chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 79 years old patient for whom vaccines may have gotten too cold and perhaps frozen in the refrigerator, blue/green bruising, swelling and hot to the touch was reported, while he/she received vaccine FLUZONE HIGH DOSE. This case is linked with 2018SA284987. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines was administered. On 10-Oct-2018, the patient received a 0.5 ml standard dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ037AA expire date: 12-May-2019 via intramuscular route in the left arm. On an unknown date, patient developed a non-serious blue/green bruising unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, patient developed a non-serious swelling, hot to the touch and blue/green bruising unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not reported. This case is actual medication error due to incorrect product storage (it was reported as vaccines may have gotten to cold and perhaps frozen in the refrigerator). Final diagnosis was hot to the touch, swelling, blue/green bruising. It was not reported if the patient received a corrective treatment. The outcome of event of outcome of other event were not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Throat tightening (mild), coughing, difficulty breathing. Thought it was an allergic reaction (I ate both squid and peanuts), but I have never had allergies to those items and have eaten both items since with zero reaction. Lasted several hours 3-4.  I took Benadryl liquid, 50mg after about 1.5 hour of symptoms. Did not help, only made me extremely drowsy.  I think I slept it off. Woke up next day completely fine.
Muscle aches, headaches, soreness at injection site, fatigue, slight fever all lasting about 24 hours
The pt developed hives on face, neck, and trunk approximately 1 1/2 hours post vax. Treated with Benadryl.
p/vax pt devel pain big toe which progressed to pain in entire foot & ankle cont-pain progressed to lt foot & ankle, both wrists;
Syncope/a complete syncopal episode while standing.  Then a 2nd one on return; unconscious approximately 30 seconds each time; chills; fatigue; muscle aches; joint aches; headaches; extreme dizziness and nausea; extreme dizziness and nausea; injure a knee when my legs pretzeled on the 2nd syncopal episode.; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 53-year-old male patient received second dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EL3248), via an unspecified route of administration on 13Jan2021 11:00 AM on Left arm at single dose for COVID-19 immunisation. Medical history included Controlled hypertension and known allergies: Hypersensitive to narcotics. Concomitant medications included Amlodipine, Irbesartan and Atoravastin. The patient previously took first dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EK9231), via an unspecified route of administration on 23Dec2020 11:00 AM on Left arm at single dose for COVID-19 immunisation. Facility type Vaccine was Hospital. No Other vaccine in four weeks. The patient experienced Syncope. He had the most common severe reactions (chillls, fatigue, muscle aches, joint aches, headaches). But when he walked to bathroom, he had extreme dizziness and nausea, then a complete syncopal episode while standing. Then a 2nd one on return. His wife said he was unconscious approximately 30 seconds each time. EMS was called but refused transport since ERs full. The patient did also injure a knee when his legs pretzeled on the 2nd syncopal episode. The events started from 16Jan2021 01:30 AM. The outcome of th events was recovered. No treatment received. No Covid prior vaccination. No covid tested post vaccination.
Report of head pain/chest pain-+ cough- +dyspnea-onset sx 3 days ago-pt is poor historian-reports hx of psych issues but not able to tell me specifically  Patient is 65-year-old male with history of type 2 diabetes and hypertension he received a Johnson & Johnson COVID vaccine in July 2 presents 3-5 day history of headache, dry cough with pain with coughing, and came in tonight due to worsening shortness of breath.  Originally felt short of breath with act activity and with rest.  Denies diarrhea or loss of sense of taste or smell.  Pt is continuing as inpatient at this time.
Metallic and floral taste to foods and some drinks. Ongoing even after 2nd dose of vaccine. It?s been 5 1/2 weeks. 2 menstrual cycles missed.
4-24-07 woke up with sore red arm. Unable to move arm. C/O severe pain and swelling at injection site 4/25/07. Face broke out and started having diarrhea. Takes Zelnorm for diarrhea
large knot on lt leg knot remains large 1 wk p/vax; pt more fussy 2DEC & 3DEC; mom giving pt APAP & used warm compresses x 3 days;
Patient reports feeling hot and anxious, she has history of anxiety attacks. Patient placed in comfortable settings. Vitals @ 5:20pm Pulse 82 BP 140/100 RESP 20. Patient had water and a cereal bar patient state she feels better ,BP 115/75 Pulse 85  RESP 18@5:36pm.
pt recvd vax;noticed large swelling of rt arm about size of orange;c/o pain & arm hard & hot to touch;spoke w/ ped & referred back to Hlth dept;localized rxn shot site,sign of spreading erythema; PC to pt on 15mar, nl;
Headache, Diarrhea, NauseaVomiting, flu-like symptoms, aches and pains in biceps, fatigue, body aches, "crazy" dreams Narrative:  employee states: she experienced flu-like symptoms including aches and pains in her calves and biceps, migraine-like headaches for days despite treatment with Tylenol 1000mg every 4 hours; body aches, fatigue, nausea, vomiting, diarrhea, urinary urgency, and "crazy" dreams. She also reports that she had soreness in the opposite arm of receiving the injection as if she had the injection in that arm.
pt recv vax;mom described pt as being asleep & unable to awaken pt for 5-10 mins;no cyanosis;20-25 mins p/ vax, pt alert, awake & active at that time per reporter, nl neurologic exam;during "event" dad was holding pt & states felt pt nl;
Red rash; Macular rash; Scaly rash; Disseminated rash, global rash; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH MACULAR (Macular rash), EXFOLIATIVE RASH (Scaly rash) and RASH (Disseminated rash, global rash) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH MACULAR (Macular rash), EXFOLIATIVE RASH (Scaly rash) and RASH (Disseminated rash, global rash). At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH MACULAR (Macular rash), EXFOLIATIVE RASH (Scaly rash) and RASH (Disseminated rash, global rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 was not applicable. Concomitant medication details was not provided by the reporter. Treatment details included none.
Approximately 15 mins after receiving the second dose of HPV the child began to have a seizure.
Slight swelling, long lasting inflammation at injection site.  Very swollen lymph node (5 days) under arm on the side of the injection.   Very painful (stabbing pain). General swelling of other lymph nodes as well, but less prominent.   Fever starting 18 hours after second dose.   Peak fever 101.7 from baseline of 98.4.  Resolved in about 12-18 hours.
HEADACHE, MUSCLE PAIN IN THE WHOLE BODY,MILD FEVER, CHILLS AND UNCONTROLLABLE TREMBLING FOR HOURS UNTIL THE NEXT DAY.
This case was reported by a nurse and described the occurrence of injection site pain in a 15 year old male pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  On 03/30/03, the pt received his second injection of Engerix-B (Lot # ENG5266C9). While injecting the vaccine, the nurse noted that it was leaking.  She did not state where the leak occurred, but she stated that it did not occur where the needle was placed on the syringe.  She noticed that some of the vaccine ran down the pt's arm. She knew that he received some of the vaccine, because the pt stated that he felt burning during the injection. The burning resolved that day. The nurse considered the injection site burning was probably related to vaccination with Engerix-B.
Patient developed tingling/pins and needles twenty minutes after receiving first COVID vaccine. This lasted about 30 minutes. Her legs ached and she had difficulty walking the next am (1/7/21). Patient usually takes the steps at work, but had to take steps 1/8/21 due to pain and generalized difficulty walking. On 1/9/21 patient was exhausted. Was standing on the bed of the truck and could not lift leg over tailgate. She also fell that day. She steadily improved beginning 1/10/21 until she was back to normal 1/17/21. MD advised that she could not get second vaccine.
Swelling and tenderness in left axillae and neck within the first 12 hours post vaccination
mild swollen tongue, patient was monitored for 30 mins. vital signs WNL. Issue resolved prior to DC
Fever (body temperature > 38 C for all night); severe discomfort with arm; extremely tired; Hands shaking.
Information has been received from a registered nurse concerning a 34 year old female with an unknown vaccination history. On an unspecified date the patient was possibly vaccinated with MMR. On an unspecified date, the patient was noted to have a negative mumps titer. It was reported that the patient was noted to be otherwise healthy. It was reported that the patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received dose 1 of BNT`61B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 21Apr2021 at 14:30 (at the age of 51-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to wheat, rice, peanut, soy, and garlic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included losartan potassium (COZAAR), acebutolol hydrochloride (SECTRAL), fexofenadine (ALLEGRA) and phentermine from unknown dates for unknown indications. On 23Apr2021 at 16:00 the patient experienced extreme tiredness exhaustion. The event was reported as non-serious. The outcome of extreme tiredness exhaustion was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient given Immunization of Meningococcal and not PREVNAR Pneumococcal.
Aspirated some vomit in lungs; Light-headed; Vomited; Nausea; Soreness; Tired; A spontaneous report was received from a consumer who was also a 94-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, tiredness, vomiting, aspiration, lightheadedness, and nausea.   The patient's medical history included major depression. Concomitant medications included fluoxetine 5 mg and celecoxib 200 mg.   On 08-feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 8411201) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, the patient began to experience soreness following vaccination. Soreness resolved within half an hour. The patient also reported feeling tired.   On 18 Feb 2021, the patient experienced vomiting, lightheadedness, and nausea. He felt as if he aspirated some vomit into his lungs.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, soreness and vomiting, were considered resolved on 18 Feb 2021.    The outcome of events, lightheadedness, aspiration, nausea, and tiredness, was unknown.; Reporter's Comments: This case concerns a 94-year-old male who experienced Serious unexpected events of Aspiration along with NS unexpected events of dizziness, pain and NS expected events of nausea, vomiting, fatigue.  The events occurred 11 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes recovered.  Based on 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.
7 days after receiving Moderna covid vaccine first dose, a 5" raised red area appeared.  it is hard, achy and itchy.
Information has been received from a physician concerning an 11 year old male who was vaccinated with VARIVAX (Oka/Merck). The patient reported that the "patient was diagnosed with breakthrough chicken pox after receiving VARIVAX when he was one years old". The patient sought unspecified medical attention. This is one of several reports from the same source. No further information is available.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-08-17.
calcification in her right ankle that needed surgery; tightness in her right ankle but it was barely mild at the beginning; tightness in her left hip but it was barely mild at the beginning; 2 weeks of bleeding heavy, but it was not her period; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period), JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning), MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning) and CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 9399U1) for COVID-19 vaccination.   The patient's past medical history included Surgery on 13-Jun-2022. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and PARACETAMOL (TYLENOL) for Pain and Inflammation.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Oct-2021, the patient experienced VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period). On 30-Oct-2021, the patient experienced JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning) and MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning). On 13-Jun-2022, the patient experienced CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery). On 30-Oct-2021, VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period) had resolved. At the time of the report, JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning) and MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning) had not resolved and CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: a calcification in her ankle.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have Allergies with medications, food and other products.  Patient never had COVID + test or diagnosis.  Patient did not mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The AE cause patient to seek medical care visited orthopedic doctor, surgeon.  The patient did not experience a similar event in the past.  Treatment reported as Surgery, physical therapy, and pain medicine and anti-inflammatory like Advil or Tylenol.   This case was linked to MOD-2021-339090 (Patient Link).
Pain down arm 1 hour post injection. Malaise, fatigue, chills 8 hours post injection. Follow up next day Ok but still tingling. Take flu shot annually. This has never happened.
Child received Pediarix vaccine, ActHib, PCV7, and rotavirus vaccines at a 6month well child check at lunch time on 7/1/08.  By 5pm that same day his mother checked his temperature and it was 105.2 rectally.  She was able to eventually get the fever down and by this morning his temp was at 100.2.  Per mother, he did not show any signs of having seizures or any other adverse effects.
Dad called stating patient has half-dollar sized red, raised area and c/o itching on left arm. OTC Hydrocortisone cream to area and recheck by MD if not any better.
Information has been received from a pharmacist concerning a 62 year old female patient with type 2 diabetes mellitus, hypertension and no drug reactions or allergies. The patient might has shingles in the past. On 11-JAN-2014 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX lot # J011338, exp date 19-DEC-2014, subcutaneous for prophylaxis (dose number not provided). Concomitant therapies included INVOKANA, metformin and EDARBYCLOR. In January 2014 a patient developed a red, raised, round, slightly swollen area and fluid filled blister "the size of a quarter" on her arm at the injection site after receiving ZOSTAVAX. The pharmacist stated that patient reporter to her, that this area was tender to touch. There was no treatment given for the events. There were no labs performed. The outcome of patient developed a red, raised, round, slightly swollen area and fluid filled blister "the size of a quarter" on her arm at the injection site after receiving ZOSTAVAX was reported as not recovered/not resolved. It was reported that patient came back into the pharmacy. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were unknown. On an unknown date the patient was inadvertently vaccinated with (wistar ra 27-3) M-M-R II (lot number and expiry date unknown) (dosing regimen and frequency unknown) and Oka-Merck PROQUAD (lot number and expiry date unknown) (dosing regimen and frequency unknown) for prophylaxis (inappropriate schedule of drug administration). It was unknown if this medication error was due to a product confusion. It was reported that the vaccines were administered with a sterile diluent (manufacturer unknown). No adverse event (reported as no adverse effect) was reported. The action taken with suspect products and the outcome of the event was unknown. There was no product quality compliant was reported.
19OCT92 noticed swollen lymph node, rt neck; 20OCT92 notice swollen lymph node, rt clavicular area, seen by MD who sent pt to surgeon;s office; 27OCT92 biopsy report from surgeon diffused bacteria in lymph node;
1 hour after getting the vaccine patient called to related nausea, vomiting, dizziness & lightheadedness. Patient was directed to sit/lay down & elevate feet. Nausea & lightheadedness continued for several hours.
MYOCARDITIS; This spontaneous report received from a consumer via a company representative via social media (J&J Corporate social media) concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown ) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 2 patients had myocarditis. As per reporter already had it for 3 days. my husband works in homes. over 3,000 now. NEVER SICK. my jabbed daughter. 3 times. 2 very serious causing pneumonia. too many side effects. 2 friends with myocarditis. one had a stroke. one a clot. 2 now with kidney issues. A niece miscarried twice. a young 38 year old friends daughter died of a heart attack. you along with the medical industry were programmed to push it. we ARENT DYING. now several have "cold symptoms" You need to listen to the whistle blower nurses..the Drs who have records. The insurance companies paying out for too many young. funeral directors saying the same. we have a lot of customers in all sorts of occupations. they all realize this is making pharma money along with politicians who invested and affecting too many jabbed. The studies are coming out. I hope some day you can see that the therapeutics are what works. now people are losing their immunity to everything. cancers coming back of course another scare will be here just in time for elections but ask yourself. why cant you sue pharma for death or side effects. Why are the millions of illegals coming in not jabbed. Soon you will be overwhelmed with polio, measles. whatever they have brought in along with jab side effects.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220750085, 20220750167, 20220750301, 20220752074 and 20220752219.; Sender's Comments: V0: 20220750036- covid-19 vaccine ad26.cov2.s-myocarditis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.