chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ninety minutes after the dose, mild tightness  in chest noted, remained stable. At 15 hours after the dose, awakened with marked body and joint aches, headache, fever; felt too sick to arise to check temperature. This persisted; at 30 hours when feeling somewhat better, temperature was 38.2. Fever and aches resolved by 48 hrs, fatigue and headache persist another several days. Sister (an RN) has anaphylaxis with the flu vaccine. This was my first ever flu vaccine, which I reluctantly received as it became a requirement for hospital staff. Previous history of unexpected response to and infection with (rubeola and rubella) when living overseas in the 80s.
My wife presented with severe stomach pain, which was believed to be a sign of pancreatitis (a known adverse effect due to her ALK+ lung cancer tyrosine kinase inhibitor treatment) so we went to the ER on Apr 23.  Following a CT scan, she was diagnosed with acute appendicitis.  She had elevated IGA and IGG.  Additionally, she was discovered to have a pulmonary embolism.    Through the ER treatment, her blood pressure dropped below 60/40 - which was later discovered to be an unknown allergy to beta lactam antibiotics (piperacillin).  This required her to be admitted to the ICU.  Surgery was scheduled to remove her appendix Apr 24.  Post surgical complications ensued resulting in an additional 9 day hospital stay to correct a herniated surgical site and eventually remove a hematoma.  The NSCLC treatment had started 3 days prior to the vaccine , and was dose escalated on Apr 19th.  The tyrosine kinase inhibitor (TKI) is particularly susceptible to CYP3A4 inhibitors and inducers, which she was also taking (e.g. Dexamethasone, omeprazole, and THC).  Her blood pressure was well above baseline at the ER on Apr 23 before the blood pressure crash following administration of piperacillin, which was mostly reversed through administration of norepinephrine.   Whether the appendicitis was triggered by an unsafe pooling of her TKI due to the concomitant use of other CYP3A4 inducers and inhibitors, or whether the vaccine played a role is unknown.  At the time, we were unaware of the need to avoid CYP3A4 inhibitors.   However the higher IGA levels has been previously shown to tie more to a vaccine response which led us to believe the appendix played a role in IGA levels rather than adverse effects from the TKI and concomitant use of CYP3A4 inhibitors.  For this reason, it was suggested that we fill out a VEARS report.
Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient's guardian
On 4/21/01, pt developed a fever of 104F and a swollen axillary lymph node. Addtl info rcvd from MD on 5/29/01 indicated that the pt recovered.
Right ear clog can't hear feels like fluid; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number- UNKNOWN), via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 57-years-old) as single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had history of allergy to penicillin. The patient did not receive any concomitant medication. 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 4 weeks prior to the COVID vaccine. On 30Mar2021 at 10:00, patient experienced right ear clog and reported that he could not hear and it felt like fluid. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event ear clog can't hear felt like fluid were not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The first vaccine I got covid arm after 7 days it went away in 4 days and I did fine. Second vaccine It was sore a few days warm to touch and a knot then next few weeks kept getting more sore and I called the pharmacy who said it might have triggered a autoimmune flair up that I was not aware I had. Few more months went by and the arm became more sore snd I was having trouble moving it or using it with having excruciating pain. I told my primary doctor who did blood work that showed normal but was basic blood work. I ended up at the ER in excruciating pain in arm who told me I needed different blood work or possible test done to take the paper to my provider to do because they didn?t bathe capabilities to do it at the emergency room. I have no insurance and I am a self pay do I can?t afford to have the test done. In the meantime I?m in severe pain.The test the ER recommended was blood first consisting of  Ana, c3,c4,(send rate),crp, antiphospholipid antibodies , and cadiolipin antibodies  . I can?t afford to do this right now because I?m self pay at doctors and we only have my husbands income of 1280. Month I?m off work taking care of him because he has chronic illnesses With COPD, Emphysema, heart failure, kidney failure and diabetes. Please help me get tested to get well or point me in the right direction to get this cured.
Flu like symptoms 4 hours after shot continuing up to today 5/15/18 at 4 pm when I checked in with the patient. Taking ALEVE per MD. Body aches, chills, stomach ache, malaise.
local rxn rt leg 9 days later 1 1/2 x 2 1/2cm rxn site;
Observed patient fixated looking at the floor and seemed to be confused. We asked medical hx and she has seizure and clonazepam prescription. Pt was able to verbalize name and location but struggled in talking. Paramedics responded. Vitals within normal range.
Awakened on 10/22 at 10 am, 18 hours post vaccination with hives on arms and legs. No airway involvement. Took Benadryl. Progressed over next 3 days to chest, trunk. On 10/24, c/o swelling of the tongue and difficulty speaking; no c/o difficulty breathing. States this followed eating vanilla ice cream. Went to ER and was assessed with no known cause determined. Denied any reaction in past, nothing new in diet, detergent, the usual things. No known allergies to meds or foods.  Improved with Benadryl and then reappeared today but much less/lighter/ no itching
patient has only received one dose of Shingrix/ did not receive 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has only received one dose of Shingrix/ did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-OCT-2023 The pharmacist reported a patient had only received one dose of Shingrix. Pharmacist could not provide lot number, expiration date, patient demographics, or date of administration.  No additional details provided. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
client explained that she was feeling itchy. Nurse assess client and checked vitals  for 3:05 pm BP 134/84, BPM 76, Oxygen 99%, temp 97.1. AT 3:10 pm vitals  BP 138/86, BPM 80, Oxygen 99%, temp 97.5 and at 3:15 pm BP was 139/82, BPM 80, Oxygen 99%,  temp 97.7. client expalined that she hasn't taken her medication for her hypertension all day. Thus resulted in the BP reading. client was cleared by Nurse.
Patient received 2 doses of Moderna Covid vaccine from another facility and patient received Pfizer as the booster shot.
There is a prenatal diagnosis of fetal cleft lip and palate made after vaccination.   The vaccine was first administered at 12 weeks gestation. The fetal abnormality was observed at 24 weeks. There is no family history of this disorder.  The estimated due date is 11/11/2021.  The patient is currently still pregnant. The diagnosis still needs to be confirmed for the child after delivery.
Patient developed Idiopathic thrombocytopenia within 30 days of receiving the MMR vaccine. He has required immunglobulin multiple times. At 16 months of age he continues to have low platelet counts, is at risk for bleeding diathesis.  11/2/07 Reviewed hospital medical records which reveal patient experienced progressive bruising over 3 day period on bilateral LEs.  Developed additional bruising over arms, trunk & nose w/nosebleed. Admitted 6/25-6/28/07.  Exam revealed petechiae of hard palate as well as multiple ecchymosis & petechaie.  Received IVIG x 2 doses.  Improved & d/c to home w/helmet, f/u labs & hematology clinic. FINAL DX: Immune thrombocytopenic purpura.
Dizziness, fainting, slurred speech, nauseous. Happened 13 hours after shot. Treated with cold compress and water and rest. Outcome feeling better at the moment.
Numbness in arm & joint above the shoulder area. Extreme weakness in legs when standing. Feeling of being ill.
Received Moderna COVID vaccine 8/5/2020 and 9/2/2020 as a drug study.    3/23/21 developed cough and congestion.   Rapid and PCR tests positive for COVID.
blood in stool; cramping in lower abdominal area; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 13Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She experienced blood in stool and cramping in lower abdominal area on an unspecified date. Lasted 2 days. She wanted to report her experience. Outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Within 5 minutes post vax the injection site swelled to the size of a softball. The injection area was very hot and swollen. A second red area was noticed south of the injection site down the right thigh. This area was swollen, hot and the size of a half dollar. The patient was given Benadryl immediately.
8.5x6 cm erythema & induration (aches c/w dt booster).
Woke up with (L) arm red, itchy, painful, approx. 5-6 cm diameter.
Patient is experiencing body aches and severe throat pain and vomiting  for 6 days so far. 2 ER visits and 1 visit for family care doctor. Given IV fluids for dehydration and Toradol injections for throat pain and swelling 2 times.  Her lymph nodes in throat are very swollen and swallowing is extremely painful.
Inflammation and tenderness of the lymph node by the left collarbone. This had little impact other than being quite painful when the seat belt caught it on hard braking.
COVID vaccination and she still got breakthrough COVID; COVID vaccination and she still got breakthrough COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient younger than 10 years old (0-9 years old) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID vaccination and she still got breakthrough COVID". DR reported that her girlfriend's daughter experienced inefficacy after Pfizer COVID vaccine. And she did her, him, COVID vaccination and she still got breakthrough COVID and she's like, it was a little more susceptible, like she could have been better protected with a higher dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Quickly after immunization pt developed mild itching which was relieved with Benadryl later that day.  On 3/19, the patient called to report bruising, more itching and a hard red bump at site of injection.  Pt instructed to take more Benadryl and contact physician if no relief or if condition got worse.  On 3/20, pt seen at urgent care clinic and given a 3 day course of prednisone 20mg daily and continued Benadryl.  Spoke with patient on 3/22 for a follow up call and patient symptoms seemed to improve.
Patient developed a large round rash at the site of injection that is very red and warm to the touch. Patient also experienced tingling sensation  on the arm.
April 9, 2010 4:10 PM.  Mother & client came to county Health Department concerned about redness & swelling & itching at VARIVAX injection site.  Noted redness, induration "hive - like" appearance with lighter edge measuring 2" wide & 1 1/2" depth.  R.N., C.N.P. advised ice pack 20 min. on & 20 min. off, if worse or blisters to go to Urgent Care.  April 10, 2010 to Urgent Care due to blisters within the welt.  Triple antibiotic & gauze wrap ordered.  April 15, 2010 per mother blisters gone, swelling decreased, but some redness remains.
A report has been received from a Health Professional concerning a 50 year old, Male subject, who had been receiving Nasal FLUMIST Quadrivalent, 0.2 milliliters. FLUMIST Quadrivalent started on 26-OCT-2015. Physician Assistant reported that FLUMIST was administered to 50 year old male on OCT 26, 2015. This information was considered as Drug use in unapproved age group. The outcome of the event of administration to 50 year old is unknown. The report was considered to be non-serious.
The afternoon after vaccine I saw redness near the site, 2 ½ inches long 1 inch wide, didn?t itch or wasn?t hot. At the top of the area there was white dot that resembled a mosquito bite or hive but it did not itch.
Puking; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0179) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had experienced puking and chills on an unknown date. The clinical outcome of the events puking and chills was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
This case was reported by a other health professional via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that she worked in a nursing home for years and every time they gave flu shots to the patients, they all got the flu. Then they had to give another medication to counter act it for 3 months. The reporter worked the Alzheimer's unit and that made them really lively it was awful. So the reporter never got the flu shots except for some dumb reason the swine flu shot her 3 son's and herself and they all had bad ear infections that winter. The reporter blamed it on that shot. Her sons were supposed to get a 2nd one but they banned them so they still say they got the flu from that. The reporter reported that anyone could get flu.
w/in 2days of vax pt devel extensive muscle aches throughout entire body;called MD for advise;missed 2 days of work;did not need to see MD T100;MD advised to complete series;
"Bad" headache, fatigue, general full body aches and joint pain + felt "warm" with 24 hr of vax.  Improvement within 48 hr but @ 72 hr - all sx returned.  Person rested on the 4th day and was better by day 5 although not 100 %.  On day 5 still had mild headache.
Information has been received from a case in litigation via a case report concerning a 53-year-old male who on 04-NOV-2000 was vaccinated with a second dose of RECOMBIVAX HB.  At the time of vaccination he had symptoms of cough and congestion that had started the day before (03-NOV-2000).  On 01-DEC-2000, he returned to his physician complaining of tingling in his feet, going up his legs and some tingling in his fingers that began on 30-NOV-2000.  The patient was diagnosed with transverse myelitis (TM).  Three physicians considered the TM to be post-vaccinal with upper respiratory infection as a likely or possible contributing factor.  Follow-up information received from a case in litigation via a case report indicated that a Special Masters has awarded benefits to a man who alleged that RECOMBIVAX HB in conjunction with an upper respiratory infection (URI) at the time of his vaccination brought on transverse myelitis (TM).  It was noted "in this case, two factors, RECOMBIVAX HB vaccination and an upper respiratory infection, can both be substantial factors in causing the patient's transverse myelitis.  Upon internal review, transverse myelitis was determined to be an other important medical event.  No further information is available.
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 17-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Developed myocarditis 2 hr after smallpox vaccine.  07/09/2007 MR received for several visits beginning 4/27/2007 including an Admission sheet with DX of Myocarditis and 2D Echo for that date, an ER visit for chest pain on 6/22/2007, and F/U 6/25/2007.   F/U 6/25/2007 for vaccinia associated myopericarditis and Tricuspid regurgitation.  Still c/o occ sharp chest pain and fatigue.  Assessment:  Acute Myopericarditis: Resolved since 4/2007.  Fatigue: Unclear etiology. 07/10/2007 Record appears incomplete, MR requested from alternate facility mentioned in MR above. 07/17/2007 MR received from treating hospital for admission 4/27-5/1/2007. Pt presented to ER with 3 day hx of substernal chest pain/pressure which increased in intensity to 10/10 on DOA.  Vomited x 4 that am.  DX: Post-smallpox vaccination perimyocarditis.
Myalgia Narrative: Employee reported experiencing arm pain/soreness/swelling (3-4/10 on pain scale), which began about 1 hour after vaccine administration and lasted about 3 hours. Reports resolved gradually over next couple of days. Reports on day 4 post-vaccination, developed a headache ("sinus pressure") that progressed over 3 days to headaches, muscle aches, nausea, diarrhea, and general malaise. Employee also reported cough and runny nose on 12/28/2020. COVID test scheduled (results unknown as of date of this entry). Employee to contact PCP for sinus symptoms as has a history of allergies/sinus infections.
Within minutes, patient stated she was very light headed and felt like she was going to vomit. Patient then proceeded to pass out, but returned responsive within 30 seconds. Patient came to, but was unable to speak or respond immediately. She was able to nod her head and open and close her mouth. However, she was not speaking. When prompted with the question of whether she felt like her throat was closing, she nodded her head. However, patient continued to breath effectively and swallow. I asked if her lips were tingly and she responded yes. I asked if they felt numb and she responded yes. I proceeded to give her 25mg of oral diphenhydramine. Patient swallowed the liquid with no trouble. She was slowly opening and closing her eyes. Within minutes, patient started to speak again as well. I continued to ask her what her name, date of birth, day of the week and patient was able to correctly answer. She continued to take very deep breaths, and paused in between speech. I asked the patient to count backwards, which she successfully did. She was also able to squeeze my hands, and felt pressure on her arms and legs. She complained of her legs and arms "feeling numb and tingly". She was also able to provide us with her cell phone code and told us how to reach her husband. EMS arrived within 10 minutes of initial reaction. She left the pharmacy and was transported to local hospital.
5Sep - fever to 100, headache, nausea, abdominal pain, myalgias. 6Sep - (R) hand numbness, patchy paresthesias in neck, head, (L) arm, (L) foot.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: patient expierenced a redness, rash that burned and itched all the way around her arm and was about 3 inches wide. patinet also complained of have chest pains-Medium
Diffuse itchy hives that started 2 days after second shot. Temporarily relieved with Benadryl, Claritin and Pepcid but return following day. Hives mostly on face and scalp, also on torso and back of legs. Before this she had no recent history of ANY allergies  or allergic reactions, she did have hives at age 5 after a dose of Penicillin.
Myalgia, Arthralgia, Fever, UrticariaPruritus, Purpura, NUMBNESS OF 2ND TOE, PURPURA/DARK TOE PADS