chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Tinnitus
Clinical narrative: Received 2nd dose of Shingrix vaccine at pharmacy by pharmacist. 5 hours later experienced severe chills, shivering at night in bed, got up at 9:30 am and immediately noticed hissing in both ears, face flushed and red, feverish feeling, had difficulty concentrating as if had a brain fog, the next day had a bad headache, still had chills and hissing noise in both ears. Did not have this ear noise prior to getting vaccine. 4 days later still had hissing in ears and feeling unwell, went to Urgent Care and they said immune system did not like something in the vaccine, inflammatory reaction, prescribed 5 day course of prednisone which improved symptoms but after finishing course the hissing in ears returned. Went to family doctor who said he was not aware of this reaction from anyone after a shingles vaccine but he did not give them..he did blood work and said if ear noise continued go to an ENT doctor. He did not prescribe anything for me for this.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient developed fever 101F, chills, myalgias approximately 15 hours after receiving vaccine. Patient well-appearing, no other signs or symptoms of illness, no known sick contacts. Seen in clinic approximately 20 hours after vaccine administration.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal distension, Arthralgia, Asthenia, Fatigue, Muscle discomfort
Clinical narrative: I have received a seasonal flu shot every year for the last 20 years with almost no symptoms ever. This is the first year I have had three days of moderate body aches. No fever after 24 hours, 99.0 Fahrenheit. Whole body felt puffy bloated. General muscular discomfort whole body. Joint pain. I went for a walk at 1 PM approximately 24 hours after the injection. During the walk I pulled a muscle in my low back whole body felt achy.  I took some ibuprofen and felt some relief. The moderate body aches, joint pain, muscle aches, weakness and tiredness continued for four days.  I finally started to feel good on Thursday the fifth day.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle strain, Pain, Pyrexia
Clinical narrative: I have received a seasonal flu shot every year for the last 20 years with almost no symptoms ever. This is the first year I have had three days of moderate body aches. No fever after 24 hours, 99.0 Fahrenheit. Whole body felt puffy bloated. General muscular discomfort whole body. Joint pain. I went for a walk at 1 PM approximately 24 hours after the injection. During the walk I pulled a muscle in my low back whole body felt achy.  I took some ibuprofen and felt some relief. The moderate body aches, joint pain, muscle aches, weakness and tiredness continued for four days.  I finally started to feel good on Thursday the fifth day.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Injection site pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch. Pain at injection site. This is my second vaccine for this in 1.5 years. I got both during pregnancies . My first baby was born and weighed 8lbs 1oz. My second baby is due February 12, 2021
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: she was instructed to continue topical tretinoin cream and also obtain human papillomavirus (HPV) immunization; Literature report: Pediatric Dermatology. 2020.  This literature marketed report has been received from authors of the literature article entitled as stated above. Treatment of verruca plana was often challenging, and multiple treatment modalities, both pharmacologic and destructive, were frequently necessary to clear lesions.  This report referred to a 16-year-old girl presented to the dermatology clinic with a 2-year history of asymptomatic, flesh-colored, flat, polygonal papules of the forehead, temples and upper periorbital skin. She reported fairly rapid onset and gradual growth of papules to current size. She had previously seen another physician and had been misdiagnosed with acne vulgaris. Subsequently, she was prescribed topical 0.1% tretinoin cream, which she had used aggressively prior to dermatology evaluation. On dermatology evaluation, she was diagnosed with verruca plana. After treatment options were discussed, the patient decided to pursue photodynamic therapy (PDT) but wanted to delay her treatment for several months. In the meantime, she was instructed to continue topical tretinoin cream.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (dose, strength, route, lot# and expiration date were unknown) for verruca plana (off label use).  When the patient presented for follow-up six weeks later, she reported an approximate 50% improvement in the number of lesions and requested delay of PDT in favor of continuing current treatment. Six weeks after that, her skin had completely cleared. She had still only obtained her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) immunization but pledged to get the second and third doses.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: TEMPERATURE EXCURSION; This spontaneous report has been received from licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 02-NOV-2020,  the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) formulation not reported but defaulted to subcutaneous injection, 0.5 milliliter, Lot # t006345, expiration date 20-FEB-2022 for prophylaxis (dosage regimen and patient route of administration were not reported).   The temperature was reported to had been at -13.9°Celsius (°C) to -14.7°C . For 30 minutes, the temperature was in between -14°C to -10°C (-13.9°C). For 15 minutes, the temperature was in between -14°C to -10°C (-14.2°C). For 20 minutes, the temperature was in between -14°C to -10°C (-14.7°C). For 5 minutes, the temperature was in between -14°C to -10°C (-14.6°C).There was digital data logger involved.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: no additional AE; expired GARDASIL 9 lhat was accidently administered to a patient today; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-NOV-2020, the patient was vaccinated with expired first of three in series dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # N035032 with expiration date on 24-SEP-2020 (route of administration and anatomical location was not reported) for prophylaxis. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Foetal exposure during pregnancy
Clinical narrative: Maternal exposure timing unspecified; This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age.   The patient had a history of 1 previous pregnancy and 1 live birth(s) and she was second gravida. It was mentioned that in the previous pregnancy  was not reported birth defects. Pertinent  medical history, current conditions and concomitant medications were reported as none.  The patient became pregnant with last menstrual period (LMP) reported as  on 14-APR-2020 and estimated date of delivery (EDD)  reported as on 19-JAN-2021.   On 10-AUG-2020 a maternal serum alpha-fetoprotein was performed, and the result showed was normal; On 11-SEP-2020, an ultrasound was performed, and the results was reported as normal anatomy.   On 11-NOV-2020,  the patient was vaccinated with a first  dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe lot # R030453, expiration date not reported, but upon internal validation established as: 23-JUL-2021 for prophylaxis (dose, and  route of administration, were not reported).   The patient became pregnant with last menstrual period (LMP) reported as  on 14-APR-2020 and estimated date of delivery (EDD)  reported as on 19-JAN-2021.   The therapy was taken during the third trimester of pregnancy (maternal exposure during pregnancy). The pregnancy outcome was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; 2 year old male patient received a partial dose of GARDASIL 9; 2 year old male patient received a partial dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a 2-year-old male patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-NOV-2020, the patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot # and expiration date not reporterd) intramuscularly (IM) for prophylaxis (Product administered to patient of inappropriate age).  The vaccine was meant for the patient's sister, once the nurse realized the vaccine was not meant for the patient, she stopped administration and as a result, the patient only received a partial dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Incorrect dose administered). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first shot and 2 days later got Shingles.  The patient asked if he or she should decline 2nd Shot.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Hyperhidrosis
Clinical narrative: Tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of rash erythematous (1st dose received on 6th November 2020 on Friday, and patient experienced chills, intense pain around the injection site,pain in her joints, back, feet and hands, nausea, sweating and chills.) and Zostavax.   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 tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness. At the time of call patient mentioned she gots the flu shot. She could not provide any additional information. The reporter did not consent to follow up. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222199:same reporter US-GLAXOSMITHKLINE-US2020222182:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Nausea, Pain in extremity, Rash erythematous
Clinical narrative: Tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of rash erythematous (1st dose received on 6th November 2020 on Friday, and patient experienced chills, intense pain around the injection site,pain in her joints, back, feet and hands, nausea, sweating and chills.) and Zostavax.   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 tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness. At the time of call patient mentioned she gots the flu shot. She could not provide any additional information. The reporter did not consent to follow up. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222199:same reporter US-GLAXOSMITHKLINE-US2020222182:same reporter
Sex: F
Vaccine: MEN
Symptoms: Influenza
Clinical narrative: starting having flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a year after receiving Meningococcal B vaccine, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter just gave that shot all together with other three that she needed and the reaction was horrible. The reporter never got any kind of reactions before to any other regular vaccine but for this new one. Since that garbage she started having flu very often which never had happened.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Localized muscle pain, at the site of the injection; Fever (100.9); This case was reported by a consumer via interactive digital media and described the occurrence of injection site muscle pain in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site muscle pain and fever. On an unknown date, the outcome of the injection site muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient had body temperature test which results 100.9 degree F. After receiving 1st dose of Shingrix, the patient experienced localized muscle pain, at the site of the injectionand fever. The reporter reported that ycan you estimate how long these side effect symptoms might last. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 2nd dose / Significant arm pain again; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 69-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 unknown date.. please refer the case US2020AMR226395).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced significant arm pain upon 2nd dose. The reporter does believe pain was related Shingrix administration.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR226395:Same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Contusion, Gait disturbance, Hypersensitivity, Injection site discomfort
Clinical narrative: might be an allergic reaction; She could barely walk; It hurt to touch them as if they were bruised; they were bruised; injection site soreness/ It did hurt during administration; Injection site swelling; Significant knee pain (joint pain) inside both of her knees; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (of the toes and lower spine).   On 30th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced allergic reaction, knee pain, walking difficulty, tenderness and contusion. On 30th October 2020, the patient experienced injection site pain and injection site swelling. On 6th November 2020, the outcome of the knee pain and tenderness were recovered/resolved. On an unknown date, the outcome of the allergic reaction, walking difficulty and contusion were unknown and the outcome of the injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, knee pain, walking difficulty, tenderness and contusion to be related to Shingrix. The reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient had shot 1 of Shingrix in the left deltoid. The patient did not have the lot number. The patient was not sure if it was given intramuscularly because she looked away and did not see how long the needle was. The patient said that it hurt during administration and she said that her pharmacist told her that Shingrix tends to hurt and the injection site area was swollen and sore afterwards. The injection site soreness and swelling resolved after 2-3 days.   Within 24 hours after the Shingrix shot the patient had significant knee pain (joint pain) inside both of her knees and she could barely walk. It hurt to touch them as if they were bruised.  The patient wanted to report that she had no other change other than the Shingrix shot. She had no change to her diet or to her activity level. The patient reported the knee pain to her pharmacist and to her physician. The patient was concerned it might be an allergic reaction to Shingrix. She was concerned about whether or not she should get the second shot. The patient did some research online and she said she found in some online forums that others had reported joint pain. The knee pain lessoned and was resolved one week later.  The had a history of arthritis in her toes and lower spine and was on a unspecified medication and that arthritis did not flare up after the Shingrix shot. But the patient never had a problem with her knees before. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Injection site swelling, Tenderness
Clinical narrative: might be an allergic reaction; She could barely walk; It hurt to touch them as if they were bruised; they were bruised; injection site soreness/ It did hurt during administration; Injection site swelling; Significant knee pain (joint pain) inside both of her knees; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (of the toes and lower spine).   On 30th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced allergic reaction, knee pain, walking difficulty, tenderness and contusion. On 30th October 2020, the patient experienced injection site pain and injection site swelling. On 6th November 2020, the outcome of the knee pain and tenderness were recovered/resolved. On an unknown date, the outcome of the allergic reaction, walking difficulty and contusion were unknown and the outcome of the injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, knee pain, walking difficulty, tenderness and contusion to be related to Shingrix. The reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient had shot 1 of Shingrix in the left deltoid. The patient did not have the lot number. The patient was not sure if it was given intramuscularly because she looked away and did not see how long the needle was. The patient said that it hurt during administration and she said that her pharmacist told her that Shingrix tends to hurt and the injection site area was swollen and sore afterwards. The injection site soreness and swelling resolved after 2-3 days.   Within 24 hours after the Shingrix shot the patient had significant knee pain (joint pain) inside both of her knees and she could barely walk. It hurt to touch them as if they were bruised.  The patient wanted to report that she had no other change other than the Shingrix shot. She had no change to her diet or to her activity level. The patient reported the knee pain to her pharmacist and to her physician. The patient was concerned it might be an allergic reaction to Shingrix. She was concerned about whether or not she should get the second shot. The patient did some research online and she said she found in some online forums that others had reported joint pain. The knee pain lessoned and was resolved one week later.  The had a history of arthritis in her toes and lower spine and was on a unspecified medication and that arthritis did not flare up after the Shingrix shot. But the patient never had a problem with her knees before. The reporter consented to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chill; muscle pain; Fever 103-104°F; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix. On 4th November 2020, 1 days after receiving Shingrix, the patient experienced chills, muscle pain and fever. On an unknown date, the outcome of the chills, muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient was administrated the first dose of Shingrix and the day after the administration of the vaccine the patient experienced fever of 103-104 degrees F, chills and muscle pain. The patient was having the symptoms till the time of reporting. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: severe fever; aches / soreness; severe nausea; dizziness; received the 1st dose of Shingrix on 29Aug2018 / the 2nd one on 25Sep2018; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 37KL2, expiry date 12th February 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th September 2018, the patient received the 2nd dose of Shingrix. On 25th September 2018, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced fever, general body pain, nausea and dizziness. On an unknown date, the outcome of the fever, general body pain, nausea, dizziness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fever, general body pain, nausea and dizziness to be related to Shingrix.  Additional details were provided as follows: After receiving 2nd dose of Shingrix, the patient experienced fever, aches, soreness, nausea, dizziness and said it was the worst thing she had ever experienced in the world. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up. The case was considered as medication error with harm. This case has been linked with US2020223963, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223963:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 26th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported, but could be 59 or 60 years. The patient received Flu vaccine approximately on 26th October 2020. The patient presented an anaphylactic reaction after administration of Flu vaccine approximately two weeks ago from the time of reporting. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult 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 injection site erythema. On 12th November 2020, the outcome of the injection site erythema was recovered/resolved.   The reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the dose of shingrix and after that experienced redness at the injection site which was lasted for 6 days. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Pyrexia, Sinusitis, Somnolence
Clinical narrative: feel terrible; low grade fever; felt like he had a sinus infection; was very tired; sleepping/napping; napping; never went back for shot #2 and now is past the six month window; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles outbreak November 2017 to January  2018 caused by extreme stress) and fever blister.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise, fever, sinus infection, tiredness, somnolence, sleep disorder and incomplete course of vaccination. On an unknown date, the outcome of the malaise, somnolence, sleep disorder and incomplete course of vaccination were unknown and the outcome of the fever, sinus infection and tiredness were recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix. The reporter considered the fever, sinus infection, tiredness, somnolence and sleep disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient.  The patient received Shingrix in pharmacy in spring 2019 intramuscularly in the left deltoid. The reporter did not had the exact date of the shot in front of him and did not had paperwork given to him by the pharmacy thus did not have the lot number or expiration date. The reporter never went back for shot 2 and was past the six month window, which led to incomplete course of vaccination. The patient feel terrible for a weekend and asked to elaborate on this and said that this was over a year ago so cannot remember exactly but from what did not remember was very tired and so he was sleeping, napping and felt like he had a sinus infection and had a low grade fever. These events resolved. The reporter did not consent to follow up and did not want to provide MD contact information. The reporter provided a personal email address and did not had a personal fax number and did not want to give his exact date of birth but did state was currently age 64 and was born in 1956.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious social media case from the patient.  This case involves an unknown demographic patient who had pneumonia, after the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not reported.   On an unknown date, the patient received the first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for the prophylactic vaccination.  On an unknown date, the patient developed serious pneumonia, (unknown latency) following the administration of INFLUENZA VACCINE.   This event was assessed as medically significant.  It was reported that, the pneumonia can be a side effect of flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was not reported for pneumonia.  Information on the batch number was requested.; Sender's Comments: This poorly document social media case concerns an unknown demographic patient who had pneumonia, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Impaired work ability, Streptococcal infection, Streptococcus test positive, Upper respiratory tract infection
Clinical narrative: upper respiratory infection; viral infection tested positive for strep infection; Initial information received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who developed an upper respiratory infection (upper respiratory tract infection) and tested positive for strep. infection (streptococcal infection), after receiving INFLUENZA VACCINE.  Concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergy to raw eggs.  On an unknown date in 1995, the patient received first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious events of an upper respiratory infection (upper respiratory tract infection) and viral infection tested positive for strep infection and could not work for 2 weeks (streptococcal infection), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these reported events on an unknown date.  The patient also received the shot this year for the first time with the pneumonia shot and was good.  Other relevant laboratory data was not reported.  It was not reported if the patient was receiving any corrective treatment.  At the time of reporting, the outcome was not reported for both the events.  Information on the batch number to be requested.; Sender's Comments: This poorly documented social media case concerns a patient of unknown demographics who had upper respiratory tract infection and streptococcal infection, after vaccination with INFLUENZA VACCINE. Time to onset is unknown. The patient was allergic to raw eggs. Moreover, patient's other medical condition at the time of vaccination, concomitant medication and family history were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Pertussis
Clinical narrative: whooping cough; Initial information was received on 09-Nov-2020 regarding an unsolicited valid serious social media case from a consumer via social media.  This case involves a male patient (unknown age), who experienced whooping cough (pertussis), while the patient was treated with INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking INFLUENZA VACCINE produced by unknown manufacturer, (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious whooping cough (pertussis) (unknown latency) following the INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for the event at the time of reporting.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly document case received from social media concerns a male patient (unknown age) who had pertussis after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown.  Additional information regarding medical history, condition at the time of vaccination, concomitant medications, laboratory investigation ruling out other etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: she had been suffered with pain at the injection site at her left shoulder; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via call center.  This case involves a 69-year-old female patient who had been suffered with pain at the injection site at her left shoulder (injection site pain), while on influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2020 (3 weeks ago), the patient received on influenza quadrival a-b high dose hv vaccine, (formulation, strength, dose, frequency, batch number, expiration date, route of administration was unknown) at a 1 time dose in the right arm for prophylactic vaccination.  On 19-Oct-2020, 22 days after starting the suspect vaccine therapy it was reported that she had been suffering with pain at the injection site at her left shoulder. She contacted her HCP who advised her to treat it with interchanging heat and ice. Because the patient was still hurting today.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not resolved.  There will be no information available regarding batch number in this case.  No further relevant information was reported.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Fainted; This spontaneous case was received on 13-Nov-2020 from pharmacist via The Agency (reference number: SEQW20-05088) and concerned a 12-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 11-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, indication: not reported). The batch number reported was P100264371 and expiry date reported was 30-Jun-2021.  On the same day, after receiving Afluria Quadrivalent, the patient fainted.  On the same day, the patient recovered from the event as it was reported that she regained conscience immediately after and no further reaction occurred.  The reporter did not provide causality assessment.  The event of 'faint' was considered to be medically significant by a Physician within Company's Risk Management Department.  Company comment:The patient developed syncope on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed syncope on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint swelling, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Very hard to do daily tasks like getting dressed/interfering with daily activities like getting dressed; Her arms hurt/right arm aches; Hands and ankles swollen; Hands and ankles swollen; Difficulty bending her finger; This spontaneous case was received on 13-Nov-2020 from other non-health professional via regulatory authority and concerned a 75-year-old, female patient.    The patient's concurrent condition included high blood pressure controlled with medication. The patient's concomitant medications included ramipril, HCTZ (hydrochlorothiazide) unspecified probiotics, vitamin D and Loratadine D (loratadine, pseudoephedrine hydrochloride), all used for unreported indications.   On 23-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, right arm) for flu prophylaxis. The batch number was not reported.   On 25-Sep-2020, two days after receiving Fluad Quadrivalent, the patient experienced right arm aches, her arms hurt, hands and ankles were swollen. The patient had difficulty bending her finger and found it very hard to do daily tasks like getting dressed.   On an unknown date in 2020, the patient started taking ibuprofen, three in the morning and before she went to bed at night. Symptoms went away with ibuprofen, but they were getting worse and were interfering with daily activities.   At the time of initial reporting on 13-Nov-2020, the patient had not recovered from the events, as the symptoms had not resolved and had been getting worse overtime.  The reporter did not provide a causality assessment.   The event of 'activities of daily living impaired' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 75-year-old, female patient was administered Fluad Quadrivalent vaccine. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, peripheral swelling and joint swelling. Reportedly, the patient had difficulty bending her finger and found it very hard to do daily tasks like getting dressed. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 75-year-old, female patient was administered Fluad Quadrivalent vaccine. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, peripheral swelling and joint swelling. Reportedly, the patient had difficulty bending her finger and found it very hard to do daily tasks like getting dressed. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: PT received half of the full dose of Influenza due to faulty valve.
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Product storage error
Clinical narrative: thought to be allergic reaction; redness at injection site; Vaccines administered after temperature excursion; Information has been received from the reporting registered nurse referring to a child of unknown age and gender. The patient was reported as no illness at time of vaccine after wellness exam. And the patient was reported with no current medical condition and no known allergies.   On an unknown date, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # T013537, expiration date 17-OCT-2021) (strength and dose were not reported) subcutaneously on the left thigh for prophylaxis. On an unspecified date, the door of freezer was left ajar and the vaccine underwent temperature excursion to 15 degrees Fahrenheit for less than 15 minutes without any previous temperature excursion; The digital data logger which was involved in recording excursion details. And the child returned the next day with redness at injection site. It was thought to be an allergic reaction. The child was sent home with instruction to take diphenhydramine hydrochloride (BENADRYL). The reaction on its arm was reported as resolved. The causality between both events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA011529:
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pain, Pyrexia
Clinical narrative: Overall pain; Fever; Stomach issue; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced general body pain, fever and stomach discomfort. On an unknown date, the outcome of the general body pain, fever and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, fever and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient was curious how long overall pain, fever and stomach issue might last.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 7 days 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 details were reported as follows: The reporter was patient's husband. The age at vaccination was not reported. The reporter did not consent to follow-up. The case has been linked to US2020222174, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222174:same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Dizziness, Hyperhidrosis, Localised oedema
Clinical narrative: nausea; sweat; body ache; Chest pain/ 3 episodes of Chest pain in 24 hrs; Chills; Localized Swelling; dizziness; This case was reported by a physician via call center representative and described the occurrence of local swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced local swelling, dizziness, nausea, sweating, general body pain, chest pain and chills. On an unknown date, the outcome of the local swelling, dizziness, nausea, sweating, general body pain and chest pain were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the local swelling, dizziness, nausea, sweating, general body pain, chest pain and chills to be related to Shingrix.  Additional details were reported as follows: The physician reported that patient presented localized swelling, 4 days of dizziness, nausea , sweat and chills, body ache, 3 episodes of chest pain in 24 hours after the first dose of Shingrix. The reporter consented to follow up. This case is linked with case US2020222218, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222218:(Deleted- No GSK product)