chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vials were punctured 18 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vials were punctured 18 hours ago) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vials were punctured 18 hours ago). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The vials were punctured 18 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Reporter was not sure how may patient was given with the vaccine.
Information has been received from a certified medical assistant concerning a who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Some time after receiving the vaccine the patient developed chicken pox. It was unknown whether medical attention was sought, the patient's outcome was unknown. No product quality complaint was involved. This is one of two patients of same source. Additional information has been requested.
awful; hoarseness; This is a spontaneous report received from a contactable consumer (patient), based on information received by Pfizer. (manufacturer control number: EC-2021-090533) for BNT162B2.   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization; lenvatinib mesylate (LENVIMA, lot number: not reported) via an unspecified route of administration on 26Mar2021 at 20 mg and pembrolizumab (KEYTRUDA) via an unspecified route of administration on an unspecified date at an unspecified dose both for an unspecified indication. Medical history included C54.1 endometrial cancer. Concomitant medications were not reported. Patient previously took fluoxetine. She stated that she got her first COVID shot (unsure which one) and her first Keytruda infusion as well. She felt "awful" for a day or two after all three were on board but feels much better today. Patient also reported hoarseness. Outcome of events was unknown.   Lot/batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).  On 2nd December 2021, the patient received the 2nd dose of Shingrix. On 2nd December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were reported as follows: The age at vaccination was not reported. A patient received the 2nd dose of Shingrix earlier than recommended interval which led to shortening of vaccination schedule. No symptoms reported. The reporter consented to follow up. Health care professional (HCP) stated the patient was not immunocompromised. The HCP did not have the patient's DOB or the lot/exp.
soreness and stiff yat the die if injection for 2 days  took tylenol to treat pain
Twitching or jerking of feet and hands; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 06Mar2021 at 07:00 as a single dose for COVID-19 immunisation. Medical history included latex allergy. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced twitching or jerking of feet and hands. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event twitching or jerking of feet and hands was not recovered at the time of this report.
Death ABDOMINAL PAIN BACK PAIN J18.9, J91.8 - Pleural effusion associated with pulmonary infection E87.1 - Hyponatremia N13.2 - Hydronephrosis with renal and ureteral calculous obstruction C79.9 - Metastatic disease (CMS/HCC)
Initial misuse report received from a healthcare professional on 21 February 2014. The cases were received on 21 March 2014. A 56 years old patient received FLUZONE HD (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
I had a tingling from head to toe within five minutes of the vaccine. I woke at 3am with a metallic taste in my mouth. Twelve hours after the vaccine I had fever, chills, joint pain, muscle pain. It was like a really bad Fibromyalgia flare up. I took some Tylenol which helped with the pain. In the morning the fever was 100.4 and I had chills. I had a really bad headache which was a five out of ten and I was trying to stay hydrated. I had a dry tickling cough which was just one cough that I couldn't control. It also didn't feel like I could get enough air. I have had a dry cough when I take a deep breath or when talking. I couldn't even talk without having that uncontrollable cough. I started to take NAC six weeks after the shot because a friend said that it helped her. I started taking that and it really improved my symptoms within two weeks. I have history of surviving wildfire smoke. The cough seems to be under control at the moment.
CHIEF COMPLAINT:   Pt arrives via EMS with diff breathing. Sats upon EMS arrival 87%RA, placed on Non Re - 97%. Pt weak and unable to answer many questions. Fever upon arrival. Pt possible CoVid, states is vaccinated.   HISTORY OF PRESENT ILLNESS:     pt with covid sx for 5-6 days. went to doctor and test +, had MAB tx earlier today. noted to be difficult to wake up after laying down for nap. took nothing for fever as was drowsy. pt denies pain. Denies nausea, vomiting, diarrhea, or abdominal pain. hx somewhat limited as she is somnolent.
Localize reaction left arm 24 hours post vaccination. Warm, red, itchy, no treatment needed.
Red, swollen, warm area measuring 10x6.5cm to area directly under administration point. Pt c/o itching, burning, to site as well as night sweats.  ATB ordered doxycycline 100mg x 10 days.
Went to Urgent Care 01/17/2021.  High blood pressure and sent to ER.  R/O stoke.  Gave 3 steroids and antiviral for 10 days.  Was diagnosed with Bells Palsy.  Has facial and facial drooping.   Left eye will not blink and has to use omit to keep eye moist.
mild headache; arm pain was minimal; but I did feel a little lightheaded immediately.; slight temperature elevation; fatigue; 24 hours later I had a nosebleed (not common for me); This is a spontaneous report from a contactable consumer. A 49-year-old non-pregnant female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179 and expiry date Aug2021) via an unspecified route of administration on 30May2021 at 10:00 AM on left arm (at 49-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history, concomitant medications, prior vaccinations and relevant tests were reported as none. Patient had no history of allergies, and no other vaccine was received in four weeks. The patient did not have covid prior to vaccination and was not tested for covid tested post vaccination.The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0169) intramuscular route of administration on 09May2021 at 06:00 PM on left arm (at 49-year-old), as dose 1, single for COVID-19 immunization and experienced arm pain. On 31May2021 at 11: 00 am after the second shot, arm pain was minimal, but patient did feel a little lightheaded immediately, slight temperature elevation, fatigue and a mild headache. On the same date (31May2021) at 01:00 PM she had an unexplained nosebleed. Patient does not get nose bleeds. There was no injury or banging to nose or face. The blood just began dripping as patient was sitting on a chair relaxing in the backyard. No treatment was received for events. On an unknown date in 2021 nosebleed recovered. The outcome of rest of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Sore throat; Lower back pain (rated as 9/10),; Dry mouth; Pain on both legs (7/10); Severe chills; Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)) and CHILLS (Severe chills) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)), CHILLS (Severe chills) and ARTHRALGIA (Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking)). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)), CHILLS (Severe chills) and ARTHRALGIA (Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking)) had not resolved.            The concomitant medications were not provided. The treatment information was not provided.  The action taken with mRNA 1273 with the events were considered as not applicable.
Massive/Painful headache. Member was not able to complete the work day or tasks given. Slight swelling in right shoulder.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; FLOVENT. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Negative; (18Apr2022) Positive; (24Apr2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient had not received other medication in 2 weeks. The patient was given COVID 19 Treatment with anti-viral medication from 09Apr2022 to 13Apr2022. Patient tested negative on 16Apr2022, and then cough, congestion, sore throat and exhaustion returned on 18Apr2022 with positive Covid test. Tested negative again on 24Apr2022..  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea, Vomiting, head ache, injection site raised, fatigue,  body aches
patient fainted about 2 minutes after vaccine was given and then once on floor jerked a little bit - once he came around, we gave him pepsi and cookies and stayed with him until he felt better . I am glad his father was with him and anticipated the response since no indication was made that he was prone to respond this way to vaccines
maternal vaccine exposure with no reported adverse event; Initial information received on 31-Aug-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 35-year-old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent] in context of maternal vaccine exposure with no reported adverse event.  Data regarding this pregnancy were received prospectively. The reported maternal vaccine exposure with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date is 31-Oct-2023. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 31-Aug-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine suspension for injection (strength: unknown) (lot: UT8040NA, expiry date: Jun-2024) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) and patient had maternal vaccine exposure with no reported adverse event (maternal exposure timing unspecified) (latency: same day).  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone Quadrivalent) was not applicable.  Outcome: Unknown.  Additionally, at time of reporting, the pregnancy was still ongoing.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shingles. Concomitant products included acyclovir. On 30th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 30th January 2019, less than a day after receiving SHINGRIX, the patient experienced chills. On 31st January 2019, the patient experienced tremor and unable to walk. On an unknown date, the patient experienced headache and neck pain. The patient was treated with lorazepam. On an unknown date, the outcome of the chills, headache, neck pain and unable to walk were unknown and the outcome of the tremor was not recovered/not resolved. It was unknown if the reporter considered the chills, tremor, headache, neck pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX at night, the patient experienced chills when going to sleep. The next morning the patient got up and experienced tremors that progressed to the point where she could not walk and was taken by ambulance to emergency room (ER) around 12:30 PM the next day. The patient was not admitted to hospital and was prescribed Lorazepam and sent home. Less than a month after receiving SHINGRIX, the patient had developed severe headache and neck pain as well related to the tremors. The reporter consented to follow up.
Erythema, warmth, induration, tender to touch, and pain localized to the site of injection.
About 15 min after receiving the vaccine I started feeling flush and nauseated Vitals taken and bp and pulse was a little elevated about 10 min later I started having redness on my chest and neck vitals bp even higher and pulse as well I was then feeling dizzy and hard to swallow Epi was administered and EMS called
The pediatric patient received an adult dose of the Pfizer/BioNTech vaccine instead of the pediatric dose. Patient had no side effects or symptoms. The Pharmacist did daily follow up to check on the patient.
Day 1 - day of vaccine at 3:00 pm - no adverse effect Day 2 - full body ache, migraines, chills, fever Day 3 - nosebleed at 7:00 AM, allergic reaction on both thighs at 8:30 AM- noon, migraines &coughs throughout the day Day 4 until today - frequent coughs with mucous.
pt recv vax & devel Bell's Palsy; sx included h/a, confusion, & double vision; reporting MD indicates that the pt was referred by an internist, dx was based on taking the pt's hx & questioning the pt;
Woke up the day after receiving my 1st dose of the Pfizer Covid 19 vaccine. Immediately noticed that I had no sense of smell or taste at all. Experienced flu like symptoms for a few days after but those eventually went away. As of today I have not had my taste or smell return. Now 27 days since receiving vaccine for emloyment, I still am unable to smell or taste as I did before receiving the vaccine.
Headache; tachycardia due to dehydration; Arm soreness; Fever 100F; Chills; Nausea and vomiting; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills) and NAUSEA (Nausea and vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol, SERTRALINE for Depression, CLONAZEPAM for Sleeplessness.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills), NAUSEA (Nausea and vomiting) and VOMITING (vomiting). On 03-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills), NAUSEA (Nausea and vomiting) and VOMITING (vomiting) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: high (High) High,100F.         Physician advised the patient to drink water for the symptoms caused due to dehydration. However patient experienced headache while doing any type of forceful acts like coughing, sneezing, clearing throat and bending down.
Information has been received from a pharmacist referring to a 81 year old female patient who had no pertinent medical history. The patient was allergic to codeine and penicillin (unspecified). The patient didn't have any concomitant medication (reported as nothing related, different or new). On 25-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 0.5ml (intramuscular, 0.5ml once, lot # R012632 and expiration date 15-JAN-2020) for prophylaxis (reported as age indication). From 26-OCT-2018, the patient had swelling redness and itching at the injection site. On 29-OCT-2018(at time of the report), the patient had been recovered from the events. No treatment was given for the events. No lab diagnostics/studies were performed. The patient did not seek medical attention. The causality was not reported.
Right deltoid, red, hot, indurated area no fluctance or real tenderness. Use ice pack per doctor - patient not to receive anymore DT's
she developed swelling between her neck, collarbone, and shoulder; swelling between her shoulder; The site is "extremely tender" to the touch; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on 18Apr2021 as single dose for covid-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr-2021, patient developed swelling between her neck, collarbone, and shoulder, on the same side that the vaccine was administered on and the site is "extremely tender" to the touch on an unspecified date. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash began on trunk, spread to back, itching, fever 100, many papules with small vesicles noted.
This spontaneous report was received from medical assistant via physician and refers to a 21 year old female patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 11-MAY-2016, the patient was vaccinated with improperly stored GARDASIL 9 (dose 1) for prophylaxis. On 11-JUL-2016, the patient was vaccinated with dose 2 of GARDASIL 9 for prophylaxis. This is one of the several reports received from the same reporter (1703USA010036, 1704USA010413 and 1704USA010495). Additional information has been requested. Sender's Comments: US-009507513-1703USA010036: US-009507513-1704USA010413.