chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from the non-clinical study program. A 38-year-old female contactable consumer (unknown ethnicity) reported that received PREVNAR 13, at single dose, on 09Nov2015. Relevant medical history included type 2 diabetes mellitus. Concomitant medications were unknown. The patient experienced injection site reaction with itching immediately after injection on 09Nov2015. Treatment was received (antibiotic, antihistamine). The patient recovered from the adverse event. On 09Nov2015, the patient experienced also chills, vision problem, and nausea; while on 10Nov2015, she developed fever of 101 Fahrenheit, shortness of breath and cellulitis at injection site. Hospitalization was required. Diagnosis was cellulitis. Electrocardiogram (EKG) was performed. Treatment was received for the events (antibiotic for fever, chills, ZOFRAN for nausea and clindamycin, and ROCEPHIN for cellulitis at injection site). No treatment was received for vision problem. The patient recovered from these events. On an unspecified date, in Nov2015, the consumer reported that had chest pain and she was certain she was about to die. Clinical outcome and seriousness criteria of these events were unknown. Follow-up (23Dec2015): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious.
Pt recv vax on 4/5/99; on 4/6/99 pt exp diffuse edema of rt arm w/ warm/ tender mass
Pt reports to have joint pain in injection shoulder since receiving shot and pain has increased since then (2 weeks).  Patient can't raise arm past 90 degrees.  Patient is being referred to PCP for care.
Arm felt hot at the injection site; Redness moved down her arm; Injection site got red; Injection site was raised a tiny bit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Arm felt hot at the injection site), ERYTHEMA (Redness moved down her arm), INJECTION SITE ERYTHEMA (Injection site got red) and INJECTION SITE SWELLING (Injection site was raised a tiny bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced INJECTION SITE WARMTH (Arm felt hot at the injection site), ERYTHEMA (Redness moved down her arm), INJECTION SITE ERYTHEMA (Injection site got red) and INJECTION SITE SWELLING (Injection site was raised a tiny bit). At the time of the report, INJECTION SITE WARMTH (Arm felt hot at the injection site), ERYTHEMA (Redness moved down her arm), INJECTION SITE ERYTHEMA (Injection site got red) and INJECTION SITE SWELLING (Injection site was raised a tiny bit) outcome was unknown. Not Provided          No treatment information was provided.
High fever (not measured) the evening of vaccination. At midnight 11/14 developed numbness of R side of face, eye, area back of head and behind R ear. No other numbness or pain. Had headache 11/16 which was successfully treated with Nicotinic acid. Numbness of face continued today, 11/19.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUN-2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-DEC-2013, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I received the vaccine on 3/21.  On 4/1 I had a breakthrough grand mal seizure walking down the street after being seizure free for almost 5 years.  The seizure resulted in a fractured vertebra (T12).  On 4/5, while resting at home I woke up and had another seizure sitting in a relax the back chair.    I had a mri on my brain that I understand came back normal.  The doctors aren?t sure what caused the seizures but increased my dosage by 500 mgs per day despite my previous dosage controlling my seizures for about 5 years prior to my vaccine.   No doctor has definitively stated the seizures were caused by the vaccine.  However, the timing has prompted me to notify you of these events.
Itchy on face head neck and ears. Red blotchy rash on face and neck  Took two benadryl and lots of water rash and itchiness lasted until 9pm of 4/16/2021
"spinal ache" of the whole spine; Fatigue for 2 days; This case was reported by a physician and described the occurrence of pain in spine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included guillain barre syndrome. Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in spine and fatigue. On an unknown date, the outcome of the pain in spine and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in spine and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient with remote history of GBS (guillain barre syndrome) reported spinal ache of the whole spine and fatigue for 2 days after 2nd dose of Shingrix. She recovered completely on the 3rd day. The reporter consented to follow up.
I received the Pfizer Bivalent COVID-19 booster and a flu vaccine on 10/5/2022. On 12/24/2022, I woke up with a sore throat at about 3 AM. As the day progressed, my sinuses became more congested, and I developed a cough. I normally get an upper respiratory infection once a year, and it basically felt like that. On 12/25/2022, I got a store brand version of THERAFLU and took that. It helped clear up the sinuses somewhat, but not completely. On 12/28/2022, I went to the doctor's office, where I underwent a rapid test and got a positive result. The PA prescribed me benzonatate, PAXLOVID, and erythromycin, all of which I began taking that day. As the days progressed, I slowly got better. I began to really feel better on 12/31/2022. By 1/1/2023, I was pretty much over the illness. At the time of this writing, everything seems to be okay, and I don't think I have any residual symptoms.
2 HOURS AFTER INJECTION I EXPERIENCED SORENESS AT THE INJECTION SITE. 13.5 HOURS AFTER INJECTION I WOKE UP WITH A FEVER AND CHILLS. I TOOK ONE TYLENOL WHEN THE FEVER AND CHILLS WOKE ME. THE FEVER AND CHILLS LASTED APPROXIMATELY 3 HOURS. THE SORENESS HAD SPREAD TO MY UPPER BODY BY 4AM, 17.5 HOURS AFTER INJECTION. THE  SORENESS/BODYACHE PERSISTED FOR THE DAY FOLLOWING INJECTION. I DID NOT SEE A DOCTOR AS THE SYMPTOMS RESOLVED THEMSELVES.
debilitating vertigo occurring every 3-5 days after vaccine administration; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 30Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse. A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729 ), via intramuscular, administered in Deltoid Left on 08Apr2021 15:02 as dose 1, single for covid-19 immunization.  Medical history included lyme disease from 2013 to 2015. Concomitant medication included cetirizine hydrochloride (ALLER TEC) taken for Environmental allergies from May2020 and ongoing.  On 13Apr2021, the patient experienced serve debilitating vertigo occurring every 3-5 days after vaccine administration. It was reported that vertigo is happening to others getting the Pfizer Covid vaccine. The event involved physician office visit. The event was assessed as serious. Persistent/significant disability/ incapacity. Therapeutic measures were taken as a result of the event includes meclizine and ondansetron. The outcome of the event was recovered on 30May2021 with sequelae.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between event Vertigo 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 with vaccination adverse effects one hour after receiving multiple vaccines. PT received 1st anthrax, 1st JEV, 1st smallpox, 1st typhoid, 2nd hep A vaccinations (1st one without adverse reaction) and been having blotchy rash on basically whole body including hands, feet, and chest, fever, hoarseness, SOB, swollen hands, lightheadedness, stinging pain in hands etc. for last 4 days. PT was sent to ER and admitted for continuous care and monitoring. Measles was ruled out. Requested medical records and pictures of the patient's skin rash from hospital.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:37 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.52. Concomitant products were not provided. On 28-Feb-2021, Excursion time was 09 AM and 01 PM, temperature was 27 and 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Unknown, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43, 4 PM: 45 and 5 PM: Unknown. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Patient presented 4 days after the start of symptoms, which started 14 days after the second dose of the vaccine. Patient presented with fevers with a Tmax of 102, chills, conjunctivitis, stocking glove rash to the hands and feet and to the extensor surfaces of the extremities, and a geographic tongue.
exema; This case was reported by a consumer via media and described the occurrence of eczema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot and shot gave him/her exema. The patient had a terrible response with this shot and vaccine caused him/her so much trouble and should not have gotten that 2nd shot. The follow-up could not be possible as no contact details were available.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
no adverse side effect; TE; This spontaneous report was received from a medical assistant referring to a 6-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 mL, administered for prophylaxis (lot #W039033, expiration date: 01-OCT-2024; strength and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 mL, administered orally for prophylaxis (lot #1968385, expiration date: 22-MAY-2024; strength was not provided). Both vaccines had a current excursion at 49.1 F for 34 minutes, with two previous excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes (Product storage error). No adverse side effects were reported with the administration of the vaccines.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2307USA004472:
Received JJ vaccine March 2021. Was told I had high blood pressure during a doctor's visit to remove ear wax April 2021. (144/95) I assumed the reading was incorrect. I went to the eye doctor in Nov 2021 and they saw wool cotton spots on my eyes indicating high bp. I went to my pcp the following week and they recorded a BP reading again in the 140/90 range. I did not have a hx of high prior to April 2021. I have no risk factors of high bp.
Initially, fleeting waves of nausea.  Ended quickly. Fatigue includes sleeping during the day,  Surges of heat (maybe similar to hot flashes).  Core to head to fingers and toes. Aware of approx. every 10-15 minutes while awake. Less frequesnt  by 40-48 hours. Sensation of warmth in arthritic knuckles of fingers  Symptoms stopped as abruptly as they began.  No treatment.
I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird.  The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs.  Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad.   My stomach feels better.  Haven?t eaten anything,  I am more concerned about under my breast hurt so much when I take a deep breathe or cough.    I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting
Expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the patient care tent. BP: 128/70, P: 90, Resp: 17. Patient drank some water and ate pretzels while sitting and denied dizziness after 20 minutes of sitting up. Patient left the building feeling well and denied any dizziness.
Patient had received a flu vaccination in left arm from flu site.  She informed a lady about 3 inches down from injection site she has a bruise and a litle firmness, no redness.... Patient contacted flu coordinator for on 10/28...was told by coordinator to continue to watch it and to contact physician if any further problems...On call back at a later time patient indicated it was better.
I caught COVID-19 and set up appointment for immediate care. My doctor prescribed me a 5 day pill. I slept a lot and isolated myself. It took about 2 weeks to recover.
vaccine was administered - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/12/2021 ABDOMINAL PAIN ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 7/12/2021 ABDOMINAL PAIN ACUTE RESPIRATORY FAILURE 8/11/2021 ABDOMINAL PAIN ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 7/12/2021 ACUTE RESPIRATORY FAILURE ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 7/12/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 8/11/2021 ACUTE RESPIRATORY FAILURE
My menstruation has been extremely regular since 12 years old. It occurs once a month, at the start of the month, and lasts 5-7 days. It is heavy the first 2-3 days with intense cramps, then the cramps go away and it gradually lightens until it's done. However, since getting the first dose of the Moderna vaccine, I've had my regular period followed by maybe a week of no period, after which I start bleeding again. This bleeding does not come with cramping or any of the regular symptoms of my period: sore lower back, irritability, bloating, nausea, acne. The first time the extra bleeding happened was following my first dose of the Moderna vaccine and was extremely light, so much so that it was barely recognizable (a very faint light brown discharge). Every month since this first vaccine, the additional bleeding has continued. After getting the second dose of the Moderna vaccine, the bleeding has actually increased. It still occurs about a week after my normal period. Not only is it heavier each month, it occurs for longer. Now, for example, it is no longer simply a light brown discharge that can be taken care of with a thin panty-liner. Instead, I have to change a regular tampon a few times a day and wear an overnight pad when I sleep. It is mostly dark brown in color but when I wipe, there's sometimes a faint pink color. My first dose of the Moderna vaccine was batch # 006B21A and my second dose was batch # 032B21A.
PATIENT RECEIVED COVID VACCINE-MODERNA FOR 1ST DOSE. FOR 2ND DOSE,  PFIZER VACCINE HAS BEEN ADMINISTERED INSTEAD OF MODERNA. THE ERROR HAS BEEN REPORTED IMMEDIATELY TO THE SITE LEAD NP; NOTIFIED PT AND HER CARE GIVER . RELATED DOCUMENTATION ON HER CHART HAS BEEN COMPETED ALONG ITH VAERS.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: antigen tests and Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 30-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml once, subcutaneous, (lot # K003600, expiration date: 10-MAR-2015 (also reported as 19-MAR-2015), inadvertently which was expired. No adverse effect was reported. Additional information has been requested.
Flu shot given at 5:00 pm 10/5/11. About 8:30 felt dizzy had an itching or hives on arms & trunk BS up to 266 last night.
This spontaneous report as received from a physician and his medical assistant refers to a 14 year old patient. Pertinent medical histories, current condition, reactions and allergies were not reported. On 21-JUL-2014, the patient was vaccinated with GARDASIL (dosage regiment were not reported) (lot # J006850, expiry date: 31-MAR-2016), intramuscular and a dose of GARDASIL 9 (dosage regiment were not reported) (lot # L014415, Expiry date: 25-JUL-2017) on 20-AUG-2015 (patient experienced inappropriate schedule of drug administration and incorrect drug administration duration). Concomitant medications were not reported. The patient has not experienced an adverse effect. No additional information was provided. No Product quality complaint (PQC) was involved. Additional information has been requested.