chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Flu like symptoms; feeling kind of bleh; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number Y5J27, expiry date 8th November 2021) for prophylaxis.   On 23rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd November 2019, less than a day after receiving Shingrix, the patient experienced fatigue, influenza-like symptoms and feeling abnormal. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fatigue and influenza-like symptoms were not recovered/not resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the fatigue, influenza-like symptoms and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the 1 st dose of Shingrix vaccine and developed flu like symptoms like fatigue and feeling kind of bleh. It started the evening of the vaccine, seemed worse on sunday and then it was about the same. The patient reports she felt a little better after taking Tylenol. The patient went to the doctor and the doctor did prescribe Amoxicillin and Steroids. The reporter consented to follow up.
1st dose of vaccine, sore arm on day of vaccination. The 2nd day nausea, headache, dizziness, weakness, fatigue, chills,severe  sweating, achy had to take an alieve  tablet to stop the headache and nausea in order to get my facilities in order.
This spontaneous report was received from a certified medical assistant (C.M.A.) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (Lot # reported as L030585 Expiration date: 10-FEB-2017) (doses, route and anatomical location of administration were not reported). No adverse events were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
The ProQuad series was already completed, but patient received an extra dose.  No adverse events occurred or have been reported.  Physician explained to mother that an extra dose was given and while it is not harmful to the patient, it was unnecessary.
PAIN/SORENESS/REDNESS IN AREA WHERE THE PATIENT RECEIVED THE VACCINE, SO HE WENT TO SEE HIS DOCTOR AND WAS GIVEN ANTIBIOTIC. AS OF TODAY, PATIENT REPORTED THAT HIS ARM IS STILL IN PAIN/REDNESS, BUT IT'S GETTING BETTER.
Headache, NauseaVomiting, fatigue, pain in arm around injection site Narrative:
Headache /body ache /pain in the ribs and numbness in back. Took one dose of Tylenol on 24th, was feeling better.  Except for pain in the ribs everything is fine.
BURNING SENSATION ON BOTH BUTTOCKS; ITCHY SENSATION ON BOTH BUTTOCKS; This spontaneous report received from a patient . The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, NSAIDs, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced burning sensation on both buttocks, and itchy sensation on both buttocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation on both buttocks and itchy sensation on both buttocks was not reported. This report was non-serious.
This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial). No concomitant product use was reported.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was unknown if patient experienced any symptoms after getting the vaccine. Treatment information was unknown.
Patient was sweating, felt faint and vomited, w/in 15 minutes of administration. She recovered completely and was observed for 20 minutes after was checked up on in 14 1/2 hours at her home via phone and was feeling better.
Lymphadenopathy to Axilla, supraclavicular & cervical of left side (arm which injection was given).  Painful and sensitive to the touch. Began 1 day following injection of COVID-19 vaccine.
Pt recvd vax 23JUL92 & 5 mins p/vax rt arm became numb to elbow; 3 to 4 hrs p/vax became listless; 24JUL92 devel rash & hives; 25JUL92 devel swollen throat;
Right side face numbing  Pain down whole left arm into hand Headache  Stuffy  Sore throat
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/17/2023 Discharge Date: 2/19/2023   Clinical Narrative: Patient was started on ceftriaxone, doxycycline, Mucinex and breathing treatments p.r.n. for presumed bacterial pneumonia, he has remained afebrile, mild leukocytosis which is presumed to be reactive, procalcitonin was 0.04 which was normal.  He has clinically improved, oxygen has been weaned off and is doing well on room air both at rest and ambulating staying above 90%.  He may be discharged on oral Augmentin and doxycycline to complete 5 more days Patient was positive for COVID-19 and he was past the window period for remdesivir, he is advised to continue social distancing Acute kidney injury on admission resolved with IV fluids, was felt to be prerenal
Had vaccines on 3/5/12. Started with elevated temp & chills later that evening. Elevated to 101 degrees on 3/6/12 at 1310. Labs & blood cx care. Developed redness & warmth to left arm on 3/7/12. IV antibiotics given. On 3/8/12 arm not as reddened. Patient discharged.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain and bruise injection site. The healthcare professional attributed the bruise to how the vaccine may have been administered. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 subjects had received FLULAVAL and had experienced injection site pain. This is case 5 of 5 (see case IDs A0949586A, A0949593A-A0949595A for details of the other reports).
Patient experienced difficulty breathing on 4/6/2021 (10 days after receiving the vaccine). She called EMS was hospitalized. She reports her PO2 at the time was 93%. During her hospital stay she reports she was given nutrient and fluid replacements, antibiotics, and her chronic medications. She was hospitalized for a total of 5 days. Patient recently followed up with her PCP and he recommended she receive the second COVID vaccine because it is difficult to say if this event is related to the vaccine. Patient is currently scheduled to receive her second Pfizer COVID-19 vaccine on 4/20/2021.
development of lymphadenopathy in left sub mandibular region. The lymphadenopathy is about 35*12*10 mm, firm, mobile, non-tender, and positive for little pain and discomfort.; positive for little pain and discomfort.; This is a spontaneous report from a contactable physician, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9263) via an unspecified route of administration in the left arm on 02Feb2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other unspecified medications within two weeks of COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On 10Feb2021, after a week after receiving the second dose, the patient noticed development of lymphadenopathy in left sub mandibular region, the lymphadenopathy was about 35*12*10 mm, firm, mobile, non-tender, and positive for little pain and discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event development of lymphadenopathy in left sub mandibular region and positive for little pain and discomfort was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
A month after the shot, dizzyness, heart palpatations, off balance, trouble speaking. Officially diagnosed as having TIA stroke.  First episode in March. Other episode in April, May and June. Second eposide in April was more severe than in March.
A couple of my kids got fever so I kept taking my temperature but did not have a fever. I was coughing, had a sore throat and lethargy. I tested positive and contacted my doctor who told me to take Mucinex which I take every 12 hours. The Mucinex kept the symptoms under control. My symptoms were mild. I was tired. I am still coughing at least once an hour. I have a little bronchial thing every couple hours which I am pushing fluids for. I don't think that I have recovered fully yet. I'm maybe at 85 to 90%.
Client given 2nd dose Moderna. Client 17 years old. Moderna not approved for persons under 18
Patient received immunization and immediately became nauseous and light headed. Helped to floor within a couple minutes after receiving shot. Patient was diaphoretic, pale with cyanotic oral mucousa/lips. Patient had lost conciousness and regained within 5 to 10 seconds. After coming too, patient was alert and oriented. Monitored patient and she was stable quickly after. Called patient the next day and she reported no adverse effects.
Constant  ringing  in both that won?t stop.  Saw urgent care doctor said ear drums swollen.  Told to try antihistamine.  Didn?t work.  Went to ENT, did ear test.  Both ears have  mild hearing loss with it being more in right ear.  Prescribed nasal spray, anti staminé and vitamins to help with ringing .  I am a covid survivor.  Had covid fall of 2020 and recovered few weeks later.   Ringing is new since vaccine
diagnosed with Rheumatoid Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (diagnosed with Rheumatoid Arthritis) 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. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (diagnosed with Rheumatoid Arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (diagnosed with Rheumatoid Arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medical information were reported.  No treatment information was reported.  The patient reports that after she was diagnosed with Rheumatoid Arthritis that she went to a Reumatoid arthritis support group on social media. Several other patients on this  group report getting Rheumatoid Arthritis after receiving the Moderna Covid-19 vaccine.  Company comment: Based on the 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.; Sender's Comments: Based on the 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.
Fever and chills started evening of 4/10/21 Woke up on 4/11/21 with bleeding gums, fever, chills, and body aches
I was shadowing another interpreter on Jan. 11, 2021  and started to feel warm, nausea. I sat down and the PA asked if I was ok and then I don't remember anything. I then fainted and my Heart rate was 30 and they called a code blue. They took me to the ER and ran test and gave me IV and everything came back normal.  After that incident, there was at least two other times I had to sit down because I was getting all the same symptoms again and thought it would happen again.  I did donate blood on January 8. I was feeling fine when prior and the following two days.
per patient "flu-like symptoms, feel really bad has been going on for 3 weeks and still feel like that today"
This spontaneous report was received from a registered nurse concerning to multiple unspecified patients of unknown demographics. The patients' concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not provided. On unspecified dates in 2017, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis (the lot #, expiration date, dose, route, and strength were not provided). The storage conditions were reported as follows: temperature range. 6° F to 14° F; reportedly, the nurse did not think the overall average temperature was between -58°F to 5°F, the time frame was 48 days (02-FEB-2017 through 20-MAR-2017), with not previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Patient reports a bilateral lower extremity rash, slight rash on bilateral arms as well, started today, 6 days after administration. No changes in detergents/soaps/lotions. Has not been doing yardwork or near poison ivy. Does not itch. Rash not elevated.
patient was inadvertently administered an expired dose of the Tenivac, no adverse event; Initial information was received on 27-May-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves a 65 year old female patient who was inadvertently administered an expired dose of the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 27-May-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U5854AB, expiry date 25-Jan-2020, single dose vial) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Pt received Tdap, Hep A then YFV. About 1 min. after receiving YFV she became pale, eyes rolled back and she became rigid. Lowered her to floor from chair. This lasted about 30 sec. When supine she immediately woke frightened. Ice pack to back of neck, rapid resps for 2 min. Color became pink and she was coherent. Supine 10 min., chair 2 min. seemed distracted, supine 5 min., chair 5 min. Dad present, drove her home.
Mild itching and tingling Vital Signs 0708 - BP 146/85, HR 73, RR 16, Temp 97.3, SPO2 99% Vital Signs 0730 - BP 142/100, HR 77, RR 16, Temp 97.0, SPO2 99% Vital Signs 0750 - BP 152/89 Benadryl administered at 0715 by RN
pt recv vax & had local rxn described as approx the size of a 50 cent piece, red, indurated, warm & hard;
Patient noticed problems with memory, balance and speech twelve hours after receiving the Pfizer Covid vaccination.  He was taken to hospital for diagnosis and treatment.
Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that he/she got shingles right after he/she got the first shingles vaccine shot within days. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
pt recvd vax; lt upper arm redness 3cm around inject site followed by diffused red morbiliform rash over body w/ mild itching the next day; also devel tonsillitis & fever of 101 the next day;
Spots starting oozing a discharge yesterday; spots on both of his legs that were very itchy; His arm was sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included warfarin sodium (Coumadin).   In JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 02-JUL-2023, less than a month after receiving Shingrix, the patient experienced pruritus (Verbatim: spots on both of his legs that were very itchy). On 06-JUL-2023, the patient experienced skin discharge (Verbatim: Spots starting oozing a discharge yesterday). On an unknown date, the patient experienced pain in arm (Verbatim: His arm was sore). The patient was treated with white soft paraffin (Vaseline). The outcome of the pruritus and skin discharge were not resolved and the outcome of the pain in arm was resolved (duration 4 days).   It was unknown if the reporter considered the pruritus, pain in arm and skin discharge to be related to Shingrix.     It was unknown if the company considered the pruritus, pain in arm and skin discharge to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUL-2023 The reporter was a patient. The reporter reported that he received Shingrix vaccine and starting the evening of the vaccine or the next morning, his arm was sore and remained sore for about 4 days (no specific dates provided). The patient also reports that, he noticed he had spots on both of his legs that were very itchy, randomly spaced, some close together and others 5 to 6 inches apart and, these spots starting oozing a discharge. Patient reports these spots itch more at night than during the day, and he put vaseline on them because he thought they might be bug bites. The reporter reported that he still had the spots, itching and discharge to the reporting day. Patient also mentioned he was on Coumadin 7.5MG and Coumadin 3.75MG (pre existing medication before the Shingrix Vaccine). The patient did not had any lot/expiry information. The reporter did consent to follow up.
Patient administered expired flu vaccine consulted with district, state, agency and manufacturer-revaccinated on 10/5/06 no problem with expired flu vaccine.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-OCT-2011, at age 71, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Vaccine beyond use date has been given to pt, unable to contact pt to f/u on this case
After getting the vaccine on March 27, 2021, on March 31 I noticed a rash across both shoulders. It was itchy red bumps. In the following days it got progressively worse spreading down the arms, chest and back. I called Dr.  on Monday April 5 and saw him at 3:45 pm that afternoon. He did not know what was causing the rash. He performed a biopsy and sent it off to be tested and prescribed Triamcinolone Acetonide Cream USP .1% to be used twice daily to the arms, chest and back. The rash has continued to spread downwards but may be showing signs of slowing down this morning. Will be able to tell more tomorrow.
Pfizer COVID-19 Vaccine EUA  Pt received 1st dose of Pfizer COVID vaccine and was scheduled to be monitored for 30 minutes afterwards due to her history of anaphylaxis with penicilins. About 10 minutes after vaccination, pt had a sudden onset of headache (frontal and temoral) and an increase in her blood pressure. Within 20 minutes of vaccination, pt had body tremors. At 30 minutes, patient was transferred to convenient care.  At convenient care, pt presented with headache, elevated blood pressure, tremors. Denied swelling of tongue or thorat, difficulty swallowing, or breathing. BP was 148/89, pulse 10, respiratory rate 18. Pt received diphenhydramine 25 mg IM x 1, ibuprofen 800 mg PO x 1. Convenent care provider diagnosed reaction as anaphylactic reaction and recommended she follow up with PCP regarding receiving 2nd dose. Pt was discharged to home after 1-1.5 hours of monitoring.