chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in wrist immediately after injection blurry vision an hour and half after injection brain fog, flushed face, feeling of swollen face, shortness of breath about throughout the night and into the next morning along with elevated blood pressure.
Temp to 101.6 reported to service at 8:30 pm. No site reaction, or other sx.
Itching began on 1/21/2021.  1/22/2021 pain, warmth, redness and swelling in an area about the size of a baseball.  No fever.
Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; This is a spontaneous report from a contactable Other Health Professional (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 02:30 at single dose for COVID-19 immunization.  The patient had no relevant medical history and concurrent conditions.  Known allergies: No (Allergies to medications, food, or other products: No). Other medical history: None. Concomitant medication received within 2 weeks of vaccination included biotin, meclizine (MECLOZINE), multivitamin. The patient experienced tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows on 05Jan2021 12:30 with outcome of recovered in Jan2021. The patient underwent lab tests and procedures which included COVID test post vaccination: Nasal Swab (Prc) on 27Dec2020 with result negative. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Ibuprofen received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about Lot/Batch has been requested.
Started hearing ringing in my ears at night. Went to ENT at local Hospital for treatment and he gave me steroids.
Less than a week after booster, my leg had bumps that were hard and big. The lumps were on my left leg, the middle of my thigh down to my knee. It felt and looked black, blue, and red. My doctor got me in on Monday 11/08/21. I was taken to get an ultrasound which confirmed it's not a deep vein clot. I was told to use warm compresses and wear compression socks. I was told to take Aleve for pain and that it should be gone in a couple of weeks and if not, I am to go back to the doctor.
Nurse gave an Expired COVID-19 vaccine Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse gave an Expired COVID-19 vaccine Moderna) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse gave an Expired COVID-19 vaccine Moderna). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse gave an Expired COVID-19 vaccine Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported  Vial was initially stored in the refrigerator on 08-JAN-2022.. Vial didn't undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Follow-up contains Non-Significant information
Occurring approximately 2 weeks post vax, pt experienced 3-4 weeks of scars and scabbing inside both nostrils. Before Anthrax, no previous episodes of scars. Resolves with treatment of Bacitracin and does not occur until next shot.
Around 1am the morning following the initial vaccine dose, patient woke with chest pain. Patient took Advil and the pain had subsided by 3am. Patient called primary care physician morning of 04 June 2021 and primary care physician recommended patient visit local ER so he did. Day of 04 June 2021, patient continued to have pressure in the chest area but no pain. Feeling of chest pressure resolved by 05 June 2021.
Blood gluclose levels went really high  Went to over 400 anfter I had taken regular dose of insulin.
This case was reported by a consumer via call center representative and described the occurrence of immunization reaction in a adult male patient who received Influenza vaccine Quadrivalent. Co-suspect products included Tetanus Shot. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and Tetanus Shot at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent, the patient experienced immunization reaction. On an unknown date, the outcome of the immunization reaction was unknown. It was unknown if the reporter considered the immunization reaction to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The age at vaccination was not reported. The patient reported that, he felt iffy a day or two after his tetanus and flu shots. The patient described this iffy feeling as a mild immune response to the injections. A manufacturer or brand name was unknown. The patient declined to proceed with safety report.
passed out at home, diarrhea and nausea, and blood in stool this all
General discomfort following day: esp chills. 2d day: syncope 4 episodes, nausea. Ambulance: IV fluids. Hospital : IV fluids (1) Zofran (2ml).
Headache started in middle of night. Slight fever, extreme fatigue, weakness. Missed work and stayed in bed for 1.5 days. Felt back to normal by 8/5 (2.5 days after symptoms started).
Information has been received from a healthcare worker (immunization official) referring to a 3 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-JUN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K010440(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
At 2:30pm Pneumococcal was administered 12-4-06 in left deltoid. No pain or problem at injection. That night lots of pain in arm 7 hours after injection. At midnight intense pain in arm, numbness in arm and hand. Some improvement for a few days now more pain unable to move arm on his own. Pain on scale 1-10 is a 7.
Patient had his Vaccine on 2-28-2021.  Patient passed away on 3-3-2021.  Do not know the cause, just found out from our tech and thought we should report it in case.
autoimmune disorder but never had a reaction in the past; had an edema response in her tear troughs; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): GL-021622-4085 (Agency).  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 03Oct2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunization; hyaluronic acid, lidocaine (RESTYLANE L) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 03Jan2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, single), administration date: 24Jan2021, for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset Oct2021, outcome "unknown", described as "autoimmune disorder but never had a reaction in the past"; INJECTION SITE OEDEMA (non-serious) with onset 2021, outcome "unknown", described as "had an edema response in her tear troughs". The action taken for hyaluronic acid, lidocaine was unknown. Clinical course was reported as: Patient got injected with Restylane-L and had an edema response in her tear troughs. She got her booster the week prior and an autoimmune disorder but never had a reaction in the past.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
PT received COVID-19 Moderna vaccines in December 2020 and January 2021. Pt presented to the ED with complaints of right hip pain. Pt found to be COVID positive on 09/08/21. CXR on 09/08/21 consistent with COVID pneumonia. Pt noted to be hypoxic and was placed on supplemental oxygen. Pt was started on Remdesivir
painful lump in the back of my neck; painful lump in the back of my neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (painful lump in the back of my neck), HEADACHE (headache) and NECK PAIN (painful lump in the back 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (painful lump in the back of my neck), HEADACHE (headache) and NECK PAIN (painful lump in the back of my neck). At the time of the report, SWELLING (painful lump in the back of my neck), HEADACHE (headache) and NECK PAIN (painful lump in the back of my neck) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
This case was reported by a nurse and described the occurrence of agitation in a 88-year-old female patient who received FLULAVAL (batch number 3E532, expiry date June 2015). Concurrent medical conditions included dementia. Concomitant products included FLULAVAL, lorazepam, SEROQUEL, calcium carbonate, Calcium CO3 + Minerals + Vitamins and IMMODIUM. On 25th October 2014, the patient received the 2nd dose of FLULAVAL. On 26th October 2014, 1 days after receiving FLULAVAL, the patient experienced agitation and irritability. On an unknown date, the patient experienced extra dose administered. The patient was treated with TYLENOL. On an unknown date, the outcome of the agitation and irritability were not recovered/not resolved and the outcome of the extra dose administered was unknown. The reporter considered the agitation and irritability to be possibly related to FLULAVAL. Additional information received: Nurse stated that on Friday 24 October 2014 she gave a dose to patient, then on Saturday 25 October 2014 another nurse gave a dose. She said this was due to miscommunication. The patient had dementia, so it is hard to determine if they are experiencing AE's from being given 2 doses of flu vaccine. They don't know if the agitation that the patient is experiencing is from this or not.
Chills; flu-like symptoms; lost all the skin on the palms of hands, except for right hand (not so many blisters on her fingers); Migraine; pain; loss of bowel control for two weeks; Swollen lymph nodes; roughness in her palms; some soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (roughness in her palms), VACCINATION SITE PAIN (some soreness at injection site), CHILLS (Chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and BLISTER (lost all the skin on the palms of hands, except for right hand (not so many blisters on her fingers)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 098A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS (does not take medication for it).   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 12-Feb-2021, the patient experienced DRY SKIN (roughness in her palms) and VACCINATION SITE PAIN (some soreness at injection site). On 13-Mar-2021, the patient experienced CHILLS (Chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (pain) and CONSTIPATION (loss of bowel control for two weeks). On an unknown date, the patient experienced BLISTER (lost all the skin on the palms of hands, except for right hand (not so many blisters on her fingers)), MIGRAINE (Migraine) and loss of bowel control for two weeks. The patient was treated with CELECOXIB (CELEBREX) for Pain management, at an unspecified dose and frequency and CLOBETASOL for Heavy feeling in arms & legs, at an unspecified dose and frequency. On 22-Feb-2021, DRY SKIN (roughness in her palms) had resolved. At the time of the report, VACCINATION SITE PAIN (some soreness at injection site), CHILLS (Chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), MIGRAINE (Migraine), loss of bowel control for two weeks, PAIN (pain) and CONSTIPATION (loss of bowel control for two weeks) outcome was unknown.            No concomitant medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-060821 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060821:Dose2
Who should I talk to if I get "covid arm"?; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Who should I talk to if I get "covid arm"?) 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 PAIN IN EXTREMITY (Who should I talk to if I get "covid arm"?). At the time of the report, PAIN IN EXTREMITY (Who should I talk to if I get "covid arm"?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported  Treatment medication was not reported
missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) 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 an unknown date, 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 (missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
Pt with photosensitivity reaction, consisting of erythema, nodules and plaques in sun exposed area of the face and hands.  Itching of areas, no pain.
within 3-4 hours i felt a  huge soreness under my left armpit and yesterday  a lump formed i think its my lymph node. is a side affect of the flu shot your lymph nodes get inflamed. it hurts if i press on it or press my arm against my side. i have been using heating pad at home and motrin but im concerned.
HYPOTENSION ACUTE PULMONARY EMBOLISM 3/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vaccinated 6 pm. Returned home was playful. Around 12 midnight called for mother. Was warm to touch , twitching and jerking. Mom gave Tylenol T1/2 after Tylenol 102.5. Symptoms persisted called ER, then took patient to ER. Diagnosed moderate reaction to vaccine. Discussed with mom to observe for. Mom contacted doctor again questioned viral infection.
7/10/2021 l was diagnosed with Myocarditis with a possible slight Pericarditis  7/8/2021 I started to feel like I was getting an allergy attack (Hay Fever) that turned into a real fever.  7/9/2021 I was starting to feel dizzy and my legs were starting to hurt really bad. I also had shortness of breath, a bad headache and a sensitivity to light. In and out of fever 7/10/2021 I woke up with a horrible chest pain (pressure) got up and almost passed out while I had the overwhelming feeling of nausea. In and out of fever. Blood results show that my Troponin levels were 3.730 ng/mL. It took four days for them to start to come back down.
After 1st capsule: back and face itching, eyes puffy; 2nd capsule: swollen tongue, shortness of breath.
Fever over 100.8, server body ache, swollen on arm, lump size of fist under my arm, vexation pain , shortness of breath
Daptacel was given to a 4 month old twice within 10 days/no AE; 14-feb-2020 dose was administered beyond expiry date of 07-Feb-2020/no AE; Initial information received on 17-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 months old female patient who received 0.5 ml single second dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] twice within 10 days (extra dose administered) on 04-Feb-2020 via intramuscular route in the right thigh) and another dose allegedly on 14-Feb-2020 (post expiry of batch) (lot C5366AA, expiry date: 07-Feb-2020) (Expired product administered) for prophylactic vaccination.  Patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) (no dosing details reported).  It was of actual medication error due to Expired vaccine used and Extra dose administered.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Evening of 2/12 it started with a scratchy throat, and the next day I woke up with a runny nose.  I got tested at pharmacy with PCR, Positive.  Televisit with Doctor who proscribed Paxlovid and maintain vigilance on Oxygen saturation.  Symptoms diminished to nothing within 24 hours of starting Paxlovid.  Dry cough lingers occasionally.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 12Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "Known allergies: penicillin and sulfa allergy" (unspecified if ongoing); "Known allergies: penicillin and sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
arm was swollen; The injection hurt my shoulder; weak; Pain increased in the arm; feverish; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "stent in iliac vein" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; GABAPENTIN; TRAMADOL; ELIQUIS; ASPIRIN (E.C.). Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Cymbalta, reaction(s): "Allergies: cymbalta"; Lyrica, reaction(s): "Allergies: lyrica". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 06Oct2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), when the patient was 69 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "arm was swollen"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "The injection hurt my shoulder"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weak"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Pain increased in the arm"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, arthralgia, asthenia, pain in extremity, pyrexia.  Additional Information: Physician reported in response to the HCP letter sent that included: We did not give her the vaccine and we did not treat her for this (name withheld) MD. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.