chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2012, the patient was vaccinated by a healthcare provider with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) prescribed by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: ocular shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69- year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a healthcare provider at a hospital for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced ocular shingles and was treated for the event by a healthcare provider at a hospital. The outcome of the event was not provided. The reporter considered ocular shingles to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the event of ocular shingles was determined to be medically significant.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 55-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions.On an unknown date, the patient experienced herpes zoster, for which was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster, for which was treated by a healthcare provider. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; muscle pain; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix. In May 2019, less than a day after receiving Shingrix, the patient experienced fever, muscle pain and chills. On an unknown date, the outcome of the fever, muscle pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever, muscle pain and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had the Shingrix shot and during the night the patient experienced chills, fever and muscle pain.  The patient wanted to know how long does the side effects last.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Flatulence, Muscle spasms
Clinical narrative: Patient reports extreme stomach pain starting the day after injection  Wednesday 6/5/19 that lasted for 3 days. She described it as bloating, extreme gas pain and cramping. Relieved by pressure.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: 6 hours post vaccination I felt very tired.  By 9pm I had a muscle aches and pain (I felt like I had the flu, but I had no respiratory symptoms..no cough nor congestion)  and a fever greater than 101F.  This lasted until approximately 12 noon 6/11/19.   Fever resolved...muscle pains slowly went away.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Localized warmth, palm-sized redness at injection site, significantly painful to the touch which only began at 7:00 PM the day after injection (prior to this was "normal" vaccine symptoms, small red spot and normal site tenderness)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt reported "symmetrical shingles" for 4 days in deltoid of both arms. Patient reported no difficulty with this issue. Re-assured patient.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Feeling cold, Headache, Injection site mass, Nausea
Clinical narrative: Sstarted with being extremely cold (uncontrollable shaking almost like rigors) , could not get warm despite covers, turning heat up.  Headache, generalized aches, fever (highest was 102 with ear thermometer), nausea, sore arm into armpit with lump at site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Sstarted with being extremely cold (uncontrollable shaking almost like rigors) , could not get warm despite covers, turning heat up.  Headache, generalized aches, fever (highest was 102 with ear thermometer), nausea, sore arm into armpit with lump at site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash
Clinical narrative: Patchy rash near injection sight on right arm
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Injection site erythema
Clinical narrative: Symptoms of red around the injection site and fatigued from Sunday night (6/9/19) until Tuesday morning (6/11/19). No treatment necessary.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Dizziness, Drooling, Headache, Hyperhidrosis
Clinical narrative: On Monday Jun 10th I received my second shot of the shingles vaccine. I felt fine all day Monday. That night I woke up in a feverish sweat and crazy dreams. I drank some water, put another blanket on the bed and was able to go back to sleep. Tuesday I woke up at 7:30 AM and took some Advil as I felt achy. I went downstairs for some coffee and sat in a chair. I quickly broke out into a full body sweat from head to toe. I was dripping wet and my partner said I was drewling. I was light headed and didn't feel like walking back up stairs to bed. I asked for towels for the floor, laid on them and got covered in another towel as I was cold. I took my temperature and it was 100.7°. It seems like I was there for about 20-30 minutes and the sweating stopped. I then fell alseep for about an hour. When I woke up I felt better and ate a little breakfast. Then went back updtairs to bed. I spent most of the day in bed, sleeping, drinking water and taking Advil. For most of the day I had a low grade fever and off and on would have a headache and feel achy. This morning, Wednesday June 12th I don't have a fever and feel back to normal.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: On Monday Jun 10th I received my second shot of the shingles vaccine. I felt fine all day Monday. That night I woke up in a feverish sweat and crazy dreams. I drank some water, put another blanket on the bed and was able to go back to sleep. Tuesday I woke up at 7:30 AM and took some Advil as I felt achy. I went downstairs for some coffee and sat in a chair. I quickly broke out into a full body sweat from head to toe. I was dripping wet and my partner said I was drewling. I was light headed and didn't feel like walking back up stairs to bed. I asked for towels for the floor, laid on them and got covered in another towel as I was cold. I took my temperature and it was 100.7°. It seems like I was there for about 20-30 minutes and the sweating stopped. I then fell alseep for about an hour. When I woke up I felt better and ate a little breakfast. Then went back updtairs to bed. I spent most of the day in bed, sleeping, drinking water and taking Advil. For most of the day I had a low grade fever and off and on would have a headache and feel achy. This morning, Wednesday June 12th I don't have a fever and feel back to normal.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema
Clinical narrative: Symptoms of red around the injection site and fatigued from Sunday night (6/9/19) until Tuesday morning (6/11/19). No treatment necessary.
Age: 21.0
Sex: F
Vaccine: DTAP, HEPA, TYP
Symptoms: Epistaxis
Clinical narrative: Nosebleed, 19 hours after vaccination, lasting about 2 minutes, pinched and held nose to make bleeding stop
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Disorientation, Fall, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient fainted and fell to the floor while leaving the office, very pale, diaphoretic, smelling salts used, somewhat disoriented and vomited.  Wheeled back to exam room BP taken, vomited again and became more oriented after 10 minutes.  at 15 minutes after the event patient felt better and left without complaints accompanied by her sister.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Patient fainted and fell to the floor while leaving the office, very pale, diaphoretic, smelling salts used, somewhat disoriented and vomited.  Wheeled back to exam room BP taken, vomited again and became more oriented after 10 minutes.  at 15 minutes after the event patient felt better and left without complaints accompanied by her sister.
Sex: U
Vaccine: MMR, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; patient received second dose of MMR II series on 5/29/2019 after receiving first dose on 5/10/2019; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 10-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. On 29-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 2, therapy type rHA, lot # R031681 and expiration date: 01-NOV-2020 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). Other suspect therapies included sterile diluent(STERILE DILUENT) lot # N029829 and expiration date 01-MAY-2020 (dose, frequency and route were not provided). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: varicella despite vaccination; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 128 children of unknown gender, who took part in active surveillance for varicella outbreaks and clusters in schools from 2012 to 2015. Outbreaks of varicella were defined as  equal or more than 5 cases in a school within at least 1 incubation period (21 days). No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients was vaccinated with first or second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis.        On an unknown date, 42 patients experienced varicella despite vaccination after 1 dose and 68 after 2 doses in outbreak group; 7 after 1 dose and 11 after 2 doses in cluster group, respectively.   The outcome of vaccination failure was unknown.  The reporter considered vaccination failure to be related to varicella virus vaccine live (Oka/Merck) (VARIVAX).     A copy of the published article is attached as further document of the patients' experience.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information was reported regarding the patient's concomitant medications, concurrent conditions or medical history.  On 04-APR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # M037245 with expiration date on 21-FEB-2019 (route of administration was not reported) for prophylaxis. However, no adverse effects were reported.  Lot number M037245 is not a valid lot for hepatitis a vaccine, inactivated(VAQTA).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002785:
Sex: F
Vaccine: FLUX
Symptoms: Injection site nerve damage, Pain in extremity
Clinical narrative: pain in arm; Injection site nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm and injection site nerve damage. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site nerve damage was unknown.   It was unknown if the reporter considered the pain in arm and injection site nerve damage to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Flu vaccine in October and reported that the arm still hurts. The patient reported that they told her that they hit a nerve. The patient stated that, she knew few people had the same problem and would never get that shot again. This case has been linked to US2019GSK105671, reported y the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter had a patient that called with redness at site of injection.  They indicated it was 1 to 1 and half 2 inch around of the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: arm swollen/swelling; arm redness; injection site warmth/arm hot to the touch; itching; This case was reported by a physician via sales rep and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced swelling arm, erythema of extremities, skin warm and itchy upper limbs. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the swelling arm and erythema of extremities were not recovered/not resolved and the outcome of the skin warm and itchy upper limbs were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and itchy upper limbs to be related to Shingles vaccine.  Additional details were reported as follows:  The age at vaccination was not reported.  The patient had shingles vaccine 2 weeks before the reporting date and her arm was still swollen and red. The patient states that it was hot to the touch and itching and swelling was increased.  The physician spoke to the patient and recommended Tylenol and Motrin.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site mass, Injection site swelling, Pain in extremity, Tenderness
Clinical narrative: chills; injection site bump; arm pain/tender in arm; This case was reported by a consumer via sales rep and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, injection site swelling and pain in arm. On an unknown date, the outcome of the chills, injection site swelling and pain in arm were unknown.   It was unknown if the reporter considered the chills, injection site swelling and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, however it could be 65 or 66 years. The case was reported by the retired vaccine representative. The patient was attending a coalition event and approached to the reporter learning was GSK representative.  The patient was wanted to tell her experience with receiving Shingrix injection.  The patient said three months past she received first Shingrix injection.  Within 3 hours the patient had chills, within a day the patient had a significant bump around the injection site and patient arm was tender and hurt.  The reporter don't know when the first shot was given.  The reporter did not know the lot number the second shot was about one month before the reporting date. The reporter did not agree to follow up with GlaxoSmithKline. For tolerance after 2nd dose refer case US2019GSK088801.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Joint stiffness, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine; Headache; fever; Joint stiffness; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 8 months ago from the reporting date).   On 2nd May 2019, the patient received the 2nd dose of Shingrix. On 2nd May 2019, 12 hrs after receiving Shingrix, the patient experienced headache, fever and stiff joint. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the headache, fever, stiff joint and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, fever and stiff joint to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient asked do the two Shingrix vaccine shots had to be separated by 2 to 6 months in order to be effective, which led to lengthening of the vaccination schedule. The clinic scheduled the shots 8 months apart and the patient wonder if I am adequately vaccinated. Also, the patient had side effects headaches, fever and joint stiffness. The patient had the 2nd shot at 10 this morning, so 12 hours before the reporting date.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Pyrexia, Rhinitis allergic
Clinical narrative: fever; Nasal allergies; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included allergic rhinitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and allergic rhinitis. On an unknown date, the outcome of the fever and allergic rhinitis were unknown.   It was unknown if the reporter considered the fever and allergic rhinitis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had initial shinglix vaccine and the patient temperature spiked to 102 and had been experiencing heightened issues with nasal allergies after taking this vaccine. The patient was expecting the temperature rising, the fatigue, etc.  The patient asked there a correlation between the vaccine and nasal type allergies. This had been difficult.      Lab Comments: lab test performed on an unknown date
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Oral herpes
Clinical narrative: Cold sore; Pain at site; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received Shingrix. On 1st May 2019, 2 hrs after receiving Shingrix, the patient experienced injection site pain. On 2nd May 2019, the patient experienced cold sores. On an unknown date, the outcome of the cold sores and injection site pain were unknown.   It was unknown if the reporter considered the cold sores and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine on an unknown deltoid, 24 hours ago from the date of reporting and experienced pain at injection site 2 hours after administration on the whole deltoid and then the cold sore a bit before. The patient asked whether the event pain at injection site and cold sore were the possible site effect of the vaccine.  The reporter  gave consented to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: Achy; Flu like symptoms; Product supply issue; felt bad for about 24 hrs; Aching back; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 25th August 2018, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feeling unwell, back pain and tiredness. On an unknown date, the patient experienced pain, influenza-like symptoms and product supply issue. On an unknown date, the outcome of the feeling unwell, pain, influenza-like symptoms, back pain, tiredness and product supply issue were unknown.   It was unknown if the reporter considered the feeling unwell, pain, influenza-like symptoms, back pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient received 1st dose and had pain, feeling unwell, influenza-like symptoms, back pain and tiredness. The patient did not receive the 2nd dose between 2 to 6 months due to product supply issue. The reporter asked do the patient need to have the 2nd dose within 6 months after the 1st dose or might the patient need to get a 3rd dose. The patient mom had shingles many years ago.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Product supply issue
Clinical narrative: Achy; Flu like symptoms; Product supply issue; felt bad for about 24 hrs; Aching back; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 25th August 2018, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feeling unwell, back pain and tiredness. On an unknown date, the patient experienced pain, influenza-like symptoms and product supply issue. On an unknown date, the outcome of the feeling unwell, pain, influenza-like symptoms, back pain, tiredness and product supply issue were unknown.   It was unknown if the reporter considered the feeling unwell, pain, influenza-like symptoms, back pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient received 1st dose and had pain, feeling unwell, influenza-like symptoms, back pain and tiredness. The patient did not receive the 2nd dose between 2 to 6 months due to product supply issue. The reporter asked do the patient need to have the 2nd dose within 6 months after the 1st dose or might the patient need to get a 3rd dose. The patient mom had shingles many years ago.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever blister; This case was reported by a pharmacist via other manufacturer and described the occurrence of fever blister in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and broken out with a fever blister. The pharmacist asked, if the patient could take Valtrex or would it compromise the efficacy of the vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain in extremity, Pruritus
Clinical narrative: headache; itchiness; arm pain; arm red; shivers; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever, headache, pruritus, pain in arm, erythema of extremities and shivers. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache, pruritus, pain in arm, erythema of extremities and shivers were unknown.   It was unknown if the reporter considered the fever, headache, pruritus, pain in arm, erythema of extremities and shivers to be related to Shingrix.  Additional details were provided as follows: The patient got a shingle shot about 2 days ago and she ran a high fever shivers and a very strong headache, her arm was very red and itched a lot. The patient asked what could she do to relieve the itchiness and doctor told her to go to the emergency room but she took Tylenol and her fever went down but the pain in her arm was bad and the itchiness was so bad.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: headache; itchiness; arm pain; arm red; shivers; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever, headache, pruritus, pain in arm, erythema of extremities and shivers. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache, pruritus, pain in arm, erythema of extremities and shivers were unknown.   It was unknown if the reporter considered the fever, headache, pruritus, pain in arm, erythema of extremities and shivers to be related to Shingrix.  Additional details were provided as follows: The patient got a shingle shot about 2 days ago and she ran a high fever shivers and a very strong headache, her arm was very red and itched a lot. The patient asked what could she do to relieve the itchiness and doctor told her to go to the emergency room but she took Tylenol and her fever went down but the pain in her arm was bad and the itchiness was so bad.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Ocular hyperaemia, Periorbital swelling
Clinical narrative: swelling around eyes; redness around eyes; eye red; This case was reported by a consumer and described the occurrence of periocular swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced periocular swelling, erythema periorbital and eye red. On an unknown date, the outcome of the periocular swelling, erythema periorbital and eye red were not recovered/not resolved.   It was unknown if the reporter considered the periocular swelling, erythema periorbital and eye red to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient went to primary care doctor, Ears, nose and throat doctor, eye doctor and allergist and none of the them know why this occurred three days after the patient had the Shingnx shingles shot.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: chills; fever; nausea; difficult to work; This case was reported by a nurse via call center representative and described the occurrence of chills in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 2nd dose of Shingrix. On 30th May 2019, 1 days after receiving Shingrix, the patient experienced chills, fever, nausea and activities of daily living impaired. On an unknown date, the outcome of the chills, fever, nausea and activities of daily living impaired were unknown.   It was unknown if the reporter considered the chills, fever, nausea and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follow: The patient experienced chills, body temperature was recorded as 100.5 and nausea after receiving a booster dose of Shingrix. The patient found very difficult to work. The reporter wanted to know is this common effects.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos. 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 age at vaccination was not reported. The patient was healthy person taking no other medications. The patient experienced shingles 5 weeks ago after receiving Shingrix vaccine. The reporter had suspicion that the vaccine caused this even though she have read it cannot. The reporter wanted to know how long does she wait for the 2nd dose.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypersomnia, Pain
Clinical narrative: pain; sleeping a lot; This case was reported by a consumer via call center representative and described the occurrence of pain in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced pain and sleep excessive. On an unknown date, the outcome of the pain and sleep excessive were unknown.   It was unknown if the reporter considered the pain and sleep excessive to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient slept for 14 hours at last night before the reporting and had only been awake for 5 hours. The patient felt like again go back to slept for 14 hours.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Condition aggravated, Dizziness, Fatigue, Headache
Clinical narrative: not feel well; flu-like symptoms; tiredness; headaches; muscle pain; upset stomach; vomiting; Muscle problem on leg; sore arm; dizziness; vertigo; Vertigo condition aggrevated; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received on an unknown date). Concurrent medical conditions included vertigo.   On 25th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced dizziness, vertigo and condition aggravated. On 25th May 2019, the patient experienced pain in arm. On 26th May 2019, the patient experienced feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, vomiting and muscle disorder. On 26th May 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, condition aggravated and muscle disorder were unknown and the outcome of the vomiting, dizziness and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, vomiting, dizziness, vertigo, condition aggravated and muscle disorder to be related to Shingrix.  Additional details were provided as follows: On 25th May 2019, less than a day after receiving Shingrix, the Patient experienced sore arm which resolved the next day from the first dose. On 26h May 2019, 1 day after receiving Shinrix vaccine, the patient began experiencing flu-like symptoms and she slept and was not feeling well. She stated her flu-like symptoms also included tiredness, headaches, muscle pain, upset stomach, vomiting. The patient also mentioned a muscle problem  on her leg.  The patient also experienced dizziness and vertigo began a couple of days after the flu-like symptoms.   The patient has pre-existing vertigo but had not experienced any issues in eight months, she had 4 attacks of vertigo since Shingrix. The patient mentioned vomiting again. The reporter did not consented to follow-up. The patient declined to proceed with Safety report.   The patient implied flu like symptoms were resolved at the time of reporting, but unable to fully clarify during call. Therefore leaving outcome blank on those events.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Muscle disorder, Myalgia, Pain in extremity
Clinical narrative: not feel well; flu-like symptoms; tiredness; headaches; muscle pain; upset stomach; vomiting; Muscle problem on leg; sore arm; dizziness; vertigo; Vertigo condition aggrevated; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received on an unknown date). Concurrent medical conditions included vertigo.   On 25th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced dizziness, vertigo and condition aggravated. On 25th May 2019, the patient experienced pain in arm. On 26th May 2019, the patient experienced feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, vomiting and muscle disorder. On 26th May 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, condition aggravated and muscle disorder were unknown and the outcome of the vomiting, dizziness and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, vomiting, dizziness, vertigo, condition aggravated and muscle disorder to be related to Shingrix.  Additional details were provided as follows: On 25th May 2019, less than a day after receiving Shingrix, the Patient experienced sore arm which resolved the next day from the first dose. On 26h May 2019, 1 day after receiving Shinrix vaccine, the patient began experiencing flu-like symptoms and she slept and was not feeling well. She stated her flu-like symptoms also included tiredness, headaches, muscle pain, upset stomach, vomiting. The patient also mentioned a muscle problem  on her leg.  The patient also experienced dizziness and vertigo began a couple of days after the flu-like symptoms.   The patient has pre-existing vertigo but had not experienced any issues in eight months, she had 4 attacks of vertigo since Shingrix. The patient mentioned vomiting again. The reporter did not consented to follow-up. The patient declined to proceed with Safety report.   The patient implied flu like symptoms were resolved at the time of reporting, but unable to fully clarify during call. Therefore leaving outcome blank on those events.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo, Vomiting
Clinical narrative: not feel well; flu-like symptoms; tiredness; headaches; muscle pain; upset stomach; vomiting; Muscle problem on leg; sore arm; dizziness; vertigo; Vertigo condition aggrevated; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received on an unknown date). Concurrent medical conditions included vertigo.   On 25th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced dizziness, vertigo and condition aggravated. On 25th May 2019, the patient experienced pain in arm. On 26th May 2019, the patient experienced feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, vomiting and muscle disorder. On 26th May 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, condition aggravated and muscle disorder were unknown and the outcome of the vomiting, dizziness and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, influenza-like symptoms, tiredness, headache, muscle pain, upset stomach, vomiting, dizziness, vertigo, condition aggravated and muscle disorder to be related to Shingrix.  Additional details were provided as follows: On 25th May 2019, less than a day after receiving Shingrix, the Patient experienced sore arm which resolved the next day from the first dose. On 26h May 2019, 1 day after receiving Shinrix vaccine, the patient began experiencing flu-like symptoms and she slept and was not feeling well. She stated her flu-like symptoms also included tiredness, headaches, muscle pain, upset stomach, vomiting. The patient also mentioned a muscle problem  on her leg.  The patient also experienced dizziness and vertigo began a couple of days after the flu-like symptoms.   The patient has pre-existing vertigo but had not experienced any issues in eight months, she had 4 attacks of vertigo since Shingrix. The patient mentioned vomiting again. The reporter did not consented to follow-up. The patient declined to proceed with Safety report.   The patient implied flu like symptoms were resolved at the time of reporting, but unable to fully clarify during call. Therefore leaving outcome blank on those events.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: weakness; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced weakness. On an unknown date, the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the weakness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's sister. It was reported that the patient received her first dose of Shingrix about one month before the date of reporting and the morning following her vaccine, she was weak for 4 to 5 days. The reporter did not have all the information for her sister's adverse event. The case has been linked with the case US2019100967, reported by same reporter.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: tingling rash; itching; Tingling rash; This case was reported by a nurse via call center representative and described the occurrence of tingling in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 28th May 2019, less than a day after receiving Shingrix, the patient experienced tingling, pruritus and rash. On an unknown date, the outcome of the tingling, pruritus and rash were unknown.   It was unknown if the reporter considered the tingling, pruritus and rash to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on the right arm. The patient experienced itching, tingling rash on her back in the bra area underneath her shoulder blades. The rash was noticed the evening of 2nd June 2019 and it had gotten worse. The tingling was described as occurring intermittently, and the itching described as occurring once in a while. The reporters main question for calling was to ask what was the likelihood of Shingrix causing shingles.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Nausea, Pyrexia
Clinical narrative: Reaction after second dose (but not to the first): Headache, fever, nausea, and chills (started the day after the vaccine and lasted 24 hours)  Rash at the injection site 6 days after the injection
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Confusional state, Feeling abnormal, Headache
Clinical narrative: Fever, chills, body aches and pains, arm pain around injection site, nausea, mental confusion, headache, lethargy,... Basically at first, I thought I might have to go to the hospital because the reaction was so severe and weird, unlike any vaccine reaction or flu I've ever felt. It felt like I had been hit by a truck and punched in the stomach. The symptoms slowly went away over the next two and a half days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches and pains, arm pain around injection site, nausea, mental confusion, headache, lethargy,... Basically at first, I thought I might have to go to the hospital because the reaction was so severe and weird, unlike any vaccine reaction or flu I've ever felt. It felt like I had been hit by a truck and punched in the stomach. The symptoms slowly went away over the next two and a half days.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine on 6/10/19, mother states no issues arose during administration. Mother noticed redness, swelling, and heat at injection site on 6/11/19 around 5pm. Pt did not have any fevers, trouble breathing, or tenderness to area. Mother has not administered any medications. Mother brought patient back to clinic for Same-Day appointment with Dr. Swelling has decreased today (6/12/19) however the redness and warm to touch has continued. Dr. has determined patient had a local reaction to vaccine but it will not prevent her from receiving vaccines in the future.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash and redness localized to injection site. Patient was seen on 6/10/19 @ 5:37 PM by CNP, mother refused treatment stating "will give her son benadryl and take son to primary care doctor if worse." Attempts have been made to contact mother for follow up on patient, awaiting call back.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Sore Arm immediately and throughout the day/night following Muscle Pain in larger muscles, 24 hours after injection Headache feels like I am very dehydrated, ibuprofen Extreme Chills the first night, lasted 2 hours, took 4 ibuprofen for pain Nausea lack of appetite started 24 hours later Profuse Sweating after extreme chills  Itching all over started 24 hours later - claritan
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Pruritus generalised
Clinical narrative: Sore Arm immediately and throughout the day/night following Muscle Pain in larger muscles, 24 hours after injection Headache feels like I am very dehydrated, ibuprofen Extreme Chills the first night, lasted 2 hours, took 4 ibuprofen for pain Nausea lack of appetite started 24 hours later Profuse Sweating after extreme chills  Itching all over started 24 hours later - claritan
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on back and abdomen.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Dysstasia, Gait disturbance, Pain in extremity, Sensory disturbance
Clinical narrative: Initial arm soreness, followed by a sensation that his legs were "not there". Patient suffered leg pain and had difficulty standing and walking. Patient had no other symptoms. Patient called MD, but did not see MD. Issues all resolved over a 5 to 7 day period.