chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; sore arm and injection site; slight headache; fatigue; feeling cold; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she received the Pfizer COVID vaccine and on 03Mar2021 she experienced side effects including sore arm and injection site, slight headache, fatigue, and feeling cold. The clinical outcomes of sore arm and injection site, slight headache, fatigue, and feeling cold were unknown.                      No follow-up attempts are possible; information about lot/batch number cannot be obtained
A non-serious spontaneous report of FLUMIST administered to a 53 year old was received from a health professional concerning a 53-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 31-Oct-2011, FLUMIST was administered to a 53-year-old patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Jaw hurst when trying to move it and trying to eat.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw hurst when trying to move it and trying to eat.) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN JAW (Jaw hurst when trying to move it and trying to eat.). At the time of the report, PAIN IN JAW (Jaw hurst when trying to move it and trying to eat.) outcome was unknown.            Concomitant medication included high blood pressure medication.  Treatment information was not provided.   This case was linked to MOD-2021-389209, MOD-2021-389210 (Patient Link).
Chest Pain, Shortness of Breath, Dypsnea and epigastric pain. Started approximately 3 am on 3/18/21. Patient received second dose Moderna on 3/17/21
Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 84 with comorbidities of CKD, COPD, Coronary arteriosclerosis w/ 2 stents. Death was reported by daughter and unclear of the cause.
Legal report of a male patient who experienced mercury poisoning coincident with Certiva. Between 12/02/1996 to 12/19/1998, the patient received Certiva vaccination for immunization. On an unreported date, the patient experienced mercury poisoning, which led to toxic neurological effects. Pertinent laboratory test, diagnostic procedure, medical history or concomitant medication information was not provided. The patient was a child. The event of mercury poisoning was considered medically significant (OMIC).
After the 3rd vaccine 10/27/21, my mom had severe arm pain and weakness.  She then had a stroke 7 days later.
I got shot on 9/13 approx an hour later my shoulder was sore but I thought it was just normal soreness from the flu shot, over the next couple of days it progressed into my shoulder joint.  Now I can't lift my arm above 30 degrees without having pain in my shoulder joint. Today is the first day I've noted a slight amount of improvement but still painful when lifting my arm without support or pushing/pulling objects.
Approximately 6 hours after the shot there was fatigue and a slight headache.  The headache gradually worsened over the next few hours.  Nausea started around 8 hours after, and vomiting started 9 hours after.  Rest and hydration helped.  Approximately 18 hours after the injection another episode of headaches/nausea started.  This was treated with Ibupofren.  Fatigue lasted for about 24 hours after it started.
Rash after taking Shingrix; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient was vaccinated with Shingrix. The patient developed rash after taking Shingrix vaccine. The follow-up would not be provided as no contact details were available.
Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
The patient experienced no symptoms; on 6/12/2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not provided.  On 12-JUN-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (vaccination scheme and anatomical site of administration were not reported; lot number T003833, which has been verified to be valid, expiration date reported and validated as 01-AUG-2021), administered subcutaneously as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number T000494, which has been verified to be valid, expiration date reported and validated as 06-JUL-2022).  The vaccine experienced a temperature excursion of 43.8 degrees Fahrenheit (F) for 29 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion. The patient experienced no symptoms.
Patient presented with flu-like symptoms, nausea, and a headache the day after the vaccine. After 48 hours the patient had difficulty walking due to severe pain in her legs, also felt fatigued, achy, lost appetite and stated that she lost consciousness just before starting her car. On 5/04/2018 the patient stated that a Scarlett red rash developed at the site of the injection. The 6-7 inch wide rash ran horizontal across her arm and was warm to the touch. The patient didn't go to the hospital and didn't tell us about the adverse event until 05/10/2018. The patient came into the pharmacy the day after the vaccination with flu-like symptoms and we told the patient that was a normal side effect of the vaccine but then presented with the other adverse effects 48 hours after the vaccine. The patient also stated she had a bad case of the chicken pox at the age of 34.
Hives; Feeling hot; Sensation to throat closing; redness; Rash all over the body, it was itchy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), FEELING HOT (Feeling hot), DYSPHAGIA (Sensation to throat closing), RASH PRURITIC (Rash all over the body, it was itchy) and ERYTHEMA (redness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance (allergy to dairy), Penicillin allergy (allergy to penicillin), Asthma since 10-Mar-1982, Gluten sensitivity (allergy to gluten), Drug allergy (allergy to Tramadol) and Drug allergy (allergy to Imitrex). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 01-Jan-2020 to 05-Jan-2020 for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) from 01-Jan-2019 to an unknown date for Anxiety and Depression, DOCUSATE SODIUM (LAXOPOL [DOCUSATE SODIUM]) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced RASH PRURITIC (Rash all over the body, it was itchy). On an unknown date, the patient experienced URTICARIA (Hives), FEELING HOT (Feeling hot), DYSPHAGIA (Sensation to throat closing) and ERYTHEMA (redness). At the time of the report, URTICARIA (Hives), FEELING HOT (Feeling hot), DYSPHAGIA (Sensation to throat closing) and ERYTHEMA (redness) outcome was unknown and RASH PRURITIC (Rash all over the body, it was itchy) had not 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.   Treatment for the event included a steroid shot and she took a six day pack of steroids. 13 day pack steroid cream, start date-22jan2021, stop date-07mar2021 pill daily for allegra(24hours), start date-22jan2021 ongoing.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient demographic was updated. New events added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
got very achey all over - joints ached so bad, the patient reported they could hardly move. had to miss work was so sick. headache/neck-ache. just "did not feel good at all"
Approximately 10-12 hours after injection experienced extreme chills (chattering teeth, uncontrollable shivering), generalized body ache/pain. Injection site very tender, inflamed, slight swelling. Took 1000mg acetaminophen. Overall feeling throughout next 72 hours was "I felt like I was hit by a Mack truck": fatigue, aches, body & muscle pain, left arm very painful; could not raise or move arm without pain. I rarely take acetaminophen but continued to take 500-1000mg for next 2-3 days every 4-6 hours. Arm tenderness persisted for 5-6 days.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received MENVEO. On an unknown date, the patient received the 1st dose of MENVEO. On an unknown date, an unknown time after receiving MENVEO, the patient experienced injection site pain, injection site swelling and injection site redness. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site redness to be related to MENVEO. The reporter considered the injection site swelling to be related to MENVEO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The patient received a dose of MENVEO (in right deltoid) and experienced pain, redness, and significant swelling at the injection site which lasted for seven days. The reporter sent a picture by the parents of the patient showing the significant swelling. The field representative was unable to provide any further details.
anxious, shaking 5 min after vaccine. BP 118/79, O2: 99%, HR:135. Pt. assessed by MD and EMT, observed for 35 minutes and sent home. No meds required.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 06-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX lot # L043624 with expiration date of 03-NOV-2017 (dose and route of administration were not reported), which was under -10 Celsius degrees for 12 hours and -14 Celsius degrees for 3 hours. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
I received the latest Pfizer vaccine (released September 2022) on Monday, September 12. The next day, I saw a red rash forming on my chest and belly. This rash became more pronounced the next morning (Wednesday, September 14), with what used to be small red dots now expanding to large red patches on my chest, belly, and back, and also with smaller dots extending down my arms and thighs. From this point on in time, the rash continued to worsen in my back area, spreading to large patches throughout my back. It also spread to my ears and parts of my lower face.  The rash is itchy, prickly, and feels very irritated, despite my not scratching and avoiding warm or hot showers. I had originally intended to let the allergic reaction to run its course and only took Benadryl the first two days to try and alleviate symptoms. However, the rash continued to grow, and I have seen in the past that my more serious allergic reactions require intervention in order for them to stop. I decided to take a prednisone pill that I had leftover from a previous prescription, both to stop the symptoms from getting worse and also because the rash was very uncomfortable. After I took the prednisone this morning (September 15), the rash started to dissipate, though at this point in time there is still some redness, and my skin is still prickly and irritated.
pt ex inject site reaction described as blotchy, red and tender. also fever 100-102 F
Vaccine was not administered in the deltoid.  I was administered approximately 5.5 inches below the shoulder in the left arm.  The day after vaccination, the arm was painful, red, hot, hard, and swollen.  Over subsequent days, the red area increased and became itchy while remaining red, hot, hard and swollen.  The red area was a well-defined circle 10cm circle.  The skin temperature of the area was between 101-104 degrees F.   The redness and swelling resolved on day 5-6, then on day 7 (January 6) I awoke with severe nausea and my left arm was again hot, swollen, red, and itchy.  This lasted for two days.    The arm has returned to normal, except for intermittent itching that occurs sporadically, not associated with redness or edema.
Initial unsolicited report received from a physician on 14-Nov-2016. This case involves a 44-year-old male patient, who was vaccinated with a 0.5 ml of FLUZONE QIV (batch number: UI640AB, expiry date: 30-Jun-2017; route and dose in series not reported) at right deltoid on 30-Sep-2016. Patient received Bicillin on 04-Sep-2016. It was also reported that illness at the time of vaccination was none. Concomitant medication was not reported. It was also reported that any other vaccinations within four weeks of vaccinations was none. On 01-Oct-2016, one day after the vaccination, patient developed a red, raised, painful lesion at injection site, that increased in size to the size of patient's palm and area was very warm to touch, and appeared to have fluid in the center of the reddened area. Patient required ER/doctor visit. The patient's laboratory data was reported as none. Patient received Benadryl and Naproxen and cold compress were applied. Patient recovered from all the events on an unknown date within 48-hour of onset. List of the documents held by sender: none.
Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer). This case involves a patient (age and gender unknown) who experienced allergy to tetanus toxoids, while he/she received vaccine TETANUS TOXOID. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus toxoids (allergy to vaccine) with unknown latency following the administration of TETANUS TOXOID. Lab data was not provided. Final diagnosis was allergy to tetanus toxoids. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus toxoids. List of documents held by sender: none.
REDNESS AROUND INJECTION ABOUT 3 INCHES IN DIAMETER. PATIENT WAS GIVEN DIPHENHYDRAMINE 12.5MG/5ML - 10 ML FOUR TIMES A DAY. LINE WAS DRAWN AROUND SITE AND PATIENT AND MOTHER WERE TO RETURN TO HOSPITAL IF AREA ENLARGED OR FAILED TO RESOLVE. PATIENT WAS NOT IN ANY DISTRESS.
On the 11/17/2021 i received the Covid vaccine. On the 04/06/2022 around 5:30 I had a fever, sore throat and heavy chest. I took Tylenol and felt a little better. As the day went on I started to get worse and decided to get tested. I was positive. I had sore throat short of breath and chills. This lasted about 4 weeks. After I developed bronchitis and was put on antibiotics.
Vaccine on 1-30, developed dizziness and SOB 2-3, persisted intermittently until 2-5 when had syncopal episode with no LOC, symptoms gradually resolved over next few days with no further syncope
received vaccine at 1140, by 1630 I felt flushed, and light headed, and slightly hypotensive at 98/56, over night I spiked a fever rangeing from 99.8-100.8, with chills, dizziness, generalized fatigue and body aches, some sob w/ activity, and speech, some tachycardia w/ a hr 115-125, I was unable to report to work 01/15/2021, sxs did not improve until late afternoon 01/17/2021, was able to return to work 1/18/21 with continued sob w/ exertion, generalized body aches, and fatigue
Blood pressure dropped, she passed out in the kitchen, hit the floor, knocked her out, broke her wrist, hit her head, spent 10 hours in the er. ER doc said it was a result of the vaccine
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose given to a 13 year old) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021 at 3:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose given to a 13 year old). On 15-Nov-2021 at 3:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose given to a 13 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant product use was provided by the reporter. No treatment medication was provided.Patient did not had any events till the time of reporting. This case was linked to MOD21-164677 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow-up received include reporter, patient and product details.
Guillain-Barre syndrome; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Guillain-Barre syndrome. The reporter consented to follow-up.
2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by severe pain in muscles "all over her body".    She had severe headache.   She had a fever of 101.9.     She had no appetite and "could not eat" .   She remained in bed, barely able to walk to the bathroom for 7-8 days.   She was "so weak", could not get up.   She did not have solid food for 1 week and was not able to take more than sips of liquid.   She has continued weakness fever.  Now 3 wks following the vaccine,  her temp is 100.2.
Abnormal swelling and redness  of arm around injection site. Patient states she had symptoms of pain and itching as well on the affected arm. She said she ws told by an RPh here to take Ibuprofen for the swelling. The patient was also instructed by a RPh to take Benadryl and contact her doctor should it be a true allergic RXN. Patient stated that she did take the Ibuprofen, but not the Benadryl and her arm has gotten a lot better. Symptoms lasted about 24 hours give or take.
Dry Throat; swollen, dry, burning, itchy eyes; rapid onset shortness of breath; Anaphylaxis.
12/06/21 presents to EC ED for "L sided sharp, intermittent abdominal pain". PMHx of "crohn's disease"
Information has been received from a medical assistant referring to a 2 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-OCT-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (wrong product stored), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007549: US-009507513-1902USA007548: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007544: US-009507513-1902USA007550: US-009507513-1902USA007537.
I had shortness  of breath starting shortly  after receiving the vaccine.  I had a huge lump develope on my collarbone,  and I starting having my period every other week, with extremely heavy  blood flow and clotting  which I have never had before.  I am now anemic as well.