chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the administration of vaccines, patient and mother went to a dental clinic room.  After 5 minutes, the patient was in the mothers lap when the patient lost color and went completely pale. Initially, this was thought to be a possible syncopal episode. However, the patient started to have circumoral cyanosis. Spo2 at this time was 98%. It was then indicated to have our nurse practitioner check him out. His lips were still a blue tint and patient was not speaking once in the exam room . Patient was still alert. Patient was checked out by our Nurse Practitioner, who indicated the need for EMS due to his pale color, diaphoresis, cyanosis to lips and circumoral area, as well as his eyes with repetitive lateral movement, and his lack of response to commands or touch. Patient at this time was still breathing and had an spo2 of 96% on room air and a blood pressure of 82/56.  While performing a  second try for a blood pressure, the patients response improved when speaking to mother, and was able to fixate on her and speak to her. Overall cyanosis improved along with paleness at the time.  EMS arrived for transport to take child to the hospital to be examined.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001839 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (first out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  This case is linked to cases no. US-BN-2022-001851, US-BN-2022-001852, US-BN-2022-001853, US-BN-2022-001854, US-BN-2022-001855, US-BN-2022-001856, US-BN-2022-001857 and US-BN-2022-001858, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
pt called 9/26/2019 reported left arm was swollen size of baseball, raised and hot.
BLOOD SUGAR WAS 9; BLOOD PRESSURE 132/95; NAUSEA; PAIN IN BACK OF HEAD; DIZZINESS; LOSS OF CONSCIOUSNESS; This spontaneous report received from a physician concerned a 26 year old male. The patient's weight was 245 pounds, and height was 172.7 centimeters. The patient had no known allergies and had no chronic medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 202A21A and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient complained of dizziness, nausea and pain in back of his head. Once the nurse arrived at the cell, the patient was on the floor with loss of consciousness. He was placed on a stretcher following which he regained consciousness. His vitals signs (unspecified) were stable, blood sugar was 9 (unit not provided), blood pressure was 132/95 (unit not provided) and respiratory rate was at 18 (unit not provided) (NR: not provided for all tests). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness on APR-2021, had not recovered from dizziness, nausea, and pain in back of head, and the outcome of blood sugar was 9 and blood pressure 132/95 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210420193- Covid-19 vaccine ad26.cov2.s-loss of consciousness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
12-15 hours after vaccine administration (the following morning) symptoms of nausea, pale, diarrhea, faint, sweating, lightheadedness, dizziness. Near fainting, laid down with feet up to avoid. Feeling of nausea and malaise with possible fainting for 3-4 hours following original episode.
Patient noted within 1 week developed numbness and waves of burning, stinging pain down arm into left thumb.  Mild redness that comes and goes.  No papules or blisters.  Over this last week, less frequent episodes.  Mild tenderness at base of nail.
Severe abdominal cramps followed by early menstrual cycle which lasted about a week.  She has had menstrual cycles every 2 wks since then.  Prior to COVID vaccines, her menstrual pattern was regular for a year (though she has a more remote history of irregular menses).
Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get out of bed. Extreme weakness, joint pain, back and neck pain, swollen gland under left armpit, pain, headache, fever up to 102.5. 2/18/21 low grade temp. 99.9. joint pain, headache. Used Tylenol, 2 pills every 4 to 6 hours.
pt recvd several doses of rubella vax & failed to seroconvert;pt exp flu-like sx,diarrhea,neck pain,abd pain,skeletal pain,arthritis & fatigue;no further details were provided;
My COVID-19 symptoms started on 03/10/2023 in the morning. I had congestions, runny nose, and cough. It was mild. On 03/11/2023 I went to a clinic where they prescribed me PAXLOVID and a nasal spray. I also took ibuprofen as per needed. I was negative on day 5 then I became positive on day 8. For the rebound I had congestions and cough. It was mild. I took ADVIL and used the same nasal spray. I tested negative by day 14.
Urticaria at injection site spreading across torso to RUE and subsequently to LEs throughout 24 hour period.
Constant temple headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 54 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 01:45 (Lot number: ER8734) at the age of 54 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication included: XARELTO. Past drug history included: Diclofenac, reaction: "drug allergy", notes: Known allergies: Diclofenac. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021 09:00, outcome "not recovered", described as "Constant temple headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient had other unspecified concomitant medications since an unknown date and for unknown indications. On 01Apr2021 at 09:00, next day of the vaccination, the patient experienced constant temple headache for 10 days and had taken tylenol as a therapeutic measure for the event, but it had not worked. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Started to get get low grade dull pain in front left thigh about 6 inches from groin. Over the course of the next 6-12 hours I started to have other similar pains all over body as well as tingling/burning skin sensation mostly left side of the body.  Over the following 24-48 hours pain and tingling/burning sensation spread to every body extremity. No torso pain or tingling. Following the 96 hours pain started to subside. 6 Days out nearly all symptoms were gone. Days 7-9 no symptoms at all. Evening of day 10 most symptoms returned with minimal severity. Days 10-12 thus far is intermittent pain and or burning. Throughout the timeline I have had muscle fatigue mostly in legs.   Nearly all symptoms seem to go down with movement. Ibuprofen 400-600 has had minimal effect.
Pain under tongue and on the sides of tongue; Mouth pain; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 09:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously 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 08Feb2021 at 10:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021, at 11:00 the patient experienced mouth pain, specifically pain under tongue and on the sides of tongue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 02Mar2021, the patient underwent saliva rapid test and the result was negative. The clinical outcome of the event mouth pain and pain under tongue and on the sides of tongue were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pregnant with baby #4. Typical soreness and warmth over the injection site. Within the following few days I developed a high fever, intense headaches and nausea/vomiting. The symptoms continued for approximately two (2) weeks without relief. Went to Labor & Delivery where they provided medication to reduce the fever & assist with the "migraine"; however, they would not listen when I insisted this was not a migraine. I have a history of migraines. This was more like intense pressure over my entire head with the most pressure at the base of my skull, top of my neck. The medication they provided assisted in bringing the fever down, but did not improve the headache I was experiencing. Although the high fever has since dissipated, I continue to have a low-grade fever nearly every night and sweat it out. In addition, I continue to have a raised bump, similar to a mosquito bite, at the site of injection.
Red bumps in right arm (where vaccine was given) that are itchy and have spread across the arm to the right side of the chest.
Pt presented 1/25 with symptoms of shortness of breath x 1 day. Found to be in SVT with EF 15% CI 1.3 myocarditis of unclear etiology:  possibly tachycarrhythmia-mediated vs fulminant viral myocarditis vs sequelae of connective tissue disorder. Patient was previously working and active 1/23. Pt now requiring ecmo plan to transition to  LVAD/ RVAD.
Extremely swollen lymph nodes in left armpit, pain in left fingers, low-grade fever
This spontaneous report was received from a Registered Nurse refers to an unknown number of female patients (out of the 4 clients) of unknown age. The nurse reported that on an unknown date, the patients got their doses of GARDASIL a bit early. The patients received the second dose of GARDASIL(lot#, route, dose not reported) 4 weeks after the first dose and the third dose was received 12 weeks later. No adverse effects reported. This is 1 of 2 reports received from the same reporter. Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of idiopathic thrombocytopenic purpura in a 83-year-old female patient who received SHINGRIX. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 14 days after receiving SHINGRIX, the patient experienced idiopathic thrombocytopenic purpura (serious criteria hospitalization, GSK medically significant and other: As per reporter). SHINGRIX was discontinued. On an unknown date, the outcome of the idiopathic thrombocytopenic purpura was unknown. It was unknown if the reporter considered the idiopathic thrombocytopenic purpura to be related to SHINGRIX. Additional information were provided as follows: The nurse reported that the patient was hospitalized for acute ITP (idiopathic thrombocytopenic purpura). The patient's platelets count dropped to 4. The hematologist or oncologist consulted about the patient was insistent that this event caused due to SHINGRIX.
4/21/21 High fever, fatigue, headache 4/30/21 Sudden hearing loss in right ear and tinnitus  4/30/21 went to walk in clinic. No obstruction in ear. Prescribed Claritin and Flonase  5/4/21 still experiencing hearing loss went back to walk in clinic got referred to ENT 5/19/21 ENT appointment - ENT & Allergy, first intratympanic steroid shot and started pregnazon 5/ 26/21 ENT - 2nd steroid shot 6/2/21 ENT - 3rd steroid shot 8/4/21 ENT - second hearing assessment with no positive results. Sudden hearing loss is permanent
Arm very sore, pain down to wrist. Took pain reliever to no avail. Blisters developed over injection site. About 4 inches across the arm. Very itchy. Got shot on Thursday, Friday & Saturday blisters at worst. Sunday & today receding. Itching gone but arm still sore. Notified my PCP Saturday & was instructed to use antibiotic cream. Suggested I had allergic reaction to shot at site of injection.
Diarrhea; Chills; Slight headache; Nausea; Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Slight headache), NAUSEA (Nausea) and ARTHRALGIA (Joint aches) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Slight headache), NAUSEA (Nausea) and ARTHRALGIA (Joint aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Slight headache), NAUSEA (Nausea) and ARTHRALGIA (Joint aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Company comment: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Headache, nausea arthralgia and chills are consistent with the known safety profile of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Event outcome updated; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Headache, nausea arthralgia and chills are consistent with the known safety profile of the vaccine.
after first vaccine was given 4/08, patient became very weak, tired and slept almost the entire 3 weeks, when it was time to take the second dose, on 4/29 she drove herself to the hospital, got the shot and went home, that evening she becan to feel very weak and fell down, calling an ambulance for help, the following day, she fell down once again, called 911 and got help getting to her feet, she began to realize her body was too weak to carry herself and when she fell the 3rd time called 911 and asked to go to the hospital. arriving she was immediately give blood transfusions, being told her kidneys had somehow gotten much much worse out of no where and they were no longer producing red blood cells properly, within the first week she was in the hospital, she was given 4 total blood transfusions and was told her heart was not functioning properly, There were elevated enzymes. She was beginning to bloat as her kidneys were not working at all anymore, she was no longer urinating. she was scheduled to have a dialysis port put in and she started dialysis. she was given medication and was sent to a rehab facility for a few weeks where she made no progress at all, she was still weak and unable to walk. due to her inability to walk she was sent home from the rehab, our family had to rally around her to help keep her clean, no bed was sent to us, no commode, we had to find money for all of these things, she quickly got bed sores and we tried all we could do to care for her with little help there was home health coming to see her twice a week, and we repeatedly asked if someone could look into the vaccine doing this to her no one cared to hear our suspicions of the vaccine doing this to our mother, she went to the dialysis clinic 3 times a week all the while paying for her own 800 dollar a week gurney transportation due to her inability to walk, on july 15th she finally got to see her dr, upon taking her vital signs they found no pulse, no blood pressure and no pulse ox but the dr did not seem to think  this was a good reason to go to the hospital. we asked if the vaccine did this to her, the dr laughed it off, she went back home and was very tired, she went to sleep and the next morning when my father tried to wake her up for dialysis, she would not wake, 911 was called and she was once again rushed to the hospital, where her heart stopped within minutes of arriving.we asked the people in the ER if there was anyway we could talk to someone about the vaccine doing this to her. our mother is dead!! we were advised to call the health department, they told us to call the cdc, and i was directed to the compensation fund
Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded.  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.
Pericarditis, I am now going to have to have a pericardiectomy.
Hep A pediatric dose a week after expiration; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Hepatitis A vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.      Additional Information: GSK receipt date: 28-SEP-2022 Reporters comment:  The reporter reported that as per chat information on vaccines and their administration after expiration, the Hep A pediatric dose a week after expiration was unknown, manufacturer unknown, no reporter details, product details, patient details were provided as chat dropped, Unknown if this occurred or even if this was a GSK vaccine The reporter did not consent to follow-up. Additional Supportive information: No confirmation of the brand or if the expired vaccine was administered were provided. As no consent for Follow up was given, the event Expired vaccine used was conservatively coded and Hepatitis A vaccine was coded as the suspect product. .
Pt returned to the office on 3/6/14 following up on local skin reaction/rash, red, raised lesions and fever x2 days. Rash appeared approx 9 days after getting varicella vaccine to lt thigh.
Patient passed out.  tingling in finger. light headedness. chest pain related to anxiety. occurred after about 15 minutes
Rec'd vaccine at 15 mo. PE on 3-1-10. Exam unremarkable. On 3-4-10 had new onset seizure. Seen at ED - labs, CT head unremarkable.
4 days after receiving the HPV vaccine patient developed itching red eyes, face and small red bumps all over body and was scratching a lot. Patient was given ZYRTEC 10mg 1 QD and BENADRYL 25mg-50mg HS. She was advised to return to the clinic if symptoms persist or worsen.
approx 1 mo p/ vax pt devel 10-15 skin lesions that were described as very itchy. rpt MD felt skin lesions were not related to therapy w/varicella virus vax
Pt received MMR vaccine in office on way home about 30 minutes after injection had lip swelling and 1 episode of vomiting, eyes then started to tear and get red, was referred to ER, in ER got 1 dose of oral Benadryl, sx resolved-was observed and sent home
Shot on Monday. Noticed Tuesday morning when got dressed. Injection site @ back of arm raised. Size of a silver dollar. States warm not hot. Denies fever. Did not use cold compressors
Pt came in with red swollen upper forearm near injection site. Pt received shot on 10/21/15. Asked pt to see MD. (Left am).