chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Echocardiogram, Laboratory test, Palpitations
Clinical narrative: 4 days after the vaccine, heart palpitations began. I had no prior history of these palpitations. They were so frequent to the point where I had to go to my doctor. He heard them with his stethoscope and believed they were Premature ventricular contractions. (PVCs). After almost 3 weeks, they slowly diminished. I just got my 2nd shot today, and I am hoping it does not continue.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Urticaria
Clinical narrative: Very itchy arm that has persisted, this far, to a month after getting the vaccine. At the injection site and around that general portion of my upper arm. Sometimes it's perfectly fine, sometimes it's red or pink and either will or will not be itchy as well. If I scratch at it too much, which I try really hard not to but it's really hard not to, and then the little rash-looking areas turns into a small area of mini skin hives. Still redish/pink and itchy. Then I try not to mess with it for the most part, but it's just consisted since then. Idk if this is a me problem, specifically cause I got some weird skin hive stuff going on actually on my eyes at night (randomly) that randomly occur. And that started way before I got the vaccine. With the hives on my arms, it will persist for a while at a time and go away before coming right back again as itchy as ever. It's been basically every single day since I got my vaccine that these side effects have been going on. #StillSupportIt lol. (:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paresis, Hypoaesthesia
Clinical narrative: 3 days after second dose of Pfizer vaccine,  (01/30/2021), went to emergency room for facial droopiness and numbness on the left side. Was diagnosed with Bell?s palsy in the ED.  Currently taking prednisone (60 mg - once a day). Valtrax (1mg - 3x a day), Erythromyocin eye ointment (.5% - 4x daily)
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA  1.) Diffuse muscle pain/stiffness over entire body (most notably in neck and back) 2.) Severe lethargy/fatigue 3.) Intermittent nausea  Symptoms lasted 48 hours and required no medical intervention aside from an OTC NSAID which only mildly improved symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Livedo reticularis, Peripheral swelling
Clinical narrative: 24 hours after vaccine, my legs became mottled. My doctor confirmed Livedo Reticularis. No pain swelling or issues, just discolored. It has been visible majority of the day (I am not ?cold? and i wear warm clothes). It has been a week, and has not gone away yet. I also started to get swelling / redness and a lump on my arm exactly 7 days after vaccine was given.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Chest pain, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: Tolerated first vaccine one month prior without incident. Today, developed 10/10 headache with photophobia starting five minutes after recieving the injection. Developed a cough and then crushing chest pain. Initial blood pressure and heart rate were within normal limits, and continuous pulse oximetry showed consistent Oxygenation of 98%. Patient was able to speak in full sentences although unable to take a deep breath. Pain was physically limiting, and patient was transported to ER, for immediate evaluation and treatment. At the ER, pateint was normotensive and nontachycardic. He received IV epinephrine and dexamethsasone. Per paramedic report while in ER, patient shortly afterward developed hypotension with left
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Mobility decreased, Muscular weakness, Nystagmus
Clinical narrative: Tolerated first vaccine one month prior without incident. Today, developed 10/10 headache with photophobia starting five minutes after recieving the injection. Developed a cough and then crushing chest pain. Initial blood pressure and heart rate were within normal limits, and continuous pulse oximetry showed consistent Oxygenation of 98%. Patient was able to speak in full sentences although unable to take a deep breath. Pain was physically limiting, and patient was transported to ER, for immediate evaluation and treatment. At the ER, pateint was normotensive and nontachycardic. He received IV epinephrine and dexamethsasone. Per paramedic report while in ER, patient shortly afterward developed hypotension with left
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Tolerated first vaccine one month prior without incident. Today, developed 10/10 headache with photophobia starting five minutes after recieving the injection. Developed a cough and then crushing chest pain. Initial blood pressure and heart rate were within normal limits, and continuous pulse oximetry showed consistent Oxygenation of 98%. Patient was able to speak in full sentences although unable to take a deep breath. Pain was physically limiting, and patient was transported to ER, for immediate evaluation and treatment. At the ER, pateint was normotensive and nontachycardic. He received IV epinephrine and dexamethsasone. Per paramedic report while in ER, patient shortly afterward developed hypotension with left
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain in extremity
Clinical narrative: Left arm hurts, head hurts and stomach hurts
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Developed itchy rash on upper arm just below vaccination site. Treated with cortisone cream.  I have photo
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Disorientation, Dyspnoea, Erythema, Feeling abnormal
Clinical narrative: I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Itchy raised bumps on left arm the day after the vaccine and hives as well as increased itchiness throughout my body as the days progressed
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red rash below injection site, size of a quarter, warm to touch, itchy, no pain,  started 7 days after injection was received, grew in size daily. Resolved after 1 week.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Extreme itchy arm, huge red spot at injection site, hard, hot, painful to the touch
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in lower extremities from the waist down, which began 4-5 days after receiving my 1st dose of the Moderna COVID vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Insomnia, Nausea
Clinical narrative: Fever Chills Headache Body Ache Nausea Tiredness Insomnia
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever Chills Headache Body Ache Nausea Tiredness Insomnia
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Approximately 24 hours after first Moderna vaccination,  malaise, slight headache, generally feeling unwell.  Took 1 baby aspirin.  Symptoms lasted 8-12 hours and resolved after good night's sleep.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: an improperly stored vaccine was administered on 25JAN202 l.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On On 25-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T013546 was confirmed to be valid, expiration date was reported as 27-OCT-2021, but upon internal validation, it was established as 28-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  The temperature excursion was above 9 Celsius degrees (C) (13.4 C) for 2 hours and 9 minutes. There were no previous excursions reported. The digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine was administered on 25JAN2021; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, prefilled syringe, lot # T026954, expiration date 13-APR-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of above 9 degrees Celsius (13.4 degrees Celsius) for 2 hours and 9 minutes.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026954; expirationdate: 13-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Therapeutic response unexpected
Clinical narrative: strongest reaction/ had fairly bad flue like symptoms, but only where I have sports injuries, back, hips, knees, ankles, etc; not feeling well; have had more than two or three days of painless; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anterior cruciate ligament reconstruction (twice) and sports injury. Previously administered products included Plague vaccine, encephalitis vaccine and Yellow fever vaccine. Concurrent medical conditions included knee pain (probably 20 years or more).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, feeling unwell and unexpected therapeutic effect. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell and unexpected therapeutic effect were unknown.   It was unknown if the reporter considered the influenza-like symptoms, feeling unwell and unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had a very positive side effect from Shingrix vaccination after he/she received first round shot. The patient had discussed it with the physician and explained that the patient should contact about this, as there was a positive side effect that could allow some component of the vaccination to be used for other purposes. The patient was warned when the shot was received that he/she might have some flu like symptoms. When it was given to the patient, the patient did indeed had the strongest reaction he/she ever had from any vaccination in their life and the patient had traveled all over the world, getting plague, encephalitis, yellow fever, etc. vaccinations. Interestingly, the patient had fairly bad flue like symptoms, but only where he/she had sports injuries, back, hips, knees, ankles, etc. However, after two days of not feeling well, the patient's left knee, which the patient had anterior cruciate ligament (ACL) reconstruction surgery on twice, had no pain for about the last month, which led to unexpected therapeutic effect. The pain was starting to come back just in the last couple of days from time of reporting. This was the first time in probably 20 years or more the patient had more than two or three days of painless time with the knee. The patient stated it was quiet remarkable. The patient agreed to provide more information and hoped there was a benefit in this for all people with chronic joint pain.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Pain
Clinical narrative: body aches; exhaustion; chills; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 4th December 2020, 1 days after receiving Shingrix, the patient experienced general body pain and exhaustion. In December 2020, the patient experienced chills. On an unknown date, the outcome of the chills, general body pain and exhaustion were unknown.   It was unknown if the reporter considered the chills, general body pain and exhaustion to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting the patient received 2nd dose of Shingrix and had chills at night. On the day of reporting, the patient went to work and had to leave early because of body aches and exhaustion. The patient asked was that a normal side effect.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: received her first dose / on 12/12/2019  / experienced a sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient experienced a sore arm. The reporter consented to follow up. For further tolerance after 2nd and 3rd dose of Shingrix refer linked cases US2020AMR248212 and US2020247551 respectively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020247551:3rd dose US-GLAXOSMITHKLINE-US2020AMR248212:2nd dose
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: second dose on 02/11/2020 / experienced a sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 12th December 2019, refer linked case US2020AMR248211).   On 11th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient experienced a sore arm. The reporter consented to follow up. For further tolerance after 3rd dose of Shingrix refer linked cases US2020247551.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR248211:1st dose US-GLAXOSMITHKLINE-US2020247551:3rd dose
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Inflammation, Lymphadenopathy, Nausea
Clinical narrative: arm became significantly inflamed; large welts; lymph nodes by my clavicle were huge; fever; chills; ACHES; HEADACHE; Nausea; This case was reported by a consumer and described the occurrence of inflammation localized in a 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 inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea. On an unknown date, the outcome of the inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea were unknown.   It was unknown if the reporter considered the inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. After receiving Shingrix, the patient's arm became significantly inflamed with large welts, lymph nodes by clavicle were huge, had a fever, chills, aches, headache and nausea. The patient was looking for the ingredients that were in the Shingrix shingles vaccine and want to know if the patient was allergic to this to prepare for 2nd dose and any other vaccines that might contain similar ingredients.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: arm became significantly inflamed; large welts; lymph nodes by my clavicle were huge; fever; chills; ACHES; HEADACHE; Nausea; This case was reported by a consumer and described the occurrence of inflammation localized in a 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 inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea. On an unknown date, the outcome of the inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea were unknown.   It was unknown if the reporter considered the inflammation localized, welts, enlargement of lymph nodes, fever, chills, pain, headache and nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. After receiving Shingrix, the patient's arm became significantly inflamed with large welts, lymph nodes by clavicle were huge, had a fever, chills, aches, headache and nausea. The patient was looking for the ingredients that were in the Shingrix shingles vaccine and want to know if the patient was allergic to this to prepare for 2nd dose and any other vaccines that might contain similar ingredients.
Sex: U
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: injection site pain; aches; fever; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain, pain and fever. On an unknown date, the outcome of the injection site pain, pain and fever were unknown.   It was unknown if the reporter considered the injection site pain, pain and fever to be related to Flu vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The common flu shots caused injection site pain, aches and fever. This case has been linked with the case US2020AMR248144, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: I wake up with a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received Shingrix. On 14th December 2020, 2 days 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 reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On Saturday, the patient received Shingrix and on the day of reporting the patient woke up with a rash.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 2nd dose of Shingrix. On 14th December 2020, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing chills, but not fever.  It was 5 day later and reporter asked how long would these side effects continue.  The reporter considering a COVID test but had no fever nor any of the common symptoms of COVID.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: GOT THE 1ST VACCINE / I SWEAR I HAVE THE SHINGLES NOW / FEELING ON MY LOWER BACK; This case was reported by a pharmacist and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced shingles. 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 reporter was the patient. The age at vaccination was not repored. The age group of the patient was not reported but selcted as an adult as per vaccine indication. The reporter stated that, received 1st dose on wednesday and had shingles on the lower back. The reporter asked if should receive acyclovir.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: I have 102.8 fever after vaccine; This case was reported by a consumer and described the occurrence of fever in a adult patient 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 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 (102.8 degree F).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Headache, Injection site pain, Oropharyngeal pain, Paranasal sinus discomfort
Clinical narrative: Headache / migraine medicine did not help; Chest pain; Pain at the injection site; Chest congestion / better but would come and go; Sore throat; Runny nose; Fever of 99.2 / her temperture normally runs low; Sinus pressure / Sinus issues; Sinus pain / Sinus issues; Scratchy throat; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine and allergy.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation. On 20th November 2020, the patient experienced chest pain and injection site pain. On 22nd November 2020, the patient experienced headache. The patient was treated with antimigraine preparations (Generic Migraine Medicine (Name Unknown)). On 10th December 2020, the outcome of the lung congestion, sinus pressure, sinus pain and throat irritation were recovered/resolved. On an unknown date, the outcome of the chest pain, injection site pain, headache, sore throat, runny nose and fever were unknown.   It was unknown if the reporter considered the lung congestion, chest pain, injection site pain, headache, sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. Next day after receiving Shingrix, the patient had chest pain and pain at the injection site. The patient also had a headache that her migraine medicine did not help. The patient also experienced sore throat, runny nose, fever of 99.2-degree F, sinus pressure and sinus pain and chest congestion. The patient had as covid test which was negative. On 04th December 2020, scratchy throat, sinus issues and chest congestion better but would come and go. The events lasted until 10th December 2020. The patient mentioned that her temperature normally ran low at 96.8-degree F. The reporter provided permission to follow up with healthcare professional. For the tolerance of 2nd dose, refer linked case US2021AMR019262.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019262:Same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pulmonary congestion, Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative, Sinus pain
Clinical narrative: Headache / migraine medicine did not help; Chest pain; Pain at the injection site; Chest congestion / better but would come and go; Sore throat; Runny nose; Fever of 99.2 / her temperture normally runs low; Sinus pressure / Sinus issues; Sinus pain / Sinus issues; Scratchy throat; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine and allergy.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation. On 20th November 2020, the patient experienced chest pain and injection site pain. On 22nd November 2020, the patient experienced headache. The patient was treated with antimigraine preparations (Generic Migraine Medicine (Name Unknown)). On 10th December 2020, the outcome of the lung congestion, sinus pressure, sinus pain and throat irritation were recovered/resolved. On an unknown date, the outcome of the chest pain, injection site pain, headache, sore throat, runny nose and fever were unknown.   It was unknown if the reporter considered the lung congestion, chest pain, injection site pain, headache, sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. Next day after receiving Shingrix, the patient had chest pain and pain at the injection site. The patient also had a headache that her migraine medicine did not help. The patient also experienced sore throat, runny nose, fever of 99.2-degree F, sinus pressure and sinus pain and chest congestion. The patient had as covid test which was negative. On 04th December 2020, scratchy throat, sinus issues and chest congestion better but would come and go. The events lasted until 10th December 2020. The patient mentioned that her temperature normally ran low at 96.8-degree F. The reporter provided permission to follow up with healthcare professional. For the tolerance of 2nd dose, refer linked case US2021AMR019262.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019262:Same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: Headache / migraine medicine did not help; Chest pain; Pain at the injection site; Chest congestion / better but would come and go; Sore throat; Runny nose; Fever of 99.2 / her temperture normally runs low; Sinus pressure / Sinus issues; Sinus pain / Sinus issues; Scratchy throat; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine and allergy.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation. On 20th November 2020, the patient experienced chest pain and injection site pain. On 22nd November 2020, the patient experienced headache. The patient was treated with antimigraine preparations (Generic Migraine Medicine (Name Unknown)). On 10th December 2020, the outcome of the lung congestion, sinus pressure, sinus pain and throat irritation were recovered/resolved. On an unknown date, the outcome of the chest pain, injection site pain, headache, sore throat, runny nose and fever were unknown.   It was unknown if the reporter considered the lung congestion, chest pain, injection site pain, headache, sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. Next day after receiving Shingrix, the patient had chest pain and pain at the injection site. The patient also had a headache that her migraine medicine did not help. The patient also experienced sore throat, runny nose, fever of 99.2-degree F, sinus pressure and sinus pain and chest congestion. The patient had as covid test which was negative. On 04th December 2020, scratchy throat, sinus issues and chest congestion better but would come and go. The events lasted until 10th December 2020. The patient mentioned that her temperature normally ran low at 96.8-degree F. The reporter provided permission to follow up with healthcare professional. For the tolerance of 2nd dose, refer linked case US2021AMR019262.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019262:Same reporter.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Burning sensation, Erythema
Clinical narrative: burning sensation on her arm; redness on her arm / growing larger toward her chest; This case was reported by a consumer and described the occurrence of extremities burning sensation of in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included venetoclax (Venclexta) tablet for chronic lymphocytic leukemia.   Concurrent medical conditions included chronic lymphocytic leukemia and drug allergy (allergic to Lipitor, Oxycodone and Penicillins). Concomitant products included allopurinol, metformin, sitagliptin (Januvia), paracetamol (Tylenol) and obinutuzumab (Gazyva).   On an unknown date, the patient received Shingrix. On 24th September 2020, the patient started Venclexta (oral) 100 mg 3 times daily (400 mg daily). On 13th January 2021, less than 4 months after receiving Shingrix and an unknown time after starting allopurinol, the patient experienced extremities burning sensation of and erythema of extremities. Venclexta was continued with no change. On an unknown date, the outcome of the extremities burning sensation of and erythema of extremities were unknown.   It was unknown if the reporter considered the extremities burning sensation of and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 65 or 66 years. The patient had a response to Shingrix vaccine while being on Venclexta.  The 13th January 2021, 3 months and 20 days after receiving Venclexta and less than 4 months after receiving Shingrix, the patient experienced a redness and a burning sensation on the arm that was growing larger towards the chest. It was unknown if the reporter considered the extremities burning sensation of and erythema of extremities to be related to Venclexta.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site reaction, Pain in extremity
Clinical narrative: Vertigo; Pain / Sore arm; Redness / red whelp at the injection site; Vomiting; Shivering; Sweats; This case was reported by a consumer and described the occurrence of vertigo in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meniere's disease.   On 2nd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 36 hrs after receiving Shingrix, the patient experienced vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema. On an unknown date, the outcome of the vertigo, pain in arm and injection site erythema were unknown and the outcome of the vomiting, shivering and sweating were recovered/resolved.   It was unknown if the reporter considered the vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received  first dose of Shingrix and approximately thirty six hours later, she had severe Vertigo and Vomiting for three hours, and then it resolved. The patient stated she then had Shivering and Sweats for one hour. She reported that she had pain as in a sore arm and redness or a red whelp at the injection site  The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Vertigo, Vomiting
Clinical narrative: Vertigo; Pain / Sore arm; Redness / red whelp at the injection site; Vomiting; Shivering; Sweats; This case was reported by a consumer and described the occurrence of vertigo in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meniere's disease.   On 2nd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 36 hrs after receiving Shingrix, the patient experienced vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema. On an unknown date, the outcome of the vertigo, pain in arm and injection site erythema were unknown and the outcome of the vomiting, shivering and sweating were recovered/resolved.   It was unknown if the reporter considered the vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received  first dose of Shingrix and approximately thirty six hours later, she had severe Vertigo and Vomiting for three hours, and then it resolved. The patient stated she then had Shivering and Sweats for one hour. She reported that she had pain as in a sore arm and redness or a red whelp at the injection site  The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 23Oct2020 and 2nd dose on 02Dec2020.; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) (batch number LN399, expiry date 9th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than recommended interval which led to shortening of vaccination schedule.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Herpes zoster, Post herpetic neuralgia
Clinical narrative: Breakout on his face / shingles/chickenpox virus; Lesions themselves are not painful / the postherpetic pain is; Redness (from top of left shoulder to the elbow); Chills; Headache; This case was reported by a consumer and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, 1 days after receiving Shingrix, the patient experienced erythema, chills and headache. On an unknown date, the patient experienced shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valtrex). On 31st July 2020, the outcome of the erythema, chills and headache were recovered/resolved. On an unknown date, the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, erythema, chills and headache to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on upper left arm. The day after getting Shingrix, the patient experienced redness (from top of left shoulder to the elbow), chills, and headache which lasted two days. Less than 6 months after receiving Shingrix, the patient experienced a breakout on his face that he describes as the shingles or chickenpox virus. The patient initially thought it was adult onset acne, but it spread from the right side of his face to the left side. He reports that the lesions themselves were not painful, but the postherpetic pain was. The patient had seen his HCP and was advised to not get the 2nd dose of the vaccine until the outbreaks stops. HCP prescribed Valtrex that he was still currently taking (day of reporting was his fourth day on Valtrex). On the day of reporting, the patient noticed that there were spots on his left arm, left inner elbow, and on his stomach as well. However, he stated the outbreak was primarily isolated to his face.  Not all information was available. The reporter consented to follow up. The patient gave permission to follow-up with their HCP and provided the contact information. The patient was unable to provide HCP's email or fax at the time of report.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Pruritus, Pyrexia
Clinical narrative: Fatigue; Fever; Itchy body; Chills; Lower back pain; This case was reported by a pharmacist and described the occurrence of fatigue in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date unknown) for prophylaxis.   On 18th January 2020, the patient received the 1st dose of Shingrix. On 18th January 2020, less than a day after receiving Shingrix, the patient experienced fatigue, fever, generalized pruritus, chills and low back pain. On an unknown date, the outcome of the fatigue, fever, generalized pruritus, chills and low back pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever, generalized pruritus, chills and low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix, and experienced fatigue, chills, itchy body, fever and lower back pain. This case was linked with US2020AMR242120, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR242120:Same reporter. Case for dose 2
Sex: M
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: severe reaction that culminated in transverse myelitis; This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a male 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 myelitis transverse (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse was recovered/resolved.   It was unknown if the reporter considered the myelitis transverse to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose approximately 2 years ago from the date of reporting.  The reporter reported a severe reaction that culminated in transverse myelitis.  The reporter stated that a detailed account had been reported via a vaccine website and by their neurologist. The reporter did not consent to follow-up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 72-year-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249, expiry date unknown) via an unspecified route of administration on the left arm on 15Jan2021, 11:30AM at a single dose for COVID-19 immunization. The patient's medical history included being overweight. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 15Jan2021 22:00, the patient experienced injection spot was a little sore, was very tired that night, and had some chills. No treatment was received in response to the events. Outcome of the events at the time of last observation was recovered. The events were considered non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Muscle spasms, Muscular weakness, Paraesthesia
Clinical narrative: felt like a cramp in face on one side of her cheek and it felt like her face was not working right; arm and legs were tired; tingling in her forehead and in nose/tingling in arms and in legs and her feet felt the worst; numbness; Muscle weakness; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications. The patient reported that she had some things happened just after receiving the COVID-19 vaccine on Tuesday morning (12Jan2021). The patient later on experienced tingling in her forehead and in nose on 13Jan2021. The next day (14Jan2021), it started like tingling in arms and in legs and her feet felt the worst.  On 14Jan2021, two days after (Thursday), she felt like her arm and legs were tired. On Friday (15Jan2021), she woke up and felt like a cramp in face on one side of her cheek and it felt like her face was not working right. Three days later (Friday), she still feels that it is better than it was. The patient also experienced numbness and muscle weakness (both in Jan2021). She don't know what she should do or if she should get the next shot, she almost felt like it was the worst and need to go to the hospital but her body was not so fatigued, she felt her muscle worked hard, described as weak. The patient haven't seen by her doctor or visited in emergency room. The patient did not receive treatment for the events. Outcome of the events was unknown. The events were assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; patient already has missed the second dose on schedule; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 on unspecified date. The patient already has missed the second dose on schedule. Outcome of the events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.