chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Tendonitis
Clinical narrative: biceps tendonitis at injection site; This case was reported by a consumer via call center representative and described the occurrence of tendonitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. In October 2019, unknown after receiving Shingrix, the patient experienced tendonitis. On an unknown date, the outcome of the tendonitis was not recovered/not resolved.   It was unknown if the reporter considered the tendonitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix had been experiencing bicep tendonitis since October. The reporter asked could this condition had been a result of this procedure. The condition was near the area where the injection was placed.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: like the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date the patient received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced aches like the flu.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Local injection site pain; Myalgia; headache; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On 13th January 2020, 12 hrs after receiving Shingrix, the patient experienced injection site pain, myalgia, headache and influenza-like symptoms. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, myalgia, headache and influenza-like symptoms were unknown.   It was unknown if the reporter considered the injection site pain, myalgia, headache and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about 12 hours later she started to experience local injection site pain, myalgia, headache and flu like symptoms. Reporter consented to follow up. Vaccination dates were reported as 13th and 14th January 2020, it was considered as 13th January 2020 as per source document.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site haemorrhage
Clinical narrative: Shingles; bleeding at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles and injection site hemorrhage. On an unknown date, the outcome of the shingles and injection site hemorrhage were unknown.   It was unknown if the reporter considered the shingles and injection site hemorrhage to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced Shingles after receiving the first dose of Shingrix. The patient also experienced bleeding at the injection site after vaccination. The reporter consented to follow up. No lot number or expiration date of the vaccine was provided.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Regurgitation
Clinical narrative: spit out rotarix during administration; Accidental underdose; This case was reported by a other health professional via call center representative and described the occurrence of regurgitation of medication in a infant patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix (oral). On an unknown date, immediately after receiving Rotarix, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient spit out rotarix during administration, which led to regurgitation of medication and accidental underdose. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain in the arm; Fever; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced pain in the arm and fever. Field representative was unable to provide additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling of body temperature change, Myalgia
Clinical narrative: Tiredness; alternating hot and cold; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, tiredness and feeling hot and cold. On an unknown date, the outcome of the muscle pain, tiredness and feeling hot and cold were unknown.   It was unknown if the reporter considered the muscle pain, tiredness and feeling hot and cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced muscle pain, tiredness and alternating hot and cold. The reporter was unwilling to provide additional details.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Mass, Myalgia
Clinical narrative: lump; muscle ache; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2020, the patient received the 2nd dose of Shingrix. On 11th January 2020, less than a day after receiving Shingrix, the patient experienced mass and muscle pain. On 13th January 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the mass and muscle pain were recovering/resolving.   The reporter considered the injection site erythema and muscle pain to be related to Shingrix. It was unknown if the reporter considered the mass to be related to Shingrix.  Additional details were provided as follows: The patient stated the site of injection developed a redness 3 days before the time of reporting.   The muscle ache and the lump had improved. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site Swelling; injection site became very red; Painful/Sore at injection site; injection site Itchy; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On 13th January 2020, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm and. The patient experienced the injection site became very red, painful, sore, swollen and itchy.  The reporter describes the area around the injection site as approximately 3 inches in area on Monday,  but on Wednesday the area increased to approximately 6 inches. At the time of reporting,  affected area was approximately the same size.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Bedridden, Fatigue, Injection site pain, Labelled drug-drug interaction medication error
Clinical narrative: injection site soreness; fatigue; bedridden; labelled drug drug interaction; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix and the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 3 months after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain, fatigue, bedridden and labeled drug-drug interaction medication error. On an unknown date, the outcome of the injection site pain, bedridden and labeled drug-drug interaction medication error were unknown and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue and bedridden to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported but it could be 76 or 77 years old. The patient received the first dose of the Shingrix vaccine with a Influenza vaccine Quadrivalent 2019-2020 season in left arm, which led to labeled drug-drug interaction medication error. The patient experienced some injection site soreness and she states she felt extremely fatigue that she could not get out of bed. The fatigue resolved before the 24 hour mark. No additional information provided. Consent to follow up was denied.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after receiving the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix and experienced shingles. Reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles rash; discomfort; rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, the patient received the 2nd dose of Shingles vaccine. On 8th January 2020, 264 days after receiving Shingrix and 197 days after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, discomfort and rash. The patient was treated with valaciclovir hydrochloride (Valtrex (Valaciclovir Hydrochloride)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, discomfort and rash were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, discomfort and rash to be related to Shingrix and Shingles vaccine.  Additional details were provided as follows: The patient thought that he was experiencing discomfort from chigger bites that lasted several days. The patient went to a physician and was diagnosed as having shingles.  The patient was prescribed Valtrex and is on his 3rd day of treatment. The rash was subsiding. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles were not provided.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased
Clinical narrative: Elevated temp (axillary) to 101.4. No other symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: 4-5 hours after the vaccination (9-10pm), I had a bad headache. 6 hours after receiving the vaccination (11pm), I started to feel flu-like symptoms. Throughout the night, I had chills, was hot, sweating, body aches, etc. By 7 am, i felt like had the flu blown flu. I could barely walk, my body hurt so bad. I had a fever of 100.1. I had slight nausea. It lasted 24 hours. The next day, I felt 85% better. The following day, the symptoms were gone.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: 4-5 hours after the vaccination (9-10pm), I had a bad headache. 6 hours after receiving the vaccination (11pm), I started to feel flu-like symptoms. Throughout the night, I had chills, was hot, sweating, body aches, etc. By 7 am, i felt like had the flu blown flu. I could barely walk, my body hurt so bad. I had a fever of 100.1. I had slight nausea. It lasted 24 hours. The next day, I felt 85% better. The following day, the symptoms were gone.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia, Limb discomfort, Muscular weakness
Clinical narrative: Reaction from Flu shot. Dizziness, Weakness and numbing of arms and legs. Shot received on October 16, 2019. Symptoms onset started October 23, 2019. Required physician treatment. States reaction settled in lower back then dissipates, numbness in bilateral legs, foot cold, legs felt heavy, increased heart rate, night sweats times 3 nights.  After high dose prednisone, strength back and some dizziness
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Night sweats, Peripheral coldness
Clinical narrative: Reaction from Flu shot. Dizziness, Weakness and numbing of arms and legs. Shot received on October 16, 2019. Symptoms onset started October 23, 2019. Required physician treatment. States reaction settled in lower back then dissipates, numbness in bilateral legs, foot cold, legs felt heavy, increased heart rate, night sweats times 3 nights.  After high dose prednisone, strength back and some dizziness
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: 1) Very sore arm the next day (10/05/2019)  2) Several days later, experienced some loss of motion due to extreme pain. Assumed pain would "go away" over time but didn't. Endured this for 2 months. 3) On 12/04/19, I saw my doctor and presented with "positional" pain in left shoulder. There was no known prior cause for this pain. I mentioned, as an aside, that I had received a flu shot in my left arm. My doctor did not react to this comment (I suspect she was not aware of SIRVA, as I was not). Doctor ordered an X-ray and physical therapy regimen which I am still doing. 4) I told pharmacy on 1/03/2020 about this issue but they were uncooperative. They said to fill out this report. The two pharmacists that I talked to were unaware of SIRVA. The pharmacy manager was not interested in seeing me to discuss this issue so I never met them.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Insomnia, Loss of personal independence in daily activities, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Extreme shoulder & underarm pain, swelling opposite of injection site on deltoid, disruption of daily activity and difficulty sleeping
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Extreme shoulder & underarm pain, swelling opposite of injection site on deltoid, disruption of daily activity and difficulty sleeping
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient reported a rash on her stomach
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event noted. Meant to give Pentacel and gave PediaRix. Client received 2 doses of Hep B. Notified clients mom and no concerns or reactions noted.
Age: 14.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Disorientation, Dizziness, Immediate post-injection reaction, Opisthotonus
Clinical narrative: 1:25pm Immediately after receiving vaccines, patient's limbs were in a sustained fully extended position with an arched back. He also had his head turned to the right and the right arm extended out. The episode lasted about 30 seconds. He then sat down and appeared pale. Mother reports he only ate one balleada (1 tortilla with beans) for lunch.   1:35pm  When I (Dr.) saw him, he appeared pale and clammy.  He also complained that he was having trouble seeing and was unable to answer my questions regarding where he was, his name, or how old he was.  Initial blood pressure taken with a child cuff at 1:30pm was 61/35 with a pulse of 61.  At that point, patient was given a juice which he quickly drank.  Immediately after drinking the juice, his color started returning and he was able to answer basic questions including his full name, his birthday and where he was.  When asked questions regarding his family (how many siblings he had and how old they were), he was unable to answer them.  At this point, he also still feeling dizzy.  We continued to observe him and rechecked his blood pressure at 1:37.  At that time it was 94/57 and patient was beginning to feel back to normal.  Patient continued to be observed in clinic and blood pressure was retaken again at 1:51pm at which time it was 115/58 with a pulse of 72.  At that time, patient denied feeling dizzy or nauseous and mom felt that color was back to normal.  However, patient continued to complain that he felt very sleepy.  I examined patient's heart and it was RRR without any murmurs.  Patient was able to walk across clinic with normal gait and without dizziness.     At that time, neurology was contacted and patient continued to be observed.  At 3pm, neurology still had not called back but patient was completely back to baseline and sleepiness had resolved.     Return precautions discussed with mom including any recurrence of symptoms.  Mom instructed that if symptoms recurred, she needed to take patient to ER.  Appointment also made for well child check on Monday 1/27/20.  Mom also instructed that we would call her with any further instruction after we talked to neurology.
Age: 14.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Pallor, Posture abnormal, Somnolence, Visual impairment
Clinical narrative: 1:25pm Immediately after receiving vaccines, patient's limbs were in a sustained fully extended position with an arched back. He also had his head turned to the right and the right arm extended out. The episode lasted about 30 seconds. He then sat down and appeared pale. Mother reports he only ate one balleada (1 tortilla with beans) for lunch.   1:35pm  When I (Dr.) saw him, he appeared pale and clammy.  He also complained that he was having trouble seeing and was unable to answer my questions regarding where he was, his name, or how old he was.  Initial blood pressure taken with a child cuff at 1:30pm was 61/35 with a pulse of 61.  At that point, patient was given a juice which he quickly drank.  Immediately after drinking the juice, his color started returning and he was able to answer basic questions including his full name, his birthday and where he was.  When asked questions regarding his family (how many siblings he had and how old they were), he was unable to answer them.  At this point, he also still feeling dizzy.  We continued to observe him and rechecked his blood pressure at 1:37.  At that time it was 94/57 and patient was beginning to feel back to normal.  Patient continued to be observed in clinic and blood pressure was retaken again at 1:51pm at which time it was 115/58 with a pulse of 72.  At that time, patient denied feeling dizzy or nauseous and mom felt that color was back to normal.  However, patient continued to complain that he felt very sleepy.  I examined patient's heart and it was RRR without any murmurs.  Patient was able to walk across clinic with normal gait and without dizziness.     At that time, neurology was contacted and patient continued to be observed.  At 3pm, neurology still had not called back but patient was completely back to baseline and sleepiness had resolved.     Return precautions discussed with mom including any recurrence of symptoms.  Mom instructed that if symptoms recurred, she needed to take patient to ER.  Appointment also made for well child check on Monday 1/27/20.  Mom also instructed that we would call her with any further instruction after we talked to neurology.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient experienced no symptoms.; The patient administered a first dose of GARD ASIL 9 on 27-SEP-2017 and second dose on 16-DEC-2019; This spontaneous report was received from a Pharmacy intern referring to a 23 year old patient, of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.    On 16-DEC-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) at age 21 years old and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly with lot 1621929, and expiration date 6-DEC-2021 on 16-DEC-2019. The patient experienced no symptoms.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: Paresthesia got worse after the 2nd dose; first dose ofShingrix in early Nov 2019 and the 2nd dose in early Dec 2019; This case was reported by a consumer via call center representative and described the occurrence of paresthesia aggravated in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019). Concurrent medical conditions included paresthesia.   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced paresthesia aggravated. On an unknown date, the outcome of the paresthesia aggravated was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the paresthesia aggravated to be related to Shingrix.  Additional details were provided as follows: In November 2019, the patient received 1st dose of Shingrix. The patient received 2nd dose of Shingrix in early December 2019. After vaccination, paresthesia got worse. The patient received 2nd  dose early than the recommended schedule, which led to shortening of vaccination schedule. The reporter stated that at the time of reporting, paresthesia aggravated plateaued.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Muscular weakness, Vaccine positive rechallenge
Clinical narrative: Tenderness at the injection site; Redness at the injection site; Fatigue; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (received in 2016). Previously administered products included Immunosupressive drugs (were stopped a couple of years prior to getting the Shingrix vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). In January 2019, 2 weeks after receiving Shingrix, the patient experienced muscle weakness. On 29th December 2019, the patient experienced fatigue. On an unknown date, the patient experienced injection site tenderness and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue was not recovered/not resolved and the outcome of the muscle weakness, injection site tenderness and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle weakness, injection site tenderness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix intramuscularly and experienced muscle weakness and fatigue after one week. He experienced tenderness and redness at the injection.  The reporter consented to follow up. For tolerances of 1st dose, refer case US2020009048, reported by same reporter for the same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Dysstasia, Eye haemorrhage, Feeling of body temperature change
Clinical narrative: discs have deteriorated; Difficulty in standing; Eye hemorrhage; arm pain; flu-like symptoms; feeling hot and cold; could not lift arm; whole body shut down/ could barely move/ cannot stand for long periods/ feeling paralyzed; fever; leg problems/ legs feel brittle; burning knee caps; hurts to walk; aches and pain in legs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number YE53N, expiry date 7th November 2021) for prophylaxis.   The patient's past medical history included muscle strain (just finished therapy for a hip strain and she was feeling no pain.), eye disorder and pain. Concurrent medical conditions included joint inflammation. Concomitant products included prednisone.   On 28th August 2019, the patient received Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement and leg pain. On an unknown date, the patient experienced intervertebral disc degeneration, difficulty in standing and eye hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder and fever were recovered/resolved and the outcome of the mobility decreased, limb discomfort, burning sensation in joints, pain upon movement and leg pain were not recovered/not resolved and the outcome of the intervertebral disc degeneration, difficulty in standing and eye hemorrhage were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement, leg pain, intervertebral disc degeneration and difficulty in standing to be related to Shingrix. The reporter considered the eye hemorrhage to be unrelated to Shingrix.  Additional details were provided as follows: The patient had visited her internist 3 times and has had her back scanned.  The patient's discs had deteriorated and her blood work showed that her inflammation levels were now normal. The patient had a hemorrhage in her right eye in late November, it was not related to her Shingrix vaccine. The reporter consented to follow up.      Lab Comments: On an unspecified day the patient underwent laboratory tests.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammatory marker test, Influenza like illness, Intervertebral disc degeneration, Limb discomfort, Mobility decreased
Clinical narrative: discs have deteriorated; Difficulty in standing; Eye hemorrhage; arm pain; flu-like symptoms; feeling hot and cold; could not lift arm; whole body shut down/ could barely move/ cannot stand for long periods/ feeling paralyzed; fever; leg problems/ legs feel brittle; burning knee caps; hurts to walk; aches and pain in legs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number YE53N, expiry date 7th November 2021) for prophylaxis.   The patient's past medical history included muscle strain (just finished therapy for a hip strain and she was feeling no pain.), eye disorder and pain. Concurrent medical conditions included joint inflammation. Concomitant products included prednisone.   On 28th August 2019, the patient received Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement and leg pain. On an unknown date, the patient experienced intervertebral disc degeneration, difficulty in standing and eye hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder and fever were recovered/resolved and the outcome of the mobility decreased, limb discomfort, burning sensation in joints, pain upon movement and leg pain were not recovered/not resolved and the outcome of the intervertebral disc degeneration, difficulty in standing and eye hemorrhage were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement, leg pain, intervertebral disc degeneration and difficulty in standing to be related to Shingrix. The reporter considered the eye hemorrhage to be unrelated to Shingrix.  Additional details were provided as follows: The patient had visited her internist 3 times and has had her back scanned.  The patient's discs had deteriorated and her blood work showed that her inflammation levels were now normal. The patient had a hemorrhage in her right eye in late November, it was not related to her Shingrix vaccine. The reporter consented to follow up.      Lab Comments: On an unspecified day the patient underwent laboratory tests.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Pain, Pain in extremity, Pyrexia, Scan abnormal
Clinical narrative: discs have deteriorated; Difficulty in standing; Eye hemorrhage; arm pain; flu-like symptoms; feeling hot and cold; could not lift arm; whole body shut down/ could barely move/ cannot stand for long periods/ feeling paralyzed; fever; leg problems/ legs feel brittle; burning knee caps; hurts to walk; aches and pain in legs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number YE53N, expiry date 7th November 2021) for prophylaxis.   The patient's past medical history included muscle strain (just finished therapy for a hip strain and she was feeling no pain.), eye disorder and pain. Concurrent medical conditions included joint inflammation. Concomitant products included prednisone.   On 28th August 2019, the patient received Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement and leg pain. On an unknown date, the patient experienced intervertebral disc degeneration, difficulty in standing and eye hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder and fever were recovered/resolved and the outcome of the mobility decreased, limb discomfort, burning sensation in joints, pain upon movement and leg pain were not recovered/not resolved and the outcome of the intervertebral disc degeneration, difficulty in standing and eye hemorrhage were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement, leg pain, intervertebral disc degeneration and difficulty in standing to be related to Shingrix. The reporter considered the eye hemorrhage to be unrelated to Shingrix.  Additional details were provided as follows: The patient had visited her internist 3 times and has had her back scanned.  The patient's discs had deteriorated and her blood work showed that her inflammation levels were now normal. The patient had a hemorrhage in her right eye in late November, it was not related to her Shingrix vaccine. The reporter consented to follow up.      Lab Comments: On an unspecified day the patient underwent laboratory tests.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Ageusia
Clinical narrative: lost sense of taste; This case was reported by a nurse via call center representative and described the occurrence of taste absent in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 8th October 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 4 months after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced taste absent. On an unknown date, the outcome of the taste absent was not recovered/not resolved.   It was unknown if the reporter considered the taste absent to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix in one arm and flu in the other and lost her sense of taste after receiving these shots and it has not resolved.  The reporter did not consent to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Shoulder pain; Severe soreness on left side of arm extending through shoulder, neck and head; Severe soreness on left side of arm extending through shoulder, neck and head; Severe soreness on left side of arm extending through shoulder, neck and head; Radiating pain; Arm was sore / Severe soreness on left side of arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 2nd dose of Shingrix. On 9th January 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, musculoskeletal pain, neck pain, headache and radiating pain. On an unknown date, the patient experienced shoulder pain. On an unknown date, the outcome of the pain in arm, musculoskeletal pain, neck pain, headache and radiating pain were not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the pain in arm, musculoskeletal pain, neck pain, headache, radiating pain and shoulder pain to be related to Shingrix.  Additional deatils were provided  as follows: The patient received dose of Shingrix in the left arm. After vaccination, the patient had arm soreness for approximately 1 week. On January 11, 2020 at night, the patient reported severe soreness on left side of arm extending through shoulder, neck and head. The patient reported that, every time moves wanted to scream. On the day of reporting, the soreness was worse. The reporter did not provide a health care professional for follow up due to changing doctors, but was not opposed to health care professional follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shoulder pain; Severe soreness on left side of arm extending through shoulder, neck and head; Severe soreness on left side of arm extending through shoulder, neck and head; Severe soreness on left side of arm extending through shoulder, neck and head; Radiating pain; Arm was sore / Severe soreness on left side of arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 2nd dose of Shingrix. On 9th January 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, musculoskeletal pain, neck pain, headache and radiating pain. On an unknown date, the patient experienced shoulder pain. On an unknown date, the outcome of the pain in arm, musculoskeletal pain, neck pain, headache and radiating pain were not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the pain in arm, musculoskeletal pain, neck pain, headache, radiating pain and shoulder pain to be related to Shingrix.  Additional deatils were provided  as follows: The patient received dose of Shingrix in the left arm. After vaccination, the patient had arm soreness for approximately 1 week. On January 11, 2020 at night, the patient reported severe soreness on left side of arm extending through shoulder, neck and head. The patient reported that, every time moves wanted to scream. On the day of reporting, the soreness was worse. The reporter did not provide a health care professional for follow up due to changing doctors, but was not opposed to health care professional follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Burning, radiating paresthesia; Burning, radiating paresthesia; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced burning sensation and paresthesia. On an unknown date, the outcome of the burning sensation and paresthesia were not recovered/not resolved.   It was unknown if the reporter considered the burning sensation and paresthesia to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrixvaccine on November 2019 and experienced burning, radiating paresthesia from his neck down to arm  where he got the injection. This case has been linked with US2020AMR008056, reported by same reporter.
Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injected limb mobility decreased, Myalgia, Nausea
Clinical narrative: Nausea; Diarrhea; Myalgia; Influenza-like symptoms; Upper respiratory infection; Difficulty lifting right arm; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included osteoporosis. Previously administered products included flu vaccine (in the past and did not experience these side effects). Concomitant products included denosumab (Prolia).   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced nausea, diarrhea, myalgia, influenza-like symptoms, upper respiratory tract infection and injected limb mobility decreased. On an unknown date, the outcome of the nausea, diarrhea, myalgia, influenza-like symptoms and injected limb mobility decreased were recovered/resolved and the outcome of the upper respiratory tract infection was not recovered/not resolved.   The reporter considered the nausea, diarrhea, myalgia, influenza-like symptoms and injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the upper respiratory tract infection to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the nausea, diarrhea, myalgia and influenza-like symptoms to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient Shingrix vaccine and a flu vaccine and says within 24 to 36 received Shingrix in her right deltoid and flu vaccine in her hours after receiving both vaccines, she experienced difficulty lifting up her right arm, nausea, diarrhea, myalgia, and flu-like symptoms. She cannot recall specific dates but said all these side effects resolved about two weeks later. She believes these side effects were caused by Shingrix because she said she has received flu vaccines in the past and did not experience these side effects.  The reporter consented to follow up. The patient was due for my 2nd Shringrix vaccine at the time of reporting which has been held pending my recovering from an upper respiratory infection that was still resolving.  The patient received Prolia injections every 6 months for osteoporosis with my next Prolia to be given. The reporter asked was there potential for interaction, decreased efficacy, or any contraindications to administering the Prolia and Shingrix in close proximity to each other.
Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: Nausea; Diarrhea; Myalgia; Influenza-like symptoms; Upper respiratory infection; Difficulty lifting right arm; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included osteoporosis. Previously administered products included flu vaccine (in the past and did not experience these side effects). Concomitant products included denosumab (Prolia).   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced nausea, diarrhea, myalgia, influenza-like symptoms, upper respiratory tract infection and injected limb mobility decreased. On an unknown date, the outcome of the nausea, diarrhea, myalgia, influenza-like symptoms and injected limb mobility decreased were recovered/resolved and the outcome of the upper respiratory tract infection was not recovered/not resolved.   The reporter considered the nausea, diarrhea, myalgia, influenza-like symptoms and injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the upper respiratory tract infection to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the nausea, diarrhea, myalgia and influenza-like symptoms to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient Shingrix vaccine and a flu vaccine and says within 24 to 36 received Shingrix in her right deltoid and flu vaccine in her hours after receiving both vaccines, she experienced difficulty lifting up her right arm, nausea, diarrhea, myalgia, and flu-like symptoms. She cannot recall specific dates but said all these side effects resolved about two weeks later. She believes these side effects were caused by Shingrix because she said she has received flu vaccines in the past and did not experience these side effects.  The reporter consented to follow up. The patient was due for my 2nd Shringrix vaccine at the time of reporting which has been held pending my recovering from an upper respiratory infection that was still resolving.  The patient received Prolia injections every 6 months for osteoporosis with my next Prolia to be given. The reporter asked was there potential for interaction, decreased efficacy, or any contraindications to administering the Prolia and Shingrix in close proximity to each other.