chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This prompted her to test for COVID, which came back positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (This prompted her to test for COVID, which came back positive) in a 39-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (This prompted her to test for COVID, which came back positive). At the time of the report, COVID-19 (This prompted her to test for COVID, which came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2023, SARS-CoV-2 test: (Positive) This prompted her to test for COVID, which came back positive..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.    Caller stated that she and her daughter received a dose of the Spikevax 2023-2024 vaccine on 3 NOV 2023. This was the patients sixth dose. Caller states that on 14 NOV 2023, she woke up with her throat feeling terrible. Her head hurt with a pounding headache. She was sneezing and blowing her nose and had a whole body ache. This prompted her to test for COVID, which came back positive. She also felt like a sloth and did not want to move at all. She says that she was still coughing and her throat still feels sore, but it was not as bad as before. She also still has a headache but that too, was not as bad as before. She felt like she was on the "uptick" with her symptoms. She says that it feels like COVID is more prevalent than the flu, but goes unnoticed because people are only doing home tests.   This case was linked to US-MODERNATX, INC.-MOD-2023-750124 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750124:Daughter case
I received the second Shingrix injection on Tuesday November 10, 2020 around 1pm. By the time I returned home (a 10 minute drive from the pharmacy to my house) I was displaying some confusion. This developed into a loss of memory and an inability to communicate with my husband. Went to bed and have no memory of the evening. Woke up at 1am and spent the rest of the night throwing up. It is the confusion and memory loss that concerns me. We ate and drank the same things that day and didn't take anything out of the ordinary.
Client reports that, she has experienced clogged of the ears, also ringing the ears, feeling really bad, difficulty sleeping, with elevated tinnitus.
pt recvd vax;adm to hosp w/ fever of 102.7;pt was crying & cyanotic;szs were present;14dec fever of 104.7;IV's started;adm to peds 15dec;pt much improved; fever down to 101.7;
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
suspected vaccination failure/have the vaccine but still got Shingles; shingles; This case was reported by a consumer via interactive digital 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 provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the shot of Shingles vaccine and still got hit will shingles. Follow-up would not be possible as no contact details available. The case is considered as suspected vaccination failure since the details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Shot was at 3pm. all was normal, slightly sore on left arm. At 10:30pm I woke up feeling terrible, very odd. I took my blood pressure 3 times, all three times it was around 220/117. I did fall to sleep again, in morning was feeling somewhat normal. Now, I have pounding heart and sometimes feeling like it is squeezed. One night recently I woke up 'hearing' my heart beating, it was a noise similar to a tire being inflated, off and on with each heart beat.
Left upper arm erythematous circumferential, swollen hot.  Treated with cephalexin, Benadryl, tuamcinalone
feel like they "got hit by a truck"; very tired; flu-like symptoms; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like they "got hit by a truck"), FATIGUE (very tired), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FEELING ABNORMAL (feel like they "got hit by a truck"), FATIGUE (very tired), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feel like they "got hit by a truck"), FATIGUE (very tired), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
3X3 RED, RAISED RASH TO RLE.  PAIN NOTED BY CHILD, FAVORING LEG.
Paramedic assessed patient.  Pt stated neck tension on the side (R) arm, 3/10 pain, light head, natural low pulse rate.  Vitals BP 159/78, HR 51 bpm, respiratory 16.  Pt was monitored and stale to leave upon expired observation time frame.
My child has had a migraine headache for 30+ days and we have seen a number of Dr about this. He received 2 meningitis vaccines on February 18th of 2022 his symptoms started on February 20th of 2022 and has been ongoing since has not had any relief from these migraines we have been in the hospital twice.
stomach issues; diarrhea; nausea; lost 12 pounds; cannot eat; does not have an appetite; wakes up sick, sweating, and panic; has anxiety when he wakes up sweating; sweating; used to be able to lift but now he would have to stop lifting as he cannot breathe; feels bad/it bothers him; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds) and EATING DISORDER (cannot eat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, 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 experienced ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him). The patient was treated with RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (nausea), WEIGHT DECREASED (lost 12 pounds), EATING DISORDER (cannot eat), DECREASED APPETITE (does not have an appetite), MALAISE (wakes up sick, sweating, and panic), ANXIETY (has anxiety when he wakes up sweating), HYPERHIDROSIS (sweating), DYSPNOEA (used to be able to lift but now he would have to stop lifting as he cannot breathe) and FEELING ABNORMAL (feels bad/it bothers him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Tried a new diet and ate more vegetables   This case was linked to MOD-2021-251774 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient received ZOSTAVAX (lot#H017447, expiration date 20-DEC-2013, route of administration not reported) on 13-FEB-2013 that was reconstituted with expired sterile diluent (lot#6008Y, expiration date September 2011). ZOSTAVAX was not expired only the sterile diluent used to reconstitute the ZOSTAVAX. No adverse symptoms reported. Additional information has been requested.
The COVID-19 vaccine administered through  vaccine administrator, , between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
I received the Hep B 5/30/97,6/30/97,11/25/97. Varicella 6/30/97, 8/5/97. MMR 6/30/97.TD 5/30/97. PPD 5/30/97, 8/25/97. after receiving all these vaccines in such a short period of time. I was diagnosed with Hashimotos thyroiditis in Oct.97. My immune system crashed. I had no idea that the number of vaccines I received would cause me to have auto-immune disorder. As I get older my allergies keep getting worse. Now I have Chronic fatigue and fibromyalgia. I also have severe asthma. I am now on SSA disablility for depression from all my ailments. I don't have diabetes, but I do have perpheral neuropathy. I take armour thyroid,tegretol,paxil,qvar,proventel,protonix, zantac, vistril, xyzal, fexophen, ultram.  1/16/2009 MR received from PCP from 2/18/1998-2/2002. Pt presents for multiple sick visits with the following DX:  Bronchitis, URI, Fatigue, H/A, hypothyroidism, multiple episode of t sinusitis, disc syndrome, epistaxis, rotator cuff syndrome, UTI, acute pharyngitis, viral illness, NOS. ENT visit for Nasal polyposis and pansinustis. 1/27/2010 I have Hashimotos thyroiditis, peripheral neuropathy, chronic fatgue, adrenal fatigue, autoimmune disorder, severe allergies, environmental and food and drug, asthma.
Caller reports diarrhea 4 days after the 1st dose; This is a spontaneous report from contactable consumer(patient) via a Pfizer-sponsored program Pfizer First Connect.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced caller reports diarrhoea 4 days after the 1st dose on an unspecified date. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
28JAN vax 29JAN noon pt found on floor & eyes rolling up, head dropped forward, responded immed when name spoken; not voiding, somnolence, nuchal rigidity, t102 ax, OM, strep, pharyngitis;
Pain, swelling, tenderness and some redness in right wrist and right distal radius; pain and tenderness in lateral epicondyle of left elbow.
Pt had redness, swelling and warmth on (L) arm from shoulder to elbow. Lasted 3 days.
Dizziness, trouble walking, trouble focusing, trouble seeing.  Lasted X 6 days.
rash, light, pink, raised, itching, about 5-6cm around site; resolved
Muscle cramps the first three weeks after the vaccine. Itching on side of face a week after that. Pressure on bridge of nose a week and a half ago. Of note, pt had no systemic sxs, fevers, chills, or rash.
Patient stated that she developed a bad rash on her face, neck and mouth within 24 hours of getting the vaccine. She did not report it until 5/24/18.
Information has been received from a physician concerning a 9 month old male patient who on 18-NOV-2009 was vaccinated with his third oral dose of ROTATEQ.  No adverse symptoms were reported.  Additional information has been requested.
pt recvd vax & w/in 2 hrs post vax exp nausea,vomiting,diarrhea,& flu-like sx (aches);sx subsided w/in 12hrs;
metal taste; This spontaneous report as received from a consumer via other company (Pfizer, manufacturer control # 2021279132) refers to a currently 62-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, reported as "in November", the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and influenza vaccine (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced metal taste.  The outcome of the event and the relatedness between the event and the suspect vaccines were not reported.
Fatigue, shivering, body aches, and cramping bout 12 hours after 2nd moderna vaccine.
This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a nurse concerning a 21 year old female patient who on 21-SEP-2007 was vaccinated with a dose of GARDASIL (lot # 658563/1063U). Within one hour of vaccination the patient had nausea and dizziness. The patient had hand tingling and feet tingling as well as general malaise. The patient then progressed to neck pain and had swollen glands. The patient went to ER and had a CT scan and MRI done. The patient was not admitted to the hospital The patient's outcome was unknown. No further information is expected.
patient received her first vaccine on January 16th and had no problem other than a sore arm at injection site.  9 days later she developed a red rash at injection site it's warm to touch, swollen and a little itchy. She denies pain.
Complains of heart palpitations , pulse 120 when checked. Please went down to 105.
Pt calls and states she received TD shpt around 8: this am, it is now 11:00 and she has a red rash on her neck, that itches. She has called her DR and was told to take 25mg Benadryl.
Fever of 102 Migraine,  with ringing in the ears, kind of like a tinnitus Joint aches, especially in arthritic joints  Muscle aches  Recovered from fevers and migraine and muscle aches, I have arthritis in me knees and left shoulder, those joints are still very painful, like walking on rice (2 days after side effects)
Common Variable Immune Deficiency and received the vaccine anyway; A spontaneous report was received from a consumer concerning a 56-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events common variable immune deficiency 9immune system disorder) and received the vaccine anyway.  The patient's medical history was not provided.Concomitant medications  reported include immunoglobulin human normal, hydroxychloroquine sulfate, tamoxifen, denosumab, guaifenesin, diclofenac diethylamine, famotidine, pantoprazole, QVAR inhaler, antibiotics, asthma inhaler.   On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On an unknown date patient experienced, common Variable Immune Deficiency and received the vaccine anyway.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), common variable immune deficiency and received the vaccine anyway,  was unknown.
Arm soreness; This is a spontaneous report from a contactable Consumer. A adult male patient received BNT162B2, via an unspecified route of administration on Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had arm soreness on Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The treatment was not received for the adverse events. The outcome of the event was unknown.
Doses were administered past the 30-day beyond use date in the refrigerator; Doses were administered past the 30-day beyond use date in the refrigerator; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR. At the time of the report, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The reporter stated that for lot number 062E21A, the date vaccine moved to refrigerator on 8/18/21 and last Date Administered was 12/21/21 and for lot number 040C21A, the date vaccine moved to refrigerator on 8/24/21 and last Date Administered was 12/14/21.  The reporter stated that Moderna Lot analysis, regarding dose(s) administered on and after November 11, 2021 from lot number 062E21A; and doses administered on and after October 11, 2021 from lot number 040C21A: Moderna cannot guarantee patients received full protection against the COVID-19 Virus.  No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes on 04-Jan-2022 Follow up received included Updated information in narrative supplement and also updated outcome of the event product storage error.
kinrix given to a 19 month old; was due for 3rd dose of ipv and dtap / Kinrix was administered on 3/4/2021 as a 3rd dose in the series; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTPa-IPV vaccine (Received 2nd dose on March 2020.).   On 4th March 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient received 3rd dose of Kinrix at 19 months of age which leads to inappropriate age at vaccination and inappropriate schedule of vaccine administered. Medical administrator called to inquire how should they continue with vaccination. Forget to ask for follow up, , however did collect contact information if necessary.
Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser in the reported that a 38-year-old female patient (race and ethnicity unknown) [Patient 3] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM at the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 939304, expiration date 16-Mar-2024, and NDC # 43528-003-01) in the left deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.