chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adacel were administered post excursion/max/low temperature reached: 28 f/duration out of labelled range: 41 hours and 30 minutes, with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 17 years old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered post excursion (max/low temperature reached: 28 f; duration out of labelled range: 41 hours and 30 minutes), with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: 2CA23T1; expiry date: 08-Dec-2024) via unknown route in unknown administration site for Prophylactic vaccination (immunization) post excursion (max/low temperature reached: 28 f; duration out of labelled range: 41 hours and 30 minutes; Human error: No), with no reported adverse event (poor quality product administered) (same day latency).   Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event adacel were administered post excursion/max/low temperature reached: 28 f/duration out of labelled range: 41 hours and 30 minutes, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA221635:related inquiry US-SA-2023SA220996:01697707
Severe paronychia (infection under the fingernail) that developed within 24 hours of administration of the first dose of Moderna. No previous history of skin/ nail infections.  Nail turned green, finger swollen and extremely painful spreading downward toward the knuckle within 2 days. Required 3 trips to Urgent Care and one trip to the ER. Antibiotic resistant infection that began to spread up the arm. Second antibiotic required 2 week course to resolve infection. Pain and sensitivity continue after one month.
Subsequently post vax, the pt experienced severe whole injection arm ache, fever, headache, shoulder ache, and neck ache. She was in bed for several days and needed to see a physician. Symptoms are improving but are not resolved yet.
p/ pt recv vax approx 11 days later pt devel a red, welt-like area @ inject site & 2 pimple like-lesions on face.
erythema & induration @ inj site;tx w/cold compress, cortoid topically & Ibuprofen orally;
hosp adm due to sz & high fever 8DEC94; had MMR 8 days prior; CBC-nl x/sl inc MCV 76.9- diff 15% monos otherwise unremarkable;CO2 = 19.3 - subsequent CP nl; spinal fluid neg; gram stain-bacterial antigens;
For the first couple of days, I've been experienced some side effects, like pain in the arm I got shot, tiredness, headache, fatigue, rapid heart rate, muscle pain and nausea. Some of them were completely gone afterwards, but rapid heart rate, pain in the chest (both of them last for quite a while and don't seem to appear after any physical activity but at rest), shortness of breath even at rest, fatigue, sometimes nausea (that come and go pretty fast without any reason) are still with me after a week after the first shot. I don't feel like I'm able to do any workout also. I also have a slight cough too.
shingles after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles after second dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles after second dose). Not Provided          This case was linked to MOD-2021-150332 (Patient Link).
administered only liquid conjugate portion; administered only liquid conjugate portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 26-Jul-2022. Reporter's Comments: The medical assistant reported that the patient was administered only the liquid conjugate portion of the Menveo vaccine. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not have details available for call but would provide by follow up preferred email above. The reporter consented to follow up. Additional Supportive Information: The patient was administered only the liquid conjugate portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt states had a small sore arm on rt deltoid; 30JAN93 AM which had progressed by 31JAN93 AM to a small, swollen hard area hat was very tender to the touch; pt states that by 1FEB93 swollen, sore area extended from top of arm;
Patient developed swelling, redness "4x2" over outer aspect left upper arm approximately 36 degrees after injection of Dtap and IPV.
severe arm pain 3 days, dizziness, nausea, irritated urination, severe stomach pain, pinching in bladder, double vision, chills
Immediate tinnitus after shot. Within an hour developed fever (up to 102F), chills, myalgias. Then developed swelling in her left neck and axillary areas (shot was in left arm). Very tender. Fever up to 102 lasted until late that evening and then has gradually improved since then.Note that her usual body temperature is about 96F. She also developed sinus congestion and some chest tightness. Chest tightness has resolved. Myalgias and swelling are gradually improving. She has not taken any OTC medications as she did not want to dampen her immune response. Arm and leg weakness.
This spontaneous report as received from a registered nurse refers to 11 month old patient. On 20-NOV-2014 (reported as 6 days prior to the first birthday) the patient was vaccinated with M-M-R II (Inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Pain radiating from (L) delt IM site, to (L) shoulder, to (L) neck since im on 8/4/07 through today 8/10/07
Within 24hrs of vaccination (the next am) pt had about 1 1/2 cm area of raised, fine erythema at our (L) thigh injection site with T 99.1 ear. Checked in office 8/30/2012.
0.5 ml of flu vaccine given of the 36 months and older vacc.  Pt is only 24 months.  No reactions occurred as of yet.
Pt devel GBS w/paralysis approx 3 wks p/receiving influenza vax; pt believes the vax caused this problem;
she started to draw it up she noticed the "bottom of the vial was completely gone" and the medicine went all over her, no AE; bottom of the vial was completely gone, vail was cracked on the bottom, no AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case involves a female patient (age not reported) who was exposed to DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ208ABA) while preparing product for administration via unknown route in unknown administration site for prophylactic vaccination on an unknown date (occupational exposure to product and product physical issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of occupational exposure while preparing product for administration and cracked product  It was reported that when she started to draw vaccine up she noticed the "bottom of the vial was completely gone" and the medicine went all over her. She removed another vial from the carton and started to withdraw the medication and noticed it was cracked on the bottom. Incident happened prior to use.  At the time of reporting, no adverse event was reported.  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.
28FEB97 pt devel achiness in neck & shoulders;pt became completely disabled w/pain;every joint in body hurt & pt could not stand or sit;pt could not perform duties @ work;some days could not lift arms or use hands;dx rheumatoid arthritis;
Approximately 36 hours (1.5 days) after vaccination, profuse and voluminous yellow-bile vomiting almost every hour (13 times throughout the first day). No food was able to be kept down during, except approximately 2 ounces of Pedialyte toward end of day and a dropperful of Gripe water. After the first day of vomiting, vomiting slowed to every few (4 to 6) hours. After 10 days (when this form is being filled out) there have only been 3 days where he has not vomited, and frequency has slowed considerably to only once a day (if he does vomit). Extreme diarrhea beginning 58 hours after vaccination. Lasted approximately 4 days, after which stools were runny. Solid poop beginning approximately 6 days after the first bout of diarrhea.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL TARTRATE, start date: Oct2020; ALENDRONATE SODIUM, start date: Jun2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Antiviral details includes COVID-19 Treatment of Paxlovid treatment started on 12Dec2022 and treatment stopped on 16Dec2022. Other medication in 2weeks product includes metoprolol tartrate and alendronate sodium  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Infanrix instead of Boostrix; Infanrix administered to patinet older than 10 YO; had 5 Dtaps prior to this shot.; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adolescent male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap vaccine (received 5 doses of Dtap vaccines prior to this shot).   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose 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 Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The patient already had 5 Dtaps vaccines prior to the shot. The nurse reported that the patient received Infanrix instead of Boostrix. The reporter consented to follow-up by email. Additional supportive information: The patient received Infanrix instead of Boostrix at inappropriate age after 5 Dtap vaccines, which led to wrong vaccine used and inappropriate age at vaccine administration and extra dose administered. In worst approach, inappropriate age at vaccine administration event was coded as patient was older than 10 years and for the same follow-up request was raised.
15 minutes after vaccination, pt mentioned to receptionist that her tongue "feels funny".  States it feels "like right before you throw up".  No shortness of breath or breathing difficulty.  BP-148/100, P-60, regular.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L028666, exp. date: 04-NOV-2016) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT CLAIMS 2 DAYS AFTER RECIEVING THE VACCINE SHE HAD FLU LIKE SYMPTOMS WHICH GOT WORSE OVER THE NEXT 24 HOURS. SHE SAYS SHE ENDED IN THE HOSPITAL WITH CHEST PAIN AND WAS EVENTUALLY DIAGNOSED WITH A PERICARDIAL EFFUSION WHICH HER MEDICAL PROVIDERS THINK/WERE CONVINCED WAS QUITE SUDDEN AND SUSPECT WAS DUE TO THE SHINGRIX VACCINE ADMINISTERED TO HER.
Vaccine given on  Sunday, 1/30/22. On Monday, the following day, noticed a few red spots at hairline on forehead. A couple or so days later, rash had spread to temple on both sides. More so on the right. By the time I went to dermatologist on 2/7/22, rash had spread down my jawline on both sides, but again mainly on the right and was slightly itchy. By 2/14 it had spread down onto my neck. On 2/18 it started to itch quite frequently and by yesterday, 2/19,  was feeling a burning/stinging sensation and the itching had intensified. Dermatologist thought it might be rosacea and I was instructed to use OTC hydrocortisone cream and to come back if it progressed but not to wait much more than 2-3 wks. I have had no changes to shampoos, detergents, etc. Not sure this is related to that vaccine, however, I have no other explanation that makes sense. What does make sense, is the fact that this rash is following an apparent nerve path, in that it started on my forehead and follows my jawline down onto the neck, similar to what shingles would do. I am not scheduled to go back to dermatologist until 3/3. Being that this has progressively gotten worse in the last 2 days, I will be contacting his office tomorrow morning.
Developed an increased heart rate of 118 with an average of 90. Pulse rate prior to receiving Adacel was 60-70 beats per minute. Symptoms began 8/18/2009, 2 days after receiving Adacel and continue to persist as of 8/24/2009.
Ankles and feet on both sides are incredibly swollen; Sore lymph node; Achy; Swollen lymph node; Highest fever reached 102.8F; Flu-like symptoms; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Not feeling well), JOINT SWELLING (Ankles and feet on both sides are incredibly swollen), LYMPH NODE PAIN (Sore lymph node) and MYALGIA (Achy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MONTELUKAST SODIUM (SINGULAIR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Not feeling well), LYMPH NODE PAIN (Sore lymph node), MYALGIA (Achy), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Highest fever reached 102.8F). On 26-Jul-2021, the patient experienced JOINT SWELLING (Ankles and feet on both sides are incredibly swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Not feeling well), JOINT SWELLING (Ankles and feet on both sides are incredibly swollen), LYMPH NODE PAIN (Sore lymph node), MYALGIA (Achy), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Highest fever reached 102.8F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Body temperature: 102.8 (High) 102.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also include high potency iron.
Felt warm to touch (temp not taken immediately), crying that his arm was extremely sore. Visibly red, swollen and enlarged injection site. Injection site very hot to the touch. Later on, temperature was taken - reading 101.5. Complaints of arm pain continued - redness increased (deepened in color) and he began crying that his lips hurt and started pulling on them because they felt tight.
This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot number: M027879 expiry date: 24-JAN-2018, route of administration was not reported. Temperature time excursion was 1 hour > 46 degree of Fahrenheit but < 77 degree of Fahrenheit, and 3 hours between 32 degree of Fahrenheit and 36 degree of Fahrenheit. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007041: US-009507513-1702USA007042: US-009507513-1702USA006595.
EXTREMELY HEAVY MENSTRUAL BLEEDING OCCURED ON THE DAY OF THE  SHOT, CLUMPS OF BLOOD WERE RELEASED AND THIS HEAVY CLUMP MENSTRUATION LASTED FOR OVER 2 WEEKS, LEADING ME TO SEEK MEDICAL HELP.  PERIOD LASTED 3 WEEKS AND MENSTRUATION HAS BEEN IRREGULAR EVER SINCE
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The medical assistant reported on an unknown date, unknown number of patients were vaccinated with a dose of GARDASIL (lot#, dose/frequency and route unknown) which were improperly stored. No adverse effects reported. This is one of three reports (MARRS#: 1403USA009143; 1403USA009144) received from the same reporter. Additional information has been requested.
Redness, swelling, bruise, tenderness on site left deltoid arm 3x4 cm.
Itching and hives all over the body.  Legs, arms, hands, feet, chest, back, and face.
This spontaneous report as received from a 79 year old male patient concerning himself. 6 month ago, in January 2013 the patient was vaccinated with ZOSTAVAX (lot number, dose and injection site were not reported) (one time, subcutaneous). On 08-JUL-2013 the patient's doctor diagnosed him with shingles on his head and scalp. It had not blistered, but was painful and he said he had a rash on the right side of his head. The patient had seen his clinician for medical attention. Treatment was given as valacyclovir hydrochloride 1 gram taken every 8 hours. There was no lab diagnostics studies performed. The action taken and outcome were not provided. Additional information has been requested.
This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M031945, expiration date 27-DEC-2017; lot # M044575, expiration date 04-MAY-2018 and lot # M041082, expiration date 04-APR-2018 (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 3 hours and 49 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA010341:
This spontaneous report was received from a register nurse refers to an unknown number of patients of unknown age and gender. Medical history was reported. The reporter informed that on an unknown date the patients were vaccinated with ZOSTAVAX vial, lot number, expiration date, strength, dosage and route were not reported. Also informed that the ZOSTAVAX was exposed to -14C for an unknown number of hours occurring intermittently over a period of 20 months. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.