chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered at 10:30am syncopal episode x30 seconds with small amount of emesis at 10:46am. Patient monitored by EMS and MD. Vitals were initially BP 80/50 HR 60, then BP 110/70 HR 80, then BP 110/78 HR 70. By 11:05am patient was feeling better and sent home in a private vehicle driven by her parent. Water and juice provided.
Patient developed sudden onset of an ulcerative colitis flare within a week of receiving her 2nd Trumenba dose.  She had bloody diarrhea rectal bleeding and more frequent BMs).  She subsequently required a steroid burst, 16-day hospitalization at two different hospitals, and a change in her UC med from Entyvio to Xeljanz.
Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient delayed receiving the second dose of the Moderna COVID-19 vaccine for more than 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
severe shivering, was so bad that she could not dial a phone; severe headache; nausea; dizziness; had her first dose in April or May of 2019.; This case was reported by a consumer and described the occurrence of shivering in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 30 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, headache, nausea, dizziness and incomplete course of vaccination. On an unknown date, the outcome of the shivering, headache, nausea and dizziness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering, headache, nausea and dizziness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. In April or May 2019, the patient received 1st dose of Shingrix and experinced severe shivering so bad that she could not dial a phone, severe headache, nausea and dizziness. The symptoms lasted approximately an hour before reducing in severity but had not resolved until 6 to 8 hours later. The reporter consented to follow up.
fever (101f) for 12 hours, muscle/joint ache, reduced mobility in left shoulder
Following administration of Moderna vaccine pt was waiting out his 15 minutes when it was noted that he had decreased LOC, skin was pale and clammy and would arouse with minimal stimulation. Code yellow called,  vs- 50/33, 47, 85% on ra------O2 applied via NRB and then changed to NC after a few minutes. Pt's symptoms resolved spontaneously, vs stabilized out, pt was monitored for an additional 15 minutes and then assessed by a practitioner before leaving the facility.
My arm hurt; stiffness spread up over my shoulder, across my collarbone and up the side of my neck; discomfort spread up over my shoulder, across my collarbone and up the side of my neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt), MUSCULOSKELETAL STIFFNESS (stiffness spread up over my shoulder, across my collarbone and up the side of my neck) and MUSCULOSKELETAL DISCOMFORT (discomfort spread up over my shoulder, across my collarbone and up the side of my neck) 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 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness spread up over my shoulder, across my collarbone and up the side of my neck) and MUSCULOSKELETAL DISCOMFORT (discomfort spread up over my shoulder, across my collarbone and up the side of my neck). On 05-Sep-2021, the patient experienced PAIN IN EXTREMITY (My arm hurt). At the time of the report, PAIN IN EXTREMITY (My arm hurt) and MUSCULOSKELETAL STIFFNESS (stiffness spread up over my shoulder, across my collarbone and up the side of my neck) outcome was unknown and MUSCULOSKELETAL DISCOMFORT (discomfort spread up over my shoulder, across my collarbone and up the side of my neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
hurts; swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age 74 units unspecified) received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 06Mar2021 18:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after the vaccination the patient experienced side effects, it hurts likes a son of a gun and slightly swollen. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
Fever started approximately 24 hours after vaccines. Pt with history of febrile sz & had a 3 min sz. 12 hrs after fever started. Did well after.
Pt presents with swelling on left arm. Swelling started approx 2 inches above elbow. No redness, swelling noted at injection site. Swelling continues to lower arm and all fingers.
My first shot the shot sight was very swollen and was hot to the touch. 4th day I had a lot of pain on the left side of my back in line with my shoulder. The pain was at least a six. Next day I had a rash exactly where the pain was day before and then pain was maybe a 2 the day after. Second shot the shot sight was just a little sore but the back has be unbearable on the back. I had the shot in the same arm. The day after second shot I had very bad flu symptoms. Today is 4/8/21 and I am still feeling pain in the area described.
Low grade headache; chills; Body aches; dark bruise-like area on the skin outside each eye; extreme tiredness; food tasted bitter for 24 hours; This is a spontaneous report received from contactable consumer, the patient. A 74-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6207) via an unspecified route of administration in the left arm on 16Mar2021 at 15:00 (at the age of 74-years-old), as single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. On 16Mar2021 at 16:15, the patient experienced low grade headache (almost immediately), chills, body aches, dark bruise-like area on the skin outside each eye (side of eye not over or under), extreme tiredness, food tasted bitter for 24 hours. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events low grade headache, chills, body aches, dark bruise-like area on the skin outside each eye (side of eye not over or under), extreme tiredness, food tasted bitter for 24 hours was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
On 8/22/01 pt came to clinic with right arm reddened from shoulder to elbow. She was referred to MD. On 8/23/01 pt returned for recheck. The swelling and redness had gone down but it was still warm to touch.
After the patient is given 1 st dose of Moderna and sat in the chair for 10 to 15 min. When he came to pharmacy register to make 2nd appointment, he fainted and hit his head on the floor. No bleeding found. He looked pale and was sweating, no redness or SOB.  Applied a cold compress to patients face, neck and wrist. BP is normal 107/58. Pt is alerted and oriented. Store management called 911 and EMT came to monitor patient. Patient feel better and doesn't want to ER.
Changing BP. From 116-151/67-121. Pulse 68-90. Temperature 99.5-100.4. Took Tylenol 3 times during the day for achy joints. Had a light headache most of the day. Just sat around and watched TV. By nightfall had a pretty good headache. Took a Tylenol PM at 9PM and went to bed. Feel pretty good today except for the daily achy joints. Don't have a Dr. right now.  But I need to get one set up. Haven't had a checkup In over a year.
Patient did not suffer any adverse event or need treatment. The patient was administered the COVID-19 Moderna vaccine #1, three days prior to the patient's 18th birthday.
PATIENT EXPERIENCED VASOVAGAL RESPONSE ~2 MINUTES AFTER VACCINATION. UNCONSCIOUS FOR 20 SECONDS. LETHARGIC AND VOMITING OCCURRED UPON WAKING. EMS WAS CALLED, CHECKED PULSE AND BLOOD PRESSURE. PROVIDED EMESIS BASIN AND COLD CLOTHS. AFTER EMS EVALUATION PATIENT WAS APPROPRIATELY RESPONDING AND LEFT WITH FAMILY.
Reappearance of symptoms and positive COVID at home antigen test after day 10; Reappearance of symptoms and positive COVID at home antigen test after day 10; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfas" (unspecified if ongoing), notes: Known allergies: Sulfas. Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; FLUOXETINE; ROSUVASTATIN; TESTOSTERONE; RED YEAST RICE; FISH OIL; NIACIN; IMODIUM; ALLERTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Reappearance of symptoms and positive COVID at home antigen test after day 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication: Treatment of COVID-19; (Jul2022) Positive, notes: positive COVID at home antigen test after day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment was initiated with Paxlovid from 22Jul2022 to 26Jul 2022. All concomitants were taken in time period of 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Development of new onset severe Parasoriasis approximately 1 month post second Moderna vaccination - Has since been mostly treatment resistant with topical medications. Beginning phototherapy treatment. Unable to undergo immune treatment due to current 21 week pregnancy
pt recv vax 3JUL96 & 12AUG96 pt devel 40 vesicles;
Woke up on 5/18/2019 at approximately 10:00 AM CST with large outbreak of itchy, red colored hives on top of left hand. Symptoms are ongoing. Pharmacist advised to monitor condition to see if it improves or worsens.
Muscle weakness, numbness, tingling in entire arm immediately after the SQ injection to the posterior upper arm.
Hot flash followed by head ache "tightness across forehead"  similar to "brain freeze from ice cream"
The vaccine given was the orig. Pfizer vaccine. It was supposed to be the bi-valent version of Pfizer!!
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-JUN-2017 the patient was vaccinated with VAQTA lot # N005274 for prophylaxis. Concomitant therapies included hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) and hib conj vaccine (unspecified carrier)(HIB CONJ VACCINE (UNSPECIFIED CARRIER)). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown.The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006507:
Patient said that throat felt like it was closing and she was getting shortness of breath. At 2:23 pm a dose of epinephrine was injected into her right upper thigh.
Generalized Rash all over upper torso with feeling itchy.  Apparent to RN at approximately 15 minutes post vaccination.  Patient (Health Care worker/employee) did not seem aware until it was brought to his attention.  15mg Benadryl administered and sent to Emergency Department for observation.  No further symptoms occurred and patient dismissed.
Rush on the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rush on the body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rush on the body). At the time of the report, RASH (Rush on the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever 103 degrees, dizziness, lightheadedness, fatigue, asthmatic episode - Mother left message on our service on 4/8/11 describing the symptoms listed on left side. She did not return our calls until 4/11/11 - stating son was fine now. He used inhaler 1 time only. No additional symptoms or problems noted. No treatment.
Moderna COVID-19 VACCINE EUA Patient stated she began to have left side weakness and confusion, Evaluated by onsite EMS. Heart rate was 127. Transported to hospital by EMS. Spoke with patient who stated she was in ER for about two hours for observation and then went home. Feels fine now.
Injection sight became hot and red (9th day after injection) and very itchy.  Lasted three days.  Today injection sight is not red or itchy, just slightly bruised looking..
Severe Entire Body Aches, Severe Sore Arm, Extreme fatigue
fever over 100 degrees; chills; body aches; fatigue; Shingles appear on the arm; itched; warm; blistered, leaked clear fluid; This case was reported by a consumer and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had a light case of chicken pox as a infant) and shingles (patient had a shingles at  the age of 15 years old for 1 week).   On 1st September 2022, the patient received the 2nd dose of Shingrix. In September 2022, 12 hrs after receiving Shingrix, the patient experienced fever, chills, general body pain, fatigue, shingles, pruritus, feeling of warmth and blister. On an unknown date, the outcome of the fever, chills, general body pain, fatigue, shingles, pruritus, feeling of warmth and blister were unknown.   It was unknown if the reporter considered the fever, chills, general body pain, fatigue, shingles, pruritus, feeling of warmth and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 3-Sep-2022 Reporter's Comment:  The patient had a light case of chicken pox as a infant and then a week long bout with shingles at 15 years old. The patient received the 2nd Shingrix vaccination and had several side effects starting 12 hours later including a fever over 100 degrees, chills, body aches, fatigue, but also had what looks like two Shingles appear on the arm opposite the one that received the shot. The itched, were warm, blistered and leaked clear fluid with in 48 hours of the shot. Less than a weeks after vaccination, the patient experienced pruritus, feeling of warmth and blister. This needs to be reported as a possible side effect.
Fever; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
allergies are off the chart today; 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 rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies are off the chart today". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included covid, start date: Feb2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), IMMUNISATION (medically significant) all with onset 2021, outcome unknown. Patient reported Covid went right into lungs and the shots had provided zero protection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
About 2 hours after the vaccine administration, my left knee started to stiffen up.  It continued to do this over a few more hours, and became swollen and achy.  It is now 39 hours after injection, my knee is still very swollen, and I can feel fluid building.   It is increasingly difficult to walk, and it will not flex nor extend much beyond a neutral position.  Stiffness, pain, inability, and fatigue in my leg and knee are also severe.  This feeling/pain/stiffness/inability is mimicking what it felt like when I got Lyme Disease 3 years ago.  My other joints are also a little stiff, but the left knee (which had a [cadaver] ACL replacement 5 years ago), is severely affected.  Thank you.
More than 36 days have passed since first dose, still hasn't got second shot; Couldn't speak/Couldn't talk; Couldn't wake up; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still hasn't got second shot), APHASIA (Couldn't speak/Couldn't talk), SOMNOLENCE (Couldn't wake up) and FATIGUE (Very tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Infusion (Bamlanivimab Infusion) on 17-Dec-2020 and Stroke in 2010. Concomitant products included APIXABAN (ELIQUIS), OXYBUTYNIN, METOPROLOL, ROSUVASTATIN, FAMOTIDINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SOMNOLENCE (Couldn't wake up) and FATIGUE (Very tired). On 18-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still hasn't got second shot) and APHASIA (Couldn't speak/Couldn't talk). On 17-Feb-2021, SOMNOLENCE (Couldn't wake up) had resolved. On 18-Feb-2021, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still hasn't got second shot) and APHASIA (Couldn't speak/Couldn't talk) had resolved. At the time of the report, FATIGUE (Very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  after first dose was that I had injection at 11 AM and then came home and got very tired like around 6 or 7 pm I went to bed and slept soundly and couldn't wake up. I obliged myself to get up and made coffee and did few things and then I got very tired again. I leigh down on the couch and so this is around 8 in the morning and woke up with the phone ringing and when I answered I couldn't speak; I couldn't talk to my friend. My friend thought I was having a stroke, but I already had a stroke in 2010 so I know what that was and I wasn't having a stroke. My friend then called my sister and she also thought I was having a stroke. This lasted for some hours and then I felt good. I was able to talk again. By four o clock the nurse from the health insurance came for annual check up and I was fine with her. This lasted for about 6 to 8 hours.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information is requested.