chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos vaccine was administered 21 days after the first dose; Case reference number US-BN-2022-002579 is a spontaneous case report initially received on 20-Sep-2022 from a nurse via Company (reference number: USBAV22-1470) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 25-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at an unknown dose, route or site of administration, for monkeypox prophylaxis.  On an unspecified date, 21 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown), at an unknown dose, route or site of administration, for monkeypox prophylaxis (explicitly coded as 'inappropriate schedule of product administration').  It was reported that no treatment was given to the patient due to adverse event and no laboratory tests have been performed.  At the time of this report, no adverse reaction was reported.  Additional information received from Bavarian Nordic on 21-Sep-2022 included the local BN case ID.  No further information was provided.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine, at an unknown dose, route or site of administration, for monkeypox prophylaxis, on the day 21 after the first dose, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has 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 patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine, at an unknown dose, route or site of administration, for monkeypox prophylaxis, on the day 21 after the first dose, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Patient recieved Pneumovax on 5.31.07 in Dr.'s office.  Patient states 4 hours after injection he started with redness to site.  He called MD in AM was instructed to use ice and use Motrin.  He also started to get a HA, joint pain and low back pain.  He presents today to ED stable vital signs, cellulitiss to right upper arm where he states injection was given.
Moderna Covid-19 Vaccine EUA.  Patient reported ear pain / sensitivity, which radiated from ear to shoulder, beginning approximately one hour after vaccination, and lasting approximately three hours.  The event then recurred ten days later, and, again, lasted approximately three hours. Patient also reported lymph node swelling in the arm pit of the left arm, where the injection was given.
15 mins after receiving MMR, child started coughing, wheezing. She developed a red, itchy rash subsequently (no urticaria) described as "red skin." She was treated with Benadryl, Albuterol, Epi nephrons, and Orapred.
Initial dizziness  then later in the evening fatigue, chills, low grade temperature, swollen hard area around injection site
Pt states she had really bad nausea all night beginning early on 2/21/2020 and vertigo when she went to get up this morning.  States she was still lying down when she called the pharmacy today around 9:45am because she is scared to get up.  Recommended she call a family member and go to her physician or urgent care for follow-up.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 02-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N022728 and expiration date 31-MAY-2020) for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018  was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Patient is an 87 year old male with a history of dementia, COPD, anemia, duodenal ulcer due to meloxicam use 11/2020, s/p hemoclips, injection with epinephrine, and argon plasma coagulation, s/p IR embolization of gastric duodenal artery, vitamin B12 deficiency, childhood asthma, hearing impairment, hypertension, hyperlipidemia, coronary Artery Disease s/p coronary stent, prostate CA, thoracic aortic aneurysm, who returns to hospital on 8/16/21 with anemia requiring blood transfusion. Hgb was 6.8 upon admission. He is on ASA.  There is no reports of hematemesis, melena, or hematochezia. Patient was seen last month by Hematology because of the same anemia but no GI bleeding was identified.  Bone marrow biopsy as outpatient was considered before he was released. He underwent bone marrow biopsy this time and it showed MDS. Only supportive measures are recommended currently. He had COVID infection in January 2021, s/p remdesivir and dexamethasone. He is also fully vaccinated with Pfizer, first dose 1/23/21 and second dose 2/13/21. Patient was tested positive x 2 positive (8/18/21 and 8/19/21) before transferring back to SNF. CRP and ferritin are also elevated. However, patient had not required increase in oxygen from baseline line, and CXR clear. He currently does not require treatments. Patient is cleared to be discharged pending placement.
Severe rash all over body. Some swelling in face and around infection site.  No itchiness or pain.
Pt left arm was swollen from the shoulder down to his elbow. It was red and warn to the touch. Pt complained of pain when touched. Mom noted a rash that had cleared up by the time he was seen in the office. Pt was treated with Motrin and Benadryl prior to appt.
Patient went to the hospital with eyes swollen, facial / neck swelling, and tongue swelling, the next day after getting second dose of vaccine.  Patient went to the hospital where she was treated for allergic reaction to vaccine with, benadryl and steroids. When patient came to get scripts all swelling had decreased.  Patient didnt have any issues after first dose.
Information has been received from a physician concerning a female under the age of 25 who was vaccinated (date not reported) intramuscularly (site not reported) with the 1st and 2nd dose of Gardasil (lot # not reported).  Subsequently, post vaccination, the patient developed flu-like symptoms.  At time of reporting, the patient's outcome was unknown.  This is one of 2 reports from the same source.  Additional information has been requested.
Soreness in joints and pain in arm from shoulder to elbow.  Soreness is going into upper portion of back and neck on right side.  Very hard to lift arm.
Since the vaccine I have experienced increasing hypersomnia and had to seek medical care. I visited PCP then had a sleep study and was diagnosed with idiopathic hypersomnia (rule/out narcolepsy). I am now taking armodafanil daily so that I can complete routine day to day activities without falling asleep.
A little over 24 hours post vaccination (09JAN2021), I started to experience some tongue numbness/tingling along the lateral edges and the tip of my tongue.  This is ongoing as of time of this report.  This is not interfering with function, but it is a new symptom that I did not have prior to receiving my vaccination.  As additional medical history in the last 30 days, I had dental work done for a broken filling on 21DEC2020 (multiple numbing injections during this visit - two molars grounded down to prepare for placement of two crowns of left lower molars).   2 crowns placed on 06JAN2021 (1 numbing injection at this visit). Additionally, I also started with symptoms of inner ear infection on 03JAN2021, was evaluated by medical provider on 05JAN2021 and diagnosed with suspected inner ear infection, for which I am currently taking doxycycline and sudafed for.
MINUTES AFTER VACCINATION PATIENT EXPERIENCED BRADYCARDIA, SYNCOPE AND HYPOTENSION. EMS ON SITE. PATIENT TRANSPORTED TO ER.
After administration of vaccine - itching, red, swollen and warm - next day still red and swollen itching stopped.
Raised, swollen, red skin, painful to touch at injection site on right arm.; Raised, swollen, red skin, painful to touch at injection site on right arm.; Raised, swollen, red skin, painful to touch at injection site on right arm.; Woke up next day with 100.8 fever with headache.; Woke up next day with 100.8 fever with headache.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration in the right arm on 20Apr2021 (at the age of 34-year-old) as dose 2, single for COVID-19 immunisation. Medical history included celiac disease, generalized anxiety disorder, depression, allergy to gluten (gluten sensitivity), allergy to wheat (food allergy) and computer vision syndrome (CVS eye fatigue). Concomitant medications included lorazepam (MANUFACTURER UNKNOWN), desvenlafaxine (MANUFACTURER UNKNOWN); for unknown indication and CVS eye fatigue vitamin (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing. 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 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation and experienced skin discoloration on left arm at injection site (also reported from 25Mar2021). On 21Apr2021 at 06:00, the patient experienced raised, swollen, red skin, painful to touch at injection site on right arm. Woke up next day with 100.8 fever (unspecified units) with headache. The patient underwent lab tests and procedures which included Body temperature: 100.8 (unspecified units) on 21Apr2021. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event raised, swollen, red skin, painful to touch at injection site on right arm, 100.8 fever (unspecified units) and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient admitted for a fib; This is a spontaneous report from a contactable consumer. A female patient in her 70s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was unknown, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and  concomitant medications were not reported. It was reported that the patient received vaccine on Tuesday, 05Jan2021. On Thursday, 07Jan2021, patient did not feel good-pulse and blood pressure. It was mentioned that the patient admitted for a fib. Two days after receiving Pfizer-BioNTech Covid 19 vaccine, the woman patient in her 70s was admitted for a fib.  Information about lot/batch number has been requested.
Received 2nd dose of Pfizer vaccine on 1/29/2021. The day after the vaccine patient started experiencing bilateral itchy eyes. She went to urgent care and they gave her eye drops (unknown medication) but they made her sleepy so she discontinued. Patient presented to employee health and was recommended to take 10 days of oral anti-histamine without improvement. Re-presented to employee health 2/9/21 reports of increased eye itching  and that itching was migrating down to her neck. She denied itchiness of the throat, rash, or redness. Employee health sent patient to urgent care.
she gave it much higher than had vaccine administered before, usually get it in muscle in arm, little bit high up in shoulder but not that high, was painful when she did it, not hurting too much now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HG4629) at the age of 50 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Sep2023, outcome "unknown", described as "she gave it much higher than had vaccine administered before, usually get it in muscle in arm, little bit high up in shoulder but not that high, was painful when she did it, not hurting too much now".  Additional information: The patient reports that she gave it much higher than he had a vaccine administered before, usually you get it in the muscle in the arm, little bit high up in the shoulder but not that high, was painful when he did it, not hurting too much now. He just want to make sure she got a good dose of the vaccine. Patient was calling about the Pfizer covid vaccine he said it was the new bivalent one, he went in today and the lady that did the injection told him there was an air bubble in the vaccine and she was trying to flick ended up squeezing the plunger and said you could hear the air coming out seem did not usual to him. He also was concerned the lady injected really high in his shoulder / is it effective in this case, wants to know about the air bubble." The air bubble wouldn't impact how much fluid was in there, because some of the fluid might not come in there.
pt recvd vax;devel fever above 102;loss of appetite,vomiting,irritability & urinary tract infect;urine test revealed 5-10 white blood cells & a few red blood cells;tx w/ amoxicillin;fever dec;reporter felt rxn probably not related to vax;
Patient called and complained of increased pain in administration arm. Tried moving arm around but no improvement. nothing done in addition to increase movement noted by patient.
This spontaneous case reported by a consumer, describes the occurrence of rash (on the waistline), rash (down the whole back) and rash (from the neck down the chest) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On May 19, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (on the waistline), rash (down the whole back) and rash (from the neck down the chest). At the time of the report, rash (on the waistline), rash (down the whole back) and rash (from the neck down the chest) outcome: unknown. The action taken with either mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Everytime patient take a flu shot the patient get sick.; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient with unknown demography who got sick every time (illness), while he/she received vaccine INFLUENZA VACCINE.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced got sick every time (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
3rd dose PFIZER COVID VACCINE GIVEN 10/12/21, LOT #FH8020; EMS called to house fire; pt found unconscious without a pulse; CPR and medications started; continued to be PEA; intubated; pt regained pulse, placed on a ventilator; grade III inhalation injury; 4% TBSA partial and full thickness burns to head, bilateral arms, back; pt tested positive for COVID; taken to Burn ICU; pt's condition worsened; hypotensive requiring vasopressors; vital signs began to trend downward; family transitioned pt to comfort measures and she expired in the hospital
This patient received a Flu shot on 10/2/07 and started running fever on 10/5/07 of 104.  She stayed home Friday and Saturday and had 104 fever on Saturday evening.  On Sunday at 1620 with c/o fever and chills with generlized weakness and falls. WBC 7.0 At the time of this report the patient is an Inpatient at Piggott Community Hospital.  10/10/2007 MR received for hospital DOS10/07-09/2007 for the Assessment/DX of Fever, Weakness, Chronic A-fib.  Pt presented to ER with c/o chills, generalized weakness, and 2 recent falls at home.  Admitted for IVF and abx.  PE significant for T'=102.7.  Heart sounds irregularly irregular with 3/6 systolic murmur.  2+ edema in legs. Per 60 day follow up: Pt's husband stated the doctor's did not think the illness was related to the Flu vaccine-she is doing well.
DEVELOPED RASH/HIVES ON LEFT SIDE OF NECK/UPPER SHOULDER. TOOK BENADRYL AND RASH WENT AWAY. RASH HAS NOT RETURNED.
1405: Client was feeling "light headed and hot", vital signs stable. Client reported feeling this way with her first dose. She also reported hives that started at injection site and spread to the left side of her body. Client has history of multiple allergies and anaphylactic reaction to peanuts. Biosafety nurse provided client with icepack, water and chips and a small fan. Client then reported that she felt better at 1420. Client continued to rest in observation until 1445. Client declined to have EMS contacted. Vital signs stable when client left site. Vitals: 112/72, hr 88, O2 96%
Report regarding administration of protein-conjugate pneumococcal vaccine to patients who have invasive disease after splenectomy despite their having received received 23 valent pneumococcal polysaccharide vaccine. Information has been received from the authors of a published literature article, concerning a 57 year old male with a history of splenectomy in 1978 because of a complication of intestinal bypass surgery who in 1999 was vaccinated with his first does of pneumococcal 23v polysaccharide vaccine (manufacturer not reported). In 2001 the patient developed septic shock. S. pneumoniae serotype 4 was isolated from blood. Subsequently, the patient recovered. Subsequently, the patient was vaccinated with his second dose of pneumococcal 23v polysaccharide vaccine. Serum obtained after his recovery, and after he had received an additional dos of pneumococcal 23v polysaccharide vaccine, lacked detectable antibody to any of the 7 polysaccharides (PS) contained in heptavalent protein-conjugate pneumococcal vaccine (PCPV-7), including serotype 4 PS (see laboratory data table). Subsequently, the patient was vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), 0.5 ml of vaccine into each deltoid muscle for a total volume of 1.0 ml. Six weeks after his vaccination the pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), the patient had immunoglobulin (Ig) G to all of the PSs contained in PCPV-7, including serotype 4 PS. The reporter felt that the capacity to respond to 23 valent pneumococcal polysaccharide vaccine by producing IgG is genetically regulated, and that some portion of adults do not respond: "Recurrent pneumococcal bacteremia in patients in patients who have undergone splenectomy may indicate a genetically regulated failure to respond to 23 valent pneumococcal polysaccharide vaccine; heptavalent protein-conjugate pneumococcal vaccine may stimulated production of IgG to PSs in such patients". No further information is available. Upon internal review, septic shock was considered an other important medical event. Cross reference with WAES0503USA04856) (OMIC)
Within 20 minutes of receiving injection, experienced acute onset of diffuse paresthesia (pins and needles). Intensity and frequency lessened over time but did not completely resolve for approximately 6 months. Approximately 8 weeks after injection, began experiencing acute and transient burning in left foot toes (injection was on left side). Within 2 weeks, burning progressed into numbness and transient stabbing pain in left foot toes that radiated into leg, and transient numbness in left fingertips (primarily 5th digit) radiating at times into left hand and arm. Neurologist indicated possible idiopathic small nerve fiber neuropathy.
Febrile seizure 3 days after vaccine, tonic clonic lasting about 1-2 minutes with post ictal state lasting 5-10 minutes.
Pruritic body rash starting about 8pm on 8/30/06. Started today 8/31/06 that rash was better, Examined by Dr.
I started feeling symptoms on the evening of 02/24. It caught my attention because I don't get sick very often. I started feeling symptoms like a congested head and felt off. I used a rapid test that evening and had a negative result. I went to bed and the next morning, my head felt even more congested. I was a little tired and a little achy. I took another test on 02/25/2023 and it was positive immediately. Because that was a Saturday, I called my doctor's office and had the on call doctor. I discussed my symptoms with him and I told him I had mild symptoms. He said my only risk factor is age. We talked about PAXLOVID and he said that I did meet the requirements and I would be eligible if I wanted to. He said I may not need to take it because of the mild symptoms, but I can if I want to. He did also notate that the atorvastatin was not compatible with the PAXLOVID. I last took atorvastatin on 02/24/2023 and on the 02/26/2023 was when I started taking the PAXLOVID. On the 26th, the head fullness was going away and I didn't have any body aches anymore. Just tired. On Monday, my nose wasn't running as much. I was never really too sick and I was still able to do things. I didn't feel super sick. The doctor said on Saturday that if I didn't feel better on that Sunday, he said to call back. I continued to feel pretty good really. I was never horribly ill and wasn't too frightened by it either. I was concerned about long COVID. I've been doing well and I'm still testing positive. I got in touch with my doctor and he noted it was possible to test positive for 3 months. They said I was long past the 5 and 10 day windows and they said I can go out with a mask and to avoid large crowds. I do feel great.
Spherical red, painful, hard lump about 4 inches in diameter the evening 6/4/2019. Irritation of skin, highly itchy allover body. Took benadryl. As of today, no lump or redness but still itch. She talked to her allergist.