chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope as patient was leaving exam room. Patient collapsed against wall, father caught her, father and RN eased patient to floor. Patient awoke quickly. After a few minutes, patient accepted and consumed juice and a granola bar. Was able to walk to a chair, rested there for another 10 minutes or more, then left with her father.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The 12-year-old patient received a 5?11-year-old dose of Pfizer (2023-2024 formula COVID-19).  At the time of this writing, no known adverse events for the patient.   Our recommendations and outcomes for error prevention is to reinforce 5 rights of medication administration with medical staff, ensure medication safeguards/prompts are in place for both flu and covid vaccine administration, and ensure that the orders/documentation are accurate in electronic health record.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: The day after the second dose, my right ear completely plugged and I've had tinnitus ever since.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Platelet count decreased
Clinical narrative: Low platelet count
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: DTaP administered to patient, incorrect vaccine timing, patient is 11 years old. TDaP should have been administered to patient.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: Itchy blisters on both arms that resemble chicken pox, swelling, redness, and soreness around injection site.
Age: 48.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Arthralgia, Bursitis, Shoulder injury related to vaccine administration, X-ray limb
Clinical narrative: Severe pain in both shoulders within a few hours of the vaccine. Pain never subsided. Diagnosed with Subacromial Bursitis 06/03/2024
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose and experienced sore arm, reference case US2024AMR067369).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024AMR067369   Additional Information: GSK Receipt date: 27-MAY-2024  This case was reported by patient via interactive digital media. About 2 months later the patient got the 2nd shot and had sore arm again.  The patient would put up with that vs the alternative. By the way even though you have had shingles get the shots, you could get them again.; Sender's Comments:  US-GSK-US2024AMR067369:Case for 1 st dose
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Thrombosis
Clinical narrative: Blood clots; Ischemic stroke; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: ISCHAEMIC STROKE (medically significant) with onset 2021, outcome "unknown", described as "Ischemic stroke"; THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots". Therapeutic measures were taken as a result of thrombosis. Clinical course: Patient reported an incident almost 3 years ago. She had a ischemic stroke soon after she received the Pfizer booster shot. She was on blood thinners Eliquis for life because she had blood clots. She was forced to retire and she was now collecting social security.   Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Purulent discharge, Skin discolouration, Staphylococcus test positive, Wound, Wound complication
Clinical narrative: 10/21/23 - 11/6/23 Developed black & blue which turned into large painful open wound with purulent discharge.  11/7/23 Went to Primary Care - Dr. It was opined that the wound was caused by improper vaccination procedures. Pictures were taken & wound measured by Dr's assistant. Prescribed Amox-Clav 500/125mg Tablet Qty. 20. 11/8/23 Pharmacy was contacted Incident ID#S-9905091. 12-28-23 Went back to Dr. wound was still open & still had purulent discharge after 8 weeks. Was referred to Wound & Hyperbaric. Appt. 1/2/2024 wound was still ope, painful & draining. Culture was taken & sent to lab. Was told to get VascheWound Solution & inject it into wound 2-3 times per day. 1/9/2024 Returned to Wound Center. Was told wound was starting to heal & to apply trip[e antibiotic ointment. Result from culture sent to Lab - Heavy growth of Staphylococcus Aureus.  3/26/24 Went to Dr. for regular Check-up & asked why the arm still hurt especially when in a prone position. Nerve damage which might or might not be permanent. Pain in arm at scar site still comes and goes as of 6/5/2024.
Age: 68.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Culture wound positive, Nerve injury, Pain in extremity, Purulent discharge, Scar
Clinical narrative: 10/21/23 - 11/6/23 Developed black & blue which turned into large painful open wound with purulent discharge.  11/7/23 Went to Primary Care - Dr. It was opined that the wound was caused by improper vaccination procedures. Pictures were taken & wound measured by Dr's assistant. Prescribed Amox-Clav 500/125mg Tablet Qty. 20. 11/8/23 Pharmacy was contacted Incident ID#S-9905091. 12-28-23 Went back to Dr. wound was still open & still had purulent discharge after 8 weeks. Was referred to Wound & Hyperbaric. Appt. 1/2/2024 wound was still ope, painful & draining. Culture was taken & sent to lab. Was told to get VascheWound Solution & inject it into wound 2-3 times per day. 1/9/2024 Returned to Wound Center. Was told wound was starting to heal & to apply trip[e antibiotic ointment. Result from culture sent to Lab - Heavy growth of Staphylococcus Aureus.  3/26/24 Went to Dr. for regular Check-up & asked why the arm still hurt especially when in a prone position. Nerve damage which might or might not be permanent. Pain in arm at scar site still comes and goes as of 6/5/2024.
Age: 68.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Skin discolouration, Staphylococcus test positive, Wound, Wound complication, Wrong technique in product usage process
Clinical narrative: 10/21/23 - 11/6/23 Developed black & blue which turned into large painful open wound with purulent discharge.  11/7/23 Went to Primary Care - Dr. It was opined that the wound was caused by improper vaccination procedures. Pictures were taken & wound measured by Dr's assistant. Prescribed Amox-Clav 500/125mg Tablet Qty. 20. 11/8/23 Pharmacy was contacted Incident ID#S-9905091. 12-28-23 Went back to Dr. wound was still open & still had purulent discharge after 8 weeks. Was referred to Wound & Hyperbaric. Appt. 1/2/2024 wound was still ope, painful & draining. Culture was taken & sent to lab. Was told to get VascheWound Solution & inject it into wound 2-3 times per day. 1/9/2024 Returned to Wound Center. Was told wound was starting to heal & to apply trip[e antibiotic ointment. Result from culture sent to Lab - Heavy growth of Staphylococcus Aureus.  3/26/24 Went to Dr. for regular Check-up & asked why the arm still hurt especially when in a prone position. Nerve damage which might or might not be permanent. Pain in arm at scar site still comes and goes as of 6/5/2024.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, General physical health deterioration, Interchange of vaccine products, Syncope
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), 0.3 ml single (Lot number: GH9694, Expiration Date: 30Jun2023) at the age of 79 years intramuscular, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, 0.3 ml single (Lot number: EL9266, Expiration Date: 21May2021), in arm, on 10Mar2021 as dose 2, 0.3 ml single (Lot number: EN6206), in arm and on 17Nov2021 as dose 3 (booster), 0.3 ml single (Lot number: 3303BD, Expiration Date: 31May2022), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing); "Hypothyroidism/Low thyroid" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hypertension (slight)" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. The following information was reported: COVID-19 (hospitalization, medically significant) with onset 12Mar2023, outcome "unknown"; VACCINATION FAILURE (hospitalization, medically significant) with onset 12Mar2023, outcome "unknown". The patient was hospitalized for vaccination failure, covid-19 (start date: 2023, discharge date: 2023, hospitalization duration: 1 day(s)). The events "vaccination failure" and "covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (12Mar2023) 102 degree; SARS-CoV-2 test: (12Mar2023) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: It was reported that Hospital nurse also did a covid test and she tested positive for covid; Symptoms were only fever of 102 degrees. Patient was not allergic to any previous vaccination, medications, food or other products.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400072953 Same patient, different dose/ AE;US-PFIZER INC-PV202400061360 Same patient, different dose/ AE;
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), 0.3 ml single (Lot number: GH9694, Expiration Date: 30Jun2023) at the age of 79 years intramuscular, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, 0.3 ml single (Lot number: EL9266, Expiration Date: 21May2021), in arm, on 10Mar2021 as dose 2, 0.3 ml single (Lot number: EN6206), in arm and on 17Nov2021 as dose 3 (booster), 0.3 ml single (Lot number: 3303BD, Expiration Date: 31May2022), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing); "Hypothyroidism/Low thyroid" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hypertension (slight)" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. The following information was reported: COVID-19 (hospitalization, medically significant) with onset 12Mar2023, outcome "unknown"; VACCINATION FAILURE (hospitalization, medically significant) with onset 12Mar2023, outcome "unknown". The patient was hospitalized for vaccination failure, covid-19 (start date: 2023, discharge date: 2023, hospitalization duration: 1 day(s)). The events "vaccination failure" and "covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (12Mar2023) 102 degree; SARS-CoV-2 test: (12Mar2023) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: It was reported that Hospital nurse also did a covid test and she tested positive for covid; Symptoms were only fever of 102 degrees. Patient was not allergic to any previous vaccination, medications, food or other products.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400072953 Same patient, different dose/ AE;US-PFIZER INC-PV202400061360 Same patient, different dose/ AE;
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported expired dose of MMR II was administered.; Temperature 10.9 C/Time frame: 1 hour 30 minutes 0 Seconds/Date of administration: 5/10/2024; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent condition and concomitant medication was not provided.  On 10-MAY-2024 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) (lot# X005836 with expiration date: 03-MAY-2024, dose: 0.5 milliliter, strength unknown) subcutaneously for prophylaxis (expired product administered). Operator of Device: Health Professional. No other information provided.  No additional adverse events or product quality complaints reported.   Nurse reports showed administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) experienced the temperature excursion below 10.9 degree Celsius for 1 hour 30 minutes 0 Seconds on 18-DEC-2023 (Product storage error).
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received first dose on 15Aug2023 and has not received the second dose yet; Initial report received on 30-May-2024.  A pharmacist reported that a 32-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 15-Aug-2023 and had not yet received the second dose.  No relevant medical history was reported.    No concomitant medications were reported.    On 15-Aug-2023, the patient received the first dose of HEPLISAV-B (lot #, expiration date and NDC # not reported) at a pharmacy that was not the pharmacy the reporter worked at.  At the time of reporting, the patient had not received the second dose yet.  The reporter stated that there was no way to get the lot number, expiration date, or NDC # as it was not available to him.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion for 21 minutes on fridge, temp. was 34.31° C, vaccine was given at this time (with no reported adverse event); Initial information received on 24-May-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 9-year-old female patient (121 cm and 44.4 kg), IPV (VERO) [IPOL] excursion for 21 minutes on fridge, temp. was 34.31â° c, vaccine was given at this time (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml Booster dose of suspect IPV (VERO), Suspension for injection (strength, expiry date: unknown) (lot: WIC751M) via intramuscular route in the left deltoid as prophylactic vaccination (immunization) and excursion for 21 minutes on fridge, temp. was 34.31â° c, vaccine was given at this time (with no reported adverse event) (poor quality product administered) (unknown latency).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the 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.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: cellulitis; Initial information received on 29-May-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 3 unknown age and gender patients who experienced cellulitis after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: 2CA77C1) (with an unknown strength, expiry date) via intramuscular route in unknown administration site for immunization.  On an unknown date in May-2024, the patients developed event of cellulitis (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: at pediatric office we never administer Pfizer Covid vaccine and we received as Routine Covid Pfizer and due to always administer Covid Moderna in our office Medical Assistant gave Covid Pfizer as instructions for Covid Moderna it's human error.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Gaze palsy, Generalised tonic-clonic seizure, Infant irritability, Postictal state, Respiratory pathogen panel
Clinical narrative: Patient received motrin at 1515p, tylenol at 1950p, patient was laid down for sleep and mom noted patient seizing (around 2030) .  Lasted about 25 sec per mom, tonic/clonic per mom, eyes rolled back, seizure self resolved, EMS arrived when post ictal, lasted about 15 min after EMS arrived, on EMS arrival, patient was awake, alert, fussy.  Patient was transported by EMS to Emergency Room at 21:27p
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction
Clinical narrative: Pain and redness at the injection site for 5 days. Started immediately after and worsening about 36 hours after vaccine given. Did not begin to improve until day 4 after the injection. Did resolve on its own.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sore 2 weeks after the vaccine. Then again on 6/4/24.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Heart rate decreased, Injection site pain, Myalgia, Pain
Clinical narrative: Fever 5/30-6/1. Redness in arm 5/31, 6/1. 5/30- pain direct injection site, pain in arm shoulder to elbow, hurt to lift arm.  5/31-6/1 pain injection site, muscle soreness from shoulder to elbow sore to lift arm.  5/30-6/1-sleepiness (took naps) never take. (6/26- Low heart rate 48 for over 10 minutes.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever 5/30-6/1. Redness in arm 5/31, 6/1. 5/30- pain direct injection site, pain in arm shoulder to elbow, hurt to lift arm.  5/31-6/1 pain injection site, muscle soreness from shoulder to elbow sore to lift arm.  5/30-6/1-sleepiness (took naps) never take. (6/26- Low heart rate 48 for over 10 minutes.
Age: 15.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was given Kinrix and should have only received Polio.  Pt is 15 years old so had aged out of this vaccine and had already had Tdap in 2020.
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given at 9 months of age cut off is 8 months
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: felt sick, body aches, vomiting, headache, fatigue, chills, muscles pain, within a few hours after having vaccine.  patient advised to take 50 mg of Benadryl. patient recovered after 2 days of symptoms.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Vomiting
Clinical narrative: felt sick, body aches, vomiting, headache, fatigue, chills, muscles pain, within a few hours after having vaccine.  patient advised to take 50 mg of Benadryl. patient recovered after 2 days of symptoms.
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented on 6/5 with severe redness, and swollen tissue from right shoulder to elbow. States was hot and painful. Patient went to primary care provider, was diagnosis with cellulitis, and prescribed Doxycycline.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Diabetic ketoacidosis, Electrolyte depletion, Hyperglycaemia, Mental status changes
Clinical narrative: Hospitalized 2/19/23-2/24/23 Altered mental status, hyperglycemia, tachypneic, unresponsive/non-verbal, DKA,  metabolic acidosis and electrolyte deficiencies, elevated troponin, metabolic encephalopathy, anemia,
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic acidosis, Metabolic encephalopathy, Speech disorder, Tachypnoea, Troponin increased
Clinical narrative: Hospitalized 2/19/23-2/24/23 Altered mental status, hyperglycemia, tachypneic, unresponsive/non-verbal, DKA,  metabolic acidosis and electrolyte deficiencies, elevated troponin, metabolic encephalopathy, anemia,
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Hospitalized 2/19/23-2/24/23 Altered mental status, hyperglycemia, tachypneic, unresponsive/non-verbal, DKA,  metabolic acidosis and electrolyte deficiencies, elevated troponin, metabolic encephalopathy, anemia,
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Feeling hot
Clinical narrative: After vaccines were administered, client became dizzy with warm, clammy skin. She was slowly assisted into a chair with minimal assistance. She was alert and able to answer questions correctly and independently. Client rested in a cool room, drank a small juice box and ate crackers. Client denied nausea and stated she felt much better after eating and drinking. Client shared that she didn't eat much throughout the day. Client left with her mom, stating she felt "good", and walking without dizziness.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: PATIENT GOT THE TETANUS VACCINE ON SUNDAY 6/2/24 AND HAS BEEN EXPERIENCING DIARRHEA, NAUSEA AND VOMITING
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tachycardia
Clinical narrative: Patient experienced tachycardia after bedtime at approximately 2230.  She was unable to sleep, getting up around 0200 on 5/25/24, taking her pulse which was 120.  She was not able to sleep due to tachycardia until daylight, which was approximately 0400.  The symptoms resolved by then.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Hospitalized 2/21/23-2/25/23 respiratory failure, SOB, hypoxia, cough, fatigue, decreased oral intake, loose stools, O2 supplementation, AKI,
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypophagia, Hypoxia, Respiratory failure
Clinical narrative: Hospitalized 2/21/23-2/25/23 respiratory failure, SOB, hypoxia, cough, fatigue, decreased oral intake, loose stools, O2 supplementation, AKI,
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Syncope
Clinical narrative: Fainting, chills, sweating happening at same time as fainting one day after vaccination.  Constant headache, aches and pains  throughout body for 2 days after vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccines administered 5/31/24; Proquad (MMRV) and varicella administered together; Proquad not appopriate for patients age.  To date 6/5/24, no adverse reactions to child.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Deep vein thrombosis, Dyspnoea, Pain in extremity
Clinical narrative: Hospitalized 2/28/23-3/2/23 SOB, left leg pain, cough, DVT, PE,
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 3/31/2024. Administered on 4/5/2024
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccine was unproperly stored, it was stored in the fridge as opposed to manufacturer recommendations to store in the freezer
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute myocardial infarction, Chest pain, Cough, Decreased appetite
Clinical narrative: Hopspitalized 3/3/23-3/10/23 chest pain, SOB, cough, N/V, abd pain, fatigue, decreased appetite,N-STEMI, elevated troponin
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Nausea, Troponin increased, Vomiting
Clinical narrative: Hopspitalized 3/3/23-3/10/23 chest pain, SOB, cough, N/V, abd pain, fatigue, decreased appetite,N-STEMI, elevated troponin
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Dermatitis, Erythema, Pain in extremity
Clinical narrative: PATIENT RECEIVED VACCINE 5/29/24 AND ON 6/4/24 BEFORE SHE WENT TO BED HAD A VERY SORE LEFT ARM, WOKE UP 6/5/24 WITH SORE ARM AND ARM IS EXTREMLY RED AND INFLAMMED.  TOLD PATIENT TO KEEP CLOSE EYE ON ARM...TO TAKE MOTRIN AND PUT ICE PACK ON TODAY, IF NO BETTER TOMORROW TO CONTACT PROVIDER.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest X-ray abnormal, Chills, Dyspnoea, Gait inability
Clinical narrative: Body ache, chills, fever headache short of breath, unable to walk. Contact my provider prescribed antibodies and had chest x-ray that showed mildly enlarged heart with bilateral lung opacities pneumonia. In bedrest for two weeks.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lung opacity, Pain, Pyrexia
Clinical narrative: Body ache, chills, fever headache short of breath, unable to walk. Contact my provider prescribed antibodies and had chest x-ray that showed mildly enlarged heart with bilateral lung opacities pneumonia. In bedrest for two weeks.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The client should have not received this vaccine because she was not of age. There was no adverse reaction to the youth from giving the vaccine.
Age: 1.25
Sex: M
Vaccine: DTAP, DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered for patient to have pedvax hib vaccine and pediarix was prepared and given to patient on 6/5/24 at 9:20 am. pt had no adverse reactions not shot.  parents were notified and informed and provider stated pt would be okay to wait til apt in sept. to get the pedvaxhib vaccine.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient is approximately 8 weeks pregnant. G1P0.  Approximately 02/2025 delivery date. Patient is not displaying any adverse signs or reactions to vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Skin warm
Clinical narrative: Arm became red and hot the morning after her vaccine. Later that day she was hot and had chills. Symptoms lasted for 4 days but feels better now.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity, Pruritus
Clinical narrative: Achy upper arm immediately after, but turned to very itchy on 6/3 and still itchy on 6/5.  Daily Zyrtec but still itchy.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: welts on body
Age: 54.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Patient uncooperative
Clinical narrative: Patient states that when he was given the first vaccine he felt something that was painful and pulled away.  At that time the pharmacist told him she would have to poke him again to administer the rest of the vaccine and did. Then the other vaccine was given. The patient states he has been experiencing pain in this arm since that date and is unable to lift it. As a side note, he did receive another dose of heplisav in the same are on 11/03/23
Age: 1.83
Sex: F
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Adverse event: dose of MMR-V and Varicella given at same time. Treatment: family contacted. Outcome: family report child has no symptoms at this time i.e. fever, rash, etc.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events happened. Vaccine storage was compromised, Varivax vaccine is usually kept in the freezer however was left in the fridge for over 20 days  and given to  patient.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Gardasil HPV vaccine #3 too soon. Dose 1 was given 02/12/10, Dose 2 was given 04/17/24.
Age: 0.42
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Rotovirus at 22 wks of age
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was inadvertently administered to patient. No symptoms at this time.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Periarthritis, Shoulder injury related to vaccine administration
Clinical narrative: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (FROZEN SHOULDER) WAS THE OFFICIAL DIAGNOSIS BY THE ED AT HOSPITAL. THE TREATMENT WAS PREDNISONE AND FLEXIBILITY EXERCISES (BROOM STRETCH)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cold urticaria
Clinical narrative: Developed cold urticaria after vaccine. I get urticaria all over my skin every time i leave my house even when it?s not cold but a bit windy.  I had an emergency a few times when i swam in the ocean which brought me to w realization the urticaria was to cold. It happened wight after i took a vaccine, the cold season after that started and my issues have started
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient received Prevnar 20 08/01/23. Patient had an appointment on 5/8/24 for his yearly health exam and was given another Prevnar 20 by RMA. State Shots record was reviewed per staff but she stated she did not see where Prevnar 20 had been administered. Immunization was given before Dr. went in to see the patient. Staff notified Dr. of administering a 2nd Prevnar 20. ID inc form was completed and I instructed Staff that she needed to report the incident to office Manager. Patient came to Dr. office on 05/30/24 for a BP check and reported to this writer that ever since receiving the 2nd Prevnar 20 immunization he was having muscle aches, joint pain, fatigue and violent headaches. Note sent to Dr. notifying him of patient's symptoms. Patient was prescribed Prednisone 40 mg daily for 5 days on 5/31/24. I spoke with patient on 6/3/24 and 6/4/24 to check on how he was feeling. Patient stated to this writer that the Prednisone was helping his joint and muscle pain and he had a headache over the weekend but not like the "violent headaches" he was having prior to receiving the Prednisone prescription.
Age: 24.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given the Moderna COVID 19 vaccine after the 30 day period that it was taken out of the freezer. The patient was notified. No known adverse reaction.
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Client falsified his name and was given extra Hep A vaccine.  Initial vaccine was on 5/17/24.  Client was not due for second dose until 11/17/24.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left arm started to feel warm the following day (04/25/2024) and then vaccine recipient noticed redness and swelling the following Sunday when talking a shower.
Age: 22.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The COVID 19 vaccine was given after the 30 day period that it had been removed from the freezer. No known adverse effects/symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Mass excision, Nodule, Sarcoma, Scan
Clinical narrative: He got his vaccine.  Within 10 days he got COVID and did not give him any medical care.  After that about 2 years old he ended up with a knot on his arm that grew.  They removed the mass and it came back as being a sarcoma on 5/28/24.  He has to get another scan to see if they got the cancer, and they will determine if he needs chemo or radiation at that time.  He has a follow up appointment on 6/12/24.  They gave him pain medication for after the surgery, but is on no other medications at this time.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Tumour biopsy, Tumour excision
Clinical narrative: He got his vaccine.  Within 10 days he got COVID and did not give him any medical care.  After that about 2 years old he ended up with a knot on his arm that grew.  They removed the mass and it came back as being a sarcoma on 5/28/24.  He has to get another scan to see if they got the cancer, and they will determine if he needs chemo or radiation at that time.  He has a follow up appointment on 6/12/24.  They gave him pain medication for after the surgery, but is on no other medications at this time.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Vital were taken in the exam room at 11:15am before vaccine administration. Vaccines were given and patient was told to wait in waiting area for 15 minutes for observation. A few minutes passed and patient's mother started yelling that patient had fainted. Patient was found on the floor passed out. Patient was pale to the face and sweating. EMS was called and patient was checked out. Patient found to be okay. Patient was released to go home. Patient's mother was told to monitor him and if any problems to call 911. Time course was from 11:19 from start and EMS left at 11:45.
Age: 16.0
Sex: F
Vaccine: CHIK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: informed by staff on 06/05/2024 0900.   MMRV given at MA visit on 06/04/2024 at 1630 instead of the intended MMR.  Interventions: called home and informed family and patient. Patient is in her usual state of good health. No adverse event noted. and VAERS report to be done.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dyspnoea, Erythema, Pain in extremity
Clinical narrative: Vaccine administered 5/30. Patient returned to pharmacy on 6/3 to pick up rx for steroid stating her arm was still sore and red.  There was a topical reaction at the administration site.  Patient then again returned to pharmacy on 6/5 stating she had been treated in ER due to shortness of breath. Patient states hospitalist attributed SOB to vaccine.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This patient received a vaccine that had been expired for less than a month. No adverse reactions noted.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient requested Tdap vaccine but was given COVID-19 vaccine by mistake by a pharmacy technician. Patient stated she was planning on getting COVID-19 vaccine the following week. Patient has not reported any side effects. Patient contacted CDC and a confirmation number from VAERS report was requested.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Cartilage injury, Rheumatoid arthritis
Clinical narrative: Rhumatoid arthritis has affected back of my legs, upper back, wrists,right thumb and I have a labral tear in my right hip. They don?t know how it happened. Rheumatoid arthritis has affected the hip itself too. Both of these issues came in 08/2023 and they haven?t left only gotten worse I?ve been on ibuprofen 800mg which helps both issues but temporarily.
Age: 47.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: RASH ARMS, THORAX, ABDOMEN, HYDROCOTISONE, CHLORFENAMIN AND RANITIDINE WERE TREATED IN THE EMERGENCY
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given expired immunization. no adverse effect
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Lethargy
Clinical narrative: Moderate headache, lethargy; light-headed
Age: 33.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Myopericarditis
Clinical narrative: Diagnosed with myopericarditis
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Injection site erythema, Muscle spasms
Clinical narrative: Redness at injection site and below on left arm. Customer also states that she has cramping and constipation. Customer advised to follow up with healthcare provider if symptoms worsen or continue.
Age: 57.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; MMRII  was reconstituted with expired diluent; she administered another dose of MMRII; This spontaneous report has been received from a pharmacist, regarding to a 57-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 18-MAY-2024, the patient was vaccinated (at 57 years-old) with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, as prophylaxis, (lot number U7595AB which was determined to be invalid, expiration date reported and validated as 11-MAR-2025), it dose was reconstituted with expired sterile diluent (lot number X004656  which was determined to be valid, expiration date reported and validated as 15-JAN-2024) (Expired product administered), therefore, the patient received another dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Overdose), that was reconstituted with diluent that was not expired (lot number 1946077 which was determined to be valid, expiration date reported and validated as 01-NOV-2025) (Strengths, doses, routes of administration, and anatomical sites of injection were not reported).  No additional adverse events were reported in the patient.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE; A HCP called to report an AE in which a 1-year old child came in on 02/14/2024 for a routine 1-year check-up in which the child received a dose of VARIVAX and was supposed to received a first dose of MMR II, but was instead inadvertently administered; A HCP called to report an AE in which a 1-year old child came in on 02/14/2024 for a routine 1-year check-up in which the child received a dose of VARIVAX and was supposed to received a first dose of MMR II, but was instead inadvertently administered; This spontaneous report as received from a nurse referring to a 1-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent(STERILE DILUENT).        On 14-FEB-2024, the patient went for routine 1-year check-up in which the child received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL once, Lot # X021282, expiration date not reported but upon internal validation established as 20-AUG-2025 for prophylaxis (strength, dose, route of administration and anatomical location were not reported) and was supposed to received a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), but was instead inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mL once, Albumin status rHA Lot # X018813, expiration date not reported but upon internal validation established as 07-JAN-2025 (strength, dose, route of administration and anatomical location were not reported) and was not given the individual dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered and accidental overdose). No adverse event (AE) was reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE / no side effects reported; ROTATEQ was administered after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On 03-JUN-2024, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot # 2003148, expiration date: 31-MAY-2025 (exact dose and dose number were not reported), for prophylaxis. The vaccine underwent a temperature excursion of 35.2 degree Fahrenheit for 43 minutes (Product storage error). There was no previous temperature excursion. No side effects or additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypoaesthesia, Pain
Clinical narrative: body aches; numbness in fingers; friday was my right thumb and pointer.then Friday to sat was my left thumb and pointer (Shivering); This non-serious case was reported by a consumer and described the occurrence of shivering in a 42-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22-MAY-2024, the patient received Shingles vaccine. On 22-MAY-2024, less than a day after receiving Shingles vaccine, the patient experienced shivering (Verbatim: friday was my right thumb and pointer.then Friday to sat was my left thumb and pointer (Shivering)). On 23-MAY-2024, the patient experienced general body pain (Verbatim: body aches) and numbness in fingers (Verbatim: numbness in fingers). On 23-MAY-2024, the outcome of the shivering and general body pain were resolved.  On 24-MAY-2024, the outcome of the numbness in fingers was resolved.   It was unknown if the reporter considered the shivering, general body pain and numbness in fingers to be related to Shingles vaccine.     It was unknown if the company considered the shivering, general body pain and numbness in fingers to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-MAY-2024 The patient reported that she received Shingles vaccine and on Friday her right thumb and pointer was shivering and then Friday to Saturday her left thumb and pointer was shivering. Also patient reported that the she experienced body aches and numbness in fingers. The reporter requested to consent the follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes ophthalmic, Vaccination failure
Clinical narrative: Vaccination failure/Suspected vaccination failure; developed herpes ophthalmic; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Vaccination failure/Suspected vaccination failure) (serious criteria GSK medically significant) and herpes ophthalmic (Verbatim: developed herpes ophthalmic) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the herpes ophthalmic was not reported.   It was unknown if the reporter considered the vaccination failure and herpes ophthalmic to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the herpes ophthalmic to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2024 The immunization specialist reported that there was a patient who received the 1st and 2nd dose Shingrix vaccine at the facility. The 2nd dose was at 6 months not the recommended between 2 and 4 months and the patient developed herpes ophthalmic besides being immunized. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).  Herpes ophthalmic is an unlisted event which is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pharmacist has a 67 year old patient that got an Infanrix vaccine by accident instead of Adacel vaccine; Pharmacist has a 67 year old patient that got an Infanrix vaccine by accident instead of Adacel vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a female patient who received DTPa (Infanrix) (batch number 73FX2, expiry date 26-MAR-2026) for prophylaxis.   Co-suspect products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 5-COMPONENT;TETANUS VACCINE TOXOID (ADACEL) for prophylaxis.   On 29-MAY-2024, the patient received Infanrix. On an unknown date, the patient received ADACEL. On 29-MAY-2024, an unknown time after receiving Infanrix, the patient experienced interchange of vaccine products (Verbatim: Pharmacist has a 67 year old patient that got an Infanrix vaccine by accident instead of Adacel vaccine) and inappropriate age at vaccine administration (Verbatim: Pharmacist has a 67 year old patient that got an Infanrix vaccine by accident instead of Adacel vaccine). The outcome of the interchange of vaccine products and inappropriate age at vaccine administration 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: 30-MAY-2024 Pharmacist has a 67 year old patient that got an Infanrix vaccine by accident instead of Adacel vaccine which led to interchange of vaccine products and inappropriate age at vaccine administration.