chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild
Patient is a healthcare worker who received the first dose of the COVID-19 vaccine.  Later that day, patient had excessive fatigue and some site injection pain.  The next morning patient has loss of consciousness witnessed by husband.  At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.
pt's mom states pt passed out, was unresponsive & pale @ approx 9PM 29SEP92; pt was taken to hosp ER for treatment; pt placed on cardiac monitor over noc & blood drawn;
With movement of arm has pain in shoulder and middle of back with difficulty sleeping.  States Tylenol ineffective.  Suggested use of anti-inflammatory and alternating use of cold and heat to site. Recommended client see physician.
Unsure where the patient received vaccination but was admitted to the ER after not feeling well chief complaints of fatigue and generalized weakness 5 days post vaccine. She was admitted for hyponatremia, hypokalemia, and hypomagnesemia. Treatment included repletion of electrolytes.
This medically confirmed spontaneous report (initial receipt: 13-Oct-2011) concerns a 50 year old male patient, who had no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination. On 04-Oct-2011 the patient received an unidentified "flu vaccine" into the right arm. On the same day at 16:33 the patient also received 0.5 mL of PNEUMOVAX 23 injection (lot number 0614AA) intramuscularly into left arm deltoid for vaccination. On 04-Oct-2011 at around 22:30 to 23:00, the patient complained of left arm painful, red and hot to touch. On examination his left deltoid area was hot, red and swelling. The redness extended from shoulder to elbow. He had decreased range of motion. The patient had some nausea and low grade flu-like symptoms (temperature of 98.4 degrees F (Fahrenheit)) when seen by a doctor on 06-Oct-2011. The patient was diagnosed with staphylococcal infection of skin and prescribed doxycycline 100 mg twice daily for 7 days. It was reported that the patient had no reaction to the unidentified "flu vaccine" that was administered to the right arm. On 11-Oct-2011 the patient was seen again during a 'care visit' where the nurse noted the reaction had resolved and there were no residual effects. The event outcome was recovered. The reporter stated that the dose of PNEUMOVAX 23 given was one of the two final doses from the multi dose vial. Follow-up (18-Nov-2011): additional AE terms, PNEUMOVAX 23 vaccination time, event summary description, AE onset date, no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination.
Patient reported that shortly after receiving the vaccine, she encountered a sore throat and jaw pain.  The jaw pain was described as "like biting on a needle."  Patient reported that symptoms did resolve after a day or two, and she has had no problems since.
THe vaccine expired on 12/5/2022 and was given to patient on 12/20/22. No symptoms or side effects
Jynneos vaccine was administered intradermally, past beyond use date; Jynneos vaccine was administered intradermally, past beyond use date; Case reference number US-BN-2023-000322 is a spontaneous case report initially received on 21-Feb-2023 from other health care professional via Communications (reference: USBAV23-0302) and concerns a male patient.  The patient's medical history and concomitant medications details were not provided.  On 13-Feb-2023, the patient was vaccinated with the first dose of Jynneos vaccine (batch number: FDP00015; expiration date: 30-Sep-2024), at a dose of 0.1 mL, at unknown site of administration, intradermally (explicitly coded as 'intradermal injection'), for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023 (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Feb-2023 from Bavarian Nordic included local BN case ID.  This case is linked to US-BN-2023-000316, US-BN-2023-000317, US-BN-2023-000318, US-BN-2023-000319, US-BN-2023-000320, US-BN-2023-000321, US-BN-2023-000323 and US-BN-2023-000324, concerning same reporter.; Reporter's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 13-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos vaccine on 13-Feb-2023, at a dose of 0.1 mL, at unknown site of administration, intradermally, which is considered as intradermal injection, for smallpox/monkeypox prophylaxis, with beyond use date of 26-Jan-2023, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Large rash and baseball size swelling at point of injection on left arm.  Occurred 8 days after receiving shot.  Still present.
Mom came in 14NOV91 & reported that p/last shot 11JUN91 pt cried alot, very irritable; pt finally felt asleep around 3 or 4 o'clock PM 1 hr later mom felt pt was burning up; t104 mom called ER;
within 24 hours the injection site became red, painful and swollen. I ran a fever and had body aches. Then I broke out in hives and had tightness in my chest. I then took 50mg of benadryl and it helped with the hives.
40 minutes after vaccination, patient reported feeling dizzy and "drunk." Patient ate a granola bar and drank a bottle of water as we monitored. 80 minutes after patient reported sharp chest pain and heaviness. He took one of his SQ Nitroglycerin pills, still had chest pain five minutes later and took another. After the second Nitroglycerin we called 911 and he continued to take his third Nitroglycerin tablet.
Fatigue; Joint pain; He felt too warm; Nausea; This is a spontaneous report from a non-contactable nurse (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient had the first dose of COVID 19 vaccine (BNT162B2; reported as Pfizer) on an unknown date. Patient apparently received his second dose in Jan2021 (reported as looked like he got second dose on the 11th and the following days of 12th, he began experiencing symptom), he said it's been 24 hours he experienced fatigue, mild joint pain and he felt too warm, he then 4 to 8 hours he experienced nausea. No treatments were received in response to the events reported; reported as no medical treatment basically, just staying in bed. The outcome of the events fatigue, mild joint pain, he felt too warm and nausea was recovered in Jan2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
tested + for covid on     12-27-2021       , deceased 2-6-22
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26. cov2. s, the patient experienced covid and that "still had symptoms 20 days after" (coded as suspected clinical vaccination failure and suspected covid-19 infection) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product Quality Complaint number: 90000208871.; Sender's Comments: V0 - 20211258498- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fatigue/lassitude, mild mild headache diarrhea  start 8 am on 1/12/21 end 8 am on 1/13/21  approx 6 episodes;  2 doses of peptobismol taken no fever
brain fog; lightheaded; This is a spontaneous report received from a contactable other healthcare professional. A 55-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in left arm on 10Mar2021 at 17:30 for COVID-19 immunisation (at the age of 55-year-old). The patient past medical history included asthma, gastroparesis and hypothyroid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient had allergies to sulfa and Keflex .The patients concomitant medication included escitalopram (LEXAPRO) ,levothyroxine (LEVOTHYROXINE) rabeprazole (ZEGRID).On 11Mar2021 the patient experienced brain fog and light headed for 4 days after. The patient did not receive any treatment for the events. The clinical outcome of the events brain fog and light headed was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
unable to breathe, coughing to the point to loss of almost passing out. Headache, nausea and extreme fatigue and chills.
Patient received a dose of monovalent Pfizer on 4/17/2023 and was due to receive a dose of bivalent Pfizer 8 weeks after that date. He received a dose of bivalent Pfizer at 3 weeks; which was earlier than the 8 week minimum interval. No adverse reactions were noted. Patient was notified.
Information has been received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 28-JUL-2016, the patient was vaccinated with improperly stored GARDASIL 9 (0.5 ml, lot # L045700, expiration date 22-FEB-2018) intramuscularly. The vaccine had been stored under temperature of 47 Fahrenheit degree for 10 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Chills, body aches, nausea, @7pm to 12am  Headache 12am till 10pm (
4 to 5 inch bruise to injection site, soreness to left arm starting from shoulder Patient has applied cold compress with no relief. Recommended applying heating pad to left shoulder and to takeTylenol as directed. If symptoms worsen advised to see primary provider.
4 hrs after vaccine - Malaise, chills, faint, nausea severe body ache fever 102.4F oral headache. Seen 5:44pm on same day at Urgent Care clinic temp 102.7 - No focal infection. Dx: Febrile vaccine reaction. Rx: NSAID's.
pt recv vax; inject arm red around area; devel rash which sent down to wrist compacted together;upper lt arm now cleared;no longer red or sore but rash remains;seen by MD;MD not sure if due to vax;pt nl now;
Tightness of chest with suppressed breathing abilities.  Subsequently, on and off impaired breathing;  unknown as to relation(s) to ongoing medical problems or illness in my trunk (torso) area.
Swelling and tenderness of lymph nodes under arm pit, around the size of golf ball. Symptoms noticed when waking up the second day (10/28) after getting shot (10/26).
Pt (R) upper arm swollen and red, pt states it is itching. T 99.1. Seen by PCP. TYLENOL given for high temp & antibiotics, PREDNISONE, LORATADINE - Pt to follow up 6/24/10.
fever of 100; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 100). At the time of the report, PYREXIA (fever of 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported,  No treatment medication was reported.
Narrative:  COVID INFECTION AFTER COVID VACCINE 9/27/21 01/15 COVID vaccine dose #1 02/05 COVID vaccine dose #2 09/27 tested for COVID due to exposure to close exposure to COVID positive wife and kids; tested POSITIVE for COVID 09/28 c/o cough, Fatigue, Runny nose (Rhinorrhea), treated with Casirivimab 600mg/Imdevimab 600mg infusion 10/4 reports continued cough
Injection site Rash about 3"; Minor injection site Itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Injection site Rash about 3") and INJECTION SITE PRURITUS (Minor injection site Itching) in a 76-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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Injection site Rash about 3") and INJECTION SITE PRURITUS (Minor injection site Itching). At the time of the report, INJECTION SITE RASH (Injection site Rash about 3") and INJECTION SITE PRURITUS (Minor injection site Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported. Treatment information was provided as diphenhydramine.     Reporter did not allow further contact
Red circle around the injection site; Painful at injection site; Itchy at injection site; Rash in the neck, face and chest; CHILLS; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Rash in the neck, face and chest) and CHILLS (CHILLS) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Rash in the neck, face and chest) and CHILLS (CHILLS). On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around the injection site). On 14-Feb-2021, VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 26-SEP-2014, the patient was vaccinated inadvertently with an expired dose of PNEUMOVAX23 (lot # J006921, expiration date 08-AUG-2014) 0.5 ml, intramuscular. No adverse events reported. Additional information has been requested.
urticarial rash on the face later the body after the immunization of seasonal flumist, H1N1 flushot and Hib
Patient states that he received his 4th dose of AVA on 01/07/2003.  He reports that as the vaccine was being injected he immediately experienced burning at the site.  Following the injection, the subject reports redness, swelling, itching, tenderness and muscle aches following vaccination.  He states that he went home and fell asleep.  After one week, all of his symptoms went away except for the extreme fatigue.  He reports that all he wanted to do was sleep.  He reports that he experienced a decrease of about 30% in his physical activity.  At the time he thought the fatigue was jet lag, but states that it continued up until his 5th dose on 07/30/2003 and has never gone away.
1/20/2021 @ 11:00am Fatigue, low grade fever 99.9, chills and headache until 1/22/2021
By evening of 5/6 developed intense abdominal cramps, lasting off and on for 3 hours. At times, cramps included sweats and dizziness. In one instance I passed out. After some diarrhea,  cramps lessened. I did not throw up.  Today 5/7 no symptoms, mild nausea.
Flu symptoms; Full body ache; Headache; Could not function; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27May2021 at 14:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure/ high cholesterol and COVID-19. Concomitant medications included alfuzosin hydrochloride (MANUFACTURER UNKNOWN), olmesartan medoxomil(OMESAR), rosuvastatin (MANUFACTURER UNKNOWN) and tadalafil (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously took clindamycin (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient experienced full body ache to include headache, by 24 hours patient could not function. On 29May2021, day 3, pain was subsiding. On 30May2021, by day 4, the patient experienced flu symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event full body ache, headache, could not function and flu symptoms was recovered on an unknown date of 2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Pt with known egg allergy, given 1/10th dose 1st in Allergist office.  Previously tolerated full dose seasonal flu twice (recently).  Developed unilateral conjunctival inflammation erythema of left cheek, ear pinna and one hive on back.  Lungs were clear, no CNS symptoms, no cardiac symptoms.  Oxygen saturation was normal.  Given 5 mg CETIRIZINE and resolved.  Vaccine is latex free.  Office is latex free.
As per parent child developed moderate swelling to her lips approximately 30 minutes following vaccination. As per parent the swelling persisted for approxiamtely 30 minutes and resolved completely. As per parent, child also experienced a low grade fever throughout the night.
I got chilly; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I got chilly) and HEADACHE (mild headache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024821A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (I got chilly) and HEADACHE (mild headache). At the time of the report, CHILLS (I got chilly) and HEADACHE (mild headache) had resolved.            Concomitant and treatment information was not reported.   This case was linked to MOD-2022-542607, MOD-2022-542613, MOD-2022-542615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up received contains no new information.
sick; arm was sore; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves an unknown demographic patient who was sick (illness) and arm was sore (pain in extremity), while the patient received INFLUENZA VACCINE, VARICELLA ZOSTER VACCINE RGE (CHO) [SHINGRIX] and PNEUMOCOCCAL VACCINE.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer), PNEUMOCOCCAL VACCINE (not produced by Sanofi Pasteur) and SHINGRIX (not produced by Sanofi Pasteur), batch number and expiry date not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) for three days and arm was sore (pain in extremity) for a week (non-serious events, unknown latency) following the administration of INFLUENZA VACCINE, PNEUMOCOCCAL VACCINE and SHINGRIX.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of both the event was unknown.  There will be no information available on the batch number for this case.