chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; arm very swollen and red; arm very swollen and red; heart palpitation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neosporin [gramicidin;neomycin sulfate;polymyxin b sulfate], reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2 manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5 manufacturer unknown), for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 07Nov2023, outcome "unknown", described as "allergic reaction"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 07Nov2023, outcome "unknown" and all described as "arm very swollen and red"; PALPITATIONS (non-serious) with onset Nov2023, outcome "unknown", described as "heart palpitation". The events "allergic reaction", "arm very swollen and red" and "heart palpitation" required physician office visit. Therapeutic measures were not taken as a result of hypersensitivity, peripheral swelling, erythema, palpitations.  Additional information: the patient had vaccine on 7Nov2023, within a couple hours, arm got very swollen and red. She didn't take anything, was worried she was having allergic reaction. She was at another doctor's office, they said to go to at the Medical Center, where she had it. Went back there, spoke to the nurse, didn't seem like she really knew. Was getting the feeling she wasn't taking down the information but, she looked at it. Trying to figure out if she had allergic reaction to this or not. Had 5 of these before, never had reaction. Wondering what they put in the formula this year that could be different. Is kind of in her mind a lot. Was not Covid arm, which comes days after, this was pretty immediate, unless, you can get Covid arm right away. Noticed it getting red, by the time get home to take shower, it was all red. Happened so fast. Didn't have any breathing things she could think of. Last night, felt a little heart palpitation. She is allergic to something in Neosporin, wondering if they put Neosporin in it.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacy technician refers to a 22-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 09-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a 22 year old female physician's receptionist, who on approximately 13-JUN-2007 was vaccinated IM with her first dose of Gardasil. On approximately 13-JUN-2007 the patient experienced pain at the injection and a hematoma at injection site (lump). The pain at the injection lasted about 4 to 5 days. The patient's hematoma at injection site (lump) persisted. Additional information has been requested.
Strong chills, shivering and excruciating body aches from morning and through the night  without improvement from Jan 21 till present  Jan 29.  On Jan 28 started feeling tingling in the right side of my mouth: lower lip, toung ON Jan 29the tigling and numbness increased and spread wider, not to right cheek, right ear, entire lower lip and tounge
Pt. reports tenderness at inj. site x 6 wks with aches & fatigue 2-4 wks after inj.
Patient complained of pressure and neck swelling shortly after receiving 2nd Pfizer COVID vaccine. No difficulty swallowing or breathing. Provider order Benadryl 50mg by mouth. After 15 minutes, patient states his throat feels better. 30 minutes after Benadryl, patient states no abnormality in his throat at all. Left facility with parent. Given warning signs of when to seek higher level of care.
3/16/22 night started with small rash and mild fever on 3/17/22.
Moderna...2nd vaccine  Went to bed at 9:30 pm.  Awike atv3 an with a fever if 103°.   LASTED 4 HRS UPON AWAKENING... DON'T  KNOW TIME IT STARTED.  I ACHED, MY MUSCLES AND MY BONES.  EVEN MY EARS N EYES WERE BURNING UP.  4 HRS LATER I WAS SO COLD MY HANDS N FEET FELT LIKE ICE.  MY TEMP DROPPED TO 100.5°.  ALSO SICK STOMACH N LATER A 3 DAY HEADACHE.  THAT MORNING I CALLED N SAW MY DR.  He prescribed extra strength Tylenol every 6 hrs, , electrolyte drink, and a extremely bland diet which i followed for 4 days.  Said it was good because i was building good antibodies.     Today I feel great.  Today is Mon. 03/22/2021.  Or 5 days later.  Drs. Nurse called this morning to ck on how i was doing.   Really nice
Fever (100.8) and malaise, nasal congestion, muscle aches, joint pain, cough, 24 hours. Red, blotchy patch near -- but not on -- the injection site, appeared after 24 hours and remained another 24 hours.
Caller reports multiple doses of VAXELIS administered since temperature excursion that occurred 16JUN2022. Names of vaccines involved VAXELIS; This non-serious spontaneous report was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
Fifteen minutes after vaccination, pt began to feel dizzy with nausea. Pt assisted to lay down where symptoms persisted. Pt reported feeling that her eyes felt like they wanted to roll back and she could not focus them.  No vision changes and no loss of consciousness. Pt hypertensive and tachy. EMS activated. Paramedics on scene initiated IV and administration of Zofran, with relief of nausea. Care transferred to ambulance and patient transported to local hospital.
Came down with Type 2 Diabetes four months after my first booster shot.  NO PRIOR HISTORY OF DIABETES
pt recvd vax & was mottled, shivering & lethargic; eyes were glassy; hospital was called & pt sent directly to Er; pt was released from ER shortly approx 520-530PM;
patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient who is passed 42 days from the first Moderna Coviid 19 vaccine. The patient received their vaccine 47 days ago on 9MAY2021.) 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 medication information available. No Treatment medication information provided by the Reporter.
Information has been received from a Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-SEP-2016, the patient was vaccinated with an expired dose of VAQTA (lot # L004439, expiration date 15-FEB-2016, dose and route unknown). In addition, the reporter was certain that the dose was exposed to room temperature for an unspecified period of time. No adverse experience had been observed or reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an approximately 75 year old female patient, with diabetes and drug reactions/allergies to sulfa drugs. On 30-MAY-2012, the patient was vaccinated with ZOSTAVAX(vial), 0.65 ml, subcutaneous in the left arm, lot reported as: 0241AE, expiration date: 26-APR-2013. Concomitant therapies included LEXAPRO and trazodone hydrochloride. Approximately in May 2012, reported as "shortly after receiving ZOSTAVAX", the patient developed "burning" pain in the area over the abdomen/stomach. The pharmacist did not know the exact onset time of the "burning" pain. The patient has been treated with Gabapentin, VICODIN, Tramadol and LYRICA, at different times since receiving ZOSTAVAX. Laboratory diagnostics studies performed included: Nerve conduction tests, no results provided. The patient sought medical attention, visited office. The outcome of burning pain in the area over the abdomen/stomach was reported as not recovered. Additional information has been requested.
severe swelling & redness from shot site;T102,arm sore, aches, pains;sought med attention
about 10 minutes after vaccine patient became unresponsive, could not feel a pulse on her and was not responding to verbal commands per Dr.  She became incontinent of urine. Sinus rhythm on monitor, pulse in low 60-70s. BP 170/81 RR 18 oxygen saturation 96%, blood glucose 107. Patient began to feel nausea no vomiting while at clinic, was taken to ER by EMS who were on site at the clinic. She was responsive when she left the clinic A&O x 3.
Arm was sore for 3 days after injection. 1 week after receiving the vaccine, an injection site reaction occurred.  A 2 inch red circle appeared on the arm around the injection site. It was warm to the touch and slightly itchy. Visible and itchy for 3 days.
I got COVID-19     06JAN2023 while taking care of my dad, I wore a mask the whole time. It started with a cough really bad sore throat  a lot of fatigue my at home test was negative I went to my doctor office for a PCR test and they had none. I did want to Paxlovid without knowing I had Covid -19 so I went to an Urgent care center a took a PCVR test which was positive 07JAN2023.  I had a fever and slight cough no asthma symptoms, I was incredibly fatigued. After ten days my husband caught COVID-19 I had a full body rash with a lot of inflammation and ulcers in my bladder with heavy fatigue for the next six weeks.
Erythema at injection site, warmth. Starting 10/01/2021 Tx prednisone, Benadryl & Pepcid
she can not move her right leg at all where she had the cancer, it is in so much pain; she can not move her right leg at all where she had the cancer; right arm injection site pain; reports that she had could not breathe and had shortness of breath; about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (reports that she had could not breathe and had shortness of breath), PAIN IN EXTREMITY (she can not move her right leg at all where she had the cancer, it is in so much pain), HYPOKINESIA (she can not move her right leg at all where she had the cancer), MYALGIA (about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain) and VACCINATION SITE PAIN (right arm injection site pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Leukemia (had blood cancer in the left arm) and Sarcoma (had sarcoma in the right leg and had chemotherapy and radiation (this cancer attacked her entire right femur and she had to get an incision from the groin all the way down to the knee)). Concomitant products included VITAMINS NOS, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ZOLPIDEM TARTRATE (AMBIEN) and ALPRAZOLAM (XANAX) for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced DYSPNOEA (reports that she had could not breathe and had shortness of breath) and MYALGIA (about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain). On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (she can not move her right leg at all where she had the cancer, it is in so much pain), HYPOKINESIA (she can not move her right leg at all where she had the cancer) and VACCINATION SITE PAIN (right arm injection site pain). At the time of the report, DYSPNOEA (reports that she had could not breathe and had shortness of breath), PAIN IN EXTREMITY (she can not move her right leg at all where she had the cancer, it is in so much pain), HYPOKINESIA (she can not move her right leg at all where she had the cancer), MYALGIA (about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain) and VACCINATION SITE PAIN (right arm injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2021, Heart rate: 120 heart beats per minute (High) 120 bpm (as per patient high for her age).         No treatment information was provided.   This case was linked to MOD-2021-193250 (Patient Link).
Vomiting all night and morning until I went to the ER Uncontrollable body trembling  Migraine
Patient states he started having sudden onset of left facial droop, left-sided arm and leg 15 minutes prior to arrival on 1/23 while driving. Pt got the Moderna vaccine second dose 2 days ago (1/21). Patient denies any history of stroke, DVT, PE. tPA was administered. Found to have clot in the Right MCA territory and taken for mechanical thrombectomy to remove the clot. Patient remains hospitalized and further workup is going.
Patient on rehab unit for therapy and tested detected for COVID.  Mildly symptomatic, no hypoxia.  Provider d/c note:  "1. Patient had mildly symptomatic covid-19 but has been removed from isolation and is asymptomatic and afebrile at discharge."
2/3/21- tested positive for COVID with the following symptoms: fever, cough, fatigue, nasal and chest congestion
This case was reported by a dentist and described the occurrence of erythema of extremities in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, tenderness and skin warm. On an unknown date, the outcome of the erythema of extremities, tenderness and skin warm were unknown. It was unknown if the reporter considered the erythema of extremities, tenderness and skin warm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingles vaccine two days ago and now had a very large red area on the arm that was tender to touch and warm. The patient had no other problem from the injection. The reporter wanted to know was there a problem with taking the second dose after 8 weeks.
This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0150, expiry date: not specified), at the vaccination age of 68, via an unspecified route of administration, in right arm, on May 4, 2021, at 09:15, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# ER8734, expiry date: not specified), at the vaccination age of 68, via an unspecified route of administration, in right arm, on Apr 13, 2021, single dose, for COVID-19 immunization. There was no prior vaccination within 4 weeks, no additional vaccines administered on same date of the Pfizer suspect. The patient noticed his face was swollen on May 8, 2021, and he just wanted to report that. The event didn't require a visit to emergency room or physician office. Patient did not receive any treatment for the event. Outcome of event: not recovered. No follow-up attempts needed. No further information expected.
Information has been received concerning a 5 year old white female who on 05/28/97 was vaccinated with varicella virus vaccine. On 12/26/2000, the patient developed chicken pox. FOLLOW-UP infornation received from the physician's office indicated that the patient transferred out of their office on 05/11/00. Additional infection is not expected.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with improperly stored VAQTA (lot #, expiration date, dose and route were not reported). No adverse symptoms were reported. Additional information has been requested.
Red swelled; Red swelled; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red swelled) and SWELLING (Red swelled) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red swelled) and SWELLING (Red swelled). At the time of the report, ERYTHEMA (Red swelled) and SWELLING (Red swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was reported.
I got TDAP vaccine even tho doctor was aware I had had TD vaccination in 2007. By day after this latest vaccination (Sat, 18 Dec '10) felt very tired after good night's sleep. Fever and chills began at 1pm, continued over next 10 hours, along with dizziness & lack of appetite. Still felt tired & dizzy (no fever, tho) on Sun, 12/19/10. No warning from doctor or nurse re side effects.
Case number PHEH2011US02397 is an initial spontaneous report received from a nurse on 22 Aug 2011. This report refers to a male child. His medical history included asthma. He was given only the MenCYW lyophilized liquid conjugate component of MENVEO (batch number: 090901) intramuscularly on 20 Jul 2011. On the same day he was also given the booster dose of Hep A vaccine (manufacturer and batch number: unknown). No other adverse reaction was reported.
Headache; Slight Fever (100.4 F); Fatigue; Chills; Moderate pain at Injection Site; This is a spontaneous report received from a contactable consumer. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 03Feb2021 15:30 to Left arm at single dose for COVID-19 immunization. Medical history included Shellfish, Tree Nuts (Migraine Trigger). Concomitant medications were not reported. Past drug included BNT162B2 (dose number:1). It was reported as on 04Feb2021 06:30 patient experienced with Slight Fever (100.4 F), Headache, Fatigue, Chills and Moderate pain at Injection Site. Treatment was not received for events. Outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
hives; fever blister; blister on top lip; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 05Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LIP BLISTER (non-serious) with onset 19Oct2022, outcome "recovering", described as "blister on top lip"; ORAL HERPES (non-serious) with onset 19Oct2022, outcome "recovering", described as "fever blister"; URTICARIA (non-serious) with onset 23Oct2022, outcome "recovering", described as "hives". The events "fever blister", "blister on top lip" and "hives" required physician office visit. Therapeutic measures were taken as a result of oral herpes, lip blister, urticaria.  Additional Information: The patient had received Influenza vaccine within four weeks of covid-19 vaccine. After receiving the 4th bivalent vaccine, he developed a fever blister on top lip which appeared to be similar to hsv1 type lesion (no personal history of fevers blister or any previous lip lesions) and on 23Oct after eating out at a restaurant (grits, shrimp, bacon, mushroom, onion, coffee, white potato) within 30 minutes broke out in hives. The patient had no previous history of food allergies or similar type reactions and had no medical history. The patient was treated with Abreva, Claritin 10 mg Benadryl 50 mg famotidine 40 mg for adverse events. The patient had Covid-19 prior to vaccination and was not tested for Covid-19 post vaccination.   Follow-up attempts are completed. No further information is expected.