chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 cm round red circle around the injection site; small bump at the injection site; bump at the injection site and it is slightly warm to the touch.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The patient experienced 10 cm round red circle around the injection site, a small bump at the injection site and it was slightly warm to the touch. The reporter consented to follow up. This case is linked with case US2020222259, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222259:same reporter
Child had onset rash over body with temperature of 100 taken per ear. Was seen by doctor for evaluation.
SWOLLEN ARM; REDNESS; PAINFUL; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (SWOLLEN ARM), VACCINATION SITE ERYTHEMA (REDNESS) and AXILLARY PAIN (PAINFUL) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE SWELLING (SWOLLEN ARM), VACCINATION SITE ERYTHEMA (REDNESS) and AXILLARY PAIN (PAINFUL).   At the time of the report, VACCINATION SITE SWELLING (SWOLLEN ARM), VACCINATION SITE ERYTHEMA (REDNESS) and AXILLARY PAIN (PAINFUL) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Delayed spontaneous urticaria on entire body 11 days after vaccine. Started as itchy scalp and palms of hands around day 9 post vaccine. By day eleven it had manifested itself as a full body rash with exceptionally itchy throat and hot itchy ears. By day 15 had swollen tongue and swollen eyelids. Nearly 5 weeks later it still has not resolved and is only being managed by antihistamines.
Pt stated that she experienced a red and itchy rash "all over her body."  She tried taking Benadryl but that did not help.  She went to see her PCP this morning and she was given a steroid injection, a prescription for a topical steroid and told to take Claritin OTC.
Vaccines were administered on June 2, 15. Call from parent 6/12/15 that there was a red hard lump at inj. site. Parent went to urgent care and started KEFLEX for dx cellulitis. Fever: None; Location: Left; Onset: 3-7 days; Duration: Acute; Severity: Mild; Quality: Worsening. Possible reaction to vaccines. Left leg swelling with fevers (102-103), treated as a cellulitis at office (taking KEFLEX). Was warm to touch, swollen etc with some excoriations.
no additional AE reported; GARDASIL 9 was administered to a patient after experiencing temperatue excursion; This spontaneous report has been received from other reporter and refers to 12- years-old male patient. Information about medical history, concurrent conditions, concomitant therapies and drug reactions or allergies was not provided.  On 18-JAN-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, intramuscularly in left arm for prophylaxis (lot # 1687291 with expiration date 11-SEP-2022) for prophylaxis. The vaccine was stored at 31.0 degrees Fahrenheit for 1 hour and 15 minutes.(it was also reported that the fridge was out of range to -0.28 for 30 minutes). The vaccine experienced previous temperature excursions of 68 degrees Fahrenheit for 17 hours and 30 minutes. The digital data logger was involved. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Muscle pain. Joint pain. Nausea. Dizzy. High fever. Sweat. Chills. Fatigue.
pain on lower back; pain across chest; pain between his shoulder blades/pain on hips/Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain on lower back), CHEST PAIN (pain across chest) and ARTHRALGIA (pain between his shoulder blades/pain on hips/Knee pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, APIXABAN (ELIQUIS) for Anticoagulant therapy, LOVASTATIN for Cholesterol, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Gastrooesophageal reflux disease, LEUPRORELIN ACETATE (LUPRON DEPOT) for Prostate cancer, LISINOPRIL, FUROSEMIDE, METFORMIN, METOPROLOL and ENZALUTAMIDE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain on lower back), CHEST PAIN (pain across chest) and ARTHRALGIA (pain between his shoulder blades/pain on hips/Knee pain). At the time of the report, BACK PAIN (pain on lower back), CHEST PAIN (pain across chest) and ARTHRALGIA (pain between his shoulder blades/pain on hips/Knee pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment history was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: follow up information received on 07apr2021 . new concomitant medication added
Approximately ten minutes following vaccination patient decided to check his blood pressure at the automated machine because he didn't feel well. Patient passed out sitting at the machine and lost control of his bladder. Patient's eyes were open and he was making snoring noises. Upon checking pulse, it was faint. Patient was breathing. Team moved patient to lying position on the floor. Pulse became more prominent and patient woke up. EMS arrived and took patient to local hospital for precautionary testing. Patient discharge home 2 hours later.
barely stand and walk; Left underarm swelled up like a softball, very tender to touch; joint pain; Left underarm swelled up like a softball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Dec2021 13:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cancer survivor" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Allergy:  hazelnuts" (unspecified if ongoing); "Allergy: walnuts" (unspecified if ongoing); "Allergy: Pecans" (unspecified if ongoing); "Allergy: Brazil nuts" (unspecified if ongoing). The patient took concomitant medications (other unspecified medications received within 2 weeks of vaccination). Past drug history included: Keflex, reaction(s): "Allergy: Keflex"; Augmentin, reaction(s): "Allergy: Augmentin". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: Apr2021, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: Mar2021, for Covid-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  The following information was reported: GAIT DISTURBANCE (medically significant) with onset 04Dec2021, outcome "recovering", described as "barely stand and walk"; AXILLARY PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Left underarm swelled up like a softball, very tender to touch "; ARTHRALGIA (non-serious) with onset 04Dec2021, outcome "recovering", described as "joint pain"; SWELLING (non-serious) with onset 04Dec2021, outcome "recovering", described as "Left underarm swelled up like a softball". Patient described the clinical course of events as follows: Woke up the next day with severe joint pain. Could barely stand and walk. Left underarm swelled up like a softball, very tender to touch or even put ice on. Joint pain dissipated after 3 days, but underarm is still swollen and tender to touch. Therapeutic measures were not taken as a result of gait disturbance, axillary pain, arthralgia, swelling.  The lot number for vaccine, bnt162b2, was not provided and will be requested during follow up.
Information has been received from a physician concerning a 50 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647635/0864N). Subsequently, the pt experienced cellulitis. It was reported that she was not hospitalized, but she did seek medical attention and was treated with an antibiotic. The pt has recovered. No additional information was provided. No product quality complaint was involved.  Additional information is not expected.
Information has been received from a registered nurse concerning an 18 month old male with no medical history who on 28-FEB-2007 was vaccinated intramuscularly with a dose of hepatitis A virus vaccine inactivated (lot# 656320/1281F). Concomitant therapy included Pediarix, poliovirus vaccine and influenza virus vaccine (unspecified). On 28-FEB-2007 the patient experienced injection site reaction in left thigh that consisted of redness, swelling, and pain in the left thigh, and 102 degrees fever. The patient's injection site reaction in left thigh and 102 degrees fever persisted. The patient sought unspecified medical attention. He was seen by the physician and still having the symptoms. The reporter felt that injection site reaction in left thigh and 102 degrees fever were related to therapy with hepatitis A virus vaccine inactivated. A lot check has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. Additional information has been requested.
This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported.  On an unknown date the patient missed a dose of RECOMBIVAX  HB lot # J007946, expiration date 24-MAR-2015 and lot J012567 expiration date 30-JAN-2016, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported. PQC involved. This is one of several reports from the same source. Additional information has been requested.
reports fatigue 2 days post inject for Hep B; fatigue has cont & pt missed 3 days of work due to extreme fatigue;
Patient's mom stated his arm was really sore where injection given when did follow-up call on 11/3/09.
Resident getting rehab therapy in the facility and has a long history of Parkinson's Disease. On 01/29/21, he received the COVID vaccine on left deltoid, resident was recently hospitalized due to Pneumonia and was on antibiotic IV and was recently placed on GT feeding due to severe dysphagia from his Parkinson's disease. On 01/31/21, started having increased congestion. On 02/02/21, started having increased temperature and WBC went up >20,000 on 02/03/21, started on Vancomycin IV on 02/04/21 but was transferred to the hospital. Facility was notified today (02/18/21) that resident expired in the hospital.
I am a clinician and received my COVID booster (Pfizer) on 11/6/21. On 11/10/21, developed pruritus to S1 dermatome and shortly thereafter, experienced intermittent shooting, burning discomfort consistent with zoster. I noticed the first lesions on 11/11/21 and has since noticed several additional lesions, some vesicular, along the S1 dermatome. I looked up the possibility of the COVID vaccine resulting in reactivation of zoster and there has been 2 cases reported specifically with the Pfizer vaccine. I thought it important to report my symptoms. I have not sought medical help as I am certain this is zoster. I work in oncology and am very familiar with diagnosing zoster and decided not to start anti-viral since it is not overly uncomfortable.
chest heaviness; having a hard time breathing; throat very scratchy; due to her allergies; lips swollen; "windpipe is shutting off" and "esophagus is closing; "windpipe is shutting off" and "esophagus is closing; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration on 15Mar2021 at single dose for COVID-19 immunization. Medical history included bronchitis in the past. The patient's concomitant medications were not reported. The patient  stated she "felt good" from that 15Mar2021 to 17Mar2021. She stated on 18Mar2021 she started experiencing heaviness in her chest and stated she was having a hard time breathing, and stated that on 26Mar2021 it was the same thing. She stated that her chest felt "Almost like bronchitis" as she stated she had bronchitis in the past. She reported that her throat was "very scratchy" and that it felt like her "windpipe was shutting off" and "esophagus was closing." The patient made a noise like she was clearing her throat and stated that that "helps it go away." She also reported that her lips are a little swollen, but stated this may be due to her allergies and stated she had taken a loratadine (CLARITIN) in the morning of 27Mar2021 for that. She reported that her head was fine, her temperature was 97.2, and her blood pressure was fine. She would like to know how long these side effects are expected to last. She spoke with her son who told her that these were side effects of the vaccine. She really did not want to go to the emergency room and reported she had tried to call her doctor but was on hold for a while. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
After 1 dose:  tender lymph nodes under left arm pit, no visible swelling  lasted  2 weeks After 2 dose: Red swollen upper arm, lasted 5 days. Large Swollen underarm  lymph node lasted 7 days
pt recv vax which had previously expired;pt devel a fine maculopapular measles-like rash on abd, chest, back, neck & face;pt sought unspecified medical attention;
Contracted Covid-19 on Dec 22,2021.  Respiratory symptoms-coughing, sore throat, sinus congestion and drainage.
Angioedema; urticarial rash; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Multiple sclerosis (stable multiple sclerosis, not on therapy).    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 ANGIOEDEMA (Angioedema) (seriousness criterion medically significant) and URTICARIA (urticarial rash). The patient was treated with DIPHENHYDRAMINE (oral) for Angioedema, at a dose of UNK, one time dose. At the time of the report, ANGIOEDEMA (Angioedema) and URTICARIA (urticarial rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Angioedema) and URTICARIA (urticarial rash) to be related.    Patient experienced an urticarial rash distributed on the trunk and upper and lower extremities, followed by angioedema of the lips and other soft tissues of the face within 48 hours of the first dose of her Moderna vaccine.  Treatment included  patient-initiated baking soda baths for  urticarial rash that persisted for 3 days and resolved  The patient did not have a known COVID-19 infection prior to vaccine administration. Additionally, she had no prior history of skin disease, no prior history of cutaneous reactions after other vaccines, nor known allergies to injectable medications.  The patient was advised against obtaining the second Moderna vaccine dose due to the risk of airway obstruction with fatal asphyxiation and/or systemic circulatory symptoms.  Company Comment - This literature non-study concerns a 68 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of angioedema and unexpected non serious event of urticaria. The events occurred within 48hrs after first dose of mRNA-1273 vaccine. As reported, the patient presented with angioedema of the lips and other soft tissues of the face within 48 hours of the first dose of mRNA-1273. The angioedema was short-lived, persisting for several hours before resolving with a patient-initiated one-time dose of oral diphenhydramine. The patient was advised against obtaining the second Moderna vaccine dose due to the risk of airway obstruction with fatal asphyxiation and/or systemic circulatory symptoms. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-491407, MOD-2022-491408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Upon internal review on 12-Jun-2023, significant correction was performed to upgrade the event Angioedema to serious medically significant.
7/10/23 FOC, called this nurse to ask what company manufactured the RotaTeq vaccine his daughter received on 6/16/23. He explained his daughter had a "bad reaction" and was wanting to see if they could try a different rotavirus vaccine. RN asked about pts reaction and FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks, and is "just not starting to feel better" (approx. 1 month after vaccine). FOC talked to their pediatrician, but would also appreciate talking to the medical director of the clinic. This RN informed Dr. who called pt. Dr. emailed RN with this summary:  "I called him and we discussed his child at some length.  It turns out she was in quite a bit of pain when she had her diarrhea and so though they didn't see any blood the possibility of a spontaneous resolution of intussusception is a possibility.  I advised to discuss with their pediatrician Dr. and deferred the decision to further vaccinate with rotavirus to them."
Within a few hours I have had muscle aches and pains. Fever overnight - still going on.
second dose administered on 14-NOV-2013; This spontaneous report was received from a physician via an immunization record from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (MARRS # 2303USA000366) and concerns an approximately 10-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 07-DEC-2011 and 14-NOV-2013, the patient was vaccinated with the first and second dose respectively of hepatitis a vaccine, inactivated (VAQTA) (lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis. This was considered an inappropriate schedule of vaccine administered.   This is one of four reports regarding the same patient.; Sender's Comments:  US-009507513-2303USA000366: US-009507513-2305USA005505: US-009507513-2305USA005504:
Hospitalization: 1/16/2023 - 1/25/2023 (9 days) Presentation to the ED: hypoxia COVID + date: 1/16/2023 Treatment: remdesivir & Decadron Discharge to: home with hospice. patient expired 1/30/2023.   038K20A 2/2/2021 031M20A 3/2/2021 051F21A 11/6/2021
Started with the regular symptoms shaking (like with a fever) nausea. Was on a road trip in a snow storm don?t know if it just was a combination of the nausea and the dizziness of the snow flying towards the windshield. But started to feel like throwing up. Pulled over and passed out, my wife says I was shaking. Came back to and throw up a few times.  After that I was just not feeling well and had nausea. Started feeling better later that day.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media company representative concerned a female of unspecified age, race and ethnicity. 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 (Dose number in series 1)(suspension for injection, route of admin, batch number:unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced bad cold for a week and half. Patient had suspected clinical vaccination failure, and suspected covid-19 infection (Dose number in series 1). As per reporter, "My wife and I took the J&J shots. We've had 2 of them now. No after effects, barely felt the shots. We both got Covid but it was after many months, and basically we had a bad cold for a week and a half. Our friend had no shots and he ended up in the hospital for a week." The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number:unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination.It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000217260. This case, from the same reporter is linked to 20220230288.; Sender's Comments: V0: 20220230357-COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
I did not have an adverse reaction to the vaccine. I tested positive with a home test for COVID-19 on 07/12/2022. I had sore throat, nasal congestion, short of breath, cough and very tired. I contacted my doctor and they prescribed PAXLOVID. After starting PAXLOVID I starting feeling better.