chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began experiencing right posterior shoulder rash, fever of 100.2 F and lethargy at 1700 on 7/4/2017. Patient continued to experience intermittent rash, fever and lethargy from that point on. Fever (up to 100.4 F) was treated with Ibuprofen Q6H as needed. Rash would subside within a few hours following ibuprofen administration. Patient has experienced rashes on right thigh, buttocks, right posterior shoulder, entire anterior abdomen & partial left lateral-posterior abdomen at independent times. Patient has had decreased appetite since 7/4/2017.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (past 2 to 3 years ago). Previously administered products included ZOSTAVAX. Concurrent medical conditions included pruritus (itching was present on the top of his head, and the left side of the face and top of the eye). On 27th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain and pruritus aggravated. On an unknown date, the outcome of the injection site pain and pruritus aggravated were recovered/resolved. It was unknown if the reporter considered the injection site pain and pruritus aggravated to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. He had Shingles in the past 2 to 3 years from the date of reporting, and he was left with itching from the Shingles that he had. The itching was present on the top of his head, and the left side of the face and top of the eye. After receiving SHINGRIX the itching got aggravated. As of the day of reporting he had recovered from the itching. The patient also experienced pain at the injection site which lasted for total of 3 days. The reporter consented to follow up.
Red rash appeared around site of injection.  Rash was warm and painful to the touch, swollen, and blanched around its periphery.
Narrative: COVID infection following COVID vaccine series 01/05, Moderna , dose #1 02/02, Moderna , dose #2 04/05 CXR impression: 1. Interstitial scaring on background of COPD without evidence for active pulmonary process. 08/19 pt cc: chills, cough, fatigue, headache, dyspnea, sore throat exposure: unknown 08/23 COVID swab, result: detected 08/23 SARS-COV-2 Variant Sequencing result: pending 09/13 COVID swab, result: NOT detected
Patient reports that several hours after receiving the vaccine that he became short of breath, he was taken to the hospital via ems, Diagnosed with blood clots at hospital. Reports he is now on blood thinners. I spoke with the patient and told him I would be reporting this information and that he may be contacted.
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received; Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140:
sneezing; runny nose; pain at the site of injection; headache; This is a spontaneous report from a contactable physician. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the first dose of Pfizer COVID 19 vaccine on 05Mar2021. In Mar2021, patient had pain at the site of injection and a little bit of headache. On 09Mar2021, patient started sneezing and started having runny nose. Patient knew these aren't side effects of the vaccine, and asked if she should get a COVID test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upsted stomach after first dose; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, 4 days after receiving Shingles vaccine, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was unknown.   It was unknown if the reporter considered the stomach discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The patient reported that, he/she got the vaccine for shingles on Monday and four days later the patient still having stomach discomfort.  The patient asked anything he/she could do about this
headache, sore throat, chills, body aches, loss of taste, loss of smell, diarrhea, ear pain, sinus congestion, nasal congestion. starting 12/27/21
I had fever and chills, sore throat, fatigue. They lasted 3-4 days and then I rebounded the following week for about 2-3 days. I took PAXLOVID. I went to the ER on the 3rd night because my oxygen level dropped to 88. At the ER they monitored me until it came to 90 and had me walk around. Then they let me go home after observation.
On March 3, 2022 the paramedics came to my house to give me the Monoclonal Antibodies. I still experienced headache, shortness of breath after and I started to feel better seven days letter.
Patient complained of swollen injection site. Pain upon lifting arm. Recommended Benadryl and NSAID to patient. Informed if reaction worsens to seek medical attention from a Doctor.
About a week after the vaccines, I broke out with red spots. They were itchy, stinging, and burning. Then when they started to leave, a few were replace with itchy whelps. Especially on right arm.
Rash on face after first injection. Still have a rash. It comes and goes   Shingles after 2nd shot.  Dizziness for two weeks.  Near syncope 24 hours after shot. And 4 days later.
Initial unsolicited report received from pharmacist on 28-Sep-2018. This case involves a [69 years old] male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ024AA, expiration date: 29-APR-2019 and site of administration: left deltoid and route was not reported) on 28-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to syringe issue (needle seemed loose, quite a bit of the immunization leaked out on the patient's arm and leaked out of where the needle attaches to the syringe). It was unknown whether patient experienced any adverse event following vaccination. 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.
Vaccine at 600pm on 1/7. Waking up every hour from 330am-800am. Woke up 8am chest scratchiness/itchiness, generalized joint pain, and body aches, and fatigue. Episode of lightheadedness at around 6pm and near syncope. Started experiencing axillary swelling and pain. All symptoms resoled by 1/9 except for L axillary swelling which persisted until 1/11.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. It was reported that the anonymous patient missed a dose of PNEUMOVAX23 (dose and lot # not reported) because the vial was broken. PQC reported for broken vial. No adverse event was reported. Additional information has been requested.
No Symptoms reported. No other AE details; One dose of VARIVAX that was involved in the TE was administered to a patient; This spontaneous report has been received from a registered nurse, concerning a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/once (lot number X006978 with expiration date reported as 07-MAR-2025), administered as prophylaxis (route of administration and anatomical location were not provided). The vaccine administered was involved in a temperature excursion (TE) of 5.5 degree Fahrenheit (F), during a time frame of 3 minutes, and did not suffered previous temperature excursions (Product storage error). No symptoms reported nor other adverse events (AEs) were reported.
This spontaneous report was received from a pharmacist refers to a 57-year-old female patient. Current conditions included high cholesterol, allergic to cephalosporin, migraines and allergic to penicillin. The patient's medical history included head injury without seizures. On 22-MAY-2013 the patient was vaccinated with dose 1, ZOSTAVAX (lot # J000853, expiration date 23-APR-2014) (reported as 23-APR-2013) subcutaneously in the right deltoid. Concomitant medications included phenobarbital, COMBIPATCH, pravastatin and IMITREX. On 23-MAY-2013, the patient experienced a welt around the injection site which does not itch but it "hurts" and rash around the injection site. There was no relevant lab data. As of 25-MAY-2013, it was unknown if she would continue to receive ZOSTAVAX or if she experienced a welt. The outcome of the events were unknown. Causality was not reported. This is one of the two reports from the same source. Additional information has been requested.
Sore throat; Cold; This is a spontaneous report from a contactable consumer (patient mother) from Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported) via an unspecified route of administration on 17May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that just 3 days ago the patient got a cold and sore throat. The reporter was wondering if she still takes the 2nd one, she is supposed to get it today. The outcome of the events was unknown.  Limited information was available over the call.  Information about batch/lot number has been requested.
After the injection was administered a lot of blood oozed from the injection site.  I worry that the vaccine was not administered appropriately and I am not fully vaccinated against COVID.
Loss of vision R eye; Started having photosensitivity right after the second HPV Immunization.  10/27/09:  Ophthalmology records received for dates of service 10/14/09 to 10/27/09.   Dx:  Infiltrative Keratitis. Assessment:  Presented with moderate to severe loss of vision in R eye and diagnosed with  diffuse Infiltrative Keratitis.   Prescribed Pred. Forte and Vigamox and instructed to d/c contact lens use.  One week later, patients level of comfort was good, but vision was still blurry.  Instructed to continue meds. QID. 6 days later vision remained blurry.
Fatigue, emesis, pruritus, headache and rash within 48 hours of vaccine. Visit office Jan 7, 2014 given, Z-PAK, B-12, TORADOL with no relief of symptoms. Visit MC Jan 9, 14 given BENADRYL and sent home x 2 days. Jan 13 follow up and symptoms much improved.
right side paralysis; This serious case was reported by a consumer and described the occurrence of right sided paralysis in a 78-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included implantable cardioverter defibrillator insertion. Concomitant products included amiodarone, amiodarone, atenolol, acetylsalicylic acid (Aspirin (Baby)), losartan potassium (Cosaar (Losartan)) and atorvastatin calcium (Lipitor).   On 09-SEP-2023, the patient received RSV vaccine. On 09-SEP-2023, less than an hour after receiving RSV vaccine, the patient experienced right sided paralysis (Verbatim: right side paralysis) (serious criteria hospitalization, GSK medically significant, clinically significant/intervention required and other: serious as per reporter). On 09-SEP-2023, the outcome of the right sided paralysis was resolved.   It was unknown if the reporter considered the right sided paralysis to be related to RSV vaccine.     It was unknown if the company considered the right sided paralysis to be related to RSV vaccine.   Additional Information: GSK receipt date: 13-SEP-2023 This case was reported by patient's wife. The patient was in hospital for 30 minutes after the injection of the RSV vaccine patient experienced right side paralysis.  The reporter called 911 and he was transported to the hospital. By the time, he was taken to the Emergency department (ED), intervention required (unspecified). The patient's Implantable cardioverter defibrillator (ICD) was interrogated on September 2011 and showed no issues and NO AFIB, he had completely recovered.  All tests in the hospital were normal including 2 CT scans and he could not do MRI due to his ICD. The reporter consented to follow up
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-418891 (Patient Link).
On 10/18/16, patient got dizzy then fell. She hit a brick wall and required stitches near her eye. She reports weakness after getting flu shot too.
2nd Tdap catch-up dose was Infanrix; Patient 16 yo, 2nd Tdap catch-up dose was Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 12th July 2021).   On 13th October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-APR-2022  Reporter's Comments: Nurse stated a previously unvaccinated patient started catch-up immunizations at the age of 16.  The patient's first dose of the tetanus, diptheria, and pertussis series was a dose of Boostrix and the second catch-up dose was Infanrix. No further details provided.  Prior to transfer from first line specialist, the nurse became irritated and stated she did not want to answer any more questions.  Submitting event with limited details available. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Infanrix instead of Boostrix, which led wrong vaccine administered and inappropriate age at vaccine administration.
The patient came in for a third (booster) dose. She received her previous covid-19 vaccines from 2 different facilities. We administered the booster dose of 0.25ml at 9:15am on 04/08/22. Immediately after administration it was discovered that the vaccine product expired 7 days ago, on April 1 2022. It was received only a month ago and the expiration date was not checked correctly, nor have we had a product so short dated previously. The vaccine administrator/RPH contacted Moderna directly and we are waiting to determine if the patient will need an additional vaccine or if the vaccine given is still viable. No adverse effects took place for the patient, and we have explained the situation and will contact her as soon as we hear from Moderna what further action if any needs to be taken.
Sore arm, moderate pain, tiredness, fever, muscle pain, headache, shivering, stomach pain, nausea,  dizziness and rashes.
This spontaneous report was received from a Registered Nurse (RN) and refers to a patient of unknown age and gender.  Medical history and concomitant medications were not provided. In June 2017, the patient received PNEUMOVAX 23 0.5 mL one time intramuscularly (lot # N003997; expiration 20-OCT-2018). The RN reported that the patient received the vaccine, which had undergone a temperature excursion on 27-JUN-2017. Total time in the range of 47 degrees F to 77 degrees F: 52F, 1 hour (30 minutes rounded up to one hour). A data logger was involved. When asked if these same vaccine vials/tubes had previous temperature excursion, the RN replied "yes". The details of the previous excursion was 24-JUN-2017, 52 degrees F for one hour (30 minutes rounded up to one hour). The patient had not called the reporter's facility to report any adverse reaction. The outcome was unknown. Additional information has been requested.
Pt felt light headed after vaccine administration, laid down, elevated head. Recovered. Respiration none-labored - no distress. BP 114/60, P 80, R 12. Ambulates independently, no diff. Seek medical attention prn.
SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
Mother of PT states her son started showing symptoms on 06-14-2021 after his second dose. Mother of PT states her son had upper respiratory symptoms, such as congestion, fever of 101.6 and ear pain. PT mother states her so was evaluated by his pediatrician who performed a Covid test which was negative.  Mother of PT states her son still continues to have upper respiratory infection, but his symptoms are improving.
13DEC 630-7PM pt devel fever of 105; less appetite, clingy; some fussy-but consolable; stool mushy; 14DEC mom called to report prev noc sx;
Terrible Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Terrible Rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Terrible Rash). At the time of the report, RASH (Terrible Rash) outcome was unknown.        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 medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-393255, MOD-2021-392096 (Patient Link).
All day: mild fatigue, mild soreness and occasional itchiness at site of vaccination Evening: moderate nausea after eating, moderate abdominal pain, moderate chills and feverish feeling, moderate fatigue  No medications taken to treat symptoms; symptoms treated with rest.
PATIENT WAS ADMINISTERED DOSE #2  SIX DAYS AFTER DOSE  #1
Fatigue turned into fever (100 F - normal for me is 96.5), aches, pains, chills for about 36 hours. My arm showed a red growing circle and it continued to grow for the next 5 days. By day 7, today, it is minimal and much less uncomfortable. Fatigue continues hitting about mid-day. On Monday after the vaccine, I tried to exercise but broke out in a fever sweat.   I took no pain relief as knew if was my immune system working and I was not sick. On Monday I started taking Benadryl for my arm.
Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a contactable other healthcare professional reporting for a patient.  A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 19Jan2021 at 11:15 (at the age of 71 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included hypertension, seizures, hypothyroid, and attention deficit disorder all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication names were not reported, but it was reported that she used other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination,  The vaccine was given at a Nursing Home/Senior Living Facility. On 20Jan2021 at 12:00AM, the patient experienced fever 103.6F with chills, and vomiting. The patient received treatment of Tylenol 1gm once only for fever and chills. The clinical outcome of fever 103.6F with chills, and vomiting was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Aphthous ulcers began to appeared on 03/14/14, the day after the first dose of Oral Typhoid taken 03/13/14.  Pt continued with the scheduled dose on 03/15/14, when more appeared under the tongue on same day.  Pt stopped taking the oral typhoid and did not take dose 3 or dose 4.
Arm swelled (2 half dollar size), red & sore to touch, black & yellow bruise, lump by injection site.