chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm was stiff; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Her arm was stiff) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Her arm was stiff). At the time of the report, MUSCULOSKELETAL STIFFNESS (Her arm was stiff) outcome was unknown. Not Provided      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.   No concomitant medications were mentioned. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-116546 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116546:Reporter's mother case
11-7-12 Approx 4-5 hrs after Influenza vaccination, patient developed red & runny eyes, sore throat, lower lip was red & felt numb, no swelling, no hives. Patient took an ALLER-FEX, an antihistamine but experienced no significant relief. Advised patient to contact his physician. Will f/u with patient in one day. 11-8-12 T.C. to patient. Patient reports sx have resolved & is now fine. No further f/u.
Fever of 103ºF; severe full body ache; severe coughing; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103ºF), MYALGIA (severe full body ache) and COUGH (severe coughing) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21a and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (Fever of 103ºF), MYALGIA (severe full body ache) and COUGH (severe coughing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 103ºF), MYALGIA (severe full body ache) and COUGH (severe coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 103 (High) 103 degree F.         No concomitant medications information was reported.
Pt reports developing  tremors about 2 weeks after his second vaccine. Presents today for work up
Severely short of breath in the a.m. - I  needed to sit up to breathe. I couldn't sleep because I couldn't breathe. Doctor gave me a Lasix - Diuretic  but didn't  help any. ER.  160 heart rate - several doses of Cartazen injections and gave me Oxygen (which I had been getting at home - the oxygen) and the blood pressure was a bit elevated. They sent me home after his heart rate went down with those injections. Added the Lopressor to his Regimen (CartaZen.) I never really got better. Shortness of breath for about four days and so called regular physician and I sent us back to ER. They did more tests and gave me Lasix and at that point I was having ankle swelling and edema.  They diagnosed me with Congestive Health Failure. Gave him Lasix - Put out about 2 liters. They wanted to keep in hospital but I refused.  At that point, I was going to see a cardiologist they referred me to. They wanted an echo-cardiogram and was unable to get that done for two months. I also had an abdominal ultrasound. Under the care of cardiologist, ordered further testing. Heart patch to monitor heart rate - wore it for two weeks. They did an echo cardiogram finally and I saw the doctor - 20-25% cardiac output (normal is 50). I had a cardiac angiogram - heart cath to see if there was any heart damage or blockage - and there was not. My arteries were wide open. So now I continue under the cardiologist's care and they have changed the medication multiple times because I remain in Atrial Fibulation. They changed my meds two days ago. The first med - I was slowly getting better and second one, I went backwards and now the third med I've been on for two days and so far it's promising. Echo-Cardiogram - October 13th.
same symptoms I had with covid approx 11/4/20: extreme fatigue, night sweats, muscle aches
FLARE LOWER BACK/ SCALP/EARS AND ON FACE; A LOT OF PAIN; MAKING DAILY ACTIVITIES DIFFICULT; This solicited report received from a patient via PPSIMM001960: Pharmacy concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy. The patient was treated with guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, from 25-SEP-2020 for psoriatic arthritis. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Expiry : unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included naproxen for drug used for unknown indication, hydrochlorothiazide/triamterene, losartan potassium, metformin, and metoprolol.  On MAY-2021, the patient experienced flare of Psoriatic arthritis in the lower back/ scalp/ears and on face. The patient was also experiencing a lot of pain, making daily activities difficult. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The patient had not recovered from flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult was not related; and between guselkumab, and flare lower back/ scalp/ears and on face was related, and between guselkumab, and a lot of pain, and making daily activities difficult was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210652721-covid-19 vaccine ad26.cov2. s- flare lower back/ scalp/ears and on face. This event(s) is considered not related. The event(s) has an unknown/unclear 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: UNDERLYING DISEASE. V0: 20210652721- Guselkumab- flare lower back/ scalp/ears and on face was related. This event(s) is labeled per regulatory authority and is therefore considered potentially related.
She started to have stomach pain when eating on 08/05. She got to the point where eating any food made her stomach worse so her weight declined very fast.  To date, he has lost 18+ lbs.  She is very weak.  on 08/28 the school called the ambulance because her jaw was clenched shut, and her hands wouldn't work, she had numbness and tingling in her feet, and legs.  She was very unstable and weak and we had to carry her in.  She is still in abdominal pain and weak.
This case was reported by a consumer via call center representative and described the occurrence of buttock pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (8 to 9 years ago) and post herpetic neuralgia (8 to 9 years ago, PHN for about 9 months in left buttock and down back of left leg). On 2nd October 2018, the patient received the 1st dose of SHINGRIX 50 ug. On 4th October 2018, 2 days after receiving SHINGRIX, the patient experienced buttock pain and leg pain. The patient was treated with gabapentin. On an unknown date, the outcome of the buttock pain and leg pain were not recovered/not resolved. It was unknown if the reporter considered the buttock pain and leg pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine, 2 to 3 days later she developed severe pain in her left buttock and down the back of her left leg. The pain was occurring in the same place where she had post herpetic neuralgia 8 to 9 years ago. She was taking extra gabapentin to help with the pain. She described her current pain as like having shingles again.
Felt like she had a rush type feeling in arm then became light headed and in general didn't feel good.  Blood pressure taken 170/106 (left) sitting.  Said it would come and go in waves lasting several minutes.  Also said her arm feels disconnected from body.  11/06/2003: PC made to patient and she said by a few hours she felt well until 01:00 am then had the same feeling for about 2 hours.  Today has felt well.
pt began having acute joint pain & swelling;acute muscle pain lasting to present;began running elevated temp 101;all glands in neck swell w/pain;inject site became red, swollen and hot;
The patient has left thigh pain, with redness, and induration. The site feels warm and hard.
There was no response immediately at the time of the vaccine.  The patient complained of redness, swelling on her arm.  I told her that could be a normal response to the vaccine, but she came in the show me her arm.  I noticed what appeared to be a scratch and 2 mosquito or ants bites around her left elbow.  This is the area where the inflammation was.  It was red, swollen, and warm to the touch.  I suggested she try tylenol and benadryl to see if that helps and to see an MD if it doesn't clear up in a few days.  The patient decided to see an MD where she was prescribed Keflex 500mg 1 po TID x10d
I started having a hardness in my belly a month after vaccination. Had a cyst on my left ovary (13cm) which had to be removed 07/16/2021.
Case number PHEH2015US026446, is an initial spontaneous report received from a nurse on 08 Dec 2015. This report refers to a patient of an unknown age and an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient vaccinated with FLUVIRIN (batch/lot number: 1515701/ 1516601, expiry date: Jun 2016) on 08 Dec 2015 which was stored out of temperature range at 33 Fahrenheit for 6 days and 30 minutes. The reporter stated that their refrigerator thermometer had not been calibrated for 5 years. No adverse event was reported as following medication errors.
Pain in her spleen; chest pain/feels like she had chest inflammation; vomiting; Right arm injection site pain; Patient felt feverish; Felt like she had the flu; Did not feel well/patient feels like she has chest inflamation; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), ABDOMINAL PAIN (Pain in her spleen), CHEST PAIN (chest pain/feels like she had chest inflammation) and VOMITING (vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spleen pain (after a tetanus shot 10 years ago) and COVID-19 (patient experienced chest pain at this time) on 13-Mar-2020.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), INJECTION SITE PAIN (Right arm injection site pain) and PYREXIA (Patient felt feverish). On 15-Aug-2021, the patient experienced VOMITING (vomiting). On 17-Aug-2021, the patient experienced CHEST PAIN (chest pain/feels like she had chest inflammation). On an unknown date, the patient experienced ABDOMINAL PAIN (Pain in her spleen). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) on 15-Aug-2021 for Vomiting, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Did not feel well/patient feels like she has chest inflamation), ABDOMINAL PAIN (Pain in her spleen), CHEST PAIN (chest pain/feels like she had chest inflammation), VOMITING (vomiting), INJECTION SITE PAIN (Right arm injection site pain) and PYREXIA (Patient felt feverish) was resolving.            Concomitant medications also include: antibiotic and steam compresses.    This case was linked to MOD-2021-330758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up received contained Non significant information.
A non-serious spontaneous report of migraine headaches and abdominal pain was received from a medical assistant in a physician's office concerning an 11-year-old female, subsequent to FLUMIST. The patient received FLUMIST ON 03-Nov-2008. Within several hours after the dose of FLUMIST the patient developed a migraine headache and abdominal pain. The events remained unresolved at the time of the report.
pt recvd vax 7JAN93 mom stated pt taken to ER that evening w/severe local reaction, redness pain & now devel knot in lt leg; Is applying cool cloth to area & to return to family MD;
This spontaneous report as received from a registered nurse concerning a patient of unknown gender, over 60 years old, who in September 2013 was vaccinated with a dose of ZOSTAVAX 0.65 ml, intradermally in the anterior forearm of the deltoid region. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that on an unspecified date, the patient experienced huge painful wheal. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
no additional adverse effect; for temperature excursion for GARDASIL 9. Caller stated the vaccine was given four times today.; This spontaneous report was received from a medical assistant and refers to a 18-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 28-JUL-2021, the patient was vaccinated improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml; lot # 1687291 with expiration date 11-SEP-2022 (exact dose and dose number were not provided) for prophylaxis.  The temperature excursion was 80.6 Fahrenheit (F) for 14 hours and 51 minutes. Previous excursions included: 73.2 F for 9 hours and 25 minutes, 73.4F for 8 hours and 48 minutes. The digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: 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 criteria for reportability; Sender's Comments:  US-009507513-2107USA008566: US-009507513-2107USA008701: US-009507513-2107USA008462:
One day following the initial vaccine, experienced fatigue, nausea, painful swelling below the injection site, loss of appetite, and acne. One week following the vaccine, arm broke out in a rash in the same area where swelling was present the week prior.
I have had Tinitus since the day after my first dose...got a bit worse after the booster
Immediate reaction of leg swelling after 2 month WB immunizations. Right worse than left. R-IPV, Hep B
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: BP 112/70 HR 65 bpm
The pt experienced a 1 x 2 cm are of redness with 5cm area of firm edema under injection site. No lymphangitis. No fever. Localized Cellulitis.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media (Facebook) and concerned a patient of unspecified age, sex, 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 (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, 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 had covid-19 symptoms (suspected clinical vaccine failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190742.; Sender's Comments: V0:20210849222-Covid-19 vaccine ad26.cov2.s -SUSPECTED CLINICAL VACCINE FAILURE. This event(s) is considered not related. 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
103 fever for 36 hours, headache, nausea, body aches, swollen lymph nodes in armpit for 48+ hours
This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Private pay/ Insurance. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
4 month old awoke in am with generalized tonic seizure brought to ER afebrile work- up. Blood chem normal, Brain CT/MRI normal, LP normal. Received immunization 16-18 hours earlier.
MD notified of react 5AUG94; according to mom pt recvd vax 24FEB93; approx 6 hrs p/vax had t104 R temp & was shaking all over; parents called ER they were told to give APAP & tepid bath;
"eight to nine rashes now"; rash starting on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash starting on arm of injection) and RASH ("eight to nine rashes now") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant products included ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (ENALAPRIL HCT) and ATORVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced INJECTION SITE RASH (rash starting on arm of injection) and RASH ("eight to nine rashes now"). At the time of the report, INJECTION SITE RASH (rash starting on arm of injection) and RASH ("eight to nine rashes now") had not resolved. Not Provided          This case was linked to MOD-2021-071311 (Patient Link).   Reporter did not allow further contact
after her first dose she experienced lower back pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She mentioned that after her first dose she experienced lower backpain. She mentioned that she and her husband had the first dose on 06May2021 and would like to know when they will get the second dose.  The outcome of the event was unknown.  Follow up attempts are needed. Information about lot/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606338 different patient, same drug and event.
Cellulitis Hives Fever Vomiting Anemia Diarrhea Severe headache Swelling around eye Abnormal white blood cell activity
Patient received flu shot in left deltoid on 10/10.  Patient developed pain and swelling in her right deltoid for 3 days.  Tenderness in the left thigh.  Patient noticed 2cm blister on left deltoid. Discomfort in left buttock and left thigh.  On patient, the blister is noticeably swollen and some ? with 2cm blister. Pt received flu shot in left deltoid 10/20/03. Developed pain and swelling in left buttock, 36 hrs later. Pt noted weakness and tenderness in left thigh. 2cm blister on left buttock noted 10/22/03. Currently resolving. On exam swollen left buttock, tender, 2cm overlying blister treated by pt's PMP. Dx zoster. Rx ? not known.
Received the Moderna Shot and within 7-8 weeks after passed away; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Received the Moderna Shot and within 7-8 weeks after passed away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported by reporter.  Patient died on an unknown date approximately 7 to 8 weeks after receiving vaccination.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown casuse of death
tachycardia, chest tightness, SOB, dizziness, throat tightness about 20 minutes after vaccination. Epi-pen administered shortly after patient reported symptoms.  Symptoms improved within 1-2 minutes of epi-pen administration.
Moderna COVID 19 Bivalent ordered by provider and administered by Medical Assistant. Patient waited the 15-20min triage time for evaluation and reported no symptoms and well to return home. After administration it was brought to our attention that vaccine that was given was expired as of August 8th, 2023. Patient informed and counseled by PCP, Dr. before leaving clinic.