred approximately one week after completing full dosing regimen. First home/rapid antigen test on 23May was positive. Retest on 04Jun, after symptoms recurred, tested positive. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up sweating, nauseous, alternating between hot and cold but always with sweat. Unable to work that night. Lasted about 20 hours
Chills, body aches, headache, diarreah, fatigue, stuffy nose , pain in  & around injection site plus soreness in armpit on same side as shot was given.
No adverse reaction or side effect was experienced; Pneumovax 23 administered on 02-SEP-2014 and PREVNAR 13 administered on 05-MAY-2015; This spontaneous report was received from a physician via a Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (# 1810USA005885), concerning a 66-year-old male patient.  On 02-SEP-2014 (at 65 years old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal (PPSV23)) (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) as prophylaxis, and on 05-MAY-2015, patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (reported as pneumococcal (PCV13)) (strength, dose, route of administration, anatomical location, indication, lot number, and expiration date were not reported) (inappropriate schedule of product administration). It was stated that no adverse reaction or side effect was experienced due to the patient's vaccination.; Sender's Comments:  US-009507513-1810USA005885:
pt to ED with c/o SOB and cough; O2 supplementation - BiPAP; tested positive for COVID; ABX; pancytopenia, new AKI, lactic acidosis, A Fib with RVR; pt's condition continued to worsen; transitioned to DNR/DNI; condition deteriorated and pt passed away in the hospital
Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11.  By 12am 1/12 unable to sleep due to Such severe pain all over head to toe, chills/shaking , vomiting and sweats. As of now today 1/12 1pm still very achey and fatigued with waves of nausea.
As per patient, he got the second dose of Pfizer COVID vaccine on the 05/13/2021, and the  following day, 05/14/2021, he had fever with chills and muscle aches; however, those subsided.  Then,  on following day, 05/15/2021, he woke up with chest pain/pressure like and burning pain throughout the day, and then the patient's pain became more severe; however, it became less around the night, at 11  p.m. and then he went to sleep, and he woke in the morning with the pain, around 3:30 am.  The pain was  6-7/10, pressure-like, burning sensation, no radiation, associated with mild nausea.
Neck sore; Sleeping all day yesterday and today; Spot 2in below the site of injection; Left arm sore; Left shoulder sore; A spontaneous report was received from a consumer concerning himself, a 59-year-old, male patient who experienced a sore neck [Neck pain], sleepiness [Somnolence], a spot 2 inches below the injection site [vaccination site reaction], soreness in left arm [Pain in extremity] and soreness in shoulder [Arthralgia].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31-Dec-2020, the patient reported he noticed a spot 2 inches below the site of the injection. He also reported that his shoulder, arm and neck are sore, and he has been sleeping all day for two days. He was unable to provide the lot number received due to the number being unclear. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not reported; Reporter's Comments: This case concerns a 59 Y/O M with a nonserious unexpected event of neck pain, somnolence, and expected vaccination site reaction, pain in extremity and arthralgia. Event onset 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Generalized rash - hives on chest, back, arms & face.  Started < 24 hrs after vaccines were administered.  Treated with diphenhydramine.
The patient experienced lightheadedness, weakness, and blurry vision for several hours after receiving his flu vaccine at school.  He reported to my clinic for evaluation later in the afternoon when the symptoms had resolved and had a normal exam at that time.
Pt received flu vaccine on 11/23/00 and developed Bell's Palsy to left side of face, within 24 hours, post vax.
heat rash, tiny ones, on her stomach; 5 big hives on her chest; still feeling dizzy; extremely tired; left arm is still swelling around the injection site; upset stomach; voice is all scratchy; itchy on the same arm of the injection site, also inside of her elbow; big hives on the same arm of the injection site, also inside her elbow; arm is itchy; nauseous, but nothing severe; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous, but nothing severe), PRURITUS (arm is itchy), VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow), RASH (heat rash, tiny ones, on her stomach) and URTICARIA (5 big hives on her chest) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced NAUSEA (nauseous, but nothing severe). On 08-Feb-2021, the patient experienced PRURITUS (arm is itchy). On 09-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow) and PRURITUS (itchy on the same arm of the injection site, also inside of her elbow). On an unknown date, the patient experienced RASH (heat rash, tiny ones, on her stomach), URTICARIA (5 big hives on her chest), DIZZINESS (still feeling dizzy), FATIGUE (extremely tired), VACCINATION SITE SWELLING (left arm is still swelling around the injection site), ABDOMINAL DISCOMFORT (upset stomach) and DYSPHONIA (voice is all scratchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous, but nothing severe), PRURITUS (arm is itchy), VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow), RASH (heat rash, tiny ones, on her stomach), URTICARIA (5 big hives on her chest), DIZZINESS (still feeling dizzy), FATIGUE (extremely tired), VACCINATION SITE SWELLING (left arm is still swelling around the injection site), ABDOMINAL DISCOMFORT (upset stomach), DYSPHONIA (voice is all scratchy) and PRURITUS (itchy on the same arm of the injection site, also inside of her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Rash - Diphenhydramine HCL 12.5 mg/5mL 1 teaspoon PO every 6 hours.
VERY SORE ARM, RED AND HOT ARM.  RASH AROUND INJECTION SITE.  SEVERE BODY ACHES AND MALAISE
pt was given the incorrect vaccine. Pt received Moderna Pediatric NDC 80777-275-99 instead of Moderna Bivalent NDC 80777-0282-05
Immediately upon vaccination, the site bruised and swelling @ 1 cm in diameter and 2-3 mm high.
No adverse event; Administered the vaccine to 346 patients after the 30 day by used; Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 14-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 14-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 14-Jul-2022).    No concomitant medication were reported. The vial was initially stored in the refrigerator was on 4Jun2022. The vial didn't undergo any temperature excursions. No treatment information were provided.
Patient describes gradual loss of facial hair and then body hair that started approximately two weeks after completing vaccination series. He c/o local arm pain for several days after the injection, but no other adverse effects.
pt exp lt leg & groin swelling;A large knot was noted @ the inj site, along w/redness & bruising;
PATIENT REFERS THAT FELT AN ITCH IN THE HEAD AND THE BODY. PRESENTED WITH RASH IN CHEST. PALENESS.
This is in follow-up to report (s) previously submitted on 5/14/2007 Information has been received from a company representative, reporting in a literature article (article name and author not specified) concerning a 22 year old female who was vaccinated with a dose or doses of GARDASIL (date unspecified). According to the article, the woman "became infected with the 4 strains of HPV, "although she was "involved in the studies" for GARDASIL and had shown a "strong conversion" during the studies. Additional information has been requested. Follow up information confirmed that only one patient was identified or involved with the events (WAES #0610USA04009). Therefore, WAES # 0704USA00327 is being deleted from our files. No further information is expected. This report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007.
Injection at 10:45-headache by noon within 2 hours. Noticed flashes, fatigue, shivering, flushed skin. Over day 1 and day 2; on day 3 swelling of hands, face, chest hurt, red skin, generalized itching. Required MD attention and adrenalin injection at local immediate care facility.
Initial report received from a physician on 04 Dec 2009: This patient, who was below the age of 4 years, received FLUVIRIN 0.5 ml intramuscular, batch no.: 102130P1, on 25 Nov 2009. No adverse event was reported.
throat was tight, out of breath, sweating, 15-20 min p/inj;
Approximately 3 weeks after vaccine the opposite arm from the injection site began swelling. Caused pain in arm, shoulder, and upper back. Pain was helped with NSAIDS. Lasted for 6 weeks.
could not move; fever went to 102.3; shaking so bad; my legs felt like rubber and every time i would try to get up i would fall down; terrible pain; serious discomfort; This is a spontaneous report from a contactable consumer. This 63-year-old male consumer reported that he received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6208) on 15Mar2021 02:00 PM at right arm for COVID-19 immunisation. Medical history included kidney disease, known allergies: Penicillin and high blood pressure. The patient had received other medications in two weeks. The patient reported everything was going great. He took a nap 15 hours after shot, woke up hour later and could not move. Fever went to 102.3 and he was shaking so bad and his legs felt like rubber and every time he would try to get up he would fall down. He was so scared he called somebody to come be with him, things got better about 28 hours of terrible pain and serious discomfort. He was in such pain and he need to know if he should arrange someone to be with him for second dose. Event onset date was reported as 16Mar2021 10:00 AM. The event resulted in: Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment was received as paracetamol (TYLENOL EX). Outcome of the event was not resolved.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither relevant medical history nor the concomitant medications have been reported for this patient. The product expired on 01-Jan-2012. On 02-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 02-Apr-2012 and incorporated into the narrative: No late occurring adverse events.
This case was reported by the Health Authority on 04/Oct/2012, the original reporter was the consumer, Ref: GB-MHRA-ADR 21862962. This case is not medically confirmed. A 13 year old female patient patient with with unreported medical history received HPV vaccine, batch and manufacturer not reported, on 01/Oct/2010, dose and route of administration not reported. An unreported time post vaccination on an unreported date, the patient experienced chronic fatigue, post viral fatigue syndrome, aching in limb, dizziness, feeling sick, headache and weakness. The patient had not recovered from the chronic fatigue and post viral fatigue syndrome and the outcome of the remaining events was unknown at the time of reporting to the agency. Pacing was recommended for the patient. The reporter and the agency considered the case to be serious due to disability and being medically significant.
Patient began to complain of hands and arms feeling numb and tingling, feeling of unable to breathe. Pt given a cold wash cloth for forehead and neck. Pt was placed in supine position with feet up. Pt had redness of chest and neck and began to complain of shortness of breath. "Cannot feel my hands." "Throat is closing." Epi-Pen 0.3 mg was given IM on L thigh. Patient stated it did not feel like she was getting better. Nurses tried calming tactics to encourage pt to breath and relax. Pt stated she has had an anxiety attack before, but this did not feel like her last anxiety attack. 911 was called, assessed pt, and referred to ER. Pt and husband drove themselves to local ER to be assessed further.
This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with VAQTA 50/1.0 u/ml (lot number and dose were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Pfizer Covid 19 EUA The patient was a 54 YOF presented with a headache in the observation area. We arrived to find a stable patient with a Chief complaint of a headache. Upon further questioning she had not drank any water today. ED was contacted and a report was generated through Heartland dispatch center.  Incident # 2021-00020233. An AMA was signed by the patient and released.
Patient was given 1st dose of Pfizer monovalent COVID 19 vaccine that was passed the 10 week BUD. BUD was 12/23/2022 and vaccine administered on 12/27/2022.
metallic taste in mouth, throbbing pain behind right ear, throbbing pain in right shoulder and neck, dizziness, partial paralysis of right side of face
body aches; fatigue; sinus pressure; headache; nausea; general flu symptoms; tingle; numb; This is a spontaneous report from a contactable other health care professional, the patient. A 23-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration on 15Feb2021 (23-year-old at the time of vaccination) at 1500 as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on 24Jan2021 at 1100 as a single dose for COVID-19 immunisation.   The patient had no medical history. Prior to the COVID vaccine within the four weeks the patient did not receive any other vaccines. Prior to the vaccine the patient was not diagnosed with COVID-19.  Concomitant medications included ibuprofen(MANUFACTURER UNKNOWN). Patient had not tested positive for COVID-19 since having the vaccine. On 15Feb2021, the patient reported that about three hours after receiving the vaccine, the left side of her face (the cheek beginning at her eyebrow and going down to her jaw) began to noticeably hurt, but mildly enough that she could continue normal activities. Then, within a half hour it began to tingle and soon after went numb for about two or three hours. It returned to normal that evening. On 16Feb2021, the patient experienced body aches, fatigue, sinus pressure, headache, nausea and Just typical general flu symptoms. No therapeutic measures were taken for the reported events. The clinical outcome of the events tingling and numbness were recovered on 15Feb2021; while that of body aches, fatigue, sinus pressure, headache, nausea and general flu symptoms were unknown at the time of this report.   No follow up attempts are needed. No further information is expected.
Pt reported painful swelling in the injection site radiating toward her armpit and down to her elbow.  She denied any shortness or breath or rash.  Called pt back on 8/31 and most swelling had gone down put one tiny red spot on elbow.
PATIENT HAD REDNESS AND SORENESS, AND SOME WARMTH AT SITE OF INJECTION AND AROUND SITE OF INJECTION. PT INFORMED ME ON 08/31 & I CALLED THE DR THE SAME DAY. HE SAID HE SAID PT CAN USE ICE PACKS, BUT SHE CAN COME SEE HIM SO HE CAN LOOK IT. AFTER PT SAW DR SHE TOLD ME DR SAID TO USE ICE PACKS TO HELP WITH REDNESS/SORENESS. SAW PT AT WORK ON 09/05, REDNESS/SORENESS CLEARED AT SITE OF INJECTION AND AROUND INJECTION, BUT NOW PT HAD REDNESS BELOW AND INTERIOR SIDE OF ARM. SHE SAID SHE FELT A LITTLE WARMTH IN THE AREA. PT CALLED ME IN THE AFTERNOON AND SAW THE DR. SHE SAID DR WAS BUSY WITH PATIENTS, SO SHE WAS TOLD TO RELAY INFORMATION TO ME. SHE SAID DR SAID HE IS NOT CONCERNED OF AN INFECTION & PT HAD A POSSIBLE REACTION TO THE SHOTS. SHE SAID HE TOLD HER TO MONITOR THE AREA AND I BELIEVE SHE SAID HE CALLED HER IN SOME PROPHYLACTIC MEDICATIONS TO HER PHARMACY.
Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 24-Oct-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
SEVERE PAIN ON LEFT SIDE OF LOWER BACK. PT SAID IT WAS A COMPLETELY DEBILITATING PAIN THAT FELT LIKE IT WAS COMING FROM HER KIDNEY.  HER PAIN WAS SEVERE THE DAY AFTER VACCINATION AND HAS PROGESSIVELY GOTTEN BETTER THROUGH TODAY. SHE PRESENTED TODAY 4/29 AND SAID SHE WOULD NOT BE GETTING HER SECOND DOSE AS A RESULT OF HOW SHE FELT.