chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.83
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Swollen and red area in my child's left thigh after 12 hours of injection, 3rd series - same brand. Area swollen bigger than 2 inch which has covered at least 60% of her thigh. 3rd day after injection area has worsen and tendered, contacted pediatricians and answered questions asked.  4th day swelling decreased and 5th day massive bruise occurred. It looked painful however child didn't seem to avoid using the leg and no fever noticed.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/3/2023,  3/4/2023,  2/2/2023,  2/19/2023,  2/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood magnesium decreased, Blood potassium decreased, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: Patient had feeling of fatigue immediately after administration. Heart rate began elevating approximately 20:00 on 7/31/2023 on the same day of administration. Patient began having shortness of breath and dyspnea and was brought to emergency room via ambulance. Patient was treated with IV Benadryl, Solumedrol, Pepcid, Lorazepam and Duo-neb respiratory treatment. Magnesium and potassium levels dropped requiring replacement of PO potassium.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrolyte substitution therapy, Fatigue, Full blood count, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Patient had feeling of fatigue immediately after administration. Heart rate began elevating approximately 20:00 on 7/31/2023 on the same day of administration. Patient began having shortness of breath and dyspnea and was brought to emergency room via ambulance. Patient was treated with IV Benadryl, Solumedrol, Pepcid, Lorazepam and Duo-neb respiratory treatment. Magnesium and potassium levels dropped requiring replacement of PO potassium.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test, Troponin
Clinical narrative: Patient had feeling of fatigue immediately after administration. Heart rate began elevating approximately 20:00 on 7/31/2023 on the same day of administration. Patient began having shortness of breath and dyspnea and was brought to emergency room via ambulance. Patient was treated with IV Benadryl, Solumedrol, Pepcid, Lorazepam and Duo-neb respiratory treatment. Magnesium and potassium levels dropped requiring replacement of PO potassium.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: About 2 days after the shot was given a 3 in wide x 2.5 in high swollen reddish spot appeared on the upper arm by where the shot was given that was very warm to the touch.  By 7 days after the shot, the spot had grown to 4 in wide by 7 in high and was very itchy.  Hydrocortisone lotion was being applied to reduce the itch.  Still warm to the touch, but not as warm as it was to begin with.  Still mostly red.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Oral herpes
Clinical narrative: Noticed a cold sore type place in the middle of her top lip after receiving her 3rd Gardasil dose earlier in the day. Denies any other side effects. States sister does get these cold sores but that she has never had one before. Client states that she did not run a fever with the vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines ; Moderna 3/10/21 lot# 011M20A ; Moderna 4/8/21 lot# 010M20A
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines  Moderna 2/1/21 lot# 015M20A;  Moderna 3/11/21 lot# 030A21A;  Moderna 12/4/21 lot# 012H21B;  Moderna 11/18/22 lot# 014H22A
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 5/17/21 lot# EM9810;  Pfizer 6/8/21 lot# EN6202
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 5 vaccines Pfizer 1/19/21 lot# EL1283;  Pfizer 2/9/21 lot# EL9265;  Pfizer 10/28/21 lot# FF2589;  Pfizer 4/1/22 lot# FJ6369;  Pfizer 10/6/22 lot# GJ2524
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV1
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was to receive just Hib but instead was given Pentacel in addition to her scheduled vaccines of pediarix, rotavirus and Prevnar13 which caused  her to have an extra dose of DTAP and IPV.  Parents notified and no adverse reactions at time.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 7/28/21 lot# EW0164;  Pfizer 8/18/21 lot# EW0164;  Pfizer 6/14/22 lot# FM7553
Age: 13.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Pt had a vasovagal episode roughly about 2 minutes after receiving Menquadfi and Tdap vaccines about 08:56. She slowly fell from her chair face first. She hit her head on the floor but did not bruise. She appeared pale after episode. Nurses elevated her feet and fanned her. She quickly returned to be alert oriented and responsive. Blood pressure check was 102/72 at 9:00 am. pt sat up and ate some candy and her color returned prior to leaving clinic. Guardian states that she has a lot of anxiety.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Moderna 1/14/21 lot# 01J20A;  Moderna 2/1/21 lot# 013M20A;  Moderna 12/3/21 lot# 066H21A;
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypotension
Clinical narrative: LEFT BELLS PALSY CHRONIC HYPOTENSION
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 9/21/21 lot# FC3183;  Pfizer 10/12/21 lot# FF2589
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, Pain, SARS-CoV-2 test positive
Clinical narrative: I was vacationing abroad when on the afternoon of 8/24/2022, I began to feel more tired than usual and had a little bit of a sore throat. I wasn't concerned, because we had had a full day, so I just chalked it up to travel. The following day, I felt worse and more fatigued, but I went ahead with my itinerary. On the morning of 8/26/2022, I took a home antigen test and got a positive result. We flew back home the next day and isolated when we got home. With regard to my symptoms, I just had a mild sore throat, body aches, and a mild fever for about three days. This was followed by low-grade fatigue for about three weeks. I treated my symptoms with Tylenol, and I made sure to drink plenty of fluids. I have asthma, so I feel lucky that I didn't have any major respiratory issues. I also feel lucky to have not experienced loss of taste or smell. Also, I have friends who are dealing with long COVID-19 symptoms, and I feel fortunate to have recovered quickly from my symptoms.
Age: 37.0
Sex: M
Vaccine: FLU4, HEPAB, TYP, YF
Symptoms: Hypoaesthesia, Immunisation reaction, Injection site haemorrhage, Injection site inflammation, Injection site swelling
Clinical narrative: I got I think it was 3 or 4 vaccine shots (Sept 19th 2022) prior to my trip in October 2022, during the shots on my left arm, the LPN lost focus for a second and jabbed the needle in crooked into my arm and it started to bleed. After about 3-4 days my elbow on my left arm became inflamed and extremely swollen. At the time of the incident, I went to my PCP office near my house and they said it should go away.  I have seen my chiropractor twice a month for several years now, and he saw it at the time. After about 2 months, my elbow swelling went down but then immediately my pinky and index finger on the side near my pinky became numb.... So I'd say since late November 2022 til the present date my pinky has been numb.  My chiropractor till now doesn't think it a problem with a pinched nerve and its something more acute and something related to the vaccine shots, like maybe it overloaded my thyroid in my left arm and damaged my nerve?   Something to note, I called up the Clinic about 2 months after it happened and they said it should go away in 3-4 months, 4 months had gone by I called them up and they said for me to give it 3 more months, so I did then I called them up after 7 months and they said go to my PCP; they gave me anti-inflammatory steroids and it made no change. its been 11 months now and my pinky finger is still numb.  I've been supplementing with a B complex daily, hoping it would help.   As mentioned I've been seeking help from doctors and the Clinic on several occasions, but no one is seeming to take this matter seriously and I'd just like to get function back in my pinky after getting all of these vaccine shots. I only got all of them cause it was advised from the agency I get all of these prior to traveling overseas. I never imagined this nerve damage would be a result of this effort to remain protected.   I'm seeking help for this acute vaccination event!  Note: I don't known the manufacturer's of each vaccine shot (so I guessed, fair heads up), the lot number, route, all I do know it was in my left and right arms but I don't recall which shot was in which arms, its been nearly 11 months, I cant remember, lol.   I have the paperwork from the shots, but none of this information is on the printout. I think cause of HIPPA the  Clinic didn't put it on the paperwork or something. But I'm sure they have this information someplace.   As for 22, I got a Pfizer booster in my left arm about a month prior; I think it was my 2nd booster. i.e the 1st two shots was Pfizer came out was to me shot 1 and 2, then we I got my 1st booster, and this shot a month prior was my 2nd booster, so I put down shot 4.
Age: 37.0
Sex: M
Vaccine: FLU4, HEPAB, TYP, YF
Symptoms: Musculoskeletal disorder, Nerve injury, Thyroid disorder, Wrong technique in product usage process
Clinical narrative: I got I think it was 3 or 4 vaccine shots (Sept 19th 2022) prior to my trip in October 2022, during the shots on my left arm, the LPN lost focus for a second and jabbed the needle in crooked into my arm and it started to bleed. After about 3-4 days my elbow on my left arm became inflamed and extremely swollen. At the time of the incident, I went to my PCP office near my house and they said it should go away.  I have seen my chiropractor twice a month for several years now, and he saw it at the time. After about 2 months, my elbow swelling went down but then immediately my pinky and index finger on the side near my pinky became numb.... So I'd say since late November 2022 til the present date my pinky has been numb.  My chiropractor till now doesn't think it a problem with a pinched nerve and its something more acute and something related to the vaccine shots, like maybe it overloaded my thyroid in my left arm and damaged my nerve?   Something to note, I called up the Clinic about 2 months after it happened and they said it should go away in 3-4 months, 4 months had gone by I called them up and they said for me to give it 3 more months, so I did then I called them up after 7 months and they said go to my PCP; they gave me anti-inflammatory steroids and it made no change. its been 11 months now and my pinky finger is still numb.  I've been supplementing with a B complex daily, hoping it would help.   As mentioned I've been seeking help from doctors and the Clinic on several occasions, but no one is seeming to take this matter seriously and I'd just like to get function back in my pinky after getting all of these vaccine shots. I only got all of them cause it was advised from the agency I get all of these prior to traveling overseas. I never imagined this nerve damage would be a result of this effort to remain protected.   I'm seeking help for this acute vaccination event!  Note: I don't known the manufacturer's of each vaccine shot (so I guessed, fair heads up), the lot number, route, all I do know it was in my left and right arms but I don't recall which shot was in which arms, its been nearly 11 months, I cant remember, lol.   I have the paperwork from the shots, but none of this information is on the printout. I think cause of HIPPA the  Clinic didn't put it on the paperwork or something. But I'm sure they have this information someplace.   As for 22, I got a Pfizer booster in my left arm about a month prior; I think it was my 2nd booster. i.e the 1st two shots was Pfizer came out was to me shot 1 and 2, then we I got my 1st booster, and this shot a month prior was my 2nd booster, so I put down shot 4.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: CHRONIC HYPOTENSION HYPOTENSION 2/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored at refrigerated temperature, with 70 day expiration dating and expired 7/3/23. Vaccine was administered 11 days after expiration.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Moderna 2/15/21 lot# 015M20A;  Moderna 3/15/21 lot# 002B21A;  Moderna 11/19/21 lot# 012H2
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Sleep disorder
Clinical narrative: Itchy rash started 3 days after she received the 2nd Shingrix shot per patient. She said it is all over her body and is itchy enough to prevent her from sleeping.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 14 days past expiration.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/12/2022,  3/5/2023,  1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 16.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given the wrong vaccine, was supposed to receive Meningococcal. Did not have any reaction to receiving the Prevnar 13.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 16 days past expiration.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: Child presented to clinic on 7/28/2023, with facial swelling, parent stated this occurred on 7/21/2023. Child denies and shortness of breathe, difficulty breathing or itching. Parent advice to take child to PCP.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Breathing-related sleep disorder
Clinical narrative: BREATHING RELATED SLEEP DISORDER
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Inadvertently administered Prevnar 13 instead of HPV.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Cerebrovascular accident, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/30/2022 &  9/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 21 days past expiration.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An administration error; vaccine was given outside of the date parameters.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted approximately 10 mins post vaccine while leaving the clinic.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 28 days past expiration.
Age: 29.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Inadvertently administered Prevnar 13 instead of HPV vaccine
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An administration error; vaccine was given outside of the date parameters.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Reversible ischaemic neurological deficit
Clinical narrative: REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 2/8/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction has happened. The pt was given this as a first dose of meningococcal vaccine instead of the MCV4. This pt is also under the recommended age of 16 for Bexsero
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration error; vaccine was given outside of the date parameters.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fatigue, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: The patient is a 11 year, 1 month old male who presents with a complaint of Rash. Patient accompanied by and independent history obtained from father. The rash has been occurring for 1-2 days. The rash is characterized as raised above the skin. The rash is described as being located on the entire body. Symptoms include itching, drinking well, eating well and fatigue, while symptoms do not include fever, uri symptoms, runny nose, congestion, cough, sore throat, nausea, vomiting, diarrhea or headache. Medications used at home include other (Zyrtec for itching) . Note for "Rash": Started on abdomen and feet yesterday and has now spread diffuse all over the body. Described as raised, red, and mildly pruritic. No discharge of purulence. No new skin exposures or new skin products. No known skin contacts. On 7/26, received meningococcal, HPV, and TDap.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash pruritic, Streptococcus test negative
Clinical narrative: The patient is a 11 year, 1 month old male who presents with a complaint of Rash. Patient accompanied by and independent history obtained from father. The rash has been occurring for 1-2 days. The rash is characterized as raised above the skin. The rash is described as being located on the entire body. Symptoms include itching, drinking well, eating well and fatigue, while symptoms do not include fever, uri symptoms, runny nose, congestion, cough, sore throat, nausea, vomiting, diarrhea or headache. Medications used at home include other (Zyrtec for itching) . Note for "Rash": Started on abdomen and feet yesterday and has now spread diffuse all over the body. Described as raised, red, and mildly pruritic. No discharge of purulence. No new skin exposures or new skin products. No known skin contacts. On 7/26, received meningococcal, HPV, and TDap.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MENB, TDAP, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There is no adverse reaction to report. The pt was given Bexsero as their first meningococcal vaccine ever instead of MCV4 and he is under the recommended age of 16 for Bexsero
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient  provided a immunization record with one dose of shingrix recorded. She states that she needed second dose. AFter the vaccine was administered and recorded it was noted in her chart that she had already received 2 doses. She states that she does not recall receiving second dose although it was administered. She states that she feel well, no adverse effects noted at this time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm, flu like symptoms, headache, period started 3 days after vaccine (patient thought she was already in menopause)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Patient had red rash at site in injection that spread on arm to bicep area
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient came to the clinic accompanied by mom to be vaccinated. It was determined the patient needed  a TDAP vaccine. After screening patient and ordering the TDAP in computer, I mistakening asked the vaccine  manager for a DTAP. I then input the vaccine information into computer under TDAP and administered the  vaccine to the patient in the left deltoid. The patient was then monitored in post vaccination for 15  minutes for any adverse reaction. No reactions were noted and the patient left the vaccine area with  mom. While doing a final count at the end of clinic it was discovered that I had given a DTAP instead of TDAP to the mentioned patient
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Blood pressure increased, Dysgeusia, Hypersensitivity, Swollen tongue
Clinical narrative: PATIENT RECEIVED SHINGRIX VACCINE, RETURNED TO PHARMACY AFTER 10 MINUTES COMPLAINING OF TONGUE FEELING SWOLLEN/TINGLING AND ODD TASTE. PATIENT BEGAN TO GET AGITATED; BLOOD PRESSURE WAS TAKEN AND IT WAS ELEVATED. EMS WAS IMMEDIATELY CONTACTED. PRIOR TO EMS ARRIVAL PATIENT WAS GIVEN TWO 25MG BENADRYL TABLETS (50MG) BY ORAL ROUTE. ONCE PARAMEDICS ARRIVED, VITALS WERE TAKEN AND EMS DETERMINED SHE WAS STABLE AND IN GOOD CONDITIONS TO GO HOME WITH A MILD ALLERGIC REACTION.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received dose two of their Hepatitis A vaccine too soon.
Age: 63.0
Sex: M
Vaccine: HEP, HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received the Pediatric/Child Dose (10mcg/0.5ml) in error for first 2 doses of the 3 dose series. Patient required adult doses. No adverse effects occurred from either incident. Following CDC Guidance to anyone under-dosed to restart the series for adult dose.
Age: 1.58
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC15
Symptoms: Syringe issue
Clinical narrative: After administering the Vaxneuvance vaccine, I went to engage the safety needle and the syringe broke. The safety didn't engage, but I had moved it away from the patient and caregiver and nobody was injured.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Fatigue, Pain in extremity, Tenderness
Clinical narrative: Fatigue and arm pain for 6 days, red, tender area that is 13 mm x 7 mm in size
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: I was given the order from provider to give immunization to pt. I went to the med room I got the immunization, went to go give them to the patient, then went to chart them I realized that I administered the wrong vaccination.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Anger, Feeling abnormal, Irritability
Clinical narrative: Patient's wife called to report psychiatric side effect of patient feeling "funny" and  have uncontrollable anger and irritability starting 30 minutes after vaccine was given.  Advised patient to contact md and go to ER if symptoms did not resolve, continued, or got worse.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Immune thrombocytopenia
Clinical narrative: Patient developed ITP(acute thrombocytopenic purpura),as per hematologist's office,its an auto immune disease and cause is still unknown
Age: 17.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: The patient received Meningcoccal B(Trumenba) for the second dose of the series instead of Meningococcal (bexsero) which the patient received as the first dose
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Sex: M
Vaccine: HEP, UNK
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE; HCP calling to report accidental vaccination of RECOMBIVAX in combination with VAXELIS for 6 month old male patient.; This spontaneous report has been received from a medical assistant concerning a 6-month-old male patient.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 27-JUL-2023, the patient was accidentally vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) single dose (dose, anatomical location, route of administration, lot#, expiration date were not reported) for prophylaxis in combination with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) single dose (dose, anatomical location, route of administration, lot#, expiration date were not reported) (accidental overdose). No additional adverse events were reported.
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea
Clinical narrative: experienced difficulty breathing; This non-serious case was reported by a physician via sales rep and described the occurrence of difficulty breathing in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced difficulty breathing (Verbatim: experienced difficulty breathing). The outcome of the difficulty breathing was resolved.   It was unknown if the reporter considered the difficulty breathing to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the difficulty breathing to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 26-JUL-2023 A physician reported that a patient received Bexsero and then later experienced difficulty breathing that required a visit to the emergency Department.  The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired vaccine). The outcome of the expired vaccine used was 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: 28-Jul-2023 The HCP asked if the expired dose was valid. The health care professional reported the administration of an expired Infanrix dose to a patient, which led expired vaccine used. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 12 month old received 1 mL dose instead of 0.5 mL dose; 12 month old received 1 mL dose instead of 0.5 mL dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-month-old male patient who received HAV (Havrix 1440 adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 24-JUL-2023, the patient received Havrix 1440 adult. On 24-JUL-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: 12 month old received 1 mL dose instead of 0.5 mL dose) and inappropriate age at vaccine administration (Verbatim: 12 month old received 1 mL dose instead of 0.5 mL dose). The outcome of the overdose 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: 27-JUL-2023 The nurse stated that new shipment of Havrix vaccines came in, and office did not realize the new shipment was 1 mL doses instead of 0.5 mL doses. A 1ml of dose was given on 24 July 2023 to a 12 month old patient which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up. This case had been linked with US2023103052 by same reporter for different patient. The vaccine administration facility is the same as primary reporter.; Sender's Comments:  US-GSK-US2023103052:Same reporter
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 month patient received 1 mL doses instead of 0.5 mL doses; 18 month patient received 1 mL doses instead of 0.5 mL doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-month-old male patient who received HAV (Havrix 1440) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 25-JUL-2023, the patient received Havrix 1440. On 25-JUL-2023, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: 18 month patient received 1 mL doses instead of 0.5 mL doses) and inappropriate age at vaccine administration (Verbatim: 18 month patient received 1 mL doses instead of 0.5 mL doses). The outcome of the overdose 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: 27-JUL-2023 The reporter reported that the new shipment of Havrix vaccine was came in and the office did not realized the new shipment was 1 ml doses instead of 0.5 ml. The reporter stated that the dose was given to the 18 months old male patient. The vaccine administration facility was the same as primary reporter. The infant patient was administered an adult dose of Havrix , which led to overdose and inappropriate age at vaccine administration. This case had been linked with US2023103051 by same reporter for different patient. The reporter did consent to follow up.; Sender's Comments:  US-GSK-US2023103051:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible late second dose of Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late second dose of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 27-JUL-2023 and 28-JUL-2023 The reporter reported possible late second dose of Shingrix. The vaccine administration facility was the same as primary reporter. No additional adverse event (AE) details available.  The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Injection site swelling
Clinical narrative: Shingles outbreak; Blisters; Injection site pain; Injection site swelling; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site swelling (Verbatim: Injection site swelling), shingles (Verbatim: Shingles outbreak) and blister (Verbatim: Blisters). The outcome of the injection site pain and injection site swelling were resolved (duration 9 days) and the outcome of the shingles was resolved and the outcome of the blister was not reported.   It was unknown if the reporter considered the injection site pain, injection site swelling, shingles and blister to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, shingles and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter reported that the patient received Shingrix vaccine and experienced injection site pain and swelling that was lasted for 9 days. The reporter stated that the patient also had a small shingles outbreak, reportedly the size of a silver dollar with blisters in it. The reporter reported that the patient received Shingrix vaccine in a different state, so reporter did not know the date of vaccine, but stated that it was within a window for the second dose. The reporter did not know which arm the injection was administered and did not know the location of the shingles outbreak.   The reporter reported that the shingles was resolved now, but she was unsure how long it lasted or if it was treated with any medication.   The reporter stated that at the time of reporting, the second dose of Shingrix has not been administered. The reporter did consent to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: accidentally an adult dose of Havrix was administered to a pediatric patient; accidentally an adult dose of Havrix was administered to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 22-month-old female patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 27-JUL-2023, the patient received Havrix adult. On 27-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: accidentally an adult dose of Havrix was administered to a pediatric patient) and adult product administered to child (Verbatim: accidentally an adult dose of Havrix was administered to a pediatric patient). The outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter did not consent to follow-up. The pediatric patient accidentally received an adult dose of Havrix, which led to accidental overdose and adult product administered to child.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix was given to an 11-year-old patient that was supposed to receive Boostrix; 11 year old received Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 3M9Y7, expiry date 03-MAR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Infanrix. On 28-JUL-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix was given to an 11-year-old patient that was supposed to receive Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 year old received Infanrix). The outcome of the wrong vaccine administered 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: 28-Jul-2023 The reporter consented to follow-up via email. The patient was supposed to receive Boostrix but received Infanrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: a vaccine given to a patient that was reconstituted wrong; a vaccine given to a patient that was reconstituted wrong; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   On 27-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 27-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: a vaccine given to a patient that was reconstituted wrong) and inappropriate dose of vaccine administered (Verbatim: a vaccine given to a patient that was reconstituted wrong). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 Nurse reported that a vaccine given to a patient that was reconstituted wrong (Inappropriate reconstitution technique).  This was 2 of 2 cases, reported by the same reporter. The reporter consented to follow up. The Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant and was administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023103550:Same reporter
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Boostrix(exp:7/15/23) dose to a patient today on 7/28/23; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 28-JUL-2023, the patient received Boostrix (intramuscular, left arm). On 28-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Boostrix(exp:7/15/23) dose to a patient today on 7/28/23). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-Jul-2023 The pharmacist called to inquired that the dose was valid or the patient would need to be revaccinated. The reporter did not consent to follow-up. The patient was inadvertently administered an expire dose of Boostrix on the day of reporting, which led to expired vaccine used.
Age: 0.67
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 month old patient received their 2nd dose of Rotarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   On 24-JUL-2023, the patient received the 2nd dose of Rotarix lyophilized formulation. On 24-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 month old patient received their 2nd dose of Rotarix). The outcome of the inappropriate age at vaccine administration was 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: 28-JUL-2023 The reporter reported that baby came in for 6 month vaccines and they were doing catch-up and the 8 month old patient received their dose of Rotarix. The reporter consented to follow up. The patient received 2nd dose of Rotarix above than the recommended age, which led to inappropriate age at vaccine administration.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Boostrix was administered on 7/25/2023 and it was discovered after it was administered that she also had Boostrix back in 2019; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 49-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29-NOV-2024) for prophylaxis.   Previously administered products included Boostrix (1st dose received in 2019).   On 25-JUL-2023, the patient received Boostrix. On 25-JUL-2023, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: Boostrix was administered on 7/25/2023 and it was discovered after it was administered that she also had Boostrix back in 2019). The outcome of the drug dose administration interval too short was 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: 28-JUL-2023 The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via postal. The patient received 2nd dose of Boostrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 28-JUL-2023, the patient received Havrix. On 28-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was 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: 28-JUL-2023 The reporter was a medical assistant. The reporter did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. The reporter stated that a patient inadvertently received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a consumer concerned multiple patients of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient's died from myocarditis. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  This case, from the same reporter is linked to 20230762281 and 20230756395.; Sender's Comments: V0: 20230754574- myocarditis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: MYOCARDITIS
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: DIED OF COUGHING; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin 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, and batch number were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died of coughing. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20230756395-Died of coughing. 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.; Reported Cause(s) of Death: DIED OF COUGHING