chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, lot#, expiration date and route were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles.  On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
First day after the injection, a small pustule was found at the site. On day seven, after the injection, a 0.5 inch knot was found at the injection site (not involving the previously mentioned pustule, which had scabbed over). This knot grow over the next 12 hours to be 3-4 inches in diameter. It was tender, red, and hot. After approximately 24 hours, the swelling/knot subsided.  On day 11, post injection, the site was found to have an irregular, red, raised border, approx 3.5 inches in diameter in an almost circular shape.
Patient became dizzy and nauseous with vomiting after HPV 3 dose. No reaction to first 2 doses.
Chest pain ,hurting on the inside; Pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain ,hurting on the inside) and BACK PAIN (Pain in the back) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Around 7 Months ago).    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 CHEST PAIN (Chest pain ,hurting on the inside) and BACK PAIN (Pain in the back). At the time of the report, CHEST PAIN (Chest pain ,hurting on the inside) and BACK PAIN (Pain in the back) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-361232 (Patient Link).
Urticarial rash over body Nausea                                                    Vomiting Diarrhea lasting at least 48hours when seen in clinic
Nose bleeds began the week after the first vaccine dose and continue at one or two per week when bending over, picking up broken branches,  yard waste,  etc.    My husband has so far refused to see a doctor.  Does not have a regular physician.  Did not tell me initially.  Claims to not have had any for past ten days.  Symptoms did not seem to be worse after second dose, but I can't be sure.
pt recvd vax;began unconsolable crying which lasted approx 4 hrs; pt refused to take a bottle;mom cont apap q 4 hrs;no fever or inflammation at inject site;family MD called but did not see pt;
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 6/03/2021 and 7/01/2021. Covid19 + 2/08/22.  Presented to ED 2/8/22 after 3-4 days of Covid sxs w/increasing SOB, wheezing and body aches. Covid+. Admitted for acute on chronic resp failure 2/2 hypoxia-multifactorial 2/2 Covid PNA and COPD exacerbation. Increased O2 demand from home O2 via NC. Remained on NC overnight but was found to be off telemetry early the next morning. Pt was slumped /pulseless, and code blue was called. Intubated and regained pulse twice but then there was no further response.  Treated with decadron. Expired 02/09/22.
PATIENT IS HAVING FULL BODY PAIN AND WEAKNESS, PARTICULARLY IN HER LEGS, SO MUCH SO THAT SHE CANNOT STAND UP. SHE HAS BRUISING AT THE INJECTION SITE, NOTHING ABNORMAL THERE. PT IS TRYING TO GET SOME SLEEP AND SEE HOW SHE FEELS IN THE MORNING, ADVISED TO CALL HER MD IF NO BETTER IN THE MORNING.
Time course to date from 2/22/22 to present. On 2/22/22 I got up out of bed and fell when my feet hit the floor. No pain or weakness prior. A was able to pull myself up used bed post to come to standing. My legs felt numb as if I were walking through mud. From onset to current I use walls and chairs for balance safety,  I use a cane for distance and when tired. Symptoms include frequent falls, bowel incontinence with inability to get to bathroom on time to urinate, balance issues, numbness and tingling, swallowing issues, crawling up stairs, descending stairs one step at a time, inability to climb hills, inability to perform self care, husband installed assistive bars to shower. Inability to walk more than 5 minutes at a time. Unable to navigate long aisles in stores causing me to shop with home delivery which is costly. Weakness/decreased strength both hands. Pins and needles, numbness from feet fingers arms face since onset. very mild to severe like a jolt of electricity. I am unable to get to emergencies quickly at work  and find it a great hardship being at work for a full 8 hours as I become extremely weak. I am unable to carry objects in both hands while walking as I lose my balance and fall.
Patient noticed bruise after she left the  pharmacy when she took the bandaid off.  still has the bruise.  no pain.
First vaccine she was fine. Fever, chills, body aches, head ache and bad soreness in her arm.
only took 1shot/did not take the second shot; burning in my chest that spread to my throat into my mouth; burning in my chest that spread to my throat into my mouth; burning in my chest that spread to my throat into my mouth; Cooking from the injection site that spread across my chest; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (only took 1shot/did not take the second shot), CHEST PAIN (burning in my chest that spread to my throat into my mouth), THROAT IRRITATION (burning in my chest that spread to my throat into my mouth), ORAL DISCOMFORT (burning in my chest that spread to my throat into my mouth) and FEELING ABNORMAL (Cooking from the injection site that spread across my chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (only took 1shot/did not take the second shot), CHEST PAIN (burning in my chest that spread to my throat into my mouth), THROAT IRRITATION (burning in my chest that spread to my throat into my mouth), ORAL DISCOMFORT (burning in my chest that spread to my throat into my mouth) and FEELING ABNORMAL (Cooking from the injection site that spread across my chest). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (only took 1shot/did not take the second shot) had resolved and CHEST PAIN (burning in my chest that spread to my throat into my mouth), THROAT IRRITATION (burning in my chest that spread to my throat into my mouth), ORAL DISCOMFORT (burning in my chest that spread to my throat into my mouth) and FEELING ABNORMAL (Cooking from the injection site that spread across my chest) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported. No treatment medication was reported.
He then felt dizzines and a headache the following day.  On 6/2/2021(4 days after vaccination) he had slurred speech which prompted his family to bring him to ER.  CT brain negative for acute CVA. Pt was placed on DAPT (Plavix and ASA).  On 6/25/2021-- pt was hospitalized again for severe mixed aphasia and dysarthria--- second stroke with hemorrhagic conversion.
PCR; Positive; Nasal Swab; PCR; Positive; Nasal Swab; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL3247), on 01Mar2021 as dose 2, single (Lot number: EL3247) and on 04Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 02Apr2022, outcome "unknown" and all described as "PCR; Positive; Nasal Swab". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Apr2022) Positive, notes: COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: 02Apr sick cough HA stuffy nose and chill d fever and then + PCR test 04Apr2022. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
The patient received the vaccine and there were not issues at the time of vaccination. The patient left the pharmacy and walked to the front of the store. When she got to the front of the store, she fell down. When she was approached, she reported she felt faint and lightheaded and that was why she fell. She did not hit her head or lose consciousness. She was carefully helped into a chair and provided with some water. She sat in the chair for about 20 minutes and tried to stand. When she stood, she felt some pain in her groin and thought she may have pulled a muscle. She did not want to take an ambulance. Her daughter picked her up and took her home. When she left, she was able to walk and was not dizzy or lightheaded anymore.
VARIVAX was administerd following a tempeature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T027301, expiring on 12-AUG-2022, 0.5 milliliter, once, for prophylaxis (route and site of administration were not reported) (product storage error).   The administered dose of the vaccine experienced a temperature excursion of -9°Celsius for 1 hours and 1 minutes. The vaccine had had a previous temperature excursion (no details provided).  There was no product quality complaint was involved.
swelling/numbness left side of face; sob; severe sweating; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (swelling/numbness left side of face), DYSPNOEA (sob), HYPERHIDROSIS (severe sweating) and FATIGUE (fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (swelling/numbness left side of face), DYSPNOEA (sob), HYPERHIDROSIS (severe sweating) and FATIGUE (fatigue). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (swelling/numbness left side of face), DYSPNOEA (sob), HYPERHIDROSIS (severe sweating) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.
MD reported that a 9yo white female was adm MMR in FEB84-pt developed mumps & all the sx; @ the time of the report, she was still recovering; No further details were provided;
Pain in left shoulder/ arm started  approximately two hours after vaccine. Pain  Consistently  getting worse into Wednesday evening to where I was having trouble moving my arm up down behind me a crossed my midsection and out away from my side, pain getting worse intoThursday morning. Called off work Thursday/Friday. Other symptoms subsided after 48 hrs but not the pain in Site area and shoulder.  Saturday not improving went to clinic in afternoon.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-APR-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (expiration date, route and site of administrations were not provided) that was exposed to temperatures outside of the recommended range for 24 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
4 days after vaccine rec'd awoke with 103.5 temp and measles rash over back, chest, all 4 extremities.  Was febrile for about 4 days.  Rash slowly dissipated over a 2 week period.  Speech ceased with the measles rash. Pt now has a diagnosis on the ASD (in process of differntiating PDD vs. Aspergers)
The DTap was given at 12:00 pm on 7/6/17. By 4:00pm on the same day, he was complaining of extreme pain and difficulty walking. He was walking with a limp. Motrin was administered. On 7/7/17, he continued to complain of pain, and there was some localized swelling. By the morning of 7/8/17, he was complaining of extreme pain, and his entire left thigh was red, swollen and hot to the touch. I took a picture, and you can see in the picture that his left thigh is more than twice the size of his right. By Saturday afternoon, the swelling and redness had extended about an inch below his knee and about an inch up into his groin in addition to encompassing his entire left thigh. After being treated with Motrin, multiple epsom salt baths, and  bentonite clay packs throughout the day on 7/8/17, the redness and swelling eventually began to subside by the morning of 7/9/17.
Knocked off his feet; This is a spontaneous report from a contactable consumer or other non hcp (Reporter's Son-in-law). This is report 2 of 4. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included covid-19 from Jul2020 to an unknown date Verbatim: had Covid back in Jul. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced knocked off his feet. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness and inflammation resulting in Rx for Prednisone. Occurred over three days.
Flare up/had reaction to the Moderna COVID 19 booster shot; Sinus Cold; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Cold) and IMMUNISATION REACTION (Flare up/had reaction to the Moderna COVID 19 booster shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In November 2021, the patient experienced SINUSITIS (Sinus Cold). On an unknown date, the patient experienced IMMUNISATION REACTION (Flare up/had reaction to the Moderna COVID 19 booster shot). In 2021, SINUSITIS (Sinus Cold) had resolved. At the time of the report, IMMUNISATION REACTION (Flare up/had reaction to the Moderna COVID 19 booster shot) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Headache, Myalgia, Arthralgia, flushed, chills Narrative:
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 4-years-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (°C) to -10°C for 3 hours and from -10°C to 8°C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).; Sender's Comments:  US-009507513-2205USA008004: US-009507513- 2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
About 8-10 days after the shot I started getting numbness/tingling in my face. I also go the numbness in my legs. My legs felt weaker. I have cold sensations on my skin and sweat dripping from my fingertip.
Patient noticed blotches on both legs approximately 6 to 7 days after vaccine was administered.  On 03/30/2021, patient fell to ground, unable to get up.  Patient was taken by ambulance to Hospital  emergency room.  Scans revealed patient had multiple blood clots and was operated on.  Later in the stay, patient developed widespread hematomas in groin, stomach, rear, and both legs.  Patient was released from hospital on 4/8/2021.
The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-2022; No adverse event; Patient used Moderna Covid-19 vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-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 (Patient used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administered on 05-Aug-2022). No concomitant medications were reported. The patient received second booster dose. The vial was initially stored in the refrigerator on 30-Jun-2022. Vial did not undergo any temperature excursions. No treatment information was provided.
tunnel vision; dizziness; headache in different regions; A spontaneous report received from a consumer concerning a 47-years-old  male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, tunnel vision, and headache in different regions.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient experienced dizziness, had tunnel vision and headache in different regions. Went to the ER.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events,Tunnel vision, dizziness and headache in different regions, was unknown.; Reporter'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.
ACUTE ONSET OF ARTHRITIC SYMPTOMS IN BOTH HANDS - STARTED ABOUT 24 HOURS AFTER DOSE 2.  TOOK IBUPROFEN AND ACETAMINOPHEN.  RESOLVED WITHIN 24-30 HOURS LATER.
This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported for a male patient an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had his first dose of COVID-19 vaccine on 08Feb2021. Since then, he had a medical diagnosis of cancer and he needed chemo treatment and now it's been over the 6-week window from his first dose. The pharmacist was inquiring if the patient can have the second dose of the vaccine. Outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, the event "medical diagnosis of cancer" is likely to be an intercurrent event unrelated to the use of suspect product BNT162B2. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.