chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent. A 5-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 1, single (Lot number: FK5127, Expiration Date: 03Dec2021), on 17Dec2021 as dose 2, single (Lot number: FK5127, Expiration Date: 21Jan2022) and on 23May2022 as dose 3 (booster), single (Lot number: FL0007) at the age of 5 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "got vaccinated still tested positive for covid19 afterwards". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Clinical course: Caller stated, she was vaccinated and twice boosted mother of 4 and part time acute care speech language pathologist. Her husband and four children (Ages 5, 5 (twins), 7, and 9) have each had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. They contracted COVID-19, likely 03Jul. Only one of the five year old's has remained negative via at home antigen testing. She was writing to ask if there are any studies that they could participate in that would assist you. Caller stated early in the pandemic they all signed up for the trial however they didn't get selected. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient;
Her arm is still hurting a lot to even lift it.; It's hard in the area and hurting all the way to her shoulder; Arm is still hurting a lot to even lift it; Hurting all the way to shoulder; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Her arm is still hurting a lot to even lift it.), VACCINATION SITE INDURATION (It's hard in the area and hurting all the way to her shoulder), VACCINATION SITE PAIN (Arm is still hurting a lot to even lift it) and ARTHRALGIA (Hurting all the way to shoulder) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     Patient had no allergies. Patient had never tested COVID-19 positive.  Previously administered products included for Product used for unknown indication: Janssen (Dose number 1) on 08-May-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Type II diabetes mellitus, Blood pressure high (High blood pressure) and Spinal osteoarthritis (Arthritis in the spine).    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Her arm is still hurting a lot to even lift it.), VACCINATION SITE INDURATION (It's hard in the area and hurting all the way to her shoulder), VACCINATION SITE PAIN (Arm is still hurting a lot to even lift it) and ARTHRALGIA (Hurting all the way to shoulder). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Her arm is still hurting a lot to even lift it.), VACCINATION SITE INDURATION (It's hard in the area and hurting all the way to her shoulder), VACCINATION SITE PAIN (Arm is still hurting a lot to even lift it) and ARTHRALGIA (Hurting all the way to shoulder) had not resolved.            No concomitant medications were reported. It was reported that the pain started the night of the injection. AE did not caused patient to seek medical care. Patient had not experienced a similar event in the past. Symptoms were worsened. No treatment details were reported.
Throat tightened up- chest congestion, general body aches- began 2 hrs after vaccines.  Went to ER- after 3 hrs wait, went home.  Took BENADRYL- improved.
swollen lips x 24hr-denies difficulty breathing;pruritic pin-point red rash migrating form arms, to legs, back for 2 wk;extreme restlessness & jumping out of skin;no ER visit;no meds taken;
Erythema and raised area, 85 x 70 cm, oblong in shape to MMR vaccination site.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Additional Details: Patient experienced pain in lower back, knee and nausea.  Conscious, speaking, recovered slightly upon arrival of 911
after vax pt exp intestinal cramps lasted until 4-4:30am, then diarrhea started & cont until 6:30pm
Information has been received from a physician referring to a 70 year old male patient with cardiomegaly and diabetes mellitus. There were no known drug reactions or allergies for the patient. On 06-APR-2015 the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown) in his left upper arm. Concomitant therapies included metformin, fluticasone, digoxin, losartan potassium (manufacturer unknown) and RITALIN. On 07-APR-2015 the patient experienced muscle pain in his right leg. On 08-APR-2015 the muscle pain also started in his left leg, and then on 09-APR-2015, the muscle pain started in his buttocks. The patient sought medical attention via office visit on 10-APR-2015, and he continued to experience pain in his bilateral legs and buttocks. Also the doctor noted the patient grimacing with pain upon walking. No lab diagnostics studies were performed. The physician stated he was going to prescribe prednisone and tramadol to treat the patient's symptomatically. At the time of report, the patient was not recovered from the events. The events were considered to be disabling. The causality between ZOSTAVAX and the events was unknown. Additional information has been requested.
Her husband is unable to get the 2nd shot and was recommended by his cardiologist because he has a tooth that needs to be worked on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH DISORDER (non-serious), outcome "unknown", described as "Her husband is unable to get the 2nd shot and was recommended by his cardiologist because he has a tooth that needs to be worked on". The event "her husband is unable to get the 2nd shot and was recommended by his cardiologist because he has a tooth that needs to be worked on" was evaluated at the physician office visit.  Additional information: The reporter wanted to know how much protection one shot can give. She mentioned that her husband was unable to get the 2nd shot and was recommended by his cardiologist because he had a tooth that needed to be worked on.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Upon injection (it?s like I?m seeing stars) to Few minutes after shot- lightheadedness, until now. Vision change, tingling on hands, sweating feet (slight)
Expired vaccine stored and then administered; We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine to patients last month on 23Jul2022.) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Confirmed expiration date was reported as 27-Mar-2022.  The vial was initially stored in the refrigerator on 23-Jul-2022. The vial did not undergo any temperature excursions.            No treatment information was provided by the reporter.
POSSIBLE INCORRECT ROUTE OF ADMINISTRATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced possible incorrect route of administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible incorrect route of administration was not reported. This report was non-serious.
AM next day very fatigued arm very sore painful, cold chills and body aches in pains later in the day. Ibuprofen dose, provided relief, resolved. 1/13/2021 Headache nausea dry hives in AM, vomited once at 11AM.
Started feeling pain in my arm and shoulder and it never went away. Then 2 weeks later I started getting various rashes on my body. The rashes were hot and spread sporatically. Started getting hot flashes that still remains. Gets dizzy a lot. Participant has been trying to get his PCP to take him seriously, but doesn't feel like they have. Has started taking pictures of the rashes.
Injection site soreness, intense left chest pain, body chills, fatigue, and shortness of breath
A few hours post injection (1) I felt fatigued but quickly recovered. For a few days after my arm was red at the injection site but went away until the following Friday (5/7) when I had intense nausea and noticed the injection shot was very red and raised again. The nausea passed but returned 1-2x that Sunday-Monday (5/9-10). The most severe reaction began that Sunday evening  and was at it's worst from Monday (5/10) to Tuesday (5/11) where I was bed-ridden and weak, experiencing diarrhea 4-5x per day. The diarrhea & loose bowels continued until this  Sunday (5/16). The severity and frequency got better and better each day until disappearing by Monday (5/17). In the beginning it was as if every time I ate or drank, it would go straight through me.
Aching pain at the right upper arm, mild malaise and no abnormal findings on examination.
This 24 year-old patient was transferred to our hospital, from a separate nearby hospital on 8/9/21. He had presented on 8/8/21 with acute respiratory failure requiring intubation, and pneumonia. He was admitted to Hospital on 8/9/21 and discharged home on 8/20/21.   Treatment at transferring hospital on 8/8/21 included Remdesivir, dexamethasone, azithromycin, rocephin, cefapime, vancomycin, and 3L NS. H & P at receiving hospital, says:  Reportedly multiple COVID 19 testing negative, however elevated inflammatory markers concerning for possible COVID, for this reason placed on isolation. Diagnosed with respiratory failure, sepsis, MSSA pneumonia POA, infective endocarditis, acute normocytic anemia, and others.
Patient developed complaint of headache and dizziness , "whoozy", post vaccination nearly immediately after injection.  Stated prone to dizziness when gets shots.  Not SOB no rash.  Monitored over 30 minutes, given juice, blood sugar 89 BP 129/78, EMS on scene and assessing along with NP.  Pt felt better and discharged from vaccination clinic but about an hour later patient called to report dizziness and persistent headache and returned to vaccination clinic for re-evaluation.  EMS on scene administered 2L o2 via NC for comfort as pt highly anxious and tearful reporting feeling dizzy and frontal HA.  Is not with Shortness of breath or chest pain.  Advised transport to ED for further evaluation and management
Pt received a Bivalent Pfizer Booter 12+ dose which was a higher than recommended dose as she should have received a bivalent 5-11 dose.
This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, 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 FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not provided. The report reported that a couple of patients received the FLULAVAL QIV vaccine last year and still ended up getting the flu. No further information was available or reported regarding the event. This case was considered as suspected vaccination failure case as the laboratory confirmation and exact time to onset for influenza was not provided.
Pt came in to get their Flu shot but was administered a Covid vaccine. They were given the pediatric strength and dose. They had already been given their 1st dose a week or so ago.  I spoke to the patient's MD and she said that there are no signs/symptoms of any kind and she is not worried about it. SHe told the parents that they would be fine and to let her know if anything else happened or was needed.
collagenos colitis; Migraine; the arm starting hurting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COLITIS MICROSCOPIC (collagenos colitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer, Chronic pain (left arm), Colitis collagenous and Mastectomy bilateral on 20-Oct-2011. Concurrent medical conditions included Headache. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eye, COLECALCIFEROL (VITAMIN D 3) for Nutritional supplement, LORAZEPAM for Sleep disorder NOS.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced COLITIS MICROSCOPIC (collagenos colitis) (seriousness criterion medically significant), MIGRAINE (Migraine) and PAIN IN EXTREMITY (the arm starting hurting). At the time of the report, COLITIS MICROSCOPIC (collagenos colitis), MIGRAINE (Migraine) and PAIN IN EXTREMITY (the arm starting hurting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had previous health issues and these problems returned with vengeance. The patient had a history of headaches but mild she started having migraines. The patient had breast surgery and had previously had problems in her left arm because of infections and had 12 surgeries. The arm got better and haven't had any pain in years. The arm was started hurting again. The patient was diagnosed with collagenous colitis. It hasn't bothered her in many years. It was back and worse than ever. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: This case concerns a 78-year-old female with PMH of collagenous colitis, had a serious unexpected event of colitis microscopic, and non-serious unexpected migraine and pain in extremity. Event onset 12 days after second dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-075459 (Patient Link).; Sender's Comments: This case concerns a 78-year-old female with PMH of collagenous colitis, had a serious unexpected event of colitis microscopic, and nonserious unexpected migraine and pain in extremity. Event onset 12 days after second dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
numbness on the left side of her face and left side of her nose as well as tingling in her nose, after a few minutes, she then developed numbness on the right side of her face which progressed down the left side of her neck,  pt reported a "weird" sensation in her chest and abdomen as well as feeling dizzy,  some chest tightness.
Patient was administered with a 5/8 inch needle instead of a 1 inch needle. Per CDC guidelines re-vaccination is recommended in this situation. Patient received their re-vaccination same day in right arm at 2:22PM.
Pfizer / BioNTech: Dose Number: 1,2,3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 1,2,3; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) 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 had no relevant medical history. Concomitant medication(s) included: LEXAPRO taken for antidepressant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 1,2,3; Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. Other medication in 2weeks product: Antidepressant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received First Dose of Heplisav-B, and Second Dose of Engerix; Initial report received on 23-Aug-2023  A physician reported that a 25-year-old male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Energix-B as the second dose.  Medical history at the time of vaccination was reported as unknown. The patient had an allergy to Motrin (ibuprofen), which gives him a rash. Concomitant medications was not reported.  On 26-Jun-2023, the patient received the first dose of HEPLISAV-B (Lot # 941580, expiration date 06 Jan 2025, NDC #43528-002-01; route and injection site not reported).   On 18-Aug-2023, 54 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received Energix-B (no details provided) as the second dose. The patient did not have any side effects.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
VACCINE WAS ADMINISTERED THE AFTERNOON BEFORE HIS 12TH BIRTHDAY.   CALLED MOM AFTER DISCOVERY, SHE SAID THERE WAS SOME MISCOMMUNICATION BECAUSE SHE HAD ASKED THE TECH IF 1 DAY AHEAD WAS OK, AND THOUGHT THAT A DAY OR 2 BEFORE HIM TURNING 12 WOULDNT MATTER.  SHE EVEN WROTE "AGE 12" ON THE CONSENT FORM.  PATIENT FEELING FINE, NO SIDE EFFECTS.
Patient did not get the 2nd dose within the recommended time frame; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose within the recommended time frame) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose within the recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose within the recommended time frame) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter. No Treatment Medications were Provided  by the reporter.
This spontaneous report was received from a physician and a licensed practical nurse and refers to a male patient of an unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (route and site of administration, dose, lot number and expiration date were not reported). He received the second and the third dose of GARDASIL 9) injection (route and site of administration, dose, lot number and expiration date were not reported) on 13-JAN-2017 and 30-MAR-2017, respectively. No adverse effect was reported. No additional information was provided. Additional information has been requested.
body aches after taking  the first dose; had fever; This is a spontaneous report received from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received 1st dose of bnt162b2 (Pfizer's COVID-19 vaccine,Batch/Lot Number: EL9269), via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced body aches after taking the first dose and had fever on an unspecified date.  No follow-up attempts are possible. No further Information is expected.
Case number PHEH2012US019260 is an initial spontaneous report received from a pharmacist on 25 Sep 2012. This report refers to a 65-years-old female patient. She did not have any known drug allergies and her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1206701, expiry date: 30 Jun 2013) on to upper arm on 19 Sep 2012. After vaccination, she experienced vaccination site reactions which were described as red and swollen upper arm on 19 Sep 2012. The event lasted for few days and she went to emergency room. She was diagnosed with cellulitis in emergency room. She was instructed to take BENADRYL. The outcome of the event was not reported. No further information was available.
Vaccine error, FLUZONE 0.1 cc given intradermal by mistake, instead of PPD. 20 min after 4x2 cm redness, swelling, hot, not change at 1hr, 8.5 x 6.5 cm at 24 hours. Tx: BENADRYL, NSAIDs, Ice.
Client reports that a few hours after vaccination she began to experience "chest tightening with a pain of 4/10". It resolved on its own within about 2 hours. The client did not take any medication or complete any other intervention.
Aching pain (not sharp pain) under foot, specifically under arch of left foot.  Only on left foot and not on right foot.  Pain also has sporadically some tingling and burning sensation.  Pain is chronic and doesn't subside and has lasted for over 3 months now.