chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching Rash / Hives  It started slowly early in the afternoon and progressively got worse. It would start maybe on my arm then move to my calf, then would go away and then it would start up again on my chest or thigh .it rotated around my body no hands, feet or head  , and the itching was driving me crazy.
2 supraclavicular nodes on L (node 1- size of dime; node 2- size of penny); nodular swelling noted on March 28, 2021; symptoms still present. L arm swelling/ tenderness/ pain at injection site noted on March 27, 2021; symptoms are improving.
After  four days I still have some pain in the injection site.  My muscles in my upper legs are sore and throbbing.  I still feel fatigued,  very tired, and a headache.   My entire body aches.
The pt received the vaccines on 7/30/1996 and was then diagnosed with Varicella on 2/23/01. The pt was exposed 10 days prior to eruption.
Patient received vaccines- DTAP, IPV and MMRV as part of his 4 year annual physical exam.  Discharged.  Returned about 1 hour later (walk in) with mother stating that his eyes were red and puffy.  He was seen immediately by a nurse practitioner.  There was minimal redness and swelling of eyes, otherwise negative exam.  Given 12.5 mg PO Benadryl.  Observed.  After 10 minutes he became lethargic and less responsive.  MD exam, epinephrine administred.  Taken to ED.  Observed for 4 hours without further intervention and then discharged.  No symptoms at discharge.
Patients get injection site pain; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 22nd November 2022, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: HCP (Health Care Professional) mentioned in general he had seen patients get injection site pain. The reporter did not consent to follow-up.
w/in 5 minutes of getting MMR pt had quarter size whelp w/redness approx 2-3 inches surrounding whelp @ inject site; crying inconsolably; called MD office per moms request; MD gave pt DPH & told mom to watch pt;
Patient received Pfizer BioNTech COVID-19 Vaccine at approximately 9:43am. Patient was then sitting in the post-vaccination waiting area in a chair and at approximately 9:46am when patient had syncopal episode and fell to the floor off of his chair. Pharmacist ran out to help patient who came to after approximately 5 seconds of being unconscious. Patient rested on floor for approximately 30 minutes before he felt comfortable enough to rise. At this time the patient's mother presented to the pharmacy to help. Mother reported that the patient and his sister have had previous episodes of syncope. Previous episodes were not reported by patient on consent form prior to vaccination. Patient left the store with his mother declining to fill out accident form with store management.
First symptom was vomiting. Vomiting lasted 6 days - 2 to 3 times a day. No treatment given. Second symptoms was red rash/ hives over torso, neck, arms, legs. Rash started 01/06/17 and lasted 5 days. Doctor recommended Benadryl.
skin started feeling funny; itchy spots on arm the size of bug bites; red  itchy spots on arm the size of bug bites; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN DISORDER (skin started feeling funny), VACCINATION SITE PRURITUS (itchy spots on arm the size of bug bites) and VACCINATION SITE ERYTHEMA (red  itchy spots on arm the size of bug bites) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy spots on arm the size of bug bites) and VACCINATION SITE ERYTHEMA (red  itchy spots on arm the size of bug bites). On an unknown date, the patient experienced SKIN DISORDER (skin started feeling funny). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (skin started feeling funny), VACCINATION SITE PRURITUS (itchy spots on arm the size of bug bites) and VACCINATION SITE ERYTHEMA (red  itchy spots on arm the size of bug bites) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
started to itch; arm was red at injection site; swollen; fever 100.2F; Arm started to hurt at night/arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started to hurt at night/arm was sore), VACCINATION SITE PRURITUS (started to itch), VACCINATION SITE ERYTHEMA (arm was red at injection site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever 100.2F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0280L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes, Blood pressure high, High cholesterol, Cardiac arrhythmia, Mitral valve prolapse, Hyperaldosteronism, Anemia, Neuropathy, Diverticulitis, Sleep apnea, Gout, Occlusion retinal vein (in right eye), Goiter, GERD and COVID-19 (tested positive for COVID-19 in November 2020) in November 2020. Concurrent medical conditions included Allergic reaction to drug (Propulsid) since January 2021 and Allergic reaction to drug (Bactrim) since January 2021. Concomitant products included ALOPURINOL, ATENOLOL, GLIMEPIRIDE (AMARYL), SPIRONOLACTONE (ALDACTONE A), WARFARIN SODIUM (COUMADIN) and PRAVASTATIN SODIUM (PRAVACHOL) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt at night/arm was sore). On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red at injection site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever 100.2F). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (started to itch). On 28-Jan-2021, PYREXIA (fever 100.2F) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm started to hurt at night/arm was sore), VACCINATION SITE PRURITUS (started to itch), VACCINATION SITE ERYTHEMA (arm was red at injection site) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included Tylenol.   This case was linked to MOD-2021-091979 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information, address and second dose details updated.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Minor Vertigo on Sat evening 3/6/21. Moderate Vertigo event on Sunday morning 3/7/21. Both of these events subsided with an hour or so after laying down. Severe vertigo event Tuesday morning3/9/21 after dental cleaning (reclined in dental chair from 30 minutes) lasted several hours and then subsided after reclining for 2 hours.
approx 6mos p/vax pt exp varicella lesions w/fever & extreme irritability;hosp 5/27/99; dx w/group A streptococcal sepsis & aortic valve endocarditis s/p varicella;  Annual follow-up received on 11/27/00 provided no additional data.
TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-718) was received from a pharmacist on 25-Mar-2019. It describes a female consumer who "took two doses in a row", while being on Vivotif for an unknown indication.   Case report: The consumer took the first two doses in a row. The doses were taken on 21-Mar-2019, 22-Mar-2019, and then on 24-Mar-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two doses in a row" was unknown.
frequent numerous loose stools, gas, bloating, myalgia and arthralgia, swollen lymph nodes in neck, headache, chest pain
Under my left arm and my left side chest has swollen, it feels swollen inside can't move my arm up based on the vaccine; Under my left arm and my left side chest has swollen, it feels swollen inside can't move my arm up based on the vaccine; my left side chest has swollen; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 11:30 (Lot number: Ph8020) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID prior vaccination" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0173, Location of injection: Arm Left, Vaccine Administration Time: 16:30), administration date: 28May2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0167, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 11May2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious) all with onset 14Nov2021 16:30, outcome "unknown" and all described as "Under my left arm and my left side chest has swollen, it feels swollen inside can't move my arm up based on the vaccine"; SWELLING (non-serious) with onset 14Nov2021 16:30, outcome "unknown", described as "my left side chest has swollen"; IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "Dose Number: 3". Therapeutic measures were not taken as a result of peripheral swelling, mobility decreased, swelling.  Additional information: No known allergies was reported. Events required no prolonged hospitalization. The patient had not received any other vaccine within four weeks prior to the COVID vaccine. The patient was not tested for Covid-19 since vaccination. Device date was reported as 14Nov2021.  Follow-up attempts are completed. No further information is expected
Chest tightness, radiating to my neck to my jaw to my face to my head and giving me headaches,  a week later I started having shortness of breath,  I feel some mucus inside my chest and causing me to vomit and mucus are coming out.
A day after the patient received the vaccine, they noticed irritation and a light rash not localized to the injection site. Patient consulted their doctor who suggested the events could be related to the immunization.
Headache, Myalgia, Arthralgia, Fever, body aches, fatigue Narrative: Pt reported the following ADRs the day after dose #2 of covid vaccine: Fever, body aches, headache, arthralgia, myalgia, fatigue. Pt reported took tylenol for relief.
miscarriage; This is a spontaneous report from a contactable consumer. This 33-year old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot Ew0185) on 04Sep2021 07:30 AM at right arm for COVID-19 immunization. Age at vaccination: 33 years old. Medical history included Covid-19 and two healthy pregnancies with no issues. Concomitant drugs were not provided. The patient received the shot on 04Sep2021 and found out she was pregnant on 06Sep2021. She had five tests, all positive. On 10Sep2021 07:30 AM, she woke up bleeding and did not show a strong pregnancy line on the tests. The patient had miscarriage. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient needed to call doctor and see what to do next. Outcome of the event was unknown. Second Pfizer Covid-19 vaccine was scheduled for 25Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101190080 mother/baby case
red about a size of a nickle; achiness; sore left arm; 12 to 14 hours, she started with fever(101); After 12 to 14 hours, chills and achiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Nov-2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, FAMOTIDINE and LOSARTAN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Feb-2021, the patient experienced ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, Body temperature: 101 (High) high fever. On 04-Nov-2020, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concurrent condition were not reported. In November of unspecified year, the patient was vaccinated with improperly stored VARIVAX (lot# R018140, expiration date: 25-JUN-2020; strength and dose detail were not reported) subcutaneously for prophylaxis, which was reconstituted with properly stored sterile diluent. Current temperature excursion: 15 Fahrenheit degree to 46 Fahrenheit degree (27.5 F) for 30 minutes. There was no previous temperature excursion. No Adverse effects were reported. Data logger was involved. The physician also reported that unspecified amount of improperly stored improperly stored VARIVAX and PROQUAD were administered between "October and December" (linked case#1903USA005021). Sender's Comments: US-009507513-1903USA005021:
Covid vaccine booster on 12/29/2021, previous two Moderna vaccines were March 31, 2021 and April 2021.  Patient admitted to the hospital on 2/1/2022.  She presented with tachycardia, fatigue/malaise, hypotension and found with hemoglobin of 6.3 g/dl.  Diagnosis is autoimmune warm antibody hemolytic anemia
Client reports first night left arm became swollen about fist size and reddened.  Client then had nausea and a fever up to 102 degrees.  Client took Tylenol.  By 4-5-23 client started having diarrhea and then from 4:30 to 10 PM client had projectile vomiting and the temperature continued and the diarrhea continued.  By the late PM client was home alone with no one to care for her and she felt worn out so she went the the local ER and was given IV fluids.  Client called to report this on 4-7-23.
This case was reported by a healthcare professional and described the occurrence of severe adverse reaction in a female subject of unspecified age who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (unknown route, injection site and batch number). At an unspecified time after vaccination with FLUARIX QUADRIVALENT, the subject experienced severe adverse reaction. At the time of reporting, the outcome of the event was unspecified.
Immunizations received 9:30 AM on 11/5/07. Patient developed headache, then fever and arm pain and swelling ~ 12 hours later-  Temp 103.1 degrees. Improved somewhat during day on 11/6/07, then more redness, swelling and tenderness at site (R deltoid) in AM on 11/7/07.
On patient interview, patient reported no medical conditions, no medications, and stated he "did fine" with the two previous shots.  Patient reported no immediate issues after injection and sat down in a chair in front of the pharmacy.  about 10 min later, patient became dizzy, got up, and collapsed in front of the pharmacy.  At this time, he said he had not had anything to eat or drink today, and "this has happened before."  Patient was given some water and orange juice, monitored for results, and was better after about 10 min,  Instructed patient to eat before future injections and notify RPh so that he can be monitored after shots.
right eye was swollen; toes swollen; mouth full of water from jaw and throat and taste of medicine on her mouth."; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY HYPERSECRETION (mouth full of water from jaw and throat and taste of medicine on her mouth."), EYE SWELLING (right eye was swollen) and JOINT SWELLING (toes swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SALIVARY HYPERSECRETION (mouth full of water from jaw and throat and taste of medicine on her mouth."). On 22-Apr-2021, the patient experienced EYE SWELLING (right eye was swollen) and JOINT SWELLING (toes swollen). At the time of the report, SALIVARY HYPERSECRETION (mouth full of water from jaw and throat and taste of medicine on her mouth."), EYE SWELLING (right eye was swollen) and JOINT SWELLING (toes swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided Patient applied warm water to her swollen right eye.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: NNI
Brugada syndrome; 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), as dose 1, single (Lot number: EL9265) and as dose 2, single (Lot number: EN6201) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRUGADA SYNDROME (medically significant), outcome "not recovered".  No follow-up attempts are possible. No further information is expected.
Redness and warmth - starting today. Redness may be about 8 inches.
03/16/2021: Presented to the emergency department with intractable headache (last 3 days) and vision changes (last 6 months). The patient was admitted for uncontrolled hypertension and rule out meningitis. The patient is still currently admitted.
has a scab at the injection site/the injection site still has a scab on it; This is a spontaneous report from a contactable Consumer. This female Consumer (patient reported for herself):  A 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date as a dose 1, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included carvedilol (CARVEDILOL) 12.5mg twice daily. On an unspecified date the patient experienced scab at the injection site/the injection site still has a scab on it. Patient reported that after receiving the first dose of the Pfizer Covid 19 vaccine she had a scab at the injection site that won't go away. Patient queried if this could be caused by her carvedilol (blood thinner) or if there are any contraindications to taking carvedilol with the vaccine. Patient also stated that she had heard a rumoured that the location where she received the first dose was not going to be giving the vaccine there anymore. The outcome for the reported event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
arm hurt like crazy; patient got the booster vaccine and is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt like crazy) and EXTRA DOSE ADMINISTERED (patient got the booster vaccine and is not immunocompromised) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm hurt like crazy). 15-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient got the booster vaccine and is not immunocompromised). On 15-Aug-2021, EXTRA DOSE ADMINISTERED (patient got the booster vaccine and is not immunocompromised) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurt like crazy) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient got the booster vaccine the same day they got the flu shot and less than 8 month after getting the second dose.   This case was linked to MOD-2021-294085 (Patient Link).
patient fainted, pupils dilated, diaphoretic. called 911, patient came to approximately 5 minutes later,  responders checked her out blood pressure, oxygen level,  she felt better did not want to go to hospital, left pharmacy with husband.
Confusion; Blurry vision; altered mental state; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other caregiver and describes the occurrence of CONFUSIONAL STATE (Confusion), VISION BLURRED (Blurry vision), VOMITING (Vomiting) and MENTAL DISORDER (altered mental state) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion), VISION BLURRED (Blurry vision), VOMITING (Vomiting) and MENTAL DISORDER (altered mental state). At the time of the report, CONFUSIONAL STATE (Confusion), VISION BLURRED (Blurry vision), VOMITING (Vomiting) and MENTAL DISORDER (altered mental state) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter. It was reported that stayed overnight, his cardiac outcomes went up, from the lab results they were elevated. They performed CT scans, neurological checks, a Holter monitor, MRI, multiple blood works and everything was clear.   Reporter did not allow further contact