chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dementia; there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces; there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces; experienced some "goofy things"; dropped 30lbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Deaf" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: DEMENTIA (medically significant), outcome "unknown", described as "dementia"; PRODUCTIVE COUGH (non-serious), MUCOUS STOOLS (non-serious), outcome "unknown" and all described as "there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces"; WEIGHT DECREASED (non-serious) with onset May2021, outcome "unknown", described as "dropped 30lbs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "experienced some "goofy things"". The patient underwent the following laboratory tests and procedures: weight: (May2021) 30 lbs, notes: dropped 30lbs. Clinical course: The patient got second shot of the Pfizer-BioNTech Covid19 vaccine on 13May2021, and after the second shot started having problems it affected his body in a way, patient dropped 30 lbs since May2021 and experienced some "goofy things", there a lot of mucus whenever patient was coughing up and when defecates, there was more mucus than faeces. Per caller, the doctor's think that patient was having dementia and does not believe the patient and the hospital said to call Pfizer for information on how to counter whatever patient was experiencing.  The lot number for bnt162b2 was not provided and will be requested during follow up.
1. Pneumonia due to COVID-19 virus  2. Arthritis of left foot  3. Fatigue, unspecified type
Patient reported feeling nauseated and had a headache the day after the vaccination (Tuesday, 11/13/18) but is not sure if that was associated with the vaccination or not. On Thursday AM (11/15/18), pt reports a rash developed on her neck, moving up toward her face, and around her axilla. It is red, but not itchy. She spoke to her primary care MD, on the phone who advised she use BENADRYL. She reported the event to us on that same day. Spoke to the pt Saturday 11/17/18 to follow-up. She reports the rash is improving but has not fully resolved yet. She will contact us back if it does not resolved in the next few days.
I was playing soccer on 7/28/2021 when I had sharp chest pains and shortness of breath. Went to hospital by EMS where any cardiac, electrolyte or neurological abnormalities were ruled out. Over the next couple months I had these episodes 2-3 times a week. I work as a healthcare professional and took a nitro and realized it helped relieve my symptoms. I am being followed by a cardiologist now who put me on amlodipine and nitro. A typical episode will start with respiratory depression like I want to take a breath but don't, like something is sitting on my chest, then I will get chest pains like someone is punching me in my chest radiating to the back as well. I will get numbness, burning, and pain down left arm and up jaw.   In about October 2021, I was rushed to the hospital due to my nitro not working and sharp stabbing chest pains. EKG by EMS showed ST depression in anterior V leads. When this was occurring I was clenching my chest, rolled up in a ball on my floor in agony. I was only relived by nitro paste.   I continued to have episodes so I was put on higher dose of amlodipine and started on Imdur, which has helped alot. My episodes are weaker but still about 1-2 a week when the long acting Imdur is worn off.  They are provoked by physical activity and at random.
The school district is requiring that she get a second shot of MMRII.; The school district is requiring that she get a second shot of MMRII.; The patient did not report any adverse events after receiving the vaccination / No additional AE reported.; the prescribing information is not clear; This spontaneous report was received from a pharmacist and refers to a 34-year-old non-pregnant female patient who was a teacher in a public school. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in June 2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) injectable dosage form, one dose in the left arm, lot # T013728, expiration date: 21-APR-2022 (strength, dose number and route of administration were not reported) for vaccination against Measles, Mumps, and Rubella.  On an unspecified date, the school district was requiring that she got a second shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter stated that it was not clear in the prescribing information (product label confusion), but it appeared that she only needed to receive one vaccination (circumstance or information capable of leading to medication error, inappropriate schedule of product administration). The pharmacist inquired whether the patient needed to receive a second vaccination. The patient did not report any adverse events after receiving the vaccination (no adverse event).  The outcome was unknown.
Extreme Chills; Hot Flashes; loss of use in left arm, inability to lift anything; dizziness/lightheadedness; headache; swollen injection site; swollen are in left armpit and directly below the area; prev dose brand=Johnson & Johnson; prev dose brand=Johnson & Johnson; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 14:00 (Batch/Lot number: unknown) at the age of 29 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Sleep apnoea" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown: Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Brand: Johnson & Johnson), administration date: 24Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 11Jan2022, outcome "recovering" and all described as "prev dose brand=Johnson & Johnson"; CHILLS (non-serious) with onset 12Jan2022 11:30, outcome "recovering", described as "Extreme Chills"; HOT FLUSH (non-serious) with onset 12Jan2022 11:30, outcome "recovering", described as "Hot Flashes"; MOBILITY DECREASED (non-serious) with onset 12Jan2022 11:30, outcome "recovering", described as "loss of use in left arm, inability to lift anything"; DIZZINESS (non-serious) with onset 12Jan2022 11:30, outcome "recovering", described as "dizziness/lightheadedness"; HEADACHE (non-serious) with onset 12Jan2022 11:30, outcome "recovering", described as "headache"; VACCINATION SITE SWELLING (non-serious) with onset 12Jan2022 11:30, outcome "recovering", described as "swollen injection site"; PERIPHERAL SWELLING (non-serious) with onset 12Jan2022 11:30, outcome "recovering", described as "swollen are in left armpit and directly below the area". Therapeutic measures were not taken as a result of off label use, interchange of vaccine products, chills, hot flush, mobility decreased, dizziness, headache, vaccination site swelling, peripheral swelling. Additional information: Other vaccine in four weeks was reported as yes. Other vaccine in 4 weeks was reported as allergy Injections. Other vaccine in 4weeks vaccine date was reported as 04Jan2022, other vaccine location was reported as both arms. Other medications in two weeks was reported as allergy Injections. Adverse events reported as extreme Chills/hot flashes, loss of use in left arm, inability to lift anything more than a gallon of water, dizziness, light-headedness, headache, swollen injection site, swollen are in left armpit and directly below that area. Events did not result in emergency room visit or physician office visit. It was unknown whether patient had covid prior vaccination. Did not get covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
got Flu; Initial information regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (patient) on 26-Oct-2020.  This case involves patient of unknown demographics who got flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication 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 not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date in 2006 (reported: 14 years ago), the patient got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE and was sicker than a dog. Never again.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Pt. c/o pain and redness at vaccine site on 12/23/2020 around 7 pm.. also c/o headache.  Took Benadryl 25 mg PO q 4-6 hours and Ibuprofen and Aleve.  Pt. states redness was worse the next morning, 12/24/20, and noticed significant swelling at site.  Pt. states symptoms improved by 12/25/20.  Seven days later, patient states noticed swelling and itching at the vaccine site again.  Also states started having bruising and streaking.  Took Benadryl 25 mg PO q 4-6 hours, Ibuprofen and Aleve.  Swelling has improved, but bruising is still present.
Perineal area pressure with urgency and frequency((first 2 days) and decreased urine output,thirst,  right flank pain. bad headache, fever chills shaking loss of appetite nausea muscle aches (thighs and back and neck) sweats fatigue and weakness with abdominal discomfort for 2 weeks.  Then sinus pain and headache for week 3, lessening up to week 4.  All symptoms coming in waves every 3 - 5 hours.  required tylenol 500mg progressing to 1 gm every 2-3 hours, alieve for 3 days, tylenol sinus.   Four weeks Dec 23, fatigue persists, emotional symptoms , abdominal discomfort persists
has a bad skin reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID:   A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: SKIN DISORDER (non-serious), outcome "unknown", described as "has a bad skin reaction".  Additional information: Caller's concern: A caller said she would like to talk with someone about the COVID-19 vaccine because her husband had a reaction to the vaccine. He has a bad skin reaction. She said he completed the 3 doses. While trying to transfer the caller disconnected from the call. This is a notification generated from the  system. New/updated information pertaining to an AE was reported.  You are receiving this notification because you have been identified as a Recipient for this record. A brief summary of this CITI / Complaint Contact is listed:  Pfizer Receipt Date (PRD): 13Sep2022. Responsible Person: (name withheld) (id withheld) . Triage Location / Country: AE Reference Number: Status: Processing Complaint Creation. Please use the following link to log into the system and view the full details of this CITI / Complaint Contact:  Reporter Information: Is Reporter Anonymous is No. Product Description: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very High fever for a few days following. Uncontrollable crying and noticable pain. Regression of speech/words and loss of abilities he was previously able to do. No longer repeats words back to us just babbles the same thing over and over, lots of temper tantrums where he was not doing previously.
pt recvd vax 12APR93 w/in 24 hrs devel skin tender, muscles weak, fever, nausea, flu like sx, pain/tenderness of site persisted x 3 days; reported to clinic 16APR93; outer aspect of lt upper arm inflammed, warm to touch & swollen to elbow;
Patient 28 weeks pregnant received intranasal H1N1 vaccine.  11/13/09: Ante partum examination records received for dates 06/03/09-11/04/09: Diagnosis: Pregnant EDC 01/27/2010   Routine office examinations. Visit 11/04/09 fetal heart (FH) 150.
No adverse event has occurred to present time. I was expecting to receive Varivax to fulfill my second Varicella vaccination requirement for college. I should have received Varivax, however instead I was given Zostavax. Zostavax is intended for patients of at least 50 years of age, I was 22 years old at the time of administration. On the patient vaccination form, expiration date was concerning as well, not entirely sure if '7/26/17' or 7/26/19', looks more like a '7' making it out of date as well.
Extreme stomach pain, diarrhea, burning pain in neck and head for several hours. Extreme head ache, body aches, fever. I am still recovering today.
9 days p/vax pt reported onset of sx which included arthralgias esp knees, ankles, elbows; tender swollen lymph nodes inc palpable post cervical lymph node & erythematous facial rash; fatigue;
left side of her head is hurting/the whole left side of her head hurts from her temple to her chin; in pain; migraine; This is a spontaneous report from Pfizer Sponsored program,received by a contactable consumer (patient's daughter).  A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 21Jan2021 at a single dose for COVID-19 immunisation. Relevant medical history included some dementia. (ongoing). No relevant concomitant medications were provided. She said her mother had no side effects at the time she received the COVID-19 Vaccine. She said her mother's arm didn't even hurt. She said her mother (who lives with her) woke up this morning (25Jan2021) around 4:30AM to go to bathroom, and then went back to bed. Caller stated she, herself, had left her house around 7:00AM this morning to go shopping, and when she got back from shopping 25 minutes later, her husband said her mother was in pain, left side of her head is hurting and he gave her mother a couple of paracetamol (TYLENOL). She said her mother told her the whole left side of her head hurts from her temple to her chin. Her mother was talking fine, and her mother was able to lift both her arms up, so she didn't think her mother had a stroke. She said for the past 20 minutes her mother has been laying back down and seemed to be doing better. The reporter stated that her mother could be having a migraine. She asked if anyone has previously reported to Pfizer developing a headache 4 days after receiving the COVID-19 Vaccine. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Approx 1.5 weeks after shot was given. Pt had sharp stabbing pain intermittently throughout abdomen that would be so painful that pt stated "she felt like she had been stabbed". These lasted for 2 weeks then self resolved.
Swelling; itching and pain at the sight, extends to underarm; (Pt reporting an arm where Zoster was administered).
Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)
Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2022: Follow up document received, additional reporter was added.
Pt called and reported size width of silver dollar, redness. Informed to apply topical antibiotic or OTC cortisone 1% if itchy.
Chills; This is a spontaneous report received from a non-contactable Other Health Care Professional. A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot no: EN6206) via an unspecified route of administration on 15Mar2021 as 2nd dose, single dose for COVID-19 immunization. Patient was 40-years-old at the time of vaccination. Patient medical history included morbidly obese and concurrent conditions and social and family history were not reported. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot no- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. During her 30 minutes waiting period after the injection, the patient began to experience chills. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness. She is morbidly obese and diaphoretic. Treatment included: water, snacks and laying down and covered with blanket. Follow up response to treatment was good. Patient was discharged was stable to go home and follow up with PCP. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's age/units captured, historical vaccine dosage updated, medical history was added and stop date was added for the suspect drug.
Patient was given Moderna bivalent booster instead of 2nd dose of primary series. His initial primary dose of Moderna was given 3/7/23.
No additional AE/PQC reported; Medical assistant calling to report expired PROQUAD administered to patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 18-MAR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliters once, lot number T030760 (rHA) and expiration date 08-MAR-2022 (route of administration were not provided) as prophylaxis (expired vaccine used).  No adverse symptoms or temperature excursion was reported.
Pt recieved Meningococcal MCV4 and Menogoccal B in error. Doses were for her older sister. No adverse reaction noted 45 minutes after injections.  C/O soreness at injections sites.
drippy nose; This spontaneous case was reported by a non-health professional and describes the occurrence of RHINORRHEA (drippy nose) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced RHINORRHEA (drippy nose). At the time of the report, RHINORRHEA (drippy nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-086723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086723:
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 18Dec2020, and was tested positive for COVID yesterday, 29Dec2020. States that she knows she only has had the first dose and states her exposure level was high, states that she cannot believe she made it this far before testing positive. Second dose scheduled for 08Jan2021, wanting to know if she should get the second dose since she was now positive. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th September 2018, batch number:dd43m and expiry date:9th September 2019).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter agreed to be contacted for follow-up.
itchy eyes, throat scratchy same sx as when exposed to other allergies;reported by phone to MD;