chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, UNK, UNK, UNK, UNK
Symptoms: Laboratory test, Lethargy, Pyrexia, Sedative therapy, Seizure
Clinical narrative: Patient got her vaccines on 9/24/19. She was fine the rest of that day. It was either Wed evening or Thursday she started running a very low fever. I believe it stayed under 100 and Tylenol knocked it out. The doctor told us she could run a low fever due to the shots and that was normal, so we didn't think much of it. Overall her behavior was normal. Over the weekend the low fever was still hanging around getting slightly over 100 on Sunday. I called the doctor Monday morning. They said bring her in at 3pm. By around noon, her fever was higher maybe 102 and she was acting pretty lethargic. We packed her up and took her in then. In the waiting room at the doctors office she had a seizure. They gave her some oxygen and called the ambulance. The ambulance took us to the hospital. Once they got the seizures to stop, she was air lifted to Hospital. She spent 16 days in ICU and then 10 more days in a regular room. Over the first few days she had several more seizures and they kept her sedated. She had an external drain put in her head on 10/3 to help with the pressure. She was never able to handle the pressure of brain fluids on her own after that and had a VP Shunt put in on the 19th. Once the seizures stopped, I think the last seizure was on the 4th, she was woken up. After a few days I noticed she wasn't responding to sound. Her complete loss of hear was confirmed with the ENT two weeks after being discharged. She went home on seizure meds that were weaned off this past May. And a blood thinner shot, due to the small blood clots in her brain caused by "at least 3 Stroke like activity", We gave her the shots twice a day for 3 months after leaving the hospital. She's had follow ups and has been cleared from infectious disease, hematology, and neurology. The infectious and hematology were cleared from about 3 month after leaving the hospital. As for the hearing, she got the cochlear implant on Dec 17. Left ear only as the VP Shut is in the place of where the right side would need to go. She will have follow-ups on the cochlear and VP shunt for life. All of this has caused significant development delays. We see a physical therapist twice a week and a speech therapist once a week. Her Pediatrics Developmental and Behavioral doctor scored her as an 10-11 month old when she was 18 months old. We were told that the extent of brain damage can't be determined until she is older.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, UNK, UNK, UNK, UNK
Symptoms: Thrombosis, Ventricular drainage, Ventriculo-peritoneal shunt
Clinical narrative: Patient got her vaccines on 9/24/19. She was fine the rest of that day. It was either Wed evening or Thursday she started running a very low fever. I believe it stayed under 100 and Tylenol knocked it out. The doctor told us she could run a low fever due to the shots and that was normal, so we didn't think much of it. Overall her behavior was normal. Over the weekend the low fever was still hanging around getting slightly over 100 on Sunday. I called the doctor Monday morning. They said bring her in at 3pm. By around noon, her fever was higher maybe 102 and she was acting pretty lethargic. We packed her up and took her in then. In the waiting room at the doctors office she had a seizure. They gave her some oxygen and called the ambulance. The ambulance took us to the hospital. Once they got the seizures to stop, she was air lifted to Hospital. She spent 16 days in ICU and then 10 more days in a regular room. Over the first few days she had several more seizures and they kept her sedated. She had an external drain put in her head on 10/3 to help with the pressure. She was never able to handle the pressure of brain fluids on her own after that and had a VP Shunt put in on the 19th. Once the seizures stopped, I think the last seizure was on the 4th, she was woken up. After a few days I noticed she wasn't responding to sound. Her complete loss of hear was confirmed with the ENT two weeks after being discharged. She went home on seizure meds that were weaned off this past May. And a blood thinner shot, due to the small blood clots in her brain caused by "at least 3 Stroke like activity", We gave her the shots twice a day for 3 months after leaving the hospital. She's had follow ups and has been cleared from infectious disease, hematology, and neurology. The infectious and hematology were cleared from about 3 month after leaving the hospital. As for the hearing, she got the cochlear implant on Dec 17. Left ear only as the VP Shut is in the place of where the right side would need to go. She will have follow-ups on the cochlear and VP shunt for life. All of this has caused significant development delays. We see a physical therapist twice a week and a speech therapist once a week. Her Pediatrics Developmental and Behavioral doctor scored her as an 10-11 month old when she was 18 months old. We were told that the extent of brain damage can't be determined until she is older.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Local reaction, Pruritus, Tenderness
Clinical narrative: Drug dose administration interval too short; reaction at the injection site; Redness at injection site/she noticed it started to spread down and around to the back of the right arm.; Itchiness; Arm is tender to the touch; Arm is tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (received 1st dose on 9th August 2020, refer case US2020202278).   On 7th October 2020, the patient received the 2nd dose of Shingrix. On 7th October 2020, less than a day after receiving Shingrix, the patient experienced injection site reaction, injection site erythema, pruritus, pain in arm and tenderness. On an unknown date, the patient experienced drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site reaction, injection site erythema, pruritus and pain in arm were not recovered/not resolved and the outcome of the tenderness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site reaction, injection site erythema, pruritus, pain in arm and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing a reaction at the injection site.  The patient reported redness at the injection site, itchiness, and arm was tender to the touch. The patient stated it started out as a small, red streak half an inch from the injection site.  The patient noticed it started to spread down and around to the back of the right arm and the reaction was still ongoing, but the redness was not as red and the tenderness was not as tender.  The reporter consented to follow up. Not all information was available.  The Patient gave permission to follow up with their HCP and provided the following contact information. The patient was unable to provide email and fax at the time of report. The patient received 2nd dose early, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202278:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site streaking, Pain in extremity, Pruritus
Clinical narrative: Drug dose administration interval too short; reaction at the injection site; Redness at injection site/she noticed it started to spread down and around to the back of the right arm.; Itchiness; Arm is tender to the touch; Arm is tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (received 1st dose on 9th August 2020, refer case US2020202278).   On 7th October 2020, the patient received the 2nd dose of Shingrix. On 7th October 2020, less than a day after receiving Shingrix, the patient experienced injection site reaction, injection site erythema, pruritus, pain in arm and tenderness. On an unknown date, the patient experienced drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site reaction, injection site erythema, pruritus and pain in arm were not recovered/not resolved and the outcome of the tenderness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site reaction, injection site erythema, pruritus, pain in arm and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing a reaction at the injection site.  The patient reported redness at the injection site, itchiness, and arm was tender to the touch. The patient stated it started out as a small, red streak half an inch from the injection site.  The patient noticed it started to spread down and around to the back of the right arm and the reaction was still ongoing, but the redness was not as red and the tenderness was not as tender.  The reporter consented to follow up. Not all information was available.  The Patient gave permission to follow up with their HCP and provided the following contact information. The patient was unable to provide email and fax at the time of report. The patient received 2nd dose early, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202278:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness
Clinical narrative: Drug dose administration interval too short; reaction at the injection site; Redness at injection site/she noticed it started to spread down and around to the back of the right arm.; Itchiness; Arm is tender to the touch; Arm is tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (received 1st dose on 9th August 2020, refer case US2020202278).   On 7th October 2020, the patient received the 2nd dose of Shingrix. On 7th October 2020, less than a day after receiving Shingrix, the patient experienced injection site reaction, injection site erythema, pruritus, pain in arm and tenderness. On an unknown date, the patient experienced drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site reaction, injection site erythema, pruritus and pain in arm were not recovered/not resolved and the outcome of the tenderness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site reaction, injection site erythema, pruritus, pain in arm and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing a reaction at the injection site.  The patient reported redness at the injection site, itchiness, and arm was tender to the touch. The patient stated it started out as a small, red streak half an inch from the injection site.  The patient noticed it started to spread down and around to the back of the right arm and the reaction was still ongoing, but the redness was not as red and the tenderness was not as tender.  The reporter consented to follow up. Not all information was available.  The Patient gave permission to follow up with their HCP and provided the following contact information. The patient was unable to provide email and fax at the time of report. The patient received 2nd dose early, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202278:same reporter
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Administered vaccine to patient and monitored per protocol. While monitoring, patients body became stiff and he was unable to move. Within a minute patient was able to regain control of body. Per patient, he did not remember what happened, he said it was a lapse of consciousness/black out. I continued monitoring patient for 15 minutes, and provided water.   I asked the patient and cargiver if we can administer an epi-pen and call an ambulance, they denied both.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm was red, swollen, and painful
Age: 50.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Feeling abnormal, Impaired work ability, Malaise, Pain in extremity, Sleep disorder
Clinical narrative: I got my shingles vaccine and flu shot on Thursday, Oct 1.   I noticed my arm was hurting that night and I just didn't feel right.  By Friday morning I did not feel well.  I tried to work on Friday but all I could do was lay down. I would start a call and thankfully they all ended early so I was able to lay down for 15-20 minutes before next call was to start.  By noon I had to tell my boss I couldn?t do it any longer and laid down on my futon by my workstation.  At 23:39 I remember getting mad at the girls who were fighting over roblox on the pc next to the futon and kicking them out of the basement.  It was a restless night of sleep.  My back was killing me from tossing and turning and sleeping wrong.  I got woozy frequently and had to rest but was able to replace my mom?s mail box on Saturday, but it took much longer than it should have. :(
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Pain, Pyrexia, Rash morbilliform, Regurgitation
Clinical narrative: Spitting up Fever 99-100.7 Soreness Measles looking rash on body Measles looking rash in mouth
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Mild bodyaches, exhaustion, and chills
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: the inside of his arm looked like it was sun burned, and it went all the way down to his wrist; This spontaneous report was received from a 71-year-old male consumer referring to himself. The patient's pertinent concurrent conditions included prostate cancer. The patient's medical history included heart stents (vascular stent insertion). The patient had a previous allergy to intravenous dye. The patient received  influenza virus vaccine inactivated (unspecified) (reported as flu shot), his concomitant medications included cefadroxil and other unspecified medications.    On 28-SEP-2020 (reported as 10 days ago, conflicting information also reported as 29-SEP-2020), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection as prophylaxis (concentration, number of administered dose, anatomical location and route of administration, lot number and expiration date were not reported).       On 28-SEP-2020 (reported as 10 days ago), the inside of the patient's arm looked like it was sun burned, and it went all the way down to his wrist (limb injury). The patient went to the doctor and prescribed him an unspecified antibiotic as treatment. The outcome of limb injury was reported as recovered/resolved.       The causality assessment between suspect therapy and the aforementioned event was not reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: she compared it to a really bad allergy shot.; The patient also reported that on Friday 10/9/2020 she received Shingrix and that it hurt and her arm was "sore yesterday as a result of the vaccination; The patient reported to the caller that about 10 years ago, when she was 60 or 61 years old, she received ZOSTAVAX and a year later she came down with shingles.; This spontaneous report was received from a consumer via a company representative, referring to herself as a 72-year-old female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   In approximately 2010, when the patient was 60 or 61-year-old, she was vaccinated with zoster vaccine live (ZOSTAVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported).  In approximately 2011, a year later after the vaccination, she came down with shingles (herpes zoster).  On 09-OCT-2020, it was administered to the patient zoster rge vaccine (mammalian) (SHINGRIX) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, indication, lot number and expiration date were not reported).  At the time of this report, the patient stated that; it hurt and her arm was "sore yesterday as a result of the vaccination, she compared it to a really bad allergy shot" (pain in extremity and allergy to vaccine).  The outcome of herpes zoster was reported as recovered; at the time of this report the outcome of pain in extremity and allergy to vaccine was not provided. The causality assessment between zoster vaccine live (ZOSTAVAX) and zoster rge vaccine (mammalian) (SHINGRIX) with the aforementioned events was not provided.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 15 year old female fainted on the 3rd dose of GARDASIL 9 on 6/13/2016; Information has been received from a physician, referring to a 15 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis.        On 13-JUN-2016, the patient fainted (syncope) on the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of syncope was unknown.       The casuality assessment between the syncope and the vaccination with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got mild case of shingles; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date at 60 years of age).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 11 days after receiving Shingrix, the patient experienced shingles. The patient was treated with remdesivir. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient took 1st shot of vaccination in the 2 shot series and got mild case of shingles about 11 days after the 1st shot.  As per physician's advice the patient took the anti viral remdesivir orally for 1 week. The patient asked if she should return for the 2nd shot. The patient's physician and his nurses refused to recommend if the patient should or should not return. The patient commented that the web did not have much data on this particular dilemma and that any advice would be appreciated.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Decreased activity, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: January 2020 /uncomfortable feeling progressed to a burning sensation; painful when touched; had to sleep on her stomach only; and couldn't ride her stationary bike; uncomfortable feeling progressed; uncomfortable feeling progressed; This case was reported by a consumer via call center representative and described the occurrence of burning leg in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of limb discomfort (1st dose received in October 2019, refer case US2020203023). Concurrent medical conditions included dizziness. Concomitant products included gabapentin.   In December 2019, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 months after receiving Shingrix, the patient experienced burning leg, tenderness, sleep disorder, decreased activity, leg discomfort and condition aggravated. On an unknown date, the outcome of the burning leg, leg discomfort and condition aggravated were not recovered/not resolved and the outcome of the tenderness, sleep disorder and decreased activity were unknown.   It was unknown if the reporter considered the burning leg, tenderness, sleep disorder, decreased activity, leg discomfort and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient had been taking 300 mg gabapentin every 4 hours which causes some dizziness. The patient received 2nd shot of Shingrix in left arm. By January 2020, the uncomfortable feeling progressed to a burning sensation that felt like a bad sun burn that was painful when touched. It was to the point where she had to sleep on her stomach only and could not ride her stationary bike. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203023:same patient (1st dose)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Tenderness
Clinical narrative: January 2020 /uncomfortable feeling progressed to a burning sensation; painful when touched; had to sleep on her stomach only; and couldn't ride her stationary bike; uncomfortable feeling progressed; uncomfortable feeling progressed; This case was reported by a consumer via call center representative and described the occurrence of burning leg in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of limb discomfort (1st dose received in October 2019, refer case US2020203023). Concurrent medical conditions included dizziness. Concomitant products included gabapentin.   In December 2019, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 months after receiving Shingrix, the patient experienced burning leg, tenderness, sleep disorder, decreased activity, leg discomfort and condition aggravated. On an unknown date, the outcome of the burning leg, leg discomfort and condition aggravated were not recovered/not resolved and the outcome of the tenderness, sleep disorder and decreased activity were unknown.   It was unknown if the reporter considered the burning leg, tenderness, sleep disorder, decreased activity, leg discomfort and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient had been taking 300 mg gabapentin every 4 hours which causes some dizziness. The patient received 2nd shot of Shingrix in left arm. By January 2020, the uncomfortable feeling progressed to a burning sensation that felt like a bad sun burn that was painful when touched. It was to the point where she had to sleep on her stomach only and could not ride her stationary bike. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203023:same patient (1st dose)
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Carbohydrate antigen 125 increased
Clinical narrative: CA125 has gone up; This case was reported by a consumer via patient support programs and described the occurrence of ca 125 increased in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Shingrix and PNEUMONIA SHOT. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced ca 125 increased. On an unknown date, the outcome of the ca 125 increased was unknown.   It was unknown if the reporter considered the ca 125 increased to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that her CA125 had gone up a little (24).  This case has been linked with US2020AMR130729 reported by same reporter. Her doctors said it was from the flu shot, shingles shot and peumonia shots. The reporter did not know if that was true. This case has been linked with US2020AMR130729 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR130729:Same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Product administered at inappropriate site, Sluggishness
Clinical narrative: Feeling slow; First dose of Shingrix in 2018 and second dose of Shingrix October 7, 2020; Administered high up on her arm; Stiff Arm; This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in 2018).   On 7th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2020, less than a day after receiving Shingrix, the patient experienced sluggishness, drug dose administration interval too long and vaccine administered at inappropriate site. In October 2020, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness and sluggishness were not recovered/not resolved and the outcome of the drug dose administration interval too long and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the limbs stiffness, sluggishness, drug dose administration interval too long and vaccine administered at inappropriate site to be related to Shingrix.  Additional details were reported as follows: The patient received first dose of Shingrix in 2018 and second dose of Shingrix 7th October 2020 (inappropriate schedule of vaccine).  The patient felt slow and a stiff arm after vaccine that has not resolved.  The vaccine was administered high up on her arm (wrong Injection Technique). The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202295:same reporter
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Product complaint, Pyrexia
Clinical narrative: She suspects that the batch of Shingrix caused the shingles; pain in the right abdomen; shingles; fever; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis. This case was associated with a product complaint.   On 27th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2020, less than a day after receiving Shingrix, the patient experienced fever. On 6th August 2020, the patient experienced shingles and abdominal pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the fever, abdominal pain and pharmaceutical product complaint were unknown.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the fever and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The daughter of the patient is the reporter.   The patient received 1st dose of Shingrix at an unspecified pharmacy. The patient reported that 10 days after receiving the Shingrix dose, he developed shingles. The reporter noted her mother received dose 1 of Shingrix, batch number EJ4NB, at the same time as the patient and she had no side effects and the lot number was different than the patient's dose. The suspected that the batch of Shingrix caused the shingles. The reporter was explained that Shingrix is not a live vaccine but the reporter was insistent. There was not product to return and the reporter obtained the lot number from the pharmacy paperwork. The patient also experienced fever and pain in the right abdomen. Emergency room visit required. There was no return or credit. The reporter did not consent to follow up.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: hives surrounding the injection site; redness /  surrounding the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site hives in a 5-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2SM24, expiry date 30th June 2021) for prophylaxis.   On 8th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 8th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site hives and injection site erythema. On an unknown date, the outcome of the injection site hives and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site hives and injection site erythema to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient received FluLaval Tetra 2020-2021 season and presented with redness and hives surrounding the injection site which had resolved. The reporter consented to follow up. The Doctor Address to be used for contact.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202330:same reporter
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incomplete course of vaccination, Pain
Clinical narrative: redness; soreness; first dose of Shingrix in January 2020; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema, pain and incomplete course of vaccination. On an unknown date, the outcome of the erythema and pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient was vaccinated with 1st dose of Shingrix and experienced soreness and redness for 5 to 7 days after vaccination. Till the time of reporting patient did not received 2nd dose which led to incomplete course of vaccination. On 6th October 2020 patient was on doctor's office was told, he should get the 2nd shot at this time. The patient was hesitant to receive the second shot due to he experinced events after 1st dose. The patient was also concerned it may not be as effective since he was getting it after the 6 month window.   The patient  planned to get 2nd shot in reporting week. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Cough, Dizziness, Fatigue
Clinical narrative: Coughing; light headedness; Injection site inflammation; Muscle pain; joint pain; Tiredness; shivering; Pain at the injection site; Redness at the injection site; Injection site swelling; Fever; This case was reported by a consumer via call center representative and described the occurrence of cough in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix (injection). On 9th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and shivering. On 10th October 2020, the patient experienced cough, light headedness, injection site inflammation, muscle pain, joint pain and tiredness. In October 2020, the patient experienced fever. On an unknown date, the outcome of the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever were recovered/resolved.   It was unknown if the reporter considered the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that he received the Shingrix on his left arm on 9th October,2020 and experienced coughing and lightheadedness also stated he experienced inflammation, pain,redness and swelling at the injection site with that patient also experienced muscle pain, joint pain, tiredness, shivering, and a fever.  Patient stated that he no longer experiencing those problems. The patient wanted to know if coughing was listed as a side effect. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Coughing; light headedness; Injection site inflammation; Muscle pain; joint pain; Tiredness; shivering; Pain at the injection site; Redness at the injection site; Injection site swelling; Fever; This case was reported by a consumer via call center representative and described the occurrence of cough in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix (injection). On 9th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and shivering. On 10th October 2020, the patient experienced cough, light headedness, injection site inflammation, muscle pain, joint pain and tiredness. In October 2020, the patient experienced fever. On an unknown date, the outcome of the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever were recovered/resolved.   It was unknown if the reporter considered the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that he received the Shingrix on his left arm on 9th October,2020 and experienced coughing and lightheadedness also stated he experienced inflammation, pain,redness and swelling at the injection site with that patient also experienced muscle pain, joint pain, tiredness, shivering, and a fever.  Patient stated that he no longer experiencing those problems. The patient wanted to know if coughing was listed as a side effect. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Coughing; light headedness; Injection site inflammation; Muscle pain; joint pain; Tiredness; shivering; Pain at the injection site; Redness at the injection site; Injection site swelling; Fever; This case was reported by a consumer via call center representative and described the occurrence of cough in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix (injection). On 9th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and shivering. On 10th October 2020, the patient experienced cough, light headedness, injection site inflammation, muscle pain, joint pain and tiredness. In October 2020, the patient experienced fever. On an unknown date, the outcome of the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever were recovered/resolved.   It was unknown if the reporter considered the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that he received the Shingrix on his left arm on 9th October,2020 and experienced coughing and lightheadedness also stated he experienced inflammation, pain,redness and swelling at the injection site with that patient also experienced muscle pain, joint pain, tiredness, shivering, and a fever.  Patient stated that he no longer experiencing those problems. The patient wanted to know if coughing was listed as a side effect. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Headache, Herpes zoster, Rash
Clinical narrative: face underneath eye and around cheek is red extending to lips; Swelling / Affected area is also swollen; eye is swollen; diagnosed with shingles / both doses of Shingrix last year; Shingles; Eruptions; Headache; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On 20th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 1st October 2020, not applicable after receiving Shingrix and 530 days after receiving Shingrix, the patient experienced headache. On 9th October 2020, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, erythema, swelling and eye swelling. On 7th October 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the vaccination failure and eye swelling were unknown and the outcome of the shingles, rash, erythema and swelling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, erythema, swelling and eye swelling to be related to Shingrix and Shingrix. It was unknown if the reporter considered the headache to be related to Shingrix.  Additional information was provided as follows: The reporter reported that series of events began on October 1, 2020 with a severe headache that lasted 7 days. After approximately 7 to 8 days swelling and eruptions occurred.  First eruption noticed on Friday, October 9, 2020 on the left side of nose near left eye.  Left eye was swollen, and left side of face underneath eye and around cheek was red extending to lips. Affected area was also swollen. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Vaccination failure
Clinical narrative: face underneath eye and around cheek is red extending to lips; Swelling / Affected area is also swollen; eye is swollen; diagnosed with shingles / both doses of Shingrix last year; Shingles; Eruptions; Headache; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On 20th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 1st October 2020, not applicable after receiving Shingrix and 530 days after receiving Shingrix, the patient experienced headache. On 9th October 2020, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, erythema, swelling and eye swelling. On 7th October 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the vaccination failure and eye swelling were unknown and the outcome of the shingles, rash, erythema and swelling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, erythema, swelling and eye swelling to be related to Shingrix and Shingrix. It was unknown if the reporter considered the headache to be related to Shingrix.  Additional information was provided as follows: The reporter reported that series of events began on October 1, 2020 with a severe headache that lasted 7 days. After approximately 7 to 8 days swelling and eruptions occurred.  First eruption noticed on Friday, October 9, 2020 on the left side of nose near left eye.  Left eye was swollen, and left side of face underneath eye and around cheek was red extending to lips. Affected area was also swollen. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: after receiving the 1st dose / uncomfortable feeling on the back of her legs; This case was reported by a consumer via call center representative and described the occurrence of leg discomfort in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dizziness. Concomitant products included gabapentin.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, immediately after receiving Shingrix, the patient experienced leg discomfort. On an unknown date, the outcome of the leg discomfort was not recovered/not resolved.   It was unknown if the reporter considered the leg discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 74 or 75 years. The had been taking 300 mg gabapentin every 4 hours which causes some dizziness. The patient had the 1st dose in in left arm. Shortly after receiving the vaccine she started to experience an uncomfortable feeling on the back of her legs 3 quarters of the way up to her buttocks. There is no rash or redness present. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020AMR204346.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR204346:same patient (2nd dose)
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: fever of 101F; body aches; sore throat; runny nose; cough; This case was reported by a nurse via call center representative and described the occurrence of fever in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number NA23N, expiry date unknown) for prophylaxis.   On 5th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 5th October 2020, 8 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced fever, general body pain, sore throat, runny nose and cough. On an unknown date, the outcome of the fever, general body pain, sore throat, runny nose and cough were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, sore throat, runny nose and cough to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received a dose of Fluarix and 8 hours later the patient developed a fever of 101 degree Fahrenheit, body aches, sore throat, runny nose and then eventually a cough. The patient tested for COVID twice and was negative. The patient said that runny nose, sore throat and fever had resolved, mostly in her chest till the time of reporting. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: fever of 101F; body aches; sore throat; runny nose; cough; This case was reported by a nurse via call center representative and described the occurrence of fever in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number NA23N, expiry date unknown) for prophylaxis.   On 5th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 5th October 2020, 8 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced fever, general body pain, sore throat, runny nose and cough. On an unknown date, the outcome of the fever, general body pain, sore throat, runny nose and cough were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, sore throat, runny nose and cough to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received a dose of Fluarix and 8 hours later the patient developed a fever of 101 degree Fahrenheit, body aches, sore throat, runny nose and then eventually a cough. The patient tested for COVID twice and was negative. The patient said that runny nose, sore throat and fever had resolved, mostly in her chest till the time of reporting. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Product preparation issue
Clinical narrative: pain; headache; administrated a first dose of Shingrix only the adjuvant without the powder; administrated a first dose of Shingrix only the adjuvant without the powder; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced pain, headache, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain, headache, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain and headache to be related to Shingrix.  Additional deatils were provided as follows: The patient was vaccinated with 1st dose of Shingrix and experienced pain and headache. While vaccination patient administered  only the adjuvant without the powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Pharmacist did not know who given just the adjuvant to patient. This case was linked with case US2020203914 as reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203914:same reporter