chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Pain in right shoulder and upper arm. Seen by PA in my primary care doctors office. I was given steroids when they did not work after 5 months I had an MRI which showed Frozen Shoulder Syndrome and a couple tears in shoulder area. Saw an Orthropedic  Surgeon given another round of steroids and am now doing Physical Therapy while symptoms persist.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Extra dose administered
Clinical narrative: Patient began to experience hearing loss 2 days after receiving her 2nd booster. She states she did not have any illness when she received the vaccine and did not do anything else around this time that she suspected may have caused hearing loss. Initially hearing was almost completely lost in the left ear, but has improved over time, although not completely. She has been seen by her primary care physician since receiving vaccine and made them aware of the issue. She was referred to an audiologist who suggested surgical intervention, which the patient declined for the moment.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: Patient reported redness (quarter size) at the injection site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test normal, Computerised tomogram, Condition aggravated, Cyst
Clinical narrative: Lower half of body (waist down) aches, like one would expect with all over body aches with the flu or like I had with the 2nd dose.  Upper body was fine. This started to occur late at night about 10-12 hours after shot on Friday May 20th, 2022.  Next morning, symptoms worsened but I carried on. Left home and when returning around 11:30am, had much difficulty ascending stairs as the pain in back and legs were quite noticeable.   Laid down and rested. Symptoms continued to get worse and I had to lay in bed with alternating ice and heat packs to get relief. Took Tylenol. Already was on Meloxicam so did not take any more NSAIDS.  Ultimately had to start taking Vicodin (I have Rx leftover from a surgery) and only got out of bed to go to the bathroom. By Wednesday, May 25th, the pain was so severe I had to be taken to the ER.   X-rays, CT and MRI completed.  Finding of Turkic cysts on either side of spine at S1-2.  These were considered incidental findings but I was given two steroid injections that helped. While in the hospital, my acid reflux became severe.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gastrooesophageal reflux disease, Magnetic resonance imaging, Mobility decreased, Pain in extremity
Clinical narrative: Lower half of body (waist down) aches, like one would expect with all over body aches with the flu or like I had with the 2nd dose.  Upper body was fine. This started to occur late at night about 10-12 hours after shot on Friday May 20th, 2022.  Next morning, symptoms worsened but I carried on. Left home and when returning around 11:30am, had much difficulty ascending stairs as the pain in back and legs were quite noticeable.   Laid down and rested. Symptoms continued to get worse and I had to lay in bed with alternating ice and heat packs to get relief. Took Tylenol. Already was on Meloxicam so did not take any more NSAIDS.  Ultimately had to start taking Vicodin (I have Rx leftover from a surgery) and only got out of bed to go to the bathroom. By Wednesday, May 25th, the pain was so severe I had to be taken to the ER.   X-rays, CT and MRI completed.  Finding of Turkic cysts on either side of spine at S1-2.  These were considered incidental findings but I was given two steroid injections that helped. While in the hospital, my acid reflux became severe.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Lower half of body (waist down) aches, like one would expect with all over body aches with the flu or like I had with the 2nd dose.  Upper body was fine. This started to occur late at night about 10-12 hours after shot on Friday May 20th, 2022.  Next morning, symptoms worsened but I carried on. Left home and when returning around 11:30am, had much difficulty ascending stairs as the pain in back and legs were quite noticeable.   Laid down and rested. Symptoms continued to get worse and I had to lay in bed with alternating ice and heat packs to get relief. Took Tylenol. Already was on Meloxicam so did not take any more NSAIDS.  Ultimately had to start taking Vicodin (I have Rx leftover from a surgery) and only got out of bed to go to the bathroom. By Wednesday, May 25th, the pain was so severe I had to be taken to the ER.   X-rays, CT and MRI completed.  Finding of Turkic cysts on either side of spine at S1-2.  These were considered incidental findings but I was given two steroid injections that helped. While in the hospital, my acid reflux became severe.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Postural orthostatic tachycardia syndrome, Sinus tachycardia, Syncope
Clinical narrative: vasovagal syncope, sinus tachycardia, PVCs, inappropriate tachycardia, POTS, all since vaccination
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tilt table test positive, Ventricular extrasystoles
Clinical narrative: vasovagal syncope, sinus tachycardia, PVCs, inappropriate tachycardia, POTS, all since vaccination
Age: 61.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient has been experiencing pain from the shoulder to the elbow on right side.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incontinence
Clinical narrative: 2 incidents of incontinence one hour apart
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Surgery
Clinical narrative: appendix surgery
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: started day as shot and has lasted last 6 days. vomiting, diarrhea, complete loss of appetite, extreme fatigue, violent headaches at the back of head
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: started day as shot and has lasted last 6 days. vomiting, diarrhea, complete loss of appetite, extreme fatigue, violent headaches at the back of head
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Decreased appetite, Headache, Injected limb mobility decreased
Clinical narrative: Sore arm, can't lift left arm where shot was given. Pain in my neck and back, chills and headaches.  Chills last  2 days. No appetite.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Sore arm, can't lift left arm where shot was given. Pain in my neck and back, chills and headaches.  Chills last  2 days. No appetite.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Chills, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever, chills, body aches. Brief prickly pin point rash in the abdomen. Next day mid face swelling below the lower eyelid area around the maxillary area with very mild tenderness. Angioedemq
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling face, Tenderness
Clinical narrative: Fever, chills, body aches. Brief prickly pin point rash in the abdomen. Next day mid face swelling below the lower eyelid area around the maxillary area with very mild tenderness. Angioedemq
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Biopsy, Chest X-ray, Colitis microscopic, Colonoscopy
Clinical narrative: Auto immune disorder: Lymphocytic colitis  diagnosed Feb 9, 2022 by colon biopsy after 35 days of acute diarrhea (6-8 x's per day) and loss of 14 pounds. Started 9mg Budesonide for 4 weeks (Feb 18-Mar 18), 6 mg for 4 weeks (Mar 19-April 9), 3 mg for 3 weeks, 3 days (April 10-May 3) Auto immune complication: Uveitis diagnosed Feb 14, 2022 with severe inflammation of cornea in both eyes, pain, and vision impairment.  Prednisolone drops each hour for 2 weeks. Gradual reduction in drops until last on April 16, 2022 Inflammation in nerves of right hand: thumb and middle finger May 6, 2022. Cortizone injection in right wrist May 26, 2022
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Electromyogram, Inflammation, Keratitis, Laboratory test
Clinical narrative: Auto immune disorder: Lymphocytic colitis  diagnosed Feb 9, 2022 by colon biopsy after 35 days of acute diarrhea (6-8 x's per day) and loss of 14 pounds. Started 9mg Budesonide for 4 weeks (Feb 18-Mar 18), 6 mg for 4 weeks (Mar 19-April 9), 3 mg for 3 weeks, 3 days (April 10-May 3) Auto immune complication: Uveitis diagnosed Feb 14, 2022 with severe inflammation of cornea in both eyes, pain, and vision impairment.  Prednisolone drops each hour for 2 weeks. Gradual reduction in drops until last on April 16, 2022 Inflammation in nerves of right hand: thumb and middle finger May 6, 2022. Cortizone injection in right wrist May 26, 2022
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain, Stool analysis, Uveitis, Visual impairment
Clinical narrative: Auto immune disorder: Lymphocytic colitis  diagnosed Feb 9, 2022 by colon biopsy after 35 days of acute diarrhea (6-8 x's per day) and loss of 14 pounds. Started 9mg Budesonide for 4 weeks (Feb 18-Mar 18), 6 mg for 4 weeks (Mar 19-April 9), 3 mg for 3 weeks, 3 days (April 10-May 3) Auto immune complication: Uveitis diagnosed Feb 14, 2022 with severe inflammation of cornea in both eyes, pain, and vision impairment.  Prednisolone drops each hour for 2 weeks. Gradual reduction in drops until last on April 16, 2022 Inflammation in nerves of right hand: thumb and middle finger May 6, 2022. Cortizone injection in right wrist May 26, 2022
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Auto immune disorder: Lymphocytic colitis  diagnosed Feb 9, 2022 by colon biopsy after 35 days of acute diarrhea (6-8 x's per day) and loss of 14 pounds. Started 9mg Budesonide for 4 weeks (Feb 18-Mar 18), 6 mg for 4 weeks (Mar 19-April 9), 3 mg for 3 weeks, 3 days (April 10-May 3) Auto immune complication: Uveitis diagnosed Feb 14, 2022 with severe inflammation of cornea in both eyes, pain, and vision impairment.  Prednisolone drops each hour for 2 weeks. Gradual reduction in drops until last on April 16, 2022 Inflammation in nerves of right hand: thumb and middle finger May 6, 2022. Cortizone injection in right wrist May 26, 2022
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Allergy test, Dysphonia, Injection site bruising, Injection site swelling
Clinical narrative: Swelling, bruising at site for almost 6 months.  Intense stomach pain on left side, had to go to emergency (had this after my allergic reaction to flu vaccine too where my arm went paralyzed)   My vocal chords swelled up and I couldn?t speak for 2-3 weeks until a series of steroids. I?m a news anchor and 9 months later Im still having voice problems (range, hoarseness, sometimes pain in vocal chords)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Speech disorder, Vocal cord disorder
Clinical narrative: Swelling, bruising at site for almost 6 months.  Intense stomach pain on left side, had to go to emergency (had this after my allergic reaction to flu vaccine too where my arm went paralyzed)   My vocal chords swelled up and I couldn?t speak for 2-3 weeks until a series of steroids. I?m a news anchor and 9 months later Im still having voice problems (range, hoarseness, sometimes pain in vocal chords)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed
Clinical narrative: Delay of menstrual period by 6 weeks, when menstruation returned it was heavy prolonged bleeding. This happened with the initial vaccines and again with the booster I got 11/23/21.  The bleeding was heavier and more prolonged with the booster. Two cycles of heavy, prolonged bleeding until I used birth control to stop the bleeding.  The bleeding became bad enough to soak through a pad, two layers of clothing, a towel and a blanket.  After 6 weeks of birth control cycle went back to normal.  In 16 years of menstruating (8 off birth control and 8 on birth control) I had never experienced heavy or prolonged bleeding. Only after delayed cycles directly after the original set of vaccines and then with the booster shot.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Gave the wrong dose of 0.3ml or 30 ug Gray cap instead of 10 ug 0.2ml
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I don't know where else to report this, but after my initial shots in March/April 2021, my psoriasis completely went away! It started to come back just before I got my first booster in October 2021, and then cleared up again until late May, 2022.  I just got my second booster in June 2022, so I don't quite know if the psoriasis will go away again, but fingers crossed! This is a wonderful side effect that you all might want to know about!
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 test with symptoms
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Five year old received adult formulation of Pfizer 0.2ml drawn and administered by APRN
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus has been escalating in severity.  Just wanted to be included in the data that I do believe the vaccine has exacerbated what was an occasional low level issue to high scale. (Note: i also experienced diabetic type symptoms TEMPORARILY but the tinnitus did not disappear and has been increasing.)
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Each day after that it got bigger and blotchy; Big red bull eye in  left arm/Moderna red arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm) and RASH MACULAR (Each day after that it got bigger and blotchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm). On an unknown date, the patient experienced RASH MACULAR (Each day after that it got bigger and blotchy). At the time of the report, VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm) and RASH MACULAR (Each day after that it got bigger and blotchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported that she's taking concomitant medications but names were not specified. She reported that after the 1st dose, 10 days later she had a big red bull eye in left arm but It did not itch. She stated she was not sick. She also stated that after each day it got bigger and blotchy. It was then resolved. No treatment medications were reported.   This case was linked to MOD-2022-589356, MOD-2022-589342 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular, Vaccination site erythema
Clinical narrative: Each day after that it got bigger and blotchy; Big red bull eye in  left arm/Moderna red arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm) and RASH MACULAR (Each day after that it got bigger and blotchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm). On an unknown date, the patient experienced RASH MACULAR (Each day after that it got bigger and blotchy). At the time of the report, VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm) and RASH MACULAR (Each day after that it got bigger and blotchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported that she's taking concomitant medications but names were not specified. She reported that after the 1st dose, 10 days later she had a big red bull eye in left arm but It did not itch. She stated she was not sick. She also stated that after each day it got bigger and blotchy. It was then resolved. No treatment medications were reported.   This case was linked to MOD-2022-589356, MOD-2022-589342 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Rash, Urticaria, Vaccination site lymphadenopathy, Vaccination site mass
Clinical narrative: Each day after that it got bigger and blotchy; Big red bull eye in  left arm/Moderna red arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm) and RASH MACULAR (Each day after that it got bigger and blotchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm). On an unknown date, the patient experienced RASH MACULAR (Each day after that it got bigger and blotchy). At the time of the report, VACCINATION SITE ERYTHEMA (Big red bull eye in  left arm/Moderna red arm) and RASH MACULAR (Each day after that it got bigger and blotchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported that she's taking concomitant medications but names were not specified. She reported that after the 1st dose, 10 days later she had a big red bull eye in left arm but It did not itch. She stated she was not sick. She also stated that after each day it got bigger and blotchy. It was then resolved. No treatment medications were reported.   This case was linked to MOD-2022-589356, MOD-2022-589342 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: She had either hives/rash (red bumps from neck to knees); 3 days later she had rash all over her body; Nausea; All the lymph nodes swell up in the left side of underarm.; She had big lump back of the left arm; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 010M20A and 002A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm). At the time of the report, URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm) outcome was unknown.            Patient was taking unspecified medications. Patient had received the first booster dose on 01-Nov-2021. It was reported that patient was healthy. Patient  wanted to know if she developed an allergic reaction to the vaccine. Patient stated it seemed odd that her reaction got worst with the half dosage of the vaccine.  No treatment medication was provided.   This case was linked to MOD-2022-589308, MOD-2022-589342 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular, Vaccination site erythema
Clinical narrative: She had either hives/rash (red bumps from neck to knees); 3 days later she had rash all over her body; Nausea; All the lymph nodes swell up in the left side of underarm.; She had big lump back of the left arm; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 010M20A and 002A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm). At the time of the report, URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm) outcome was unknown.            Patient was taking unspecified medications. Patient had received the first booster dose on 01-Nov-2021. It was reported that patient was healthy. Patient  wanted to know if she developed an allergic reaction to the vaccine. Patient stated it seemed odd that her reaction got worst with the half dosage of the vaccine.  No treatment medication was provided.   This case was linked to MOD-2022-589308, MOD-2022-589342 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Rash, Urticaria, Vaccination site lymphadenopathy, Vaccination site mass
Clinical narrative: She had either hives/rash (red bumps from neck to knees); 3 days later she had rash all over her body; Nausea; All the lymph nodes swell up in the left side of underarm.; She had big lump back of the left arm; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 010M20A and 002A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm). At the time of the report, URTICARIA (She had either hives/rash (red bumps from neck to knees)), RASH (3 days later she had rash all over her body), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (All the lymph nodes swell up in the left side of underarm.) and VACCINATION SITE MASS (She had big lump back of the left arm) outcome was unknown.            Patient was taking unspecified medications. Patient had received the first booster dose on 01-Nov-2021. It was reported that patient was healthy. Patient  wanted to know if she developed an allergic reaction to the vaccine. Patient stated it seemed odd that her reaction got worst with the half dosage of the vaccine.  No treatment medication was provided.   This case was linked to MOD-2022-589308, MOD-2022-589342 (Patient Link).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the temperate excuration occurred, vaccines have been administered; This spontaneous report was received from a medical assistant and referred to 1-year-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 23-MAR-2022, the temperate excursion occurred to verified viability vaccine varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion. The digital data logger was involved.   On 27-APR-2022, at a private doctor's officer/hospital, the patient was vaccinated by a healthcare professional with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot # U025790 with expiration date: 19-AUG-2023; strength and dose not provided) administered subcutaneously for prophylaxis (product storage error). This initially used vaccine was not available for return/evaluation due to being given to the patient. There was no prescription drug treatment for the experience required. No additional adverse event details (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Administered Infanrix after temperature excursion; Patient with , got Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2022, the patient received the 5th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 31st March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: Receipt Date: 15-June-2022 Reporter's Comments: The medical assistant reported that a male patient was administered on 31st March 2022 the infanrix vaccine after a temperature excursion. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Infanrix at inappropriate age which led to inappropriate age at vaccine administration. The patient administered with Infanrix that underwent temperature excursions, which led to incorrect storage of drug. This is 1 of 12 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093645:Same reporter. US-GLAXOSMITHKLINE-US2022093646:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (Dose-1) on 07-Jan-2021, Pfizer (Dose-2) on 28-Jan-2021 and Pfizer (Dose-3) in October 2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date and time vial was first punctured was on 15 Jun 2022 at 9.15 AM, the vial undergo temperature excursions of plus1.9C to plus 6.4 C. Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F.  No treatment medication were reported.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Psoriasis
Clinical narrative: Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control; Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021). In March 2022, the patient experienced PSORIASIS (Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control). At the time of the report, PSORIASIS (Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. Primary reporter did not have the lot information because the packaging was discarded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022; doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-Jun-2022, the patient received booster dose (batch no. 058A22-2A) of Moderna COVID-19 Vaccine.  Vial was initially stored in the refrigerator on 09-Jun-2022 and was first punctured on 10-Jun-2022 at 1:05 PM. Post puncture vial was stored in a container to protect from the light and kept in the fridge. All 4 doses administered on 13Jun2022 at 11:24 AM, 12:30 PM, 1:30 PM, 3:00 PM. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was Approximately 5 times, but did not reported a exact amount of time. Vial was not exposed to room temperature for more than 24 hours. It was unknown that Patient was experiencing any symptoms.  No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022; Doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator was on 09 Jun 2022. Date and time the vial was first punctured was 10Jun2022 at 1:05 PM. The vial was stored post puncture in a container to protect from the light and kept in the fridge.The vial did not undergo any temperature excursions It was reported that the vial did not undergo any temperature excursions and total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) approximately 5 times, but did not have a exact amount of time out exposed to room temperature for more than 24 hours It was unknown that Patient was experiencing any symptoms.  No treatment medication were reported.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired dose of Menactra with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a 25-year-old female patient who was administered an expired dose of menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination.  On 08-Jun-2022, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6951AA expiration date 06-Jun-2022 via intramuscular route in the left deltoid for prophylactic vaccination. The patient was administered an expired dose of menactra with no reported adverse event (expired product administered).  Action taken: Not applicable  Outcome: Unknown      This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient received MENQUADFI during Pregnancy with no reported adverse event; Initial information received on 13-Jun-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 16 years old female patient who was exposed to vaccine meningococcal a-c-y-w135 (t conj) vaccine (Menquadfi) during pregnancy with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received MENQUADFI during Pregnancy with no reported adverse event occurred at 3 weeks of pregnancy and the patient was exposed to MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE at 3 weeks of pregnancy, during first pregnancy trimester for MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  The date of last menstrual period was reported as 09-Feb-2022. The estimated due date is 10-Sep-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy/ies: not reported  Concomitant medications included influenza vaccine inact split 3v (Flulaval) and Trumemba.  On 16-Feb-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine at a dose of 0.5 ml with lot U6936AA via intramuscular route in the right deltoid for Immunization.  On 16-Feb-2022 the patient developed a non-serious patient received menquadfi during pregnancy with no reported adverse event (exposure during pregnancy) following the administration of meningococcal a-c-y-w135 (t conj) vaccine. Relevant prenatal testing after exposure included   Action taken: not applicable.  Outcome: Unknown   Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: the liquid dtap-ipv portion of pentacel was administered but not the lyophilized hib portion of the vaccine  with no reported adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient and it was reported that the liquid dtap-ipv portion of pentacel was administered but not the lyophilized hib portion of the vaccine ,with no reported adverse event , while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).   On 09-JUN-2022 the patient was given the liquid dtap-ipv portion of pentacel was administered but not the lyophilized hib portion of the vaccine on with no reported adverse event (single component of a two-component product administered) (latency: same day), at dose of 0.5 ml once ( DTaP-IPV: U7256AB ; expiry date: 13-May-2023:; Lot for ACTHIB: UJ670AA ; expiry date: 13-May-2023) via intramuscular route in the left vastus lateralis for immunization.  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 month old was inadvertently administered a dose of Fluzone Quadrivalent with no adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 2 months old female patient who was inadvertently administered a dose of fluzone quadrivalent with no adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj (pneumococcal conjugate vaccine) for immunisation; and rotavirus vaccine live reassort oral 5v (rotateq) for Immunisation.  On 14-Jun-2022, the patient received 0.5 ml dose of suspect influenza quadrival a-b vaccine (batch lot UT7347MA,Expiry date:30-Jun-2022) prefilled syringe via intramuscular route in Left Vastus Lateralis.  On 14-Jun-2022 (latency :same day) the patient developed a non-serious event of  2 month old was inadvertently administered a dose of fluzone quadrivalent with no adverse event (product administered to patient of inappropriate age) following the administration of influenza quadrival a-b vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.