chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administering fluzone quadrivalent to a 72-year-old patient instead of fluzone high dose quadrivalent with no reported adverse event; administering fluzone quadrivalent at a dose of 0.25 ml with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 72-years-old female patient who was administered influenza quadrival A-B vaccine [Fluzone Quadrivalent] instead of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] at a dose of 0.25 ml with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant(s): No other vaccines.  On 19-Sep-2023, the patient received 0.25 mL dose of suspect influenza quadrival A-B vaccine, Suspension for injection (Frequency: once; Strength: standard) (batch number: UT8134LA; expiry date: 30-Jun-2024) instead of influenza quadrival A-B high dose HV vaccine (batch number; expiry date: unknown) via intramuscular route in unknown administration site for Immunization with no reported adverse event (wrong product administered) (incorrect dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 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.
The next morning at around 8 AM I noticed his left eyelid starting to swell. He also had a low-grade fever of about 100. By 12:30 PM, his eye lid was so super swollen and his temperature was at 103.9. We took him to the pediatrician and she tested for strep throat and flu which both came back negative. We were told to monitor him and were sent home. When we got back home the swelling on his left I started to subside, and all the swelling shifted to the right side of his face. His Right cheek and down to his lip started to severely swell. His temperature was also at 103.We called my pediatrician back and they recommended going to the ER which we did. At the ER they gave him an epinephrine shot and another dose of BENADRYL. It is now two days after the dose of vaccines, and my sons eye is still swollen.
the noc of flu vax pt felt cold & hot;never felt good rest of the wk, feverish & chills on the weekend;went to MD 3NOV because of chills & fever;found no visible infect;no urinary infect either;
Patient has since developed heart failure and had a thrombus in his left ventricle.  He also developed shingles as well.
0952 C/O Dizziness, blurred vision. BP 115/72,HR 78, sats 97%, resp 18. 0956 symptoms resolved. 1020 Left ambulating home states her grandfather will drive her home .
about 5 minutes after receiving the Pfizer vaccine passed out, his body tensed up and he started shaking for about 30 seconds and started groaning. He came to and began talking with the pharmacist and his son. He got some water and a trash can because he felt sick to his stomach. After about 20 minutes he felt fine and left the store.
Face was all hot, red and blotchy. Symptom lasted for about a half hour and then went away.
The say after receiving the vaccine, 12/24, I experienced normal side effects including pain in my arm, fatigue, and mild fever.  These SEs improved daily and by Monday, 12/28, I was free from SEs.  However on the morning of 12/31 I began experiencing mild pain in my upper left arm again. By mid day I had developed a raised, red, warm area around the injection site a bit smaller than a baseball.  I applied an ice pack.  The area enlarged by 1/1 and I continued to apply ice and took a dose of diphenhydramine.  It appeared to be less red on 1/2 but started to worsen again on 1/3, becoming larger and redder again.  It began to itch on 1/4.  Today it is larger than the size of my entire hand (including fingers), extending to about 3 inches above the bend of my arm.  It continues to be itchy, warm, raised, and red, primarily around the perimeter and the lower portion of the site.  While this is not a severe reaction it concerns me that it was delayed and continues to worsen and is not improved by diphenhydramine.
Patient presented to the ED immediately after receiving COVID vaccination with swollen tongue and difficulty swallowing. Per doctor's note: she received intramuscular epinephrine, IV Pepcid, IV Solu-Medrol and IV fluids.  Monitored until 3 hours after exposure, no new or worsening signs or symptoms.
Patient had HPV vaccine at approximately 1400h and by 1700h was coughing up yellow secretions a vomiting.
Temp 100.9 after vaccines. 24 hours later no redness or discomfort.
On 04-01-2021, I started to experience fever, chills and terrible  headaches. I also developed pneumonia. A chest x-ray was done which demonstrated ground glass opacities. My breathing was also bad. I also have an enlarged heart.  I also do not have any blood clots. I did not have problems before the J&J vaccine. To this day I still have headaches that come and go.  I do not know if the J&J vaccine attributed to my symptoms and my doctor is till monitoring me.
Insomnia; High blood pressure; Headache; a very very bad reaction; a violent debilitating migraine for 13 days; she can barely move her body; couldn't move her arm for 3 days; she was very very ill; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (a very very bad reaction), MIGRAINE (a violent debilitating migraine for 13 days), MALAISE (she was very very ill), DISCOMFORT (she can barely move her body) and LIMB DISCOMFORT (couldn't move her arm for 3 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Rheumatoid arthritis, Fibromyalgia, Parkinson's disease and Osteoarthritis. Concomitant products included GABAPENTIN (NEUROTIN [GABAPENTIN]), FLUOXETINE HYDROCHLORIDE (PROZAC), TOPIRAMATE, ZOLPIDEM TARTRATE (AMBIEN), CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), TRAMADOL HYDROCHLORIDE (ULTRAM ER) and FENTANYL (FENTANYL ABZ) for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (she was very very ill). On 05-Feb-2021, the patient experienced ADVERSE REACTION (a very very bad reaction), MIGRAINE (a violent debilitating migraine for 13 days), DISCOMFORT (she can barely move her body) and LIMB DISCOMFORT (couldn't move her arm for 3 days). On an unknown date, the patient experienced INSOMNIA (Insomnia), HYPERTENSION (High blood pressure) and HEADACHE (Headache). The patient was treated with SUMATRIPTAN at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) for Migraine, at an unspecified dose and frequency and PROPRANOLOL HYDROCHLORIDE (INDERAL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (a very very bad reaction), MIGRAINE (a violent debilitating migraine for 13 days), MALAISE (she was very very ill), DISCOMFORT (she can barely move her body), LIMB DISCOMFORT (couldn't move her arm for 3 days), INSOMNIA (Insomnia), HYPERTENSION (High blood pressure) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 156/128 (Inconclusive) 156/128 and 196/148 (High) 196/148. On an unknown date, Heart rate: 126 (Inconclusive) pulse 126. On an unknown date, Oxygen saturation: 70 (High) 70's and 80 (Low) 80's.         Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Lab tests, Toradol and Inderal treatment medication, Insomnia, Hypertension and Headache events added.
Pt recd vax @ clinic 15NOV91 became ill on 17NOV91 w/fever 102 & confusion taken to ER admitted while hospitalized discovered urinary tract tumor; p/4 days hospitalized discharged by MD; dx encephalopathy/post influenza vax-encephalitis;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No current condition was reported. No historical medication was reported. On 21-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose strength was reported). No concomitant medication was reported. Pharmacist reported that expired PNEUMOVAX23 was given to patient on 21-AUG-2014. No adverse effect was reported. The outcome of expired PNEUMOVAX23 was given to patient was unknown. No PQC was involved. Additional information has been requested.
Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.
The patient received a routine booster shot with Td-170 on Friday, 02/01/2008. Immediately, she felt a burning sensation, and then developed a large red circle around the injection site with a bump. The reddened area was also hot to the touch. 2/25/2008: Multiple attempts to obtain follow- up information on the patient's recovery have been unsuccessful.
About a week after I received the 1st dose of the vaccination I noticed redness, swelling, and tenderness just below the the site of the injection. The symptoms lasted for about 24 hours before they resolved.
SICK ALL THE TIME; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was never sick in the winter until took the shots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick all the time. This report was non-serious.
On 10/17/2022 tested due to exposure and mild symptoms, and tested positive. On first day I experienced slight headache, congestion, and sore throat. On day 2 began having runny nose. Reached out to PCP on 10/17/2022 and began PAXLOVID the same day. Began experiencing improvements in symptoms between 12-24 hours after beginning anti-viral.
Severe swelling, pain at injection site: 7 days; Severe headache, day 7-12; fatigue and flu-like fatigue and body aches, day 12-21; extreme diarrhea, day 12-present; nausea and vomiting, day 12-21; severe rash, day 21-present.
pt fussy 8DEC95;woke up screaming 9DEC95;temp 104.6R; saw MD @ ER;was told that it was adverse rxn to pertussis;family to give advil/APAP & warm baths
Elevated blood pressure. Extremely cold, chills, very fast heartbeat. Increased respirations. Shaking, drymouth, could not move. Tingling sensations. Weak, fatigued - headache. Increased appetite. Treatment = given oxygen and VISTARIL. RE: REACTION TO H1N1 VACCINATION ON 11/20/2009. I am writing to inform you about the reaction I got from H1N1 vaccination on November 20, 2009 and the costs to me and my insurance company. On the stated date, I received H1N1 injection at 2:45 pm and went to my unit upstairs through the elevator to work. Within the space of 3 minutes after the injection, I became dizzy, short of breath with tingling all over my body, I became very weak that I could not walk, I bad horrible chills and was shaking, my mouth became very dry and I had increased appetite, my blood pressure was increased to 177/88, my heart was beating beyond proportion as if it was going to fall off from me, my respiratory rate was very high, my O2 sats was 55. 911 WAS CALLED. I ENDED UP IN THE HOSPITAL. LOT # FOR THE VACCINE = 102044P1. Prior to receiving the vaccine, I had no health issues. I was very healthy. All the above reactions came right after I had the H1N1 injection. I was off work on the 11th and 12th of November 2009 as a result and I do not know what permanent damage it has done to my body system. My work comp declined payment of the reaction and stated that I chose to have the injection. I have made efforts to have them pay and they refused. So I ended up having my insurance pay part of the bill while I paid the other part. Recently, I received a letter from VAERS urging me to seek compensation for the reaction. I even contacted an agency and they referred me back to my work comp. After a while I gave up hope until the VAERS wrote me (copy of the letter is enclosed). I have attached some documents relating to the incident. If you have any further questions please contact me on the telephone number listed above.
really bad flu symptoms; waking up sweaty on wet sheets; feeling hot; feeling nauseous; body aches; headache; feeling really tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous) and MYALGIA (body aches) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (feeling really tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (really bad flu symptoms), HYPERHIDROSIS (waking up sweaty on wet sheets), FEELING HOT (feeling hot), NAUSEA (feeling nauseous), MYALGIA (body aches) and FATIGUE (feeling really tired) had not resolved and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Child began to have seizures at home; was seen at medical center and seizures observed at medical center. Had follow-up visit.
This case was reported by a healthcare professional and described the occurrence of nodule injection site in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 28 May 2012 at 11:00 the subject received 1st dose of BOOSTRIX (unknown, left deltoid). On 30 May 2012, 2 days after vaccination with BOOSTRIX, the subject experienced nodule injection site and hardness injection site. The healthcare professional reporter the subject developed a hard knot at the injection site. Heat application was used. At the time of reporting the nodule injection site and hardness injection site were unresolved. The healthcare professional considered the nodule injection site and hardness injection site were possibly related to vaccination with BOOSTRIX.
Blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 20th September 2021) for prophylaxis.   On 14th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. The patient experienced blisters on her hand and her back.  The patient at the time of reporting had recovered from the blisters.  No further details were provided.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unknown race/ethnicity received TRUMENBA in Nov2017 at single dose via an unspecified route of administration for immunization. On the same date the patient received MENACTRA and influenza vaccine. On the same date the patient passed out. Patient's concomitant medications, medical conditions, and investigations were unknown. The information on the lot number has been requested. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine contributed to the development of the reported event "passed out".
110-115 pulse rate; Pain in the left arm (8 out of 10 pain); Brain fog; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm (8 out of 10 pain)), CONFUSIONAL STATE (Brain fog) and PULSE ABNORMAL (110-115 pulse rate) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm (8 out of 10 pain)) and CONFUSIONAL STATE (Brain fog). On an unknown date, the patient experienced PULSE ABNORMAL (110-115 pulse rate). On 11-Jan-2021, PAIN IN EXTREMITY (Pain in the left arm (8 out of 10 pain)) and CONFUSIONAL STATE (Brain fog) had resolved. At the time of the report, PULSE ABNORMAL (110-115 pulse rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Heart rate: 110-115 pulse rate.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-128001 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128001:Same patient (2nd dose)
Breakthrough COVID infection. Patient reports chest pain, shortness of breath, headache, nausea and vomiting starting 08/07/2022. Tested positive 08/08/2022.
starting  4 to 5 days following the vaccine, she  developed a bilateral rash with hives from the top of her hands to above the elbows.
Information has been received from a pharmacist concerning an elderly patient who on 18-SEP-2006 was vaccinated with Varivax instead of Zostavax. The "mix-up" occurred when the pharmacy sent up the Varivax instead of the Zostavax that had been ordered and it was administered to the patient. No additional information was provided.
vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022; vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) and PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 038A21A, 040B21A and 013H21B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Blood pressure increased.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 12-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 22-Dec-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 10:00 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022). On 19-May-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) and PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (vaccine was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 19-May-2022).    No concomitant medication was reported. The vial expired on 13-May-2022 was placed in refrigerator on 21-Jan-2022.  The event did not cause patient to seek medical care. The reporter did not report any other potential causes. The patient did not experienced a similar event in the past.  Allergies to medications, food, and other products was reported as unknown. Acute illnesses at the time of vaccination and up to one month before was reported as unknown.  No treatment medication was reported.
Boost dose given prior to recommended 28 day interval.  (given on day  20)
Fever; chills; muscle pain; joint pain in knees and elbows; This is a spontaneous report from a non-contactable consumer reported for a patient. A 44-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 03Feb2021 at 09:45 am (age at vaccination was 44 years) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COPD, former smoker, depression/mental health. The patient did not have any known allergies. Concomitant medications patient received within 2 weeks of vaccination included loratadine, pseudoephedrine sulfate (CLARITIN-D), spironolactone, multivitamin, colecalciferol (VITAMIN D [COLECALCIFEROL]). On 03Feb2021 at 13:30 pm, the patient experienced fever, chills, muscle pain and joint pain in knees and elbows. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.