chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning her 6 year old white son who was vaccinated on 20-MAR-2001 with a first dose of Varivax. On 27-APR-2006, the patient experienced full blown breakthrough varicella with 100 lesions and a fever of 100 to 101 degrees Fahrenheit. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the reporter who indicated that on 27-APR-2006 the patient was diagnosed with varicella. Additional information is not expected. The nurse also reported that her three other children had a similar event after therapy with Varivax (WAES number 0605USA00191, 0605USA00082, and 0605USA00017).
Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 months old female patient who was vaccinated PENTACEL lot C5590A Expiration Date 18-Oct-2019 via intramuscular route in the left thigh, on 27-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13, HEPATITIS B VACCINE and ROTAVIRUS VACCINE. It was an actual medication case error due wrong technique in product usage process and incorrect product storage. It was reported that PENTACEL was reconstituted on 26Mar2019 and given on 27Mar2019, (DTaP/IPV Lot C5447AA, Expiration Date: 18Oct2019. Hib Vial Lot C5590A, Expiration Date: 18Oct2019). It was reported that, no adverse reaction observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
cried unconsolably for 2-3 hrs; had high pitched cry; temp to 104 R; leg swelled @ inject site;
Information has been received from a Nurse Practitioner (N.P.) concerning a 16 year old female patient who "about one week ago" (on approximately 22-JUN-2009) was vaccinated with the second dose of GARDASIL. It was reported that since receiving the vaccine, "about one week ago" (on approximately 22-JUN-2009) the patient had noticed her left arm, the arm where the injection was administered, had been feeling strange and tingly. It was reported that that patient had been lifting and cleaning at the camp and had reported other muscle type pain. The vaccines was not reintroduced. The patient sought unspecified medical attention. The patient had not recovered at the time of the report. Additional information has been requested.
girlfriends husband got the shot and ended up with shingles in his eyes / suspected vaccination failure; shingles in his eyes; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's wife's boyfriend. The age at vaccination was not reported. The patient received Shingles vaccine and ended up with shingles in his eyes. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Bad flu-like symptoms for at least 3 days! Chills, fever, sore muscles, loss of appetite, restless sleep... Never had a bad reaction to flu shots before, Perhaps there is a combinatory side effect?
-About 5 minutes after receiving vaccine I began to cough continuously. At 15 minutes after receiving vaccine my tongue was tingling, my throat got tight, my mouth and jaw felt weird.  - I took liquid Benadryl 10 ml.  -About 50 minutes after receiving vaccine the tingling, and funny feeling in mouth began to subside.  - my cough became less frequent.  - it is 1:30 am on 1/18/21 and I cough often
The patient began feeling a tightness in his chest and by 12/8/2021 it had worsened to shortness of breath, cough and fever.
Redness, swelling and severe pain starting at shoulder, then to elbow and forearm by 10-23-15. Woke up 10-22-15 01:30 w/rapid breathing, dizzy, nauseated, and severe chills. Went to doctors - 10-23-15 5:00 PM and received Rx for 20 mg prednisone, for 10 days. Symptoms started to clear up the next day.
Patient called call center only to report side effects from 1st dose Pfizer vaccine on 4/12. Pt denied emergency symptoms at time of call. Only wanted to report what happened after first dose, per advisement from PCP.  4/12 pt received 1st dose Pfizer vacc  4/21 evening pt experienced intense tinnitus.  4/22 pt states she experienced complete hearing loss in one ear. Received medical attention from PCP @outside insitutation. Per PCP pt was told not to receive 2nd dose of Pfizer vaccine. Pt is on 2 week steroid treatment, still reports complete hearing loss in one ear."
A week after the vaccine, the site started to swell and a red raised circle about 2 inches in diameter appeared. Very itchy and slightly painful. I?ve seen it referred to as ?modern arm?.
tested positive covid; tested positive covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: she got tested positive for covid again after taking the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy feeling all over, red welts and hives on torso,  limbs, neck and head.  coughing
Diarrhea; Mild headache; Mild aches and pain; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild aches and pain), PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea) and HEADACHE (Mild headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Mild aches and pain), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Mild headache). On 02-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PAIN (Mild aches and pain), PAIN IN EXTREMITY (Arm soreness), DIARRHOEA (Diarrhea) and HEADACHE (Mild headache) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-064039 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Sep2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (Sep2022) Negative, notes: Tested negative days 5-10; (Sep2022) Positive, notes: Tested positive again on Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid from 10Sep2022 to 15Sep2022 used for the treatment of covid-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Information has been received from a registered pharmacist concerning a 72 year old female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot : 663195/1416X). On an unspecified date the patient's teeth hurt, had fever sores on mouth, throat pain and left arm pain. On an unspecified date the patient recovered from all her symptoms and was "feeling better". This is one of several reports from the same source. Additional information is not expected.
Excruciating Joint pain / arm pain/leg pain;  numbness in left hand and both feet
Information has been received from a physician concerning a 21 years old female with no pertinent medical history who was vaccinated with GARDASIL (lot#, dose, route and site of administration not reported) by a physician's assistant at the office on 05-MAY-2009 or 07-MAY-2009. The patient experienced headache, dizziness and an injection site reaction several hours after getting the vaccine. The patient was told to take ACETAMINOPHEN (manufacturer unspecified). Subsequently, the patient recovered. Additional information has been requested.
Fatigue began around 4:30 pm. During the night I experienced shivering, muscle pain and headache. Woke with a headache and also was sweating profusely.  Also had nausea in the early morning and light headedness.
Pt was given vaccination in office (0950). Mom phoned to say that by that time arrived home (15 mins). Pt was covered in hives. Returned to office in 10-15 min. Hives on back, abdomen, face. Mom gave dose of BENADRYL.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L020482, expiration date: 02-SEP-2016) (dose and frequency were unspecified). Concomitant therapies included Influenza virus vaccine (unspecified) in the opposite arm. On an unspecified date in November 2015, the patient called to the pharmacist to inform her that her arm was tender to the touch at the injection site (injection site pain) and that she developed rash under both arms in the breast area (rash). No product quality complaint was involved. At the time of the report, the outcome of injection site pain and rash was unknown. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information has been requested.
2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.). At the time of the report, MENSTRUATION IRREGULAR (2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient went to her primary doctor for the event she was experienced and was told that she was the 2nd person who had similar kind of situation after getting the Moderna vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720346, US-MODERNATX, INC.-MOD-2023-720348 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720346:Reporter case US-MODERNATX, INC.-MOD-2023-720348:daughter's friend's mother
She received her first dose of the Pfizer COVID-19 vaccine in April of 2021, she was diagnosed with COVID-19 after her first dose; She received her first dose of the Pfizer COVID-19 vaccine in April of 2021, she was diagnosed with COVID-19 after her first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: high risk patient with history of high blood pressure, asthma, and COPD. The patient's concomitant medications were not reported. The following information was reported: At the time of report, patient currently 63 years old, is due for her Pfizer Covid-19 Booster dose on Jan2022. She received her first dose in Apr2021, then was diagnosed with COVID-19 on an unspecified date in 2021, and had her second dose in Jul2021. Patient was asking if can she take the Booster dose in Dec2021 due to her medical history. The patient underwent the following laboratory tests and procedures: COVID-19: (2021) then was diagnosed with COVID-19. The outcome of the event was unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101772894 Same patient/ vaccine, different dose/AE
placenta separate after the vaccine (unconfirmed vaccine); baby was delivered at 32 weeks; pregnancy; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)), PREMATURE DELIVERY (baby was delivered at 32 weeks) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)) (seriousness criteria hospitalization and medically significant), PREMATURE DELIVERY (baby was delivered at 32 weeks) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) (seriousness criterion hospitalization). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. At the time of the report, PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)), PREMATURE DELIVERY (baby was delivered at 32 weeks) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  This is a case of product exposure during pregnancy with associated AEs. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs. Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Pt was given Moderna Bivalent Booster vaccine (0.25ml) instead of Moderna (6m-5y) monovalent vaccine.   No adverse reactions to vaccine per pt's mother
Nasal congestion, light-headed and limb weakness. Symptoms improved after approximately 15 minutes of rest.
patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port"; Patient has no other symptoms after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of CATHETER MANAGEMENT (patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port") and NO ADVERSE EVENT (Patient has no other symptoms after receiving the vaccine) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CATHETER MANAGEMENT (patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port") and NO ADVERSE EVENT (Patient has no other symptoms after receiving the vaccine). At the time of the report, CATHETER MANAGEMENT (patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port") and NO ADVERSE EVENT (Patient has no other symptoms after receiving the vaccine) outcome was unknown. Unknown      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 relevant concomitant medication was reported. Treatment information was not provided.  Patient reported that they used a solution called draino to help flush out the port.
pea-sized lumps in armpit are (injected arm)  Narrative: 70 yo male called triage line on 3/29/2021 to report that he found pea-sized lumps in his armpit on the arm that he had the covid-19 moderna vaccine. Pt received his second moderna dose on 3/13/2021. First dose was administered on 2/13/2021 without complications. Per triage note, patient described them as "pimples", "peasized", and that he had 6 to 8 bumps. On the same day, the team nurse tried to call patient back to schedule a same day appt but patient did not pick up. No other information found in chart regarding patient's reaction.
Diarrhea - started 45min-1hr post injection and continued throughout the day until 10:45p Nausea - started roughly 2 hours after. Had continued into next day
Red and spreading warm to touch and hard no trouble breathing or vomiting. Mom states child is running and jumping.
Temperature Excursion; No further AE; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date in 2023, the patient was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) (manufacturer GlaxoSmith Kline [GSK]) (lot# DD7F7, expiration date: 06-DEC-2025) administered in the left thigh, and with meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI) (manufacturer Sanofi) (lot# U7673AA, expiration date: 29-JUN-2025) administered in the right thigh. For both vaccines, indication, strength, frequency, vaccination scheme, and route of administration were not reported.   On 17-AUG-2023, the patient was vaccinated with an improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  pre-filled syringe (lot # X005578 has been verified to be a valid lot number hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and established as 30-NOV-2024), administered in the left thigh for prophylaxis (strength, dose, vaccination scheme and route of administration). The temperature of storage, time frame of the excursion, if a digital data logger was involved and if the vaccine experienced a previous temperature excursion were not reported. It was stated that vaccine was safe to use. There was no further adverse event reported.
Bruising started about 2 weeks after the booster and then I started to accumulate them. I thought it was the blood thinner I was on. They had me stop it but they still continued and ran bloodwork for my presurgery check. Then added a vitamin d just to be sure.
Injection site reaction - redness/pain/soreness but no rash. On 1/18/12 (approximately 2 days after shot) got shingles rash on mid-right back & along with increased nerve sensation/pain. Initiated antiviral therapy on 1/19/12 for shingles.
Chills and elevated temp (99.6 degrees) beginning the morning after the injection. Lasted less than 24 hours. No treatment needed.
Left arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Left arm is still sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-219) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Past medical history includes high blood pressure) and Seasonal allergy. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ATORVASTATIN, CITALOPRAM, CHLORTHALIDONE and POTASSIUM for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Left arm is still sore). At the time of the report, JOINT RANGE OF MOTION DECREASED (Left arm is still sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.