chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atelectasis, Chest X-ray, Computerised tomogram thorax, Diarrhoea
Clinical narrative: Acute onset dyspnea with tachycardia , generalized weakness , diarrhea  Diagnosed PULMONARY EMBOLISM distal right pulmonary artery per testing at Hospital 12/01/23 Moderate right Pleural Effusion w compressive atelectasis w seveerly dilated right ventricle on echo   treated w heparin, transitioned to Eliquis and sent home ONGOING TREATMENT AND FOLLOW UP NEEDED
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Pulmonary embolism, Right ventricular dilatation, Tachycardia
Clinical narrative: Acute onset dyspnea with tachycardia , generalized weakness , diarrhea  Diagnosed PULMONARY EMBOLISM distal right pulmonary artery per testing at Hospital 12/01/23 Moderate right Pleural Effusion w compressive atelectasis w seveerly dilated right ventricle on echo   treated w heparin, transitioned to Eliquis and sent home ONGOING TREATMENT AND FOLLOW UP NEEDED
Age: 14.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Asthenia, Headache, Hypoaesthesia, Hyporesponsive to stimuli, Musculoskeletal disorder
Clinical narrative: Client came into clinic room anxious about getting vaccines. After giving vaccines, client became weak,slow to answer questions, unable to move or feel lower legs below knees.  Had client recline on exam table. At 2:35pm B/P 125/83, HR 73 temp 98.6. 2:40pm B/P 123/79 HR 80 sitting, 2:41pm B/P 122/82 HR 82 standing. 2:43pm neuro checks per RN client was able to follow all commands and each check was reactive and equal. 2:48pm B/P 136/73 HR 60. Client gave thumbs up to being ok at 2:49pm.  Mom present and choose to take to PCP, urgent care or ER if needed.Client complains of headache. Client drank a few sips of soda before leavi Client left the building ambulating with mom and male cousin.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient requested the Pfizer COVID shot for this year.  At the time of vaccination, the patient stated that it had been quite a while since her last vaccine.  After the vaccine she asked to look up some information on her profile, where it was discovered, she had a Pfizer COVID vaccine in September and should not have received the vaccine at this time.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Muscle spasms, Nausea
Clinical narrative: Nausea, vomiting,  muscle spasms,  tremors
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Nausea, vomiting,  muscle spasms,  tremors
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Neuralgia, Pain, Pain in extremity
Clinical narrative: initial swelling around injection site, with subsequent nerve pain shooting down the half the arm and then ultimately radiating up into the shoulder blade area. saidpain is sharp, but not consistent. still experiencing episodes of pain, but seems to be improving.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Bone hypertrophy, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Spondylitis
Clinical narrative: *Hyperstosis sternoclavicular joint-my collarbone grows extra bone *Spondylo arthritis  All this is only on the side I got my vaccine on (leftside) I can no longer lift left arm above my head
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: *Hyperstosis sternoclavicular joint-my collarbone grows extra bone *Spondylo arthritis  All this is only on the side I got my vaccine on (leftside) I can no longer lift left arm above my head
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt states she had redness and pain at site of injection and it was warm to the touch.
Age: 85.0
Sex: M
Vaccine: FLUA4
Symptoms: Death, Hypersomnia, Hypophagia
Clinical narrative: After receiving the vaccine the patient began to sleep more and not eat.  Eventually passing away.  The staff does not know if it was related to vaccine or not.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient vomited one time under an hour after receiving vaccine. Parent dropped child off at daycare with no repeat events reported.
Age: 17.0
Sex: F
Vaccine: COVID19, FLUA4, MENB
Symptoms: Dizziness, Head injury, Nausea, Syncope, Vomiting
Clinical narrative: Nausea starting the night after, nausea in the AM, fainted and hit her head, ongoing nausea , dizziness and vomiting that day
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site urticaria, Lip erythema, Lip swelling, Urticaria
Clinical narrative: At 1140 pt c/o urticaria at vaccine sites, lip swelling and erythema, lip welts.  diphenhydramine 50 mg/1 mL given IM at 1153 Pt reported symptoms being resolved by 1209
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Lip swelling, Pruritus, Swollen tongue, Tongue disorder
Clinical narrative: At 1140 pt c/o urticaria at vaccine sites, lip swelling and erythema, lip welts.  diphenhydramine 50 mg/1 mL given IM at 1153 Pt reported symptoms being resolved by 1209
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Lip swelling, Pruritus
Clinical narrative: At 1140 pt c/o urticaria at vaccine sites, lip swelling and erythema, lip welts.  diphenhydramine 50 mg/1 mL given IM at 1153 Pt reported symptoms being resolved by 1209
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported; Nurse Prescriber reported she administered expired MMRII today, 11/6/2023, expired on 9/22/2023. Confirmed no previous or current temperature excursions. No side effects or symptoms reported. Read the supported disclaimer to customer as this was supp; This spontaneous report as received from a Nurse Practitioner (NP) refers to a patient of unknown age and gender.  The subject's concurrent conditions, medical history and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA albumin status lot # U029620, the expiration date: 22-SEP-2023 (expired product administered), 0.5 milliliter, (route was not reported) for prophylaxis.  Other suspect therapies included sterile diluent (MERCK STERILE DILUENT). No side effects or symptoms reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a registered nurse (RN) referring to a patient of unspecified age or gender. Information of concurrent condition, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 20-OCT-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) injection (1 dosage form (reported as 1 dose), lot# X019553, expiration date 19-JAN-2025, route, anatomical location and strength were not reported) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at minus 9.2 degree Celsius (C) for 1 hour 7 minutes and minus 11.2 degree Celsius (C) for 31 minutes (product storage error). There were no previous temperature excursions. No additional adverse events (AEs) were reported (no adverse event), no further information was provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE and no PQC; HBP calling to report administration of an expired dose of PROQUAD to a patient on 11/27/2023.  Caller confirmed no previous temperature excursions for this product and stored in the recommended range.  HBP states there are no symptoms or further det; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 27-NOV-2023, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as prophylaxis (lot number: W023865, which was determined to be valid, with an expiration date on 29-OCT-2023) (strength, dose, scheme, route and anatomical location of administration were not reported) (Expired product administered).  Caller confirmed no previous temperature excursions for this product and stored in the recommended range.  No additional adverse event was reported, there were no symptoms or further details to report.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE was reported.; Nurse reported that a patient received an expired PNEUMOVAX 23.; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 29-NOV-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter (ml) once (valid lot number w007035 [expiration date 20-OCT-2023]) (dose number, vaccination scheme, frequency and route of administration were not provided) for prophylaxis (expired product administered).   No additional adverse event (AE).
Sex: U
Vaccine: PNC15
Symptoms: Incorrect dose administered, Product storage error
Clinical narrative: HCP calling to report AE for administered supported TE's.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-NOV-2023, the patient was vaccinated with an improperly dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, single dose, valid lot #X012044, expiration date: 10-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion occurred at 47 Fahrenheit (F) (47.44 F) for 10 minutes. No previous temperature excursion was reported.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: THIS WAS A VACCINE ERROR.   MODERNA SPIKEVAX WAS EXPIRED ON 11/24/23 WHICH DOES HAVE MANUFACTURING EXP DATE: 5-16-23.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Breast pain, Chest pain, Chills, Condition aggravated, Eczema
Clinical narrative: The day I was given the vaccine I experienced a headache, chills, fatigue, nausea after 4 hours. Each day after I experienced fatiguee, muscle aches. Starting 11/28/23, I sexperienced an eczema outbreak and itchiness all over my body. There were also chest pain, throat pain, breast pain but was fleeting. I overall have experienced a prolonged illness that has impacted my ability to show up my best.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Illness, Myalgia, Nausea
Clinical narrative: The day I was given the vaccine I experienced a headache, chills, fatigue, nausea after 4 hours. Each day after I experienced fatiguee, muscle aches. Starting 11/28/23, I sexperienced an eczema outbreak and itchiness all over my body. There were also chest pain, throat pain, breast pain but was fleeting. I overall have experienced a prolonged illness that has impacted my ability to show up my best.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pruritus
Clinical narrative: The day I was given the vaccine I experienced a headache, chills, fatigue, nausea after 4 hours. Each day after I experienced fatiguee, muscle aches. Starting 11/28/23, I sexperienced an eczema outbreak and itchiness all over my body. There were also chest pain, throat pain, breast pain but was fleeting. I overall have experienced a prolonged illness that has impacted my ability to show up my best.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: INCIDENT ERROR.   COVID MODERNA SPIKEVAX GIVEN TO EMPLOYEE EXPIRED FROM FRIDGE 11/24/23, MANUFACTURING EXPIRATION DATE: 5/16/23
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Device connection issue, Exposure via skin contact, Immunisation, Underdose
Clinical narrative: Needle was not fully attached to vaccine syringe so dose came out at attachment point and ran down patient's arm.  Had to give patient a second administration.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received Heplisav-B on 7/21 and Went to Another Pharmacy on 8/21 and Got Another Hepatitis Vaccine; Initial report received on 13-Sep-2023  A pharmacy student reported that a 20-year-old male patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then got another hepatitis vaccine (not specified).  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.  On 21-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot # 943241, expiration date 07J ul 2025, NDC # 43528-003-05) intramuscularly in the left arm. No adverse effects were reported.  On 21-Aug-2023, 32 days after having been vaccinated with HEPLISAV-B, the patient went to another pharmacy and got another hepatitis vaccine as the second dose (no product information available).  No additional information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Patient reported a red, sore arm with a knot in the middle of the injection site. Patient stated that she continued to have these symptoms at the 5 day mark (date of this report).
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Migraine
Clinical narrative: Severe Migraine, elevated temp of 100.0 degrees
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Acne, Coagulopathy, Contusion, Gingival bleeding, Immunoglobulin therapy
Clinical narrative: The day after the vaccine (04/07/23) I had normal arm soreness from the vaccine and a slight fever. The next two days (04/08/23 & 04/09/23) my arm my still slightly sore. On 04/16/2023, I was in the middle of my shift at work when I noticed petechiae all on my legs, arms, and hands. I also had a random bruise on my hand out of nowhere, as well as a pimple I had popped that didn't clot properly and turned into a black bruise. The next day (04/17/2023) it was still there, but by nighttime I had blood blisters form inside my mouth on the inside if my cheeks and lips. On 04/18/23, I woke up to the petechiae still in the same areas, blood blisters still in my mouth, as well as my gums bleeding right when I woke up. On this same day is when I went to the ER and was admitted into the hospital.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Oral blood blister, Pain in extremity, Petechiae, Platelet count decreased, Platelet count increased
Clinical narrative: The day after the vaccine (04/07/23) I had normal arm soreness from the vaccine and a slight fever. The next two days (04/08/23 & 04/09/23) my arm my still slightly sore. On 04/16/2023, I was in the middle of my shift at work when I noticed petechiae all on my legs, arms, and hands. I also had a random bruise on my hand out of nowhere, as well as a pimple I had popped that didn't clot properly and turned into a black bruise. The next day (04/17/2023) it was still there, but by nighttime I had blood blisters form inside my mouth on the inside if my cheeks and lips. On 04/18/23, I woke up to the petechiae still in the same areas, blood blisters still in my mouth, as well as my gums bleeding right when I woke up. On this same day is when I went to the ER and was admitted into the hospital.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Platelet transfusion, Pyrexia
Clinical narrative: The day after the vaccine (04/07/23) I had normal arm soreness from the vaccine and a slight fever. The next two days (04/08/23 & 04/09/23) my arm my still slightly sore. On 04/16/2023, I was in the middle of my shift at work when I noticed petechiae all on my legs, arms, and hands. I also had a random bruise on my hand out of nowhere, as well as a pimple I had popped that didn't clot properly and turned into a black bruise. The next day (04/17/2023) it was still there, but by nighttime I had blood blisters form inside my mouth on the inside if my cheeks and lips. On 04/18/23, I woke up to the petechiae still in the same areas, blood blisters still in my mouth, as well as my gums bleeding right when I woke up. On this same day is when I went to the ER and was admitted into the hospital.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site rash, Malaise
Clinical narrative: The morning after the shingrix vaccine, I noticed intense constant pain in my right arm with painful range of motion (much worse than the TDAP given in my left arm).  I also had nausea, chills, fatigue and feeling sick.   Then today (2 days after vaccine) I noticed a painful raised 5 x 5 cm rash  located 7 cm distal to the injection site on my right arm.  The rash is tender to the touch and appears consistent with shingles.  I continue to have constant pain over the rash and it is tender to the touch.  I also continue to have chills.  I am both the patient and a MD (medical doctor).  I have taken a picture of it which I can send you.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Rash, Rash papular
Clinical narrative: The morning after the shingrix vaccine, I noticed intense constant pain in my right arm with painful range of motion (much worse than the TDAP given in my left arm).  I also had nausea, chills, fatigue and feeling sick.   Then today (2 days after vaccine) I noticed a painful raised 5 x 5 cm rash  located 7 cm distal to the injection site on my right arm.  The rash is tender to the touch and appears consistent with shingles.  I continue to have constant pain over the rash and it is tender to the touch.  I also continue to have chills.  I am both the patient and a MD (medical doctor).  I have taken a picture of it which I can send you.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received 0.25ml dose
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - ringing, screeching in ears.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Client stated that the following day after the vaccine, 12/01/2023, her right deltoid, shoulder and neck is warm, red, stiff and painful to touch and movement.  She has been using, ibuprofen, benadryl and cold compress. She stated that today 12/04/2023 the injection site is itching.  She stated that she had doctors appointment 12/06/2023.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Skin warm
Clinical narrative: Client stated that the following day after the vaccine, 12/01/2023, her right deltoid, shoulder and neck is warm, red, stiff and painful to touch and movement.  She has been using, ibuprofen, benadryl and cold compress. She stated that today 12/04/2023 the injection site is itching.  She stated that she had doctors appointment 12/06/2023.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Skin warm, Swelling
Clinical narrative: Per patient-painful arm, swelling, unable to raise arm, warm to touch
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Migraine
Clinical narrative: PT STATES THAT THE DAY FOLLOWING ADMINISTRATION, SHE WOKE UP WITH A MIGRAINE. SHE HAS A HISTORY OF MIGRAINES, BUT STATES THAT SHE HAS BEEN UNABLE TO AFFECTIVELY RESOLVE HER SYMPTOMS WITH HER NORMAL REGIMEN OF MEDICATION AND NON-PHARMACOLOGICAL MEASURES.  SHE CALLED THE PHARMACY TODAY, 12/4/23, TO REPORT THAT HER MIGRAINES HAVE BEEN CONTINUOUS WITH NO RELIEF (11/30/23-12/4/23)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Sleep disorder
Clinical narrative: I was given the injection at about 11:30 am on 12/2/23. At around 2:30 am on 12/3/23 I woke with a fever of 101.1. I took ibuprofen at 2:30 and 7:30. My fever broke aroune 12:30 pm on 12/3/23.  At the injection site, there is a red swollen area that is highly sensitive to the touch.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: An 11-year-old erroneously received a 12-year-old to adult dose of COVID-19 vaccine.
Age: 82.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Haematoma, Injection site swelling, Pain, Peripheral swelling, Reaction to previous exposure to any vaccine
Clinical narrative: Pt stated that his right arm started to swell a day after he got the shot and grew 3 times as big.  This swelling continued down his shoulder to his wrist. He got a painful haematoma and the swelling is still there.  He is being treated for the pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: swollen Lymph nodes on collar bone; stiff neck
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Patient has had cramping and continuous watery diarrhea since Saturday, December 2nd (48 hours after receiving RSV vaccine).  Patient is moderating symptoms with loperamide, eating a soft diet and drinking plenty of fluids with electrolytes.  Tolerating symptoms from home.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Diplopia
Clinical narrative: Sever double vision and loss of equilibrium that lasted a week and slowly subsided over the following few days
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: Patient states that they had arm swelling on left arm at injection site on Sunday night, Patient states they are okay now and it has gotten better as of Monday.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Peripheral swelling
Clinical narrative: Injection Site Rock Hard; Injection Site Hot to Touch; Injection Site a Light Shade of Purple; Swelling in Arm; Injection Site Red; Initial report received on 14-Sep-2023  A registered nurse reported that a 20-year-old female patient (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had swelling in the arm, and a rock hard, red with a light shade of purple, and hot to the touch injection site that lasted 4 days.   Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had allergies to ketamine, fentanyl, Versed (midazolam) (causes "reactive airway"), Tamiflu (oseltamivir) (causes vomiting and a bloody nose with blood clots), and amoxicillin (causes itching and migraines).  On an unspecified date, one month before receiving the HEPLISAV-B vaccine, the patient received Engerix B (no details provided).  On 14-Aug-2023, the patient received a dose of HEPLISAV-B (Lot # 941428, expiration date 30-Apr- 2025, NDC # unknown; injection site not reported) intramuscularly. The patient experienced swelling in the arm; and the injection site was rock hard, red with a light shade of purple, and hot to the touch. After the patient took Benadryl (diphenhydramine) twice a day for three days, the symptoms resolved after four days.  No additional information was available.  Company Comment:  The company considers the events as non-serious.; Sender's Comments: The company considers the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Second Dose With Pediatric Dose of Engerix; Initial report received on 15-Sep-2023  A licensed practical nurse reported that a 19-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B (pediatric dose) as the second dose.   Medical history and concomitant medications at the time of vaccination were not reported. The patient has no allergies or previous reactions to other vaccines.  On 07-Aug-2023, the patient received a dose of HEPLISAV-B (Lot # 941589, expiration date 31-Aug-2023, NDC # 43528-003-05; route not reported) in the left deltoid.  On 15-Sep-2023, 40 days after having been vaccinated with HEPLISAV-B, the patient received a pediatric dose of Engerix-B from a medical assistant. No adverse reactions were reported.  No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: adult male patient received a pediatric dose of Havrix; adult male patient received a pediatric dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 61-year-old male patient who received HAV (Havrix pediatric) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   On 11-OCT-2023, the patient received the 1st dose of Havrix pediatric. On 11-OCT-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: adult male patient received a pediatric dose of Havrix) and adult use of a child product (Verbatim: adult male patient received a pediatric dose of Havrix). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 27-NOV-2023 The pharmacist stated an adult male patient received a pediatric dose of Havrix (Havrix 720), which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: Suspected Vaccination failure; breakthrough cases of mild shingles; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (every 4 or 5 years had breakthrough cases of mild shingles).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: breakthrough cases of mild shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-NOV-2023 The physician wanted to know if recurrent cases of shingles had occurred in vaccinated patient. The physician reported that patient had vaccinated of Shingrix vaccine and who she believed every 4 or 5 years had breakthrough cases of mild shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consent to follow up. No additional details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: due to a needle leakage, a patient didn't receive the full dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 27440) for prophylaxis.   On 28-NOV-2023, the patient received the 1st dose of Shingrix. On 28-NOV-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: due to a needle leakage, a patient didn't receive the full dose of Shingrix). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 28-NOV-2023 The reporter called to inform that earlier that day, due to a needle leakage, a patient did not receive the full dose of Shingrix, which led to incomplete dose administered. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Coma
Clinical narrative: IN COMA FOR 13 DAYS; This spontaneous report received from a consumer via a company representative via communication (other source) concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number, and expiry were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after vaccination patient was in coma for 13 days. Since then, the patient had to fight to get back every single day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from in coma for 13 days. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231181442-In coma for 13 days. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Malaise
Clinical narrative: felt a little under the weather; sore injection site arm; after his second dose almost felt like the flu but it did not last for very long; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (after his second dose almost felt like the flu but it did not last for very long), MALAISE (felt a little under the weather) and INJECTION SITE PAIN (sore injection site arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Stent placement in 2001 and Heart valve replacement NOS in 2001. Concomitant products included WARFARIN, LISINOPRIL and TADALAFIL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MALAISE (felt a little under the weather) and INJECTION SITE PAIN (sore injection site arm). In 2021, the patient experienced INFLUENZA LIKE ILLNESS (after his second dose almost felt like the flu but it did not last for very long). In 2021, INFLUENZA LIKE ILLNESS (after his second dose almost felt like the flu but it did not last for very long) had resolved. At the time of the report, MALAISE (felt a little under the weather) and INJECTION SITE PAIN (sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received his first Moderna Covid-19 vaccine in early (February) 2021 lot number and expiration date are not available. He does not remember which arm that he received his vaccine in. He reports a sore injection site arm and felt a little under the weather.   He received his second Moderna Covid-19 vaccine about 28 days after the first Moderna Covid-19 vaccine lot number and expiration date are not known. He does not remember which arm that he received his second vaccine in. He reports that he felt more under the weather after his second dose almost felt like the flu, but it did not last for very long. He had a sore injection site arm for a brief period.  He received his first Moderna booster dose sometime in October 2021. The lot number and expiration date are not known. Injection site arm is not known. No Adverse Reactions are reported.   He did receive additional booster doses in 2022, does not provide history on these booster doses as he does not remember much about these doses. He does not report any additional adverse reactions.   This case was linked to MOD-2023-751294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2023: Live follow-up received on 29 Nov 2023 contain significant information- reporter email id updated. Reference id updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Muscle atrophy, Pain, Paraesthesia
Clinical narrative: uti symptoms; weakness; pain; muscle atrophy; numbness in arms, legs and torso; tingling in arms, legs and torso; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (uti symptoms), ASTHENIA (weakness), PAIN (pain), MUSCLE ATROPHY (muscle atrophy) and HYPOAESTHESIA (numbness in arms, legs and torso) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. Lot 3030371) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 29-Sep-2023, the patient experienced URINARY TRACT INFECTION (uti symptoms), ASTHENIA (weakness), PAIN (pain), MUSCLE ATROPHY (muscle atrophy), HYPOAESTHESIA (numbness in arms, legs and torso) and PARAESTHESIA (tingling in arms, legs and torso). At the time of the report, URINARY TRACT INFECTION (uti symptoms), ASTHENIA (weakness), PAIN (pain), MUSCLE ATROPHY (muscle atrophy), HYPOAESTHESIA (numbness in arms, legs and torso) and PARAESTHESIA (tingling in arms, legs and torso) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient experienced UTI symptoms that were constant, numbness/tingling in arms, legs and torso, weakness, pain, muscle atrophy. It was unknown if the patient experienced any additional symptoms/events.   Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: uti symptoms; weakness; pain; muscle atrophy; numbness in arms, legs and torso; tingling in arms, legs and torso; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (uti symptoms), ASTHENIA (weakness), PAIN (pain), MUSCLE ATROPHY (muscle atrophy) and HYPOAESTHESIA (numbness in arms, legs and torso) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. Lot 3030371) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 29-Sep-2023, the patient experienced URINARY TRACT INFECTION (uti symptoms), ASTHENIA (weakness), PAIN (pain), MUSCLE ATROPHY (muscle atrophy), HYPOAESTHESIA (numbness in arms, legs and torso) and PARAESTHESIA (tingling in arms, legs and torso). At the time of the report, URINARY TRACT INFECTION (uti symptoms), ASTHENIA (weakness), PAIN (pain), MUSCLE ATROPHY (muscle atrophy), HYPOAESTHESIA (numbness in arms, legs and torso) and PARAESTHESIA (tingling in arms, legs and torso) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient experienced UTI symptoms that were constant, numbness/tingling in arms, legs and torso, weakness, pain, muscle atrophy. It was unknown if the patient experienced any additional symptoms/events.   Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: The injection site was hot, hard, sore.; sore/The injection site was hot, hard, sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (The injection site was hot, hard, sore.) and VACCINATION SITE PAIN (sore/The injection site was hot, hard, sore) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 043422A) for COVID-19 prophylaxis.     Patient did not receive other in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna Vaccine (Lot 028L20A) on 20-Jan-2021, Moderna Vaccine (Lot 004M20A) on 17-Feb-2021, Moderna Vaccine (Lot 013F21A) on 28-Nov-2021 and Moderna Vaccine (Lot 013F21A) on 28-Nov-2021; for Product used for unknown indication: Pneumonia shot and Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot, Moderna Vaccine, Moderna Vaccine and Pneumonia shot; Vaccination site pain with Moderna Vaccine; and Vaccination site warmth with Moderna Vaccine. Concurrent medical conditions included Allergy to antibiotic, Allergy to NSAIDs (They are body sensitives.), Hypothyroidism, Fibromyalgia, Arthritis, DVT and Pulmonary embolism (which they hopefully have resolved, last time in the hospital for it was 2022). Concomitant products included METHYLPREDNISOLONE for Arthritis, APIXABAN (ELIQUIS) for DVT and Pulmonary embolism.    On 12-Dec-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (The injection site was hot, hard, sore.) and VACCINATION SITE PAIN (sore/The injection site was hot, hard, sore). At the time of the report, VACCINATION SITE WARMTH (The injection site was hot, hard, sore.) and VACCINATION SITE PAIN (sore/The injection site was hot, hard, sore) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was reported that every time they got the initial and second booster, they have had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore. No treatment medication was reported.   This case was linked to MOD-2023-751584 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Urticaria, Vaccination site rash
Clinical narrative: At the same time I began to develop hives down the same arm and to a lesser extent over my body, creases of arms, chest, stomach, and back; One week after vaccine I developed rash at injection site.; Within 24 hours of vaccine I felt groggy; had low grade fever.; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Within 24 hours of vaccine I felt groggy), URTICARIA (At the same time I began to develop hives down the same arm and to a lesser extent over my body, creases of arms, chest, stomach, and back), PYREXIA (had low grade fever.) and VACCINATION SITE RASH (One week after vaccine I developed rash at injection site.) in a 33-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3832B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 13-Nov-2023, the patient experienced URTICARIA (At the same time I began to develop hives down the same arm and to a lesser extent over my body, creases of arms, chest, stomach, and back) and VACCINATION SITE RASH (One week after vaccine I developed rash at injection site.). In November 2023, the patient experienced SOMNOLENCE (Within 24 hours of vaccine I felt groggy) and PYREXIA (had low grade fever.). At the time of the report, SOMNOLENCE (Within 24 hours of vaccine I felt groggy), URTICARIA (At the same time I began to develop hives down the same arm and to a lesser extent over my body, creases of arms, chest, stomach, and back), PYREXIA (had low grade fever.) and VACCINATION SITE RASH (One week after vaccine I developed rash at injection site.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: instability walking; weakness of the legs; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (instability walking) and MUSCULAR WEAKNESS (weakness of the legs) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (012L20A) on 09-Jan-2021, Moderna covid-19 vaccine on 01-Apr-2022 and Moderna covid-19 vaccine on 08-Sep-2022; for Product used for unknown indication: Flu vaccine in 2023 and RSV in 2023. Past adverse reactions to the above products included No adverse event with Flu vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and RSV.   On 09-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Apr-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced GAIT DISTURBANCE (instability walking) and MUSCULAR WEAKNESS (weakness of the legs). At the time of the report, GAIT DISTURBANCE (instability walking) and MUSCULAR WEAKNESS (weakness of the legs) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Caller mentioned the neurologist did not give them a diagnosis yet but her husband will do bloodwork on 30-NOV-2023 and MRI and other test next week.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Arm was very painful; arm was very painful and got red; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was very painful) and INJECTION SITE ERYTHEMA (arm was very painful and got red) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Oct-2022, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was very painful) and INJECTION SITE ERYTHEMA (arm was very painful and got red). At the time of the report, PAIN IN EXTREMITY (Arm was very painful) and INJECTION SITE ERYTHEMA (arm was very painful and got red) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia, Vomiting
Clinical narrative: He's feeling really bad today; aches, and pains; fever chills; throwing up; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (He's feeling really bad today), PAIN (aches, and pains), PYREXIA (fever chills) and VOMITING (throwing up) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN (aches, and pains), PYREXIA (fever chills) and VOMITING (throwing up). On 30-Nov-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FEELING ABNORMAL (He's feeling really bad today). At the time of the report, FEELING ABNORMAL (He's feeling really bad today), PAIN (aches, and pains), PYREXIA (fever chills) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.