chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient did not experience any issues, side effects, or adverse events that he was aware of; he accidentally administered a dose of GARDASIL 9 to instead of the intended vaccine VAXNUEVANCE /; he accidentally administered a dose of GARDASIL 9 to instead of the intended vaccine VAXNUEVANCE / package inserts had a similar color and he accidentally grabbed the GARDASIL 9; The spontaneous report was received from a physician regarding a 4-month-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 28-JUL-2023, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5mL via injection in the left thigh (lot number X004375 and expiration date 02-JAN-2025 have verified to be valid) (no more vaccination details were provided) as prophylaxis instead of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (wrong product administered). The reporter wanted to know how to "deal with and proceed" and "what to tell the parents of a 4-month-old" that he accidentally administered that dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) instead of the intended vaccine pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). The reporter was the person who administered the vaccine as an experienced user stating that the package inserts had a similar color, and he accidentally grabbed the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) mistaking it for the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (product packaging confusion). The patient did not experience any issues, side effects, or adverse events that he was aware of (no adverse event), and he did not realize the error until after the patient left his office.
No anaphylaxis/swelling/SOB. Patient fainted once then recovered then fainted again and turned pale and body appeared to seize (seizure) for less than 30 seconds and patient return to normal and talking. Ambulance arrived but recovered and did not go to ER as suggested. Patient recovered and said mom had a similar reaction to vaccine after the fact.
Extreme muscle pain and weakness in the RIGHT arm and shoulder- the arm opposite of the injection site arm.  Painful and difficult/weak to lift fist of this arm above head level.  The injection site arm pain and rash improved since the day injection but the opposite arm and shoulder became worse and does not seem to have diminished in pain in the days after the injection.
At first he complained of being very weak. For three days he kept complaining of being weak and just layed around. On the third day he started developing some sort of rash/bumps on his jaw line. It took 3 weeks for it to clear up. I didn't realize he had a reaction until about a week after the vaccine, by this time his symptoms were starting to clear up, so I decided not to contact his Dr.
Trigeminal Neuralgia  Face and tooth pain. Hurts to eat, talk and brush teeth.
necrotizing pneumonia; necrotizing pneumonia; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 3-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA NECROTISING (medically significant), outcome "unknown" and all described as "necrotizing pneumonia". The patient underwent the following laboratory tests and procedures: lab work: IGG protection for 5 of the 13 serotypes, notes: IGG protection for 5 of the 13 serotypes in Prevnar 13. Additional information: A 03-year-old had necrotizing pneumonia and the physician had lab work performed which showed IGG protection for 5 of the 13 serotypes in Prevnar 13. Event took place after use of product.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine PREVENAR 13 administration.
Patient administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Oct-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 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Reporter reported that Vaccine moved to refrigeration on 15Oct2021 and Used by13Oct2021   This case was linked to MOD-2021-013872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up document included no new information.
Kinrix administered to a 6 months-old; Kinrix as 3rd dose of DTap and IPV; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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 Information: GSK receipt date: 04-Nov-2022 Reporter's comment:  The registered nurse called to inquire how to proceed and what to look for. The registered nurse reported the patient was inadvertently administered Kinrix at their facility. The escalated to 2nd Line expert. Upon escalation expert noted patient was due for their DTap and IPV.  The Kinrix was their 3rd dose of each. The reporter did not consent to follow up. Additional supportive information: The 6 months old patient was inadvertently administered Kinrix, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Started with generalized pain in my left arm and shoulder.  Yesterday I developed quite a bit of swelling and discomfort in my left armpit area.
injection  area sore 1 hr. After injection.  5 am. On 4 woke up to whole body hurting. Lasted about 24 hrs.
Patient called today and stated that she developed pain in left arm, armpit and left side  down to around the breast line.  She also stated that she had slight swelling under her arm and side.  I suggested that she follow up with her PCP or go to urgent care.
Patient was given vaccine by LPN during office visit yesterday with primary care provider. Patient reports she had pain when vaccine was administered, and pain continued. Patient then reports she noticed swelling to her left arm approx. 6pm yesterday evening. Today, was at pre-op for surgery, and was told to come back to PCP office for evaluation for redness, swelling, tenderness and warmth to left upper arm. Patient arrived to our "walk in" side of the clinic for evaluation. Seen by PA. Contacted local "shot line" and given this information. Patient was given AUGMENTIN course and return precautions. Patient states she had to reschedule her surgery. She was ambulatory without any respiratory distress.
C/O feeling aching pain in back. H/o anxiety. BP 152/90 (pulse 64). Final BP 139/82 (pulse 59). O2 sats 100%.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 56 years old female patient and reported that most of the vaccine leaked out on the patient and on the floor patient received only a partial dose of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 04-Oct-2018, the patient received a partial 0.5 ml one time dose suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number-UT6301NA, expiry date-30-Jun-2019 and dose in series was not reported) via intramuscular route in the left deltoid. It was a case of actual medication error due to underdose. It was also a case of syringe issue. It was unknown if the patient had any adverse event. 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 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.
Pt was exposed to mumps case 4/10 by hugging. 4/10 came for immunization 4/22, no prc h/o immunization. Developed right peri-auricular lymphadenopathy x2
Developed seizure activity. Admitted to hospital and treated with anti-convulsant. MRI normal. Spinal tap with 15 WBC. HSV and EV PCR negative. Acyclovir discontinued.  Discharged but readmitted to another hospital with new seizure activity and ataxia as well as mild mental status change. Repeat MRI negative. Repeat lumbar puncture with continued 11 WBC. Repeat HSV PCR negative. Adenovirus PCR From nasopharyngeal swab positive but CSF negative. Required multiple anti-convulsant to control seizure and discharged on combination anticonvulsant therapy.
Information has been received from a physician concerning a 19 year old female who in early August 2006, was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml).  The physician reported that at the time of vaccination, the patient experienced injection site pain.  The patient later experienced decreased range of motion in the arm she received the vaccination.  It was reported that the patient's arm hurt when she raised it above her head.  At the time of this report, the patient's injection site pain, decreased range of motion in arm pain persisted.  Unspecified medical attention was sought. Additional information has been requested.
Radiating shoulder pain and injection site pain to R shoulder where covid injection was given. The injection felt very painful and was "high" up on her shoulder. The pain continues and radiates down her arm, especially when lifting and typing. No numbness or tingling.
This is in follow-up report(s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 19 year old female who in December 2006, was vaccinated with her second dose of Gardasil (lot number unknown). Subsequently the patient experienced pain at the injection site for 1 week after her vaccination.  There was no treatment required.  Subsequently, the patient recovered.  Additional information has been requested. No further information was available.
fatigue; muscle soreness; headache; joints sore; fatigue; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of FATIGUE, the first episode of MYALGIA, HEADACHE, ARTHRALGIA and the second episode of FATIGUE in a 69-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.     No Medical History information was reported.   On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced the first episode of FATIGUE and the first episode of MYALGIA. In December 2021, the patient experienced HEADACHE, ARTHRALGIA, the second episode of FATIGUE and the second episode of MYALGIA. At the time of the report, HEADACHE, ARTHRALGIA, the last episode of FATIGUE and the last episode of MYALGIA had not resolved.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-412034 (Patient Link).
caller reports multiple patients received a full dose for the booster.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (caller reports multiple patients received a full dose for the booster.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (caller reports multiple patients received a full dose for the booster.). At the time of the report, ACCIDENTAL OVERDOSE (caller reports multiple patients received a full dose for the booster.) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Discovered a lump about three inches to the left of my throat while I was on my way to my doctor's office for my annual wellness exam    when I  felt a sharp pain near that area.  I instinctively reached over and put my hand on the area and immediately felt a lump. My doctor examined me and asked me some questions about when I first felt the lump and how was I feeling, etc.  I told her I had my second vaccine three days prior.  She gave me a prescription for bloodwork which is part of my annual exam process along with an appointment to see me again on March 16th.   I had the bloodwork yesterday morning.
experienced cramps but cycle has still not come. As of sending this notification cycle is now 13 days late. Cycle has never been late - regular; experienced cramps but cycle has still not come. As of sending this notification cycle is now 13 days late. Cycle has never been late - regular; This is a spontaneous report from a contactable consumer. A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0175) via an unspecified route of administration on 18May2021 18:00 PM administered in left arm as DOSE 1, SINGLE for covid-19 immunization (age of 14 years). The patient medical history included asthma - seasonal and food allergies of cashews and pistachios. The patient concomitant medications were none. It was reported that patient did not took any vaccination in four weeks and did not experienced COVID prior to vaccination. On 31May2021, the patient had experienced cramps but cycle has still not come. As of sending this notification cycle is now 13 days late. Cycle has never been late - regular. The patient did not undergo any lab test for COVID -19 after vaccination. The patient had received unknown therapeutic measure of the adverse events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
6cm wide x 5.5cm long, raised & erythema warm to touch. (L) elbow pain radiating up to (L) upper arm.
Erythema; Hives; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old patient who experienced erythema (erythema) and hives (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry dates not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious erythema (erythema) and hives (urticaria) (after 24 hours of vaccine) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was hives and erythema.  The patient was treated with PREDNISONE (PREDNISONE).  On an unknown date, the outcome was reported as recovered after 4 days taking prednisone.  Information on the batch number was requested.
I gave the 1st dose of a 2 shot series to a person who is only 16 years old.
Information has been received from a nurse practitioner concerning a newborn, 4 day old male, who had problems at birth. He was noted to develop temperature instability and was sent to the ICU. His ICU diagnosis was to rule out sepsis. He was on prophylactic antibiotics for 2 days and sepsis was ruled out. Other treatment included acetaminophen. He also had an increase of bilirubin and trouble eating, which resolved. The nurse practitioner clarified that these problems occurred at birth, prior to vaccination. On 3/5/05 and 3/6/06, the patient was vaccinated IM in the right vastus lateralis and left vastus lateralis with the first and second 0.5 microgram doses of hepatitis B virus vaccine (lot #'s 648242/0944P and 647171/0180P), respectively. It was reported that he had a temperature of 100.6 degrees and irritability. The patient was discharged form the hospital on 3/7/05. It was noted that he recovered. There was no product quality complaint involved. The patient's experiences were considered to be other important medical events (OMIC) by the reporter. No additional information is expected.
high fever/fever 101.7F/fever 100.3F; chills; fatigue; headache; heavy feeling effecting whole head; agitated by movement; discomfort also at the neck just below the back of the head; pressure at the nose bridge, waxes and wanes in intesity; This is a spontaneous report from a contactable consumer(patient) other health care professional (HCP). A 22-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in left arm on 08Apr2021 at 12:00 (at the age of 22 years old) as dose 2, single for covid-19 immunisation. Medical history included hypertension. The patient had no known allergies. Concomitant medications in two weeks included amlodipine besilate (AMLODIPINE BESILATE); duloxetine. Historical vaccine included first dose of BNT162B2 (Lot number: EP7534), via an unspecified route of administration in left arm on 18Mar2021 at 08:00 PM for covid-19 immunisation. 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. Since the vaccination, the patient has been tested for COVID-19. On 08Apr2021 at 19:00 patient experienced 4/8 evening: high fever; chills; fatigue; headache (heavy feeling effecting whole head, positional and shifting from front to rear and vice versa, agitated by movement, discomfort also at the neck just below the back of the head). This headache persists until noted 4/9 fever 101.7F; chills; fatigue; (using Ibuprofen and Acetaminophen at this point and continuing) 4/10 fever 100.3F; chills and fatigue gone; tested negative for COVID 4/11 temperature normal; started Medrol dose pack for persistent headache (headache is the only symptom at this point) 4/12 headache at 15% of the worst, now a 2-3/10 discomfort level (headache is now primarily frontal, all across the forehead from temple to temple, also pressure at the nose bridge, waxes and wanes in intesity) 4/13 Emergency Room visit for persistent headache; head CT was done-normal; received benadryl, reglan, and toradol IV which eliminated the headache 4/14 same headache as described 4/12 returns 4/15 to current: headache persists. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab, LUMIRADX SARS-COV-2 AG TEST): negative on 10Apr2021. Therapeutic measures were taken as a result of high fever/fever 101.7f/fever 100.3f, chills, fatigue, headache, heavy feeling effecting whole head, agitated by movement, discomfort also at the neck just below the back of the head, pressure at the nose bridge, waxes and wanes in intensity with medrol dose pack; IV benadryl, reglan, and Toradol. The patient visited emergency room for persistent headache. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
first dose / around 08/2018  / had some injection site pain.; This case was reported by a other health professional and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in May 2018), nerve pain (right trochanteric nerve pain in May 2018) and chickenpox.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself, who was a retired physical therapist. The patient received 1st dose in her left arm and she had some injection site pain. The reporter did not have Shingrix lot number. The reporter did not want to provide pharmacy information. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2021AMR061122.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061122:Same reporter
Information has been received from a registered nurse concerning a four year old male patient with no allergies or pertinent medical history who on 17-AUG-2001 was vaccinated with varicella virus vaccine live (Oka/Merck) by his previous pediatrician. The patient was not ill at the time of vaccination. On 17-JUL-2005 a rash appeared., it was reported to be a chicken-pox breakthrough (also reported as "not clear cut varicella, but suspicious"). It is unknown as to whether the patient has a fever because no temperature was taken, but as per the patient's mother the patient felt warm. The patient presented to the office on 19-JUL-2005 with less than 50 non-vesicle lesions on his face, back, and behind ears. The patient's treatment was reported as symptomatic treatment which included instruction to watch for fever. There were no laboratory or diagnostic tests performed. The patient recovered on 20-JUL-2005. The patient did not have adverse events following prior vaccinations. There was no product quality complaint reported. No additional information is expected. The reporter also mentioned that the patient's male sibling had chicken pox breakthrough following vaccination with varicella virus vaccine live (Oka/Merck) (WAES# 0507USA02835).