chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse said the vaccine had not expired since Expiration Date was for next year. However, the vial was first punctured on 02-Sep-2021 at 1:20pm. It was removed from the refrigerator two times for about 10 minutes each time. The vial did not undergo any previous excursion.  No concomitant medication was provided.  No treatment medication was provided.  First dose was administered on 17SEP2021, it was the first dose for the patient, the patient has not called to report any adverse effects.   This case was linked to MOD-2021-326530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow up received, Containing Non significant Information
Started having random heart racing, pounding and not beating properly. Now on medicine for AFib and have to see cardiologist.
4 days p/vax pt devel sterile abscess @ inj site. Abscess drained & pt tx w/dicloxacillin & recovered.
Sore arm the first few days with swollen lymph glands making it difficult to raise above my head, but that subsided.  On day 5, my left arm began itching (to the point of awakening me from a night's sleep) and by day 7, a red swollen hot and itchy area about the size of an orange appeared and the skin was very dry and coarse to the touch.  The itching continued for days with the red area increasing in size to encompass about three-fourths of my upper arm.  While the area increased in size, the itching and swelling decreased and  by day 15, it was all gone,  (I took pictures of it on 2/21 and 2/25 to document.)
Pt vaccinated with DTP and developed fever 101.0, tremors in lt leg 4 days duration (immunized in lt leg)
Patient came back to pharmacy on 9-22-16 with a rash. Also reports that her throat feels sore. Visible red rash on her neck, patient had taken one dose of benadryl. Recommended she start taking claritin and keep an eye on it to report back if not getting better.
Right after the 1st and 2nd shot I had extreme fatigue, nausea/vomiting, fever, muscle pains that last 3-4 days.  Since then I have still felt extremely tired and within the last month I have had very high pulse readings, high BP, and anxiety/panic attacks that are getting worse every week since the 1st one that occured at the end of February 2021.
On 11-19-13 pt first had onset of red hot to touch at area of injection was seen by physician after line marked on pt with redness spreading. On 11-20-13 mom brought pt in due to blisters that had developed around injection site, redness and hot to touch spreading and hives and welts occurring on various places of patient's body. Pt was given prescription for steroid but also went to ER for treatment that night.
12 hrs after vaccination, pt reported mild tightness in throat and mild swelling of upper lip
Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication reported  No Treatment medication reported.
tingling feeling down right arm; shooting pain in upper back and shoulder (right side); shooting pain in upper back and shoulder (right side); shake; ringing in her ears; pupils were completely dilated; felt warm to the touch; momentary light-headed feeling; vision began to blackout, then her vision when to all white; vision began to blackout, then her vision when to all white; This is a spontaneous report from a contactable consumer.   A 16-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 17:30 (Batch/Lot Number: ER8733 7/21 6023043) as DOSE 1, SINGLE (at the age of 16 years) for covid-19 immunisation.  Medical history included anxiety from an unknown date. No Known allergies. Patient did not have COVID prior vaccination. There was no COVID tested post vaccination. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced vision began to blackout, then her vision when to all white (medically significant) on 01Apr2021 with outcome of recovered , vision began to blackout, then her vision when to all white on 01Apr2021 with outcome of recovered , immediate tingling feeling down right arm following vaccination on 01Apr2021 17:30 with outcome of recovered , A few minutes (3-5) later shooting pain in upper back and shoulder on 01Apr2021 with outcome of recovered , shake  on 01Apr2021 with outcome of recovered , ringing in her ears on 01Apr2021 with outcome of recovered , pupils were completely dilated on 01Apr2021 with outcome of recovered , felt warm to the touch on 01Apr2021 with outcome of recovered. An ambulance was called. Approximately 10 minutes later she began to feel better and did not go to the hospital. 4 hours later she had a momentary light-headed feeling 01Apr2021 with outcome of recovered.  No other vaccine given in four weeks.  No treatment was given.
hives/ hives spread to the chest at the bra line area and up to the shoulders; itchy/ still very itchy/ scalp is also itchy; rash/ rash and hives spread to the chest at the bra line area and up to the shoulders; This case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, 5 weeks after receiving Shingrix, the patient experienced hives, pruritus and rash. The patient was treated with triamcinolone acetonide, steroids nos (Steroids) and antihistamine (Antihistamines). On an unknown date, the outcome of the hives, pruritus and rash were recovering/resolving.   It was unknown if the reporter considered the hives, pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm. The rash and hives that was very itchy presented on the patient's back 5 weeks after receiving the vaccine. Several weeks later (6 weeks before time of reporting) the rash and hives had spread to the chest at the bra line area and up to the shoulders. It was very itchy till the time of reporting. The patient's scalp was also itchy. The patient had been treated by a dermatologist with various steroids and antihistamines. The patient was currently being treated with a cream and ointment called Triamcinolone acetonide 0.1% that seemed to help with the itch. The reporter consented to follow up.
Next day after vaccinations on left upper thigh pt redness, some pain and itching at site overlying erythema 3.5 cm x 2.25 cm, induration 1" x 3/4" at site of vaccination.
pt recvd vax in 1990 & subsequently failed to seroconvert for rubella or measles; No further details were provided;
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) was administered to 9 week old patient on 10-OCT-2016. The reported lot numbers are: # M014925, expiration date 16-FEB-2019 and Lot # M010439, expiration date 08-DEC-2018. It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a consumer (patient's mother) refers to a 18 year old male patient with no pertinent medical history and no drug reactions or allergies. On 12-MAY-2014, the patient was vaccinated with a first dose out of three shots of GARDASIL route reported as injection (anatomical location and lot number not reported). There were no concomitant medications. On 12-MAY-2014, the patient told the reporter (before he fainted) that his head hurt but he could not describe how it hurt. He said it felt like when your foot goes to sleep, a numbness like pain. On 12-MAY-2014, at 3 minutes after the first dose of GARDASIL, the patient fainted and fell forward. After the reporter picked him up, the patient fell backwards, shaking while he was on the floor. This lasted about 30 seconds (also reported as not recovered). The physician had the patient monitored for 15 minutes. The reporter said, he lay down for 5 minutes, sat up for 10 minutes, and then the physician released him to go home. The reporter said the patient still felt, and looked, woozy or spacey. The treatment given for the AE was reported as: Yes: doctor watched him for 15 minutes. No laboratory diagnostic studies were performed. The patient sought medical attention via contacting the physician. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Upon internal review shaking while he was on the floor was considered medically significant. Additional information has been requested.
Wife reports after leaving the Health Department, she and her husband completed some errands, the stopped approximately one hour later to let their dogs exercise.  After getting out of the truck for a few minutes, he returned to the truck, then suddenly collapsed onto her lap.  Was transported to Hopital.
The patient reported that within 1-2 hours of getting the vaccine he started to turn red all over his body (like he had a sunburn), he began to have problems breathing, his chest got tight, and he got a sore throat. He came back to the pharmacy to speak with the administering pharmacist between 5 and 6 to speak about the vaccine.  The patient reported he was concerned because the vaccine administration sheet had asked about latex, which he does have an allergy to, and he was afraid it was in the vaccine. The pharmacist spoke with the patient about that (the patient thinks the pharmacist said there is no latex in the vaccine) and the patient left. The symptoms persisted so he went to the emergency room to seek treatment.  The patient did have bloodwork done, but he was never given the results.  The hospital prescribed medication to treat the allergic reaction.  The hospital told him they were concerned there may be latex in the vaccine and they said he should not have gotten the vaccine because it interacted with his other medications (meaning the prednisone).  They also said the patient should not have had the vaccine at his age.  I consulted with my clinical team after the conversation with the patient and the vaccine is indicated in someone his age because he is a smoker, there is actually no latex in the vaccine, and although the patient was using prednisone, you can get inactive vaccinations while using prednisone, although the immune response might possibly not be as great.  Because of this, we believe the patient has an allergy to the vaccine or one of its components. I followed up with the patient today to let him know what we feel happened and to see how he was feeling.  He reported he still isn't feeling the best but he is slowly recovering.
Swollen arm, pain, redness and induration on the site of injection (12 cm x 8 cm)
Information was received on 27-JUN-2017 from a certified medical assistant regarding a 20 year old female patient who received one VARIVAX (lot# M046924, expiration 28-NOV-2018) at a 0.5ml dose subcutaneously in her right arm with sterile diluent (lot# N007760, expiration 31-MAY-2018) and one M-M-R II (lot# reported as M045395, expiration 14-NOV-2018) (see MARRS# 1707USA001861) at a 0.5ml dose subcutaneously in her left arm with sterile diluent (lot# N007760, expiration 31-MAY-2018) on 22-JUN-2017 due to a titer drawn on an unknown date showing lack of immunity to mumps and varicella. The patient's medical history included that she was a health care worker with recent titer results showing lack of immunity to mumps and varicella. The medical assistant stated that the patient has no relevant laboratory data or concomitant medications. The medical assistant reported that on 27-JUN-2017, after an interview where the patient stated that she had not received VARIVAX or M-M-R II, the patient was administered VARIVAX at a 0.5ml subcutaneous dose in her left arm and M-M-R II at a 0.5ml subcutaneous dose in her right arm. Upon a chart review later on in the day, medical assistant discovered that the patient had received these vaccines on 22-JUN-2017 as well. The medical assistant reported that the patient has not experienced an adverse reaction and therefore no treatments have been provided. The medical assistant stated that the patient received the same lot# and expiration dates of the vaccine and diluents on both administration dates. As of 27-JUN-2017, it was unknown if the patient will continue on VARIVAX and M-M-R II and the outcome of receiving doses of both of these agents in a five day interval is unknown. The is one of two cases concerning the same patient. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001861:
Immediate soreness at injection site and a 6" diameter rash has developed that has slight 'fever' to touch.  Rash still on arm after 3 weeks and still experiencing soreness.
5 hours after injection I got a headache, 101.0 fever, chills, full body aches, sever nausea and vomiting (every 20-30 minutes for 20 hours). Vomiting and Nausea subsided after 20 hours (25 hours after injection). Fever, chills, strong body aches (especially in legs) and headache lasted another 24 hours. It is now 72 hours post injections. Only remaining symptom is mild soreness at injection side but digestive system is still trying to recover from the intense vomiting that lasts 20 hours. I probably should have gone to the hospital but I don't have insurance so I tried to wait it out because I can't afford the bill and luckily I seem to be ok now.
On May 26, 1999, the pt received the first treatment with Lymerix. 48 hours later, he experienced a fever of 100.6, flu-like symptoms, and joint aches especially in the knees and elbows.  The most recent information received on 6/28/99, reports the symptoms as resolved. The joint aches resolved in 20 days.
Mild pain in the arm that lasted for about 36 hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced mild pain in the arm that lasted for about 36 hours. The clinical outcome of the event mild pain in the arm was resolved on an unknown date after 36 hours (details unspecified).  No follow-up attempts are possible. No further information is expected.
After my second dose my friends and family have noticed a personality change.  I do not laugh or smile anymore. I am easily irritated as well.  Very little desire to eat and my sleep is off.
High pitched scream X 3 days, starting 24 hours after vaccine administered, bright red thigh.
1/21/2021 During Covid 19 outbreak on the unit, resident contracted the virus.  1/21 MD updated on increased weakness, twitching, fatigue noted today. 2 rapid covid-19 tests done today, both negative. new orders cbc with diff, BMP, d. dimer stat and swab for covid and Influenza. 1/21-Covid and Influenza swab results received. PCR-Influenza negative, covid-19 positive.  Palliative care updated. 1/21-Labs drawn cbc, BMP, d. dimer Results WNL. Temp 101.2 and Occ dry cough. 1/22 Palliative MD and APRN visited. Family preference for no hospitalizations, no IV's and do not intubate. DNR. Admitted to Hospice services on 1/25. 1/21-1/29. Symptomatic with lethergy, occ cough, off and on temp and began refusing meals and meds at times. 1/31 periods of apnea. 2/1 precautions ended for Covid 19. Continued with Hospice care and with ongoing refusal of meals, condition declining and comfort maintained. Meds slowly discontinued. Expired at facility on 2/18/2021.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not applicable. The reporter stated that, he/she knew of people who after receiving Shingles vaccine, still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Information has been received from a pharmacist referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # L011538, expiration date 03-JUL-2016; dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Nurse reported that a patient received a expired dose of PROQUAD.  No other issues or concerns noted. Administered on 5/2/2022 PROQUAD: LOT: T028298 EXP: Feb 16, 2022 NO PQC.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous dug reactions, or allergies were not reported.  On 02-MAY-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T028298, expiration date 16-FEB-2022) as prophylaxis (expired product administered).
NauseaVomiting fatigue, body aches, chills, sweats Narrative:
Large puffy rash all over arm from shoulder to just above elbow, spreading outwards from site where shot was given.
He got his vaccine, he was oaky.  When he woke up on Thursday morning he was weak, muscle aches, lack of energy, not able to mentate correctly, feels feverish, headache, just does not have any motivation at all whatsoever.  He just this morning started taking some Advil, he had no motivation yesterday to do anything.  He is queazy and was forcing himself to eat and drink to take the Advil.    He has had many vaccines and experimental vaccines and has never felt this bad after a vaccine.
2nd dose:  12 hours after vaccination: severe chills. 6 1/2 hours accompanied by high fever. Both the chills and the high fever went away after about 6 1/2 hours. I was left with a low fever and fatigue for the rest of the day. Woke up the following day like new.
Moderna 1/29/21, 2/24/21. Positive on 3/3/22
Patient reported itchy rash described as hives on the injected arm over a period of several days. Self-treated with witch hazel. Advised BENADRYL cr. could be used.
mild, cold-like symptoms; 5 out of 368 employees who have tested positive with breakthrough COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID) and NASOPHARYNGITIS (mild, cold-like symptoms) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID). On an unknown date, the patient experienced NASOPHARYNGITIS (mild, cold-like symptoms). At the time of the report, COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID) and NASOPHARYNGITIS (mild, cold-like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not reported.
soreness; headache; fatigue; chills; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (FEVER) in a male 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 PAIN (soreness), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (FEVER). At the time of the report, PAIN (soreness), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Patient received second dose Pfizer-BioNTech COVID-19 vaccine on day 8 instead of day 21