chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received three doses of Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On 5th May 2021, the patient received the 3rd dose of Shingrix. On 12th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Patient received three doses of Shingrix vaccine, which led to extra dose of vaccine administered. Pharmacist asked for information about correct protocol for patient.
1st shot 10/5/2019; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 05th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable. Till the time of reporting, patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if it's okay to get the second shot now. Follow-up would not be possible as no contact details available.
First tingling in stomach, lactose intolerance, weight loss (lost 10 lbs, down to 82 lbs). Then in April neuropathy started. First right foot pain and severe muscle cramps in right calf, which then spread to rest of body. Tingling weakness numbness burning freezing sensations throughout body. Feet turned bright blue. Dizziness. Hair loss. The cramps in calves were severe enough to prevent me from walking or standing. At first it was all the time then it would go into flares and remission. There are more symptoms but too many to list. I went to several different emergency rooms, none of which helped.
past due for dose two of Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was past due for 2nd dose of Engerix B, and till the time of reporting, did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021251156, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021251156:Same reporter
Case number PHEH2014US019853 is an initial spontaneous report from the nurse received on 01 Oct 2014. This report refers to a 11-year-old female patient. On 01 Aug 2014, she inadvertently received only Men CYW-135 component of MENVEO (batch number: M14040) intramuscularly without reconstitution with Men A lyophilized component. No adverse event reported following this medication error.
Patient had redness and tenderness on left arm where injection was given. Also had 100.8 fever at that time. Patient did received MMR on the 11/04/2015.
Increase in blood sugar level ever since had the vaccination; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Increase in blood sugar level ever since had the vaccination) and FATIGUE (Extremely tired) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included METOPROLOL and LOSARTAN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Increase in blood sugar level ever since had the vaccination) and FATIGUE (Extremely tired). At the time of the report, BLOOD GLUCOSE INCREASED (Increase in blood sugar level ever since had the vaccination) and FATIGUE (Extremely tired) outcome was unknown. Not Provided          No Treatment medications were reported.  Patient reported After the first dose she was fine but after the second dose she felt extremely tired after and had to take rest for about 1.5 hours.
Fever 102.7 F; Hip Pain; A spontaneous report was received from a consumer concerning a 85-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hip pain, fever 102.7 F(Fahrenheit).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient woke up with the event(s) hip pain, fever 102.7 F.  Treatment details included Tylenol with Hydrocodone Tablet on morning for hip pain. Tthe fever came down quickly.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), hip pain, and fever 102.7 F were unknown.
Fever 100.4- 5am on 10/5 thru 10p 10/5 Headache- onset 10/4 at 5p Extreme fatigue - onset 10p 10/4 though 5a 10/6
No adverse events. Second booster dose given. Adult day care facility provided incomplete vaccination card with only the first 2 COVID-19 vaccines listed. Pharmacy administered the Moderna booster based on the dates of the vaccine card provided (2/25 and 3/25).
pt recv vax 6OCT95 & 20MAR96 pt devel a full blown case of chickenpox;had multiple, erythematous, papular lesions over the face, neck, hairline & very little on arms & chest;
At injection site skin has turned red, itchy, hot, painful, swelling, has affected ROM due to pain
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/29/2021 LEFT FACIAL MUSCLE WEAKNESS LEFT FACIAL MUSCLE WEAKNESS 7/29/2021 LEFT FACIAL MUSCLE WEAKNESS
Chest pains at the pain level of 7.  Lasted 2 hours. Okay now.
Flushed, hot feeling, sweating, rapid heartbeat, dizzy starting about 10 minutes after vaccine and lasted over 3 hours.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia and fatigue (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia and fatigue (tiredness). At the time of the report, pyrexia and fatigue (tiredness): not resolved. No concomitant medication or treatment information provided. This case linked to MOD-2021-043475 (patient link).
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 23-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Runny nose; Fever; Chills; nausea/queasy; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (nausea/queasy) and VACCINATION SITE PAIN (Soreness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (nausea/queasy) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, RHINORRHOEA (Runny nose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (nausea/queasy) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment medication information not provided.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was not provided by the reported.   This case was linked to MOD-2021-418964 (Patient Link).
Second dose 0.25 ml .; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Second dose 0.25 ml .) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Second dose 0.25 ml .). At the time of the report, ACCIDENTAL UNDERDOSE (Second dose 0.25 ml .) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
15OCT97 24hr p/vax hives started to appear;chest & back & legs well covered by 16OCT97;lymph node swelling in lt axilla;
Approximately 10-14 days post vax, the pt developed flu-like symptoms and a seizure was experienced. No fever was present.
patient was accidentally administered a moderna 6 month - 5-year dose (0.25 ml) covid vaccine for their third dose but should have actually been given the Pfizer 6 month - 4-year (0.2 ml) covid vaccine for their third dose. Error was caught directly after administration, while patient/parent still in office. provider was notified and advised the parent right away that they received the incorrect vaccine product, however, per CDC guidelines, as well as confirmation from our vaccine safety team representative, patient does not need additional dosing with Pfizer. Their series can be considered as complete. Parent was advised of this and child was observed in office 30 minutes after vaccination to ensure no side effects/adverse reactions occurred. parent was then followed up with via telephone call on 10.6.22 to check on child's status, and per parent, no adverse effects experienced. medical assistant who gave the vaccine was counseled and coached by C.N.S on 10.6.2022 to ensure events such as this can be prevented from occurring again in the future.
DIARRHEA 3 DAYS POST IMMUNIZATION; RUNNY EYES; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, and tonsillectomy, and concurrent conditions included erythromycin allergy, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021at left arm for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: Chemotherapy (NR: not provided) unknown. On FEB-2021, Laboratory data included: Surgery (NR: not provided) unknown. On APR-2021, Laboratory data included: Radiation therapy (NR: not provided) unknown. On 05-APR-2021, the subject experienced diarrhea 3 days post immunization. On 05-APR-2021, the subject experienced runny eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea 3 days post immunization, and the outcome of runny eyes was not reported. This report was non-serious.
presented for onboarding with Medical Center.   A review of her immunization records indicates the receipt of  2 Pfizer Bivalent Vaccine doses, separated by 21 days for the primary COVID-19 vaccine series.  As per the healthcare worker's  COVID-19 vaccine card  Immunization Registry, the doses were administered by Medical Group.  The vaccine lot numbers were verified by Pharmacist as Pfizer bivalent doses.  The employee denies illness or adverse effects from the vaccines. The admits she will follow-up with Medical Group.   A report  is completed as the vaccine dose sequence is outside of  currently approved guidelines.
About 3 days after receiving his 2 month immunizations our son woke up from sleep gasping for air, very stiff and acting scared. This lasted a few minutes before he just "snapped out of it" ate, and went back to sleep. The next morning we called our doctor because my husband and I believed he'd had a possible seizure. We'd noticed a few jerky movements but since it was so late at night and the lights were off it was hard to tell for sure. We did bring him in to our doctor who did not think it was a seizure. Since then he has been diagnosed with a Generalized Seizure Disorder.
Pt had shingles outbreak within 2 weeks of 2nd Pfizer COVID vaccine.; This is a spontaneous report from a contactable Nurse. A 65-years-old non pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EJ1685, expiration date unspecified), intramuscularly on 08Feb2021 as 2nd DOSE, SINGLE DOSE for covid-19 immunization. Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3246, expiration date unspecified), intramuscularly on 18Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. No other vaccine in four weeks. Medical history included DM Type 2, Hypertension. The patient's concomitant medications were not reported. The patient had allergies NSAIDS - causes lips tingling and swelling, prednisone causes hives. On 22Feb2021, Patient had shingles outbreak within 2 weeks of 2nd Pfizer COVID vaccine. The patient had to visit Doctor or other healthcare professional office/clinic visit. The patient was not tested for COVID-19 post vaccination. No covid prior vaccination. The patient was treated with Acyclovir for the event. The outcome of the event was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
administered intranasally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 16-year-old female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intranasal) and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The health department had a flu clinic one day before the reporting date. The reporter reported that they were administering Flulaval and an intranasal flu vaccine and a nurse volunteer gave Flulaval intranasally to 3 patients. The vaccine administration facility was the same as primary reporter. The facility address was also reported above in health care professional's details. The reporter consented to follow-up by phone. This was for 3 of 3 linked cases reported by same reporter. Additional supportive information: The patient received Flulaval vaccine intranasally, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2022154656:Same reporter US-GSK-US2022AMR154541:Same reporter US-GSK-US2022154655:Same reporter-Deleted
ARM HURTING AT THE INJECTION SITE; 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced arm hurting at the injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm hurting at the injection site. This report was non-serious.
01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Excedrin and ibuprofen, worked all day and by the end of the shift started feeling worse.  Symptoms to include : shaky, felt like she was freezing to death but no fever at this point, skin felt like it was on fire,  Around 8:00pm temp of 100PO at this time took 1000mg Tylenol and when she had got the shower skin was very sensitive to the water and felt like it was hot, but the water was not,   by 10:00 pm temp of 103, felt shaky, achy all over, dizziness/nausea, muscle weakness, fatigue.  Went to bed that night, had night sweats during the night. 01/10/21 got up around 4:30am to get ready for work, continued with severe muscle weakness, shaky, headache, got in shower and fell from being so weak and tired.  Gradually through the day got better, had went back to bed that morning and slept almost all day and by 3:00pm -4:00pm was feeling much better.
She stated that after receiving the first dose "she went into full-on menopause"; This spontaneous report has been received from a 42-year-old female patient, regarding herself. The patient's medical history, concurrent conditions, concomitant therapies and drugs reactions or allergies were not reported.  On 15-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (prevention of human papillomavirus [HPV]) (strength, vaccination scheme, frequency, lot number, expiration date, and route of administration were not provided).  On the same date, the patient went into full-on menopause, her hormone levels were tested and found to be at post-menopausal levels, performed by primary care physician (PCP). She was undecided if she would receive the next scheduled dose. The patient sought medical attention, and no received any treatment. At the time of reporting, the outcome of the event menopause was not provided.  The causal relationship between the event menopause and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
second shot and still get flare ups/Suspected Vaccination Failure; still get occasional flare ups; soreness; put me down for the day like the flu; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain and muscle cramp.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: second shot and still get flare ups/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still get occasional flare ups), influenza-like symptoms (Verbatim: put me down for the day like the flu) and pain (Verbatim: soreness). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the influenza-like symptoms was resolved (duration 1 day) and the outcome of the pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, influenza-like symptoms and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, influenza-like symptoms and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that his/her first bout brought him/her to the floor in excruciating pain with muscle cramping in my shoulder blades. The patient stated that even after getting the shots (the second shot put him/her down for the day like the flu). The patient still get occasional flared ups.  The massage, light exercise, and yoga helped and the soreness went away in a few days.  The patient stated that being mindful of one's diet was extremely helpful and not eating a lot of crap.     This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Resident passed away day after receiving vaccine. No signs or symptoms of allergic reaction that were reported.
Pain in the arm vaccine was given. By evening had limited mobility in arm due to extreme pain. Pain reduced, but nearly 2 weeks later there is still pain in that arm.