chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Dandruff, Dry skin, Fatigue, Immediate post-injection reaction
Clinical narrative: increased hair loss; swelling at the injection site; Fatigue; Flu-like symptoms; felt that she had a fever but did not take her temperature; patches of dry skin around her face /nose/ mouth; patches of dry skin around her hairline / skin flakes; skin flakes; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, immediately after receiving Shingrix, the patient experienced injection site swelling, fatigue, influenza-like symptoms, fever, dry skin face, dandruff and skin peeling. On an unknown date, the patient experienced accelerated hair loss. The patient was treated with medication unknown. On an unknown date, the outcome of the injection site swelling, fatigue, influenza-like symptoms, fever, dandruff and skin peeling were recovered/resolved and the outcome of the dry skin face was unknown and the outcome of the accelerated hair loss was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, fatigue, influenza-like symptoms, fever, dandruff, skin peeling and accelerated hair loss to be related to Shingrix. The reporter considered the dry skin face to be related to Shingrix.  Additional details were Provided as follows: The patient received dose of Shingrix in the left arm. Soon after receiving the vaccination, the patient had swelling at the injection site, the swelling was visible through shirts. The patient stated that,did not know how long it took for it to resolve, but did not think it lasted very long. Within approximately two days after receiving the vaccination, the patient had fatigue, and flu-like symptoms. The patient experienced fever but did not take temperature at tha time. These symptoms took a couple of weeks to resolve. Within two weeks to a month, the patient noticed patches of dry skin around her nose which spread to patches of dry skin on her face, and the corners of her mouth and into the front of her hairline (looked like dandruff). The dry skin produced a lot of skin flakes. The patient began to notice increased hair loss approximately one month after vaccination. The patient did not go to the dermatologist until a couple of months after receiving the vaccine. The dermatologist told the patient that he felt the patches of dry skin were due to the vaccine and gave her medication to put on it. The dry patches resolved with medication and took approximately four months from the time the dry skin started for it to resolve with medication.  The reporter did not consent to follow up. This case has been linked with case US2020AMR003766 and US2020003252 reported by same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Pyrexia, Skin exfoliation
Clinical narrative: increased hair loss; swelling at the injection site; Fatigue; Flu-like symptoms; felt that she had a fever but did not take her temperature; patches of dry skin around her face /nose/ mouth; patches of dry skin around her hairline / skin flakes; skin flakes; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, immediately after receiving Shingrix, the patient experienced injection site swelling, fatigue, influenza-like symptoms, fever, dry skin face, dandruff and skin peeling. On an unknown date, the patient experienced accelerated hair loss. The patient was treated with medication unknown. On an unknown date, the outcome of the injection site swelling, fatigue, influenza-like symptoms, fever, dandruff and skin peeling were recovered/resolved and the outcome of the dry skin face was unknown and the outcome of the accelerated hair loss was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, fatigue, influenza-like symptoms, fever, dandruff, skin peeling and accelerated hair loss to be related to Shingrix. The reporter considered the dry skin face to be related to Shingrix.  Additional details were Provided as follows: The patient received dose of Shingrix in the left arm. Soon after receiving the vaccination, the patient had swelling at the injection site, the swelling was visible through shirts. The patient stated that,did not know how long it took for it to resolve, but did not think it lasted very long. Within approximately two days after receiving the vaccination, the patient had fatigue, and flu-like symptoms. The patient experienced fever but did not take temperature at tha time. These symptoms took a couple of weeks to resolve. Within two weeks to a month, the patient noticed patches of dry skin around her nose which spread to patches of dry skin on her face, and the corners of her mouth and into the front of her hairline (looked like dandruff). The dry skin produced a lot of skin flakes. The patient began to notice increased hair loss approximately one month after vaccination. The patient did not go to the dermatologist until a couple of months after receiving the vaccine. The dermatologist told the patient that he felt the patches of dry skin were due to the vaccine and gave her medication to put on it. The dry patches resolved with medication and took approximately four months from the time the dry skin started for it to resolve with medication.  The reporter did not consent to follow up. This case has been linked with case US2020AMR003766 and US2020003252 reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Induration, Injection site mass, Mass
Clinical narrative: a hard lump formed off the side of the site of the Injection in the left arm; ago a hard lump formed; redness right after the injection; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 20th November 2020) for prophylaxis.   On 24th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 24th December 2019, immediately after receiving Shingrix, the patient experienced erythema. On an unknown date, the patient experienced mass and induration. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the mass and induration were unknown.   It was unknown if the reporter considered the erythema, mass and induration to be related to Shingrix.  Additional details were provided as follows: The patient had a reaction to Shingrix complained redness right after the injection which resolved. However, 4 to 5 days ago a hard lump formed in the arm bigger than a marble but smaller that a pingpong ball. The lump was movable, no current redness and warmth, and it was off to the side of the site of the injection in the left arm. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (patient received 1st dose of Shingrix, refer case US2020AMR003744.).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, between 3 and 5 months 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 unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had pain in arm. This case linked US2020003254, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: red, warm, swollen arm down to the elbow; swollen arm down to the elbow; warm, swollen arm down to the elbow; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 88-year-old male 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 erythema, swelling arm and feeling of warmth. On an unknown date, the outcome of the erythema, swelling arm and feeling of warmth were recovered/resolved.   It was unknown if the reporter considered the erythema, swelling arm and feeling of warmth to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix experienced a red, warm, swollen arm down to the elbow over several weeks. The reporter consented to follow up. The pharmacist did not have all the information for the report at the time of the call.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: flu like symptoms; body aches; tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in August 2019, refer case US2020AMR003738.).   On 4th January 2020, the patient received the 2nd dose of Shingrix. On 4th January 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and tiredness. On 5th January 2020, the outcome of the influenza-like symptoms, general body pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had influenza-like symptoms, general body pain and tiredness. The reporter did not consent to follow up. This case linked US2020AMR003672 and US2020003251, reported by same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Shivering/ Chills; neck stiffness; weakness; headache; malaise; soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th January 2020, less than a day after receiving Shingrix, the patient experienced shivering, stiff neck, weakness, headache, malaise and pain in arm. On an unknown date, the outcome of the shivering, stiff neck, weakness, headache, malaise and pain in arm were recovering/resolving.   It was unknown if the reporter considered the shivering, stiff neck, weakness, headache, malaise and pain in arm to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's partner. The reporter stated that the patient after vaccination developed shivering, neck stiffness, chills, weakness, headache, malaise and soreness in the left arm. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shivering/ Chills; neck stiffness; weakness; headache; malaise; soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th January 2020, less than a day after receiving Shingrix, the patient experienced shivering, stiff neck, weakness, headache, malaise and pain in arm. On an unknown date, the outcome of the shivering, stiff neck, weakness, headache, malaise and pain in arm were recovering/resolving.   It was unknown if the reporter considered the shivering, stiff neck, weakness, headache, malaise and pain in arm to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's partner. The reporter stated that the patient after vaccination developed shivering, neck stiffness, chills, weakness, headache, malaise and soreness in the left arm. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain at the injection site; Hot to touch at the injection site; itching at the injection site; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RR52, expiry date unknown) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site itching and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site itching and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site itching and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose received on left arm. The patient had pain, hot to touch on the arm, itching at the injection site and swelling for about 1 week after the vaccination. No expiration date of the vaccine was provided. The reporter consented to follow up. The outcome of injection site pain, injection site warmth, injection site itching and swelling were reported as recovered/resolved in the database however in source document, it was mentioned as recovered/resolved with sequel.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: hives; warmth; itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd January 2020, less than a day after receiving Shingrix, the patient experienced hives, feeling of warmth and pruritus. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the hives, feeling of warmth and pruritus were recovering/resolving.   It was unknown if the reporter considered the hives, feeling of warmth and pruritus to be related to Shingrix.  Additional details were received as follows: The patient developed hives on her arm around the injection site.  The hives were in an area about 5 by 5 inches, it was warm to the touch and very itchy.  The patient has spoken to her healthcare professional office about the hives but has not been in to visit. The patient put cold compresses on it to help the symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was recovering/resolving.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were received as follows: The case was reported via chat. The age at vaccination was not reported, but it could be 64 or 65 years. The patient after vaccination experienced muscle pain. The event was ongoing.
Sex: U
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Seizures; This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 5 months after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received the first dose of Shingrix and experienced a seizure. The reporter did not consent to follow-up. The reporter refused to provide patient and product details.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2-3 inch raised, warm red area at injection site. Has not yet resolved
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: immediately after Dtap injection - had large raised hive on Rt leg around injection site - No wheezing or difficulty breathing. Dr came in to evaluate - patient was given Dexamethasone 0.9ml by mouth. Benadryl 1 tsp given by mouth - also to take pepsid for 3 days - Kept in office for 30 minutes - no other issues.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: 12 Hours after receiving the vaccine, I developed a fever, headache, and general malaise.  It continues all night and into the morning.  The fever is being controlled by aspirin (650 mg every 6 hours)
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Disorientation, Dizziness, Exposure during pregnancy, Tachycardia
Clinical narrative: 7th pregnancy, 5 miscarriages, 1 live birth 10/2017. Current baby due 4/7/2020. Received TDaP at 28 week OB appointment. Pt has no history of gestational diabetes or pre-eclampsia, but does have moderate hyperemesis gravidarum with metabolic disturbances that is currently well-managed with zofran pump and phenergan.   Approximately 1 hour after injection, pt began suffering from moderate vertigo symptoms including dizziness and minor disorientation. Pt took 4 hour nap after returning home (3pm-7pm) on 1/15/20.  When pt awoke on 1/16/2020, she had increased vertigo symptoms with visual disturbances. Pt was advised to go to Urgent Care by a provider at OBGYN.   While at Urgent Care, provider noticed lower than average blood pressure (95/60) and mild tachycardia and ordered a urinalysis and blood glucose check. Blood glucose was 106 approximately 2 hours after pt had consumed a peanut butter sandwich. Based on UA results and in consultation with Dr., pt. was advised to go to Labor & Delivery Triage at hospital for IV fluids  Upon arrival at L&D Triage, pt was offered a glass of water which she was unable to hold down. Pt. was given antivert x2 orally after 90 minutes, and was then started on 2L of normal saline. Pt. reported decrease in vertigo symptoms within 60 minutes of antivert being administered.   Pt was discharged with a prescription for antivert. Pt took an additional dose of antivert at 8:00 PM on 1/16/19.   Pt awoke to no vertigo symptoms on 1/17/2020
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis, Vertigo, Visual impairment
Clinical narrative: 7th pregnancy, 5 miscarriages, 1 live birth 10/2017. Current baby due 4/7/2020. Received TDaP at 28 week OB appointment. Pt has no history of gestational diabetes or pre-eclampsia, but does have moderate hyperemesis gravidarum with metabolic disturbances that is currently well-managed with zofran pump and phenergan.   Approximately 1 hour after injection, pt began suffering from moderate vertigo symptoms including dizziness and minor disorientation. Pt took 4 hour nap after returning home (3pm-7pm) on 1/15/20.  When pt awoke on 1/16/2020, she had increased vertigo symptoms with visual disturbances. Pt was advised to go to Urgent Care by a provider at OBGYN.   While at Urgent Care, provider noticed lower than average blood pressure (95/60) and mild tachycardia and ordered a urinalysis and blood glucose check. Blood glucose was 106 approximately 2 hours after pt had consumed a peanut butter sandwich. Based on UA results and in consultation with Dr., pt. was advised to go to Labor & Delivery Triage at hospital for IV fluids  Upon arrival at L&D Triage, pt was offered a glass of water which she was unable to hold down. Pt. was given antivert x2 orally after 90 minutes, and was then started on 2L of normal saline. Pt. reported decrease in vertigo symptoms within 60 minutes of antivert being administered.   Pt was discharged with a prescription for antivert. Pt took an additional dose of antivert at 8:00 PM on 1/16/19.   Pt awoke to no vertigo symptoms on 1/17/2020
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis, Injection site pain, Joint swelling, Muscle tightness, Musculoskeletal pain
Clinical narrative: Extreme pain at the injection site  and upper arm the next day that lasted about a week. The pain disappeared for a couple weeks and then came back worse then the original pain.  Eventually the pain spread to my neck and left shoulder blade from tensing my muscles in reaction to the pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: Extreme pain at the injection site  and upper arm the next day that lasted about a week. The pain disappeared for a couple weeks and then came back worse then the original pain.  Eventually the pain spread to my neck and left shoulder blade from tensing my muscles in reaction to the pain.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bacterial test negative, Blood pressure decreased, Blood test normal, Cardiac function test normal, Computerised tomogram head normal
Clinical narrative: Monday morning, Dec. 30, 2019, I a headache,  felt nauseous, my fever spiked, and my blood pressure dropped dangerously low. I fainted. I was transported by ambulance with a temp of 105, BP: 70/30. I spent the day in hospital ER and was admitted to hospital that night with continued hypotension. I was released from hospital after 6PM on 12/31/19 when BP was acceptably low.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypotension, Nausea, Pyrexia, Syncope
Clinical narrative: Monday morning, Dec. 30, 2019, I a headache,  felt nauseous, my fever spiked, and my blood pressure dropped dangerously low. I fainted. I was transported by ambulance with a temp of 105, BP: 70/30. I spent the day in hospital ER and was admitted to hospital that night with continued hypotension. I was released from hospital after 6PM on 12/31/19 when BP was acceptably low.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urine analysis normal, Viral test negative
Clinical narrative: Monday morning, Dec. 30, 2019, I a headache,  felt nauseous, my fever spiked, and my blood pressure dropped dangerously low. I fainted. I was transported by ambulance with a temp of 105, BP: 70/30. I spent the day in hospital ER and was admitted to hospital that night with continued hypotension. I was released from hospital after 6PM on 12/31/19 when BP was acceptably low.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Blood pressure diastolic decreased, Chills, Headache, Laboratory test normal
Clinical narrative: Monday morning, Dec. 30, 2019, I a headache,  felt nauseous, my fever spiked, and my blood pressure dropped dangerously low. I fainted. I was transported by ambulance with a temp of 105, BP: 70/30. I spent the day in hospital ER and was admitted to hospital that night with continued hypotension. I was released from hospital after 6PM on 12/31/19 when BP was acceptably low.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pyrexia, Syncope
Clinical narrative: Monday morning, Dec. 30, 2019, I a headache,  felt nauseous, my fever spiked, and my blood pressure dropped dangerously low. I fainted. I was transported by ambulance with a temp of 105, BP: 70/30. I spent the day in hospital ER and was admitted to hospital that night with continued hypotension. I was released from hospital after 6PM on 12/31/19 when BP was acceptably low.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: patient with a contraindication receiving a live virus vaccine (vaccine error). No actual AE has occurred at this time (<24 hours after error)
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema
Clinical narrative: PATIENT DEVELOPED A LARGE RED CIRCLE AROUND INJECTION SITE. THIS WAS STILL PRESENT ON 1/16/20
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm,headache, fever, nauseous   bed rest, ibuprofen 36 hour recovery from onset of symptoms
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Gaze palsy, Generalised tonic-clonic seizure, Injection site pain, Syncope
Clinical narrative: Called by patient's sibling that child was fainting, Went into room and child having a generalized tonic clonic seizure with eyes rolled upwards halfway sitting up from bed. Staff called EMS. Turned him on side and stopped seizing. Lasted about total of 30 seconds. Normal pulses. Equal chest rise. Started saying his L upper arm really hurt at site of vaccination. BP 144/88. HR initially 55-77 throughout episode. O2 sats 99-100%. Conversing appropriately, fully alert and oriented. Mom stated this has happened before, last year after application of vaccines. Child hadn't eaten anything today or had anything to drink. Gave him Candy to eat. Kept him resting, EMS arrived and took patient to hospital.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Blood test, Gait inability, Joint stiffness, Musculoskeletal discomfort
Clinical narrative: * ITEM 17: I DO NOT KNOW WHAT TYPE OF FLU SHOT I REVIEVED, I am required by my employer (a hospital) to get the flu shot  Severe and debilitating arthritis starting in fingers and hands and eventually in ankles and toes.  I have seen my doctor 2x about this issue.  MD has ruled out gout and believe it is related to flu shot. See following for timeline of these flares. I have never experienced any type of arthritis or gout prior to this flu shot.  October 3rd- Flu Shot  October 5th- extreme joint stiffness in fingers and wrists  lasting through 10/6 October 24th flare starting with right middle finger and eventually wrists November 2nd - extreme flare starting in R  wrist  moving to fingers and eventually ankles, making it impossible to walk  this worsened through November 4th and slow dissipated through November 6th  November 24th -slight flare in wrists -bilateral  December 6th- bilateral wrists and ankles-  December 21st- wrists, ankles dissipating Dec. 22nd  December 24th- bilateral writs only Jan. 1st - bi lateral wrists and R. ankle Jan. 8th - bi-lateral writs and ankles  Jan.12th- slight flare- with continued joint discomfort to present
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: * ITEM 17: I DO NOT KNOW WHAT TYPE OF FLU SHOT I REVIEVED, I am required by my employer (a hospital) to get the flu shot  Severe and debilitating arthritis starting in fingers and hands and eventually in ankles and toes.  I have seen my doctor 2x about this issue.  MD has ruled out gout and believe it is related to flu shot. See following for timeline of these flares. I have never experienced any type of arthritis or gout prior to this flu shot.  October 3rd- Flu Shot  October 5th- extreme joint stiffness in fingers and wrists  lasting through 10/6 October 24th flare starting with right middle finger and eventually wrists November 2nd - extreme flare starting in R  wrist  moving to fingers and eventually ankles, making it impossible to walk  this worsened through November 4th and slow dissipated through November 6th  November 24th -slight flare in wrists -bilateral  December 6th- bilateral wrists and ankles-  December 21st- wrists, ankles dissipating Dec. 22nd  December 24th- bilateral writs only Jan. 1st - bi lateral wrists and R. ankle Jan. 8th - bi-lateral writs and ankles  Jan.12th- slight flare- with continued joint discomfort to present
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: flu like symptoms; Achy; Tired; Nauseous; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-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 in August 2019, refer case US2020003251).   On 3rd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain, tiredness and nausea. On 6th January 2020, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the pain, tiredness and nausea were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, pain, tiredness and nausea to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The reporter stated that after vaccination the patient on 4th January 2020, experienced flu like symptoms, achy, tired and nauseous. This case has been linked with cases US2020003251, US2020003258 and US2020AMR003738, reported for same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: shivering like crazy; fever; 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 7th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovering/resolving.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that had the second shot and had a fever and shivering chills like crazy throughout the night. The patient stated that was feeling better on the day of reporting. The patient had a question for the boyfriend who was 55 years old and need his 2nd shot and has to pay out of pocket and was there and discount he can get. The patient work in a medical field and with animals and know the important to let people know when there is reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: SHINGLES- CIRCLE BY EYE; This case was reported by a nurse via sales rep and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's disease (chronic condition).   On 27th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was seen by the provider on 30th December 2019. The patient had shingles- circle by eye the size of a quarter. The patient wanted to know if she should receive second dose of Shingrix.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Injection site pain, Neuralgia, Pyrexia
Clinical narrative: nerve pain in both legs; chills; burning sensation; fever/ elevated temperature; achy at the injection site and soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 2nd January 2020, 4 days after receiving Shingrix, the patient experienced fever. On 6th January 2020, the patient experienced burning sensation. On an unknown date, the patient experienced injection site pain, nerve pain and chills. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the nerve pain, fever, chills and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, nerve pain, fever, chills and burning sensation to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 57 or 58 years. The reporter stated that the patient experienced achiness and soreness at the injection site for 2-3 days following the vaccination. On the 4th day the patient had nerve pain presented in both legs and that night mild elevated temperature and chills presented. The patient also had burning sensation in lower back presented. The patient stated that it felt like the skin was burned but there was nothing visibly in the area.      Lab Comments: on an unknown date body temperature was recorded
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Impaired work ability, Insomnia, Myalgia, Neuralgia
Clinical narrative: nerve pain in both legs; chills; burning sensation; fever/ elevated temperature; achy at the injection site and soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 2nd January 2020, 4 days after receiving Shingrix, the patient experienced fever. On 6th January 2020, the patient experienced burning sensation. On an unknown date, the patient experienced injection site pain, nerve pain and chills. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the nerve pain, fever, chills and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, nerve pain, fever, chills and burning sensation to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 57 or 58 years. The reporter stated that the patient experienced achiness and soreness at the injection site for 2-3 days following the vaccination. On the 4th day the patient had nerve pain presented in both legs and that night mild elevated temperature and chills presented. The patient also had burning sensation in lower back presented. The patient stated that it felt like the skin was burned but there was nothing visibly in the area.      Lab Comments: on an unknown date body temperature was recorded
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pain of skin
Clinical narrative: nerve pain in both legs; chills; burning sensation; fever/ elevated temperature; achy at the injection site and soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 2nd January 2020, 4 days after receiving Shingrix, the patient experienced fever. On 6th January 2020, the patient experienced burning sensation. On an unknown date, the patient experienced injection site pain, nerve pain and chills. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the nerve pain, fever, chills and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, nerve pain, fever, chills and burning sensation to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 57 or 58 years. The reporter stated that the patient experienced achiness and soreness at the injection site for 2-3 days following the vaccination. On the 4th day the patient had nerve pain presented in both legs and that night mild elevated temperature and chills presented. The patient also had burning sensation in lower back presented. The patient stated that it felt like the skin was burned but there was nothing visibly in the area.      Lab Comments: on an unknown date body temperature was recorded
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Soreness in arm at the injection site; Chills; Fever; Sweating; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 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, unknown after receiving Shingrix, the patient experienced injection site pain, chills, fever and sweating. On an unknown date, the outcome of the injection site pain, chills, fever and sweating were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and sweating to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. It was reported that the patient had soreness in her arm at the injection site for both the first and second vaccine. The patient had chills, fever, and sweating. The reporter did not consent to follow up. For tolerance after 2nd dose refer case US2020AMR004687.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: "worsening of fever blisters on mouth"; condition aggravated; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number Y5J27, expiry date 8th November 2021) for prophylaxis.   Concurrent medical conditions included fever blister.   On 8th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced fever blister and condition aggravated. On an unknown date, the outcome of the fever blister was recovering/resolving and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the fever blister and condition aggravated to be related to Shingrix.  Additional details were reported as follows: The patient had a history of oral fever blisters previously, and these blisters was worse in the last month since receiving the vaccine. Reporter consent to follow-up.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Gait inability, Hyperaesthesia
Clinical narrative: hip pain; Unable to walk; pain in the hip if the bone is touched it hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 75-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 29th November 2019, the patient received Boostrix. On 29th November 2019, less than a day after receiving Boostrix, the patient experienced pain in hip, unable to walk and touch sensitivity increased. On an unknown date, the outcome of the pain in hip was recovering/resolving and the outcome of the unable to walk and touch sensitivity increased were unknown.   It was unknown if the reporter considered the pain in hip, unable to walk and touch sensitivity increased to be related to Boostrix.  Additional details were received as follows: The patient after vaccination experienced hip pain and was unable to walk. The patient stated that now at the time of reporting experiencing pain in the hip if the bone is touched it hurts. The patient was calling GSK to see if hip pain was a possible side effect of Boostrix. The patient was not sure if Boostrix caused the hip pain or not but she was going to ask her physician if her physician thought it could be related. The patient did not have the lot number of the Boostrix but did provide the pharmacy contact information. The patient got the injection in the arm but did not recall for sure if it was her left arm or right arm. The patient was not sure if the injection was given intramuscularly or subcutaneously. The patient did not want to give her MD contact information because she has recently switched doctors. The patient did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Erythema, Erythema of eyelid, Headache, Herpes ophthalmic
Clinical narrative: lower left eyelid erythema; sty on left eyelid; herpetic eye infection; acute herpetic eruption; swelling and redness on the nose; redness on nose; pimple; Headache; This case was reported by a physician via call center representative and described the occurrence of herpes ophthalmic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number AH992, expiry date 18th March 2022) and (batch number 9H524, expiry date 22nd October 2021) for prophylaxis.   The patient's past medical history included hypothyroidism, gastroesophageal reflux disease and gastritis. Concurrent medical conditions included lipids abnormal. Concomitant products included thyroxine sodium (Levothyroxine) and denosumab (Prolia).   On 31st December 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the dose was an unknown dose (.5 ml daily). On 31st December 2019, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir and Erythromycine, the patient experienced headache. On 4th January 2020, the patient experienced herpes virus infection, swelling, erythema and pimples. On 6th January 2020, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and stye. On 9th January 2020, the patient experienced erythema eyelid. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and erythromycin (Erythromycine). On an unknown date, the outcome of the herpes ophthalmic, herpes virus infection, swelling, erythema, pimples, stye and erythema eyelid were recovering/resolving and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the herpes ophthalmic, herpes virus infection, headache, swelling, erythema, pimples, stye and erythema eyelid to be related to Shingrix.  Additional details were provided as follows: The patient developed an acute herpetic eruption after receipt of her first dose of Shingrix.   The patient had a minimal headache for 24 hours after receving Shingrix. On 4th January 2020 had some redness and swelling on her nose with a pimple.  On 6th January 2020 she got a sty on her lower left eyelid and her eye felt funny.  She went to the eye doctor on 9th January 2020 and was diagnosed with a herpetic eye infection.  She was started on valacyclovir and erythromycin ointment with some improvement noted. The reporter consented to follow up.  The physician said the patient was a small part of the phase 3 trials for Shingrix and he had 7 more doses of Shingrix from the box this patient received her dose from if GSK want to test them.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Hordeolum, Swelling
Clinical narrative: lower left eyelid erythema; sty on left eyelid; herpetic eye infection; acute herpetic eruption; swelling and redness on the nose; redness on nose; pimple; Headache; This case was reported by a physician via call center representative and described the occurrence of herpes ophthalmic in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number AH992, expiry date 18th March 2022) and (batch number 9H524, expiry date 22nd October 2021) for prophylaxis.   The patient's past medical history included hypothyroidism, gastroesophageal reflux disease and gastritis. Concurrent medical conditions included lipids abnormal. Concomitant products included thyroxine sodium (Levothyroxine) and denosumab (Prolia).   On 31st December 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the dose was an unknown dose (.5 ml daily). On 31st December 2019, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir and Erythromycine, the patient experienced headache. On 4th January 2020, the patient experienced herpes virus infection, swelling, erythema and pimples. On 6th January 2020, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and stye. On 9th January 2020, the patient experienced erythema eyelid. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and erythromycin (Erythromycine). On an unknown date, the outcome of the herpes ophthalmic, herpes virus infection, swelling, erythema, pimples, stye and erythema eyelid were recovering/resolving and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the herpes ophthalmic, herpes virus infection, headache, swelling, erythema, pimples, stye and erythema eyelid to be related to Shingrix.  Additional details were provided as follows: The patient developed an acute herpetic eruption after receipt of her first dose of Shingrix.   The patient had a minimal headache for 24 hours after receving Shingrix. On 4th January 2020 had some redness and swelling on her nose with a pimple.  On 6th January 2020 she got a sty on her lower left eyelid and her eye felt funny.  She went to the eye doctor on 9th January 2020 and was diagnosed with a herpetic eye infection.  She was started on valacyclovir and erythromycin ointment with some improvement noted. The reporter consented to follow up.  The physician said the patient was a small part of the phase 3 trials for Shingrix and he had 7 more doses of Shingrix from the box this patient received her dose from if GSK want to test them.
Age: 46.0
Sex: M
Vaccine: FLU4, HEP, TD
Symptoms: Fatigue, Headache, Malaise, Rash pruritic
Clinical narrative: Shortly after receiving vaccines, patient describes feeling headache and generally unwell (malaise and fatigue). A couple days later erupted in an itchy rash all over. Physician could not find any other exposures  and thought symptoms may have been related to IgE-mediated true allergic reaction (headache, fatigue, malaise in a quick onset) but atypical because rash was delayed and not urticaria.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt experiencing redness, swelling, itching, heat and pain at injection site.  Itching started Wednesday evening  (1/15) followed by rest of symptoms on Thursday (1/16)
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: My right arm hurt really bad for a month, then it got somewhat better, but it has hurt for almost a year.
Age: 59.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site nodule, Joint range of motion decreased, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: L arm pain starting at time of injection and increasing since December.  Decreased ROM.  Reported weakness and intermittent 5th L digit paresthesias.  Feeling of a nodule remaining at injection site.