chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 12 month old female patient. Medical history and drug reactions/allergies were not reported. On 06-NOV-2013 the patient was vaccinated with VARIVAX lot # H016759 exp date 10-SEP-2014, 0.5 ml, subcutaneous and PROQUAD lot # H021362 exp date 29-MAY-2014, 0.5 ml, subcutaneous. Concomitant medication was not reported. The patient was observed at the office for approximately one half hour. No adverse effect reported. Additional information has been requested.
NauseaVomiting tongue dry / swelling & blisters under tongue Narrative: Seen by Dr. She states she received "a pneumonia vaccine on 12/31" - no details given; not charted in system.
Patient called health department and reported that day after her vaccine 4/16/21 in the morning she had a large lump on her arm that was swollen. She went to her doctor and he had her apply ice and hot, alternating. Her lump is now gone, about a week later.
Pt was diagnosed with cerebral venous sinus thrombosis on 3/25/21 after having severe HA x 3 days.  Looing back, she had a cbc for other reasons on 2/24/21 (3 days after her 2nd Covid vaccine) that showed a drop in platelets to 126,000 (although platelets in 2020 were 150,000)
Skin was  dry under his  arm; spots of  rashes under his both arms; fever; lymph node  behind ear was swelled up; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Skin was  dry under his  arm), RASH (spots of  rashes under his both arms), PYREXIA (fever) and LYMPHADENOPATHY (lymph node  behind ear was swelled up) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (Skin was  dry under his  arm), RASH (spots of  rashes under his both arms), PYREXIA (fever) and LYMPHADENOPATHY (lymph node  behind ear was swelled up). At the time of the report, DRY SKIN (Skin was  dry under his  arm), RASH (spots of  rashes under his both arms), PYREXIA (fever) and LYMPHADENOPATHY (lymph node  behind ear was swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included as Medication for cancer.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received  contain no new information
Narrative: Patient had a COVID positive test on 3/1/21. He did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 87 and went to the ER on 2/21/21 for a fall resulting in a vertebral fracture. Patient lives in an assisted living facility and continued to have subsequent falls including one resulting in a head injury. Patient also had advanced dementia and eventually required hospice care up until he passed on 3/9/21.
Light headedness; Nauseous; This case was reported by a consumer and described the occurrence of light headedness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced light headedness and nausea. On an unknown date, the outcome of the light headedness and nausea were unknown.   It was unknown if the reporter considered the light headedness and nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter asked can you have side effects 2 weeks after getting your first Shot. The patient said experiencing light headedness and nauseous.
Red inflammation 2" x 4" around injection site. Itch. Skin was hot to touch. Severity over fist 5 days. Slowly started to fade since. No other reactions anywhere else on body.
A few weeks after the booster, I started itching all over my body. No dry skin spots. After scratching my skin, trails where my finger nails scratched turned red and puffy.  I contacted my PCP and I got a diagnosis of dermatographism. I was asked to take 10mg zyrtec daily and benedryl 25-50mg at night to help.  The zyrtec removes the itching sensation but I still do get red streaks (dermatographism), though they do not puff up.  We're now at the end of January and if I stop taking the zyrtec, I notice the itching coming back.
10/23/2022-  Presents to Ed, passed out while on toilet. Covid + test. WBC-16.2. CXr- no infiltrates. Desat to 88% placed on 4L NC  Admit acute hypoxia in setting of obesity hypoventilation. Started decadron.  10/24/2022-No events on tele., on RA now. Normal CXR. Given betelovimab 10/25/2022-VSS. om RA. WBC- 13.4  d/c to SNF.
The patient did NOT have any adverse reaction, however, she got through all of the screening questions without disclosing that she received the 1st booster (regular Pfizer bootser) on 9/2/22.  She should have waited 2 months before getting the updated Omnicron booster.  It was not disclosed that she was too soon, until after the shot was administered and she handed over her immunization record card to have the updated booster added.  the vaccine was given over 1 month too soon.
Initial report on 19 March 2010 from a healthcare professional. The report involves a cluster of 2 patients who both received the same vaccine with the same lot number and experienced similar adverse events. The other linked case is 2010-01699.
10-05-05 Mom calld with report of child began small rash under skin on trunk (fron & back) of her body on 10/03/05 When child woke up on 10/04/05 mom noted rash all over body with red patches of rash/spots and sl raised.  Mom gave child Benadryl 1/2 tsp on 10/04/05 and repeated same dose .  10/04/05 pm rash now gone
itching over her right breast/itching had spread over her chest, back and throat; itching over her right breast/itching had spread over her chest, back and throat; itching over her right breast/itching had spread over her chest, back and throat; 3inch in diameter erythema on the right breast; breathing was louder; clearing her throat; coughing; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Sep2021 (Lot number: EW0162) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: PRURITUS (non-serious), THROAT IRRITATION (non-serious), PRURITUS (non-serious) all with onset 24Sep2021, outcome "unknown" and all described as "itching over her right breast/itching had spread over her chest, back and throat"; ERYTHEMA (non-serious) with onset 24Sep2021, outcome "unknown", described as "3inch in diameter erythema on the right breast"; RESPIRATION ABNORMAL (non-serious) with onset 24Sep2021, outcome "unknown", described as "breathing was louder"; THROAT CLEARING (non-serious) with onset 24Sep2021, outcome "unknown", described as "clearing her throat"; COUGH (non-serious) with onset 24Sep2021, outcome "unknown", described as "coughing". The events "itching over her right breast/itching had spread over her chest, back and throat", "itching over her right breast/itching had spread over her chest, back and throat", "itching over her right breast/itching had spread over her chest, back and throat", "3inch in diameter erythema on the right breast", "breathing was louder", "clearing her throat" and "coughing" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pruritus, throat irritation, pruritus, erythema. It was unknown if therapeutic measures were taken as a result of respiration abnormal, throat clearing, cough.  Additional information: Immediately after receiving the vaccine the patient reported itching over her right breast. The pharmacist visualized a 3inch in diameter erythema on the right breast. The patient denied changes in breathing or any difficulty in breathing. Benadryl 25mg PO was given. 27 minutes after the Benadryl was given the patients breathing was louder and the itching had spread over her chest, back, and throat. The patient was clearing her throat with coughing. The patient then reported to the ER.  No follow-up attempts are possible. No further information is expected.
3 hours after received vaccine face, right arm and leg swelling. Swelling still present three days later
New medication started on the same day as the vaccination.  Dr and patient unsure which cause the reaction of hives. The patient has had PNEUMOVAX 10 years ago with no reaction.
Patient was given a vaccine beyond use date, incorrect BUD was listed on the vial. BUD: 12/14/22. Contacted Pfizer to determine vaccine viability, no response back yet.
This spontaneous report as received from a 50 year old male Certified Registered Nurse Anesthetist refers to himself. The patient's medical history and past drug history were unknown. On 23-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were unknown. On an unknown date in 2014, after receiving the ZOSTAVAX, the patient experienced tingling in his nose as well as ophthalmic dermatome ("nasociliary tract"). On 01-NOV-2014 the patient was at an Urgent Care Center awaiting treatment or evaluation for an unknown reason. The patient asked what the incidence of infection was after receiving the vaccination. As of 01-NOV-2014 it was unknown if the patient continued to take ZOSTAVAX and the outcome of the tingling in his nose and ophthalmic dermatome ("nasociliary tract") was unknown. Additional information is expected.
I woke up extremely itchy, started to develop hives all over my body along with a rash. I had to take 2-3 doses of Zyrtec per day to get the hives to go away along with hydrocortisone cream for the itching. I still experience urticaria and dermatographia (it has been over a month since the reaction started) and take daily Zyrtec. The Zyrtec helps, but the rash still comes through despite the medication,
1:00 pm, sudden severe stomach pain and nausea, exhaustion, dizziness, dry heaving, by 3:00 pm severe vomiting and diarrhea. Called Dr at 6:30 and was advised to got to ER. Arrived at ER around 7:00 pm, uncontrollable vomiting and severe nausea. Given 2 IVs and intravenous medications; Protonix, ranitidine, Zofran, Benadryl, thorazine, Valium, and Solu-Medrol. Valium finally stopped the vomiting and dry heaving so I was allowed to go home (1:30 AM). Was given prescription for Valium 10 mg every 8 hours for the next 3 days, told not to miss a dose or symptoms could return.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 70-year-old female patient received the 4th (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# F59943), at the age of 70, left arm, on Apr 5, 2022, single dose, for COVID-19 immunization. Vaccination history included the 3rd (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 30145BA), in left arm, on Oct 4, 2021, the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9267), in left arm, on Feb 17, 2021, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN5318), on Jan 27, 2021; all single dose, for COVID-19 immunization. Medical history not reported. Concomitant medication included escitalopram, start date: Jun 12, 2019. The patient experienced vaccination failure (medically significant) and COVID-19 (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Additional information: COVID-19 treatment included Paxlovid. Treatment start date: Apr 28, 2022. Treatment stop date: May 2, 2022: Treatment of COVID-19. No follow-up attempts possible. No further information expected.
March 18th 2021 he noticed that when he was sitting his lower left leg felt like it was falling asleep; kept happening over a couple of days.  On March 24th, 2021 he reports a throbbing in his left thumb that came and went on throughout the day. On March 26th, 2021 he reports having chest pain. He states that when he laid down the chest pain would go away; did not go seek treatment that day. On March 27th 2021 he got his blood drawn and urine sample at the Hospital; results were normal. On March 30th he saw PCP and had EKG; results were normal. April 1st, 2021 had a stress test with normal results. On April 5th, 2021 he went and had ultrasound on left leg and chest x-ray; leg ultrasound showed complex cyst behind left knee and chest x-ray showed heart as normal size with no fluid around heart. Chest pain still continued. On April 21st, 2021 had "heart hiccup" he was working on the computer and felt like his heart stopped and started beating again and then had a headache for a few seconds. On April 22, 2021 reports that he was feeling "mostly better." He reports feeling "gassy" when he has the heart pain/pressure. Reports that when he is moving he feels better.  On April 23, 2021 he is walking around Meijer and felt lightheaded and like he could throw up; went home and BP was 155/100 with chest pain and difficulty breathing.  He then went to the ER; ran blood tests (normal), leg ultrasound repeat (complex cyst) , chest CT (normal). ER doctor recommended that he see a gastro dr. April 26, 2021 had virtual visit with PCP and he suggested that he take Motrin for the chest pain. Reports that he felt like he was having a "charley horse" in his neck. Leg sleepiness lasted a month and went away. Thumb throbbing lasted a couple weeks and went away. On April 30, 2021 reports bad chest pressure. Chest pain was not consistent,  "the pain changes." Would hurt in different locations over his heart and collar bone. May 10, 2021 reports "strange breathing." States that the chest pain and gassy feeling is constant. June 8, 2021 saw gastroenterologist. and was scheduled for an endoscopy. Endoscopy was completed on July 1, 2021; results were normal.
Incorrect dose administered. Administered 0.5ml, correct dose is 0.2ml. Vaccine was diluted according to manufacturer instructions.
TENSION MIGRAINE; PROTRUDING VEIN ON RIGHT SHOULDER; DIZZY; TIRED; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 128 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced dizzy. On 15-SEP-2021, the patient experienced tired. On 19-SEP-2021, the patient experienced protruding vein on right shoulder. On 28-SEP-2021, the patient experienced tension migraine. Laboratory data included: CT scan (NR: not provided) normal. Treatment medications included: ibuprofen. Additional treatment medications (dates unspecified) included: ketorolac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tension migraine, protruding vein on right shoulder, dizzy, and tired. This report was non-serious.
This spontaneous report as received from a register nurse refers to a patient of unknown age and gender, who in 17-JAN-2013, was vaccinated with the fourth dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on 21-JAN-2013, the patient developed chest pain and right arm numbness. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for GARDASIL. Additional information has been requested.
Started with symptoms 10-19-07 - Syncope - passing out with confusion - decreased blood pressure - Epstaxis.  HA and flushed feelings.  Insomnia and sleep disruption - lasted 1 1/2 months.  Cardiac work up done - blood work - neurologist appointments.  Neurologist questioning possible Guillian Barre.
Confusion, Depression, Dizziness, Headache, Bleeding, Thrombocytopenia,  Diarrhea & NauseaVomiting &  Narrative: 01/07 short term memory disturbances, dizziness, disorientation,  confusion, depression - lasted 3-4 days. Non healing wounds (burn - 4 after  vaccine) - still not healing after 3 weeks. (bruise - not healing and becoming infected - took abx per PCP already finished course). GI sx - nausea, diarhea,  abdominal cramps x2 weeks post vaccine. Has had hx of covid disease (end of  Jan)
Fever of 101.2; sore arm; headache; body aches; This is a spontaneous report from a contactable consumer. This consumer (patient's spouse) reported for a 37-year-old male patient that:  A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single (at the age of 37-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever of 101.2, sore arm, headache and body aches. The patient underwent lab tests and procedures which included body temperature: 101.2 on an unknown date. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
vomiting; fever of 103.2; No appetite; Tired and lethargic/Exhaustion; Tired and lethargic; Positive for flu A; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 15:00 (Lot number: FL0007) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 23Nov2021, outcome "recovering", described as "Tired and lethargic/Exhaustion"; LETHARGY (non-serious) with onset 23Nov2021, outcome "recovering", described as "Tired and lethargic"; PYREXIA (non-serious) with onset 23Nov2021 17:00, outcome "recovering", described as "fever of 103.2"; DECREASED APPETITE (non-serious) with onset 23Nov2021, outcome "recovering", described as "No appetite"; VOMITING (non-serious) with onset 24Nov2021 02:30, outcome "recovering", described as "vomiting"; INFLUENZA (non-serious) with onset 23Nov2021, outcome "recovering", described as "Positive for flu A". The events "tired and lethargic/exhaustion", "tired and lethargic", "fever of 103.2", "no appetite", "vomiting" and "positive for flu a" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, lethargy, pyrexia, decreased appetite, vomiting, influenza.  Additional Information: The patient was tired and lethargic in the morning of 23Nov2021 (day after vaccine). By 5:00 p.m. had a fever of 103.2. No appetite, exhaustion. Went to bed at 6:00 p.m. Awoke at 2:30 a.m. on 24Nov2021 after vomiting. High fever of 102.1. Slept through the rest of the night. Awoke with fever still at 102. Went to pediatrician. No flu shot administered to (name) yet this season.The facility type vaccine was reported as Public Health Clinic/Veterans Administration facility. The patient didn't received any other vaccine in 4 weeks. The patient was not tested positive for Covid prior to vaccination but tested positive post vaccination. No known allergies were reported.  Follow-up attempts are completed. No further information is expected.
Severe headache; Worst migraine; Excessive vomitting; Patient under 18 given vaccine; Hasn't felt well; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) and VOMITING (Excessive vomitting) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 627A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included DULOXETINE, CLONIDINE, HYDROXYZINE, AMITRIPTYLINE, RAMELTEON and ETHINYLESTRADIOL, NORGESTIMATE (MONO LINYAH) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MALAISE (Hasn't felt well). On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 given vaccine). On 08-Apr-2021, the patient experienced VOMITING (Excessive vomitting) (seriousness criterion medically significant). On 11-Apr-2021, the patient experienced HEADACHE (Severe headache) (seriousness criterion medically significant) and MIGRAINE (Worst migraine). On 08-Apr-2021, VOMITING (Excessive vomitting) had resolved. At the time of the report, HEADACHE (Severe headache), MIGRAINE (Worst migraine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 given vaccine) and MALAISE (Hasn't felt well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with fluids, Zofran, Benadryl, Tylenol 800mg and Aspirin for headaches.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I was given my first Moderna vaccination at Pharmacy on February 26, 2021.  I noticed at the time that the needle was open and not covered but didn't think anything about it.  Later that evening my arm was sore.  Knew that was to be expected.  Within 2 days my upper arm was beet red and swollen beyond recognition.  Finally after 10 days of pain I went to Urgent Care in and saw a doctor there.  My arm was indeed infected.  Doctor gave me prescription for Amoxicillin & Clavulanate Potassium 875 mg.  Take one twice a day.  Was also given Triamcinolone Acetonide Ointment USP 0.1% to put thin layer on arm twice a day.  Today is Monday March 8th and the redness, swelling and infection has moved down to my elbow and as far as pain is concerned it's a 5 out of 10.  It's starting to affect my fingers too.  Elbow area is now red and very swollen and HOT!  I'm going to try to get into my regular doctor today to see if she can help me.  I can't sleep it hurts so bad.