chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored PNEUMOVAX23 lot# M022947, expiration date 12-NOV-2017; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, Duration of temperature excursion): 02-NOV-2016, 47 degree Fahrenheit (F), 25 min 02-NOV-2016, 48 F, 20 min 02-NOV-2016, 34 F, 91 min 03-NOV-2016, 34 F, 115 min 11-NOV-2916, 34 F, 1 min 13-NOV-2016, 34 F, 38 min 13-NOV-2016, 33 F, 35 min 14-NOV-2016, 34 F, 350 min 14-NOV-2016, 33 F, 240 min 15-NOV-2016, 33 F, 111 min 15-NOV-2016, 34 F, 307 min 14-NOV-2016, 33 F, 112 min 14-NOV-2016, 34 F, 212 min. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007362: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007063: US-009507513-1703USA000989:
Covid positive; Covid positive; This is a spontaneous report from a contactable consumer (parent) via the Pfizer sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as single dose, and dose 1 of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose forCOVID-19 immunisation. The patient medical history and concomitant medications were not reported. As parent  reported for the daughter that his/her daughter was fully vaccinated with Pfizer Covid vaccine and she was currently Covid positive and fighting the virus. A study needed to be taken on who was vaccinated and who ended up getting the virus, so the general public was aware. The patient underwent lab tests and procedures which included COVID-19 with result of positive on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date in 2008).   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose (booster dose) of Havrix vaccine, which led to incomplete course of vaccination. The reporter enquired if patient should receive second dose now or restart the series. The reporter did not consent to follow up. No other additional details provided.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose and route of administration were unspecified) lot # N013521 (expiration date 23-JAN-2019) for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature excursion of 32 to 35 Fahrenheit degrees for a timeframe of 72 hours. There was no previous temperature excursion or digital data logger involved. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA005583.
Patient received incorrect vaccination of High Dose Flu shot. A second vaccination was given in place of Shingrix vaccination. Patient notified of incorrect vaccination being administered and incident report was completed.
Localized urticaria within 5 minutes in arm vaccinated followed by diffuse erythema and urticaria.
Almost total lack of appetite and some foods that I used to like don't appeal or make me nauseated. My weight has had an unintended loss of 25 pounds.
Pt. ran a low grade fever. She also developed a 3 inch diameter area of erythema and mild edema to injection site within the next 24 hours. Mom gave BENADRYL - MOTRIN every 6 hours for 2 days. Symptoms improved.
Woke the next morning with just a sore arm. Progressed to headache, nausea, fever, severe body aches, and weakness approx 18hrs post vaccine.
deep pain in her hands; hands appear bright red and don't function as usual; Large nodules have appeared on her hands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (deep pain in her hands), ERYTHEMA (hands appear bright red and don't function as usual) and NODULE (Large nodules have appeared on her hands) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Squamous cell carcinoma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (deep pain in her hands), ERYTHEMA (hands appear bright red and don't function as usual) and NODULE (Large nodules have appeared on her hands). At the time of the report, PAIN IN EXTREMITY (deep pain in her hands), ERYTHEMA (hands appear bright red and don't function as usual) and NODULE (Large nodules have appeared on her hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
15 MINUTES AFTER VACCINATION, CLIENT STARTED WITH REDNESS TO RT DELTOID WHERE SHE RECEIVED THE SHOT.  REDNESS STARTED AND SPREAD DOWNWARD TO HER RT FOREARM WITHIN THE NEXT 2 MINUTES.  RED SPOTS NOTED TO HER CHEST AND BACK AND SIDE OF HER FACE WITHIN THEN NEXT 1-2 MINUTES.  BENADRYL 40 MG 8ML INJECTION IM TO HER LT DELTOID.  AT 5:30 PM BY RN.  BY 5:35 ALL RASH HAD CLEARED CHILD WAS DISMISSED AT 6:00 PM AMBULATORY ACCOMPANIED BY MOTHER.
Arm broke out: from Shoulder half way towards the Elbow was red; inflamed injection site; Injection Site Felt Fevered (Clarified Hot to the touch); heart palpilation; Tiredness; had no energy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), ASTHENIA (had no energy), ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate increased.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Tiredness), ASTHENIA (had no energy) and HEART RATE INCREASED (heart palpilation). On 25-Mar-2021, the patient experienced ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)). On 25-Mar-2021, FATIGUE (Tiredness), ASTHENIA (had no energy) and HEART RATE INCREASED (heart palpilation) had resolved. At the time of the report, ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided by the reporter  treatment she took was Antihistamine also has been rubbing the Injection Site with Alcohol.
This individual is a COVID-19 vaccine breakthrough case. Individual was asymptomatic. Not hospitalized.
5 years female, with red, swollen arm around vaccine injection site 1 day after vaccination.
Orthostatic (HR 120 supine & 140 standing); reactions nausea, vomiting, h/a, weak, temp102; BP 110/60;
redness around my neck and face; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient had second shingles shot and had redness around my neck and part on my face. Additional Supportive Information: The follow up would not possible as no contact details were available.
Severe hives and itching. Started a few days after injection and almost not noticeable. Has increased until I can hardly sleep. I put otc anti itching creams and sprays all over as well as prescription topicals and pills (Hydroxyz, Ivermectin, Triamclnolon) and cortisone injections. Nothing has worked.  I had first injection 1/18/2021 and 2nd injection 2/9/2021.  Not sure of dose numbers but these  appear on vaccine card: 1ST SHOT 59267100001 EK9231  AND 2ND SHOT EL8982 59267100001
Experienced flu-like symptoms for 3 days. A week later, developed painful muscle cramps in calf muscles and muscle twitches all around the body but mainly in my legs. I also developed an internal tremor, long-term fatigue, tightening of the left cheek muscle, bad headaches, sore skin patches, scalp pain & back pain. Two years later, I still have constant twitching in my legs and around my body and some muscle cramping, as well as fatigue, a sore scalp and a sore back.
Patient vaccinated x4 (Pfizer: 2/26/21, 3/19/21, 8/18/21, 2/1/22)  Patient tested COVID+ on 6/20/22 and was admitted to the hospital
Outbreaks of Herpes 2, similar in severity and frequency to initial outbreak 40 years ago (fever, malaise, headache, diarrhea, severe blistering with bleeding lasting 4 - 5 days).  Gradual reduction in frequency and intensity of outbreaks over the following 6 months.  During the intervening 40 year period, outbreaks had been very rare, occurring less than once in every 7 - 10 years.
Pt developed a rash on her finger that spread to her wrist. Benadryl 25mg was given.. the rash improved. Pt blood pressure elevated 195/113, repeat 207/117. Pt developed nausea and abdominal pain. Pt was transported to the ER
Fever after second dose; Chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after second dose) and CHILLS (Chills after second dose) in a 35-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after second dose) and CHILLS (Chills after second dose). At the time of the report, PYREXIA (Fever after second dose) and CHILLS (Chills after second dose) outcome was unknown.            No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.
Arm swelled up (Left arm) red rash appeared, center of shot area got hard, and it itched real bad. Had shot on Nov. 30 and still have small area of red. Was told to use cold compresses and BENADRYL cream.
head foggy, fever, chills, nausea, extreme muscle and joint pain, headache
Information has been received from a nurse practitioner concerning an 18 year old female patient who on 10-OCT-2008 was vaccinated with first dose of GARDASIL  (Lot # number not reported) 0.5ml, intramuscularly in deltoid. On 10-DEC-2008 she received second dose of GARDASIL (lot # number not reported) 0.5ml, intramuscularly in deltoid. After the patient received the vaccine she developed pain at the injection site which radiates down her arm. The pain has impaired mobility and the pain has persisted for the past 19 days. There were not laboratory diagnostics performed. At the time on the report on 29-DEC-2008 the patient was not recovered. The patient sought medical attention in the office. Additional information has been requested.
29MAY92 eryth-macular eruption @ inject site w/surrounding fine erythematous macules; unk which vax  (DTP/HIB); 31JUL92 eryth macule @ site of vax; spread of erythematous fine macules to chest, abdo, back, arms & legs;
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 83 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309858, 20220310306 and 20220309972.
Expired vaccine administered to the patient 48 hours after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient 48 hours after the vial was punctured) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient 48 hours after the vial was punctured). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient 48 hours after the vial was punctured) 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.   No Concomitant medication information was reported.   No treatment medications were provided.   One vial was affected. The vial did not under go any temperature excursions. As the practice at the pharmacy is to remove a dose from the refrigerator to administer the Moderna COVID-19 vaccine the vial never reached room temperature.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up information received  contains no new significant information.
Patient was due for 2nd dose on 4/27/21, administered second dose early on 4/25/21
Later that day on 12/11/09 when the pt received the 2nd dose, the pt had bruising and swelling in both legs. On Monday 12/14/09 the pt had high fever with vomiting. On Tuesday 12/15/09 the pt developed spots all over her body. Pt was seen by ER and also by her PCP Dr. where she was dx with Henoch Schonlein Purpura.
Red, itchy, small bumps on back of hands and chest. Started about 1-2 hours after vaccination.
PATIENT WAS GETTING A BOOSTER DOSE OF MODERNA. PATIENT HAD RECEIVED JANSEEN AS THEIR INITIAL DOSE MORE THAN 2 MONTHS AGO. ABOUT 8 MINUTES AFTER GETTING VACCINE PATIENT FELT DIZZY LIGHTHEADED SWEATY NAUSEA, PATIENTS DAUGHTER REQUESTED WE CALL 911. PATAMEDICS ARRIVED A FEW MINUTES LATER BLOOD PRESSURE AND OTHER VITALS WERE OK. PATIENT FELT BETTER AFTER 45 MINUTES OR SO AND WENT HOME. PATEINT HAD RECEIVED A FLU SHOT ABOUT 2 WEEKS PRIOR TODAY AT ANOTHER LOCATION. INFORMATION ABOUT THE SHOT IS UNKNOWN TO ME
Body is sore right; started stiffening up; whole body froze; Couldn't sit up; couldn't move arms and legs; woke up vioent7ly shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (woke up violently shaking), MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up) and LIMB DISCOMFORT (couldn't move arms and legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ(or2)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug (Sulfa drugs).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced TREMOR (woke up violently shaking). On 25-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up) and LIMB DISCOMFORT (couldn't move arms and legs). On 26-Mar-2021, the patient experienced MYALGIA (Body is sore right). On 24-Mar-2021, TREMOR (woke up violently shaking) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (started stiffening up), FEELING COLD (whole body froze), FEELING ABNORMAL (Couldn't sit up), LIMB DISCOMFORT (couldn't move arms and legs) and MYALGIA (Body is sore right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Myalgia is consistent with the known safety profile of the vaccine.
No adverse effects reported; Patient inadverdently received VARIVAX concomitantly with PROQUAD at child's well visit; This spontaneous report was received from a physician refers to a 12 month old patient of unknown gender. Patient's medical history, concurrent conditions and drug allergies/reactions were not reported. On 23-MAY-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot # R030612, expiry date of 31-10-2020) subcutaneously for prophylaxis. The patient was concomitantly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot# R030799, expiration date of 22-APR-2020) subcutaneously for prophylaxis  (Inappropriate dose of vaccine administered). Patient did not experience any adverse effects (no adverse event).  No product quality complaint was associated with this case.
Headache starting 1/29/21 in the evening, continuing for approximately 4 days.  On Tuesday, 2/2/21, I woke up to a rash that was welted (hives?) and itchy all around my neck and shoulders as well as a prickly, stinging sensation on my face.  I have not contacted the doctor again.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 12 month old female was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reactions.  Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200805, PJP200200863, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
No additional AE; HCP reporting an improperly stored vaccine, PEDVAXHIB, was administered to a patient on 8Jul2022.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUL-2022, the patient was administered an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # U014992, expiration date: 29-OCT-2023 (strength, dose, anatomical site, and route of administration were not provided) administered for prophylaxis (product storage error). Before being administered, the vaccine experienced a temperature excursion of 32 degrees Fahrenheit for 40 minutes. There were no previous temperature excursions. No additional adverse events reported (no adverse event).
Pt given 2nd dose of HPV9 vaccine at 3:00. Pt left clinic with parent. On the way home pt noticed Hives on legs and arms. Pt returned to clinic. RN gave 25 mg of BENADRYL orally at 3:30. No difficulty breathing or other symptoms.
Pt recvd Hep B vax on 28FEB92 & on 4MAR92 devel insomnia, dry mouth, hot flashes, cold sweats, severe dizziness, earache, tinnitus, dec hearing, pain in shoulder, bac, & neck;
Post vax the patient developed a red patch on his arm surrounding the injection site, then became faint and vomited. The redness went away after a couple of minutes.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: ADHD. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, vaccination failure. It was reported that patient received treatment of paxlovid for Covid 19 (29May2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was administered flu vaccine in right deltoid muscle of the upper arm. Patient informed Pharmacist 12 days later that he was experiencing pain at the injection site. Pain felt like a knot at the injection site; over time pain improved but moved to front side of arm in bicep. Patient massaged injection site after administration. There was no bruising or bleeding per patient. Advised patient to monitor and if pain does not go away or improve to seek medical attention. Informed primary care physician.