chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Induration 10 x 5 cm on right thigh redness pulp tender mass noticed on 3/5/06 Sunday
fever 101.6  aches,  lasted 2 days  fatigue lasted 3-4 days      Migraine-like headache started about 12 days from shot and lasted for about 8 days . Eyes burned, short of breath and lethargic with headache.  Took one Advil and did not help.
This spontaneous case was initially received on 29-Sep-2015. Follow up information received on 30-Sep-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight : not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: 11449211A, Route of administration: Intramuscular, Dose: 0.5 ml. AFLURIA was stored at 41 degrees Fahrenheit and was not exposed to any temperature excursions. It was monitored with a digital thermometer between 38-44 degrees Fahrenheit and the alarm sounds if the temperature exceeded this range. No additional drugs suspected. On an unspecified date, the patient received an intramuscular dose of AFLURIA that may have contained a black particle floating in the vaccine (small protein-like particles). The particle was 1 mm T-shaped suspended in the solution (did not dissolve when shaken for a few seconds), described as looking like a 'piece of pepper'. The AFLURIA vial with PharmaJet device was punctured once with the adaptor cap. The particulate/foreign matter did not appear to be a piece of rubber stopper. After the pharmacist saw the black particle, he started to inspect the other vials. He could see 'white matter suspected in the solution, they look like proteins'. They appear as rod shapes but some looked like 'flakes'. Some appeared big and some are small, but they did not float. It was very hard to see and only visible when a piece of paper was held up to the vial. It was noticed after removal from carton. No adverse reactions since receiving the vaccine. The pharmacist had quarantined the vaccine. No additional information was available. The outcome was not reported. For relevant test results see appropriate report section. Reporter's assessment: non-serious. Reported the terms 'Medication error' and 'Quality defect'. Quality Assurance investigation of AFLURIA MDV batch 11449211A: As part of the investigation undertaken for this compliant, description testing was performed for the returned sample. The description testing confirmed the reported complaint. Further analysis by FTIR and SEM (Scanning Electron Microscopy) and EDS (Energy-Dispersive X-ray Spectroscopy) was performed and determined the composition of the particle to not be similar to the vial stopper. The bulk reference samples were inspected and found to be of normal appearance for the vaccine and the retention sample inspection also met the standard description of AFLURIA vaccine. The analysis of the particle shows the dimensions as approximately 665 x 610 microns. Given these dimensions, it would not have been possible for the particle to have passed through any of the filtration steps listed above. There have been no other complaints reported for this batch. Also, to date, there have been no reported complaints for particles in the sister batch (dispensed from the same bulk). In conclusion, the investigation demonstrates that the particle was most likely introduced into the vial from an unidentified external source after the stopper had been pierced.
8-16-21  Asthma symptoms got worse, starting improving 8-20-21.  On 8-20-21 5:00 AM woke up with rash on injection arm, left arm.  The rash was on the inside of the arm, covered most of the area from the wrist to the elbow, and from the elbow to the shoulder there were a couple of areas.  The rash was large red welts and the skin around the welts was red also.  8-21-21 rash was showing improvement
LIGHTHEADED; BARELY STAND FOR LONG PERIODS OF TIME; BODY ACHES; FEELING UNWELL; FATIGUE; 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced lightheaded. On 12-APR-2021, the subject experienced barely stand for long periods of time. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced feeling unwell. On 12-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue on 14-APR-2021, and had not recovered from lightheaded, feeling unwell, and barely stand for long periods of time. This report was non-serious.
Chills and low-grade fever (99.6F) beginning approximately 11-12 hours following second dose of Moderna COVID-19 vaccine. Fatigue, pain at the injection site, chills, and fever continued for approximately 24 hours, easing around 9:30pm on 3/18/2021. Woke at 7:30am on 3/19/2021 with no lasting side effects.
(L) axillary swelling on evening 5/12/11; progressed and then diminished by 5/15/11. Axillary node was soft & itchy no pain. Patient contact physician (primary). Physician aware states nodule was size of golf ball.
0.2ml of unreconstituted vaccine was administered to the patient. The total number of mcg administered is unknown.  The injector realized the error immediately after administration and notified the physician.  There was no immediate reaction. Oral ibuprofen was administered, and the patient was observed for 2 hours.  Vital signs remained stable; there was no swelling noted on her body.  There was no local swelling, redness, or pain at the injection site.  No rashes.  An Allergist was consulted.  No steroids, antihistamines, or other medications were recommended.   The Hospitalist followed-up with the family in the evening, and they reported that the patient was "fine," was playing, and did not have a fever or pain.  The patient's family will be contacted daily for 3 days.
Patient broke out in chickenpox rash 3 weeks after being vaccinated with varicalla vaccine.  Patient's case was minor, only about 30 pox.  Patient's mother took her to doctor for diagnosis.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was 6.5, indicating a low pos response;
SWOLLEN GLANDS FOR JUST A MINUTE; This spontaneous report received from a consumer 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 not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced swollen glands for just a minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands for just a minute. This report was non-serious.
Breakthrough COVID infection. Sympoms of shortness of breath, mild congestion, and productive cough. Unsure of onset of illness. Positive COVID test collected 08/18/2022
Pt c/o lip swelling and feeling warm, Ice pack given, and Benadryl 50 mg Orally given, Pt sent home
FEELING VERY SICK.  Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am going to faint. Chills low fever, Pain in joints and muscles severe headache.
all the glands in his lower area got really large; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (all the glands in his lower area got really large) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced LYMPHADENOPATHY (all the glands in his lower area got really large). At the time of the report, LYMPHADENOPATHY (all the glands in his lower area got really large) outcome was unknown.            High blood pressure concomitant medications were reported. Steroids were given as treatment.
Itching all over, arm red and burning where vaccine was injected. Burning and itchy eyes. Hives on arm that was injected.
Patient has swollen neck glands, elbow and thighs - covid + 12/27
MMR vaccine was given on 10/20/23 in the right arm. On 10/23/23 MMRV was administered in the left arm.  No adverse event happened.
Entire left arm immediately went completely numb. Felt like I was about to faint. Immediately drank cool water. Remained seated with head down and held ice-pack on the back of my neck in clinic for about 25-30 minutes before I felt stable enough to walk (assisted) out of the store. Numbness continued over 24 hours and included lips.  Later in the evening and following day, I experienced muscle soreness in my lower back. Still experiencing  feeling of pins and needles in my arm down into my fingertips.
TOOK UNREFRIGERATED COURSE OF VIVOTIF; This spontaneous case report (PVX2019-1797) was received from a pharmacist on 12-Jul-2019. It describes a female consumer who "took unrefrigerated course of Vivotif" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer left Vivotif out of the refrigerator for a week at room temperature. She took all the unrefrigerated doses in April   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.
woke up feeling all my muscles acked, felt like i had a fever, tired for 2 days,aching lasted 3 hours
I am post menopausal, I had not had a period for 12.5 months prior to the 3rd Moderna shot. Now just 1.5 months after that 3rd shot, I am suddenly experiencing very heavy vaginal bleeding.
Started with itchy bump/blister near eyebrow day before - scratched- large rash appear on forehead next day, rash became hot/prickly like a sunburn but more intense.  Put on aloe vera - didn't get better.  Went to Urgent Care on 10/17/2014 as pain getting more intense.  Was diagnosed with Shingles.  Rec'd anti viral med and anti-biotic.
Lack of drug effect; Rheumatoid arthritis flare up; This is a solicited report from a contactable consumer (Patient) based on the information received by Pfizer  (Mfr. Control No. :21K-163-4055718-00).  A 66-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose intramuscularly, then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at single dose intramuscularly for COVID-19 immunisation, methotrexate sodium for Rheumatoid Arthritis, subcutaneous adalimumab (HUMIRA) for Rheumatoid Arthritis, prednisone for an unknown indication; dates were unknown. There was no reported medical history. Concomitant medications were unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial. On unknown dates, the patient experienced rheumatoid arthritis flare ups, he did not think methotrexate sodium was working and he did not think Humira was working. In Feb2021, the patient experienced few rheumatoid arthritis flare ups. On an unknown date, rheumatoid arthritis flare ups resolved. Methotrexate sodium, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and prednisone were also considered suspect. The action taken with methotrexate sodium and HUMIRA was unknown, prednisone was permanently withdrawn on unknow date. The outcome of drug ineffective was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of rheumatoid arthritis flare ups, did not think methotrexate was working and did not think Humira was working was not provided. The reporter's causality for the event(s) of few rheumatoid arthritis flare ups with Humira (Adalimumab) was a reasonable possibility.  The reporter's causality for Rheumatoid arthritis flare up (rheumatoid arthritis) and BNT162B2 was probable  The reporter's assessment of the causal relationship of the events with the methotrexate sodium and of drug ineffective with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Pfizer is a marketing authorization holder of Methotrexate Sodium . This may be a duplicate report if another marketing authorization holder of Methotrexate Sodium has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on data given and temporal association, the event Rheumatoid arthritis is assessed as possibly related to Methotrexate and BNT162B2. The event drug ineffective is possibly related to Methotrexate and unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Patient received Moderna vaccine beyond the 30 day beyond use date. Beyond use date for lot was 17-Feb-2022 and patient received vaccine on 04-Mar-2022.
chest(heart) pain, upper shoulder and back pain, abdominal pain happen every 1-5days. weak, some time faint, nausea. duration from 1hr to whole day. more severe at beginning(March). now feel less pain.
Pt presents to the ED with c/o of worsening R hip pain after trip and fall accident this morning. Pt was evaluated in the ED and found to have an impacted R subcapital femur fracture so trauma surgery has been consulted. Pt reports just before breakfast this morning she got dizzy when she stood getting off the toilette and lost hr balance and fell onto her R side. Pt reports she was able to get back up and ambulate after, however pain and mobility worsened throughout the day so she was brought in.  She describes her pain as aching and rates it 7/10 at its worst.  Pain does not radiate; pain is exacerbated with walking and alleviated with rest.   Pt denies head trauma and LOC. Pt is not on any AC/AP therapy. Pt denies pain elsewhere.
pt recvd Td 28APr93 on 11MAy93 presented w/fever, chills, lt arm swollen, hot tender to touch w/erythemia;
Fever 10 day post vaccination, rash on trunk on 14 days post vaccine.  No other symptoms at this time
a little soreness; Vaccination site pain; A spontaneous report was received from a consumer and his wife on 29 Dec 2020. This case concerns a 77 year old male patient. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced a little soreness with the use of mRNA-1273.    There was no medical history or concomitant medications provided.  On 28 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # 309K209) intramuscularly, in the right deltoid, for prophylaxis of COVID-19 infection.  On 28 Dec 2020, approximately five hours after receiving the vaccine, the patient experienced the non-serious event a little soreness, with no additional symptoms. It was noted that the patient and his wife were "doing well and pleasantly surprised", after vaccination. The patient did not take anything to treat the arm pain.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of a little soreness was not reported.   The outcome for the reported event of a little soreness was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD20-02092:
Swelling and redness of (R) thigh with fever since yesterday. It is located on the lower body and on the (R) thigh. It is described as acute. The color is described as erythematous. Pertinent findings include fever and denies itching. TYLENOL and BENADRYL ok. Warm or cold compresses.
Pt c/o dizziness 6/3/05. He fell several times, wife discovered him after he had fell, he was admitted to medical center. MD unsure, could be related to yellow fever vaccine or infection. Pt consented to given phone numbers.
Patient received COVID-19 Vaccine 12/17/2020. Upon waking 12/18/2020 around 8am noted swelling, itching, and redness in face. Denies any shortness of breath. Patient seen in clinic and given benadryl 25mg at 1230pm.  Symptoms improved.
Within 10 minutes post vax, the pt developed lightheadedness and felt hot and trembly. She recovered within 90 minutes without treatment.
This is a spontaneous report from a contactable consumer (parent). This consumer reported that a male patient (son) received the TRUMENBA via an unspecified route of administration on 23Jun2017 at single dose for immunization. The patient medical history and concomitant medication were not reported. The parent reported that a rash appeared two days before (01Jul2017) - 8 days after the injection- but the parent didn't make the possible connection until evening the day before. The rash had changed dramatically and it occurred to the parent that the location was where the vaccine was given. It could still be a complete coincidence and have nothing to do with the vaccine but it was parent's understanding that the parent supposed to report it. On 01Jul2017, the rash was the normal skin tone and consisted of large soft bumps in the area about the size of a 50 cent piece. The day before the area was larger and uniformly red. On the reporting day the area was more of a blotchy paler red. The outcome of events was unknown.
Four hours after injection began to experience mild "fogginess." Woke up day 2 October 2, 2018 (day after injection) at 0600 with "severe dizziness, nausea, diarrhea, stomach upset" Too dizzy to walk (had to crawl to bathroom) Symptoms persisted all day. Same sx persisted on day 3 October 3, 2018 (second day after injection) but less severe. Interviewed pt on 10/5/2018 and she stated that she still felt minor dizzy sx "like I am walking on a ship at sea".
ITCHY RED RASH ON NECK, HANDS AND ARMS; This spontaneous report received from a patient concerned a 50 year old female. 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: 042A21A, expiry: not reported) dose was not reported, administered on 04-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itchy red rash on neck, hands and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy red rash on neck, hands and arms. This report was non-serious.
No adverse symptoms reported; PROQUAD was mistaken for MMRII and administered to a patient along with VARIVAX; PROQUAD was mistaken for MMRII and administered to a patient along with VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 02-DEC-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S013714 with expiration date 01-NOV-2020, for prophylaxis; dose, frequency and route of administration were not reported) which was mistaken for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (for prophylaxis; dose, frequency, route of administration, lot# and expiration date were not reported) along with varicella virus vaccine live (oka/merck)(VARIVAX) (for prophylaxis; dose, frequency, route of administration, lot# and expiration date were not reported) (wrong product administered and inappropriate schedule of product administration). No adverse symptoms were reported.
Redness at site - increasing in size, warm to touch, itching. Tx: KEFLEX 500mg BID x 10d. Prednisone 20 mg BID x 5d. ZYRTEC 10 mg.
Unexpected beneficial therapeutic response; flu like symtoms; frequent thirst; dry mouth from Lupus; Headache; felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response), INFLUENZA LIKE ILLNESS (flu like symtoms), THIRST (frequent thirst), DRY MOUTH (dry mouth from Lupus) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus and Fibromyalgia.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response), INFLUENZA LIKE ILLNESS (flu like symtoms), THIRST (frequent thirst), DRY MOUTH (dry mouth from Lupus), HEADACHE (Headache) and PYREXIA (felt feverish). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response), INFLUENZA LIKE ILLNESS (flu like symtoms), THIRST (frequent thirst), DRY MOUTH (dry mouth from Lupus), HEADACHE (Headache) and PYREXIA (felt feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced her skin is soft and soaky after receiving the vaccine. She also reported that her skin cleared up from the goosebumps  No concomitant medication reported. Ice packs used as treatment   This case was linked to MOD-2021-216514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information added include medical history and new events.