chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TIREDNESS; BURNING SENSATION IN ROOF OF MOUTH AND ON TONGUE; ACID REFLUX; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included very rare instances of heart burn, but not acid reflux, osteoporosis, high blood pressure, lung cancer, sulfa drug allergy, no alcohol use, and non smoker. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on left arm on 30-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced acid reflux. On 30-MAR-2021 15:00, the subject experienced burning sensation in roof of mouth and on tongue. On 31-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acid reflux on 30-MAR-2021, and had not recovered from burning sensation in roof of mouth and on tongue, and tiredness. This report was non-serious.
After administer ng varicella & HAVRIX in (L) thigh on 6-6-19 @ 3:30 P. Parent came out 5 min later and noted hives on (L) thigh surrounding vaccine site of varicella. 4 mL of Benadryl was given in office.
(L) arm red, blotchy with induration, red streak. Concern with cellulitis. Put on oral KEFLEX 500mg TID x 10days.
Patient's upper arm started to swell after injection was done. Patient stated that she did not have any shortness of breath and no rashes or hives were seen. Patient waited in pharmacy for 20 minutes and the swelling went down and patient did not show any signs of a reaction anymore.
Flu; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case received from a non-health care professional (patient) via social media via Global Digital Media.  This case involves a patient of unknown age and gender who had flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Had the flu one time in my life. Also happened to be a few months after I had the only flu vaccine I've ever taken".  It was unknown if the patient experienced any additional symptoms/events  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
This case was reported by a physician via call center representative and described the occurrence of nausea in a adult female patient who received FLUARIX (batch number AFLUA550AA, expiry date unknown). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced nausea, vomiting and dizziness. On an unknown date, the outcome of the nausea, vomiting and dizziness were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting and dizziness to be related to FLUARIX. Additional details were provided as follows: This case was reported by the physician, who herself was the patient. The age at vaccination was not reported. In 2010, the patient received a dose of FLUARIX vaccine and experienced symptoms of nausea, vomiting and dizziness which lasted for about 1 to 2 months. No further information was reported regarding the event.
Muscle aches all over, soreness at injection site, tiredness--all beginning around 11:30 pm on 3/25/21 and resolving by 2-3 p.m. on 3/26/21.  Minor complaints given the value of being vaccinated!
Sore at site; flu like symptoms; Tired; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 67-years-old), as a single dose for COVID-19 immunisation and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number is EN6207) via unspecified route of administration in the left arm on 19Mar2021 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. Medical history included heart attack. Concomitant medications included statin (unspecified) and cholesterol medication (unspecified) taken from an unknown date for unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 26Feb2021 at 18:00, the patient experienced sore at site, flu like symptoms and was tired. All the symptoms had gone in three days after both vaccinations. The patient had not received any treatment for the adverse events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room/department or urgent care. The clinical outcome of sore at site, flu like symptoms and tiredness were recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
feeling hot and diaphoretic; diaphoretic/ sweaty; massive headache; sleep 13 hours; swollen face; joint pain; chills; start wheezing with a dry cough; start wheezing with a dry cough; 101.8 fever/ mild fever 99.6; swelling in my lymph nodes happened immediately/ swelling; some chest tightness; hard to breathe it was like breathing through a straw; Unable to go to work; uncomfortable; Never shown allergic reaction to vaccines before this; This is a spontaneous report from a contactable other Health Professional (Patient).  A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 08:00 at single dose for covid-19 immunization in hospital. Medical history included polycystic ovary syndrome (PCOS) and possibly rheumatoid arthritis. No Known Drug Allergies. Concomitant medications in two weeks included birth control and iron supplements. The patient got the vaccine at 8:00 am on 17Dec2020 Thursday and experienced swelling in her lymph nodes happened immediately and some chest tightness. It was never hard to breathe it was like breathing through a straw. At 10:00 am hits and she got joint pain, chills, start wheezing with a dry cough and a 101.8 fever. Unable to go to work. She sleep and wake up 18Dec2020 Friday with a mild fever 99.6 and some chest tightness/swollen Lymphnodes but nothing else. On 19Dec2020 Saturday she took antihistamines to see if that would help her swelling and go to bed. The patient wake up with a swollen face which was a new reaction to this medicine I've taken before. Chest tightness was gone/ lympnodes still swollen. On 20Dec2020 Sunday she sleep 13 hours. On 21Dec2020 Monday happened and she awake to feeling hot and diaphoretic. She drank water and remove clothes/blankets go back to sleep. Wake up still sweaty with a massive headache but no fever. Lymphnodes still swollen and uncomfortable currently. Never shown allergic reaction to vaccines before this. No COVID prior vaccination, no COVID tested post vaccination. Therapeutic measures were taken as a result of swelling in lymph nodes and included antihistamines, no treatment received for the other adverse event. The outcome of the event fever was recovered in Dec2020; of the event sweaty was not recovered; of unable to work, swollen face, headache, sleep 13 hours, uncomfortable, shown allergic reaction was unknown; of the other events was recovered/resolved with sequel. The seriousness was reported as no.  The information on the batch number has been requested.
BRIGHT LIGHTS HURT EYES; PAIN INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; FELT HOT; FELT COLD; ARM STILL HURTS/PAIN IN INJECTED ARM FROM SHOULDER TO WRIST; TINGLING SENSATION INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; NUMBNESS  INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; SHIVERS/CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and dye in ultrasound contrast, and other pre-existing medical conditions included: The patient was currently taking Vitamins. The patient experienced lump that has not gone in 30 years when treated with influenza vaccine for drug used for unknown indication, and drug allergy when treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and rosuvastatin calcium. On 28-AUG-2021, the patient experienced bright lights hurt eyes. On 28-AUG-2021, the patient experienced pain into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced felt hot. On 28-AUG-2021, the patient experienced felt cold. On 28-AUG-2021, the patient experienced arm still hurts/pain in injected arm from shoulder to wrist. On 28-AUG-2021, the patient experienced tingling sensation into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced numbness into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced shivers/chills. On 28-AUG-2021, the patient experienced headache. On 28-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain into armpits, left breast, chest, neck and jaw, felt hot, felt cold, tingling sensation into armpits, left breast, chest, neck and jaw, numbness into armpits, left breast, chest, neck and jaw, shivers/chills, and fever on AUG-2021, and had not recovered from headache, arm still hurts/pain in injected arm from shoulder to wrist, and bright lights hurt eyes. This report was non-serious.
Knot at injection site 1-2 days after arm red, warm to touch, swollen, painful from shoulder to elbow 7-10 days after shot; Tx with KEFLEX 500 mg QID for 17 days.
Within 24 hours fever, chills, body aches, runny nose, disorientation, sweating.  Fever, chills, body aches, runny nose subsided within 48 hours from vaccination.  Disorientation increased to loss of balance & expressive aphasia which continue to this day.  The symptoms increase when standing and walking becoming more manageable when sitting.
After vaccines given 2:30PM child became pale, limp, stiff, put head to knees, gave grape juice, color returned able to ambulate to care with me and mother 2:50PM.
Patient received 2nd booster of Janssen instead of 2nd dose booster of a MRNA. Patient was observed for 15 minutes no adverse reaction reported,
pt recvd DTP/HIB 19SEP92 p/checkup; had OM; screaming inconsolably for over 3 hrs & t103; cried self to sleep kept waking up crying; leg was red & swollen; mom called hosp; pt also had blotchy rash, pain, macrocephaly;
12/7/21 - vomiting and nausea lasting 5 hours starting 8:30pm  12/8/21-12/9/21 constipation, loss of appetite , still nausea, excessive gas and bloat pain. bowel movements occur after honey water in night time. feels okay after.  12/10/21-12/12/2021 diarrhea starts once mild fever and nausea, 1 vomit leading to Er visit. 12/13/2021 - Findings:         Appendix: Perforated/infected: hole or blown-out tip and Abscess    Fluid amount: Diffuse (throughout the peritoneal cavity)    Fluid character: Thin serous/clear throughout, Fibrinopurulent/purulent localized to within right lower quadrant mesentery (contained abscess)    Other pertinent findings: distal small bowel obstruction due to fibrinous adhesions to proximal rectum/abscess cavity within distal small bowel mesentery.       Procedure in Detail: After informed consent was obtained the patient was transported to the OR. A timeout was performed and perioperative antibiotics were given. The patient was prepped and draped in the normal sterile fashion.   A 12mm port was inserted in the umbilical position under direct visualization and the abdomen was insufflated. A 5mm 30 degree laparoscope was introduced. Two additional ports were inserted, one in the suprapubic position and one in the left lower quadrant, under direct laparoscopic visualization without incident. There were numerous dilated small bowel loops with distally decompressed bowel loops as well as serous fluid throughout the peritoneal cavity, likely a reaction to the distal small bowel obstruction. The appendix was tucked under the distal ileal mesentery, where it had perforated, and upon mobilizing the distal ile um and its mesentery an abscess cavity was released, draining purulent fluid which was suctioned out. The appendix had a blown-out hole in its mid-body. The appendix was exposed and retracted anteriorly and inferiorly, splaying open the appendiceal mesentery. A window was made in the appendiceal mesentery with the Maryland ligasure cautery and then the appendiceal mesentery was then taken with the ligasure cautery. The base of the appendix was transected with an endoGIA stapler. The appendix was removed via the umbilical port site using a specimen retrieval bag and then the peritoneal cavity was suctioned out. The small bowel was run proximally starting at the terminal ileum, and some loose fibrinous adhesions from the small intestine to the proximal rectum/distal sigmoid were released bluntly. The transition point of the obstruction was positively identified and easily released. We ran the bowel proximally for several more feet, and there were no other points of obstruction. The bowel was still fairly dilated but was all viable.   Once this was completed the surgical bed was inspected and the staple line was noted to be intact and the hemostasis was adequate. A rectus sheath block was performed using 0.2% plain ropivacaine under laparoscopic visualization. The ports were removed under direct visualization and the abdomen was desufflated. The incisions were closed in layers with absorbable sutures, cleaned and dried, and sterile dressings were applied.
Kidney stones; Hiatal hernia; Esophagitis; Painful joints; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant), HIATUS HERNIA (Hiatal hernia), OESOPHAGITIS (Esophagitis) and ARTHRALGIA (Painful joints). At the time of the report, NEPHROLITHIASIS (Kidney stones), HIATUS HERNIA (Hiatal hernia), OESOPHAGITIS (Esophagitis) and ARTHRALGIA (Painful joints) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment  This spontaneous case reported by a consumer, concerns an elderly female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of NEPHROLITHIASIS (Kidney stones) unknown days after receiving a dose of Moderna mRNA1273 vaccine, in the covid 19 vaccination series, along with other non serious events. It was reported that the patient had received  ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The outcome of the events was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by a consumer, concerns an elderly female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of NEPHROLITHIASIS (Kidney stones) unknown days after receiving a dose of Moderna mRNA1273 vaccine, in the covid 19 vaccination series, along with other non serious events. It was reported that the patient had received  ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The outcome of the events was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
10 minutes after shot got headache and started wheezing.  Took  two puffs albuterol. better in 20 minutes. 25 minutes after shot - throat swelling - took one tablet allergy-chlor. decrease in swelling after 20 minutes. Site soreness and swelling  continues still (into 28 hours after).
then tested Covid positive 30Dec, and again positive on 05Jan; then tested Covid positive 30Dec, and again positive on 05Jan; dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing); "known allergies Gluten allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 28Dec2021, outcome "recovering" and all described as "then tested Covid positive 30Dec, and again positive on 05Jan". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive; (05Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course: Sore throat, head cold symptoms, aches and cough on 28Dec2021, then tested Covid positive 30Dec2021, and again positive on 05Jan2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received shingrix 2 years ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose of Shingrix 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comment: The reporter would like to know if the patient had to restart the series or not. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
was woken up with noticeable pain in the right eye.  it felt like it was behind the eye. vision was extremely blurry, like i had a giant fingerprint or plastic wrap covering my eye. sought doctor advice as i was scheduled to fly the next day to the west coast. i was prescribed 2 types of drops, (i don't have the names with me) which i used for the prescribed amount of time. went in for a follow up, this whole time, vision never really cleared.
Persistent soreness in right arm, chills, fatigue, aching right hand, both ankles and feet. Right side of body discomfort.  Chills and shortness of breath possibly related but uncertain. Body temperature normal.  Adverse events continue as of reporting (in excess of one week later)
Hospital Course: Complicated. Patient was brought in for ostomy reversal, had a colonoscopy performed through his colostomy which revealed the patient to have a right colonic mass, mass was an adenocarcinoma. Had a right colectomy performed , had a  massive myocardial infarction and died. Complicated 1 year, started with COVID 19 - patient was admitted prolonged amount of time due to complications of COVID 19 , developed a large decubitus ulcer which was not healing. Was being followed by Dr wound care center. Multiple debridements. Failure to heal. Referred to me for a diverting colostomy to facilitate healing of the large decubitus ulcer. Diverting colostomy was performed September 2nd 2020. Patient had plastic surgery, flap surgeries, in December 2020 and January 2021. finally healed. Brought for a ostomy reversal, found large mass in the cecum attempted endoscopic removal, with micro perforation, taken to the operating room immediately from endoscopy suite had a right colectomy. Colostomy started functioning, patient was recovering, suddenly started having chest pain and had a massive myocardial infarction.
Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushing, nausea, and tiredness. Flushing quickly resolved but patient reports nausea, abdominal pain, mild headache, and tremors since vaccination. Six days after vaccination noticed hip bruising in the absence of falls or trauma and a cut on the hand that bled more than expected.  No respiratory distress or rash noted on exam. Vital signs all within normal ranges. Patient left clinic visit stable and advised to avoid non-steroidal anti-inflammatory medications.
temp, shakes, coughs, flu or cold sx-did not have prior to vax;
80y.o. female with past medical history of COPD on 3L O2 at home, Asthma, Arthritis, B12 deficiency, Depression, GERD, Achalasia, HTN and Hypothyroidism presented with a chief complaint of cough and weakness. Patient states that she had the Johnson & Johnson vaccine on March 11th 2021 and believes she got sick from it. Since getting the vaccine, whenever she eats something she begins vomiting for the next 2 days. This has happened to the patient before, as she has a history of esophageal dysmotility/achalasia. Patient began developing a cough and SOB over the last 2 weeks that are getting worse. Patient states that she has no appetite at all and is feeling very weak due to the lack of eating.
patient experienced rash after one day and went to see her MD.   However, her MD said rash  was small enough so that she did not need treatment.   However, joint pain at the injection still remains until now, especially when she moves her arm where she received the injection.
Diffuse red rash, no bruising but note inguinal pea size lymph node enlargement; ENT-neg; no cervical or sx nodes;
After first dose I found out I was pregnant and before second dose I miscarried. Since then I have had three more miscarriages. Prior I have one live birth resulting in a healthy child. No other reasons have been found for resulting miscarriages.