chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hallucinations; Hearing voices; Nervous breakdown; Psychosis; Vomiting; Gastric issues; Severe headache; This case was reported by a physician via sales rep and described the occurrence of hallucination in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2021, the patient received Menveo, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 26th January 2021, 8 days after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced hallucination (serious criteria GSK medically significant), auditory hallucinations (serious criteria GSK medically significant), nervous breakdown, psychosis, vomiting, gastric disorder and headache. On an unknown date, the outcome of the hallucination, auditory hallucinations, nervous breakdown, psychosis, vomiting, gastric disorder and headache were unknown.   It was unknown if the reporter considered the hallucination, auditory hallucinations, nervous breakdown, psychosis, vomiting, gastric disorder and headache to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. 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 reported as follows: The patient suffered with nervous breakdown with psychosis and hallucinations, presented severe headache, gastric issues, vomiting and also hearing voices. The patient never had any of this symptoms before. The reporter did not consented to follow up because sales representative reported this, but doctor wants safety information for the patient.
Information has been received from a health care worker concerning a 15 year old female patient who on 12-JUN-2009 was vaccinated with the third dose of GARDASIL (Lot # 659054/0315Y). It was reported that on 12-JUN-2009 the patient experienced seizures, immediately following the administration. The patient sought medical attention in the physician's office. It was reported that the patient recovered the same day, 12-JUN-2009. Upon internal review seizures was considered to be another important medical event. Additional information has been requested.
He did not shake the diluent very well prior to transferring diluent into the vial/still some white substance left on the side of the syringe; Some white substance left on the side of the syringe; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate reconstitution technique in a 3-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 47Y9A, expiry date 17-FEB-2025) for prophylaxis.  On 01-FEB-2023, the patient received the 1st dose of Rotarix lyophilized formulation. On 01-FEB-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate reconstitution technique (Verbatim: He did not shake the diluent very well prior to transferring diluent into the vial/still some white substance left on the side of the syringe) and underdose (Verbatim: Some white substance left on the side of the syringe). The outcome of the inappropriate reconstitution technique and underdose 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 Information: GSK Receipt Date: 31-MAR-2023 Physician stated that, he had administered a dose of Rotarix to an infant patient, and at the time of reporting, he was questioning about the efficacy of this dose. He stated that, he did not shake the diluent very well prior to transferring diluent into the vial and so there was still some white substance left on the side of the syringe.  He saw the patient again on 31 March 2023 and had administered a properly reconstituted second dose.  The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up. At the time of reporting, the physician did not had shaken the diluent very well prior to transferring diluent into the vial, which had led to Inappropriate reconstitution technique and underdose.
Pt has a red swollen arm that is warm to the touch, painful and spreading down to the elbow.
Patient states that he started to have a chicken pox like rash that was very itchy break out on his lower back starting the day after he received the vaccine.  He stated it progressively got worse each day and on day 4 he took an oatmeal bath to help relieve the itching.  He still had a visible rash on his back 5 days post vaccine.
Information has been received from a health professional concerning a 22 year old female employee, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006.  It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck).  Subsequently the patient was diagnosed with shingles by her physician and treated.  No product quality complaint was involved.  No other information was provided.  Follow-up information from a health professional indicated that the patient had either recovered completely or was recovering.  All lesions were either gone or almost completely dried up.  This is one of several reports from the same source.  Additional information has been requested.
About 12hrs after my arm began to hurt really bad.  It hurt so bad for about 5 days it was so sensitve you couldnt touch it.  About 48 hours later I developed really bad migranes that came off and on and lasted a couple days.  I have sensitivity to light and just wanted to stay in bed because I was extremely tired and fatigued.  My arm still hurts and has sensitivity to date just not as bad as it was in the beginning
delayed localized reaction/reaction is on her whole arm from shoulder to elbow; reaction is on her whole arm from shoulder to elbow with some induration; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (delayed localized reaction/reaction is on her whole arm from shoulder to elbow) and VACCINATION SITE INDURATION (reaction is on her whole arm from shoulder to elbow with some induration) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (delayed localized reaction/reaction is on her whole arm from shoulder to elbow) and VACCINATION SITE INDURATION (reaction is on her whole arm from shoulder to elbow with some induration). At the time of the report, VACCINATION SITE REACTION (delayed localized reaction/reaction is on her whole arm from shoulder to elbow) and VACCINATION SITE INDURATION (reaction is on her whole arm from shoulder to elbow with some induration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided.  Treatment for the events were done with Zyrtec, Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient initials were updated
She got out of bed at 2AM to go to bathroom and doesn't remember a thing.  She fell face down on tile floor.
This serious initial spontaneous case, was received on 05-Sep-2017, from other non-health professional, concerning 91-year-old, elderly, male patient. The patient's historical conditions included prostate cancer which occurred and recovered on an unspecified date. The patient had taken flu vaccine previously, due to which he had diarrhoea. The patient's current conditions included glaucoma, high blood pressure and acid reflux since an unspecified date. Patient's breasts were cut off on an unspecified date. Concomitant medications included unspecified medications (reported as 4) for glaucoma and high blood pressure and NEXIUM for acid reflux. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, batch number, anatomical location, manufacturer and expiry date: not reported). It was reported that, on an unspecified date, the patient had diarrhoea from the flu shot and it was very severe over the years which lasted for a year. The patient was administered with an unspecified antibiotic before and after the flu shot. The patient stated that, there was no way to cure from the regular diarrhoea pills. He added that he cannot be on a diet. On an unspecified date, the patient was treated with unspecified antibiotics and CIPRO pills for the event. On an unspecified date, the patient had recovered from the event diarrhoea. The reporter assessed the event as non-serious.
pt reported redness and swelling around the injection site, that started to spread down pt's arm over the past 2 days. Aleve, Benadryl, and Icy hot was used per patient.
pt has redness, swelling warmth around the iinjection site towards the entire dorsal left upper arm just above the elbow
Information was received on 17-JUL-2017 from a nurse who was reporting on multiple unspecified patients (demographic were unknown). No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, an unspecified number of patients were administered doses of improperly stored MMRII (lot N010426, expires 01-MAR-2018). The lot number and expiration of the sterile diluent is unknown. The nurse also reported that on unspecified dates, an unspecified number of unspecified patients were administered separate doses of improperly stored doses for the following vaccines: PEDVAXHIB (Lot L033690, expires 14-JUN-2018), GARDASIL 9 (lot N00326, expires 14-OCT-2019) and PNEUMOVAX 23 (lot N01867, expires 08-NOV-2018) (dose, injection sites and route not reported). No adverse effects were reported. No additional information was provided. The temperature excursion involved temperature range from 9 degrees C. to 25 degrees C. for 72 hours. There was no previous temperature excursion and a data logger was not involved. The nurse called back and reported that a male patient of unknown age received a dose of improperly stored GARDASIL 9 (lot N000326, expires 14-OCT-2019) for prophylaxis. No medical history or concomitant medications were reported. A second male patient also received a dose of improperly stored GARDASIL 9 (lot N000326, expires 14-OCT-2019) (MARRS# 1708USA004621) on 14-JUL-2017.  A female patient of unknown age received a dose of improperly stored PNEUMOVAX 23 (lot N011867, expires 08-NOV-2018) vaccine on 14-JUL-2017 (MARRS 1707USA004862). No further information was provided. Follow-up information was received on 17-JUL-2017 from the nurse who reported that the actual timeframe of the temperature excursion was 96 hours. The nurse also stated that the improperly stored PEDVAXHIB and MMRII were not administered. No further adverse event information was provided. Additional information has been requested. This is one of several reports by the same reporter.
Shingles; Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in; The veins in my arm up to my shoulder are blue; had Covid arm, It was hot; had Covid arm, It was hard; had Covid arm. It was red; slight fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in), VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue), HERPES ZOSTER (Shingles) and VACCINATION SITE INDURATION (had Covid arm, It was hard) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy in December 2016. Concurrent medical conditions included Immune disorder (NOS) (patient did not have any Immunoglobulin A), Brain tumor (Patient had last chemo in Dec-2016) and Artificial cardiac pacemaker user.    On 28-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE INDURATION (had Covid arm, It was hard), VACCINATION SITE ERYTHEMA (had Covid arm. It was red) and PYREXIA (slight fever). In October 2022, the patient experienced VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in) and VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue). On 15-Nov-2022, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in), VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue), HERPES ZOSTER (Shingles), VACCINATION SITE INDURATION (had Covid arm, It was hard), VACCINATION SITE ERYTHEMA (had Covid arm. It was red) and PYREXIA (slight fever) outcome was unknown.            No concomitant drug was reported. Patient received first dose on 18Mar2021, Lot: 03N20A. Patient received second dose on 13Apr2021, Lot: 003B21A. Patient received third dose on 01Nov2021, Lot: 014F21A. Patient received fourth dose on 22Apr2022, Lot: 00ZM21A. Patient read somewhere that Covid arm should go away in about 21 days. Approximately 15Oct2022, patient left arm had a blue spot around the area that patient got injection in. The veins in patient arm up to shoulder are blue. Patient went to physician on 15-Nov-2022 and they were going to do a sonogram on patient's arm. No treatment drug was reported.
The morning after the injection complained of pain in the right arm extending from shoulder to wrist. Complained of difficulty raising arm due to the pain. Pain slowly subsided over the next several days. No reddness, swelling of fever were reported. As of today 20 days after the flu injection continue to have pain from injection site to top of shoulder. Is taking over the counter anti inflammatory which only give slight relief.
arm hot to the touch; arm started to swell; arm became red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm started to swell), VACCINATION SITE ERYTHEMA (arm became red) and VACCINATION SITE WARMTH (arm hot to the touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025320A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), RANITIDINE HYDROCHLORIDE (ZANTAC), MULTIVITAMINS [VITAMINS NOS], OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), VITAMIN K NOS and CALCIUM, COLECALCIFEROL (CALCIUM WITH D3) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm started to swell), VACCINATION SITE ERYTHEMA (arm became red) and VACCINATION SITE WARMTH (arm hot to the touch). On 06-Jan-2021, PERIPHERAL SWELLING (arm started to swell), VACCINATION SITE ERYTHEMA (arm became red) and VACCINATION SITE WARMTH (arm hot to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included ibuprofen and ice therapy.; Reporter's Comments: Based on the information provided which includes temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded.
Incorrect mRNA COVID-19 vaccine product administered for second dose in 2-dose series (Moderna Lot#023C21A given on 5/18/21); no symptoms present for 15 minutes after administration; Client advised that incorrect 2nd dose mRNA vaccine was given ; advised that best guidance was to not repeat dose; no adverse events observed; VAERS filed for record keeping and possible future follow up
Pt recvd vax about noon-high pitched crying about 3PM lasted aobut 5min; cried off & on until 10PM;
Administered with the vaccine from prefilled syringe prepared last 06Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from prefilled syringe prepared last 06Aug2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from prefilled syringe prepared last 06Aug2021). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from prefilled syringe prepared last 06Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up information received and First dose information and batch number were added.
titers were drawn and show low to no response; Underdose; Underdose; Underdose; wrong vaccine administered; wrong vaccine administered; wrong vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) (batch number 5R52M, expiry date 3rd October 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric, the 2nd dose of Engerix B pediatric and the 3rd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B pediatric and less than a year after receiving Engerix B pediatric, the patient experienced therapy non-responder, underdose, underdose, underdose, adult use of a child product, adult use of a child product and adult use of a child product. On an unknown date, the outcome of the therapy non-responder, underdose, underdose, underdose, adult use of a child product, adult use of a child product and adult use of a child product were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B pediatric, Engerix B pediatric and Engerix B pediatric.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date for 3rd dose of Engerix B pediatric was reported. The adult patient received Engerix B pediatric, which led to underdose and adult use of a child product. The reporter reported that, hepatitis B antibody titer was drawn, and showed low to no response, which led to therapy non-responder.      Lab Comments: On an unknown date, lab test was performed
Approximately 12 hours after injection I woke up with mild to sever body aches. After several minutes I began having chills. These symptoms persisted for around 2 hours before I fell back asleep. In the morning I have had lingering body aches.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 56-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Initial report received from a pharmacist on 15 Jan 2010: This patient was vaccinated with S-OIV FLUVIRIN of an unknown batch number, 0.5 ml on unknown date which was stored at temperatures as low as 34F and 35 F. No adverse event was reported.
Short of breath after several hours of vaccination. There was no adverse event at the time of vaccination. Took Tylenol (regular strength) 2 tablets every 4 hours for 3 sets. Short of breath stopped by 3rd set but body was heavy and flu like symptom persisted.