chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, MYALGIA in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS, MYALGIA and LYMPHADENOPATHY. At the time of the report, CHILLS, MYALGIA and LYMPHADENOPATHY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment of the events included an unspecified anti-inflammatory.
On 2/4/15, 31 yo M was seen in clinic for office visit. During this visit, pt was ordered to receive pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23). At 0841, LPN injected 0.5 mL of lot #K012424 (Merck; exp: 6/5/16) subcutaneously into pt's right arm. During this same visit, the pt received an influenza vaccine in left deltoid (lot # UI214AA0). On 2/6, pt called the clinic and reported that he has developed redness, swelling and a hardened area at the right arm injection site. Pt was asked to come to clinic for evaluation. On exam, the pt reported non-radiating constant aching pain in the right upper arm with a pain score of 4/10. Pt reported that the symptoms worsen with movement and palpation. Pt also endorsed a fever at home, but vitals check on presentation found a temperature WNL at 36.7 °C (98.1 °F) (Oral). Pt has self-treated with rest and ibuprofen, with no reported relief. Pt denied any chest pain, muscle weakness, numbness or tingling. MD diagnosed cellulitis and prescribed dicloxacillin (DYNAPEN) 500 MG capsule with instructions to take 1 capsule 4 times daily. Pt was also advised to take acetaminophen as needed for discomfort and follow up if symptoms do not improve or worsen.
Moderna  vaccine  (NDC  80777-0273-98)  lot # 039D21A + GTiN  00380777273983 was administered  after the beyond date of 10/23/2021. Contacted  Manufacturer  Moderna = no need to repeat the dose .
pt recv vax 22SEP95 & 17AUG97 pt devel herpes zoster lesions;21AUG97 pt was dx w/shingles;It was reported that no cult were available for analysis;
Standard high fever, chills, tiredness next day after 2nd dose. However, day 3, 5, 7 all had a dizzy spell, first two days were just moments of dizziness.  Third time the dizzy spell lasted about 10 minutes.  on day 28 after the shot, woke up lightheaded, went to work.  @ hours in, was so lightheaded and dizzy that I threw up and was taken to hospital by ambulance where I threw up again.  Spent 10 hours in the ER, running CT scans, MRI, Xrays, tests, etc thinking it might have been a stroke.  All came back clear.  Started reading blogs that are now coming up about this kind of thing and since there was no reason or difference in my life except the shot and the first 3 episodes, I felt I needed to report my story.
Cramp in right leg; soreness around the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramp in right leg), VACCINATION SITE PAIN (soreness around the injection site) and PYREXIA (Fever ) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced MUSCLE SPASMS (Cramp in right leg), VACCINATION SITE PAIN (soreness around the injection site) and PYREXIA (Fever ). At the time of the report, MUSCLE SPASMS (Cramp in right leg), VACCINATION SITE PAIN (soreness around the injection site) and PYREXIA (Fever ) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication included Tylenol and tramadol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
On her first booster she got a sore arm; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (primary immunization series completed , unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "On her first booster she got a sore arm".  Additional Information: From: withheld  Reporter Name: withheld  Reported by: Nurse Reporter Contact Information: withheld  Patient Name: withheld  Description of Event: It was reported that, the withheld told me she received the Pfizer-Biontech covid19 vaccine. On her first booster she got a sore arm. She did not have any other symptoms. Name of Product: Pfizer-BioNTech Covid-19 vaccine Awareness Date: 12May2022 Country of Occurrence: United States. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain, inflammation, and general malaise. Treated by PCP with Cephalexin and Hydrocodone for cellulitis. Treatment approx 48 hours after vaccination.
incident; Information was received from a lawyer regarding a female patient, age and history not provided.  The lawyer reported that the patient experienced a incident on 01-EB-2016 related to zoster vaccine live (ZOSTAVAX). Dates of immunization was not provided and details surrounding the incident were not provided.  Outcome of the incident was not provided.   Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's pertinent medical history included benign prostatic hypertrophy, high cholesterol and hypertension. No known drug reactions/allergies. On 15-MAR-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the right rear deltoid. Lot number J014851. Concomitant therapies included JALYN, pravastatin sodium, and ZIAC. On 16-MAR-2014 the patient stated to pharmacist that he experienced back pain that moved around to his kidney area. On unspecified dated the patient contacted his physician. It was reported that the patient declined pain medication on unspecified date. The physician prescribed a CAT Scan on an unspecified body area. The result of the CAT Scan, received on 24-MAR-2014, was negative. The patient also reported to the pharmacist that pain shifted from spine to kidney area. "Around 23-MAR-2014 or 24-MAR-2014" the patient noticed that his spine was tingling. On 24-MAR-2014 the patient's wife noticed a rash on the patient's back. On 26-MAR-2014 the patient reported to pharmacist that the rash was coming around one side of his body (side of body was unspecified) in the same spots where pain originated in kidney area since an unspecified date. On an unspecified date the patient was prescribed an unspecified antiviral medication. On 26-MAR-2014 the patient stated to pharmacist that he still has the rash, the rash is incredibly painful and uncomfortable. The outcome of experienced back pain that moved around to his kidney area and his spine was tingling is unknown. The outcome of rash on the patient's back in the same spots where pain originated in kidney area was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 20-Sep-2014. It was reported that Nurse practitioner reports they administered FLUMIST to 2 patients over 49. The outcome of the event of administered FLUMIST to two patients over 49 is unknown. The report was considered to be non-serious.
101.3 fever X 3 days, all flu symptoms- loose stool, nausea, swollen lips lasting several days at first (this symptom has reoccurred twice lasting a day both times), severe itching both shins and both nipples (yes, nipples!), psoriasis type burning rash on both elbows, both antecubital areas, both thumbs. The rash also comes in "flares" like the lip swelling.
Child received vaccines on 9/5/06, presented to office on 9/7/06 with erythema, mild induration, and warmth to right arm. Area not tender. Mother reports that child had the "same" reaction after previously administered DTaP a couple of years ago.
No adverse event; Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (History of Heart) and Stroke. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines).    Concomitant medication included Blood pressure medication.  The reporter who was infection preventionist reported that the patient had a health history of heart and stroke and was concerned.  No treatment details were reported.
Patient came to clinic for a Moderna booster, which was provided the same day on 7/5/2022. Later when doing vaccine reconciliation it was noted to be past the 30 day window of administration. This lot number had an expiration date of 10/15/2022. It arrived after ordering on 5/10/2022, so the last use-by date should have been 6/10/2022. 7/5/2022 falls outside of the last use-by date. Patient was called. No adverse effects. No recovery required. Moderna was called and verified he would not need to be revaccinated. The lot number was still effective.
Top of my head was extremely tender to the touch; impacted wisdom tooth started aching; slight fever blister started on my lip but was gone by next day; just didn't feel chipper.
Symptoms began at 4pm; felt achy.  Next day at noon, there was face and throat swelling; felt like throat was collapsing. Went back to vaccine administrator and was told that symptoms had nothing to do with vaccine.  Patient was not told about possible symptoms the day of the vaccination. Patient did not take any medicine, just drank water and went to sleep; patient could barely sleep.  Today, patient took shower and felt dizzy--had to hold on to the sink.  The throat and facial swelling is not as severe as yesterday.  Patient is currently trying to figure out how to follow-up.    Reporter wants to remain anonymous in case we need to contact the facility.
awoke frequently w/inconsolable crying not high pitched;no fever crying started early evening 28OCT97 & cont through noc & morning of 29OCT97;APAP given PMD notified;
First dose was 3/11/21- EN6208. Both were administered. Following first shot, within hours experienced roaming- targeted joint pain.  Searing hot pain in joints that have been seriously injured in the past. Each joint had pain for about an hour or two, then moved to another site. Injection site soreness for a few days. A week later got a swollen itchy large red bump on injection site, resolved with 24 hours of cortisone cream.   Second dose 4/11/21 3PM. 10 AM the next day I was experiencing intense fever and chills for hours. I did not have a themometer at the time it was the worst. By 4 pm I was feeling better and had access to a thermometer and had a temperature of 102.5. I verified this temperature with a second instrument.  That night I had additional fever and chills through the morning. Felt great after that, just worn out from fever.   My next four menstrual cycles were MUCH heavier than ever in my whole 30 years of having periods. My normal heaviest day (usually only one per cycle) had me using two super tampons in the day. the cycles following my vaccine, I was going through a Super every two - three hours for three days. My cycle was also extended by two days each of those months and the overall flow heavier even on non-heavy days. In addition, I experienced much more significant cramping those heavy days.
After receiving a 2nd dose of Moderna vaccine, patient started feeling a tingling  sensation in her whole body. Patient stated she is not feeling good and rolled her eyes back. Patient became  unresponsive for about 15-20 seconds. Pharmacist was about inject epinephrine that's when patient mumbled and started to get her consciousness back.  Patient was profusely sweating upon awaking.  Paramedics were called at pharmacy. Upon arrival, they checked patients vital signs. Patient was responding fine and declined to go to an emergency room. Patient's vital signs were normal.
I felt Like my body was hit by a truck, I nurse baby and couldn't lift her and my muscles were super wear, and my Right hand felt on fire which is opposite of the vaccination was. In the morning when I got up I couldn't open a water bottle. My fingers would kind of shake where I called in sick. I kept squeezing my hand to get my strength back.
6/16/21 patient had an episode of syncope within 5 minutes of vaccine administration - fell and hit tailbone first, then hit head against the ground and had brief seizure witnessed by mother (full body shaking), LOC, unresponsive, pale and cold/clammy. lasted for several seconds.   no PMH of syncope, seizures. no medical problems
patient admitted to ICU for sepsis secondary to COVID pneumonia vs. community-acquired bacterial pneumonia vs. catheter infection (tested + for COVID 5/2/2022).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FM), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "2 MIs" (unspecified if ongoing), notes: Other medical history: 2 MIs; "Lymphoma" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: COVID 19 Treatment; (19Jan2023) Negative, notes: 2 negative tests on days 9 and 10; (20Jan2023) Negative, notes: negative tests on days 9 and 10; (22Jan2023) Positive, notes: Symptoms and positive test Day 12; (27Jan2023) Positive, notes: Still positive on Day 6 of rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 11Jan2023 to 16Jan2023, started on day 0).
Had syncopal episode at home. Fell - stopped breathing x20 seconds. Then was "postictal" x20 seconds - ? primary seizure vs breath-holding episode.
Inflammation, severe pain, and redness started in PM on 2/17/06. By the evening of 2/18/06, patient reports severe pain, inability to move right arm, increasing redness of arm passing down past elbow with streaking. Went to ER at this point where she was given Keflex, Percocet and Benadryl. To return to primary MD on 2/21/06.
HAVE ONLY TAKEN FLU SHOT IN JANUARY 2021, WITHOUT INCIDENT
fever; lymph node swelling in left arm; chills; fever; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 18-Apr-2021, the patient experienced RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm). At the time of the report, CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) 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.   This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 18-Apr-2021, the patient experienced RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm). At the time of the report, CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) 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.   A healthcare professional called to report that a patient received the first dose of the COVID-19 vaccine on 14APR2021 and started experiencing symptoms of rash on the face, neck and waist. The patient also reported lymph node swelling in her left arm.   Treatment information included was an unknown dose of Benadryl   This case was linked to US-MODERNATX, INC.-MOD-2021-081439 (Linked Report).   This case was linked to US-MODERNATX, INC.-MOD-2021-081439 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081439:
Pt was given Pfizer 0.3ml and should have had 0.2ml.  Covid vaccine provider line called and will give second dose as 0.2ml.   No adverse reaction .
heart inflamed; enlarged heart; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220409107 (Janssen).  A 53-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Ad26.cov2.s (Dose 1, Route of administration: Unknown, Indication for use: Prophylactic vaccination, Therapy duration: Unknown), administration date: Sep2021, for Prophylactic vaccination. The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "heart inflamed"; CARDIOMEGALY (medically significant), outcome "unknown", described as "enlarged heart". The patient underwent the following laboratory tests and procedures: Blood test: Unspecified Results, notes: Classification: Unk; Cardiac monitoring: Unspecified Results, notes: Classification: Unk; Computerised tomogram: Unspecified Results, notes: Classification: Unk; Electrocardiogram: Unspecified Results, notes: Classification: Unk; Ton of tests: Unspecified Results.  Sender's comments:  covid19 vaccine ad26.cov2.s Heart- inflamed. The event (s) has unknown/ unclear temporal relationship is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event (s). Therefore this event (s) is considered unassessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7SEP t102 c/o tiredness; 7-10SEP c/o stiffness neck; c/o sore knees-swollen-difficulty walking; 10SEP chills, shaking, fever; rheumatoid arthritis;
pt rec'd vaccine (grey cap_ after it was in freezer for 22 days- we have been unsuccessful in reaching patient
Big (2.5 inches diameter) hard itchy red rash. Raised.  I?ve only had it for a few days. I still have it. It was worse yesterday and is starting to go down today
pt states he had a sore right arm the day of the vax but the next day he woke up feeling like he has the flu.  He has body aches, chills, and fever. He still has all of these symptoms and will call  his physician if they get worse.
This spontaneous report was received from a physician refers to a 25 year old female patient with vitamin C allergy (unspecified reaction) and no pertinent medical history. On 03-SEP-2013 the patient was vaccinated with 0.5 milliliters (ml), dose 1 GARDASIL (lot # J005679, expiration date 27-NOV-2015)intramuscularly in the left deltoid. Concomitant therapies included FLEXERIL. On an unknown date in September 2013 she developed a large area of tenderness and swelling at the injection site that was also itchy. The patient also reported having tender axillary and mandibular lymph nodes. The physician called into the physicians office on 06-SEP-2013 to report this event. The patient was seen by the physician on 10-SEP-2013 at which time she declined medication for treatment. The physician stated when he saw the patient, on 10-SEP-2013 she "seemed fine and was recovered". Laboratory diagnostic studies were not performed for this event. Additional information has been requested.