chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Exposure during pregnancy, Feeling abnormal, Heart rate increased, Influenza like illness
Clinical narrative: She felt short of breath and that her throat felt like it was burning 1 hour post receiving the flu shot at the clinic. Patient is pregnant, so The Medical Center admitted her to Labor and Delivery. Per the patient, the baby is fine, but the protocol is for the hospital to admit. Patient reports that it feels like she has strep throat suddenly, her head feels foggy, she can still not take a full breath, her face is puffy, and it feels like the she has flu-like symptoms. Per patient, the doctor at the hospital said that she had an adverse reaction to the flu shot and prescribed Benadryl. Her heart rate is elevated (100-110), but other vital signs are within normal limits.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Throat irritation, Vaccination complication
Clinical narrative: She felt short of breath and that her throat felt like it was burning 1 hour post receiving the flu shot at the clinic. Patient is pregnant, so The Medical Center admitted her to Labor and Delivery. Per the patient, the baby is fine, but the protocol is for the hospital to admit. Patient reports that it feels like she has strep throat suddenly, her head feels foggy, she can still not take a full breath, her face is puffy, and it feels like the she has flu-like symptoms. Per patient, the doctor at the hospital said that she had an adverse reaction to the flu shot and prescribed Benadryl. Her heart rate is elevated (100-110), but other vital signs are within normal limits.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: The site where the vaccine was administered got red, hot, inflamed and itchy
Age: 68.0
Sex: M
Vaccine: PNC13, FLUX, PNC13
Symptoms: Arthralgia, Decreased appetite, Fatigue, Hypotonia, Myalgia
Clinical narrative: Patient had bone and muscle pain in joints and extremities with the left side being worse. Patient also had nausea and decreased appetite. Patient experienced fatigue, muscle flaccidity in upper left thigh and neuropathy in both hands
Age: 68.0
Sex: M
Vaccine: PNC13, FLUX, PNC13
Symptoms: Nausea, Neuropathy peripheral, Pain in extremity
Clinical narrative: Patient had bone and muscle pain in joints and extremities with the left side being worse. Patient also had nausea and decreased appetite. Patient experienced fatigue, muscle flaccidity in upper left thigh and neuropathy in both hands
Age: 68.0
Sex: M
Vaccine: PNC13, FLUX, PNC13
Symptoms: Arthralgia, Emotional distress, Extra dose administered, Fatigue, Feeling abnormal
Clinical narrative: Patient had bone and muscle pain in joints and extremities with the left side being worse. Patient also had nausea and decreased appetite. Patient experienced fatigue, muscle flaccidity in upper left thigh and neuropathy in both hands
Age: 68.0
Sex: M
Vaccine: PNC13, FLUX, PNC13
Symptoms: Hypotonia, Musculoskeletal chest pain, Neuropathy peripheral, Non-cardiac chest pain, Poor quality sleep
Clinical narrative: Patient had bone and muscle pain in joints and extremities with the left side being worse. Patient also had nausea and decreased appetite. Patient experienced fatigue, muscle flaccidity in upper left thigh and neuropathy in both hands
Age: 68.0
Sex: M
Vaccine: PNC13, FLUX, PNC13
Symptoms: Sleep disorder
Clinical narrative: Patient had bone and muscle pain in joints and extremities with the left side being worse. Patient also had nausea and decreased appetite. Patient experienced fatigue, muscle flaccidity in upper left thigh and neuropathy in both hands
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Hyperhidrosis, Syncope
Clinical narrative: Client was given the injection, PHN read note by the clients mother stating that client has fainted in the past with injections. Client sat in chair by PHN for about 5 min, no issues or concerns. Client stood up and walked to collect a pencil, PHN still watching client. Client stood waiting for friend for about another 5 mins. As client was walking to exit area, he clasped by doorway. PHN witnessed entire event. Client hit head on door and fell onto abdomen. No apparent injuries. HR 72 and BP 110/72. Client was sweaty. PHN's had client lay on the ground for 10 min and provided water. School Nurse came down and mother was contact and PHN spoke with mother. Client recovered quickly and returned to class.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac arrest, Respiratory arrest, Resuscitation, Seizure like phenomena, Syncope
Clinical narrative: Was fine after getting the shot walked out got to car went down looked like seizure then stopped breathing/no hart beat did CPR police/ems came took over got him back took to hospital.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: Day of vaccine patient reported one-sided (right) headache and had an episode of vomiting and diarrhea. The next day the patient stayed in bed all day. Unsure if there have been further s/e as this is just the third day after vaccination.
Age: 18.0
Sex: M
Vaccine: FLU4, HEP, MNQ, TDAP, VARCEL
Symptoms: Angioedema, Urticaria
Clinical narrative: Pt on fourth day of medical processing. After immunizations experienced hives and angioedema. 50 mg Benadryl and 0.3 epinephrine administered, transported to ED via EMS.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site pain, Myalgia, Neck pain
Clinical narrative: Right upper arm, deltoid, shoulder, neck muscles, pec, and upper back muscles continue to ache .  Upper arm hurts when I roll over on it during the night.  Tylenol and ThermaCare patches do help but intermittent pain persists.  I don't need any further treatment but I did want to report that both shots in this series were very painful and that the second shot  produced persistent , dull pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder
Clinical narrative: Right upper arm, deltoid, shoulder, neck muscles, pec, and upper back muscles continue to ache .  Upper arm hurts when I roll over on it during the night.  Tylenol and ThermaCare patches do help but intermittent pain persists.  I don't need any further treatment but I did want to report that both shots in this series were very painful and that the second shot  produced persistent , dull pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Arthralgia, Crying, Infection, Joint swelling, Pain in extremity
Clinical narrative: This is an old event, but I thought I should probably file it for future reference. I sent this exact email Public Health on March 26, 2018.   March 16th - patient  was brought to the Clinic and prescribed amoxicillin for a double ear infection.  March 19th - patient was brought to hospital for his 1 year vaccinations. (Note: he has never had any adverse reactions to vaccinations yet).  March 22nd - I noticed a few red dots on patient's chest in the evening.  March 23rd - In the morning, patient's chest had the same number of pink/red dots as the day prior. I sent him to daycare because he didn't have a fever and wasn't acting sick. I asked the daycare provider to monitor the spots and let me know how he was. As the day progressed, the pink/red dots continued to get worse and he was crying/screaming in pain when his arms/legs were moved. It was visibly noticeable that his elbows and knees were red, swollen and warm and he was experiencing some sort of joint pain. I scheduled an appointment with hospital to be seen that day. We saw Dr. and he said he was obviously having an allergic reaction to something, he assumed the amoxicillin. I had mentioned that he had been vaccinated on Monday the 19th and after a lot of internet searching, it kept coming back that it could be a reaction to the MMR vaccine. It noted that "because the measles, mumps, and rubella viruses in the MMR vaccine are weak versions of the disease viruses, they may cause a very mild case of the disease they were designed to prevent." Dr. indicated that he had never seen such a case, so he didn't think it would be that. As the night progressed, the red dots only continued to get worse. Patient was given 2 mL of Benadryl that evening per doctor.  March 24th - patient was given 2 mL of Zyrtec at 9:00 a.m. per doctor. The day old red/pinks dots were now bruise like in appearance and new red/pink dots were appearing. He was having horrific joint pain; screaming, crying and inconsolable for over an hour (until ibuprofen kicked in again).   March 25th - The majority of the dots were disappearing, but still visible. No joint pain all day.  March 26th - Almost all of the dots are gone. No joint pain.   NOTE; I have quite a few pictures on my cell phone documenting the progression of the reaction that I would be happy to send to someone.   NOTE: I listed the four vaccines that were administered on March 19, 2018; however, based on his records, I cannot distinguish which Hep A vaccine he was administered (Havrix or Vaqta).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Petechiae, Screaming
Clinical narrative: This is an old event, but I thought I should probably file it for future reference. I sent this exact email Public Health on March 26, 2018.   March 16th - patient  was brought to the Clinic and prescribed amoxicillin for a double ear infection.  March 19th - patient was brought to hospital for his 1 year vaccinations. (Note: he has never had any adverse reactions to vaccinations yet).  March 22nd - I noticed a few red dots on patient's chest in the evening.  March 23rd - In the morning, patient's chest had the same number of pink/red dots as the day prior. I sent him to daycare because he didn't have a fever and wasn't acting sick. I asked the daycare provider to monitor the spots and let me know how he was. As the day progressed, the pink/red dots continued to get worse and he was crying/screaming in pain when his arms/legs were moved. It was visibly noticeable that his elbows and knees were red, swollen and warm and he was experiencing some sort of joint pain. I scheduled an appointment with hospital to be seen that day. We saw Dr. and he said he was obviously having an allergic reaction to something, he assumed the amoxicillin. I had mentioned that he had been vaccinated on Monday the 19th and after a lot of internet searching, it kept coming back that it could be a reaction to the MMR vaccine. It noted that "because the measles, mumps, and rubella viruses in the MMR vaccine are weak versions of the disease viruses, they may cause a very mild case of the disease they were designed to prevent." Dr. indicated that he had never seen such a case, so he didn't think it would be that. As the night progressed, the red dots only continued to get worse. Patient was given 2 mL of Benadryl that evening per doctor.  March 24th - patient was given 2 mL of Zyrtec at 9:00 a.m. per doctor. The day old red/pinks dots were now bruise like in appearance and new red/pink dots were appearing. He was having horrific joint pain; screaming, crying and inconsolable for over an hour (until ibuprofen kicked in again).   March 25th - The majority of the dots were disappearing, but still visible. No joint pain all day.  March 26th - Almost all of the dots are gone. No joint pain.   NOTE; I have quite a few pictures on my cell phone documenting the progression of the reaction that I would be happy to send to someone.   NOTE: I listed the four vaccines that were administered on March 19, 2018; however, based on his records, I cannot distinguish which Hep A vaccine he was administered (Havrix or Vaqta).
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal distension, Arthralgia, Dyspnoea
Clinical narrative: I am not sure if this is related to the Flu shot or not, but I had the exact same effects last year at this time, and possibly the year before at the same time.  Within a few days of the shot, I had belly bloat and felt like there was something stuck in my throat.  I would also get winded after walking up a flight of stairs.  I took Protonix because I though the belly bloat may have been GERD, which would hamper my breathing.   Plus my legs feel very sore, like to a point of muscle failure.  I am eating much healthier this year than last and I had been riding a stationary bike a few times per week and my legs never started hurting like this until a few days after the flu shot.  Last year, it took about 2-3 months for my legs to start feeling strong again and being able to climb stairs without needing a huge breath at the end.  Like I said, I am not sure if this is flu shot related, but it's suspect as its the same symptoms at the same time of year.  My plan is TO NOT get a flu shot next year and see the outcome.   I am not sure of which lot or anything we were given.
Age: 76.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Vaccination site warmth
Clinical narrative: Patient stated during the vaccination date that she is unable to get any vaccines in her left arm (pharmacist attempted to do 1 vaccine in L arm and 1 in R arm), therefore patient received both Prevnar13 and Shingrix in the R arm.  Patient stated starting on Saturday 10/24 she was experiencing chills and the area of vaccination was warm/hot to the touch.  Patient reported the event to the pharmacy on Wednesday 10/28 that the warm/hot to the touch has not gone away.  Patient was informed to go to the doctor in order to have the arm looked at.
Age: 44.0
Sex: F
Vaccine: FLUR4
Symptoms: Urticaria
Clinical narrative: Hives all over
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient called the pharmacy complaining about having swollen & red left arm. advised her to contact her pcp or go to the er if it worsens. in the afternoon, patient came in to the pharmacy and said she called her dr's office and was told " to put an ice pack on it and if it does still worsen she needed to be seen "
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Eczema, Enterocolitis, Food allergy, Infantile spitting up, Lethargy
Clinical narrative: Within a day my son developed eczema that steadily progressed in severity. He began spiting up considerably. We didn't realize ti at first, but he was reacting to foods through my milk. He never showed ANY signs of allergies or sensitivity before this. It wasn't until he began solids that we realized his allergies. Having FPIES, he would begin severe vomiting two hours after ingesting the allergen. He would have to be rushed to the hospital for fluids as he would become lethargic and risked going into shock. There is no test to determine his allergies; it's all based on trialing foods. Foods that he could safely consume a few weeks ago, could turn into an allergen later on.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Within a day my son developed eczema that steadily progressed in severity. He began spiting up considerably. We didn't realize ti at first, but he was reacting to foods through my milk. He never showed ANY signs of allergies or sensitivity before this. It wasn't until he began solids that we realized his allergies. Having FPIES, he would begin severe vomiting two hours after ingesting the allergen. He would have to be rushed to the hospital for fluids as he would become lethargic and risked going into shock. There is no test to determine his allergies; it's all based on trialing foods. Foods that he could safely consume a few weeks ago, could turn into an allergen later on.
Age: 19.0
Sex: F
Vaccine: FLU4, HEP, MNQ, TDAP
Symptoms: Angioedema, Urticaria
Clinical narrative: Pt is a recruit at military boot camp. Five minutes after receiving immunizations experienced angioedema and hived. 50 mg Benadryl and 0.3 mg epinephrine given. Transported via EMS to ED.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: As of today, 10/28/2020, I have had chronic pain and in my left shoulder at the injection site of the Shingrix vaccination ever since I had the shot 9/11/2020. I was sitting in a chair when the nurse, who was standing, gave me the shot which was also very painful. It is very painful when I lift and lower my left arm in a certain direction. I told my physician about this on 10/16/2020.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE/PQC reported.; MMRII was administered after expiration; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown day in October 2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # R028523, expiration date 04-OCT-2020, 0.5 milliliter, for prophylaxis (route of administration was not reported). No further adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: postherpetic neuralgia; herpes zoster; varicella type rash; Information was received from a lawyer regarding a case in litigation involving a female patient of unknown age. On 03-DEC-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the vaccine the patient was diagnosed with herpes zoster, postherpetic neuralgia and a varicella type rash. As a direct and proximate result of receiving zoster vaccine live (ZOSTAVAX) the patients symptoms have resulted in physical limitations not present prior to using the product. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of zoster vaccine live (ZOSTAVAX) the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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, physical impairment and injury.As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of the events was considered to be not recovered. The causality of the events was considered to be related. The events were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a other health professional via interactive digital media and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patients received Shingrix and had rash as an adverse reaction. The reporter asked what the range of time to resolution.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on unknown date, refer case US2020212045).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by the mother of the patient. The age at vaccination was not reported. The patient received Shingrix at an unspecified time and had a severe headache the first day and slight headache the second day. The reporter was the patient's mother and declined to provide PII.  Limited information was provided. This case linked with US2020212040, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212040:same reporter US-GLAXOSMITHKLINE-US2020212045:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Neck muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 hr after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient just got the Shingrix about an hour ago and already feeling neck muscle pain. The reporter asked was it possible that it already related to the shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Discomfort, Erythema, Extensive swelling of vaccinated limb, Injection site discomfort
Clinical narrative: cellulitis; big red circle swollen at the injection site (left deltoid) / swollen at the injection site (left deltoid) which was spreading down her arm; was uncomfortable; big red circle swollen at the injection site (left deltoid; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prior history of live shingles vaccine (received live shingles vaccine on an unknown date) and Prior history of seasonal flu shots with an associated reaction of injection site swelling (received flu shot on unknown date, refer case US2020AMR211753). Concurrent medical conditions included hard of hearing. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season).   On 16th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th October 2020, 4 days after receiving Shingrix and an unknown time after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, discomfort and erythema of extremities. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim Ds). On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, discomfort and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, discomfort and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. It was reported that the patient had the flu shot one month prior Septmber 2020). The patient did not have the lot/exp of the Shingrix. The patient had no issues with the flu shot received in September 2020 but that in the past she has had flu shots that sometimes swelled (at the injection site). The patient received dose 1 of Shingrix 0.5 ml injected into left deltoid intramuscularly. The pharmacist told her that the Shingrix shot could hurt more (than the flu shot) and warned her that she was likely to get a (injection site) reaction.  On 20th October 2020, the patient went to the doctor because she had a big red circle swollen at the injection site (left deltoid) which was spreading down her arm and was uncomfortable. The doctor diagnosed her with cellulitis and prescribed oral Bactrim DS (double strength). The patient said within 2 days (of being on the antibiotic) it went down and now it was almost resolved.  The physician advised patient not to get the second dose in the Shingrix series. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211096:same reporter US-GLAXOSMITHKLINE-US2020AMR211753:Same patient
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: cellulitis; big red circle swollen at the injection site (left deltoid) / swollen at the injection site (left deltoid) which was spreading down her arm; was uncomfortable; big red circle swollen at the injection site (left deltoid; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prior history of live shingles vaccine (received live shingles vaccine on an unknown date) and Prior history of seasonal flu shots with an associated reaction of injection site swelling (received flu shot on unknown date, refer case US2020AMR211753). Concurrent medical conditions included hard of hearing. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season).   On 16th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th October 2020, 4 days after receiving Shingrix and an unknown time after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, discomfort and erythema of extremities. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim Ds). On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, discomfort and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, discomfort and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. It was reported that the patient had the flu shot one month prior Septmber 2020). The patient did not have the lot/exp of the Shingrix. The patient had no issues with the flu shot received in September 2020 but that in the past she has had flu shots that sometimes swelled (at the injection site). The patient received dose 1 of Shingrix 0.5 ml injected into left deltoid intramuscularly. The pharmacist told her that the Shingrix shot could hurt more (than the flu shot) and warned her that she was likely to get a (injection site) reaction.  On 20th October 2020, the patient went to the doctor because she had a big red circle swollen at the injection site (left deltoid) which was spreading down her arm and was uncomfortable. The doctor diagnosed her with cellulitis and prescribed oral Bactrim DS (double strength). The patient said within 2 days (of being on the antibiotic) it went down and now it was almost resolved.  The physician advised patient not to get the second dose in the Shingrix series. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211096:same reporter US-GLAXOSMITHKLINE-US2020AMR211753:Same patient
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue, Pyrexia
Clinical narrative: First dose of shingirx 7/18/19 / Second dose 10/24/2020 / quarantine; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th July 2019).   On 24th October 2020, the patient received the 2nd dose of Shingrix. On 24th October 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a fever, which had resolved.  The vaccines were staggered per patient because of availability of the product and the quarantine caused by Covid19. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Product administered at inappropriate site
Clinical narrative: Bursitis; Flulaval in the Bursa of her joint; This case was reported by a pharmacist via call center representative and described the occurrence of bursitis in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   In October 2020, the patient received FluLaval Tetra 2020-2021 season. In October 2020, less than 2 weeks after receiving FluLaval Tetra 2020-2021 season, the patient experienced bursitis and inappropriate route of vaccination. On an unknown date, the outcome of the bursitis and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the bursitis to be related to FluLaval Tetra 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the female patient got her dose of Flulaval in the Bursa of her joint, which led to inappropriate route of vaccination. The patient developed bursitis after vaccination. No other information was provided. The reporter consented to follow up.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: Syncope probable approx. 15min after vaccination. Patient claimed she had not eaten all day. No injury when fall to floor- she slumped to floor kept patient in pharmacy for another 10-15 min. and pt wanted to leave. Most symptom resolved after hydrating with electrolytes ie Gatorade. Follow up with pt later in evening-showed no symptoms.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Hair growth abnormal, Vaccination site irritation, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Patient has exp swelling size of a pea, irritation and black hairs growing where the incision was located. She stated she isn't certain of the exact date when the signs started. On 10/28/2020 is when she noticed the black hairs growing from the vaccination site.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, C-reactive protein increased, Eosinophil count increased, Fatigue, Joint swelling
Clinical narrative: Swelling in both hands, swelling in both ankles, fatigue, muscle and joint pain.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Myalgia, Peripheral swelling, White blood cell count increased
Clinical narrative: Swelling in both hands, swelling in both ankles, fatigue, muscle and joint pain.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: arm pain
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The next morning after the vaccination, I woke up with a low grade fever. It ranged from 99.5 to 100.4 over a period of about 9 hours. Tylenol was able to control it.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nasal congestion, Pain, Vision blurred
Clinical narrative: 9pm - Chills & aches 4am - Woke up & must have been breathing through mouth....nose completely clogged.  Vision was foggy/smoky.  Oxygen level was 89. Fever of 101.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin burning sensation
Clinical narrative: Pt reporting standard minor reaction around the shoulder the day following the vaccination. That evening the skin on her hands began feeling like it was burned while washing her hands. No new chemical/brand exposure in the house.  There isn't pain in general, but when she flexes her hands the skin feels burned.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Irritability, Swelling face
Clinical narrative: returned to clinic 25 minutes later for fussiness, redness, swelling of the face. airway patent, afebrile, no lethargy/syncope, tachypnea, hypoxia, reflexes intact given diphenhydramine at 17:53, observed 20 minutes, swelling resolved, fussiness reduced. New rx for  diphenhydramine sent to the pharmacy  pt informed to call 911 if sxs worsen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Approx 9.5 hours after vaccination, I experienced headache and muscle aches.  Overnight aches increased, had chills and sweats, temp slightly elevated to 99.2, diarrhea and fatigue.  26 hours later at the time of completion of this form, minor aches, fatigue and chills
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Myalgia, Pain
Clinical narrative: Approx 9.5 hours after vaccination, I experienced headache and muscle aches.  Overnight aches increased, had chills and sweats, temp slightly elevated to 99.2, diarrhea and fatigue.  26 hours later at the time of completion of this form, minor aches, fatigue and chills
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Malaise, Mobility decreased, Myalgia
Clinical narrative: Fine the first 2 hours. Then injection site and muscles in left arm hurt. Hard to lift arm. Didnt feel well. Worse as night went on. By 9 pm was getting a fever and chills. Couldn't sleep until 4 am.  Woke up at 730am.  Arm still hurt but fever had broke.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Fine the first 2 hours. Then injection site and muscles in left arm hurt. Hard to lift arm. Didnt feel well. Worse as night went on. By 9 pm was getting a fever and chills. Couldn't sleep until 4 am.  Woke up at 730am.  Arm still hurt but fever had broke.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediately after administration of vaccine, the patient's left arm began to swell, ice was applied and the patient was sent over to local urgent care center for further evaluation
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Limb discomfort, Nausea, Periarthritis
Clinical narrative: Severe arm soreness leading to Frozen Shoulder lasting for months.  Steroid shot and physical therapy needed.  Still symptomatic at this time.  This was on top of the fever, chills, nausea, and fatigue for three days.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Physiotherapy, Pyrexia, X-ray
Clinical narrative: Severe arm soreness leading to Frozen Shoulder lasting for months.  Steroid shot and physical therapy needed.  Still symptomatic at this time.  This was on top of the fever, chills, nausea, and fatigue for three days.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest pain
Clinical narrative: -Chest pain after injections
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: N/A Expired vaccine given Exp: 10-21-2020
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Product reconstitution quality issue
Clinical narrative: The medications that were reconstituted on Friday were administered on Saturday; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, or concomitant medications was not provided.  On Friday 09-OCT-2020, the patient was in the nurse's office and was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines were reconstituted with sterile diluent (dose, route of administration, lot number and expiration date were not reported) and were ready to be administered that day; however, the reporter mentioned that the patient had to leave abruptly and the vaccines were not administered.  On 10-OCT-2020 (also reported as "on Saturday"), the patient returned for the vaccinations that were already reconstituted, and had administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) 0.5 milliliter (lot number reported as S013536 and expiration date 02-MAY-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot number reported as R35226 was an invalid lot number for varicella virus vaccine live (oka/merck); expiration date reported as 04-DEC-2020) (for both vaccines frequency was reported as "once", routes of administration were not reported) administered as prophylaxis (out of specification product use).
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: local soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Age group was selected as adult as per product indication. No side effects other than local soreness with 1st vaccination of Shingrix. For tolerance in 2nd dose refer case US2020AMR210044.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210044:Same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: temp of 104.4; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Fever. The reporter asked did get the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Lip blister
Clinical narrative: blister on my lips; small blister on my left wrist; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received Shingrix. In October 2020, less than a month after receiving Shingrix, the patient experienced blister. On 21st October 2020, the patient experienced lip blister. On an unknown date, the outcome of the blister was unknown and the outcome of the lip blister was not recovered/not resolved.   It was unknown if the reporter considered the blister and lip blister to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group of patient was not reported but captured as adult as per vaccine indication. The patient was vaccinated with Shingrix a few days ago from reporting day. The patient experienced small blister on  left wrist and also had a blister on lips on reporting day. The patient was asked about if it was normal that got a blister on lips after Shingrix shot.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: headache; body ache; redness; swelling at injection site; injection site hot to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE)) for prophylaxis.   On 3rd October 2020, the patient received the 1st dose of Shingrix (intramuscular) and the 1st dose of FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE) (intramuscular). On 3rd October 2020, 12 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On 4th October 2020, the patient experienced general body pain. On 5th October 2020, the patient experienced headache. The patient was treated with paracetamol (Acetaminophen) and non-drug therapy (Ice Pack (No Medication)). On 6th October 2020, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, general body pain and headache to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that she experience body aches for two days after receiving Shingrix (first dose) and Fluzone on 3rd October 2020.  She also reported headache, redness and swelling at injection site.  Till the time of reporting the patient was experiencing redness, swelling, injection site hot to touch and headache.  The patient had reported taking acetaminophen as well as using an ice pack at the site of injection. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness around the injection area; Itching around the injection area; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to plants.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was medical assistant who stated that there was a patient who received first dose of Shingrix and experienced redness and itching around the injection area. The patient was allergic to trees so she wanted to know if there was any tree component in Shingrix. The reporter did not wanted to provide further adverse event details, neither patient's details or vaccine detail's. The reporter did not wanted to provide address and said that patient did not receive Shingrix on the same facility. The reporter did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Felt itching on the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2020, the patient received Shingrix. On 30th August 2020, 5 days after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. About five days later on 30th August 2020, the patient stated she felt itching on the injection site. The itching was ongoing till the time of reporting. There was nothing visible on the skin, but the patient continued to itch. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms after receiving the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable to this report. An unknown number of patients were vaccinated with 1st dose of Shingrix. The  day or day after vaccination patients were experienced flu like symptoms. The symptoms were lasted for 3-7 days. No further details available. The reporter consent to follow up. This was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020209434:same reporter US-GLAXOSMITHKLINE-US2020209432:same reporter US-GLAXOSMITHKLINE-US2020209416:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Induration, Mass, Nodule
Clinical narrative: large red area and hard knot; large red area and hard knot; knot; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced erythema, induration and mass. On an unknown date, the outcome of the erythema, induration and mass were recovered/resolved.   It was unknown if the reporter considered the erythema, induration and mass to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not applicable to this report. The unknown number of patients were vaccinated with 1st dose of Shingrix. After vaccination patients experienced large red area and hard knot. The symptoms were started day or day after vaccination and lasted about 3 days. No further details available. This was 1 of 4 cases reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020209432:same reporter US-GLAXOSMITHKLINE-US2020209416:same reporter US-GLAXOSMITHKLINE-US2020209436:same reporter