chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer and female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2018, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. Shortly after receiving the ZOSTAVAX, the patient developed difficulty breathing. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from pneumonia. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms and diagnose(s) have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, pneumonia was determined to be medically significant. Pneumonia was considered to be disabling. Additional information has been requested.
spinal pain; Hot Flashes; Muscle Spasms; Soreness in arm; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010421A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Report not scheduled for Follow up as initial report is pending for submission On 30-Jun-2021: ADR form-AE details(possible NNI)
Patient came back to vaccine clinic area experiencing paresthesia in her upper and lower extremities. Every 15 minutes patient would experience decrease in pulse and increased breathing rate. Patient was monitored by vaccine clinic staff and was provided ginger ale, apple juice and candy. After approximately 20 minutes of monitoring patient went back to work station, however came back due to experiencing symptoms again. Patient was given a dose of diphenhydramine 25 mg and a nurse monitored her blood pressure which was normal. Patient was seen by provider who determined she was not experiencing anaphylaxis, therefore it would be safe to stop monitoring. Patient was counseled on visiting ER if symptoms worsened and was picked up by family member. Patient confirmed understanding.
This spontaneous report was received from a physician via a field representative and refers to an infant patient of unspecified age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the second dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (dose, route of administration, lot# and expiration date were not provided), at one month of age. On an unknown date, the patient received the third dose of RECOMBIVAX HB, at 2 months of age. The physician did not know if the patient received the first dose at birth. No adverse effects were reported.
New Daily Persistent Headaches began in May 2022. No history of headaches/never migraines. Symptoms have increased in number and intensity for the last 5 months. Nausea, Extreme pain from loud noises, brain fog, some unsteadiness. MRI shows no tumors or other issues. Neurologist treating with anti migraine med for a month. No change except unsteadiness symptom began. Headaches somewhat less but still daily. Contemplating retirement unless this can be halted and corrected.
I have developed a case of Shingles.  I am reporting this in the event it has some importance to this program
This spontaneous report as received from a nurse practitioner refers to a 14 month old female patient. Concurrent or medical conditions were not reported. On 20-MAY-2015, the patient was inadvertently vaccinated with (Merck) VARIVAX (dose, route and lot number were not reported) and with (Merck) PROQUAD (dose, route and lot number were not reported) at the same office visit. No adverse effect reported. Additional information has been requested.
got the flu shot got the flu; Initial information received on 26-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211201000474.  This case involves an unknown age and unknown gender patient who experienced got the flu shot got the flu (influenza) after receiving INFLUENZA VACCINE.   The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event  got the flu shot got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event (got the flu shot got the flu).  At time of reporting, the outcome was Unknown for the event got the flu shot got the flu.
Information has been received from a nurse practitioner concerning an approximately 18 year old female patient who in 2009 was vaccinated with two doses of GARDASIL (Lot number not reported) and now had a "negative pap smear result for intraepithelial lesions and malignancy that was HPV high risk positive". She stated that the patient no reported other adverse experienced and that there was no other observable adverse effects. The patient was counseled to use "protection" when having intercourse. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
sore arm; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and DIARRHOEA (diarrhea). Not Provided          This case was linked to MOD21-081406, MOD21-081427 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-081406: MOD21-081427:for his brother , follow up
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2020, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Cold sore; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot, expiry unspecified), via an unspecified route of administration on 22Dec2020 at single dose (at left arm) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Dec2020, the patient experienced cold sore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no therapy was received for the event. The patient was not diagnosed with Covid-19 prior to vaccination and since the vaccination, the patent had not been tested for Covid-19. Outcome of event was recovering.  Information about Batch/Lot number has been requested.
First dose on 18MAR2021 and second dose on 28APR2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021 and second dose on 28APR2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021 and second dose on 28APR2021). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18MAR2021 and second dose on 28APR2021) had resolved.            She is severly immunocompromised with rheumatoid arthritis and is taking medications for the condition. No treatment information were reporter by the reporter   This case was linked to MOD-2022-455422 (Patient Link).
Received 2nd dose 11 months after 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 11 months prior to the vaccination).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: A pharmacist called to ask for information about a patient who had received two doses of Shingrix. The reporter asked if the patient needs a third dose of Shingrix. The reporter neither provided patient identifiers nor data about the vaccines administered. Did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
shingles; blisters/painful blisters; painful; burning sensation; soreness in the right shoulder; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date unknown) for prophylaxis.   The patient's past medical history included chickenpox (at age 7 or 8 yrs old). Previously administered products included Zostavax (received 5  to 6 year ago).   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, 1 days after receiving Shingrix, the patient experienced shoulder soreness. On 2nd August 2019, the patient experienced shingles, blister, pain and burning sensation. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the shingles, blister, pain and burning sensation were not recovered/not resolved and the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shingles, blister, pain, burning sensation and shoulder soreness to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and developed soreness in the right shoulder that lasted for approximately 2 to 3 days.  On 2nd August 2019, 17 days days after vaccination, the patient experienced shingles, blister, pain and burning sensation. The patient stated that he noticed blisters forming on his right hip and stated that it was painful and experienced a burning sensation.  The patient stated that the area on his hip that was affected was approximately 3 or 4 square inches and there were a few lesions.  The patient stated that he went to his dermatologist and was diagnosed with Shingles.  The physician prescribed Valacyclovir and a steroid. The reporter consented to follow up. Emergency room visit required. The caller did not provide any additional information and did not have additional contact information for the health care professional at the time of the call.
PATIENT CALLED AND SAID HE GOT SHINGLES FROM THE SHINGLE VACCINE HE GOT. HE STATED THAT HE GOT RED SPOT ON HIS BACK ON 04/09/23 AND IT IS STILL RED AND SWOLLEN. HE ALSO MENTIONED THAT BEFORE 2 DAYS (IT SHOULD BE 04/16/23) ANOTHER SPOT DEVELPOED UNDER HIS CHEST AND ITS GETTING VERSE. I ASKED HIM IF HE GOT ANY MEDICAL ATTENTION AS HE SAID ITS SHINGLES. HE SAID NOT YET BUT HE KNOW, IT'S SHINGLE RASH.  HE ASKED ME FOR MANUFECTURER CONTACT INFO WHICH I GAVE TI TO HIM. HE MIGHT BE CALLING GSK TO REPORT THEM ALSO.
Symptoms (so far, still the first day of second dose vaccine): Foggy vision. As if viewing everything through  light fog
Fatigue, shortness of breath, trouble catching her breath, red face, lump in throat, dizziness, when exercising. Took rescue inhaler 5x , but did not see any improvement. Symptoms went away after an hour of rest.
Pt fever of 104.9, severe abdominal pain, right middle lobe pneumonia.
injection site Redness; injection site Swelling; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The caller was medical assistant stated that the patient received Shingrix vaccine presented to the doctor office with redness and swelling at injection site.  The patient had another visit and the patient was doing much better on the arm. No further details were provided.
patient came to pharmacy for first Pfizer pediatric vaccine. Instead of Pfizer pediatric, Engerix B was given. The Engerix B 20mcg looks similar to the Pfizer (exact same color lid). The Engerix B was diluted with 1.3 ml NaCl and then only 0.2ml of that was given. Notified the parent immediately after the error was discovered. Also called her again the next day and she reported the child was not having any adverse reaction
Hospitalization for symptomatic anemia on dates 1/1/23- 1/12/23. Treated with no medications for COVID-19.
This spontaneous report as received from a nurse, concerning to a 12 year old female patient. Her medical history and concurrent conditions were not reported. On 02-FEB-2016 at 13:15, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies were reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
delirious; experience body aches; injection site pain; feeling sick; fatigue; This case was reported by a consumer via call center representative and described the occurrence of delirium in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix. On 6th February 2020, 15 min after receiving Shingrix, the patient experienced delirium (serious criteria GSK medically significant), general body pain, injection site pain, malaise and fatigue. On an unknown date, the outcome of the delirium, general body pain, injection site pain, malaise and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the delirium, general body pain, injection site pain, malaise and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. Approximately 15 minutes later, the patient began to experience body aches, fatigue, feeling sick, delirious and injection site pain. At time of reporting, the events were unresolved. The event feeling sick was not elaborated. The reporter did not consent to follow up.
p/vax pt exp breakthrough varicella;fully disseminated  more than 50 lesions noted;pt sought unspecified medical treatment;
Dizziness, head fog, tingling all over, loss of words, headaches, seen in ER right after for observation. Followed with PCP. Symptoms continue 7 months later, some days worse than others.
At 9:30am I had the Flu Vaccine administered. Two hours after vaccination, at 11:30am, I was completely deaf in my left ear. Today is October 3, 2011 and I am still completely deaf in my left ear. There is a constant ringing (white noise) that will not stop.  It never goes away. This has taken place since my hearing loss after the vaccination.
At 4:03 complained of dizziness, diaphoretic and weak. Pt. seated in chair, given orange juice. Pt. started feeling better. Symptoms resolved per pt. At 16:15 symptoms resolved. No further evaluation needed.
Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 33 years old patient of unknown demographics who received 0.25 ml instead of 0.5 ml FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was added. On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to vaccine underdose. It was not reported whether adverse event occurred. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
very sore arm; Lightheadedness; Dizziness; feeling not right; Cold sweats; Aches; Upset stomach; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right) and HYPERHIDROSIS (Cold sweats) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right), HYPERHIDROSIS (Cold sweats), PAIN (Aches), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills) and PYREXIA (Fever). On 02-Mar-2021, PAIN IN EXTREMITY (very sore arm), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), FEELING ABNORMAL (feeling not right), HYPERHIDROSIS (Cold sweats), PAIN (Aches), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
reported measles like rash on arm & back noted about 5hr p/vax;pt stated exp similar rash p/pneumo vax in MAY96;