chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose not administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not administered) 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 treatment medication were provided.
inflammation in her rotator cuff; left arm got sore right away; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (left arm got sore right away) and ROTATOR CUFF SYNDROME (inflammation in her rotator cuff) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm got sore right away). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (inflammation in her rotator cuff). At the time of the report, PAIN IN EXTREMITY (left arm got sore right away) and ROTATOR CUFF SYNDROME (inflammation in her rotator cuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or medical history provided. Patient states she received an oral steroid taper 2 weeks after 1st shot.   This case was linked to US-MODERNATX, INC.-MOD-2021-067275 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067275:Dose 2
ACUTE HYPERCAPNIC RESPIRATORY FAILURE 12/29/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/22/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
In the recovery time frame my wife contracted covid and also tested positive; In the recovery time frame my wife contracted covid and also tested positive; This is a spontaneous report from a contactable physician. A female patient (Wife) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date in Jan2021as single dose for COVID-19 immunization. The patient 's medical history and concomitant medications were not reported. She was recently tested positive for COVID-19 infection on an unspecified date and have since recovered. In the recovery time frame she contracted COVID-19 infection and also tested positive on unspecified date. Reporter does not know if needs to be concerned about as patient case is extremely rare. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on unspecified date. The outcome of events was unknown.  Information about lot/batch number is requested.; Sender's Comments: The efficacy of a drugs and vaccines varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported events drug ineffective and COVID 19 infection cannot be ruled out.
Patient reported right facial paresthesia within 20 minutes of injection of Flulaval into right deltoid muscle. She also reported that when needle was withdrawn, a small amount of, blood 'streamed' down her arm onto floor. She also reported paresthesia surrounding right ear. No vision changes or motor issues however. The following day, she reported having a right sided temporal headache and that her right deltoid was very sore, and that her right axillary region was irritated. She was evaluated in ER night of vaccination, and released after observation.
constant headache that never goes away started morning after vaccination.  If my heart rate increases (ex. running, working out, stress, during intercourse, anything physical) my headache turns into a debilitating migraine.  My head and back of neck gets hot, light and sound bother me extremely bad,my vision gets very blurry, almost loosing vision in my left eye, very dizzy.  The pain from the migraine wraps from my temples like a band above my ears, down the back sides of my head and meets in the middle of the back of my neck.
Shortly after vaccine was given, welts appeared on face. Patient returned to office and was given Benadryl. Other than welts still present, patient was fine when left office.
Face flushing; Tachycardia; Hypertensive; This spontaneous case was reported by a physician and describes the occurrence of FLUSHING (Face flushing), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertensive) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Palpitation. Concurrent medical conditions included Drug allergy (Lidocaine, Cephalexin).    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FLUSHING (Face flushing), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertensive). At the time of the report, FLUSHING (Face flushing), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertensive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 160/110 160/110.     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.   Concomitant medications were not provided. Treatment information was not reported.
Nausea , joint, arm pain for a three days, followed by diarrhea onset same day, now persistent and copious and watery, 7 days following injection
Initially felt discomfort and itching of arm, developed swelling and warmth from shoulder to elbow of arm where vaccine placed.  Also had some headache and nausea.
Narrative: 85yo male with history of aortic valve replacement, HLD, , aortic aneurysm, and RA. Received covid vaccinations on 02/05/21 and 03/06/21. Patient died at home on 06/04/21. Unable to assess if death was related to covid vaccinations. No information available about patients death.
Sudden onset of extreme exhaustion, nausea, chills, low grade temp, face bright red & puffy, breathing labored. Severe right arm pain & inability to move it. Went to ER. Treated with oxygen & IV fluids. Symptoms resolved spontaneously after approximately an hour. Residual headache & arm pain.
VARIVAX (Merck 1613Z exp date 11/18/12) administered 6/2/2011. Seen 6/7/11 with "bulls eye "rash on (R) arm & diagnosis of Lyme Disease confirmed by serology 2-3 days later; anterior chest pain -> diagnosis of myocarditis prob secondary to Lyme Disease.
Back pain requiring Naproxen, canker sore outbreak in mouth followed by same type of sores in genital area, headaches, spiked temperatures, chills, sweats, body acne, fatigue. Back pain, headaches & fatigue continue today; genital sores and acne improved after several weeks; mouth sores lasted over a month but better now.
Onset rash 7OCT91 stomach-waist line (whelps) progresssed to rash over body; 0 temp 9OCT91 exam ped clinic rash not related to vax; r/o strep; dx: viral throat infect;
Muscle cramps; Arm cramps; She felt like someone hit me on top of my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps), MUSCLE SPASMS (Arm cramps) and MUSCULOSKELETAL DISCOMFORT (She felt like someone hit me on top of my shoulder) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle cramps), MUSCLE SPASMS (Arm cramps) and MUSCULOSKELETAL DISCOMFORT (She felt like someone hit me on top of my shoulder). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Muscle cramps), MUSCLE SPASMS (Arm cramps) and MUSCULOSKELETAL DISCOMFORT (She felt like someone hit me on top of my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant treatment included hemp rub.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received vaccine after expiry date) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 049E21A) for COVID-19 immunization. No medical history reported. On Oct 29, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Oct 29, 2021, patient administered expired product (patient received vaccine after expiry date). On Oct 29, 2021, administered expired product (patient received vaccine after expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient received first dose of Pfizer vaccine on an unspecified date; second dose of Pfizer vaccine on Mar 31, 2021.
Neurologic impairment; brain fog, headaches, fever, severe psychotic symptoms eventual psychotic break requiring hospitalization.
6/3: Injection site became itchy within 1 hour & became very red that evening. 6/4: Site became painful, swollen, tneder, redness spread, and she became itchy all over her body. That night she began to experience severe itching where she previously had singles. Per PCP, patient can return to work if blisters to not appear by Tuesday am.
This case was reported by a consumer via other and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and hyperacidity. On an unknown date, the outcome of the injection site pain and hyperacidity were unknown. It was unknown if the reporter considered the injection site pain and hyperacidity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The journalist experienced side effects after receiving SHINGRIX. Did not appear to be anything unexpected, but thought they should had it logged anyway. The patient experienced local soreness and an acid stomach for a day or two.
Local Rx right deltoid given Td and influenzae on 11/15/05 - tender, swollen 4" x 2"; no erythema, normothermia to palp injections were spaced 1/4" apart. Examined by myself on 11/17/05. Tx Q.I.D. Ibuprofen; Keflex 500 one PO B.I.D.
Pain in arm at the vaccine site; Arm was red and swollen and worsened throughout the day; Arm was red and swollen and worsened throughout the day; Extreme fatigue; Confusion; Vertigo; Shakiness; Shortness of breath; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), hydrochlorothiazide/triamterene (TRIAMTERENE/HCTZ) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 and 26Feb2021, the patient had the normal symptoms. On 01Mar2021, the patient was awakened by pain in the arm at the vaccine site. The arm was red and swollen and worsened throughout the day and also experienced symptoms of extreme fatigue, confusion, vertigo, shakiness, shortness of breath and nausea began throughout the day. The patient was trying to push through and not believe it was related to the vaccine, but after a couple days, the patient had to stop pushing. The more severe symptoms lasted two weeks and then the vertigo began to diminish. The patient was still experiencing some. The patient was giving it a month to go away. Then went to her doctor. Fatigue, shakiness and SOB were still the worst. On an unknown date, the patient underwent lab tests (unspecified) and results was normal. On an unknown date, the patient underwent electrocardiogram test (EKG) and the result was normal. On an unknown date, the patient underwent CT scan and the result was ruled out blood clots. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm at the vaccine site, arm was red and swollen, nausea, vertigo, confusion was recovered with sequelae on an unknown date in2021 and of the events extreme fatigue, shakiness and shortness of breath was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I started with chills and then probably about 1n hour into chills my face started to feel warm and I felt really really cold. I took my temp and it was 100.3F . I starred with body aches and I took a Tylenol. My fever was gone about 3AM next morning and I was able to sleep the rest of the night and when I woke up I was very tired, no fever and just body aches. About 8 or 9PM the next day I was feeling normal again.
Started vomiting on 5/21/11 and went to hospital on 5/22/11 where diagnosed with intussusception which needed to be surgically reduced.
9MAY91 Temp 106R w/jerking, arm & lips purple @ that time; ?diarrhea x 2 days; 10MAY91 red rash non raised on abd, back, & diaper area;
area of firm induration to left upper arm, overlying skin is red with vesicle formation. Area of induration is approx 10 cm in diameter. Area of redness is approx 15 cm in diameter. Vesicle patch is approx 1.5 cm in diameter.
I got a rash on both upper thighs by the evening on the day I got the shots. Later the rash spread to my whole body, face, hands, arms, legs, back, stomach, everywhere. I also developed a slight fever the day of and it worsened the day after. I still have a fever today. I also got joint pain 2 days after the shot. My neck hurt, my left hip, both ankles, and now my elbows hurt. I've also had a slight headache on and off since I got the shots.
fever 104, fussy, not eating, but taking fluids well; fever goes down but come back up; MD visit 4NOV revealed no other cause for fever;
Red, itchy, hot patch on arm developed 1 week after injection. Increased in intensity after 24 hours, then faded and disappeared after 2 days.
02/11/21@1435-Pt complaing of naueas and headache then stated she was short of breath after vaccine given. RN contacted, pt given Benadryl 12.5 mg. Pt stated she has anxiety. Pt became upset and started crying. Pt closed observed. O2 sat 94% P-73; BP 152/92. Pt states she also get migraines and feels like one is starting. Tylenol 320 mg oral liquid given. Pt started vomiting at 1450, stated she vomited Tylenol. 1453-BP 144/100; p-70; O2 95%. Pt states she has not eaten since yesterday afternoon and hasn't really been taking much fluids. Offered pt a cookie to eat and water to drink. Pt stated she felt better. Continued to observe pt. NP came out to assess pt. Pt states she would like to go to ER to be seen. Pt was instructed to go to the ER, pt refused. AMA form completed and signed. 1530- Pt's BP 164/110 right arm, 162/102 left arm. Pt started vomiting again and stated she does not feel good. Transport called and arrived. Pt's BP done by fire and rescue was 176/104. Pt taken via ambulance. gp,rn
Client approached EMT station at 1320 to inform she was experiencing blurry vision and ringing of her right ear. RN  set up anti-gravity chair and client walked and sat on chair without assistance. RN asked EMT, RN  and PHN of assistance. PHN and RN  arrived at 1321, client was sitting upright in anti-gravity chair, alert and oriented x4. EMT was taking vitals. Client reported to RN "trouble swallowing saliva." RN clarified with client if she was experiencing shortness of breath or chest pain and client denied both. Per client, "swallowing felt different." PHN  assessed for any swelling on face and tongue, hives, and flushing. Client able to answer all questions. Client stated no relevant medical history, no medications, and no history of allergies. At 1322 client verbalized trouble swallowing her saliva again. PHN offered client Benadryl and client accepted. RN  activated 911 at 1322. Vitals at 1323: blood pressure 183/104, pulse 92, oxygen sat 90%. EMT repositioned pulse oximeter, oxygen sat 94%. PHN administered 50mg Benadryl IM on left deltoid at 1324. RN  continued speaking with client who was able to answer all questions. At 1328 client stated "swallowing is better." Vitals at 1329: blood pressure: 198/116, pulse 92. Paramedics arrived at 1330 and assumed care. At 1335 client signed AMA with paramedics. PHN advised client to stay in observation 30 mins prior to leaving. Client stated "I feel fine now." Per client family member was waiting outside at vehicle for her and wanted to leave. PHN reviewed ER precautions and importance of following up with primary medical provider. Client left facility with steady gait with the use of her cane at 1344.
Pain, redness  and swelling at injection site lasting 3 or more days,  Tiredness for one day,
I had zero effects that I could identify from the vaccine until today it was clear I was having a side effect.  I had dizziness that caused me to feel light headed and have a "weird" feeling with my vision.  It caused me to sit down and wait about 5 minutes for it to pass.  I have a service dog that is sensitive to medical conditions and he came and sat very close to me for 30 minutes (unusual in my home) while this occurred.   Then it passed.
Dose was administered on 13Feb23, the beyond use date of medication (expiration of lot is 05/25/2023) was noted as 11Feb23.  Dose was administered 2 days after the 30 day beyond use date.  Have called Moderna for any additional stability date for this lot, informed it would be 3-5 business days prior to receiving stability data back.  To date no adverse effect has been reported by patient to facility
08/31/22 presents to Birth Center for "elevated LFTs" "36w0d". PMHx of "Hypothyroidism"
Initial Report Received on 10-Apr-2019. A reporter from an infectious disease clinic (unknown title) reported that a patient (gender, age, and race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was an expired dose. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient received an expired dose of HEPLISAV-B that expired on 06-Apr-2019 (lot # and NDC # not provided). On 10-Apr-2019, the reporter stated that a patient was given an expired dose of HEPLISAV-B. When the reporter was informed that additional information would need to be collected for a report, she stated that a doctor would call back and she ended her inquiry and ended the call. A case number was given to her for reference. No call was received (from the doctor). On 11-Apr-2019, the reporter was called back and a message was left that it was urgent and to call back as soon as possible. The reporter's information from her recording on the phone call was located via a search on the internet and the reporter's clinic information was able to be located. At the time of this report, the individual collecting the report was awaiting for a call back. Additional information regarding the incident or medication lot number was unable to be obtained. No further information was provided. At the time of the report, the outcome of the event was unknown. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
3 x 5 allergic reaction, huge welt (L) arm area warm to the touch.
THE PATIENT PRESENTED AT THE PHARMACY FOR THE COVID BIVALENT SHOT. THE COVID SHOT INTAKE FORM WAS FILLED OUT, THE PRESCRIPTION WAS ENTERED INTO THE PHARMACY FILLING SYSTEM AND ADJUDICATED TO INSURANCE. THE PATIENTS COVID CARD WAS REVIEWED AND UPDATED. THE SHOT WAS PREPARED, THE PATIENT WAS GIVEN AN OPPORTUINITY TO ASK AND HAVE QUESTIONS ANSWERED AND THE SHOT WAS ADMINISTERED. WHEN INPUTING THE PATIENTS INFORMATION INTO LOCAL TRACKING SYSTEM AT THE END OF THE DAY IT WAS DISCOVERED THAT THE PATIENT HAD ALREADY RECEIVED THE BIVALENT SHOT SEVERAL MONTHS PRIOR. A CALL WAS PLACED TO MODERNA FOR ADVISE ON HOW TO COUNSEL THE PATIENT, MODERNA REFERED THIS CALLER TO THE CDC. THE CDC WAS CONTACTED AND THE PATIENT CONTACTED IMMEDIATELY AFTER THAT. NO ASE REPORTED AT THE TIME, NONE REPORTED AS OF THIS DATE.
Narrative: 77yo died in long term care facility for pt's on long term ventilators. Pt died at this facility on 11/10/21. Pt died from respiratory failure due to COVID-19 pneumonia with failure to wean from ventilator. Pt had received covid vaccines on 1/21/21 & 2/22/21. Death from covid pneumonia due to vaccine failure.
Rash and redness at site of injection lasting a week at this time. Fatigue. Chills.
p/vax pt exp 2 inch area of induration around inj site, redness & swelling, whole area of lt thigh;