chrisvoncsefalvay/vaers-outcomes huggingface dataset:
autoimmune disease flareups; Condition aggravated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune disease flareups) and CONDITION AGGRAVATED (Condition aggravated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune disease flareups) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, AUTOIMMUNE DISORDER (autoimmune disease flareups) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   No treatment medication was reported.  Company Comment: 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.  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 event, a causal relationship cannot be excluded.  further information has been requested
This spontaneous report as received from a pharmacist refers to a 9 years old female patient with allergic rhinitis and asthma and no drug allergies. The patient was vaccinated with first dose of GARDASIL (lot# unspecified) intramuscularly on 25-JUL-2012. The patient was vaccinated with second dose of GARDASIL (lot number H010915, exp 13-FEB-2015) intramuscularly on 07-JAN-2013. No other co-suspects were reported. Concomitant medications included FLONASE, SINGULAIR, PROAIR and vitamins (unspecified). On some unspecified date after 07-JAN-2013, the patient experienced right knee and left elbow pain. The patient's mother had called the physician assistant for medical attention. No treatment information was given for the adverse event. No lab diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The relatedness for right knee and left elbow pain was unknown for GARDASIL. Additional information is not expected.
Relapse of ITP 1 week after 2nd dose given (after not having an issue for 2 years)
Patient received the vaccination on the afternoon of 2/11/21. She started to have a reaction in the morning of 2/12/21.  She said her lips became swollen and very chapped.  Also, her tongue lost the sense of taste in the front but it was ok in the middle.  She has sought treatment with an ENT physician and her primary physician but feels they have not helped her.  She says she is still not back to normal.  She is going to consult with an allergist at my suggestion.
Tdap given as a second dose per recommended immunization scheduled for children adolescents who start late or are more than 1 month behind. Given as per catch up schedule which says, Tdap may be substituted for any dose in a primary catch up series oar as a booster if age appropriate for Tdap. No adverse event. No treatment.
Tingling of the Tongue. 118/74, 88, BS 103 O2 sat 98% Respirations 16
REDNESS, SWELLING, WARMTH AND TENDERNESS AT INJECTION SITE THE DAY AFTER INFLUENZA VACCINE ADMINISTERED.
pt recv vax 8JUL96 & some time p/vax pt exp h/a & nausea;
pt recv vax 13APR94 & 18APR94 urticaria recurred & worsened & devel giant angioedema;pt cont to have urticaria & angioedema on & off on a random basis since that time;tx DPH;16JAN95 lab eval p/2 doses of vax revealed anti-HBs neg & ANA neg
Information has been received from a registered nurse (R.N.) concerning a 1-year-old health male with no allergies who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (dose, date and lot number not reported). There was no concomitant mediation. Subsequently, 3-4 weeks after vaccination (date unspecified) the patient experienced zoster-type rash from his left buttock down his leg to his ankle. Unspecified medical attention was sought, no diagnostic or laboratory tests were performed. At the time of this report the lesions were described as post inflammatory hyperpigmented. The patient was recovering. No product quality complaint was involved. Additional information has been requested.
After observation time was up, customer's mother asked for her to sit up to see how she was feeling.  After customer sat up she got an instant headache.  Code Red was called and EMS and nurse responded to call.  BP 123/80, HR 81, O2 99%, 37.2 (Centigrade).  Patient still had headache but stated she will be fine.
Information has been received from a nurse concerning a 27 year old male with no drug allergies who on 16MAY2003 was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) 0.5 ml subcutaneously. Concomitant therapy included hepatitis A vaccine, meningitis vaccine, poliovirus vaccine inactivated and yellow fever virus vaccine live. The health care provider reported that the patient was vaccinated with numerous vaccines on the same day. The vaccines were administered at different anatomical sites. On 18MAY2003 the patient experienced left side parotiditis, ear pain and swelling of the mouth. The patient did seek medical attention and was using Tylenol and Aleve for relief, but the nurse said that no treatment was recommended at this time. At the time of this report the outcome was unknown. Additional information has been requested.
Diarrhea, Stomach pain-burning, Headache, Sore Throat , Swollen Glands, and Canker Sore in mouth.
Fully body hives. Hives are produced from physical touch known as dermatographia. Hives can be produced from clothing to skin contact, self touch, or being touched by anything. The hives are very itchy once they occur and take about 30 minutes to subside after irritation first occurs. I have experienced these hives on my face, neck, chest, abdomen, hips, genitalia, thighs, calves, ankles, tops of feet, and palms of my hands. The palms of my hands are in a constant state of itchiness and feel hot and clammy as I am always using them.
It was reported by the safety officer that the guest complained about feeling faint and hot 10 minutes after receiving the vaccine. EMS was called to see guest. Guest became sweaty and was offered water, which he drank. Guest was conscious and talking to the EMS. Vital signs were WNL. After a few minutes the guest stated that he was feeling better and no longer felt hot. Patient was observed for an additional 15 minutes per the suggestion of EMS. After the 30 minutes, guest continued to be without symtoms and was able to stand up with out dizziness nor lightheadedness. Able to leave on his own.
heart started racing; felt like fainting; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (heart started racing) and PRESYNCOPE (felt like fainting) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (heart started racing) and PRESYNCOPE (felt like fainting). On 05-Feb-2021, PALPITATIONS (heart started racing) and PRESYNCOPE (felt like fainting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Heart rate: high heart rate (High) high heart rate.     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 product use was not provided by the reporter. Treatment information was not provided.
a week of not feeling good every single time I receive the Pfizer COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "a week of not feeling good every single time I receive the Pfizer COVID vaccine".  Additional information : Caller stated she had already reported her side effects when she first got the Pfizer COVID shots and did not want to report again. Caller stated, "It was a week of not feeling good every single time I receive the Pfizer COVID vaccine." Caller was calling in asking if the new shot will not have a side effect. Caller mentioned that when she took the last booster shot a couple of years ago, it gives a terrible side effect. The patient stated she went to the website and could not find side effects to the new Pfizer COVID vaccine for 12 years of age and older as it was still talking about the old shot. The caller had a side effect with the booster shot that she took a couple of years ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318222 Same patient, event, Different drug dose number.;
felt fatigued on the day after dosing; Moderate pain at the injection site; mild headache several hours after vaccine administration; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0165) via an unspecified route of administration in the left arm on 28Apr2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and asthma. The patient had known allergies to environmental, pet dander, and wasp. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), budesonide, formoterol fumarate (SYMBICORT), salbutamol (ALBUTEROL), fexofenadine hydrochloride (ALLEGRA), fish oil (MANUFACTURER UNKNOWN) and unspecified multivitamin; all taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 28Apr2021 at 20:00, the patient experienced moderate pain at the injection site on the day of dosing increasing towards the evening, still sore in the morning (24 hr after dosing) but improved throughout the day after dosing. Also developed a mild headache several hours after vaccine administration, but gone by the next morning. On 29Apr2021, the patient felt fatigued on the day after dosing, but started to improve towards the evening. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with EXCEDRIN and ALEVE. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate pain at the injection site and felt fatigued on the day after dosing were recovering at the time of this report while the clinical outcome of the event mild headache several hours after vaccine administration was recovered on 29Apr2021.  No follow-up attempts are needed. No further information is expected.
Initial dizziness, nausea, weakness (all very mild, and disappeared within about 15 minutes).  Within 1/2 hour, numbness in left index finger, thumb, and small area surrounding affected digits.  Numbness eventually got slightly better, but 10 days later, slight numbness still remains in finger and thumb.  Not debilitating, but somewhat annoying. Follow up to form completed on 1/01/2008:  The numbness in index finger and thumb is still present, although some improvement has occurred as of 01/30/2008.  On the morning of 01/02/2008, I noticed that my left shoulder area (injection site) was quiet sore, and range of motion was greatly diminished (to the point where I had to alter sleeping positions and was unable to wash back in shower).  The pain was constant until just a few days ago, when probably 90 percent of the pain suddenly cleared up.  My main concerns are: Will I be able to received flu vaccinations in the future?  Should I be wary of other vaccinations such as tetanus, whooping cough, etc? If I receive vaccinations in the future, should I request a different injection site such as abdomen, buttocks or thigh?
pt recvd vax; 24 hrs later exp flu-like sxs; joint pain & fatigue; resolved
tingling sensation in my bad foot; Great pain around the area that was operated on; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation in my bad foot) and PAIN (Great pain around the area that was operated on) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     The patient's past medical history included Complex regional pain syndrome (CRPS) in February 2021 and Trimalleolar fracture ( trimalleolar fracture with Weber C) in February 2021.    On 13-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling sensation in my bad foot) and PAIN (Great pain around the area that was operated on). At the time of the report, PARAESTHESIA (tingling sensation in my bad foot) and PAIN (Great pain around the area that was operated on) outcome was unknown.        mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were provided.   This case was linked to MOD-2021-223783 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No new information.
I seem to be experiencing slight Bell's Palsy on the right side of my face.; This is a spontaneous report from a contactable nurse reporting for himself. A 35-year-old male patient received the first dose of BNT162B2 (Lot Number: EN6204), intramuscular, administered in left arm on 20Mar2021 14:00 (at the age of 35-year-old) at single dose for COVID-19 immunization. Medical history included autoimmune encephalitis and obesity. No known drug allergies. Concomitant medications included aripiprazole (ABILIFY); clonazepam; propranolol; lithium carbonate (LITHEUM); naltrexone; benzatropine mesilate (COGENTIN); dexmethylphenidate hydrochloride (FOCALIN XR ER); dexamethasone, ofloxacin hydrochloride (FOCALIN); desvenlafaxine succinate (PRISTIQ); amoxicillin trihydrate, clavulanate potassium (AUGMENTIN BD); levothyroxine sodium (TIROSINT); iron (FE 10); probiotics and multivitamins (MV). No other vaccine in four weeks. No Covid prior vaccination nor tested with Covid post vaccination. The patient seems to be experiencing slight bell's palsy on the right side of his face on 22Mar2021 08:30. It was unknown if treatment was received for the event. The outcome of the event was unknown.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event facial paralysis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture; Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture) and PRODUCT STORAGE ERROR (Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K212A and 084J4A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Feb-2022 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2022 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture). In February 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture) and PRODUCT STORAGE ERROR (Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there were no known symptoms after vaccination. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree celsius) was less than 24 hours. On 13-FEB-2022 a vial of Moderna COVID-19 vaccine was left at room temperature for 24 hours and was used outside of the 12 hour limit for puncturing, though only punctured 3 times total.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Significant Follow Up appended. Batch/Lot No added. Update received states the expired vaccine was administered to 2 patients. Drug Start date obtained. On 24-Feb-2022: Follow up received contains patient initials, first dose information were added and second dose information, event start date was updated. The LLT of product storage error was added. On 24-Feb-2022: Narrative was updated contains non-significant information.
IT STARTED ON SAT 9/11 WITH WHAT SEEMED LIKE SINUS INFECTION, THAT NIGHT I WENT INTO LABOR AND WENT TO THE HOSPTIAL. DR. RAN A COVID TEST BECAUSE I HAD INCREASED HEART RATE. THEY NEEDED TO TAKE ME INTO C-SECTION RIGHT AWAY SO THEY DIDN?T WAIT FOR RESULTS. THE COVID TEST CAME BACK POSTITIVE AFTER THE BABY WAS DELIVERED. AT THAT POINT THE SYMPTOMS WERE VERY MILD. THE DR ORDERED MONOCLONAL ANITBODIES WHICH WAS GIVEN TO ME ON SUNDAY NIGHT AT THE HOSPTIAL. MONDAY MORNING I FELT REALLY GOOD, THEY DID BLOODWORK, AT NOON TIME EVERYTHING CHANGED. I STARTED TO FEEL HORRIBLE, FEELING MISERABLE, FREEZING COLD AND TERRIBLE. I KEPT CALLING THE NURSE. LAB RESULTS CAME AND SHOWED THAT I LOST MORE BLOOD THAN THEY THOUGHT DURING MY SURGERY, MY HEMOGLOBIN DROPPED TO 5.8 AND THEY NEEDED TO ORDER BLOOD TRANSFUSION FOR ME. I HAD 103 FEVER AND THEY CALLED THE URGENT RESPONSE TEAM. THE DOCTORS THOUGHT I WAS GOING INTO CEPTSIS AND TRANSFERRED ME FROM POST-PARTUM TO ICU AND WERE TRYING TO GET DOWN THE FEVER TO GIVE ME THE TRANSFUSION. THE MEDICATIONS THEY WERE GIVING ME WASN?T WORKING. WHEN THEY BROUGHT THE FEVER DOWN THEY GAVE ME 2 BAGS OF BLOOD. ONCE THAT HAPPENED I STARTED TO STABLIZE AGAIN AND KEPT ME IN OBSERVATION FOR 2 DAYS.  WHEN I HAD MY FOLLOWUP THE DR TOLD ME THAT MY BODY DID NOT KNOW WHAT TO DO AND WENT INTO CRASH MODE DUE TO COVID.  BIRTH WEIGHT 6LB 11OUNCES  DUE DATE: UNKNOWN COMPLICATIONS: BABY HAD VERY VERY MILD MURMUR (PULMONIC STINOSIS)
Severe vertigo exactly 7 days later.  Could not walk.  Sent by ambulance. In the ICU for 2 days.  All tests came back clear from neurology and CAT scan.  Still some residual signs of very mild vertigo at present.   His present doctor says it was not an allergic reaction but under potential allergies it lists "dizziness" for Moderna.
1/10/21 runny nose, congestion, fever, HA, cough, nausea, chills, body aches
felt like having Covid-19 again; fever/102 °F temperature; headache; nausea; joint pain; muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (felt like having Covid-19 again), PYREXIA (fever/102 °F temperature), HEADACHE (headache), NAUSEA (nausea) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (felt like having Covid-19 again), PYREXIA (fever/102 °F temperature), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, COVID-19 (felt like having Covid-19 again), PYREXIA (fever/102 °F temperature), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 f (High) 102 F Temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not being taken   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow up contains no new information
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Additional Details: pt. called says he has just developed a rash on his back.
Metallic taste in mouth. Tastes similar to aspirin.  Tingling feeling on lips that has a numbing slight burning effect.  Total body itches.  Pain in entire left arm like it has been punched at about a level 4/10 ain.
2nd day very sore- not unexpected. Nine days later, bruised at injection point, redness and swelling above and below bruise.  Some itching of the skin around injection point. The bruise didn?t surprise me as I bruise easily, but the redness and swelling is a new thing.  This was my first dose.
patient became flushed, lightheaded and felt rapid heart rate 15 minutes after receiving vaccine. no shortness of breath, no rash or hives.