chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; dizzy; Sleeping constantly, not even waking up to eat; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizzy), HYPERSOMNIA (Sleeping constantly, not even waking up to eat) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (autoimmune condition).   On 15-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 ASTHENIA (weakness), DIZZINESS (dizzy), HYPERSOMNIA (Sleeping constantly, not even waking up to eat) and CHILLS (chills). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizzy) and CHILLS (chills) had not resolved and HYPERSOMNIA (Sleeping constantly, not even waking up to eat) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This case concerns a 76-year-old, female patient with medical history of an autoimmune condition, who experienced the unexpected non-serious adverse event of special interest of hypersomnia and other non-serious adverse events. The event occurred on unknown date after the third dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the third dose of vaccine and no additional dosing will be given. The medical history of an autoimmune condition could be a potential confounder for the event. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
I received the flu shot last year around October at my PCP office. Within hours after receiving the shot. I was sitting down waiting TV and I started feeling nauseous and dizzy. i went to lay down and I started getting thirsty I asked my friend to get my water and she brought it in and I could not lift my head to drink the water because I was so weak. The symptoms lasted about 24 hours. I went into the PCP office the following month and reported the symptoms to the PCP and told them I would not like another flu shot like that. The nurse told me it might have been a reaction or germ in my body. No one told me to report the reaction until I came for my shot this year. This year when I went to get the flu shot I was on a Budesonide recently and the PCP stated that they were not comfortable giving me the shot because of the reaction to the flu shot last year.
Continual coughing started 2 hours after shots were given. Temperature up to 104. She was taken to MC. Nausea and vomiting lasted for 2 days. On record to hold pertussus.
On 3-27-12 at 1830 patient became limp, pale and somnolent for about 5 minutes, which spontaneously resolved. Then the episode reoccurred an hour later. Patient was taken to the ER. By the time of arrival skin color is back to normal. Patient was back to normal Dx: Reaction to immunization resolved. Sent home stable.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history, concurrent  conditions and concomitant medications were not reported. On 26-MAR-2015, the patient was inadvertently vaccinated with expired VARIVAX (Merck), vial 1350 U, 0.5 milliliter (ml), subcutaneously, lot # H013477, expiry date 11-JUL-2014. No adverse effects were reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Adacel reached a temperature of -10 F for 30 minutes as it was accidentally placed in freezer instead of refrigerator, no AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional  This case involves a female patient and the vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: u6676aa, Expiry date: 16-May-2022 ) which reached a temperature of -10 F for 30 minutes as it was accidentally placed in freezer instead of refrigerator (Product storage error).  Medical history, medical treatment(s), vaccination, concomitant medications and family history were not provided.  It was a case of an actual medication error due to Product storage error temperature too low.  At the time of report, no adverse event was 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.
I went to the doctor on 11/2/2021 at the Hospital. They told me I had shingles, and they prescribed me with Valtrex 1 gram 3xday orally.
Lung scaring, possible pneumonia. Chronic sinusitis and rhinitis. Elevated white blood cell count. He has been on 5 rounds of steroids and 4 rounds of antibiotics. He has been sick ever since he had the second vaccine.
It's been over 6 months since my 2nd Moderna shot, in my left arm. Because for a week now I have been experiencing pain in the same place as the vaccination, which has resulted in weird tingling down to my left and and up into my neck, I am filling out the VAERS form to report this. This first happened last Saturday for a short time. Since then it's happened overnight on Wednesday, as well as Thursday, and on Friday night the tingling went into my hand and was palpable enough that it kept me awake. Then last night it was both tingling and sore, into my neck. At this moment I can feel it in my upper arm radiating into my neck. I don't think it's such a big deal, but if it helps the regulatory authorities with determining effects of the vaccine, I'm going ahead and sharing my issue.
RECEIVED FLU SHOT IN TOP LEFT SHOULDER. NOW MY LEFT SHOULDER +LEFT ARM+LEFT HAND MY MUSCLES ACHE+ VERY SORE SINCE THE DAY OF THE FLU SHOT, ALSO MY OTHER BODY MUCLES ACHE TOO FOR NOW REASONS??
PATIENT HAD SEVERE SWELLING AND REDNESS IN HER UPPER LEFT ARM.
4JAN91 Hives. 5JAN91 Swollen ears. MD prescribed Benadryl; 7JAN91 swelling of eyes & lips. Given Atarax. 8JAN91 fainted when got out of bed. Taken to ER given Prednisone.
pt recv vax 7AUG96 & 9AUG96 pt exp fatigue, malaise & dizziness;
LUMP IN LEFT ARM; SORENESS IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced lump in left arm. On 12-MAY-2021, the subject experienced soreness in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump in left arm, and soreness in left arm. This report was non-serious.
sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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 arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Fainting about 16 hours after vaccine was administered.  No treatment. I came to shortly after.
tinnitus; loss of hearing on Left side; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization at hospital facility. Medical history included benign prostatic hyperplasia (BPH) and hypothyroidism. The patient had no known allergies and did not have COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), tamsulosin hydrochloride (FLOMAX), and finasteride taken within two weeks of vaccination. The patient had no other vaccine in four weeks. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK8330) via intramuscular route on the left arm on 16Dec2020 at 6:15AM. The patient experienced tinnitus and loss of hearing on left side on 13Jan2021, 7 days post 2nd dose. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Prednisone taper was given as treatment for the events. The patient had not been tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the possible contribution of suspect BNT162B2 to the events tinnitus and loss of hearing cannot be totally excluded given the time association. The detailed clinical course about these events would be helpful for further assessment. 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 had primary care appointment on 1/27/22, BP was 169/96. pt received Moderna Booster 0.25mL on 1/27/22. ED note states that pt was brought in by ambulance after being found unresponsive in someone's driveway the evening of 1/27/22 in cardiac arrest. CPR was unsuccessful and pt expired. while pt did receive booster on 1/27/22 pt has history of hypertension, high cholesterol, prostate cancer, and COPD.  While it is unknown where the pt was going it is likely he was walking home from somewhere and it is of note that it was very cold that evening. These environmental and comorbid conditions are more likely the cause of this adverse event as compared to the Moderna Booster but this practitioner still unserstood the importance of reporting this to VAERS.
In March of 2022 I gave blood at a local church. About two weeks later received a letter from the facility notifying me that I had ANTI-FYB antibody. They requested that I not give blood anymore. Every six months I give blood and have never been notified of this before. September 13, 2022, I had severe right eye pain. I went to urgent care. I was diagnosed with Iritis inflammation of the iris. I was put on a steroid, tobramycin and dexamethasone. I take these drops three times a day. They drew blood and thought that this is most likely caused by autoimmune disease. At this point all my lab results are negative. I still do not know what caused the Iritis. As of today my eye pain has resolved. I have stopped taking the drops and my eye is well.
An unvaccinated pt who was exposed to a non-rash devel varicella vaccinee;subsequently the unvaccinated pt devel a fever & a rash comprised of greater than 50 generalized lesions;
pt recv vax & 4hr later exp malaise, myalgias & T102.2 w/o any preceding;viral-like sx & no localizing source of infect;
5 days after vaccine received: malaise, falling asleep frequently in church, weak voice for about 3 hours. No treatment received.
swollen lymph node on the right side of my neck; a lot of drainage down the back of my throat; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), LYMPHADENOPATHY (swollen lymph node on the right side of my neck) and PHARYNGITIS (a lot of drainage down the back of my throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 31-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node on the right side of my neck) and PHARYNGITIS (a lot of drainage down the back of my throat). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), LYMPHADENOPATHY (swollen lymph node on the right side of my neck) and PHARYNGITIS (a lot of drainage down the back of my throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information was provided.
Post menopausal bleeding starting  April 30th and continued through until May 9th and again from May 13th - May 17th. Ultrasound ordered and norethindrone 5mg tables (5 tablets) were prescribed and taken to stop bleeding.
This spontaneous report as received from a registered nurse refers to a 14 year old patient. On 02-MAY-2013 the patient was vaccinated with PROQUAD (Lot # not provided) 0.5 ml, subcutaneous. No other co suspects were reported. No concomitant therapy was reported. The registered nurse reported that on 02-MAY-2013, the patient was inadvertently vaccinated with PROQUAD. No adverse effects were reported. Additional information has been requested.
c/o diff breathing, feeling hot, hear racing, skin itching;pt to hosp w/diff breathing & inc skin rxn;hives, erythematous urticarial plaques;pharyngeal edema;periorbital edema;dx anaphylaxis to immun;
Red, swollen arm from mid-deltoid region down to elbow, warm to touch. Sore. Symptoms started 11/20/17 evening after vaccine administration.
Hard in the injection site area; Itchy in the injection site area; Had rash in the injection site area; Red in the injection site area/red area 14cm; Swollen; Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Swollen), PAIN (Pain), VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area) and VACCINATION SITE RASH (Had rash in the injection site area) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pain in hip since April 2016 and Low back pain since April 2016.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen) and PAIN (Pain). On 13-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area), VACCINATION SITE RASH (Had rash in the injection site area) and VACCINATION SITE ERYTHEMA (Red in the injection site area/red area 14cm). On 20-Jan-2021, VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area), VACCINATION SITE RASH (Had rash in the injection site area) and VACCINATION SITE ERYTHEMA (Red in the injection site area/red area 14cm) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen) and PAIN (Pain) 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.   The patient reported that rash at the injection site was red, itchy and about 20 cm across. Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Contact information and event information updated. On 13-Apr-2021: patient demographics, medical history, product information and event details updated On 23-Jun-2021: Follow-up received contains updated patient relevant history is date is changed low back pain from ??-Mar-2019 to ??-Apr-2016
This case was reported by a physician, via a GSK sales representative, that described the occurrence of injection site hot to touch in four child subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (s), the subjects received either their 4th or their 5th dose of INFANRIX (.5 ml, unknown). Within 24 hours after vaccination with INFANRIX, the subjects experienced injection site that was hot to the touch, and swelling at the injection site. The physician's office reported that at least four child subjects experienced the same type of reaction to a particular lot of INFANRIX (Lot #AC14B085BA). Product complaints were lodged for these reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 07 October 2008 indicated that the subject was a one year old male. The events began on 14 August 2008 and resolved on an unspecified date in September 2008. In the reporter's opinion, events of injection site that was hot to the touch, and swelling at the injection site were possibly related to treatment with INFANRIX. In follow-up a 5th case was reported. Linked cases include: A0747164A, A0747167A, A0747169A and A0752555A. A safety statement received on 19 October 2008 concluded that there was no evidence for a safety signal or safety concern for the INFANRIX lot AC14B085BA.
Breakthrough covid case. Patient presented to ED on 6/16/22 with c/o of fever,  sinus pressure, postnasal drip and sore throat. Received 1 dose of Janssen on 3/18/21 at Hospital. Prescribed Paxlovid. DC home.
1st dose 31Aug2022, 2nd never; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 31st August 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 31Aug2022, 2nd never). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-APR-2023 The reporter stated he never followed up to get his second dose. He planned to get his second dose as soon as possible. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Very Severe stomach pains, upper stomach area, radiating outward. Pain started approximately 12 hours after taking first dose. Severe pain lasted 9 hours. Also felt shaky and weak. Pain to a lesser extent for an additional 24 hours. Unable to eat for duration of pain. Severe vomiting 12 hours after first dose. Stopped taking medicine, rested, didn't eat, stayed hydrated with sips of water.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 06-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
hives on the chest, neck, and both arms; no longer itching but the marks are still there; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hives on both arms, hives on chest, hives on neck, no longer itching but the marks are still there.  The patient's medical history was not provided. Concomitant medications reported were Amlodipine, Carvedilol, Triamterene Hydrochlorothiazide, Pravastatin, Gabapentin, Trelegy Inhaler for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Hives on both arms, Hives on chest, Hives on neck, no longer itching but the marks are still there.  Treatment details included Benadryl for the hives.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hives on both arms, hives on chest, hives on neck, no longer itching but the marks are still there was unknown.