chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 20-Jun-2022, 2nd on 18-Nov-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old male patient who received HAB (Twinrix) (batch number J477Y, expiry date 24th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix  (received first dose on 20th June 2022).   On 8th November 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was 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: 22-Dec-2022 Reporter's comment: The reporter called in to ask the validity of the doses given to a patient of Twinrix.  The third dose was received on 21st December 2022.  Data for the adverse event report was given, including information pertaining to patient and each vaccine's lot number and expiration date. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. As it was not clear that the reported batch number and expiration date (43SYY and 31st January 2023 and 2KL55 and 30th September 2023) were for which dose, therefore this information was captured in narrative and for further clarification query was raised.
Sore arm on days 1-3 Developed itchy rash near injection site exactly 1 week after first dose.
Day of vax, extreme arm soreness.  Next day, body muscle achiness that increased throughout day.  Checked temp apx 8:30 pm and registered 100.8.  Took acetaminophen.  Third day, feel fine, slight runny nose.
Patient received Smallpox on 08/23/2011 and 2 doses of anthrax vaccine one on 08/23/2011 and the other on 09/20/2011. Deployed and returned because she had a positive pregnancy test on 11/24/2011. Patient's first pregnancy.
5MAY93 mom states concern about pt leg leg has indentation on RLT; mom states cried real hard p/inject severe crying 48 hrs p/inject, fever 101, redness & swelling in thigh from knee to hip;
Papular rash noted on left deltoid this 03-08-06 AM.  Area is 2" by 2 1/2" inferior to the injection site.  Left deltoid is generally sore.  No other rash noted or other symptoms.  Afebrile and no symptoms of infection.  Previous Td history unknown.
16yo female who presented 7 days after vaccine with 4-6 d of body aches, lethargy and initiation of headaches (Hx of stress associated H. A. C in past) - No physical or labs findings.
Child became flushed with rash on trunk, face, and legs, and begin to scratch. Administered BENADRYL .2mg IM LAT, itching
Patient received the first dose and then felt light headed shortly after while watching his girl friend receive the shot. We had him sit down and then he passed out. A few moments later the eyes rolled to the back of his head, and then began shaking for 10 to 20 seconds, after which he immediately woke up and was aware he passed out. EMT services were called while this was happening.
extreme pain at injection site, severe diarrhea for 12 hours, upset stomach, dry heaves, tiredness Lot number is unknown
Nausea. BP 127/81; HR 76; RR 16; O2 sat 99%. Pt provided 16 oz water & time to rest in observation room.  Sx resolve. Pt stable & released
Fever 101.4 after receiving shots. Seen in ER. Septic work up done including catheterized urine and spinal tap. Baby received IM antibiotics.
Increasing pain in shoulder where vaccine was administered by the time I went to bed. By the next morning the pain was severe and I could not lift my arm above my head or across my body. I took ibuprofen and began icing my shoulder at least twice a day for 15 minutes. After nine weeks, it has improved but I still have pain if I bend my arm or move it across my body.
Fever 103,  body aches, nausea vomiting , Diarrhea  treated with Antibiotics ,  Treated with IV  Fluids
Warm rash at injection site, itchy, radiating.  Started on day 13 after injection. Today is day 14, and rash is larger and still itching.
Within minutes of  receiving the first dose of  Pfizer vaccine, I began feeling dizzy, lightheaded, and off balance. This was followed by  nausea, itchiness under my lip, fatigue and pain at the injection site.   These were gone the next day except for nausea which lasted a few more hours.
Vaccine was not administered on 3/8/21. Provider realized error and patient was contacted on 3/9/21 to come in for vaccine. He returned to clinic and received correct dose of vaccine. No harm to patient
Approximately 16 minutes after flu injection client complained of itchiness all over body and upper body including face was very flushed. Epinephrine 1:1000 0.35cc injected into flu injection site approximately 18 minutes after original flu shot. 911 called at the same time, 4-5 minutes after 1st epinephrine injection. Complained of numb, tingling feeling about face, neck and hands. Second Epi 1:1000 0.15cc injected into the same area. BP 158/84 P 60 Transported to Emergency Room via ambulance approximately 25 minutes after flu vaccine given.
started with left sided lower back pain; This is a spontaneous report from a contactable Nurse (patient). A 22-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration at left arm on 16Dec2020 13:45 at single dose for covid-19 immunization. Medical history included allergies for All fish. The patient's concomitant medications were not reported. The patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days), Life threatening illness (immediate risk of death from the event). The patient received the Heparin drip and xarelto at home for the event. The patient was not pregnant. The patient received the covid test post vaccination on 09Jan2021. Test type was Nasal Swab. The result was negative. The outcome of the event was recovered with sequel on unspecified date.; Sender's Comments: From the information provided it is unclear what is the nature of the reported event and what are the reasons that have put the subject at immediate risk of death. The event is considered possibly related to the suspect product based on the positive temporal association.
Malaise, emesis, chills, frontal headache and fever beginning the day after vaccination.
Case number PHEH2015US022799, is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 46 years old male patient. Medical history and concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 158204) at a dose of 0.5 ml intramuscularly on 02 Nov 2015. It was reported that the patient received vaccine that had been stored at 8.2 degrees Fahrenheit overnight before administration. The case was assessed as non-serious. No adverse event was reported following this maladministration.
Pain in back of neck, down arms to fingers, hip.  Swelling and or lumping of both bilateral bicep muscles.  Flu-like feelings, low grade fever and stay in bed most of the day.  My Eryth. Sed. Rate, C-Reacitve Protein and other bizzare levels show a lot of inflammation.  My other lab reports (back from Fall of 2020 to 2011 are normal).   This has been going on since March 2021.    I cannot perform caretaker duties for my wife who has Parkinson's Disease;
Mixed Series. Client received Moderna 4/7/21 and 05/05/21. Requested additional dose secondary to immunocompromised condition and received Pfizer 9/2/21
Intense headache for 2 days 102 degree fever for 2 days light sensitivity for 2 days fatigue, nausea, and body aches for 2 days  treatment: 500 mg acetaminophen every 6 hours while headache lasted, cold washcloth on forehead and eyes, lots of sleep and water
Fever up to 101 degrees. Severe headache and neck pain, hard to turn head and very light sensitive to light. Strong muscle and joint pain. Dizziness, shortness of breath, tightness in chest, elevated pulse, fatigue. Pain and a slight twitch in left arm, tender and swollen nodes in left armpit.
This is a spontaneous report from a contactable pharmacist. A 81-year-old female patient received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on right bicept on 07Oct2016 for immunization, since she was older than 65 years old. The patient medical history was not reported. Concomitant medication included influenza vaccine on left bicept on 07Oct2016 for immunization. The patient experienced right bicept pain in 2016 with outcome of not recovered.
For a full week after getting the shot I had severe depression and anxiety.  After that week it started to subside slowly, but it took approximately 2 months to be back to were I was before the vaccine.   After the first week I got a massive headache that lasted a week.  Once the headach subsided I had a twitch in my left eyelid that lasted 3 months and a floating black dot in my left eye that still exists.
Hypersensitivity (urticarial) rash to neck, chest and back starting 24 hours after vaccination
We received a call at the pharmacy at 4:30 pm on April 17. During the call, patient reports that the same day she was vaccinated she had inflammation and redness of the eyes, for which she took Zyrtec 10 mg. These symptoms were alleviated with the medication. The next day and for the past 5 days she has experienced pain in the left arm and leg, tingling in all extremities and pain at the back of the neck that radiates to the head. The symptoms interfere with her daily activities and they are very annoying according to patient.
SLEEPY; RUNNY NOSE; ABDOMINAL NOISES; PAIN IN EXTREMITY/ ARM WAS HURTING; NAUSEA; FEVER; SORE MUSCLE; HEADACHE; This spontaneous report received from a patient concerned a 25 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleepy, runny nose, abdominal noises, pain in extremity/ arm was hurting, nausea, fever, sore muscle, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, sleepy, fever, runny nose, sore muscle, headache, pain in extremity/ arm was hurting and abdominal noises was not reported. This report was non-serious.
This spontaneous report as received from a 71 years old female consumer refers to herself. The patient was vaccinated with her second dose of 0.5 ml PNEUMOVAX23 (lot number not provided) intramuscularly three years ago, in approximately December 2009. No other co-suspects were reported. No concomitant medications were reported. The patient reported the localized injection site reaction. She saw her physician and was given a five day rapid taper prednisone. It was painful and red, and swollen. The outcome of adverse events was unknown. Additional information has been requested.
Pt. held breath while receiving vaccines. She passed out & had a seizure lasting abt 10 sec. She came to with the ammonia salts - we kept her for over an hour - her pulse & resp were regular. Color good prior to sending her home. Dr was aware. She was fine when I called to check on her both that evening & the next morning. Pt. was also fine & parents said she had no further problems when she ret. 2 days later for TB reading.
EXPIRED PRODUCT GIVEN TO PATIENT; This spontaneous report received from a health care professional concerned a 55 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: 201A21A and expiry: UNKNOWN) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired product given to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product given to patient was not reported. This report was non-serious.
Unexpected benefit / Shingrix vaccine series helped with his "herpes simplex."; Shingrix shot "knocked the heck" out of him / he was "down for 3 days"; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number CZ455, expiry date 16th September 2022) for prophylaxis.   The patient's past medical history included genital herpes. Previously administered products included Valtrex with an associated reaction of dizziness (had been taking Valtrex 500 mg every day for years and was prescribed 20 years ago, refer case US2021AMR099395). Concurrent medical conditions included pain (goes from his side to his hip) and herpes simplex (Painful upper right side kidney area outbreaks of herpes simplex).   On 29th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced feels awful and unexpected therapeutic effect. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the feels awful and unexpected therapeutic effect were recovered/resolved.   It was unknown if the reporter considered the feels awful and unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself.  The age at vaccination was not reported.  The patient received Shingrix vaccine in unknown deltoid. The patient stated that the Shingrix shot knocked the heck out of him and he was down for 3 days. Recently the patient had been taking Valtrex daily to prevent what he calls herpes simplex outbreaks that he gets on his upper right side (kidney area) and the physician said that it was classic shingles.  The patient was told by his physician that he no longer had to take Valtex every day because the Shingrix would help prevent his upper right side outbreaks, so the patient stopped taking Valtrex and wanted to report the unexpected benefit of having Shingrix prevent him from getting another episode of the upper right side outbreaks which he refers to as herpes simplex. The patient wanted GlaxoSmithKline to know that the Shingrix vaccine series helped with his herpes simplex. The patient stated he took a massive amount of Valtrex and it (shingles) went away after 3 to 4 days of Valtrex. The reported did not want to share his physician information. The reporter did not consent to follow up. This is 1 of 3 cases reported by the same reporter. For tolerance with 2nd dose of Shingrix, refer case US2021097933.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR099395:Same reporter. Valtrex case. US-GLAXOSMITHKLINE-US2021097933:Same reporter. Shingrix 2nd dose case. US-GLAXOSMITHKLINE-US2021AMR099395:Same reporter. Valtrex case.
3 days after receiving PNEUMOVAX - developed erythema & edema at injection site and distal to injection site
Sore Arm; Rash; "His arm hurts a lot"; Potential Adverse Event because is a Special Population (Geriatric); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)). At the time of the report, VACCINATION SITE PAIN (Sore Arm), RASH (Rash), PAIN IN EXTREMITY ("His arm hurts a lot") and GERIATRIC ASSESSMENT (Potential Adverse Event because is a Special Population (Geriatric)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-13007, MOD21-13172 (E2B Linked Report).; Sender's Comments:  MOD21-13007:Crosslinked: Same reporter MOD21-13172:Crosslinked: Same reporter
I experienced sudden onset of extreme fatigue, dizziness, nausea, light headedness.  This has lasted for 4 days now.  I went to ER on base and was diagnosed with Benign Positional Vertigo related to sinus issues from 2 weeks prior?!
After about 10 minutes after receiving the injection my arm got hot and very itchy. Shortly after that I started to get itchy and flushed on my face and head which started to progress over my whole body. I returned to see Dr. who gave me 10mg Zyrtec. The symptoms did not improve so he gave me epinephrine IM. The itching improved after approx 15-20 minutes. I returned to work and about 2 hours later the itching and flushing on my head and face started to return. I came back to see Dr. who gave me Benadryl and prednisone (40mg). The symptoms slowly resolved. I did not have any shortness of breath, and I have never had a reaction to a flu vaccine in the past. I am not allergic to eggs.
Following day: fever, chills, nausea and red-hot swollen arm. Now two weeks later, arm is still discolored.
Noted a large lump in the left supraclavicular region of my neck. Reported to my physician later when it had still not gone away and a second smaller one was felt. Via telehealth, the physician said to wait another month and follow-up if not gone. As of 6/28/2021 they are present but smaller. An ultrasound is pending. No pain or tenderness.
36 hrs post vaccine increased rash, red, warm macule developed over deltoid region on upper L arm. No fever, pain or pruritus.
LOT OF EXTRA PAIN; This spontaneous report received from a patient concerned a 62-year-old Other race (Not Hispanic/Latino) female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, and glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced lot of extra pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lot of extra pain. This report was non-serious.
deltoid muscle where the shot was administered is swelling and feels hot and tender to the touch. muscle soreness spreading from the arm.
Moderna COVID-19 Vaccine A large raised red area around the injection site.  The raised area is swollen and warm to the touch.  There is a slight itchy feeling within the raised area.  No treatment has been necessary, the raised area is slightly uncomfortable, but treatment has not been needed.
heavy breakthrough bleedings  when she woke up on the mornings; aches,soreness; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (heavy breakthrough bleedings  when she woke up on the mornings) and MYALGIA (aches,soreness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039l20a, 029k21a and 052a21a) for COVID-19 vaccination.     "No medical history was provided by the reporter.".  Concomitant products included GABAPENTIN, VALSARTAN, CARVEDILOL, FLECAINIDE ACETATE (TAMBOCOR) and APIXABAN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (heavy breakthrough bleedings  when she woke up on the mornings) and MYALGIA (aches,soreness). At the time of the report, INTERMENSTRUAL BLEEDING (heavy breakthrough bleedings  when she woke up on the mornings) and MYALGIA (aches,soreness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Initial unsolicited report received from a nurse on 31-Jul-2018. This case is linked to 2018SA212615, 2018SA212627, 2018SA212638 and 2018SA212648 (Same reporter). This case involves a 17-month old female patient who was vaccinated with a dose of PENTACEL (Batch number: C5529AA, expiration date: 04-Oct-2019 via unknown route in unknown administration site on 30-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of PENTACEL and the reporter was unsure which one of the 5 patients who received doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. 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. List of documents held by sender: none.
Patient received his first Moderna COVID-19 vaccine on March 18th, 2020. On April 9th, 2020, patient received his second dose 5 days early due to an accidental vaccine administration error.
I was a little warm about 30 minutes after and then at about 45 minutes after I had a numbing/tingling sensation in my face and head.