chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Gait disturbance, Hangover
Clinical narrative: The soreness in her left arm (at injection site); Several flu-like symptoms developed; Not able to sleep through the night; Pt stated this shot "knocked her for a loop"; Headache; Shivering / chills; Myalgia; Fatigue; Still "walking slowly"; Feels unwell / "under the weather"; Feeling hung over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female 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 8th or 9th October 2020, refer case US2020246456) and Flu vaccine with an associated reaction of chills (received on 8th or 9th October 2020).   On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, difficulty sleeping, discomfort, headache, chills, myalgia, fatigue, walking difficulty, feeling unwell and hangover effect. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, chills and fatigue were not recovered/not resolved and the outcome of the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect were unknown and the outcome of the headache and myalgia were recovering/resolving.   The reporter considered the injection site pain, headache, chills, myalgia and fatigue to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect to be related to Shingrix.  Additional details were reported as follows: The patient stated that on the night of vaccination she did had some soreness in her left arm but no (systemic) other symptoms before bedtime, during the night however several flu-like symptoms developed and she was not able to sleep through the night because she kept waking up with symptoms. The patient stated that this 2nd dose of Shingrix knocked her for a loop.   The patient had a bad headache and the headache was going away, she did not take any medication to treat the headache. She had shivering/chills, the shivering had resolved though she still feels a little chilled. She had myalgia, she says it was still going on but getting better. The patient reported she experienced fatigue.  On the morning of reporting she stated she was feeling a little better now that she has eaten breakfast and had some coffee. The patient stated that she was still walking slowly because she feels unwell and under the weather and feeling hung over. At the time of this reporting, the soreness in her left arm (at injection site) was still sore to the touch. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246456:Same reporter. 1st dose
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Insomnia, Malaise
Clinical narrative: The soreness in her left arm (at injection site); Several flu-like symptoms developed; Not able to sleep through the night; Pt stated this shot "knocked her for a loop"; Headache; Shivering / chills; Myalgia; Fatigue; Still "walking slowly"; Feels unwell / "under the weather"; Feeling hung over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female 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 8th or 9th October 2020, refer case US2020246456) and Flu vaccine with an associated reaction of chills (received on 8th or 9th October 2020).   On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, difficulty sleeping, discomfort, headache, chills, myalgia, fatigue, walking difficulty, feeling unwell and hangover effect. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, chills and fatigue were not recovered/not resolved and the outcome of the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect were unknown and the outcome of the headache and myalgia were recovering/resolving.   The reporter considered the injection site pain, headache, chills, myalgia and fatigue to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect to be related to Shingrix.  Additional details were reported as follows: The patient stated that on the night of vaccination she did had some soreness in her left arm but no (systemic) other symptoms before bedtime, during the night however several flu-like symptoms developed and she was not able to sleep through the night because she kept waking up with symptoms. The patient stated that this 2nd dose of Shingrix knocked her for a loop.   The patient had a bad headache and the headache was going away, she did not take any medication to treat the headache. She had shivering/chills, the shivering had resolved though she still feels a little chilled. She had myalgia, she says it was still going on but getting better. The patient reported she experienced fatigue.  On the morning of reporting she stated she was feeling a little better now that she has eaten breakfast and had some coffee. The patient stated that she was still walking slowly because she feels unwell and under the weather and feeling hung over. At the time of this reporting, the soreness in her left arm (at injection site) was still sore to the touch. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246456:Same reporter. 1st dose
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: The soreness in her left arm (at injection site); Several flu-like symptoms developed; Not able to sleep through the night; Pt stated this shot "knocked her for a loop"; Headache; Shivering / chills; Myalgia; Fatigue; Still "walking slowly"; Feels unwell / "under the weather"; Feeling hung over; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female 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 8th or 9th October 2020, refer case US2020246456) and Flu vaccine with an associated reaction of chills (received on 8th or 9th October 2020).   On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, difficulty sleeping, discomfort, headache, chills, myalgia, fatigue, walking difficulty, feeling unwell and hangover effect. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, chills and fatigue were not recovered/not resolved and the outcome of the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect were unknown and the outcome of the headache and myalgia were recovering/resolving.   The reporter considered the injection site pain, headache, chills, myalgia and fatigue to be related to Shingrix. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, discomfort, walking difficulty, feeling unwell and hangover effect to be related to Shingrix.  Additional details were reported as follows: The patient stated that on the night of vaccination she did had some soreness in her left arm but no (systemic) other symptoms before bedtime, during the night however several flu-like symptoms developed and she was not able to sleep through the night because she kept waking up with symptoms. The patient stated that this 2nd dose of Shingrix knocked her for a loop.   The patient had a bad headache and the headache was going away, she did not take any medication to treat the headache. She had shivering/chills, the shivering had resolved though she still feels a little chilled. She had myalgia, she says it was still going on but getting better. The patient reported she experienced fatigue.  On the morning of reporting she stated she was feeling a little better now that she has eaten breakfast and had some coffee. The patient stated that she was still walking slowly because she feels unwell and under the weather and feeling hung over. At the time of this reporting, the soreness in her left arm (at injection site) was still sore to the touch. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020246456:Same reporter. 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: severe Shingrix vaccine reaction / hospitalized for almost three weeks; This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a male 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 hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that she had a complex issue, but it was a severe Shingrix vaccine reaction, patient was hospitalized for almost three weeks. The reporter was wondering what commonalities there might be with the new COVID vaccines. She was guessing other people have this big problem, so that to her it was something that need to figure out, so she don't  have to have her doctor track this down. The reporter consented to follow up.; Reporter's Comments: realize we have a complex issue, but it was a severe Shingrix vaccine reaction, my husband was hospitalized for almost three weeks, (inaudible) I was wondering what commonalities there may be with the new COVID vaccines. I'm guessing other people have this big problem, so that to me is something you guys need to figure out, so I don't have to have my doctor track this down.
Sex: F
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Seizures; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a female patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be related to DTaP vaccine.  Additional details were provided as follows: The age at vaccination was not reported Reporter daughter reacted to DTaP, when she was a baby. Seizures abd the like. However, when reporters daughter was older, reporter went back and got her vaccinated. She didn't react that time.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Chills, Feeling abnormal, Headache, Herpes zoster
Clinical narrative: Possible shingles; reaction at the injection site / swelling; reaction at the injection site / redness; developed a H/A; started with chills; felt feverish; with shaking; rash with radiating pain; bruising at the injection site.; she felt like she had a bug bite on her lower abdomen; rash on her L lower abdomen with radiating pain; Felt bad for 2 days; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2020 09:30, the patient received the 1st dose of Shingrix. On 4th November 2020 18:00, 8 hrs 30 min after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever and tremor. In November 2020, the patient experienced injection site bruising, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever, tremor, painful rash, shingles and lower abdominal pain were unknown and the outcome of the injection site bruising was not recovered/not resolved and the outcome of the feeling bad and radiating pain were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, headache, chills, fever, tremor, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix shot around 9:30 am and around 6 pm that evening she developed a reaction at the injection site on her left arm with redness and swelling that radiated down to the middle of her arm.  At 6 pm she also developed a headache then started with chills and felt feverish with shaking.  She took Tylenol and felt bad for 2 days. Then it resolved.  Five or 6 days later she felt like she had a bug bite on her lower abdomen but it was not itchy.  She had pain with this and that evening she noticed she developed a rash on her left lower abdomen with radiating pain for 3 days.  It spread to her back up towards her spine. She had bruising at the injection site at the time of reporting. Her physician put her on Valtrex which she had been on since 17th November 2020.  The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Possible shingles; reaction at the injection site / swelling; reaction at the injection site / redness; developed a H/A; started with chills; felt feverish; with shaking; rash with radiating pain; bruising at the injection site.; she felt like she had a bug bite on her lower abdomen; rash on her L lower abdomen with radiating pain; Felt bad for 2 days; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2020 09:30, the patient received the 1st dose of Shingrix. On 4th November 2020 18:00, 8 hrs 30 min after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever and tremor. In November 2020, the patient experienced injection site bruising, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever, tremor, painful rash, shingles and lower abdominal pain were unknown and the outcome of the injection site bruising was not recovered/not resolved and the outcome of the feeling bad and radiating pain were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, headache, chills, fever, tremor, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix shot around 9:30 am and around 6 pm that evening she developed a reaction at the injection site on her left arm with redness and swelling that radiated down to the middle of her arm.  At 6 pm she also developed a headache then started with chills and felt feverish with shaking.  She took Tylenol and felt bad for 2 days. Then it resolved.  Five or 6 days later she felt like she had a bug bite on her lower abdomen but it was not itchy.  She had pain with this and that evening she noticed she developed a rash on her left lower abdomen with radiating pain for 3 days.  It spread to her back up towards her spine. She had bruising at the injection site at the time of reporting. Her physician put her on Valtrex which she had been on since 17th November 2020.  The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tremor
Clinical narrative: Possible shingles; reaction at the injection site / swelling; reaction at the injection site / redness; developed a H/A; started with chills; felt feverish; with shaking; rash with radiating pain; bruising at the injection site.; she felt like she had a bug bite on her lower abdomen; rash on her L lower abdomen with radiating pain; Felt bad for 2 days; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2020 09:30, the patient received the 1st dose of Shingrix. On 4th November 2020 18:00, 8 hrs 30 min after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever and tremor. In November 2020, the patient experienced injection site bruising, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever, tremor, painful rash, shingles and lower abdominal pain were unknown and the outcome of the injection site bruising was not recovered/not resolved and the outcome of the feeling bad and radiating pain were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, headache, chills, fever, tremor, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix shot around 9:30 am and around 6 pm that evening she developed a reaction at the injection site on her left arm with redness and swelling that radiated down to the middle of her arm.  At 6 pm she also developed a headache then started with chills and felt feverish with shaking.  She took Tylenol and felt bad for 2 days. Then it resolved.  Five or 6 days later she felt like she had a bug bite on her lower abdomen but it was not itchy.  She had pain with this and that evening she noticed she developed a rash on her left lower abdomen with radiating pain for 3 days.  It spread to her back up towards her spine. She had bruising at the injection site at the time of reporting. Her physician put her on Valtrex which she had been on since 17th November 2020.  The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: redness around injection site; chills/ chills; FAtigue; aching in joints; aching in joints and throughout his whole body / body aches; shakes; aching in back muscles; fever up to 101 degrees/ fever; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol) and ibuprofen (Advil).   On 20th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache. On 23rd November 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, chills, joint pain, general body pain, muscular back pain, fever and headache were not recovered/not resolved and the outcome of the fatigue and tremor were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix vaccine on 20th November 2020 friday afternoon. On friday night he had chills.  On 21st November 2020, saturday morning he had fatigue, aching in joints throughout his whole body, chills, shakes, aching in back muscles and fever up to 101 degree F. On 23rd November 2020, 3 days after vaccination the patient had injection site erythema. In less than a week the patient experienced headache. Patient took Tylenol and Advil on Saturday.  The patient had body aches, headache, fever and chills at the time of repoting. The patient had redness around the injection site and just above or below the injection site as well. No further information was available. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pyrexia, Tremor
Clinical narrative: redness around injection site; chills/ chills; FAtigue; aching in joints; aching in joints and throughout his whole body / body aches; shakes; aching in back muscles; fever up to 101 degrees/ fever; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol) and ibuprofen (Advil).   On 20th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache. On 23rd November 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, chills, joint pain, general body pain, muscular back pain, fever and headache were not recovered/not resolved and the outcome of the fatigue and tremor were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix vaccine on 20th November 2020 friday afternoon. On friday night he had chills.  On 21st November 2020, saturday morning he had fatigue, aching in joints throughout his whole body, chills, shakes, aching in back muscles and fever up to 101 degree F. On 23rd November 2020, 3 days after vaccination the patient had injection site erythema. In less than a week the patient experienced headache. Patient took Tylenol and Advil on Saturday.  The patient had body aches, headache, fever and chills at the time of repoting. The patient had redness around the injection site and just above or below the injection site as well. No further information was available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Herpes zoster, Herpes zoster infection neurological, Oral pustule
Clinical narrative: 7 th cranial nerve affecting the right side of her pallet; Herpes zoster on lip; has a pustule on lip; This case was reported by a nurse via call center representative and described the occurrence of herpes zoster infection neurological in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles thrice). Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than 2 months after receiving Shingrix, the patient experienced herpes zoster infection neurological (serious criteria GSK medically significant), herpes zoster and lip pustule. On an unknown date, the outcome of the herpes zoster infection neurological was unknown and the outcome of the herpes zoster and lip pustule were not recovered/not resolved.   It was unknown if the reporter considered the herpes zoster infection neurological, herpes zoster and lip pustule to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was a retired nurse practitioner and stated a history of shingles on three separate occasions prior to receiving Shingrix and stated previously receiving shingles vaccine in the past.  The 1st dose of Shingrix was administered approximately 2 months ago and scheduled to receive second dose of Shingrix tomorrow that would be day after date of reporting since tomorrow would make 2 months and a day since receiving the first dose of Shingrix.  Approximately 4 days ago, reporter stated breaking out with shingles on her 7th cranial nerve affecting the right side of her pallet and her lip.  Reporter described current outbreak as the mildest of all previous outbreaks and that it feels like outbreak wants to progress but it was not. Reporter stated that the outbreak runs across top of pallet and had a pustule on lip.  Reporter had bloodwork drawn to measure IgG and IgM to determine if immune system was impaired in any way.  Shingles outbreak unresolved but getting better.  Reporter was comfortable forwarding lab work to Safety. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Insomnia, Nausea
Clinical narrative: Body aches / Pain and agony; Extreme chills; Stomach ache; Shortness of breath; Nausea; It kept both of them up last night; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, chills, stomach pain, shortness of breath, nausea and difficulty sleeping. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the chills, stomach pain, shortness of breath, nausea and difficulty sleeping were unknown.   The reporter considered the general body pain, chills, stomach pain, shortness of breath, nausea and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient had an extreme reaction from getting the 1st dose of the Shingrix vaccine. The patient had extreme chills, body aches, stomach pain, shortness of breath, nausea, and was just in pain and agony. The reporter stated that it was so extreme that it kept both of them up last night. The reporter stated it was a rough night for the patient. The reporter also stated it had gotten better and that the patient was over it. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches / Pain and agony; Extreme chills; Stomach ache; Shortness of breath; Nausea; It kept both of them up last night; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, chills, stomach pain, shortness of breath, nausea and difficulty sleeping. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the chills, stomach pain, shortness of breath, nausea and difficulty sleeping were unknown.   The reporter considered the general body pain, chills, stomach pain, shortness of breath, nausea and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient had an extreme reaction from getting the 1st dose of the Shingrix vaccine. The patient had extreme chills, body aches, stomach pain, shortness of breath, nausea, and was just in pain and agony. The reporter stated that it was so extreme that it kept both of them up last night. The reporter stated it was a rough night for the patient. The reporter also stated it had gotten better and that the patient was over it. The reporter did not consent to follow up.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Fatigue, Malaise, Pyrexia, Somnolence
Clinical narrative: had fever; extreme fatigue; was feeling very sleepy; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and GARDASIL for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and GARDASIL. On an unknown date, less than 3 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, fatigue, sleepiness and feeling unwell. On an unknown date, the outcome of the fever, fatigue, sleepiness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue, sleepiness and feeling unwell to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's mother. On 13th June 2019, the patient received the co suspect Meningococcal Vaccine by Sanofi Pasteur. The patient felt very sleepy, had fever, did not feel well and had extreme fatigue which all resolved in 2 days.  The reporter did not know if it was okay to get all the three vaccines on the same day.  It was unknown if the reporter considered the fever, fatigue, sleepiness and feeling unwell to be related to Gardasil  and Meningococcal Vaccine The reporter did not consent to follow-up.  The reporter did not want to provide her address or phone no. and also did not want to provide HCP information. This case has been linked with US2020AMR234292, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234292:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: spontaneous vomiting; experienced diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the vomiting and diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received flu vaccine 10-13 years ago and she experienced diarrhea and spontaneous vomiting which resolved in 2-3 days. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Myalgia, Pain in extremity, Pruritus, Rash
Clinical narrative: Shingles on both inner thighs; Muscle aches; Hamstring pain; Itchiness; Rash on her wrist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received on an unknown date, there were no adverse events).   On 5th November 2020, the patient received the 2nd dose of Shingrix. On 5th November 2020, 1 hr after receiving Shingrix, the patient experienced rash. On 19th November 2020, the patient experienced shingles, muscle pain, pain in thigh and pruritus. On an unknown date, the outcome of the shingles, rash, muscle pain, pain in thigh and pruritus were unknown.   It was unknown if the reporter considered the shingles, rash, muscle pain, pain in thigh and pruritus to be related to Shingrix.  Additional details were provided as follows: After dose 2, the patient experienced a rash on her wrist.  Two weeks after the 2nd dose, the patient experienced muscle aches, hamstring pain, shingles on both inner thighs with itchiness.  Patient had no further contact information available for physician phone number or address. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis, Myalgia, Pain in extremity, Rash, Rash pruritic
Clinical narrative: Shingles on both inner thighs; Muscle aches; Hamstring pain; Itchiness; Rash on her wrist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received on an unknown date, there were no adverse events).   On 5th November 2020, the patient received the 2nd dose of Shingrix. On 5th November 2020, 1 hr after receiving Shingrix, the patient experienced rash. On 19th November 2020, the patient experienced shingles, muscle pain, pain in thigh and pruritus. On an unknown date, the outcome of the shingles, rash, muscle pain, pain in thigh and pruritus were unknown.   It was unknown if the reporter considered the shingles, rash, muscle pain, pain in thigh and pruritus to be related to Shingrix.  Additional details were provided as follows: After dose 2, the patient experienced a rash on her wrist.  Two weeks after the 2nd dose, the patient experienced muscle aches, hamstring pain, shingles on both inner thighs with itchiness.  Patient had no further contact information available for physician phone number or address. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick in bed for 1-2 days; This case was reported by a consumer via call center representative and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 2nd dose of the Shingrix vaccine, he was sick in bed for 1 to 2 days.  The reporter did not consent to follow up
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, 2 days after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. About 2 days after dose of Shingrix, she experienced redness, swelling, and itching at the injection site. The reporter did not consent to follow up. This case is linked to the case US2020240883, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240883:same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced arm soreness; This case was reported by a consumer 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 1st December 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. After receiving the vaccine the patient experienced arm soreness.  The reporter did not consent to follow up. This case is linked to the case US2020240882, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240882:same reporter
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles in her right eye; shingles the right side of her head; pain; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (25 years before reporting).   In October 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 weeks after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and eye pain. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the shingles and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and eye pain to be related to Shingrix.  Additional information was provided as follows: The patient received the first dose of the Shingrix vaccine around last week of October 2020 in her left arm and about two weeks later she started to have shingles on the right side of her head and shingles in her right eye. The patient's physician instructed for her to be seen at the hospital.  At the hospital she was given some treatment. She was not admitted. The patient continued to have shingles and especially the shingles in the right eye was very painful. The patient had shingles about 25 years before reporting and then this was the second time she was having shingles which had not resolved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, Feeling abnormal, Hemiparesis, Incomplete course of vaccination, Pain in extremity
Clinical narrative: Has Bells Palsy as a result; Side of the body on which he received the Shingrix is weak; Sore arm; Felt lousy; First and only dose of Shingrix in June 2020; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), hemiparesis (serious criteria GSK medically significant), pain in arm, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the bell's palsy, hemiparesis, pain in arm, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the bell's palsy, hemiparesis, pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient had a sore arm, and feeling lousy.   He did not elaborate on what feeling lousy entailed.  Also, the patient's unknown side of the body on which he received the Shingrix was weak.  The patient also had bells palsy as a result. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow-up. The patient noted that, he reported this event previously, but call center representative could not find him in the system, or his phone number.  He did not wish to proceed with a safety report and did not wish to give me any demographics or further details.   The patient wanted to know whether he would have a reaction to COVID 19 vaccine due to his Shingrix experienced.   He was referred to his provider.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Hyperhidrosis, Loss of consciousness
Clinical narrative: passed out / passed out for 5 or 10 minutes; she was sweating; shivering; heart palpitations; upset stomach; felt weak for 1 whole day; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2019, 1 days after receiving Shingrix, the patient experienced upset stomach and weakness. In September 2019, the patient experienced passed out (serious criteria GSK medically significant), sweating, shivering and palpitation. On 7th September 2019, the outcome of the upset stomach and weakness were recovered/resolved. In September 2019, the outcome of the passed out, sweating, shivering and palpitation were recovered/resolved.   It was unknown if the reporter considered the passed out, sweating, shivering, palpitation, upset stomach and weakness to be related to Shingrix.  Additional details were provided as follows: 12 hours after receiving Shingrix, the patient was sweating, shivering, had heart palpitations, and then passed out.  The patient reported, she thought she was passed out for 5 or 10 minutes both times but was not sure.  The patient reported the sweating, shivering, and heart palpitations resolved after she woke up from being passed out.  The patient also had an upset stomach and felt weak for 1 whole day and then these events resolved.  The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR253265.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253265:same patient (2nd dose)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: passed out / passed out for 5 or 10 minutes; she was sweating; shivering; heart palpitations; upset stomach; felt weak for 1 whole day; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2019, 1 days after receiving Shingrix, the patient experienced upset stomach and weakness. In September 2019, the patient experienced passed out (serious criteria GSK medically significant), sweating, shivering and palpitation. On 7th September 2019, the outcome of the upset stomach and weakness were recovered/resolved. In September 2019, the outcome of the passed out, sweating, shivering and palpitation were recovered/resolved.   It was unknown if the reporter considered the passed out, sweating, shivering, palpitation, upset stomach and weakness to be related to Shingrix.  Additional details were provided as follows: 12 hours after receiving Shingrix, the patient was sweating, shivering, had heart palpitations, and then passed out.  The patient reported, she thought she was passed out for 5 or 10 minutes both times but was not sure.  The patient reported the sweating, shivering, and heart palpitations resolved after she woke up from being passed out.  The patient also had an upset stomach and felt weak for 1 whole day and then these events resolved.  The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR253265.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253265:same patient (2nd dose)
Sex: U
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; Based on information previously received, the following information [suspect was updated from Sanofi product NOS to influenza vaccine (unknown manufacturer) and classification was delete non-valid] has/have been amended.   Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a media  consumer (patient).  This case involves patient (unknown demographics) who experienced fever (pyrexia) and chills, while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever (pyrexia) and chills (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.