chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PUNCTURED VIAL REFRIGERATED AND EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, alcoholism, and cigarette smoker, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced punctured vial refrigerated and expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from punctured vial refrigerated and expired vaccine administered. This report was non-serious.
10 minutes after vaccine adm pt c/o rash left abd & (L) arm - Epi. 3 ml SQ given.
swelling of face, redness, burning feeling, temperature, nausea, body aches, chills
Extreme dizziness to the point of puking and blacking out, headaches and migraines that come in clusters, racing heart palpitations, high blood pressure and heart rate
Narrative:  89 yo male pt died on 8/1/2021. Pt hd received 1 covid vaccine (moderna) on 2/2/2021. Pt had been residing in facility but was discharged on 7/2/21 requiring a higher level of care. no further information available regarding pt's death. Likely death is not related to covid vaccinations given pt's advanced age and long time frame btwn covid vaccine & death (7 months).
Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PALPITATIONS (Heart racing). At the time of the report, PALPITATIONS (Heart racing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Mild shortness of breath occurring within 15 minutes after dose and lasting approximately 7 hours.  Worsened with exercise; booster; booster; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 11:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ESCITALOPRAM [ESCITALOPRAM OXALATE]. Vaccination history included: moderna (Dose Number: 3, Batch/Lot No: 070H21A, Location of injection: Arm Right), administration date: 22Dec2021, when the patient was 48-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; moderna (Dose Number: 2, Batch/Lot No: 025B21A, Location of injection: Arm Right), administration date: 19Apr2021, when the patient was 48-year-old, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 008B212A, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Sep2022 at 11:15, outcome "unknown"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 21Sep2022 at 11:15, outcome "unknown" and all described as "booster"; DYSPNOEA (non-serious) with onset 21Sep2022 at 11:45, outcome "recovered", described as "Mild shortness of breath occurring within 15 minutes after dose and lasting approximately 7 hours.  Worsened with exercise". Therapeutic measures were not taken as a result of dyspnoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.
I tested positive for COVID 19 12/26/2021. It started with me being congested and I had really bad back pain. I went to work and that's where they tested me and I tested positive. They sent me home and that nigh I got serve body ache and I had a fever of 103 for a few day. I had chill, cough, headache and I extremely tried. I contact my doctor 12/28/2021 and gave her my symptoms and she told me what to do. I was then off work for 14 days and then I had to go back to work. The only thing is that my energy is still low. Other than that,  I feel ok.
Patient came to ED with generalized weakness and pancytopenia.  Patient admitted to hospital with Covid and pancytopenia with immunocompromised state.
Upper left shoulder pain; swelling the size of a golf ball; Headache; (Rash) was burning; Rash on shoulder extending down to elbow; itchiness; A spontaneous report was received from a Consumer concerning a 97 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, upper left shoulder pain, swelling the size of a golf ball, rash on shoulder extending down to elbow, (rash) was burning, itchiness, headche. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient experienced the events, itchiness. On 15 Jan 2021, the patient experienced the events, upper left shoulder pain. swelling the size of a golf ball, rash on shoulder extending down to elbow, (rash) was burning, headache.  Treatment details included Benadryl Action taken with mRNA-1273 in response to the events, upper left shoulder pain, swelling the size of a golf ball, rash on shoulder extending down to elbow, (rash) was burning, itchiness, headche was not reported.  On 22 Jan 2021 the outcome of events, upper left shoulder pain , swelling the size of a golf ball , rash on shoulder extending down to elbow, (rash) was burning, itchiness, headche was resolved. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt broken out in a rash 24FEB98-raised red bumps on trunk, legs, arms & face;had a elevated temp & diarrhea 3 days prior to rash;saw MD 24FEB98 & was given med;
ANXIETY, BREATHING DIFFICULTY, ARM NUMBNESS, DIZZINESS; AFTER THAT PATIENT RECEIVED OXYGEN, RESPIRATORY THERAPY WITH ALBUTEROL, AND 911 CALLED. PATIENT RECEIVE ATTENTION AT HOSPITAL
Shortly after receiving vaccination I noticed a ringing in my ears. It has continued through today. This. morning I woke up to it being a bit more intense which is what prompted this report.
02/23/2021 I REPORTED TO THE PSYCHIATRIST WITH HIGH LEVEL OF ANXIETY. I ALSO REPORTED THAT MY TINNITUS IN MY LEFT EAR WAS LOUDER THAN IT HAS BEEN SINCE  2001. I WAS PRESCRIBED BUSPERONE AND LATER ANOTHER PSYCHIATRIST PRESCRIBED XANAX ER FOR SLEEP. 04/23/2021 I DEVELOPED AN ITCHY RASH ON MY BACK, FEET, LEGS AND THIGHS 05/06/2021  A DERMATOLOGIST DIAGNOSED EXEMA AND PRESCRIBED TRIAMCINOLONE ACETONIDE 06/15/2021 ITCHY BUMPS ON FEET DISAPPEARED. ITCHY RED BUMPS ON THE BACK WERE STILL THERE AND BLISTERS, ONE WATER FILLED, DEVELOPED ON THE INNER THIGHS. 06/15/2021 ANOTHER DERMATOLOGIST PERFORMED A BIOPSY ON ONE OF THE BLISTERS 07/02/2021 THE BIOPSY RESULTS WERE BULLOUS PEMPHIGOID, DERMATOLOGIST ORDERED A LONG TERM REGIMEN OF DOXYCYCLINE HYCLATE AND NIACINE. HE ALSO STOPPED DIOVAN WHICH HE THOUGHT MIGHT BE THE CULPRIT.
No additional AE reported; Inbound call from medical assistant who reports she administered vaccines to a patient "that didn't need them"/AE is being filed for misuse outside the prescribing information; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown dates (reported as: at one year of age), the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, exact dose, lot #, expiry date, route of administration and anatomical site of vaccination were not provided) for prophylaxis; and with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (strength, exact dose, lot #, expiry date, route of administration and anatomical site of vaccination were not provided) for prophylaxis. On 23-JAN-2023, the patient was vaccinated with a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot# W001520, expiration date 13-JAN-2024, (strength, exact dose, route of administration and anatomical site of vaccination were not provided); and with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot# W021741, expiration date 10-JUN-2024, (strength, exact dose, route of administration and anatomical site of vaccination were not provided). On the same day, the patient was administered sterile diluent (strength, dose, lot# and expiration date were not provided). According to the reporter, the patient "did not need" the second dose of the suspect vaccines (intentional product misuse to child). No additional adverse event (AE) was reported (no adverse event).
The first Moderna Covid-19 dose was given to me on March 8, 2021. On the morning of March 31, 2021, three weeks and three days after receiving the immunization, I started developing a red rash on my abdomen and back which I noticed at 8am that morning. By noon that same day, the hives had started to spread to the rest of my chest, neck and arms. I called the dermatologist and received a 4pm appointment. By the time I got to the appointment, the rash had covered 75% of my skin. Much of the rash was red and much of it was raised, itchy hives. The dermatologist gave me a prescription for prednisone and I was told to also take benadryl or zyrtec for the itching. Within two to three days, the hives disappeared. The dermatologist told me to go ahead and get the second dose of the Moderna vaccine which I am doing at 5:15pm today, April 5, 2021.
had a horrible reaction was blacking out, He was passed out for 45 minute; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (had a horrible reaction was blacking out, He was passed out for 45 minute) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Prior to getting vaccine.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (had a horrible reaction was blacking out, He was passed out for 45 minute) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (had a horrible reaction was blacking out, He was passed out for 45 minute) had resolved.            Concomitant medications were not provided. Patient got the second dose and had a horrible reaction to the second dose. After receiving vaccine for 12 or13 mins patient went blacking out. Patient doesn't remember doing but woke up by the toilet hunched over. Patient was passed out for 45 mins. Patient would be released from prison on 07 Feb 2022 and was also scared to get the booster. Patient had COVID prior to getting the vaccine. Reporter was not sure of the date of second dose.   Treatment medication was not provided.  Company comment: This case concerns a 45-year-old male patient, with no relevant medical history, who experienced the serious, unexpected event of loss of consciousness. The event occurred on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient passed out for 45 minutes. At the time of report, loss of consciousness had resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-439943 (Patient Link).; Sender's Comments: This case concerns a 45-year-old male patient, with no relevant medical history, who experienced the serious, unexpected event of loss of consciousness. The event occurred on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient passed out for 45 minutes. At the time of report, loss of consciousness had resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
3/31/2021:  6-7 HOURS S/P VACCINATION:  HEADACHE, FEVER, COLD CHILLS, SWEATING, AND DRY HEAVES 3/31/2021-4/1/2021:  UP AND DOWN ALL NIGHT, DIARRHEA, BODY ACHES, STOMACH ACHE, HEADACHE, DRY HEAVES 4/1/2021-4/4/2021:  ABOVE SYMPTOMS CONTINUED .   4/4/2021:  STARTED HAVING CHEST PAIN AND WENT TO MEDICAL CENTER - ER .  WAS ADMITTED TO HOSPITAL FOR TREATMENT OF A-FIB. 4/8/2021:  DEVELOPED A RASH ON BACK.
central retinal vein occlusion, presented with left eye pain several days following vaccination dose #2 with Pfzier.  Also had headache, fatigue that resolved.  CRVO treated with intra-vitreal avastin Persistent L eye floater
significant leakage from the site of injection; This is a spontaneous report from contactable pharmacist. This pharmacist reported similar events for two (2) patients. This is the first of the two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After administration of the vaccine, two of the doctors had significant leakage from the site of injection. This was a clear fluid leaking out of the site of injection. The pharmacist stated this type of leaking fluid is a common occurrence with the flu vaccine and asked if there is any particular guidance on what should be done in the case of this vaccine. Should the doctors get titers drawn up to determine if they need to get a 3rd dose? Should they go ahead and get the 3rd dose anyways?  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042161 same drug/event, different patients
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. The patient was prescribed gabapentin and diclofenac sodium (VOLTAREN) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient is mentally handicapped due ta Chromosomal disorder (unsure of which chromosome).She started having bleeding 2-4 wees post 2nd Moderna received 2-23-21. Patient had no bleeding x 8-10 years. Likely, she was postmenopausal, early due t chromosome disorder, Endometrial
I have been tested multiple times for COVID and never tested positive. Just prior to taking the first Pfizer shot in my right arm, i was having severe sinus drainage, which is not entirely unusual, since i have had seasonal allergies my whole life (hay fever). Around the time of the first shot, I experienced sudden hearing loss, more so in my right ear, along with tinnitus in my right ear. I had never had a hearing problem or tinnitus. I went to my primary care physician and to my ENT, and neither would prescribe an antibiotic until it had been 10 days after my second Pfizer shot for fear of interfering with the vaccine efficacy. My ear has popped and crackled at times like it is trying to unstop, but it never does.  When I lay down on my left side, the tinnitus diminishes temporarily.
Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 045B21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.). On 13-Nov-2021, ACCIDENTAL UNDERDOSE (We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was taking oral cancer medications.  The reporter stated that the patient had received 2 primary vaccine doses and a booster dose of the Moderna Covid-19 vaccine. The patient had indicated that they were a cancer patient and was taking oral cancer medications. Reportedly, the patient had come in asking for a 3rd dose and received a 0.25mL booster. The reporter now think that the patient was more appropriate for the 3rd primary series vaccine, and not the booster. The patient had not reported any known symptoms.  No treatment information was provided.
08/24/2019: Patient reported to pharmacist of redness, warmth, itchy patch below where shot was injected, appeared on 08/23/2019. Treatment: Ice, Hydrocortisone cream and Benadryl as needed for itching or discomfort. 08/25/2019: Patient reports rash is resolving with benadryl
Mild (L) deltoid tenderness at injxn site on 1/11/21. (L) deltoid warmth, erythema, pruritis on 1/13/21-1/14/21. Self resolved. Developed another warm/red/itchy patch over injxn site on 1/17/21-1/18/21. No relief w/ Hydrocortisone cream
typical macular-papular rash with accompanying mild prickling pain and some pressure, rapid onset. left forehead extending over several hours to left nares, and left vertex, V1 distribution. Dx: Acute Herpes Zoster
Influenza vaccine, Lot #U1747AA, 0.5cc administered I.M. to R Deltoid at approx. 3:35pm on 1/27/06.  Had pt wait x 15 min (1st time receiving flu vaccine).  At 3:45pm, pt was standing, leaning against wall and appeared distressed (staring straight ahead, furrowed brow) and via interpreter pt c/o sensation of lips swelling and throat closing, and mild difficulty breathing. Pt's skin warm to touch, had hand tremors, but no diaphoresis and no rash or c/o itching.  Pt was given 3 tsp (15cc) of liquid diphenhydramine HCl (12.5mg/5cc)at this time and was moved to a sitting position.  At 3:50pm condition was no better, and per interpreter, sensation of throat closing was slightly worse. Pulse=64 BPM,Reg Rate, BP 124/84. 0.3 ml of Epinepherine 1:1,000 was given S.C. in L arm at this time. At 4:00pm, pt clutched chest and throat, was gasping for breath, tears rolling down face.  He was lowered to lying position on floor and 911 was called.  BP was 110/82, pulse 82, lungs auscultated from front only-no wheezing heard, no rash or hives or c/o itching. One more tsp. of diphenhydramine was given. Pt breathing eased with movement to lying position, he remained alert, anxious,skin, warm and dry (though shivering), stated tightness in throat was no worse, but no better. Pt was covered with blankets and EMS arrived within 5 minutes, administered Oxygen via face mask and pt was transported to E.R. with interpreter for further eval. Per the pt's employer, he was felt to be recovered and was released at about 8:00 pm that evening.
Large, raised red reaction on the arm at the injection site. Area was warm to the touch and painful for bout 1 day. About size of 1/2 dollar.
Starting 96 hours after vaccination: extreme stabbing pain in left deltoid (injection site).  Soon, this was accompanied by dull but severe pain in left shoulder and upper left back (top of scapula and around collar bone), extending to base of neck. This pain lasted 2 weeks, and was severe enough to prevent patient from sitting or standing for more than a few minutes at a time, especially during the first week of pain. Painkillers (Acetaminophen or NSAIDs) or muscle relaxants (cyclobenzaprine) did not help alleviate the pain. The pain started on March 17, and finally eased up on April 2 (the vaccination was on March 13). There is still some pain and stiffness in the left arm (currently in the biceps), but it is no longer severe. By the way, in addition to the above symptoms starting at 96 hours, there were the usual expected systemic symptoms immediately after the vaccination (starting at 6 hours and ending at 36 hours): light fever, mild body ache, fatigue and mild local pain at injection site.
Pt called and stated that arm was red and warm to touch. She contacted her Dr. She was told that was common reaction. She was told to take Benadryl and Motrin.
Offender received vaccine on 4/15/21, vaccine due 4/20/21