chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; pain; This non-serious 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 Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: pain). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that pain, got the shingles shot and third day afterwards he/she had shingles. The follow up would not possible as no contact details were available.
Reporter neighbors stated that she was so sick from the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Reporter neighbors stated that she was so sick from the vaccine.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022, the patient experienced ILLNESS (Reporter neighbors stated that she was so sick from the vaccine.). At the time of the report, ILLNESS (Reporter neighbors stated that she was so sick from the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information was reported. No treatment information was provided.
Extremely weak - could hardly get out of bed, headache, nausea, vomiting , fever chills , swelling and soreness at injections site requiring ice pack.
Several minutes after vaccine administration, pt arose from chair & reported feeling lightheaded. Slumped to the floor & was unconscious for approximately 45 seconds fully recovered within minutes.
diarrhea; hot sweats; dizziness; Was very very sick and almost to call 911".; couldn't eat any thing because of constant throwing up; did not sleep on those 2 nights; throwing up; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HYPERHIDROSIS (hot sweats), DIZZINESS (dizziness), ILLNESS (Was very very sick and almost to call 911".) and FEEDING DISORDER (couldn't eat any thing because of constant throwing up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included VITAMIN D NOS for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (hot sweats), DIZZINESS (dizziness), ILLNESS (Was very very sick and almost to call 911".), FEEDING DISORDER (couldn't eat any thing because of constant throwing up), INSOMNIA (did not sleep on those 2 nights), VOMITING (throwing up) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Apr-2021, INSOMNIA (did not sleep on those 2 nights) had resolved. At the time of the report, DIARRHOEA (diarrhea), HYPERHIDROSIS (hot sweats), DIZZINESS (dizziness), ILLNESS (Was very very sick and almost to call 911".), FEEDING DISORDER (couldn't eat any thing because of constant throwing up), VOMITING (throwing up) and CHILLS (chills) outcome was unknown. Not Provided          Other Concomitant products included Cholesterol medication for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable.
occasional abdominal pain  was eventually determined to be issue with abdominal hernia, after this hernia was repaired, the  pain episodes stopped
sore arm; This is a spontaneous report received from a contactable consumer (patient mother). This consumer reported same events for three patients (her 3 kids). This is the 1st of three reports. A patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. The consumer reported that her three kids were complaining of sore arms. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433532 same reporter/drug/event, different patient;US-PFIZER INC-2021433726 same reporter/drug/event, different patient
hives in arm pits;along waist & @ wrists & possible clear blisters in back of throat;has hayfever took DPH last noc & today @ noon which improves the situation;
Pt recv vax on 11/2/98; on same day pt exp LA swelling, red, warm & hard spread to lower left neck.
Nurse administered frozen vaccine; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
Started with bone pain all over body (except knees). The worst was on her wrists, particularly on the opposite hand of the vaccination site arm.  Her feet also felt "red hot" and swollen.
5 days - very tender, swollen and hard at site of injection. 2 days - body ache all over, chills, low temperature - very tired. 2 days - rash on arms, legs, chest, stomach. 2nd Day, took Advil for pain in arm - very sore. 3rd day - more rash and itches now - took Benadryl. 1st day only - sore throat. Most symptoms gone Sunday.
not a real adverse event. Mom placed the wrong birthdate on the form on the time of administration. She put 07/04/2008 instead of 07/04/2009. Therefore, at the time of vaccination, the patient was not 12 years old yet.
C/o right arm edema, erythema, and tenderness beginning next day after vaccine administration.
No additional AE; Caller states that two 4-year old patients received an additional dose of VARlVAX.; This spontaneous report was received from a medical assistant, referring to a two 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drgu reactions or allergies and concomitant medications were not provided.   On 15-FEB-2021, the patients received an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) (extra dose administered). No additional adverse events were reported.   This is one of several reports received from the same reporter.
Lasted  continuously for 4 days after onset: symptoms included high fever, severe headache, thirst beyond normal, suppressed hunger, nausea,  sore injection site, all of which gradually tapered off on the fourth day. Did not seek medical treatment, increased fluid intake & bed rest.
Injection site became very swollen and red. It was also itchy and warm. The patient took Ibuprofen and was fine within seven days.
NA- patient refused second dose of vaccine - Patient condition at time of death  Chronic Conditions  Renal failure  Advanced age 100 y/o Cardiopulmonary arrest secondary to Covid 19
I have never had Atopic dermatits/eczema before.  Started around 48h post injection.    Pustule type rash both antecubital areas- Worse next day and spreading-  More prominent, bright, hot and now also on R jaw line.  Took Benadryl & valacyclovir incase it was a weird flare of some HSV type thing ( Have had HSV flares post flu vaccines in the past) Rash was not itching in the beginning but became very itchy on about day 4.  More areas of breaking out-  Large band around R waist and skinny band below R waist where my under ware rubbed.  Most of breaking out was on the R side (Vaccine on the R arm) but was some on L antecub area. Tried more Benadryl  PO and topicals like Aveeno anti-itch to rash area.  Went on 6/2 to Urgent care.  Rx for Kenalog topical to rash.  Felt this made it worse.  so stopped that.   Taking Cetirizine daily and Benadryl at bedtime finally helped the itching along with Aveeno topical, cool compresses & ice to extra itchy spots. Started to finally get better on 6/7.  Most areas calming down but did get a new area on R clavicle area on 6/6
Thrombocytopenia:  dropped platelets to 48,000.  Patient is on niraparib but platelets were 98,000 prior to vaccine.  Medication withheld one week prior to vaccine and not resumed until one week post vaccine.
did not get full vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021, the patient received Shingrix. On 11th October 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist reported that, during administration of Shingrix, the needle leaked and the patient did not get full vaccine which led to incomplete dose administered. No product quality complaint was reported by healthcare professional.  No other detail of vaccine or patient was available.  The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 9:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 78.88.  Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM and 10 AM, temperature was 29 and 32 respectively, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 or 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 6 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021 or 4-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.
upper right arm & right shoulder pain with right arm use; upper right arm & right shoulder pain with right arm use; swelling in right armpit and right deltoid; swelling in right armpit and right deltoid; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EM9809) via an unspecified route of administration in right arm on 10Feb2021 08:30 as dose 2, single (at the age of 50-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included asthma. The concomitant medications included aceclofenac BIOFLEX [ACECLOFENAC]) and daily multivitamins. Historical Vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9262) via an unspecified route of administration in right arm on 20Jan2021 15:45 as dose 1, single for COVID-19 immunization. Vaccination facility type was reported as other. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not COVID tested post vaccination. Patient did not receive any other vaccine in four weeks and had no known allergies. On 10Feb2021 12:00 the patient experienced upper right arm and right shoulder pain with right arm, swelling in right armpit. It was reported that since the second vaccine, she have had upper right arm and right shoulder pain with right arm use. At times, the pain occurred while resting in certain positions. The pain was not continuous, but it was persistent in the sense that it occurred every time she made specific arm movements or while resting in certain positions. There was also slight, visible swelling in right armpit and right deltoid. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
they inadvertently gave expired MENACTRA to a patient, with no reported adverse event; Initial information received on 01-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and it was reported that they inadvertently gave expired menactra to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Jul-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6951AA, expiration date: 06-Jun-2022, (strength: unknown) with Intramuscular route in the left deltoid as Immunisation.  On 01-JUL-2022, they inadvertently gave expired menactra to a patient, with no reported adverse event (expired product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Still using product : No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (they inadvertently gave expired MENACTRA to a patient, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
This spontaneous report was received from a physician via Pfizer and refers to a currently 62-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (strength, dose, frequency, route of administration, lot#, expiry date and indication were not reported).       On an unknown date, the patient experienced allergy to ZOSTAVAX. The outcome of the event was not reported. The reporter considered allergy to be related to ZOSTAVAX. Additional information has been requested.
pain and numbness on left forearm near the injection site; pain and numbness on left forearm near the injection site; mild hypertension; tachycardia; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3249 and expiry date unknown) intramuscular at the left arm on 10Jan2021 at single dose for Covid-19 immunization in a hospital. Medical history was none. It was unknown if the patient was pregnant. The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. In Jan2021, the patient experienced pain and numbness on left forearm near the injection site, mild hypertension and tachycardia. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events pain and numbness on left forearm near the injection site was recovered in Jan2021, while mild hypertension and tachycardia was unknown.
On the Day after vaccine 2/6/21 was extremely tired with muscle soreness at back of neck. On 2/8/21, 2/9/21, 2/10/21 & 2/11/21 & 2/12/21 shortness of breath and the slightest physical effort. Very weak and fatigued.  On 2/10/21 Went to the Doctor blood hemoglobin went down to 6.3.  {Just had a blood transfusion on Jan 22, Hemoglobin was 6.6 that day)   The Doctor prescribed another transfusion that took place on 2/12/21.
Pt received TD and Hep A on 5/23 and states as she left clinic room, she was complaining to her husband that the shot did not hurt but was really burning now. Right arm gradually more painful. Area located about 2 inches below site of injection. Area purplish in color, very warm to touch. Pain about a 7 on a scale of 1-10. Had a doctors appointment today (5/26) at about 3 PM. To call with allergy information. Was called on 05/30, AM and again in the PM.  Message was left both times to return call.  Two calls were made as before in the morning and evening of 05/31.
Suspected vaccination failure; I had the shot but had shingles just the same; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient 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 reported as follows: The age at vaccination was not reported. It was reported that the patient had the shot but had shingles just the same. This case was considered as suspected vaccination failure since the details regarding time to onset, completion of primary vaccination schedule and laboratory confirmation of shingles was not provided.
This 78  year old patient received the Covid shot on  2/27/21    and went to the ED on  3/1/21 with the following diagnoses listed below.  Thrombocytopenia, unspecified
Persitant screaming, baby had an apnea episode. Spontaneous crying  - another episode of apnea 15 min later.  Both episodes were assoc. /w cyanosis
This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Flu vaccine unsure of type; Became hot and nauseated then passed out and was unresponsive. Went to Urgent Care and was sent to ER with primary care follow up the next day