chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore at site of injection; low grade fever; vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-725716 (Moderna).  A 65-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Low grade fever" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE), administration date: 18Feb2021, when the patient was 63-year-old, for COVID-19 IMMUNIZATION; coviD-19 vaccine (DOSE 2, SINGLE), administration date: 13May2021, when the patient was 63-year-old, for COVID-19 IMMUNIZATION; coviD-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 07Sep2021, when the patient was 63-year-old, for COVID-19 IMMUNIZATION; coviD-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 07Apr2022, when the patient was 64-year-old, for COVID-19 IMMUNIZATION.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Sore at site of injection"; PYREXIA (non-serious), outcome "recovering", described as "low grade fever"; VERTIGO (non-serious), outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: The Safety team have your consent for follow-up. The Moderna authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Received Moderna booster on 15May2023. was sore at site of injection. Had occasional chest pressure lasting 3 day and nausea starting the day after administration and has continued. Flu-ish joint aches lasting for about 3 days. Primary 18Feb2021, 13May2021 3rd shot 07Sep2021, 4th 07Apr2022& 5th Pfizer booster Oct2022 - sore at site of injection, low grade fever, & vertigo.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Localized erythematous plaque 6cms circle on left deltoid noted @ 8:30A 11/12/2008
Narrative:  COVID infection following COVID vaccine series 02/25, Pfizer, dose #1 administered non agency facility 03/18, Pfizer, dose #2 administered non agency facility 12/17/2020 COVID swab, result: not detected 08/02 pt cc: cough, loss of taste or smell, myalgias, nausea, rhinorrhea, dyspnea, sore throat exposure: unknown 08/04 COVID swab, result: detected 08/07 pt cc: cough, headache, myalgias, rhinorrhea, dyspnea on exertion and improving, gum soreness 08/09 pt cc: cough, diarrhea, headache, myalgias, left arm/ nerve pain, dyspnea on exertion 0810 pt cc: dry cough, headache, myalgias, neck pain, rhinorrhea, congestion (pt report improving) 08/18 CXR impression: No acute intrathoracic abnormality.
ADMINISTERED 0.5 ML OF MODERNA BOOSTER INSTEAD OF 0.25 ML RECOMMENDED DOSE.
swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Pt developed a celullitis of left arm. Pt is currently being Rx'd with po antibiotics.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Medical histories, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (route, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment drug were reported.   This case was linked to MOD-2021-418964 (Patient Link).
Patient was assessed for some redness/soreness with slight reaction at approx 1.5 cm x 1.5 cm in size on Feb. 21, 2014 at 0900 hrs. No elevation or induration noted. 2/23/14 - Reaction increased to 8.0 cm x 9.0 cm. No induration/elevation noted. TX. ice pack applied. 2/25/14 - Reaction subsided no swelling no redness.
Pt reports 7/10 left leg pain starting late evening of 04/11/21 similar to a sciatic pain. Prescribed gabapentin 300mg TID for pain on 04/13/21.  On 04/13/21, pt reports to MD that the pain is mid buttock and all the way down the leg and then up to the bottom of her lower back. Butt pain is sharp and consistent, shoots down to the ankle on the back of the leg. Not relieved  by stretching.
Intense thirst lasting 24 hours, abnormal bowel evacuation, mild loss of sensitivity to smells and tastes
No additional AE; two doses were administered after a temperature excursion that occurred on 4/29/2022.; This spontaneous report was received from a Licensed Practical Nurse, referring to a 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-MAY-2022, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot # U022320, U026207, U028164, U015689 and U025791 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 15-JUL-2023, 24-AUG-2023, 09-SEP-2023, 18-MAY-2023 and 19-AUG-2023 respectively) (0.5 ml, strength, route of administration and anatomical location were not provided) (specific lot# was unspecified) (Product storage error). The temperature of storage and time frame of the excursion were 0.8 degree Celsius for 4 hours and 19 minutes respectively. There was no previous temperature excursion. No adverse event reported.   Another patient was capture in Case# 2205USA004267. This is one of some reports from same reporter.; Sender's Comments:  US-009507513-2205USA000806: US-009507513-2205USA004267:
Redness and Swelling on large area on underside of forearm between elbow and armpit.
sore arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen). At the time of the report, PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Sore in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore in the arm". Additional information: The patient was scheduled to receive the second dose of BNT162B2 and he wanted to know how soon he would be able to donate blood after receiving the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
06/24, 3 days post vax, this pt experienced sore throat. The following day he was 'ill' (NOS). 06/26, he had fever, muscle aches (back), cough, flu-like symptoms and sputum ranging in color from clear to yellow-brown. He also experienced sinus congestion, and runny nose. Symptoms of flu continue. He complains of muscle aches only. He still is unable to work. His sore throat seems to be resolving, but sinus congestion and runny nose and cough are not improving, according to the vaccinee. This case is considered serious because the vaccinee is incapacitated due to his inability to work. The most recent information received 06/29, reports the outcome of the event is ongoing.
Felt numbness in face the night after receiving first dose as well as the morning after that.  Numbness left and then moved to swelling, particularly above the eyes, which is more subtle now but ongoing as of 4/12/21.
High fever within hr of giving shot. Fevers ranged from 103.7 to 104.2 over a 48 hr period. Complained of a lot of arm pain and weakness. Also very tired and no appetite over this time period. Hydrated with Gatorade and cooled down fever with ice chips and cool compresses.
Within 10 min, mild headache. Around 2 hrs, eyes slightly swollen, dizzy. Next morning, noticed 2 itchy hives 1.5" from injection site.
This spontaneous report was received from a consumer reports three patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route and indication was not reported). On an unknown date, the patients experienced shingles. At the time of the report the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
developed sx of stuffy nose and cough 8/26/22- tested positive on binax rapid antigen test
Information has been received from a registered nurse concerning a female (age not reported) which borderline mental retardation who on an  unspecified date was vaccinated with a first dose of Gardasil. On an unspecified date, the patient was vaccinated with a second dose of Gardasil (lot # not reported) 0.5 ml injection. In December 2006, the patient experienced an interruption of her menstrual cycle after receiving the second dose of vaccine. The patient sought medical attention. At the time of reporting, the patient had not recovered. No further information was provided at the time of reporting. Additional information has been requested.
Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This is a spontaneous report from a contactable Nurse reported for herself. A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:00 at single dose on left arm for COVID-19 immunisation. Medical history included Anxiety, GERD, gluten and lactose intolerant, no known allergies, no COVID prior to vaccination. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 in Dec2020 13:00 in Left arm for COVID-19 immunization. About 20 Hours (as reported) after vaccination, on 14Jan2021 at 11:00 AM, the patient experienced fever of 100.5, headache, body aches, heaviness in chest, chills. No treatment was received for the events. The patient had not recovered from the event. The patient didn't test COVID post vaccination.  Information on the lot/batch number has been requested.
weakness; drug fever; weight loss; This spontaneous case was reported by a physician and describes the occurrence of WEIGHT DECREASED (weight loss), ASTHENIA (weakness) and PYREXIA (drug fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 21-Dec-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a day. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced WEIGHT DECREASED (weight loss). On an unknown date, the patient experienced ASTHENIA (weakness) and PYREXIA (drug fever). At the time of the report, WEIGHT DECREASED (weight loss), ASTHENIA (weakness) and PYREXIA (drug fever) had resolved.        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.   Concomitant medication use was unknown Treatment information was unknown
Treatment of COVID-19,testing positive; Treatment of COVID-19,testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "not recovered" and all described as "Treatment of COVID-19,testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Expressive aphasia facial weakness unilateral  8/29/08  Reviewed hospital medical records of 8/6/2008. FINAL DX: Transient ischemic attack vs hemiplegic migraine Records reveal patient experienced sudden onset of expressive aphasia, left facial drooping, right facial weakness, numbness & tingling, lightheadedness, anxiety.  Seen in outlying ER & had tongue deviation to the left & left facial weakness.  Speech returned in approx 4 hours; left facial weakness/droop persisted.  Symptoms resolved & all tests WNL.  D/C to home same day w/referral to outpatient neuro for continued w/u. Follow-up: This pt has now been determined to have hemiplegic migraines. She has had recurrent migraines and is on treatment.
Leaked; Leaked; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (Leaked) and UNDERDOSE (Leaked) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M0A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DEVICE CONNECTION ISSUE (Leaked) and UNDERDOSE (Leaked). On 13-Feb-2021, DEVICE CONNECTION ISSUE (Leaked) and UNDERDOSE (Leaked) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company Comment:  This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 012M0A  with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-033788 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Follow up received: Report contained no new information; Sender's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 012M0A  with no associated AEs. US-MODERNATX, INC.-MOD-2021-033788:
administered an expired Kinrix (exp:5/26/23); This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5R3KX, expiry date 26-MAY-2023) for prophylaxis.   On 12-JUN-2023, the patient received Kinrix (left thigh). On 12-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered an expired Kinrix (exp:5/26/23)). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Jun-2023 The medical physician called to inquired that how to proceed. The reporter did not consent to follow-up. The patient received an expire dose of Kinrix, which led to expired vaccine used.
both ears have a red flaky rash with small white bumps. Skin in dry to the touch and very itchy. rash has lasted 6 days at time of reporting
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, site pain Narrative:  Symptoms/Complaints: Fever, Pain/Discomfort at site of injection, Headache, Joint pain, muscle pain, fatigue, nausea, diarrhea, inflammatory response, my joints have been popping in/out of place more then usual.
Customer said that early in the morning she woke up with an itchy rash/hives across her belly.   She called the dr, who suspected it was a reaction to the Arexvy.  The rash cleared up by the next day and she is fine now.
Felt light headed about 4 hours after arriving home. Then about 2hours later my arms started to shake/tremors.  I took of Ativan and went to bed. No side effects in the morning.
He had a very high fever that night, I gave him tyllonel as his doctors office instructed. His fever lasted until the next day. We began noticing he was dating off out the corner of his eye, not making hardly any eye contact, not responding to his name, after a couple weeks we noticed he wasn't saying mama or dada or babbling at all anymore. We brought him back in and saw a nurse practioner, we told her our concerns about his last round of 9 doses of vaccines, and asked if it could be autism. She said "no, no, looking at him I can tell you right now he does not have asbergers. she said he looked fine and not to worry. I held onto her words and lived in a state of denial. My mother finally said listen hes 2 years old and not speaking or babbling, you need to get him evaluated. I did, at the Child Development Clinic on June 6, 2016 and they diagnosed him with autism spectrum disorder. We've had him speech therapy and occupational therapy ever since.
15 min. after administration, pt became short of breath and hoarse.  Hospital Rapid Response called, pt took Benadryl 50mg PO and then transported immediately to the ED for further evaluation.  ED administered Solumedrol and epinephrine.
pt recv vax 27MAR96 & on the same date pt also recv a tine test which reacted to;pt exp red rash around inj site from shoulder to the elbow;f/u info from the nurse indicated that no one has any recollection of the event;
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Severe
Fever, rash, itching. Meds: BENADRYL 12.5 mg/5mL Mupiracin  tropical ointment 2% Ibuprofen oral drops suspension 50mg/1.25mL.
This study case was received from the investigator in the trial on 29 May 2013. A 41-year-old female subject was found to have acute myocardial infarction, unspecified site 6 days after receiving the following vaccines on 06 October 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported), anthrax (manufacturer, lot number, route and site of administration not reporter) and INFLUENZA live intranasal (manufacturer, lot number and site of administration not reported). Relevant laboratory data included an abnormal troponin I of 52.04 on 14 October 2009, an abnormal echocardiogram on 13 October 2009 and an abnormal ECG on 03 November 2009. Treatments were not reported. Past medical history high blood pressure. Additional information will be requested from the investigator. The subject's outcome was not reported. Follow-up information was received from the investigator on 03 June 2013. The investigator provided the units for the Troponin I lab value from 14 October 2009, which was 52.04 ng/mL (abnormal). No other information was provided. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Itchy rash on both knees. Still present at this time. Undiagnosed rash, saw the dermatologist.
Headache, Myalgia, Arthralgia, Fever & Tachycardia  Narrative: fever 101.1, 130-140 heart rate, arm pain, ankle pain, headache and neck pain