chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Warm to touch; Itching; Dermatitis; Cognitive thought (mental bug); Atopic Dermatitis; Lump at injection site; Body rash; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Pain) and INJECTION SITE WARMTH (Warm to touch) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergy.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and INJECTION SITE WARMTH (Warm to touch). At the time of the report, PAIN (Pain) and INJECTION SITE WARMTH (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant product use was reported  Treatment information includes use of antihistamines
immediately after injection I experienced redness and swelling at injection site, fever, chills and body aches. Was advised by medical staff at testing site to wait for 30 minutes to be observed. Was cleared by staff to go home, I was too sick to return back to work. I went home and took medication for inflammation, fever & chills and was bedridden for 3 days with a temperature of 100 degrees F and chronic fever/chills. Day 3 I finally felt better and was able to get back to work. Within the following months I have experienced a change in my menstral cycles, late periods. Sharp Chest pain upon exertion, lower exercise capacity and insomnia. I also, have a history of GI issues (IBS, abdominal bloating, constipation) which have gotten worse since.
Patient had fever the night of administration and in the morning after patient had a seizure. (does have past hx of seizures)
Where VARIVAX was given (subcutaneous) was hot to touch, swollen, red, and itchy. She was put on XYZAL every day.
Initial reaction on evening of 12/20/22  booster was a low grade fever and tired and light cough. That disappeared within 24 hours. Last night on 12/22/22 around 11 pm I began coughing. By 3 am this morning on 12/23/22, my cough was severe and uncontrollable. I tried to talk and found I had laryngitis.  I was unable to sleep due to the cough. Eventually around 4 am, the coughing subsided enough for me to sleep. I still cough occassionally.  As of 2:45 pm, I can only whisper. I have no voice.
acute congestive heart failure, dilatation of thoracic aortic aneurysm to 4.4 cm
A non-serious spontaneous report of gave half the total dose of FLUMIST was received form a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medications error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that one of the children experienced adverse events.
I took the Moderna shot on 10/27/2021 at  Pharmacy . My period has always been regular coming within a day or two on the expected date. Within hours of getting the Moderna shot I menstruated very heavily and unexpected. My period lasted 9 days. I am making you aware that menstrual irregularities is definitely a side effect women should be aware of.
This spontaneous report as received from a registered nurse and refers to a currently 13 year old male patient. On 14-JUL-2005, the patient was vaccinated with a first dose of (Oka/Merck) VARIVAX (lot number reported as 0895P, dose, units, route of administration, anatomical location, expiration date were not reported). On an unknown date (also reported as some time after receiving (Oka/Merck) VARIVAX the patient developed shingles. The reporter stated that the patient was seen by this unspecified healthcare provider (date unspecified) regarding this event.The outcome of developed shingles ws not reported. The relatedness between event and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Tingling in her hands and bottom of the foot and legs; Nerves are in overdrive; Injection site pain; Tiredness; Body aches; Rash; Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling in her hands and bottom of the foot and legs), NERVE INJURY (Nerves are in overdrive), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness), MYALGIA (Body aches), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PARAESTHESIA (Tingling in her hands and bottom of the foot and legs) and NERVE INJURY (Nerves are in overdrive). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. On 08-May-2021, VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness), MYALGIA (Body aches), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PARAESTHESIA (Tingling in her hands and bottom of the foot and legs) and NERVE INJURY (Nerves are in overdrive) outcome was unknown.            No concomitant medications were provided. No treatment was reported for the events.  Action taken with the drug in response to events was not applicable.
Information regarding Flumist was received from a healthcare professional regarding a male child who experienced itchy eyes about five minutes after receiving Flumist. The pt received a dose on an unspecified date. The pt experienced itchy eyes about 5 minutes after receiving Flumist. The reporter indicated that the pt's mother also experienced the same event. The reporter stated that she doesn't know if the child "just itched his eyes because he saw his mom itch her eyes." No additional info was available at the time of this report.
Child was small for gestational age and had delayed psychomotor development from the beginning. Dxed with autism.
Fever of 101.6 the next day. Headache and body aches. Extreme fatigue. Fever ended the next day. Just tired now.
Patient received Moderna vaccine at age 14. Should have received a pfizer dose. Per CDC, dose doesn't need to be repeated.
This case was reported by a nurse and described the occurrence of injection site erythema in a patient who received KINRIX for prophylaxis. On 11th July 2018, the patient received KINRIX. On 12th July 2018, 1 days after receiving KINRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to KINRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter had a patient that was given the KINRIX vaccine, a day before reporting. On the day of reporting, the patient developed redness, large swelling, and warmth to the site. Upon visualizing the site it looked as if the administration could have gone into the vastus intermedius muscle instead of vastus lateralis muscle, which could have contributed to possible irritation to subcutaneous tissue. The reporter wanted to know if this was a situation in which they should report via VAERS or with manufacturer.
After receiving vaccines child cried incessantly, then suddenly became quiet with pallor and shallow breathing - after approximately 20-30 sec infant became alert but remained pale. POX-99% P-130 RR-30 NAD After 15-20 mins infant back to normal state.
local rxn-w/in 20min area was 6cm w/itching & some swelling;
This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a male patient who received Meningitis ACWY vaccine (potential MENVEO) for prophylaxis. On an unknown date, the patient received Meningitis ACWY vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential MENVEO), the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown. It was unknown if the reporter considered the upset stomach to be related to Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her son (patient) got sick on his stomach after receiving vaccine. The reporter stated that if she found out earlier that the patient would get it because of this shot then she would be suing.
I was told that the mother placed him in his baby bed around 20:00. About an hour later, when she checked on him, he was not breathing. I was told he died at home. COD as per autopsy report -- SIDS
DTaP/IPV in left leg & swollen- seen in office 5/17- 5 in area red, hot, swollen, tender- treated with Augmentin- much improved 24 hrs. 5/19- new raised red rash around original area of cellulitis.
Ulcerative colitis; Itching / Pruritus; Diarrhea; Rash on arm; Bloody stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody stool) and COLITIS ULCERATIVE (Ulcerative colitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Hives/urticaria), Hypersensitivity reaction, Colonoscopy (Dr. confirmed ulcerative colitis, and that the vaccine caused immune system to attack on colon.) and Diverticulitis in 2018. Concurrent medical conditions included Asthma, Hypothyroidism, Sulfonamide allergy (sulfa - Rash), Penicillin allergy (Rash), Drug allergy (Cefdinir - wekts) and Allergy to antibiotic (Moxifloxacin - Rash). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MULTIVITAMIN ACTIVE WOMAN 55+ for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HAEMATOCHEZIA (Bloody stool) (seriousness criterion medically significant). On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion medically significant), PRURITUS (Itching / Pruritus), DIARRHOEA (Diarrhea) and RASH (Rash on arm). The patient was treated with MESALAZINE (PENTASA) at a dose of Pentasa. At the time of the report, HAEMATOCHEZIA (Bloody stool), COLITIS ULCERATIVE (Ulcerative colitis), PRURITUS (Itching / Pruritus) and DIARRHOEA (Diarrhea) outcome was unknown and RASH (Rash on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient were taken as treatment medication that includes antibiotic for the rash.   This case was linked to MOD-2021-244731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional information received On 30-Jun-2021: Upon internal review on 08-DEC-2022 non-significant corrections performed to update "case received from field" to blank.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated slightly, loud noises were painful
Autism. A 60-day follow up report states: Does not verbalize. No coherent speech sounds. Does not respond to simple commands. Not able to do self-care tasks. Far below grade level. Has been diagnosed with Autism. Severe neurological damage leading to autism. No language development or communication skills. Antisocial and aggression. He has to be watched/cared for twenty-four hours a day. He has no sense of harm or danger to himself or others.
red spot; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot) and VACCINATION SITE SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE ERYTHEMA (red spot) and VACCINATION SITE SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment details included Topical anti-inflammatory medications.
Injection site pain, tingling, swelling, redness. Flushing of face. Diarrhea. Improving.
sore arm, red mark, fever, sick, upset stomach, sore neck, no energy, hand and arm going numb
Inappropriate schedule of vaccine administered; I developed tinnitus.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 15:00 (Lot number: EN6207) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild ulcerative colitis" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing), notes: irritable bowel syndrome. The patient took concomitant medications. Past drug history included: Known allergy: codeine, reaction(s): "known allergy: codeine". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Product=COVID 19, Brand=Pfizer,, Lot number=EN6201,, Lot unknown=False,, Administration date=02/Feb/2021,, Administration time=02:00 PM,, Vaccine_location=Left arm), administration date: 02Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Apr2021 10:00, outcome "not recovered", described as "Inappropriate schedule of vaccine administered"; TINNITUS (non-serious) with onset 04Apr2021 10:00, outcome "not recovered", described as "I developed tinnitus.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, tinnitus. No follow-up attempts are possible. No further information is expected.
Patient developed red area at injection site of MMR. It appeared within 10 minutes of injection. He was treated with Benadryl with complete abatement of symptoms within 20 minutes. No further symptoms were noted and no further treatment was required.
Next day site was red (2" x 2") warm, swollen. Today, 8 days later, site has ecchymotic area in a half moon above site. Left upper arm.
8 inch wide x 9 inch length bright red area, with 4x3 inch hard knot under injection site. Warm to the touch and tender at injection site with itching at injection site.
Information has been received from a nurse concerning a patient who in approximately September 2010 ("fall of 2010"), was vaccinated with one dose of 0.5 ml PNEUMOVAX 23 (lot # not reported). In approximately September 2010 ("within that week which took place in the fall of 2010"), the patient developed cellulitis like reaction at the injection site after getting the vaccine. The patient was not concerned about it. No treatment was given to the patient. No lab tests were performed. Subsequently, the patient recovered from the adverse event. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. No further information is available.
nose bleeds after first vaccine; Itching at first on arm then on body, after first vaccine; Soreness of arm after first vaccine; swelling at the injection site; This is a spontaneous report received from a contactable consumer reported for herself. A 56 years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 12:00 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated that she did not have any side effects noticeable, but reported soreness in her arm lasted for 3 to 4 days, swelling at the injection site lasted for 3 to 4 days, which went away in a few days. Caller stated she did experience itching on her arm, but it was nothing she couldn't deal with. Caller reported that within a couple of weeks, on 01Apr2021, she started having nosebleeds. Caller stated she had a second nosebleed on 04Apr2021, and a third nosebleed on 06Apr2021. Caller added that she had one more, nosebleed, at 3 o'clock on 05Apr2021. Caller then reported she was experiencing the itching on her arm but then it became body itching, she cannot explain, it is hard for her to put into words. Caller stated it was not a rash but it feels like she had to scratch. Outcome of event pruritus was unknown, of others was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
heaviness in the chest; 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 CHEST DISCOMFORT (heaviness in the chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (heaviness in the chest). At the time of the report, CHEST DISCOMFORT (heaviness in the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingles several times). Previously administered products included ZOSTAVAX. Concomitant products included SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 20th August 2018, less than a month after receiving SHINGRIX, the patient experienced painful rash, itchy rash and shingles. On an unknown date, the outcome of the painful rash, itchy rash and shingles were not recovered/not resolved. It was unknown if the reporter considered the painful rash, itchy rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in the left arm intramuscularly in May 2018 and 2nd dose in her right arm. The patient did not provide the exact vaccination dates for the 1st or 2nd dose of SHINGRIX. The patient stated that since Monday she had a painful, itchy rash on her buttocks that she believed to be Shingles. The patient had not been seen by healthcare professional or formally diagnosed with Shingles. The patient had denied permission to contact their physician.
Epstein Barr Virus; This is a spontaneous report from a contactable other hcp. A 40 (unit not provided) female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced Epstein Barr Virus. She was not able to get scheduled initially as Epstein Barr Virus and possibility of antivirals. The patient underwent lab tests and tested negative for antibody procedure. Patient concerned about administration and efficacy. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
12 hrs after I had the shot I developed a stiff neck and muscle aches.....4 hrs after that I had severe shaking and shivering for about an hour,  then developed a temp of 101 degress....took Tylenol ....extremely tired and dizzy with headaches.  Stayed in bed and slept through the day and following night....temp was gone 24hrs after shot.....48 hours after the shot I developed a fever blister on my lower lip...still have it but feel so much better.
Information has been received from a consumer concerning her 16 year old daughter allergy to cinnamon and with a history of an allergic reaction (eye redness) to neomycin (manufacturer unknown) who in August 2007, was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not reported). There was no concomitant medication. After a couple of days the patient experienced severe joint pain that she could not get up from bed and was unable to walk. Patient was given steroid injection in her feet and knees and for almost a year she was in wheel chair. The patient was given the second dose of GARDASIL (route and lot number not reported) in August 2008 and in November 2008, she was diagnosed with "polyarticular JIAR (Rheumatoid arthritis)". The patient's mother also stated that her daughter had abnormal cervical cells and small vaginal lesion. The patient's mother stated that soon her daughter will be getting steroid injection on her hands because she is unable to lift them. At the time of reporting the patient had not recovered from the events. Upon internal review polyarticular JIARS+ (Rheumatoid arthritis) and unable to walk were considered to be disabling. Additional information has been requested.  8/24/09 Consultant records received DOS 8/20/08 to 8/4/09. Assessment: Enthesopathy, amplified musculoskeletal pain. Polyarticular JIA RF(+). Patient with acquired acanthosis nigrans and obesity presents with knee, foot and neck pain. 'Walks like a duck'. Feet swollen. Nighttime awakenings secondary to pain. Stressed. Enthesitis multiple sites lower extremities and back. Torn medial menisc knee. Joint effusion. Anemia. Moodiness, anger and bruising. Joint stiffness. Feet turn blue. Wheezing. Pneumonia. Shoulder pain. Limp.
Patient was coming out of exam room when she LC. Pt was quick to recover with juice and water. B/P initially 88/62 - upon recovery was 111/72. Pt blood sugar was 111. Pt was able to self ambulate to parent car. Dr. assessed pt prior to leaving office.