chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine stored in refrigerator on 18-Nov-2021, expired product 03-Oct-2021, administered date on 03-Dec-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Nov-2021, expired product 03-Oct-2021, administered date on 03-Dec-2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Nov-2021, expired product 03-Oct-2021, administered date on 03-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Nov-2021, expired product 03-Oct-2021, administered date on 03-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 18-Nov-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  The reporter also said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
Immediately following  injection, he developed extreme back pain.  He was sent to hospital emergency room, where his back was iced, for several hours, for the pain.  Following that, he was sick in bed, with pain and flu like symptoms, for several days.
Red rash appeared first on forehead and cheeks, then covered almost entire face (chin, nose, cheeks, forehead.) Also patch on belly about 2" varying in height and about 4" long. Patches on backs of both hands and fingers up to his wrists. Transient itchiness mostly in morning. Rash peaked at about 5 days, then started subsiding. At day 7, he was much better. Treated with topical triamcinolone acetonide .1% cream no more than 1x per day (he had maybe 3 treatments total), herbally derived ointment, diphenhydramine, and cetirizine.
Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. Since October 2014 the patients were vaccinated with doses of improperly stored GARDASIL (route, lot#, dose and frequency were unknown). No adverse effects were noted. It was unspecified if the patients sought medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
afraid from getting the second shot even her health Care provider advised; vomiting; vertigo; confusion; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), CONFUSIONAL STATE (confusion), PRODUCT DOSE OMISSION ISSUE (afraid from getting the second shot even her health Care provider advised) and VOMITING (vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced VERTIGO (vertigo), CONFUSIONAL STATE (confusion) and VOMITING (vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (afraid from getting the second shot even her health Care provider advised). At the time of the report, VERTIGO (vertigo), CONFUSIONAL STATE (confusion) and VOMITING (vomiting) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (afraid from getting the second shot even her health Care provider advised) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Brown spots in the shape of a circle at different locations in the body all appearing within a few hours; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), via an unspecified route of administration on the right arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital.  The patient had allergies with detergent and soap products. Concomitant medications included fenofibrate (FENOFIBRATE) and vitamin D from unknown dates and indications. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 22Dec2020, the patient experienced brown spots in the shape of a circle at different locations in the body all appearing within a few hours.  No treatment was received for the event. Outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
I administered the flu vaccine to patient and she told one her arm was tingling. Then it spread to her right arm then to her legs over the course of 2 hours.
No further AE Information. No PQC.; HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given on 9/21/2023 to the same patient, after the products had been through a TE. Permission to contact HCP given. No further AE Information. No PQC.      ?    Names of vaccines; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, lot #U7374BA, expiration date: 06-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided). On 21-SEP-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #1968385, expiration date: 22-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 21-SEP-2023, HCP called to report that 1 dose of VAXELIS and 1 dose of ROTATEQ were given to the same patient, after the products had been through a TE (48 F for 40 minutes). Permission to contact HCP given. No further AE Information. No PQC.
Pain in finger tips post vax. Devel pain w/ range of motion from shoulder to below elbow. No open areas, redness, warmth.
Patient stated she felt as though her breathing was changing. Not sure if it was anxiety or a reaction. Assessed by myself, lungs clear, no throat swelling. Taken back for observation, while in observation, stated throat felt tight. Examined throat, no swelling noted, had physician also check and agreed.  pox 98%  r-18  120/84 and remained stable throughout obs. Patient stated she felt better, ambulated without difficulty. d/c after 30 minutes.
experienced poor response to Pneumovax 23; Literature Report:   This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 35-year-old female.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose , lot #, expiry date, and route of administration were not provided).On an unknown date, the patient experienced poor response to vaccine, particularly pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). At the time of reporting, the outcome of the event of poor response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and onset date were not known.   The event of poor response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2206USA002718:
Patient reported  to COVID-19 Vaccine clinice on 02/21/2021 for first dose of Pfizer Covid-19 Vaccine. Patient received first dose, and described a "tightness/itchiness" in her throat, radiating up her jaw. Patient was able to take benadryl by mouth at 2:50pm. Itchiness and tightness in throat did not subside, so emergency services were called around 3:00pm. Ambulance arrived a few minutes later and patient was take via ambulance for emergency medical serices. No epi-pen was administered as of time of departure from clinic.
Fever of 103.5 and extreme weakness for >24 hours.  Continued with 100-101 fever for 24-48+hrs.
Post vax, few hours later, began with red spots, rash, and itching. Went to ER on 5/13/00. Dx'd as acute allergic exanthem. No apparent distress, not toxic, and no fever. Had pronounced maculo-papular eruptions over body at ER. Benadryl Elixir was prescribed. Vomited 2 times and felt warm; temp not taken at home. Rash lasted 2 1/2 days.
My left arm which is the location I received the vaccine became swollen , painful, red and itchy.
immediately broke out in a rash (hives); First dose in April and still did not the take the second shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (immediately broke out in a rash (hives)) and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (immediately broke out in a rash (hives)) and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot). At the time of the report, URTICARIA (immediately broke out in a rash (hives)) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Itchy Rash/Hives 5 days after vaccine from pelvis up.
A knot by my collar bone; a knot and it hurts and it is on the same side with the shot.; A knot by my collar bone; a knot and it hurts and it is on the same side with the shot.; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, "I got the shot the other day and it was just started I had a knot by my collar bone. There was a knot, and it hurts, and it was on the same side with the shot was put on. I never had this knot before until I have gotten the shot and I did not know what it was (General Statement)." The clinical outcome of the event was unknown at the time of report.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 424A7, expiry date 18th April 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 424A7, expiry date 18th April 2021) for prophylaxis.   On 8th November 2018, the patient received the 1st dose of Shingrix (intramuscular). On 24th January 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th September 2020, 669 days after receiving Shingrix, 592 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir. On 22nd September 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: After receiving 2 doses of Shingrix, the patient had a shingles outbreak. The patient assisted to reporters place of work to request something for the shingles outbreak the patient had developed over Labor Day.  The patient was given Acyclovir to treat the outbreak and since patient has not returned it was assumed patient has recovered.  The consented to follow up. This case was considered as suspected vaccination failure, since the details regarding the completion of laboratory confirmation for herpes zoster was not provided. The batch number of Shingrix was reported as I24A7 and 4Z4A7, which was corrected to 424A7 as per sales data sheet.
NauseaVomiting Narrative:  Seen in the ED for nausea with 1 episode of vomiting after receiving COVID- 19 vaccine. Questionable covid 19 vaccine reaction of nausea. No evidence of serious allergic reaction, no rash, no trouble breathing. Nausea improved with zofran. No indication for benadryl or other allergy medications at this time. Patient has been observed in the ER for several hours and no new symptoms developed. Will DC home with strict return precautions.
Patient did not have any symptoms of allergic reaction, side effects or problems. The patient received Pfizer vaccine on 3/5/2021 for his first immunization. He did not have proof of immunization with immunization card. He was given Moderna vaccine on 3/26/2021 for the second dose in the series. The mistake was discovered 10 minutes after immunization. The patient was monitored for 30 minutes after immunization provided. He was notified of the incident and was provided with information regarding the incident. The patient will be contacted 24 hours and 72 hours after the event to check on any adverse problems. All future vaccinations will require proof of first vaccine prior to administration o second dose for any Moderna or Pfizer vaccinations.
Two days after injection break out of 25 cold sores on outside and inside of mouth that lasted 3 days. One week after injection, one inch welt/hive at injection site with severe arm swelling approximately 6 inch diameter around site that lasted 4 days and gradually subsided.  Took benadryl.
Patient develop hypotension BP 62/31 w/in 3-5 minutes after vaccination of GARDASIL 9 over left deltoid (IM). Patient had nausea, dizziness, tinnitus. The patient was closely observed and monitored, BP improved to 72/35 after 10 mins. Further improved to 95/50 after 5 min HR 64-70/min. So patient completely felt better after 20 minutes total. Discharged after.
Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site) and VACCINATION SITE SWELLING (Swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 017B21A) for COVID-19 vaccination.     No medical history was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced RASH MACULAR (Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site) and VACCINATION SITE SWELLING (Swollen). At the time of the report, RASH MACULAR (Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Swelling of tongue and numbness, Hives and redness at site. Fast heartbeat, dizziness, and weakness and swelling of face. Next day diarrhea swelling of hands feet and legs still going on.
Itchy rash first developed on arms below the elbow..did not extend to fingers or hands.  After a week, rash appeared on legs below the knee and all over feet.
Exhaustion, quisiness,  headache - first through third day after injection. Took extra strength tylenol, and slept most of two days.
Received Dtap left deltoid Tues. a.m.  On Wed, 8/10/11, left arm bruised around vaccination site.  Sat. night, 8/13/11, site appeared blistery and rashy and was golf ball sized.  Mon., 8/15/11, site was only slightly red.  by Tues. 8/16/11, it was completely gone.  No fever at any time.  No treatment done.
Headache; Diarrhea; Bronchospasm; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 01Apr2021 at 08:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, diverticulitis, sepsis. The patient had previously experienced milk allergy, fish allergy and allergy to nuts (walnuts allergy). The patient previously took Cipro and Flagyl and experienced drug allergy to Cipro and Flagyl. Concomitant medications taken within two weeks included aciclovir (ACYCLOVIR), propranolol (MANUFACTURER UNKNOWN) and testosterone cipionate (DEPOTESTOSTERONE) all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 10:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 14:00, the patient experienced headache, diarrhea, bronchospasm chills and fatigue. Therapeutic measures were taken as a result of the adverse events and included treatment with Ibuprofen from an unknown date. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, diarrhea, bronchospasm chills and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever, shivering, significant fatigue, generalized muscle soreness, headache, GI discomfort -- limited all activity. Took acetaminophen and slept for 12 hours. Resolved about 16 hours after onset. Other than soreness at injection site, these events did not occur after the first immunization of Shingrix on 4/17/19
My son had a fever of 103. It was controlled with fever reducer. He had rash all over his body but more profound in the diaper area. He would not eat or drink for almost a week (only breast fed and had a few bites here and there, which is not like him at all ). The symptoms and fever lasted from 6/17/2019 to 6/23/2019.
This spontaneous report was received from a nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTARIX. On 31-JUL-2015, the patient was in the office to get vaccinated with oral, ROTATEQ. No adverse effects was reported. Additional information has been requested.
one day later, headache and a few instances of vertigo. 3 days later sudden fatigue/weakness/dizziness in the evening that went into the next day.
This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: A case of autoimmune hemolytic anemia after the first dose of COVID-19 mRNA-1273 vaccine with undetected pernicious anemia. Case Rep. 2022;2036460. 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 AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) 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 considered AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) to be related. No concomitant and treatment information were provided. Company Comment: This case refers to a 42-year-old female patient with no known medical history who experienced the unexpected event of Autoimmune Haemolytic Anaemia on an unspecified date after the first dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case refers to a 42-year-old female patient with no known medical history who experienced the unexpected event of Autoimmune Haemolytic Anaemia on an unspecified date after the first dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
CALF PAIN; This spontaneous report received from a patient concerned a 65 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for discomfort in left calf, and leg pain, and colecalciferol for drug used for unknown indication. On 10-APR-2021, the subject experienced calf pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from calf pain. This report was non-serious.
w/in 1/2hr pt started having pain in the inj area;there was a 10inch diameter of local pain around inj area;pt suffered pain in movement of shoulders;approx 6hr later had a fever of 103, chills, & gen malaise;fever & chills lasted 48hr;