chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a pediatric dose of HEP A instead of an adult dose. Patient was given an apt on 07/26/18 to administer correct adult dose, patient is aware of situation and agreed to come in clinic. Pt did not state to have any abnormal symptoms.
Pt. had reaction to DTAP.Lumpy with redness to lt thigh.
Every year I get the flu shot within a few hours I start getting red irritated eyes, vomiting, fever, chills/hot flashes, clammy.  Basically, I have all the flu symptoms after getting the vaccine.  It has happened since I was a kid.
Soreness/tenderness at injection site, achy joints, left  Axillary swelling and tenderness
Sore arm, Fever, fatigue, headache, treated with Advil/Tylenol, ok by next morning.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022; Vaccine administered to patient past its 30 day expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 4:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022 at 4:25 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 24-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's ethnicity was reported. No concomitant medication was reported. On 24-Jan-2022, the patient received the booster dose of the vaccine. No treatment information was reported   This case was linked to MOD-2022-542869 (Patient Link).
No adverse event; Patient received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant medications were reported.  The patient administered with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml instead of 0.5 ml. Vaccination date was reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  No treatment information was reported.
This spontaneous report as received from a physician via a company representative refers to a 16 year old male patient. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, in 2012 the patient was vaccinated with three doses of GARDASIL (lot#, expiry date, dose not reported, intramuscularly). On an unknown date in 2015, the patient was vaccinated with the 4th dose of GARDASIL (lot#, expiry date, dose not reported, intramuscularly). The patient did not seek medical attention. No adverse event was reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 27-AUG-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot# reported as K004485, expiration date 21-AUG-2015, dose and route of administration were not reported) by an unspecified healthcare provider. No adverse effects were reported. Additional information has been requested.
Hot, red and itchy at injection site; Large hard lump at injection site; Hot, red and itchy at injection site; Swelling at injection site; Hot, red and itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot, red and itchy at injection site), VACCINATION SITE INDURATION (Large hard lump at injection site), VACCINATION SITE PRURITUS (Hot, red and itchy at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Hot, red and itchy at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot, red and itchy at injection site), VACCINATION SITE INDURATION (Large hard lump at injection site), VACCINATION SITE PRURITUS (Hot, red and itchy at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Hot, red and itchy at injection site). At the time of the report, VACCINATION SITE WARMTH (Hot, red and itchy at injection site), VACCINATION SITE INDURATION (Large hard lump at injection site), VACCINATION SITE PRURITUS (Hot, red and itchy at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Hot, red and itchy at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received treatment which included Ice and warm water.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: The Follow up case was received on 14-APR-2021. Event out come updated. On 09-Jun-2021: Follow up received on 09-jun-2021 contains no new information.
Patient reported feeling lightheaded, dizzy, and feeling "sick", Speech initially incoherent with conversation.  BP 100/49 Temp 104.3 O2: 99% HR 78
Extreme fatigue started a few hours after vaccine and lasted throughout the next day. There was a feeling of being "out of touch" or in a fog which lasted throughout the next day, as well. Stomach ache and nausea started the following evening after vaccine. By the 2nd day after, no adverse affects.
Swelling to injection site, with redness In 12/22/2013. On 12/23/2013 increased size of swelling and more redness and soreness. Dizziness with chills but is warm. Heated cheeks and goosebumps.
Swelling on the left side.  Dr prescribed a fluid pill, Furosemid, to help with swelling.  Diagnosed with Bursitis in left hip, prescribed ibuprofen 800mg for that.  Swelling has gone down, but pain remains.
Patient told us that she has passed out and vomited after receiving vaccines in the past. After getting the vaccine, she didn't feel well. We monitored her in the vaccine room for about 5 minutes. She had a drink of water, then when she was ready, her family helped her into the lobby I returned to the pharmacy, and continued to watch her. The patient's mom came to the window and said patient had fainted. I went to her, and said we need to lower her to the floor. At that point, mom said patient was not breathing I quickly lowered her to the floor, while dad supported her head. I didn't have time to verify that she wasn't breathing, because as soon as she touched the floor, she began convulsing, then sat up and w was immediately awake. She sat up, and we explained that she had passed out and I had her lie down. I stayed with her for a few minutes, asking if they wanted an ambulance (which mom and dad declined) while making sure she was ok. She was just resting at this point, so I returned to the pharmacy, and ask them to let me know if anything changed I continued to watch her from the pharmacy window, and the patient said she was nauseated. We gave mom a bag, and patient vomited in the bag. After a couple more minutes, she seemed to be recovering, and mom and dad helped her out of the store. I followed up with mom at 4:15pm, and mom said patient was still nauseated and had vomited a couple more times. I followed up one last time at 4:45pm, and patient was feeling a bit better, but mom was going to keep an eye on her I recommended that mom take her to a doctor to be evaluated, but mom said she would just keep an eye on her through the night. I told mom that I would follow up again in the morning.
Information has been received from a registered nurse concerning a 14 month old female with asthma and no allergies who on 6/3/04 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live (lot # 636582/0447M). Concomitant vaccination the same day included a first dose of MMR (lot # 644618/1036M) given SC in the left leg. Other concomitant medication includes albuterol nebulizer and fluoride supplement. There was no illness at the time of vaccination. It was reported that the varicella virus vaccine live expired on 5/23/04. No adverse symptoms were noted. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information indicated that the patient had no adverse events except for mild pain at the site of injection. On 6/4/04 the patient recovered. No further information is available.
December 1, 2021 Vaccine vial transferred from Freezer to Fridge January 6, 2022 vaccine administered.
resident received expired Moderna vaccine, expired on 10/13/2021. No ASE noted.
1st Moderna shot in right arm 4/3/2021: General fatigue and sore arm occurred and lasted 1-3 days after the first shot. On days 7-9, a red, hot-to-the-touch, extremely itchy red welt (about 3-inches round) appeared at the injection site. On 4/28/2021, a row or painful shingles rash appeared along the entire inner-side of my left index finger. The 2nd Moderna shot was given in my left arm on 5/1/2021. The fatigue was less this time but about four hours after the shot my tongue got dark red and started to swell. It remained that way for a little over a day. Then 24 hours after the shot, I got migrating nerve pain. It felt like I was being stabbed over and over. It would stay in one area 10-30 min, then feel okay for a little while, then move to a different area. This lasted about 4 days. Pain was felt in arms, armpits, feet/ankles, thighs, breasts, sides of ribcage. Index finger still hurts from weeks ago, but red blistery rash is now just skin-colored bumps.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (.5 ml, subcutaneous, unknown site) and experienced intramuscular formulation administered by other route. The BOOSTRIX is indicated to be administered intramuscularly. At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site pain and injection site redness. The nurse practitioner reported that "BOOSTRIX was inadvertently administered subcutaneously and caused pain and redness at the injection site." At the time of reporting the outcome of the events were unspecified.
Fevers: 100.7-100.9 with Tylenol Fatigue Disorientation Itching
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in lateral left arm to pinky finger
9/29/21  pt brought to hospital from SNF; had a positive COVID test on 9/1/21; another COVID test on 9/29/21 came back positive; has been on steroids; presents with difficulty talking, right sided weakness/facial droop, SOB; O2 supplementation; COVID pneumonia and stroke; ABX and Decadron given; pt's condition worsened, more hypoxic; poor prognosis; DNR/DNI; pt passed away in the hospital
neuropathy; fatigued; infected toe; Rheumatoid arthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 1K-163-4195946-00 (Abbvie).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "HIP REPLACEMENT" (unspecified if ongoing); "KNEE REPLACEMENT" (unspecified if ongoing); "SHOULDER REPLACEMENT" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Feb2021, outcome "unknown", described as "Rheumatoid arthritis"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; LOCALISED INFECTION (non-serious) with onset Aug2021, outcome "unknown", described as "infected toe"; FATIGUE (non-serious), outcome "unknown", described as "fatigued". The action taken for upadacitinib was unknown.  Additional information: The patient In August 2021 with experienced right big toe became infected after getting a thorn and it was not healing. In Feb2021, patient's arthritis symptoms increased for several months after having the covid vaccine and also mentioned being fatigued. He also had Neuropathy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events rheumatoid arthritis flare up, infected toe and neuropathywas not provided with RINVOQ (UPADACITINIB). The reporter's causality for the events rheumatoid arthritis flare up, infected toe and neuropathy was not related with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of Rheumatoid arthritis, Neuropathy peripheral and Localised infection are assessed as Unrelated to the suspect drug bnt162b2 based on  possible contributory effects from patient's medical history and/or concomitant medications.
Allergic reaction to vaccine on right thigh.  Large, round, red circle on right side of right thigh.  Size of an orange.  Mother gave Benadryl MD gave prescription for CRA pred taper and Benadryl.
Monovalent COVID 19  Booster Vaccine was administered incorrectly, since the drug agency removed the authorization.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 14-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Shaking, chills. Fever to 104. Myalgias. Red, angry arm distal to injection site.
Series 2 Shot On 05/08/2021 at 10:30am noticed hives on chest and a circular red spot (rash) at injection site.
Information has been received from a nurse referring to a patient of unknown age and gender. On 27-MAY-2015 the patient was vaccinated with the first dose of GARDASIL (lot# K001631 with expiration 06-NOV-2016 (expiration was also reported as 06-JAN-2016), 0.5 ml) intramuscularly. On 26-JUN-2015, the patient was vaccinated with the second dose of GARDASIL (lot# K023432 with expiration 18-JUN-2016, 0.5 ml) (Inappropriate schedule of vaccine administered). On 30-OCT-2015, the patient was vaccinated with the third dose of GARDASIL (lot# was reported as L016429 is an valid lot# for GARDASIL). Additional information has been requested.
2/1/2023 In the evening I had a bout of vertigo. I called the nurse line and they advised I take a trip to the ER. In the ER they checked vitals, was given something for nausea. Spent a few hours in the ER and sent me home. The vertigo slowly went away. Methocarbamol was prescribed from the ER. Took a week to fully go away.
Left side of body pain & stiffness left hip pain. Improving over time. Advised to take OTC antihistamine and OTC pain reliever.
Temperature Excursion; Initial report received on 24-Aug-2023.  A certified medical assistant reported that a 44-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.   No relevant medical history was reported.  No relevant concomitant medications were reported.    On 13-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, route, site, and NDC # not reported). On 21-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot # 941428, expiration date: 30-Aug-2025 and NDC # 43528-003-01; route not reported) in the left arm.   On 21-Aug-2023, the patient received HEPLISAV-B after a temperature excursion occurred. No adverse effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Mild, Additional Details: Patient had a rash on chest, back, stomach starting day after vaccine. Patient consumed nuts on 4-6-2021, but she thinks she already had rash when she consumed nuts
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 77.94.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 29, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021. 2 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021.  On 31-Mar-2021, Excursion time was 10 AM, temperature was 3~2, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 4 vials were sent to clinic. Vaccine BUD date was 04-Nov-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
swelling at injection site; redness at injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number LH7ED, expiry date 25th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. Nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from Nurse on 3rd April 2020 as follows: The patient's demographic details were updated. The batch number updated for the suspect vaccine.  The patient's past medical history included mixed hyperlipidemia from  28-AUG-2014.  On 10th January 2020, the patient received the 1st dose of Shingrix .5 ml.  On an unknown date, Less than 3 months, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown.  It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix. The VAERS details were updated.