chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Groin pain, Musculoskeletal pain, Pain
Clinical narrative: extreme pain in my lower left extremities; pain goes from my left toe up to my left hip; pain goes from my left toe up to my left hip across my groin; pain / across my buttox; couldn't walk; excruciating pain; This case was reported by a consumer and described the occurrence of pain in extremity in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2019, the patient received the 2nd dose of Shingrix. In April 2020, between 3 and 5 months after receiving Shingrix, the patient experienced pain in extremity, pain in hip, groin pain, buttock pain, unable to walk and pain. On an unknown date, the outcome of the pain in extremity, pain in hip, groin pain, buttock pain, unable to walk and pain were not recovered/not resolved.   The reporter considered the pain in extremity, pain in hip, groin pain, buttock pain, unable to walk and pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and had a very violent reaction to the shingles shot.  The patient had extreme pain in my lower left extremities and the pain goes from left toe up to left hip across groin and across buttox and been confined to a walker.  The patient could not walk and was in rehab for several weeks and still experiencing from excruciating pain. The patient had not contacted an attorney yet. But thought would call company to see if there were any cases on this. The patient was calling because feel company was responsible for pain and would be reaching out to company regarding the pain the suffering from.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: extreme pain in my lower left extremities; pain goes from my left toe up to my left hip; pain goes from my left toe up to my left hip across my groin; pain / across my buttox; couldn't walk; excruciating pain; This case was reported by a consumer and described the occurrence of pain in extremity in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2019, the patient received the 2nd dose of Shingrix. In April 2020, between 3 and 5 months after receiving Shingrix, the patient experienced pain in extremity, pain in hip, groin pain, buttock pain, unable to walk and pain. On an unknown date, the outcome of the pain in extremity, pain in hip, groin pain, buttock pain, unable to walk and pain were not recovered/not resolved.   The reporter considered the pain in extremity, pain in hip, groin pain, buttock pain, unable to walk and pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and had a very violent reaction to the shingles shot.  The patient had extreme pain in my lower left extremities and the pain goes from left toe up to left hip across groin and across buttox and been confined to a walker.  The patient could not walk and was in rehab for several weeks and still experiencing from excruciating pain. The patient had not contacted an attorney yet. But thought would call company to see if there were any cases on this. The patient was calling because feel company was responsible for pain and would be reaching out to company regarding the pain the suffering from.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received Shingrix. On 17th June 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 17th June 2020 at 4.16. 14 AM, the patient experienced fever after receiving the Shingrix vaccine. The patient asked, how long the fever would have.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received Shingrix. On 17th June 2020, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 17th June 2020 at 4.16. 34 AM, the patient experienced fever after receiving the Shingrix vaccine. The patient asked, how long the fever will have.
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain
Clinical narrative: Pain in eye; This case was reported by a other health professional via interactive digital media and described the occurrence of eye pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received Shingrix. On 17th June 2020, unknown after receiving Shingrix, the patient experienced eye pain. On an unknown date, the outcome of the eye pain was unknown.   It was unknown if the reporter considered the eye pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced eye pain after receiving the Shingrix vaccine. The patient asked, how long the fever would have.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Joint Pain; Sore Arm; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic back pain. Concomitant products included oxycodone.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain, pain in arm and fatigue. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the joint pain, pain in arm and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had sore arm, fatigue and joint pain. The reporter did state that they had some of the side effects after the first dose but that the second dose side effects were more extreme. The reporter consented to follow up. The reporter did not have the lot or expiry of their dose.  For tolerances of 2nd dose, refer case US2020104604, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020104604:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event 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 an adult as per the vaccine indication. The patient received Shingrix and had side effects. The reporter asked how long did the side effects last.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: low grade fever; swelling and redness and pain at the site of the vaccine; redness and pain at the site of the vaccine; pain at the site of the vaccine in my arm; random pox-like; itchy pimples; itchy pimples; This case was reported by a consumer and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. In January 2020, 2 weeks after receiving Shingrix, the patient experienced varicella-like rash, pimples and pruritus. On an unknown date, the patient experienced fever, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the fever, injection site swelling, injection site erythema, injection site pain, varicella-like rash, pimples and pruritus were unknown.   It was unknown if the reporter considered the fever, injection site swelling, injection site erythema, injection site pain, varicella-like rash, pimples and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a reaction with low grade fever and swelling and redness and pain at the site of the vaccine on my arm. In addition, a few random pox-like itchy pimples appeared up to two weeks following.  The doctor said should still get the second vaccine but the patient was asking for more advice about that and would like to report the first reaction. The patient six months was up 1st July 2020, but the doctor did not had the vaccine and not giving vaccines due to Co-Vid and the pharmacist told that the patient would wait up to a year for the second dose.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: low grade fever; swelling and redness and pain at the site of the vaccine; redness and pain at the site of the vaccine; pain at the site of the vaccine in my arm; random pox-like; itchy pimples; itchy pimples; This case was reported by a consumer and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. In January 2020, 2 weeks after receiving Shingrix, the patient experienced varicella-like rash, pimples and pruritus. On an unknown date, the patient experienced fever, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the fever, injection site swelling, injection site erythema, injection site pain, varicella-like rash, pimples and pruritus were unknown.   It was unknown if the reporter considered the fever, injection site swelling, injection site erythema, injection site pain, varicella-like rash, pimples and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a reaction with low grade fever and swelling and redness and pain at the site of the vaccine on my arm. In addition, a few random pox-like itchy pimples appeared up to two weeks following.  The doctor said should still get the second vaccine but the patient was asking for more advice about that and would like to report the first reaction. The patient six months was up 1st July 2020, but the doctor did not had the vaccine and not giving vaccines due to Co-Vid and the pharmacist told that the patient would wait up to a year for the second dose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia, Asthenia, Cough, Herpes virus infection, Herpes zoster
Clinical narrative: feels as though she has " the shingles without the blisters; shingles without the blister; chronic severe pain to the right side of her body; dry cough; generalized weakness; had seven herpatic outbreaks; hair loss; Loss of eyelashes; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix .5 ml. On 11th May 2020, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than 4 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chronic pain, dry cough, weakness, herpes virus infection, hair loss and loss of eyelashes. On an unknown date, the outcome of the vaccination failure, shingles, chronic pain, dry cough, weakness, herpes virus infection, hair loss and loss of eyelashes were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, chronic pain, dry cough, weakness, herpes virus infection, hair loss and loss of eyelashes to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, chronic pain, dry cough and weakness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 55 or 56 years old. The patient had seven herpatic outbreak, noticed hair and eyelash loss after the 1st dose of vaccine. The patient went ahead and had 2nd dose, experienced severe pain to the right side of her body, dry cough, generalised weakness and felt as she had shingles without blisters. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Madarosis, Pain, Vaccination failure
Clinical narrative: feels as though she has " the shingles without the blisters; shingles without the blister; chronic severe pain to the right side of her body; dry cough; generalized weakness; had seven herpatic outbreaks; hair loss; Loss of eyelashes; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix .5 ml. On 11th May 2020, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than 4 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chronic pain, dry cough, weakness, herpes virus infection, hair loss and loss of eyelashes. On an unknown date, the outcome of the vaccination failure, shingles, chronic pain, dry cough, weakness, herpes virus infection, hair loss and loss of eyelashes were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, chronic pain, dry cough, weakness, herpes virus infection, hair loss and loss of eyelashes to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, chronic pain, dry cough and weakness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 55 or 56 years old. The patient had seven herpatic outbreak, noticed hair and eyelash loss after the 1st dose of vaccine. The patient went ahead and had 2nd dose, experienced severe pain to the right side of her body, dry cough, generalised weakness and felt as she had shingles without blisters. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting The reporter consented to follow up.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: right upper arm was sore; awake from 1:30 AM until 3:30 4AM; This case was reported by a consumer and described the occurrence of pain in arm in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and sleep disturbance. On an unknown date, the outcome of the pain in arm and sleep disturbance were unknown.   It was unknown if the reporter considered the pain in arm and sleep disturbance to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On 18th June 2020 at 11AM the patient received the Shingrix. On the same night, the patient experienced right upper arm was sore, the patient slept on stomach. The patient normally sleeps at 9 to10 hours per day with no issues. The patient awakes from 1:30 AM until 3:30 to 4AM. Could this be drug related, as it was not a listed side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction
Clinical narrative: 1by 2 dozen blisters on my large toes; This case was reported by a consumer and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (1st dose received on unknown date. Please refer the case US2020AMR106507).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced blister. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. Since getting the 1st of Shingrix the patient experienced about 1 by 2 dozen blisters on patient's large toes for no explainable reason. The patient asked was that a possible side effect.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR106507:1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: 1 by 2 dozen blisters on my large toes; This case was reported by a consumer and described the occurrence of blister 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, immediately after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. Since getting the 1st of Shingrix the patient experienced about 1 by 2 dozen blisters on patient's large toes for no explainable reason. The patient asked Is that a possible side effect. For tolerance after 2nd dose of Shingrix, refer case US2020AMR106672.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR106498:1st dose
Age: 86.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: upset stomach; I am still dizzy; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 86-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fall (had a history of falling in the last few years).   On 20th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced upset stomach and dizziness. On an unknown date, the outcome of the upset stomach and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix two days ago (from the day of reporting) and still felt dizzy and had upset stomach. The reporter asked if anything could do to cure the dizziness.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: mild flu symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-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 on unknown date, refer case US2020107111).   On 12th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Nurse reported the case for her husband who was a physician. The age at vaccination was not reported. The patient received Shingrix in left arm and and experienced mild flu symptoms for a couple of days and then resolved. The reporter consented to follow up. The reporter could follow up with the reporter directly. This case linked with US2020107109, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107109:same reporter US-GLAXOSMITHKLINE-US2020107111:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Malaise, Myalgia, Pain
Clinical narrative: flu-like symptoms; joint and muscle aches; muscle aches; overall malaise; pains; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, joint pain, muscle pain, malaise and pain. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, malaise and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, malaise and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had influenza-like symptoms, joint pain, muscle pain, malaise, pain and no fever. No further information was provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain, Pain in extremity, Product preparation issue
Clinical narrative: body aches; Shingrix without reconstituting it with the antigen; given the adjuvant portion; sore arms (both arms were sore); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number Y9K7L, expiry date 19th March 2022) for prophylaxis.   On 4th June 2020, the patient received the 1st dose of Shingrix. On 4th June 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was given the adjuvant portion of Shingrix without reconstituting it with the antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.   Follow-up information received from pharmacist on 18th June 2020 : The patient had medical history of hypothyroidism. The patient received 1st dose of vaccine intramuscularly in unknown arm   he reporter stated that the patient was vaccinated with new bottle of shingrix adjuvant and antigen on same day but in different arm. The reporter stated that the patient did not experienced any concerning adverse events besides commonly reported ones.  In June 2020, less than 2 weeks after administration of vaccine patient experienced soreness in both arms were sore and her body aches for couple of days. The VAERS details were updated.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperkeratosis lenticularis perstans, Rash, Rash macular, Rash papular, Skin ulcer
Clinical narrative: brown and red spots on lower legs that became raised; Flegel disease; brown Rash/spots on face; brown and red spots; brown and red spots on lower legs that became raised sores; This case was reported by a consumer via call center representative and described the occurrence of flegel disease in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix. In January 2020, between 3 and 4 weeks after receiving Shingrix, the patient experienced flegel disease, rash, red spotty rash and generalized raised red spots limbs. On an unknown date, the patient experienced skin ulcer. The patient was treated with dermatologicals nos (Unspecified Cream). On an unknown date, the outcome of the flegel disease, rash, red spotty rash and generalized raised red spots limbs were not recovered/not resolved and the outcome of the skin ulcer was unknown.   It was unknown if the reporter considered the flegel disease, rash, red spotty rash, generalized raised red spots limbs and skin ulcer to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix in left arm. Approximately 3 to 4 weeks later developed rash described as initially brown and red spots on lower legs that became raised sores. Later on, she found out it was rare skin disease called Flegel.  The patient still having rash and being treated by an unspecified cream. The initial cream was described as being strong and current cream not as strong. The patient reported now having spots on arm that developed approximately 3 months post 1st dose Shingrix and then spots on face approximately months post 1st dose Shingrix. The reporter consent to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Balance disorder, Headache, Hypoaesthesia, Insomnia
Clinical narrative: Visual disturbances; Balance issues; Headaches; Extreme pain at the spinal area; Pain in their lower back; Sciatica pain; Numbness to the left leg and foot; Extreme pain; Extreme pain that kept them from sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number A5X5B, expiry date 7th March 2021) and (batch number ZJ4P2, expiry date 7th March 2021) for prophylaxis.   Concurrent medical conditions included stroke (Stroke from bacteria in the brain), cystitis interstitial and lyme disease (History of Chronic Lyme disease).   On 16th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 16th March 2020, less than a day after receiving Shingrix, the patient experienced pain and sleeplessness. On an unknown date, the patient experienced visual disturbance, balance disorder, headache, pain in spine, low back pain, sciatica and numbness in leg. Shingrix was discontinued. On an unknown date, the outcome of the pain, visual disturbance, balance disorder and headache were not recovered/not resolved and the outcome of the sleeplessness, pain in spine, low back pain, sciatica and numbness in leg were unknown.   It was unknown if the reporter considered the pain, sleeplessness, visual disturbance, balance disorder, headache, pain in spine, low back pain, sciatica and numbness in leg to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose in Shingrix, and that night had extreme pain that kept the patient from sleeping. The reported batch number 2J4P2, however changed to ZJ4P2. The patient had experienced visual disturbances, balance issues, headaches and extreme pain at the spinal area.  The patient went to emergency room to be treated for the extreme pain in their lower back (sciatica pain with numbness to the left leg and foot).  The patient was unsure if this reaction was due to their Chronic Lime history or from the vaccine and the patient health care professional does not know how to treat the symptoms that have not been resolved.  Due to these complications the patient will not be getting their 2nd dose. The patient had been contacted Centers for Disease Control and Food and Drug Administration along with their health care professional to make them aware of her reaction.  The patient's health care professional does not know how to treat her condition due to history of lyme.  The reporter consent to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sciatica, Spinal pain, Visual impairment
Clinical narrative: Visual disturbances; Balance issues; Headaches; Extreme pain at the spinal area; Pain in their lower back; Sciatica pain; Numbness to the left leg and foot; Extreme pain; Extreme pain that kept them from sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number A5X5B, expiry date 7th March 2021) and (batch number ZJ4P2, expiry date 7th March 2021) for prophylaxis.   Concurrent medical conditions included stroke (Stroke from bacteria in the brain), cystitis interstitial and lyme disease (History of Chronic Lyme disease).   On 16th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 16th March 2020, less than a day after receiving Shingrix, the patient experienced pain and sleeplessness. On an unknown date, the patient experienced visual disturbance, balance disorder, headache, pain in spine, low back pain, sciatica and numbness in leg. Shingrix was discontinued. On an unknown date, the outcome of the pain, visual disturbance, balance disorder and headache were not recovered/not resolved and the outcome of the sleeplessness, pain in spine, low back pain, sciatica and numbness in leg were unknown.   It was unknown if the reporter considered the pain, sleeplessness, visual disturbance, balance disorder, headache, pain in spine, low back pain, sciatica and numbness in leg to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose in Shingrix, and that night had extreme pain that kept the patient from sleeping. The reported batch number 2J4P2, however changed to ZJ4P2. The patient had experienced visual disturbances, balance issues, headaches and extreme pain at the spinal area.  The patient went to emergency room to be treated for the extreme pain in their lower back (sciatica pain with numbness to the left leg and foot).  The patient was unsure if this reaction was due to their Chronic Lime history or from the vaccine and the patient health care professional does not know how to treat the symptoms that have not been resolved.  Due to these complications the patient will not be getting their 2nd dose. The patient had been contacted Centers for Disease Control and Food and Drug Administration along with their health care professional to make them aware of her reaction.  The patient's health care professional does not know how to treat her condition due to history of lyme.  The reporter consent to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Bump, or swelling at the injection site; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the injection site swelling to be related to Meningitis ACWY vaccine (potential Menveo).  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced a bump, or swelling at the injection site which lasted 2 days and then resolved. The reporter did not consent to follow up. The exact name of the meningitis manufacturer or brand was not known.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: headache; sore throat; Fever; chills; Joint Pain / ankle pain; Sore Arm; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date. Please refer the case US2020AMR105128). Concurrent medical conditions included chronic back pain.   On 16th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 16th June 2020, less than a day after receiving Shingrix, the patient experienced joint pain, pain in arm and fatigue. On 17th June 2020, the patient experienced fever and chills. On 22nd June 2020, the patient experienced headache and sore throat. The patient was treated with oxycodone. Rechallenge with Shingrix was positive. On 17th June 2020, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the headache and sore throat were unknown.   It was unknown if the reporter considered the joint pain, pain in arm, fatigue, fever, chills, headache and sore throat to be related to Shingrix.  Additional case details were reported as follows: On the same day after receiving the vaccine the patient experienced joint pain, sore arm, and fatigue. On 17th June 2020, the patient experienced fever with chills that passed the same day. The patient did note that on day 3 post injection had extreme ankle pain which required them to use their oxycodone pain medication (normally used for chronic back pain). The reporter stated that on day 4 the ankle pain was getting better.  On 22nd June 2020, the patient wakes up to headache this morning, and had sore throat. The patient had some of the side effects after the 1st dose but that the 2nd dose side effects were more extreme.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR105128:Same reporter
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: headache; sore throat; Fever; chills; Joint Pain / ankle pain; Sore Arm; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date. Please refer the case US2020AMR105128). Concurrent medical conditions included chronic back pain.   On 16th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 16th June 2020, less than a day after receiving Shingrix, the patient experienced joint pain, pain in arm and fatigue. On 17th June 2020, the patient experienced fever and chills. On 22nd June 2020, the patient experienced headache and sore throat. The patient was treated with oxycodone. Rechallenge with Shingrix was positive. On 17th June 2020, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the headache and sore throat were unknown.   It was unknown if the reporter considered the joint pain, pain in arm, fatigue, fever, chills, headache and sore throat to be related to Shingrix.  Additional case details were reported as follows: On the same day after receiving the vaccine the patient experienced joint pain, sore arm, and fatigue. On 17th June 2020, the patient experienced fever with chills that passed the same day. The patient did note that on day 3 post injection had extreme ankle pain which required them to use their oxycodone pain medication (normally used for chronic back pain). The reporter stated that on day 4 the ankle pain was getting better.  On 22nd June 2020, the patient wakes up to headache this morning, and had sore throat. The patient had some of the side effects after the 1st dose but that the 2nd dose side effects were more extreme.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR105128:Same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash/Small bumps that go from the side to the upper chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix. On 31st May 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received the second dose of Shingrix and the day after she developed rash and small bumps that go from her side to the upper chest and still had this symptom. The patient said that she did not see an improvement in the symptoms after all this time.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak of Shingles after the 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 4 months after receiving Shingrix, the patient experienced shingles. In May 2020, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed an outbreak of Shingles after the 1st dose of Shingrix.  The patient had the symptoms for 3-4 weeks prior to 18thJune 2020. The reporter was consented to follow up. No additional details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental underdose, Eyelid disorder, Fatigue
Clinical narrative: received a partial 2nd dose due to it leaking; Fatigue; Heavy Lidded; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced accidental underdose, fatigue and eyelid disorder. On an unknown date, the outcome of the accidental underdose, fatigue and eyelid disorder were unknown.   It was unknown if the reporter considered the fatigue and eyelid disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a partial 2nd dose due to it leaking, which led to accidental underdose. The patient was immediately given a full 3rd dose of Shingrix and felt fatigued and heavy lidded. The reporter did not consent to follow up. No additional details were provided.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Diarrhoea, Rash pruritic, Skin discolouration, Varicella
Clinical narrative: chickenpox; itchy rash primarily on the "trunk" of her body, armpits, left leg / spread to her inner thighs and pubic area; "little" white pin-sized heads on it; rash is seen along with white spots and itching/body, armpits, left leg.; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st on 26th August 2019).   On 24th January 2020, the patient received the 2nd dose of Shingrix. On 23rd May 2020, 120 days after receiving Shingrix, the patient experienced diarrhea. On 24th May 2020, the patient experienced chickenpox, itchy rash, blister and skin discoloration. On an unknown date, the outcome of the chickenpox was unknown and the outcome of the diarrhea was recovered/resolved and the outcome of the itchy rash and blister were not recovered/not resolved and the outcome of the skin discoloration was recovering/resolving.   It was unknown if the reporter considered the chickenpox, diarrhea, itchy rash, blister and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had severe diarrhea. The patient still had diarrhea but also developed an itchy rash primarily on the trunk of her body, armpits, left leg.  She went to see her physician who she stated was not sure but thought it might be chickenpox.   The caller also stated that the itchy rash spread to her inner thighs and pubic area and had little white pin-sized heads on it.   The diarrhea has stopped but she still has areas where the rash was seen along with white spots and itching. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Emotional distress, Muscle twitching, Pain
Clinical narrative: inconsolable; pain; crying; body twitching; This case was reported by a physician via call center representative and described the occurrence of emotional distress in a 18-month-old female patient who received DTPa (Infanrix) (batch number 2C7F9, expiry date 9th February 2021) for prophylaxis.   On 15th October 2019, the patient received Infanrix. On 15th October 2019, less than a day after receiving Infanrix, the patient experienced emotional distress, pain, crying and muscle twitching. On an unknown date, the outcome of the emotional distress, pain, crying and muscle twitching were recovered/resolved.   It was unknown if the reporter considered the emotional distress, pain, crying and muscle twitching to be related to Infanrix.  Additional details were provided as follows: The patient received Shingrix and felt inconsolable, pain, crying and body twitching. The side effects lasted for 72 hours and resolved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Systemic mastocytosis
Clinical narrative: weird symptoms; mast cell cytosis; This case was reported by a physician via call center representative and described the occurrence of systemic mastocytosis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included memory disturbance.   In January 2020, the patient received the 1st dose of Shingrix. In May 2020, between 4 and 5 months after receiving Shingrix, the patient experienced systemic mastocytosis (serious criteria GSK medically significant). On an unknown date, the patient experienced weird feeling. On an unknown date, the outcome of the systemic mastocytosis and weird feeling were recovering/resolving.   It was unknown if the reporter considered the systemic mastocytosis and weird feeling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and within one week after vaccination experienced weird symptoms. Within the last month (May 2020, as per reporting date), the patient was diagnosed with mast cell cytosis.  The symptoms were episodic and ongoing still at the time of reporting. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: achy feeling in his arm; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm and he experienced an achy feeling in his arm which has resolved.   The reporter consented to follow up. The GlaxoSmithKline could follow up with the reporter directly. For tolerances of 2nd dose, refer case US2020AMR107530, reported by same reporter for the same patient. This case linked with US2020107109, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107109:same reporter US-GLAXOSMITHKLINE-US2020AMR107530:same reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Swelling face
Clinical narrative: Swelling of face and abdominal pain, sent vis EMS to ED
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Telehealth visit on 6/25/2020 localized reaction. Recommended Ice, Motrin. Skin: 1 1/2 - 1 3/4 size of half dollar midly  red/tender, egg shape L. deltoid.
Age: 57.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: 6 hours after injection: chills.  12 hours after injection: shivering and fever (101.9 by ear), headache, upset stomach, pain like a sunburn around the face, neck, shoulders.  20 hours after injection:  pain subsides.  23 hours after injection:  fever subsides.  24 hours after injection:  headache subsides
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site warmth, Pain in extremity, Rash
Clinical narrative: Pain on the left arm, rash that runs toward the front of the shoulder, warm to the touch. No itchiness in the area.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal discomfort, Breath sounds normal, Chest discomfort, Electrocardiogram, Headache
Clinical narrative: Beginning on 6/25approx late afternoon, patient felt like there was a weight on her chest,. Parent took her to ED at 2100 hours-did an EKG, lung sounds were clear to auscultation, vitals stable. Return call from parent on 6/26  chest feeling better today and doesn't have a headache like yesterday, or feel like weight on chest, today she has upset stomach, and vomiting. Afebrile.  Continue follow up phone triage/care