chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician (then the physician handed to the phone to the healthcare worker for additional reporting) refers to a 91 years old male patient with none pertinent medical history and none drug reactions/allergies, who was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 08-AUG-2012. On 20-AUG-2012 the patient developed shingles following vaccination. The physician described the rash as a red, macular rash in the right trigeminal area of the face, right eye and temple are. The physician reported that the rash was migrating over to the left side. The patient sought medical attention, by office visit on 22-AUG-2012. Antivirals (unspecified) and corticosteroids (unspecified) were given as a treatment. None lab diagnostics studies were performed. At the time of report the patient's status was not recovered. The relatedness for shingles was not reported for ZOSTAVAX by reporting physician. Additional information has been requested.
Evening of 1/19/2021 - began to feel tenderness and swelling at left axillary at the lymph area Morning of 1/20/2021 - swelling and tenderness at supraclavicular lymphs and neck region
A different patient was receiving their first dose of their Shingrix vaccination. The person filing the complaint states approximately 15 minutes later while waiting to pick up her husband's medication, claims that a drop of the Shingrix vaccine flew in her eye while she was seated in the waiting area, approximately 2 seats away.  I have a strict method in administering vaccines and I highly doubt a drop went in the person's eye. She did not immediately say anything while the patient was receiving Shingrix. Person states that she didn't experience any effects; however, will be in contact if anything arises.
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA182241, 2018SA182252, 2018SA182254, 2018SA182255 and 2018SA182256 (same reporter). This case involves a patient (age and gender not reported), who received a 0.5 mL dose of vaccine, which on 01-Jun-2018 reached to 52.8-degree F for 43 minutes and on 04-Jun-2018 product reached 48.2-degree F for more than 30 minutes, before patient received 0.5 ml dose of vaccine IPOL lot N1K921M, expiry date: 14-Nov-2019, via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage (product storage error). It was not reported if the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
fever reaching 101 degrees and lasting for approximately 5 hours in total flu-like symptoms (muscle aches, tiredness/lethargy), swollen lymph nodes, sore throat - these symptoms lasted approximately 44 hours At 45 hours post-vaccination (after showering), I noticed hives covering my body from my neck to my hips, both front and back (on my back and my abdomen). These hives lasted almost a full 2 days, and I am still slightly itchy today (5 days post-vaccination). In addition to these symptoms, I had a sore arm from the injection, which was to be expected, but I did not develop a severe rash at the injection site as I did with my second Moderna injection on 03/12/2021. Overall, the benefits of the vaccine far outweigh these side effects, yet I was asked by my pharmacist to report them. Thank you.
A tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured; A tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine; A tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured; Very very painful; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome, bipolar II disorder, allergic to cats, house dust mite allergy and house dust allergy. 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. Concomitant medications included lurasidone hydrochloride (LATUDA), gabapentin (MANUFACTURER UNKNOWN) and lamotrigine (LAMICTAL); all for unknown indication from an unknown date and unknown if ongoing. On 26Feb2021, the patient experienced a tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured which was "very very" painful. The events resulted in doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the reported events and the cyst had to be drained by MD with use of lidocaine (MANUFACTURER UNKNOWN) on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a tiny stable sebaceous cyst on left shoulder became highly inflamed within hours of the vaccine and became large and it ruptured and "very very" painful was resolved on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Per mom approx 10 minutes after imms child started vomiting every 20-30 minutes. No wet diapers for 7 hours. Stopped vomiting after 8 hours. Referred to ER for evaluation. Given Tylenol suppository in ER triage. Left ER AMA before seeing doctor. The following day child had no further vomiting , eating okay, acting normal, t-98.9ax.
Information has been received from a physician, via a company representative, concerning a female college student (age not specified), who on approximately 24-NOV-2006 ("9 months ago") was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included hormonal contraceptives (unspecified). Following the vaccination (duration of time not specified), she developed hives and swelling of her arm. After "about a week" she recovered from the events. The patient sought unspecfieid medical attention. Additional information has been requested.
Red, tender, warm slight swelling at site of injection. (localized reaction)Erythromycin initiated 5/16-5/21), ice to R arm.
COPD exacerbation - treated with IV methylprednisolone, DuoNebs and Levaquin.  She had improvement in her respiratory status and was feeling nearly back to her baseline.. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
I have two rashes on my left arm; Red rash on left arm specifically located in the left medial vein /several red rashes almost a pin point looking red rashes all over my chest and red rashes on left leg near my left knee; Severe headache for the last two days; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 01May2021 at 14:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 14:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. On 10May2021 at 08:00, the patient noticed a red rash on left arm specifically located in the left medial vein. It was approximately a dime size. The patient had two rashes on left arm and had several red rashes almost a pin point looking red rashes all over chest and red rashes on left leg near left knee. The patient was not taking any medications and it was first time to have red rashes like this, it was not itchy however. The patient had a severe headache for the last two days. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red rash on left arm specifically located in the left medial vein, two rashes on left arm, several red rashes almost a pin point looking red rashes all over chest and red rashes on left leg near left knee, a severe headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
left hip tightness; bruise size of a quarter at injection site; (left hip) pain; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (left hip tightness), VACCINATION SITE BRUISING (bruise size of a quarter at injection site) and ARTHRALGIA ((left hip) pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], SELENIUM, CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM) and ASCORBIC ACID, QUERCETIN (QUERCITIN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced LIGAMENT SPRAIN (left hip tightness), VACCINATION SITE BRUISING (bruise size of a quarter at injection site) and ARTHRALGIA ((left hip) pain). At the time of the report, LIGAMENT SPRAIN (left hip tightness), VACCINATION SITE BRUISING (bruise size of a quarter at injection site) and ARTHRALGIA ((left hip) pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
DX COVID-19, Patient presented from assisted living facility to the emergency department with COVID-19 pneumonia with symptoms of upper respiratory infection and elevated lactic acid, she remained on room air without hypoxia.  She was treated with IV fluid with normalization of lactic acid level. Patient is medically stable for discharge back to assisted living facility.
Mother stated that the patient had rash on his left arm where the patient received his 11 year shot. Rash was from his upper arm to his left elbow. Localized rash according to mother. Mother applied ice to the site for the swelling and administer BENADRYL. Mother stated that the patient rash clear up by 1-20-14.
Almost  immediately I had a "knot" at injection site. Tender to touch and warm. "Knot" never did go away and was pink.  One week to the day later injection site became very itchy, red and warm.  Extreme Itching lasted for 2 days. As of today 1/26/2021 there is an approximately 3 in reddened area around injection site, it is warm to the touch and slightly itchy intermittently.
This case was reported by a nurse and described the occurrence of bilateral knee pain in a 57-year-old female subject who was vaccinated with TWINRIX adult, (GlaxoSmithKline). Concurrent medical conditions included possible allergy to antibiotics. Concurrent medications included ulcerative colitis medication. It was unknown whether the subject experienced any adverse events following previous vaccinations. On 28 May 201, at 09"05 am, the subject received 1st dose of TWINRIX adult (unknown route, left arm). On 28 May 2014, at 11:00 pm, approximately 14 hours after vaccination with TWINRIX adult, the subject experienced bilateral knee pain. The subject consulted a healthcare professional regarding the event. No diagnosis was reported. At the time of reporting, the event was unresolved.
Fatigue; Fever; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 43-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 014CZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) dosing remained unchanged.       The patient was a vaccine compromised person, has had vaccine injury.  No concomitant medications were provided by reporter.  Patient was treated with pain medication.   This case was linked to MOD-2021-298180 (Patient Link).
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored ROTATEQ, (route, anatomical location, dose and frequency were not reported), lot # reported as L029615, expiration date 15-MAY-2017, lot # M019706, expiration date 24-OCT-2017. The total cumulative temperature excursion was reported as 117 minutes in high temperature (49.1 Fahrenheit degrees) and 225 minutes, 4 cycles, in low temperature (34.1 Fahrenheit degrees). No adverse effects were reported and no product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA. 7 days after receiving first dose I developed a large red spot at the injection site that was itchy like a bug bite and swollen. The skin felt very hard and hot to the touch. The next day the spot had more than tripled in size and covered most of my upper arm. It didn't cause much pain but it did ache and hurt if I touched it. The skin was very hard and hot to the touch, the itching was mild. Today is the third day since the reaction started and the swelling seems to have lessened, but the red spot is still there and itches.
Patient experienced anaphylaxis to first dose of Covid 19 vaccine.  Throat tightness and swelling.  She received IM diphenhydramine at 4:28pm, followed by dose of epinephrine  IM at 4:30pm and second dose of epinephrine IM at 4:37pm.  Patient was transferred via ambulance to hospital.
Nausea; Headache; Back spasms; Vomiting after second dose; Fever of 101 after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting after second dose), PYREXIA (Fever of 101 after second dose), HEADACHE (Headache), MYALGIA (Back spasms) and NAUSEA (Nausea) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 0025C21A) for COVID-19 vaccination.     No past medical history were reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced VOMITING (Vomiting after second dose) and PYREXIA (Fever of 101 after second dose). On 11-Jun-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Back spasms). On an unknown date, the patient experienced NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VOMITING (Vomiting after second dose), PYREXIA (Fever of 101 after second dose), HEADACHE (Headache), MYALGIA (Back spasms) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.
Flu-like symptoms (chills, fever), Severe pain in arm which received injection. Swelling/redness at injection site.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 71-year-old male patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 1 day after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: On 30th January 2019, the patient was diagnosed with shingles. Emergency room visit was required and the pharmacist did not have any further details. The pharmacist consented to follow up.
Client received Flucelvax PF on 10/23/21 at The Clinic and developed a mild injection site reaction (swelling of deltoid) lasting for less than two days; resolved completely. Client received Moderna booster dose 0.25 ml on 10/30/21 with no immediate reports of side effects to his parents. 11 days after receiving his booster, on 11/11/21, he broke out in a rash throughout his body.
Treatment of COVID-19; Treatment of COVID-19; Sore arm after vaccines.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in right arm and on 24Mar2021 as dose 2, single (Lot number: ER8727) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Lot number: 027C21A), in left arm and on 16May2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL, start date: 31Jan2020; FLAXSEED OIL NATURE MADE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Jun2022 at 06:00, outcome "unknown", described as "Sore arm after vaccines."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022 at 06:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of pain in extremity.  Clinical course: Anti-viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 26May2022, Treatment stop date: 31May2022, Indication: Treatment of COVID-19. Sore arm after vaccines. Lousy taste with Paxlovid. Rebound 08Jun, 7 days after finishing Paxlovid. Patient had no  Known allergies.
Pt started complaining of feeling nauseous and light headed within a hour of his vaccination.  He was able to eat a small meal; however, he started using the bathroom around 12:30pm and the diarrhea and nausea increased as the night progressed  He denies vomiting, but by today he is very fatigued and possibly dehydrated.
Sudden raised itchy red map rash.  Not flat raised. Blistery raise, like a mountain range.  left side is more severe, multiple patches within 3 X 5 inches.  Right leg patches are within 2 X 3 inch, shaped like zebra stripes.  Hot
I had the usual side effects like red, swollen arm near the site.  But, one and 1/2 weeks after shot #1 of my series, I had to go to the emergency room because of a Kidney Infection/Yeast infection.  I find this strange since I never had this problem before and have not changed anything in my lifestyle that would have contributed to this problem except the shot.  I'm currently taking Ciprofloxacine and Phenazopyridine now to stop the infection.  Will this complicate my second shot which happens tomorrow?
Information has been received from a physician concerning a patient who was intended to receive ZOSTAVAX (Oka/Merck) (MSD), was inadvertently administered VARIVAX (Oka/Merck) (lot# not reported) on an unspecified date. The physician confirmed this was a case of human error and not product confusion. No adverse symptoms reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
the flu shot is hardly 10% effective with no adverse event; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via social media.  This case involves an elderly patient of an unknown demographics who experienced the flu shot was hardly 10% effective (drug ineffective), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) reporter stated that major reaction to H1N1 shot-- now it was put in the annual flu vaccine so reporter can't take it. Also for the elderly, the flu shot was hardly 10% effective (drug ineffective).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  There will be no information available on batch number for this case.
Skin felt warm, vomited; hypotonic, hyporesponsive x 3 hrs. Sx fully resolved prior to discharge from ER.
In the morning the day after he noticed his arm was red from the injection site down to his elbow. There was also swelling, pain and it was hot to the touch. It lasted a couple of days,he marked the redness to make sure it was not going farther. He treated with ice pack and anti-inflammatory.
This case was reported by a physician and described the occurrence of leukemia in a 72 year old male who received hepatitis B vaccine recombinant for prophylaxis. The patient's past medical history included diabetes mellitus and allergies to fish and seafood. The patient had no adverse experiences following previous immunization. Concurrent medications included insulin. On 5/14/03, the patient received his third injection of Engerix-B (lot ENG5376B2). The patient pretty immediately began to experience joint pain. The joint pain continued to get worse over the last months. The patient was seen by his physician, who said he has severe arthralgia. The joint pain was worse as of 7/7/03. The reporter considered the event to be possibly related to Engerix B. Additional information was received from the patient, who is a physician, on 7/24/03. He stated that his physician made diagnosis of leukemia and arthritis. Leukemia is considered to be medically serious (OMIC). Therefore, this report has been reclassified as serious.