chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed redness initially, at the vaccine site, right upper arm.  Then developed papules over the upper arm, (within 24-36hrs), with some red papules/urticarial like on the thighs.  No fever or systemic effects.  Appetite normal, activity normal, no respiratory effects.  Only treatment topical corticosteroid for mild itching.
26SEP96 pt came into clinic for 2nd vax & stated p/1st vax arm painful, red, swollen;checked by RN no redness or swelling noted just tiny  pinhead size appeared;pt sent to see pvt MD;
Pt reported feeling dizzy and showed signs of a vasovagal . Pt was moved from vaccine chair to observation unit via wheelchair where he was observed lying down. His vitals after 10 minutes were 149/76. Pt reported feeling better and BP at 1830 was 129/76. Pt ambulated out of the facility accompanied by Dr.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 17-JAN-2014, a pharmacist administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot number not provided). On or about 16-JUN-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
About 5 minutes after injection patient report bilateral swelling and itching.  Mild erythema noted, no other rash or open areas.  No hives, or raised lesions.
woke up little dizzy and kind of been that way all day.; receive both the COVID-19 vaccine (one that is supposed to be the latest booster) and a Flu vaccine; receive both the COVID-19 vaccine (one that is supposed to be the latest booster) and a Flu vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 12Oct2022 as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Oct2022, outcome "unknown" and all described as "receive both the COVID-19 vaccine (one that is supposed to be the latest booster) and a Flu vaccine"; DIZZINESS (non-serious) with onset 15Oct2022, outcome "unknown", described as "woke up little dizzy and kind of been that way all day.". Additional information: Patient did receive both the COVID-19 vaccine (one that was supposed to be the latest booster) and also received a Flu vaccine immunization that was on Wednesday this week, the 12th. Patient didn't really had a problem until this morning, kind of woke up little dizzy and kind of been that way all day. Patient asked can a reaction happen like 60 hours later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have a large circular rash at the injection site that itches. It?s been itchy for about 4 days now. Tonight I decided to look at my arm in the mirror and noticed the rash. I don?t know when the rash developed.
Patient Vaccinated x2 (Moderna: 5/10/21, 6/7/21)  Patient hospitalized and tested COVID positive on 8/20/22
Patient reported "not feeling well" at 6 pm. Then swelling to face, neck, hands, legs, feet. Denies difficulty breathing. Denies fever. Patient is a security gaurd for the hospital and left the facility without seeing the ER physician. Traveled home and took benadryl 50mg and soaked body in ice water. Then contacted the employee health nurse who administered the vaccine. He was encouraged to go to ER, but refused stating the swelling was gone and he felt better. Follow up call the next day revealed joint aching, sorness, but no swelling, difficutly breathing, rash, or fever. Encouraged to be seen in ER, refused.
Patient stated she was experiencing nausea following receiving the vaccine.  Client was evaluated by  Fire Rescue.  Client was released to go home at 8:40 am.  Per Fire Rescue no additional evaluation needed.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: FACIAL, HAND, AND FEET NUMBNESS
Incredibly achy all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 11:30 (Lot number: EP6955) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Product- COVID-19 Vaccine, Lot number- EL3247, Administration Date- 04Mar2021, Administration Time- 11:30 , Vaccine location: Left Arm), administration date: 04Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 25Mar2021 22:00, outcome "recovering", described as "Incredibly achy all over my body". Therapeutic measures were not taken as a result of pain. Additional information: Patient was 41-years-old male and the age at vaccination was 41-years-old. The reported seriousness of the events was non-serious. Patient experienced incredibly achy all over his body on 25Mar2021 22:00 (10 hours and 30 minutes after vaccination). As the patient, he became aware of the adverse event on 25Mar2021 at 22:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient had no known allergies to medications, food, or other products. The outcome of the event was resolving without any treatment.   No follow-up attempts are possible. No further information is expected.
Phone call received from client, stated that the upper arm is "like a bruise burn down to crease in my elbows."
PATIENT EXPRIENCED FLU LIKE SYMPTOMS DAY AFTER THE VACCINE (WEAKNESS, LETHARGY, BODY ACHES) BUT NO FEVER. SYMPTOMS HAVE SUBSIDED.
This spontaneous report as received from a physician via a company representative refers to an 80-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in approximately 2014 (reported as 2 to 3 years ago), the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) for prevention of shingles. On an unknown date, after getting ZOSTAVAX, the patient experienced shingles. The patient sought medical attention by seeing a physician and received unspecified treatment for the adverse event. The outcome of shingles was reported as not recovered/not resolved. The relatedness between the adverse event and ZOSTAVAX was not reported.
This spontaneous report as received from a registered nurse refers to multiple number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. ON an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (dose and route of administration not reported) lot # K026666, expiration date 22-OCT-2106, that were improperly stored. There were no adverse effects reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been  requested.
pt recv vax & devel an inj site rxn characterized by pain, swelling, warmth, & tingling; No further information was available at the time of this report. This report was received from IMS/Medeva (Ref #96-009A).
Pt. noted right upper arm soreness later that day after the injection. Came in following afternoon, large "hive", red swollen area to bicep (Rt) upper arm and tricep area (Rt) upper arm. Itching, pain, sore.
warm rash around the injection site; warm rash around the injection site; I am itchy all over; sore achy joints; achy muscle/ sore achy muscle; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 24th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced joint pain, myalgia, chills and headache. On 27th February 2020, the patient experienced injection site rash, injection site warmth and generalized pruritus. On an unknown date, the outcome of the joint pain, myalgia, chills and headache were recovered/resolved and the outcome of the injection site rash, injection site warmth and generalized pruritus were unknown.   It was unknown if the reporter considered the joint pain, myalgia, chills, headache, injection site rash, injection site warmth and generalized pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of shingrix vaccine 72 hours ago from reporting date and experienced sore achy joints and muscles, chills, headache, which subsided after 48 hours. On 27th February 2020, in morning patient also discovered a warm rash around the injection site and patient felt itchy all over. The patient wanted to know how long these side effects might last
Ultra high pitch, continuous ringing or hissing in both ears characterized as tinnitus. Around day ten the tinnitus ceased in left ear but continues in right. Intensity varies from day to day and never disrupts sleep or poses any difficulty in hearing or concentrating. I mention the pitch as any momentary tinnitus I've experienced in my life were fleeting (minute or less), accompanied by muffled hearing, and much lower pitch. Tinnitus persists to today, 4/7/21, and I've scheduled my first appointments for intervention with a specialist (ENT).
left facial droop; given prednisone 20 mg day; prednisone 20 mg day; prednisone 10 mg day; near full improvement
Narrative: COVID infection following COVID vaccine series 01/12, MODERNA, dose #1 02/09, MODERNA, dose #2 03/08 COVID swab, result: not detected 09/0 pt cc: cough, fatigue, loss of smell or taste, fever exposure: unknown 09/09 COVID swab, result: detected 09/09 SARS-COV-2 Variant Sequencing result: pending
15-20 minutes after the injection, the patient began to become tremulous. Vital signs showed elevated HR and BP. Within a few minutes patient began to experience slurred speech, followed shortly by seizure-like activity - clonic movements. Pt dis not lose consciousness but had intermittent difficulty responding to questions. Patient was brought by EMS to nearby emergency department.
Hot to the touch Injection Site (After Second Vaccine); Swelling Doubled up in Size (Involving the entire Upper Arm); Itchy Injection Site (After Second Vaccine); Hard to the Touch Injection Site (After Second Vaccine); A Little Swollen Injection Site (After Second Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch Injection Site (After Second Vaccine)), PERIPHERAL SWELLING (Swelling Doubled up in Size (Involving the entire Upper Arm)), VACCINATION SITE PRURITUS (Itchy Injection Site (After Second Vaccine)), VACCINATION SITE SWELLING (A Little Swollen Injection Site (After Second Vaccine)) and VACCINATION SITE PAIN (Hard to the Touch Injection Site (After Second Vaccine)) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (A Little Swollen Injection Site (After Second Vaccine)). On 06-May-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site (After Second Vaccine)), PERIPHERAL SWELLING (Swelling Doubled up in Size (Involving the entire Upper Arm)), VACCINATION SITE PRURITUS (Itchy Injection Site (After Second Vaccine)) and VACCINATION SITE PAIN (Hard to the Touch Injection Site (After Second Vaccine)). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch Injection Site (After Second Vaccine)), PERIPHERAL SWELLING (Swelling Doubled up in Size (Involving the entire Upper Arm)), VACCINATION SITE PRURITUS (Itchy Injection Site (After Second Vaccine)), VACCINATION SITE SWELLING (A Little Swollen Injection Site (After Second Vaccine)) and VACCINATION SITE PAIN (Hard to the Touch Injection Site (After Second Vaccine)) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Unable to climb stairs, walk or stand up. Nausea. Fever. Shaking. Headache. Diarrhea. Starting about 12 hours after vaccination. Most severe symptoms cleared in 24 hours, but did not feel 100% for 3 days. Missed 1 day of work. Slept 18 of the 24 hours.
Feb. 26, 2021, swollen and tender lymph gland on left side of throat. Feb. 27, 2021, swelling and tenderness is reduced. No other symptoms.
Standard viral aches within 24 hours after vaccination, then recovery. Within a week, I became very itchy, with raised blotches on my skin that caused a desire to itch until bleeding, which I did often. The intense itching lasted for several weeks, only being soothed with cool compresses and hydrocortisone cream. In the insueing months, I went through several tubes of the cream.  The itching would have periods of flaring up, where sometimes it would be unnoticeable, then come back, for example, at night in several areas, across my chest, back, arms, neck, or legs. The location of these patches seemed random, although a specific patch may be triggered by irritation from a particular item of clothing.   I largely don't have them anymore, almost 6 months out, but my skin does become raised after scratching, which had not happened prior.
Diarrhea; My eyesight is degraded; She was exposed to a covid patient; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6201; Expiry date: unknown), via an unspecified route of administration as a single dose on 17Feb2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient mentioned she was exposed to a covid patient on 20Feb2021 but she believed it was on 20Feb or the 21st. On an unknown date, the patient developed diarrhea and the patient could barely read the LOT number as she was 79 years old as her eyesight was degraded. The events assessed as non-serious. Patient had concern if we had specific information on this and if it will still be safe for her to get her second shot of the vaccine. she was exposed to Covid. She stated she was not tested and was exposed, somebody came into her house with COVID. Patient had concern regarding how will this impact the fact that she will receive the second shot in other two weeks from now and I just received the shot like a few days before I was exposed shortly in the time after receiving the vaccine. She was exposed to Covid from her son possibly 3 or 4 days after getting vaccinated. The clinical outcome of the events was unknown.  Follow-up: (24Feb2021): This is a spontaneous report from a contactable consumer. This is a female consumer reported for herself that: The reporter was not a health care professional. It was unknown if the reporter's contact information available to you or a sub-contracted party. . Consumer further stated, "she doesnt believe there was a problem with the vaccine, and that was not her concern. There was no concern with the LOT# of the vaccine, the concern was special circumstances because she was exposed shortly in the time after receiving the vaccine."  No follow-up attempts are possible, information about lot/batch no. cannot be obtained.
This spontaneous report as received from a registered pharmacist via a company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified) subcutaneously. No concomitant medications were reported. On an unknown date, the patient developed swelling in his entire arm after receiving the vaccination and was angry about the swelling. The patient sought an unspecified medical attention. It was unspecified if the patient was treated or if any lab tests were performed. The outcome of swelling in his entire arm and was angry about the swelling was unknown. The relatedness for swelling in his entire arm and was angry about the swelling was unknown for ZOSTAVAX. Additional information has been requested.
Fever, abdominal pain, severe diarrhea. Generalized pain - required IV fluids on 2 occasions. Lasted at least 48 h.
Stroke requiring 911 call and subsequent hospitalization after seen in ER. Heart Arrhythmia after stroke and subsequent hospitalization after seen in ER.
Patient reported C/o redness and soreness at injection site. Observed slight bruising / redness at injection site area on 4-30-09.
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had a 3 doses mixed primary series (first and second were Pfizer, third was Moderna)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer (first dose, lot EN6206, expiry date 30Jun2021.) on 09-Mar-2021, Pfizer (Second dose, lot EP6955 and expiry date 30Jun2021) on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised. Concomitant products included METHOTREXATE, GOLIMUMAB (SIMPONI), MESALAZINE (PENTASA), LAMOTRIGINE (LAMICTAL), FUROSEMIDE (LASIX [FUROSEMIDE]), ESOMEPRAZOLE MAGNESIUM (NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]), OMEGA-3-ACID ETHYL ESTER (LOVAZA), FAMOTIDINE (PEPCID [FAMOTIDINE]) and SODIUM for an unknown indication. On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had a 3 doses mixed primary series (first and second were Pfizer, third was Moderna)). On 19-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had a 3 doses mixed primary series (first and second were Pfizer, third was Moderna)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication were provided
Chills, sweats, erythema at shot site and lymphedema of entire Right upper arm.
Positive Covid test after a few days of symptoms: fatigue, congestion, cough/post nasal drip. Sick for about 5 or 6 days.  Used albuterol to help with cough.
Shingles outbreak; This case was reported by a consumer via sales rep and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 20th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The patient received their first dose of Shingrix at pharmacy and had an outbreak of shingles. Till the time of reporting, the patient had not received second dose of Shingrix. Upon following up with the patient, the patient stated the shingles outbreak was less severe than before she received her first dose of the Shingrix vaccine. The reporter provided permission to contact healthcare professional (primary care physician). The reporter consented to follow up. No additional details were provided by the reporter.
Symptoms were: fever with chills, muscle aches, headache, mild nausea and dizziness, flushed skin. These symptoms lasted about 12 hours.
diarrhea; gas; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and FLATULENCE (gas) in a 71-year-old female patient who received mRNA-1273 for COVID-19 immunisation.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and FLATULENCE (gas). At the time of the report, DIARRHOEA (diarrhea) and FLATULENCE (gas) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was provided.   Reporter did not allow further contact
Information has been received from a physician concerning a 25 year old female with a history of obesity who on 25-OCT-2007 was vaccinated intramuscularly in the left arm with the first dose of Gardasil (657621/0387U).  Concomitant therapy included NUVARING.  On 25-OCT-2007 the patient experienced a rash on both arms immediately after vaccination and the rash has now spread to the legs.  The patient's rashes on both arms that has spread to legs persisted.  The patient sought unspecified medical attention in the physician's office.  There were no other details.  Additional information has been requested.