chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Laparoscopic surgery, Pyrexia, Scan with contrast abnormal, Sleep disorder
Clinical narrative: The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10.  The pain gradually increased, became more intense, and more constant.  Mild fever and chills started happening, and I took Ibuprofen.  By about 4 days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night.  Pain was 6-8/10.  I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis.  I underwent laparoscopic surgery and it was found to be perforated.  It was removed.  I am currently recovering in the hospital.  I received the vaccine as a health care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: During the 15min observation period, I felt flush for about a minute. I felt super hot, but it subsided. The biggest issue was the injection site. It was a huge, super hot, golf ball size welt on my arm. It spent two days growing bigger. The fourth day it began to feel better. I also had muscle stiffness, body and body aches lasting about 2-3 days.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: During the 15min observation period, I felt flush for about a minute. I felt super hot, but it subsided. The biggest issue was the injection site. It was a huge, super hot, golf ball size welt on my arm. It spent two days growing bigger. The fourth day it began to feel better. I also had muscle stiffness, body and body aches lasting about 2-3 days.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Poor Appetite
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Resident reported left arm pain
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Light Headache
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite
Clinical narrative: Lack of Energy and Poor appetite
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Feeling hot, Flushing, Pruritus, Throat irritation
Clinical narrative: Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her  sister also has similar allergy profile. She questioned if she should et the second vaccine dose.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Hypoaesthesia, Lymph node pain
Clinical narrative: Fever, chills, diaphoresis, body aches, head/neck pain, lymph node swelling/tenderness in left armpit (received vaccine in L arm), numbness/tingling/pins/needles sensation throughout entire body.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever, chills, diaphoresis, body aches, head/neck pain, lymph node swelling/tenderness in left armpit (received vaccine in L arm), numbness/tingling/pins/needles sensation throughout entire body.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Headache, Heart rate increased
Clinical narrative: Palpitations with heart rate up to 150 on 1/10/21 at 2pm accompanied by dizziness, nausea, headache and shortness of breath. Required IV fluids, EKG, labs, telehealth visit, cardiology referral and placed on Metoprolol for suspected POTS. Currently still having orthostatic tachycardia 7 days after onset of symptoms and pending cardiology referral.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: Palpitations with heart rate up to 150 on 1/10/21 at 2pm accompanied by dizziness, nausea, headache and shortness of breath. Required IV fluids, EKG, labs, telehealth visit, cardiology referral and placed on Metoprolol for suspected POTS. Currently still having orthostatic tachycardia 7 days after onset of symptoms and pending cardiology referral.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Loss of consciousness, Presyncope
Clinical narrative: Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, Unresponsive to stimuli
Clinical narrative: Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain, Pruritus
Clinical narrative: Noticed on 1/15 that there is still a silver dollar sized swollen lump that's hot and reddened at the injection site. I wouldn't be too concerned about such side effects except it is extremely itchy. To this day it is still reddened, swollen, warm and very itchy. In the beginning there was pain, which I took Tylenol for, but it is no longer painful. As stated before, the itching is what concerns me and how inflamed the site gets if I itch it.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Noticed on 1/15 that there is still a silver dollar sized swollen lump that's hot and reddened at the injection site. I wouldn't be too concerned about such side effects except it is extremely itchy. To this day it is still reddened, swollen, warm and very itchy. In the beginning there was pain, which I took Tylenol for, but it is no longer painful. As stated before, the itching is what concerns me and how inflamed the site gets if I itch it.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Headache, Musculoskeletal stiffness
Clinical narrative: I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No other AE details; temperature excursion; This spontaneous report has been received from a registered nurse referring to a 2 year old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 17-FEB-2020 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 ml, lot # T017688, expiration date 21-MAY-2022, strength and route were not reported) for prophylaxis. No other adverse event details available at this time.       Temperature excursion of this vaccine was -13.3 degrees Celsius for 4 hours and 15 minutes without any previous temperature excursion (incorrect product storage). The digital data logger was involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARlVAX was improperly stored and administered; This spontaneous report was received from a medical assistant concerning to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 04-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not provided); lot number T021824 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported and validated as 25-JUN-2022.   The administered vaccine had a temperature excursion of 16.1 degrees Fahrenheit (°F) for a time frame of 1 hours and 45 minutes, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA000920: US-009507513-2101USA000953: US-009507513-2101USA000954: US-009507513-2101USA001042:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Medical Assistant calling from HCP office to report a temperature excursion for V ARlV AX. One vaccine was administered to a patient; 0.5mL IM x one dose; This spontaneous report was received from a medical assistant from the physician's office concerning to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 04-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (ml), one dose intramuscularly for prophylaxis (formulation, strength, vaccination scheme and anatomical site of vaccination were not provided); lot number T021826 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported and validated as 25-JUN-2022.   The administered vaccine had a temperature excursion of 17.5 degrees Celsius (°C) for a time frame of 83 hours. It was reported that the data was not recorded by a digital data logger. It was also reported there was not a previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details; Nurse states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 07-DEC-2020, the patient was vaccinated with a dose of incorrectly storage hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot reported as T014835 with expiration date 17-JUL-2021 (dose, route and anatomical location were no reported) for prophylaxis. No additional adverse event was reported.  Lot number T014835 is an invalid lot number for hepatitis b vaccine (recombinant).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Nurse states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 08-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter (mL) orally for prophylaxis, lot number reported as 1684157 and expiration date as 26-JUN-2021 (formulation, strength and vaccination scheme were not provided).   The administered vaccine had a temperature excursion below 2 degrees Celsius (°C) (1.3°C) for a time frame of 24 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported a previous temperature excursion below 2°C (1.6°C) for a time frame of 24 minutes. No additional adverse events were reported.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A medical assistant reported VARIVAX was improperly stored and administered; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 04-JAN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot# T021824 and expiration date 25-JAN-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 16.1 degree fahrenheit (°F) for 1 hour and 45 minutes on an unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2101USA000916:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported; GARDASIL 9 has been administered since the temperature excursion; This spontaneous report was received from a Agent referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 30-DEC-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S010729 with expiration date 01-DEC-2021, lot # 1637648 with expiration date 19-JUN-2022; dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 32.9 Fahrenheit (F) for 24 minutes and 34F for 16 hours. It was not applicable if there was previous temperature excursion. A "data logger" was involved. No product to retrieve. No product quality complaint (PQC) reported. No other adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller states same was administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a 10-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 04-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration was not reported), lot# T002845 and expiration date 23-JAN-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -14° degree Celsius (°C) to -10°C for 2 hour and 30 minutes on an unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.; Sender's Comments:  US-009507513-2101USA000953: US-009507513-2101USA000916: US-009507513-2101USA000920: US-009507513-2101USA000954:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE detail; the vaccine was administered to patient during the excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 05-JAN-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 mL, strength and route were not reported, lot # S032036 has been verified as valid, expiration date 05-JAN-2021) for prophylaxis.  The vaccine administered experienced a temperature excursion of 16.0 degrees Fahrenheit, for a time frame of 25 minutes. There were no previous temperature excursions. The digital data logger was involved. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; other zoster-related conditions; Information has been received from an attorney regarding a case in litigation, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  In on about 01-JAN-2016, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions, at a clinic.   On unspecified date, the patient was treated by healthcare providers for Guillain-Barre Syndrome and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of patient's use of the vaccine, she had and would continue to suffer ongoing injuries, including but not limited to medical care and treatment for these injuries, medical losses and costs include care for hospitalization, monitoring treatment, medications and supplies. At the time of the report, the patient was not recovered from the adverse events. The reporter considered Guillain-Barre Syndrome and zoster-related conditions to be related to Zoster Vaccine Live (ZOSTAVAX) vaccine.   Upon internal review, the event of Guillain-Barre syndrome was considered medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: herpes zoster, postherpetic neuralgia, and vision problems.; herpes zoster, postherpetic neuralgia, and vision problems.; herpes zoster, postherpetic neuralgia, and vision problems.; This initial spontaneous report was received from a lawyer on 11-JAN-2021, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 17-DEC-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) (no additional dosage regimen information was provided). After receiving the vaccine, on an unknown date, the patient experienced herpes zoster, postherpetic neuralgia and vision problems. As a result of these symptoms, the patient was treated by medical providers and at the time of the report was still under their care. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of their condition. The patient sustained severe and permanent personal injuries. Further as a tragic consequence of vaccination, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury.  The reporter considered that herpes zoster, postherpetic neuralgia and vision problems were related to zoster vaccine live (ZOSTAVAX). The reporter considered this case as serious due to patient's disabling conditions.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This initial spontaneous report was received from a lawyer on 11-JAN-2021, regarding a case in litigation and refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. In or around 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen information was not reported) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered hearing loss. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries. Further as a tragic consequence of vaccination, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury.  At the time of the report, the outcome of deafness was as not recovered. The reporter considered deafness to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered this case as serious due to patient's disabling conditions. Upon internal review, deafness was considered to be medically significant.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, Wrong product administered
Clinical narrative: Patient received 2 doses of GARDASIL 4 years ago and 1 dose of GARDASIL 9 in December 2020; Patient received first 2 doses of GARDASIL and then received GARDASIL 9; Patient received first 2 doses of GARDASIL and then received GARDASIL 9; This spontaneous report was received from a medical assistant referring to a specific patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unspecified date in 2017 (reported as 4 years ago), the patient was vaccinated with doses 1 and 2 of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported) and then on 20-DEC-2020, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  lot number 169118, expiration date 15-NOV-2022, for prophylaxis (dose, route and site of administration were not reported) (interchange of vaccine products, wrong product administered and inappropriate schedule of product administration).    The outcome of the events was unknown.     Lot number 169118 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast).
Sex: U
Vaccine: VARCEL
Symptoms: Product temperature excursion issue
Clinical narrative: Varivax given durin teperature excursion; This spontaneous report as received from a certified medical assistant refers to a 16 year old patient of unknown  gender. Medical history, concurrent conditions and concomitant medications were not provided.  13-JAN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (route, anatomical location were not provided )(lot # S021925, expiration date 15-JUL-2021) for prophylaxis, that was given during a temperature excursion that was later found supported. Temperature excursion was  -9.1 C, during a time frame 1 hour and 11 minutes, no previous temperature excursion. No data logger was involved.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: TESTED POSITIVE FOR VIRUS; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender of Unknown ethnic origin (age 5 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number NR) 0.2 ml once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced tested positive for virus (preferred term: Influenza virus test positive).     Treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal) was not changed.     The outcome of the event was unknown.    The event was considered non-serious.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Blood pressure decreased, Chest discomfort, Chills, Cough
Clinical narrative: fever / Fever was 101; fatigue; muscle aches; chills; neck hurts; mild asthma attack /  Her peak flow number was low; nausea; chest tightness; headache presented; fist dose in May or June of 2019 / second dose 11/17/2020; was dizzy; blood pressure dropped; feeling wired; coughing; could not sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bronchitis. Previously administered products included Shingrix with an associated reaction of nausea (received 1st dose in May or June 2019, refer case US2020AMR230099) and Advair (on an unknown date received Advair).   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced insomnia and cough. On 17th November 2020, the patient experienced headache, blood pressure decreased, weird feeling, dizziness and drug dose administration interval too long. On 18th November 2020, the patient experienced chills, fever, fatigue, muscle pain, neck pain, asthmatic attack, nausea and chest tightness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, chills, fever, fatigue, muscle pain, weird feeling, neck pain and asthmatic attack were recovering/resolving and the outcome of the blood pressure decreased was recovered/resolved and the outcome of the dizziness, nausea, insomnia, chest tightness, cough and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, chills, blood pressure decreased, fever, fatigue, muscle pain, weird feeling, neck pain, asthmatic attack, dizziness, nausea, insomnia, chest tightness and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and 10 minutes after was dizzy and her blood pressure dropped and 30 minutes later the headache presented.  Fever, chills, muscle aches nausea and fatigue presented and could not sleep and reported feeling wired. The patient neck hurts and had a mild asthma attack described as chest tightness and coughing and peak flow number was low and she did a breathing treatment and was better. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230099:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: fever / Fever was 101; fatigue; muscle aches; chills; neck hurts; mild asthma attack /  Her peak flow number was low; nausea; chest tightness; headache presented; fist dose in May or June of 2019 / second dose 11/17/2020; was dizzy; blood pressure dropped; feeling wired; coughing; could not sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bronchitis. Previously administered products included Shingrix with an associated reaction of nausea (received 1st dose in May or June 2019, refer case US2020AMR230099) and Advair (on an unknown date received Advair).   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced insomnia and cough. On 17th November 2020, the patient experienced headache, blood pressure decreased, weird feeling, dizziness and drug dose administration interval too long. On 18th November 2020, the patient experienced chills, fever, fatigue, muscle pain, neck pain, asthmatic attack, nausea and chest tightness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, chills, fever, fatigue, muscle pain, weird feeling, neck pain and asthmatic attack were recovering/resolving and the outcome of the blood pressure decreased was recovered/resolved and the outcome of the dizziness, nausea, insomnia, chest tightness, cough and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, chills, blood pressure decreased, fever, fatigue, muscle pain, weird feeling, neck pain, asthmatic attack, dizziness, nausea, insomnia, chest tightness and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and 10 minutes after was dizzy and her blood pressure dropped and 30 minutes later the headache presented.  Fever, chills, muscle aches nausea and fatigue presented and could not sleep and reported feeling wired. The patient neck hurts and had a mild asthma attack described as chest tightness and coughing and peak flow number was low and she did a breathing treatment and was better. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230099:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pyrexia, Sleep disorder
Clinical narrative: fever / Fever was 101; fatigue; muscle aches; chills; neck hurts; mild asthma attack /  Her peak flow number was low; nausea; chest tightness; headache presented; fist dose in May or June of 2019 / second dose 11/17/2020; was dizzy; blood pressure dropped; feeling wired; coughing; could not sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bronchitis. Previously administered products included Shingrix with an associated reaction of nausea (received 1st dose in May or June 2019, refer case US2020AMR230099) and Advair (on an unknown date received Advair).   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced insomnia and cough. On 17th November 2020, the patient experienced headache, blood pressure decreased, weird feeling, dizziness and drug dose administration interval too long. On 18th November 2020, the patient experienced chills, fever, fatigue, muscle pain, neck pain, asthmatic attack, nausea and chest tightness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, chills, fever, fatigue, muscle pain, weird feeling, neck pain and asthmatic attack were recovering/resolving and the outcome of the blood pressure decreased was recovered/resolved and the outcome of the dizziness, nausea, insomnia, chest tightness, cough and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, chills, blood pressure decreased, fever, fatigue, muscle pain, weird feeling, neck pain, asthmatic attack, dizziness, nausea, insomnia, chest tightness and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and 10 minutes after was dizzy and her blood pressure dropped and 30 minutes later the headache presented.  Fever, chills, muscle aches nausea and fatigue presented and could not sleep and reported feeling wired. The patient neck hurts and had a mild asthma attack described as chest tightness and coughing and peak flow number was low and she did a breathing treatment and was better. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230099:same reporter
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: injection site has been sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 20th November 2020, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain 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 details were provided as follows: The case was reported by the mother for her daughter. The patient received dose of Bexsero in left arm. After receiving dose of Bexsero and Bexsero Pre-Filled Syringe Device the patient experienced injection site soreness. The customer does not have any additional details for this adverse event. The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: localized redness which resolved quickly; This case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.  Additional details were provided as follows: Reporter reported the case for her friend. The patient had dose of Shingrix in left arm.  After receiving dose of Shingrix, the patient experienced localized redness which resolved quickly. On 8th December 2020, the patient had second dose of Shingrix with no reaction. The reporter consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspepsia, Fatigue, Headache, Myalgia
Clinical narrative: indigestion; headache; muscle aches; fatigue; shivering; This case was reported by a consumer via call center representative and described the occurrence of indigestion in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2020, 6 weeks after receiving Shingrix, the patient experienced headache, muscle pain, fatigue and shivering. In December 2020, the patient experienced indigestion. On an unknown date, the outcome of the indigestion, headache, muscle pain, fatigue and shivering were recovered/resolved.   It was unknown if the reporter considered the indigestion, headache, muscle pain, fatigue and shivering to be related to Shingrix.  Additional details were reported as follows: The patient received his first dose 6 weeks ago from the day of reporting and experiencing headache, indigestion, muscle aches, fatigue and hivering.   The symptoms lasted about 36 hours. Consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: indigestion; headache; muscle aches; fatigue; shivering; This case was reported by a consumer via call center representative and described the occurrence of indigestion in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2020, 6 weeks after receiving Shingrix, the patient experienced headache, muscle pain, fatigue and shivering. In December 2020, the patient experienced indigestion. On an unknown date, the outcome of the indigestion, headache, muscle pain, fatigue and shivering were recovered/resolved.   It was unknown if the reporter considered the indigestion, headache, muscle pain, fatigue and shivering to be related to Shingrix.  Additional details were reported as follows: The patient received his first dose 6 weeks ago from the day of reporting and experiencing headache, indigestion, muscle aches, fatigue and hivering.   The symptoms lasted about 36 hours. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: painful teeth; This case was reported by a pharmacist via call center representative and described the occurrence of toothache in a male patient who received Herpes zoster (Shingrix) (batch number T79D7, expiry date 1st October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th August 2020).   On 4th January 2021, the patient received the 2nd dose of Shingrix. On 6th January 2021, 2 days after receiving Shingrix, the patient experienced toothache. On an unknown date, the outcome of the toothache was unknown.   It was unknown if the reporter considered the toothache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The experiencing reaction of painful teeth. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: had a bright, red rash on their abdomen; This case was reported by a pharmacist via and described the occurrence of red rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 2 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had received the 1st dose of the Shingrix vaccine back in September 2020, two days after getting the vaccine the patient had a bright, red rash on their abdomen.  Pharmacist could not specify which arm the vaccine was given in at the time of report. Consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Quarter of vaccine ran down patients arm during administration; A report was received from a nurse concerning a 44-year-old, female patient was participating in the mRNA-1273 Emergency Use Program and experienced a quarter of the vaccine ran down patients arm during administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their planned dose of mRNA-1273 (011J20A) on 23 Dec 2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On Dec 23 2020, the nurse was providing the vaccine to the patient and a quarter of the 0.5 mL vaccine ran down the arm of the patient. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.    The reporter did not provide causality assessment for the event, quarter of the vaccine ran down patients arm during administration.; Reporter's Comments: This case concerns a 44-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Accidental underdose without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine Leakage out of the arm after administration; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine leakage out of the arm after administration.   The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, during withdrawal of the needle from the muscle, the patient experienced vaccine leakage out of the arm after administration. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine leakage out of the arm after administration, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of Incorrect dose administered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered vaccine to 17 year old patient; A spontaneous report was received from a nurse concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, administered vaccine to 17 year old patient.  The patient's medical history was not provided. Concomitant medications were not reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 220, the nurse reported the 17-year-old vaccinated patient did not have any symptoms that they knew of. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered vaccine to 17 year old patient, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 45 year old, female patient who received Modern'a Covid-19 vaccine (mRNA-1273) from vial which has been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the event, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns the 45-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial, which had been punctured for more than 6 hours. On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. Reported event is unlisted for COVID-19 Vaccine (mRNA-1273) and causality assessment was assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Nurse administered inadvertent subcutaneous injection; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine, and the nurse administered inadvertent subcutaneous injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the pharmacist reported that the nurse administered an inadvertent subcutaneous Moderna vaccine injection to the patient. The patient did not experience any adverse reactions.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, nurse administered inadvertent subcutaneous injection, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273 (Lot number: 037K20A). There were no reported AEs associated with this case of Incorrect route of product administration.
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Administered the vaccine into gluteal muscle; A spontaneous report was received from a nurse concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273)  and was administered the vaccine into the gluteal muscle.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the gluteal muscle for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient was administered the vaccine into gluteal muscle.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered the vaccine into the gluteal muscle, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a patient who received mRNA-1273 (Lot# not reported), reporting Product administered at inappropriate site without reported associated adverse events.