chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 age at vaccination was not reported. The reporter stated that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This was 4 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR159011:Same reporter US-GLAXOSMITHKLINE-US2021AMR159013:Same reporter US-GLAXOSMITHKLINE-US2021AMR158998:Same reporter
A physician reported the occurrence of nausea in a 16-year-old male who inadvertently received an adult injection of hepatitis B vaccine recombinant (Engerix-B). The pt's medical history, concurrent conditions and concurrent medications were not reported. On 10/09/2002, the pt inadvertently received his 1st adult injection of Engerix-B. On 10/10/2002 he experienced nausea, which resolved the same day. The reporting physician stated that the nausea was possibly related to Engerix-B administration.
Hepatitis A vaccine was given mistakenly for HIB. Patient will come in for correct dose of HIB. No fever, no swelling, no redness, and no pain per mom. Patient is perfectly fine after shots mom said.
Immediate numb back half of tongue and throat, difficulty swallowing, vertigo, light-headed persisted for 4-6 hours.  Rash, itchiness 10 days later, still persisting
COVID-19 virus infection  Exposure to COVID-19 virus  Congestion of nasal sinus Infusion  10/22/2021 Outpatient Infusion clinic   Oncology COVID  Dx Medication Infusion  Reason for Visit   Progress Notes Registered Nurse ? ? Oncology Patient here for Sotrovimab infusion. Patient tolerated infusion well and was monitored for 1 hour post. Upon discharge, patient was provided a pulse ox, thermometer, after visit summary and follow up instructions. No adverse events noted during this visit.        Loss of voice
had swollen sore area in arm for 2 weeks; since 8 Sept I have been sick with upper respiratory type symptoms (bronchitis, productive cough, wheezing, sore throat). Also, I have hurt basically all over, most especially in my back, which I can describe best as arthritis-type pain in most joints.
Headache 3 weeks, severe fatigue 3 weeks.  Immediate reaction numbness in extremities, bulging veins in hands, increased heart rate.
Stress; Psoriasis flare-up/Psoriasis flare in the area by injury; Discomfort/Felt discomfort; Difficulty in walking; Injection site pain/Syringe causes pain; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress), PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis.    No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced STRESS (Stress), PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain). At the time of the report, STRESS (Stress), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain) outcome was unknown and PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Low.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided.
Information has been received from a company via a consumer who posted her daughter's experience on internet. The consumer reported that her daughter with a medical history of double pneumonia and finger laceration who on an unspecified date was vaccinated with GARDASIL (lot # not reported). Subsequently the patient experienced ovarian failure, peripheral vision loss, ulcerative colitis, allergic to most food, goes in to shock frequently. She became paraplegic on occasions and had 24/7 migraines. The patient has had numerous ER visits since GARDASIL. Before the vaccination the patient was in the ER twice in her life. Once for double pneumonia and once when she cut her finger. Since vaccination, the patient was frequent fliers and her life was at risk daily from all the food allergies. The reporter stated her daughter's life and health had been destroyed by the vaccine. At the time of the report the outcomes of the events were unknown. Food allergies were considered to be life threatening by the reporter. Upon internal review, goes in to shock frequently, peripheral vision loss and paraplegic on occasions were determined to be other important medical events. No further information is available.
Redness at the injection site; Redness at the injection site; A spontaneous report was received from a consumer, concerning herself, an 81-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the injection site (onset 30-Dec-2020 and 07-Jan-2021).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30-Dec-2020, after receiving the vaccine, the patient experienced redness at the injection site which had lasted for two days. On 07-Jan-2020 (yesterday), the event redness at the injection site had returned which was ongoing at the time of this report and patient has not tried any treatments for the same.   Action taken with mRNA-1273 in response to the events were not reported.   The event, redness at the injection site (30-Dec-2020) was considered resolved on 31-Dec-2020. The event, redness at the injection site (onset 07-Jan-2021) was considered not resolved at the time of this report.; Reporter's Comments: A spontaneous report concerns an 81-year-old female patient, who experienced redness at the injection site. The event occurred on the same day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown) and reoccurred 8 days later. No treatment was provided, and outcome was ongoing. Based on the information provided, which indicates a temporal association and redness occurring at the site of administration of mRNA-1273 vaccine, a causal association cannot be excluded. Redness at the injection site is consistent with the known safety profile of mRNA-1273 vaccine.
symptoms may indicate Parkinson's disease; difficulties with swallowing; It all began with a tremor in my right hand; Arm stiffness/ I have been waking up every morning with a frozen left arm; I have been unable to sleep properly; constant fear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARKINSON'S DISEASE (medically significant), outcome "unknown", described as "symptoms may indicate Parkinson's disease"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulties with swallowing"; TREMOR (non-serious), outcome "unknown", described as "It all began with a tremor in my right hand"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Arm stiffness/ I have been waking up every morning with a frozen left arm"; INSOMNIA (non-serious), outcome "unknown", described as "I have been unable to sleep properly"; FEAR (non-serious), outcome "unknown", described as "constant fear". The event "symptoms may indicate parkinson's disease" required physician office visit. Clinical course: It began with a tremor in the patient's right hand, followed by difficulties with swallowing. Additionally, the patient had been waking up every morning with a frozen left arm and encountering a few other uncomfortable health problems. The patient had always been a very health-conscious individual, maintaining a nutritious diet and engaging in regular exercise. The patient never imagined that something like this would happen, patient did not wish to become a burden on the patient's children. Based on the opinions of two specialists, it seems that the symptoms may indicate Parkinson's disease. The patient had been unable to sleep properly or find peace of mind. The patient wanted assistance or guidance, as the patient was living in constant fear, uncertain about what the future holds for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional via a sales representative and described the occurrence of red spotty (injection site) in a female subject of unspecified age who was vaccinated with KINRIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX in an unknown thigh.  At an unspecified time after vaccination with KINRIX, the subject experienced a red spot at the injection site.  The nurse reported that she instructed the subject to apply a cold compress to the injection site.  The spot disappeared, then reappeared at a different site near the injection site.  At the time of reporting the outcome of the event was unspecified.  It was reported that this event occurred in 4 additional subjects.  Linked case numbers include A0803829A and A0803832A through A0803834A. This case was reported by a healthcare professional via a sales representative and described the occurrence of red spotty (injection site) in a 4 year old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX in an unknown thigh. At an unspecified time after vaccination with KINRIX, the subject experienced a red spot at the injection site. The nurse reported that she instructed the subject to apply a cold compress to the injection site. The spot disappeared, then reappeared at a different site near the injection site. At the time of reporting the outcome of the event was unspecified. It was reported that this event occurred in 4 additional subjects. Linked case numbers include A0803829A and A0803832A through A0803834. Follow-up information received on 25 August 2009 indicated that follow-up information would be returned via a batch report versus specific subject information as doing this would require pulling "80" charts. It was reported that the subject was for years of age and received as concurrent vaccination HEP A, MMR vaccine and VARICELLA vaccine. It was noted that the HEP A and KINRIX  were administered inone leg and MMR vaccine and VERICELLA were given in the other. No concurrent medications were received. It was additionally reported that at the time of vaccination. Parents are told about the side effects and if they occur to use BENADRYL, cold compress and TYLENOL to treat.
This spontaneous report as received from a health professional (office manager) refers to approximately 17 year old patient of unknown gender with no drug reactions and allergies. Pertinent medical history was none. On 18-MAR-2013, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot # H014196, expiry date 19-MAR-2014, dose was not reported) intradermally in the forearm. Concomitant medications were none. Approximately on 18-MAR-2013 following vaccination, the patient experienced bacterial infection at the injection site. The next day on 19-MAR-2013, the patient returned to the physicians office with the already serious bacterial infection at the administration site and was prescribed AUGMENTIN. On 20-MAR-2013, again the patient returned to the physicians office and the infection looked even worse, hence AUGMENTIN was discontinued and the patient was prescribed with ROCEPHIN. Laboratory test performed was none. The infection had not changed and was not recovered at the time of this report. The reporter requested for the lot check since the 2 patients had received from the same lot. This is one of the reports received from the same reporter. Additional information has been requested.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Case number PHEH2014US025110, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 53-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 29 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Patient called and stated that she had an extremely sore arm and that there was a big red blotch on it.  Stated it was sore to the touch and felt warm to the touch. It was started on Sunday, one day after the the injection was given. We advised that the patient ice the arm and take Ibuprofen in the short term and follow up with a physician if the symptoms don't resolve.
DTap given at wrong age.   8/10/06 Client states no problems or reactions at this time. 8/11/06 Client here today.  No reactions noted or voiced.
I fully fainted two times about 15 hours post vaccine. I could not stand up or get out of bed because I would black and and throw up when I came to.
The evening of vaccination, the pt developed left lower extremity and left upper extremity pain and chills. The next day, left lower extremity swelling, erythema, malaise, caphalgia. The treatment for cellulitis started on 03/08. and hemorrhages noted on 03/11 on seven fingers.
left arm swollen, red, and hot after vaccine administration. Tried to contact mom- not answering.
Patient went to urgent care on Friday 8/26/22 and had some labs done on 8/26/22 ESR 90 (ref range 0-10), CRP 64.2 (ref. range <5), glucose 95, creat 1.08, alb 4.7, Tbili 1.4 (ref <1.2), alk phos 64, ast 24, alt 25, ANA negative, wbc 10.27 (diff wnl, hgb 13.1, plt 292 Patient was prescribed for Bactrim on 8/26/22, patient went to f/u to urgent care today, was changed to Doxycycline (only took one day). Tick panel negative. Rx a medrol pack - completed  Patient started having tightness and stiffness on R leg (on 8/20/22), next day had chills. Patient went to gym and sauna the next day. Patient then developed muscle tightness on both legs calves, and achilles on R foot was tight and R index finger PIP got swollen and L wrist mild pain and swelling around 8/22/22 and ended 3 days later. On the 3rd day, patient was able to walk but it was painful and tight. Patient fully able to walk on Thursday 8/25/22 and was able to go to urgent care on 8/26/22. Patient had on Friday L hand swelling and pain at MCP joint which lasted for a few days and now is mostly resolved. Patient has had on/off small red bumps on upper thighs and on left hand, now dry and scabbed. Patient denies pustules or vesicles. Patient did not have any respiratory or URI symptoms. Patient denied at the time any nausea, vomiting, abdominal pain; had loose stools the day of the fever but no diarrhea otherwise. Patient also lost appetite for the entire time. Patient denies dysuria, headaches, sore throat, enlarged lymph nodes, visual changes, bloody stools, conjunctivitis, or urethral discharge.
Began with swelling in throat, then had swollen/puffy eyes, then rash on chest, then more mouth swelling, then went to ER.
administer  expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported number of doses /vials given as 168 on 10-Nov-2021 and 11-Nov-2022.  No information was reported on the storage of vaccine in refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Significant follow-up received: Patient demographics (initials, DOB, age) were added. On 08-Jun-2022: Live Follow-up received: Additional reporter added.
Narrative: 72 yo male with a history of Afib,Type 2 DM for 10+ years, CAD S/p ACS, h/o NSTEMI in 2012 and DES/PCI in 06/2011, HTN, HLD and PAF. Covid vaccinations were administered on 3/8/21 and 4/5/21. Unable to assess if death was related to covid vaccinations. No information available about patients death.
patient attended a drive-through vaccination clinic held by a Health Clinic on 06/14/21. on CDC pre-vaccination screening form, patient has indicated that she had not received any covid vaccines prior to that date. patient received Pfizer covid vaccine dose 1 on that day. Data entry staff was unable to find patient in system ( hand-written last name was misread) a new profile was created on system and dose 1 pfizer was recorded. patient came back on july 7 ( clinic was closed for holiday) to receive dose 2 of pfizer to complete series. on 07/07/21, patient received dose 2 of pfizer vaccine.  With the correct spelling of last name, staff discovered the duplicate profile and noticed that patient had received a Moderna dose 1 on 03/09/2021. No further information ( lot number, type of injection, injection site, etc) about that dose could be identified. Dr., clinic medical director administered the second dose of pfizer and watched the patient for 15 minutes. No adverse effects have been reported. He left a message this morning (07/08/2021) on patient' s voicemail to call back and check on her.
Diagnosed with Guillain Barre syndrome. Paralyzed from neck down. Couple of weeks after flu-shot.
PT. RECIEVED INFLUENZA VACCINATION 12 JAN 08. NOTICED ON 29 JAN 08 THAT THERE WAS A QUARTER SIZED INDENTATION AT THE SITE OF THE IMMUNIZATION, NO PAIN SWELLING, SOME REDNESS.
Patient came to vaccine clinic, immediately after vaccination, hypotensive 80/60, nauseated, but no other side effects
On 5/11/04 at 10 pm, she had a fevr of 102.0F and it sounded like her heart was beating fast. So, I took her to the hospital. They gave her a pill in her butt for the fever and he said her heart beat is okay.
a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars; a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involve 12 patients of unknown demography who experienced a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars (inflammation localized), while he/she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (5 mL multi-dose vial) lot UJ237AB and expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, following the vaccination the patients experienced a little warmth and redness at the injection sites, look like there is a fever in the injection site, site has become the size of two half-dollars.  (Other relevant tests included no lab data.)  Final diagnosis was inflammation localized.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.
I am getting tingling sensations all over my face.  Mostly the left side of my face it's been happening off and on in random spots since the day I have had the shot which has been exactly two weeks now.
Patient developed Guilain Barre Syndrome GBS as confirmed by hospital neurologist. Dr felt the Covid 19 vaccination was the likely cause.