chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of swollen tongue in a 60-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). Concomitant products included Lisinopril/Hydrochlorothiazide. On 6th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2018, 3 days after receiving SHINGRIX, the patient experienced swollen tongue and difficulty breathing. On an unknown date, the outcome of the swollen tongue and difficulty breathing were recovered/resolved. It was unknown if the reporter considered the swollen tongue and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: This case was reported by registered pharmacist. The patient received SHINGRIX vaccine in the left deltoid. The patient required emergency room visit. The reporter reported that the patient followed-up with his physician.
Started having twitches wasn't responsive at daycare. Pooped all over herself. Father picked her up and took her to the pediatrician. They called the hospital ambulance came and picked her up. They said it looked like she was having seizures gave her Adavant. Thought she had an infection but everything came back negative. She was having seizures and brain swelling. They couldn't control them. She then suffered a massive stroke and was brain dead. Didn't start acting like this until two days after her shots.
Approximately 2 minutes after receiving vaccinations, pt began with swelling and darkening of bilateral legs. Father was holding the pt at the time, pt was calm, no crying, and in no acute distress. Upon noticing the reaction, the Band-Aids were removed and the pt's diaper was taken off. Warm pads were applied to the area and color began to return to normal on the legs. Bilateral inguinal and brachial pulses were strong and equal. Pt was observed for 15 minutes and remained stable, with vital signs normal and return of normal color and no further swelling of the legs. Pt was sent home with instructions to observe the area.
Information has been received from a licensed practical nurse concerning a 13 month old male with no pre-existing allergies, birth defects, medical conditions, who on 14-DEC-2007 was vaccinated IM in the left thigh at 1:00 PM with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (HSA) (lot number: 651803/0631F). Concomitant therapy given that same day included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD). The patient had no symptoms. There were no adverse events. There were no relevant diagnostic tests and laboratory symptoms. There were no adverse events following prior vaccinations. Illness at time of vaccination: "wcc." The outcome was reported as recovered immediately. There was no product quality complaint. No additional information is expected.
could not sleep; achy; she ached like she had the flu; fever; shivering; TIRED; sick to her stomach/stomach that felt like a pulled muscle.; nauseated; PAIN; Pain at injection site; cold sores; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had a bad chickenpox as a child in her ears, vagina and toenails).   On 18th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 2 weeks after receiving Shingrix and an unknown time after starting Aspirin and Abreva, the patient experienced cold sores. On 18th November 2019, the patient experienced pain in arm and injection site pain. On 19th November 2019, the patient experienced stomach pain and nausea. On 21st November 2019, the patient experienced tiredness. On 23rd November 2019, the patient experienced flu-like aching, fever, shivering and pain. On an unknown date, the patient experienced insomnia. The patient was treated with acetylsalicylic acid (Aspirin) and docosanol (Abreva). On 22nd November 2019, the outcome of the fever and shivering were recovered/resolved. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved and the outcome of the stomach pain, nausea, flu-like aching, cold sores, injection site pain and insomnia were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, tiredness, stomach pain, nausea, flu-like aching, fever, shivering, cold sores, injection site pain, insomnia and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported severe pain at the injection site during administration. The pain traveled down her arm and into her fingers. The pain down her arm and into her fingers resolved in a short time but the pain in her arm at the injection site is still present. She could not sleep on that side due to the pain. She has been treating it with aspirin. She also said she was tired after the injection and slept for 2 hours. Her arm from her deltoid to her fingers and lasted about 24 hours.  The patient was sick to her stomach, nauseated and tired. The patient ached like she had the flu but the fever and shivering were gone by the next day. She also had pain across her stomach that felt like a pulled muscle. She contracted cold sores from her husband and gets outbreaks on her nose. The reporter did not consent to follow up.
Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified
flu-like symptoms; chills; fever; nausea; he was throwing up; swollen lymph nodes; urinary infection; This is a spontaneous report from a contactable consumer (patient). A 71 years old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient stated he received the first dose of the Pfizer Covid 19 vaccine on April 2nd, the following Monday he had flu-like symptoms, he had chills, fever, nausea, he was throwing up. He also had swollen lymph nodes and a urinary infection. He is scheduled to receive his second dose this Friday. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT CAME IN COUGHING, EXCESSIVE SNEEZING, VOMITING FLUSHED, CONFUSED, FATIGUED, THEN PASSED OUT.
Patient did not have any adverse symptoms. Provider and associate notified and performed outreach to notify patient/parent.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 and expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius)for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This vaccine was prepared by a staff member and given to the pharmacist to check without the vial it was drawn out of. When preparing a subsequent dose, the lot numbers were examined. This was done for an original formation and not the new bivalent booster.
Fever with in 24 hours, local erythema, induration about 3-4 inches diameter at left arm.
Systemic: Body aches, chills, muscle fatigue (whole body), mild fever (ranging from 99.8-101)  Local: slight itchiness at injection site, muscle swelling at site, hardening of muscles at injection site, soreness in arm at site 7 days later
A spontaneous report has been received from a Physician concerning, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient reported RECEIVED EXPIRED FLUMIST which started during 2014. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
received pediatric dose instead of adult; received pediatric dose instead of adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 26-year-old female patient who received HBV (Engerix B pediatric) (batch number S22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st January 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 21st January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by Medical assistant. The reporter stated that, the patient received pediatric dose of Engerix B instead of adult, which led to underdose and adult use of a child product. Healthcare professional had not specified which number of dose was given. The reporter consented to follow up.
I had some swelling and pain the first two days following the vaccine, then all was fine.  On day 8 I awoke to a large (2.5 inch) hard, red, itchy, hot welt at the injection site.  There is mild pain when I touch it.
Redness and hives recurred on her arm; Hives on arm; Red injection site; Raised injection site; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), ERYTHEMA (Redness and hives recurred on her arm), URTICARIA (Hives on arm), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Raised injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), URTICARIA (Hives on arm), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Raised injection site). On an unknown date, the patient experienced ERYTHEMA (Redness and hives recurred on her arm). On 26-Mar-2021, PAIN IN EXTREMITY (Soreness in arm), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Raised injection site) had resolved. At the time of the report, ERYTHEMA (Redness and hives recurred on her arm) and URTICARIA (Hives on arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The symptoms went away for a day and then the redness and hives recurred on her arm.
This case was reported by a consumer (the subject) and described the occurrence of unwell in a 55-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care profession has not verified this report. Concurrent medical conditions included dust allergy (unspecified). Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given on 1 March 2011 with no adverse events noted. Concurrent medications included Allergy medications (Allergy shots), CLOROTRIMETON and FLONASE. On 17 January 2011 and 2 March 2011 the subject received 1st dose and 2nd dose of ENGERIX B (details unknown). The subject reported no ill effects after the first vaccination until 07 February 2011. On 07 February 2011, 21 days after vaccination with the 1st dose of ENGERIX B, the subject experienced unwell, nausea, vomiting, diarrhea, fatigue, lisping, vertigo, belching and abdominal pain. The subject visited the emergency room. She reported that the symptoms continued off and on. The subject received influenza vaccination on 01 March 2011 with no adverse events noted. After the next vaccination ENGERIX B the events recurred. On an unspecified date, less than one month after the 2nd vaccination with ENGERIX B, the subject experienced weakness, fatigue, vertigo "in head and neck", head feels heavy, liquid diarrhea, unable to drive and tiredness. The subject reported that these symptoms were ongoing off and on, "poor appetite, diarrhea stopped, no vomiting". The subject had consulted her physician a couple of times. Unspecified tests were reported as negative. The subject's physician had suggested an MRI due to feeling faint and heaviness of head. At the time of reporting th events were unresolved.
patient 2nd dose administered 5 days early; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient 2nd dose administered 5 days early) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 06-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient 2nd dose administered 5 days early). On 06-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient 2nd dose administered 5 days early) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt received vaccine around 3 pm on 11/4 and at around 7 pm her throat began to tighten and eyes swell. She didn't have difficulty breathing. Pt took BENADRYL.
Patient had tonic/clonic seizure 2 days post vaccine, lasting less then 5 minutes. This was her first seizure in 1 year.
No additional adverse effects reported; Gardasil 9 was improperly stored and administered; Information has been received from a nurse and refers to a patients of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On 29-JUL-2020, the patient was vaccinated with a dose of improperly stored haemophilus  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637651 and expiration date of 09-JUN-2022 (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 50 Fahrenheit degrees for 1 hour and 46 minutes. No previous temperature excursion was reported.  No adverse effects were reported.   Digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000316: US-009507513-2008USA000266:
a few aches; bruise; itching; tenderness; redness; slight fatigue "draggy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown by patient) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PREVNAR 13.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (slight fatigue "draggy). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (slight fatigue "draggy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient had gotten Hep A then came back thru and was given a second Hep A instead of J&J COVID vaccine. No Reaction noted. She was then given the J&J in the same arm at a different site.
Swelling of vaccine area and redness, associated with fever - patient also reports weakness of left upper extremity.
Patient received his second Shingrix vaccine on 4-12-2021 into the left deltoid, and a few days later he developed significant pain rated an 8/10 starting at the left upper arm and extending into the lower arm, left shoulder, and left side of neck.  Symptoms did not resolve after a 5 day course of Prednisone 40 mg and PRN Zanaflex (this was started about 6 weeks post injection).  Pain has been improving on own and now is described as a dull ache or muscle spasms.  Also having sharp pain located under left scapula. ROM is not limited.  Today is about 2.5 months post injection.
Pt recvd vax 21OCT92 & recvd hep B vax 21OCT92 & devel erythema nodosum; Lab eval on 26OCT92 revealed WBC Count 2.9, ESR & stereptozyme were high; No further details were provided;
At approximately 16:36 pt was noted writhing on the floor in the post-vaccine waiting area. Upon rapid assessment of pt, others advised to call 911. 911 was called. Pt appeared to be in pain and tense, eyes were tightly shut but pt was breathing and moving throughout the entire time, after about 10 seconds was able to speak and stated that he felt sudden onset of dizziness and fell onto the ground. Pt denied head injury or pain from fall, no signs of trauma noted to face, dentition, or head. He stated that he was able to hear the voices of people talking to him the entire time he was on the floor. Pt denied any LOC, recalled all events leading up to falling. Pt reports hx of syncope after an injection once before, years ago. Pt denied any past medical history. Pt denies taking any medications, and denies any allergies. Pt states he only take medication when he has headaches.  Assessment: Pt appeared in mild acute distress. Pt moaning and grimacing initially, once verbal, speech was clear and he was able to speak in complete sentences. Pt face was symmetrical and had purposeful movement of all extremities. Moderate diaphoresis and facial pallor noted. VS @16:38  BP 162/100 HR 113 RR 24 O2 98% @1642 BP162/99 HR 94 RR 20 O2 97%.  EMS arrival @1647 and pt was refusing to be transported to the hospital. Pt and pt's mother were advised of the importance of further evaluation in the ED despite pt insisting he felt better. Spoke with pt mother and family while pt was speaking with EMS and urged them to take pt to the hospital via private vehicle even if pt were to refuse ambulance transport. Understanding was verbalized.
* complete loss of arm function * extreme pain (10 hours of level 9 pain) and inability to rest it without experiencing pain * no movement possible for 9 days without searing, burning pain * VERY gradual improvement for the next six days, still unable to lift or hold anything very heavy * 8/8/21: significant weakness still and 5-6 level pain when right arm is lifted above waist level * ongoing sleep interruptions due to burning, aching pain in right shoulder  * cannot sleep on right side as of this date 08/11/2012
2-3 inches around injection site it is very red and firm.  Mostly below the site,  as if gravity is pulling it down.
Heavy flu symptoms first night.  On day 3 I noticed skin tightness and irritation. I was diagnosed  with Shingles  on day 4 after second covid shot.
pt recvd vax & had a mild viral illness @ time of immun; w/in 24-48 hrs p/vax devel a maculopapular rash, fever & pharyngitis; strep culture neg; tx w/PCN; final dx kawasaki disease
1st dose Aug2019, 2nd August 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, 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.      Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comments: The pharmacist reported that the patient received second dose of Shingrix in August 2022. The reporter reported that two patients were relatives (reporter´s parents) who received Shingrix the same month. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. This case was one of the 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149870:Same reporter
I had an irregular menstrual cycle for at least one cycle after getting the vaccine.  I was not pregnant and historically had extremely regular menstrual cycles fir years prior.  My OB/GYN mentioned that a lot of her patients experienced a similar reaction.
Fever followed by severe cellulitis in right arm (where pt received Pneumovax) and hypotension requiring hospital admission and IV antibiotics.
Father called and spoke with Office Manager due to language barrier in regards to vaccine reaction.  Father described patient developing a rash on injection site on Right arm showing red spots.  Office manager spoke with Nurse and instructed patient to call physician and follow up with the office.  Patient was seen the same day by Physician and notes were faxed on 1/29/2010.
Very high fever, lethargy, loss of appetite, leg pain, weight loss, food allergy, bone pain, extreme emotional reactions, sensory issues with clothing and food.