chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness around her heart/chest wall pain; Soreness in left shoulder and around heart; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Soreness around her heart/chest wall pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE BESYLATE, HYDROCHLOROTHIAZIDE, ACETAMINOPHEN, ALLOPURINOL, SIMVASTATIN, KETOCONAZOLE, FOLIC ACID, ALPRAZOLAM, PIOGLITAZONE HYDROCHLORIDE (ACTOS), MAGNESIUM OXIDE, TRIMETHOPRIM, MACROGOL 3350 (MIRALAX), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE AND SALMETEROL) and DEXLANSOPRAZOLE (DEXILANT).  On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Soreness around her heart/chest wall pain) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Soreness in left shoulder and around heart). On 13-Apr-2021, MUSCULOSKELETAL CHEST PAIN (Soreness around her heart/chest wall pain) and PAIN IN EXTREMITY (Soreness in left shoulder and around heart) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood test: 13-apr-2021 Inconclusive. On 13-Apr-2021, Chest X-ray: 13-apr-2021 Inconclusive. On 13-Apr-2021, Electrocardiogram: Inconclusive.  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.  Other Medication: oyster calcium tablet,Re senna  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Caller was coughing over the phone; He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary Immunization series complete; He previously received all the Moderna vaccines), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Sep2022, outcome "unknown", described as "He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine"; COUGH (non-serious), outcome "not recovered", described as "Caller was coughing over the phone".  Additional information: Reporter explained that he had received the booster dose in September last year (Sep2022). Despite receiving all the vaccines against COVID he got COVID about three weeks ago. His doctor informed him that he was fortunate enough to get all the boosters and all the vaccines because the COVID symptoms could have been a lot worse. He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine. He was told that it was ok to receive the booster dose of Pfizer. Reporter was coughing over the phone and mentioned that was the after effect of COVID. Reporter stated that he would like to stay most up to date with his immunization status hence the reason why he was calling to get information on the most up-to-date booster. He wanted to know whether he was eligible or not.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202300016074 same product, patient, different events;
**************COVID BREAKTHROUGH CASES*************** Friday May 20, I started having a sore throat running nose chough and my husband tested positive the day before. The next day I had body aches chills and cough continued. I was treating it with Tylenol and cough medication. Called my doctor and her referred me to go get the antibodies infusions.  I started the infusions on Saturday.
Pt return to clinic c/o swollen reaction possibly due to flu vac. Treatment f/u or 24-48 hours or return (?) if symptoms worsens. The follow up received on 11/18/03 states Rx monitor/ comfort measures has recovered.
1 Hive on left cheek at 10:00 pm gone in the morning  when I woke up
My right arm started feeling weak. I was really tired, so I rested all day then I took my blood pressure and it 225/111. I went to ER & was told I had a stroke.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX injection (lot# reported as L036830, expiration date 24-SEP-2017, dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature reported as 16 Fahrenheit (F), time frame 2 hours and there was no previous temperature excursion. Additional information has been requested.
Flu immunization given in clinic Thursday 9/28/17. Mom brought patient into clinic 9/29/17 with T degrees 101.1 and corporal rash. Mom advised to give TYLENOL for discomfort. Mom called office 10/2/17 (Monday) stating rash still present and not any worse. T degrees 100.3. Mom instructed to keep giving TYLENOL and use BENADRYL. Mom to call in 1-2 days to update.
At night had deep muscular pain in shoulder more in the underarm area than at injection site.  Pain continued until yesterday, improving gradually each day.  Advil provided relief but only made pain more tolerated.  Called doctor and emergency room for advice.
Breakthrough case admission after 2 vaccines Moderna 5/5/21 Lot# 016C21A;  Moderna 6/5/21 Lot# 036C21A
The patient experienced a fever, chills, aches, fatigue.  The fever lasted 34 hours, and at the high point was at 103.6 degrees.
Resident has increase weakness and lethargy with abnormal labs.  He was transferred to the ER.  He was admitted to the hospital and treated for worsening AKI and hypotension.
Patient was inadvertenly administered second dose Pfizer vaccine after receiving first dose of Moderna with another provider.
After two weeks straight of processing herring in seafood plant, exhausted at 0200 he took a shower and fainted in the shower. He was found semi-responsive, shivering with labored breathing and flu like symptoms. EMS was called and taken to ER for evaluation. He was released from local hospital within two -four hours when symptoms resolved.
Major non-scarring hair loss (Alopecia Areata). Loss of over 50% of hair to create in two large bald patches on top of head - resulting in high levels of stress and depression.
Low grade fever, chills, headache back of head, lower back pain. One whole day after injection.
improperly sotred PNEUMOVAX was administered; This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-SEP-2020, the patient was vaccinated with an improperly stored dose of   pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029542, expiring on 10-JUN-2021, for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of 48F for 106 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  No additional information was provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt. said that the shot was given on her upper arm- shoulder area- and hurt at the time.  Then next day she had a difficulty moving her arm and had pain in her shoulder- She called the pharmacy on 5/6/23 - She called the pharmacy 5/14/23 to tell us she saw a dr on 5/9/23 and was told that she has a fracture in a bone of her shoulder.  She said the Dr told her that it was the result of the immunization shot.
Angioedema the day after vaccine but "feel sick" after vaccine.  Angioedema for the first time in my life-healed itself then returned again. Extensive allergist test followed allergist can't find the cause
This patient is a contractor for the military.  He received Pfizer as his 1st dose.  This patient needed a 2nd dose to complete the vaccination regimen, but Pfizer was not available.  This patient received Moderna as a 2nd dose within the vaccination time window.  This patient did not experience any adverse events from the Moderna vaccination.
I experienced  bad itching and bumpiness after exercising in the palm of my hand and I use the exercise bands alot and have not had the issue happen before. That's why I got it checked because it never happen before the vaccine. Since then the itchiness in my palms has continued for no reason.
Vaccine was not diluted prior to injection pt experiencing low grade fever and fatigue and arm swelling
Patient experienced pain, redness and swelling at the injection site and these symptoms extended down to her elbow on her right arm. She stated that the symptoms started shortly after she received the vaccines and she called the pharmacy one day later and was still having symptoms. She tried ibuprofen and ice but was getting little relief.
Woke up with fever of 103.2 F and body aches. Gave him ibuprofen and checked his fever at 11 AM and it was 104.1 F.
Onset of local redness, swelling, pain, pruritus at site of AVA injection.
Received preservative free influenza vaccine 10/29/12 at 2:30 pm. Within half hour started experiencing chest pain & SOB. Tried her personal inhaler 2 puffs COMBIVENT without resolution. Went to E.D. 12 lead EKG, Bld work, PEPCID IV; observation. Discharged home.
A mother reported that her 9 month old daughter received Prevnar and Inactivated Poliomyelitis vaccines on 7/23/01. On 7/24/01, the infant developed a fever, which peaked at 101.5F and was up all night crying. She also developed eczema on her face, which is now chaffed and bleeding with red cheeks. She developed an injection site reaction, at the location of the Prevnar immunization, that "looks like a mosquito bite and about the size of a dime". The mother reports that her daughter is presently seeing an allergist and has been tested for allergies.
On Day 8 after vaccination in the upper L arm, patient developed a red, swollen, tender area just below the nail of the L ring finger.  Patient was incised and drained for what was considered to be a paronychia.  This lesion was incised and drained, packed and stitched up.  Patient was put on antibiotics.  Paitent also reported some muscle aches, tender axillary nodes.  History of nail-biting which patient credits for other episodes of paronyhia.
chills; fever like symptoms like sweats and hot but no fever; fever like symptoms like sweats and hot but no fever; headache; nausea; not feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 21Apr2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced chills, fever like symptoms like sweats and hot but no fever, headache and nausea. Caller stated she is continuing on day 8 of side effects. She reported that her daughter experienced chills, fever like symptoms like sweats and hot but no fever, headache and nausea. She stated that tylenol takes the headache away for about 3 to 4 hours. Reporter stated she gave her daughter zofran in the mornings for nausea. Reporter stated ibuprofen does not help much. She stated her daughter tested negative for covid. She stated her daughter has missed some school and athletic events and reports not feeling well. Reporter stated her daughter had better days on days 2 and 3 and her worst days were yesterday and today. She reported tylenol did not help much, only for a limited time. She was concerned that the side effects are not going away and not alleviating. She asked is this common for there to be this many side effects this many days after the first dose. Reporter asked does she move forward with the second dose. She stated the pediatrician told her to ask Pfizer. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Significant swelling, extreme heat on skin, pain, mild nausea, inability to stay focused or pay attention.
I experienced unusual fatigue and other flu-like symptoms. Though no fever measured, I felt feverish alternating with chills. This went on for about 3 days. I have experienced similar reaction to past flu shots, but not with this intensity and duration. (Previous episodes resolved after a night's sleep.) Reaction was possibly linked to fact that first shot was a leaky syringe - much fluid sprayed out rather than went into arm - so pharmacy tech gave me a second full dose.
Suspected vaccination failure; young male with IBD; experienced a mild case of Herpes Zoster; signs of inflammation; This case was reported by a physician via other manufacturer and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ibd (serious criteria GSK medically significant), herpes zoster and inflammation. The patient was treated with ustekinumab (Stelara) and tofacitinib citrate (Xeljanz). On an unknown date, the outcome of the vaccination failure, ibd, herpes zoster and inflammation were unknown.   It was unknown if the reporter considered the vaccination failure, ibd, herpes zoster and inflammation to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 20-Jul-2022. Reporter's Comments: The physician reported that young male with IBD (inflammatory bowel disease) was being treated with Stelara was uncontrolled due to inflammation and stricture was added on tofacitinib 10 mg bid.  The patient had history of 2 doses of Shingrix prior to starting on IBD treatments. The patient went into REM with dual Stelara and Tofacitinib combo and then discontinued Stelara when REM was attained. The patient experienced a mild case of Herpes Zoster while on tofacitinib 10 mg bid. The patients tofacitinib dose was then reduced to 10 mg daily. The patient was now showing signs of inflammation again so the plan to increase tofacitinib dose to 10 mg bid again. The events took place after use of product. The reporter did not wish to be contacted for follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming Herpes zoster were unknown at the time of reporting.
Vomited twice - on 11/01/2011 and the next day. Had dysentery and fever 103 F.
Rash was red, itchy and very painful. It was triangular shaped; red, itchy and very painful rash; red, itchy and very painful rash; Small rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Small rash at the injection site), VACCINATION SITE ERYTHEMA (red, itchy and very painful rash), VACCINATION SITE PRURITUS (Rash was red, itchy and very painful. It was triangular shaped) and VACCINATION SITE PAIN (red, itchy and very painful rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced VACCINATION SITE RASH (Small rash at the injection site). On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red, itchy and very painful rash), VACCINATION SITE PRURITUS (Rash was red, itchy and very painful. It was triangular shaped) and VACCINATION SITE PAIN (red, itchy and very painful rash). On 28-Feb-2021, VACCINATION SITE RASH (Small rash at the injection site) had resolved. On 01-Mar-2021, VACCINATION SITE ERYTHEMA (red, itchy and very painful rash), VACCINATION SITE PRURITUS (Rash was red, itchy and very painful. It was triangular shaped) and VACCINATION SITE PAIN (red, itchy and very painful rash) had resolved.
Waves of nausea I become lightheaded I start to sweat profusely I have to sit down and wait for it to pass numbness and tingling in left arm
Arthralgia, Fever, Chills Narrative: Early morning following injection, experienced fever, chills, joint pain
Resident developed an all over body, raised, itchy red rash. Treatment with Benadryl, Vistaril, Hydrocortisone cream, Solumedrol and Medrol dose pack. Rash has improved but not completely resolved.
Pt received Pfizer as booster dose instead of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pt received Pfizer as booster dose instead of Moderna) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 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 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pt received Pfizer as booster dose instead of Moderna). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Pt received Pfizer as booster dose instead of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Anaphylactic reaction; This is a spontaneous report received from a contactable consumer (parent; patient's father). A 19-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included sports induced asthma and family history of allergic reactions to several products and vaccinations, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date. It was reported that the patient experienced an anaphylactic reaction after her first dose and her doctor advised her not to get the 2nd shot. She has a history of sports induced asthma and used to have an inhaler for when she was active playing sports, but now, she was using an inhaler at all time after her reaction to the Pfizer Covid-19 vaccine. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
vaccine. She was waiting about 15 min after vaccination when closer to 4:45 complained of headache, cold and chills. She was asked to lay down on stretcher where her BP was checked 134/94,P=74 Pulse OX 100% on room air. She drank two small juice box and continued laying down. Raised her feet up and while she was resting she felt increased heart rate BP=143/104, P 97, Pulse OX 100%. Pt has no medical history, denies any environmental, food or vaccine allergies previous to this vaccine. She was alert, awake and oriented through the process yet escalated to transfer to ED since her BP remained elevated above her normal level of 120/80. Paramedic arrived at 17"35 and she was transferred to ED. BP 144/93 P=80, T=99.2( tympanic), Pulse Ox=100% at the time of transfer. Her chest was clear to auscultation and heart is regular with occasional iregular heart beat on auscultation. Her headache decreased yet still had mild headache.
Her shot was administered 6/25/21 about 6pm.  No issues until about 5:00AM on Saturday 6/26.  She began to have a migraine-level headache she said was about a 9 out of 10 pain (zero being no pain), extreme fatigue, nausea and vomiting every 20-30 minutes.  She was not able to keep down liquids or tylenol, so there was no relief of symptoms until she finally was able to eat a little and take tylenol late Saturday night.  By 10am she said the headache was down to a 1 out of 10, felt less fatigue, muscle pain from the vomiting, and overall about 80% functional.  By 2pm Sunday she said about 85-90%, and now today Monday 6/28 she feels 95% and is fully functional.
While sleeping in mothers arms, head began jerking forward and backward and body moving like a worm. Episode lasted approximately 3-5 seconds and was a one time occurrence.
Migraine headache for 10 hours, nerve pain 10 hours, fever 8 hours, nausea 4 hours, kidney pain the follow day.