chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLUA4, FLUA3
Symptoms: Sleep disorder
Clinical narrative: Day 1 - muscle soreness within 2 to 3 hours after injection; pain became bad enough at night to impact my sleep Day 2 - significant muscle soreness and weakness remains, plus having chills, lethargy Day 3 - chills and lethargy gone, but significant muscle soreness and weakness remain Day 4 - significant muscle soreness and weakness remain - I've never had this continue for so long after a flu shot. Is this considered adverse? How much longer should this pain and weakness continue? Even typing  or driving a car hurts like crazy.
Age: 66.0
Sex: M
Vaccine: FLUA4, FLUA3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Day 1 - muscle soreness within 2 to 3 hours after injection; pain became bad enough at night to impact my sleep Day 2 - significant muscle soreness and weakness remains, plus having chills, lethargy Day 3 - chills and lethargy gone, but significant muscle soreness and weakness remain Day 4 - significant muscle soreness and weakness remain - I've never had this continue for so long after a flu shot. Is this considered adverse? How much longer should this pain and weakness continue? Even typing  or driving a car hurts like crazy.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Chlamydia test, Circumstance or information capable of leading to medication error, Exposure during pregnancy, Glucose tolerance test, No adverse event
Clinical narrative: the patient had no reaction/adverse event after VARIVAX was given; vaccine exposure during pregnancy; This spontaneous prospective pregnancy report was received from a 23-year-old female patient who was reporting on herself. The patient's medical history included pre-term labor. The patient's concomitant medications included iron supplements. The patient was pregnant with gestation period of 33 weeks and 4 days. No information regarding the patient's drug reactions or allergies was provided.  On 19-AUG-2020, the patient was unintentionally vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # t008129, expiration date reported as ??-MAR-2022, but upon internal validation established as06-MAR-2022, 0.5 milliliter, subcutaneously (anatomic location was not reported). The wrong order was entered and the patient was supposed to receive a lab draw to check "varicella level", however she was vaccinated with  varicella virus vaccine live (oka/merck) (VARIVAX)  instead. The patient's last menstrual period was (LMP) was estimated as 28-DEC-2019 and estimated date of delivery w(EDD) was 03-OCT-2020. The pregnancy outcome was pending. There was no adverse event reported. No treatment was given. The patient had glucose tolerance teat and chlamydia/gonorrhea test performed, however no results were provided. The patient sought for medical attention.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Sexually transmitted disease test
Clinical narrative: the patient had no reaction/adverse event after VARIVAX was given; vaccine exposure during pregnancy; This spontaneous prospective pregnancy report was received from a 23-year-old female patient who was reporting on herself. The patient's medical history included pre-term labor. The patient's concomitant medications included iron supplements. The patient was pregnant with gestation period of 33 weeks and 4 days. No information regarding the patient's drug reactions or allergies was provided.  On 19-AUG-2020, the patient was unintentionally vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # t008129, expiration date reported as ??-MAR-2022, but upon internal validation established as06-MAR-2022, 0.5 milliliter, subcutaneously (anatomic location was not reported). The wrong order was entered and the patient was supposed to receive a lab draw to check "varicella level", however she was vaccinated with  varicella virus vaccine live (oka/merck) (VARIVAX)  instead. The patient's last menstrual period was (LMP) was estimated as 28-DEC-2019 and estimated date of delivery w(EDD) was 03-OCT-2020. The pregnancy outcome was pending. There was no adverse event reported. No treatment was given. The patient had glucose tolerance teat and chlamydia/gonorrhea test performed, however no results were provided. The patient sought for medical attention.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the patient had no reaction/adverse event after VARIVAX was given; vaccine exposure during pregnancy; This spontaneous prospective pregnancy report was received from a 23-year-old female patient who was reporting on herself. The patient's medical history included pre-term labor. The patient's concomitant medications included iron supplements. The patient was pregnant with gestation period of 33 weeks and 4 days. No information regarding the patient's drug reactions or allergies was provided.  On 19-AUG-2020, the patient was unintentionally vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # t008129, expiration date reported as ??-MAR-2022, but upon internal validation established as06-MAR-2022, 0.5 milliliter, subcutaneously (anatomic location was not reported). The wrong order was entered and the patient was supposed to receive a lab draw to check "varicella level", however she was vaccinated with  varicella virus vaccine live (oka/merck) (VARIVAX)  instead. The patient's last menstrual period was (LMP) was estimated as 28-DEC-2019 and estimated date of delivery w(EDD) was 03-OCT-2020. The pregnancy outcome was pending. There was no adverse event reported. No treatment was given. The patient had glucose tolerance teat and chlamydia/gonorrhea test performed, however no results were provided. The patient sought for medical attention.
Age: 25.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was vaccinated with improperly stored vaccine of GARDASIL 9; This spontaneous report was received from a nurse and was referring to a 25 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  On 24-AUG-2020, the patient was vaccinated for prophylaxis with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 ml (Dosage regimen, route of administration and anatomical location were not reported, lot number: S008151 and expiration date: 20-NOV-2021).   The improperly stored of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature of 48.39 F for 1 hour and 45 minutes, without a previous temperature excursion and was call because a digital data logger. No additional adverse event details available. 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: S008151; expirationdate: 21-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: raised area of skin around the injection site; soreness around the injection site; first dose - 11/5/19 - not received the second dose yet; redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved and the outcome of the incomplete course of vaccination was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and reported a raised area of skin around the injection site, redness around the injection site, and soreness around the injection site.  The patient reported the soreness around the site and raised area around the site lasted about a week and then resolved.  The redness around the injection site lasted about 10 days and then resolved. The patient had not received the second dose yet, which led to incomplete course of vaccination. The reporter did not consent to follow up. The reporter did not had lot number or expiration date information to provide. The reporter did not give permission to follow up with HCP.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A patient received 2 doses of Fluzone High Dose in one day /No adverse event; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a patient of unknown demographic who received two doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in one day lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination on an unknown date.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Fatigue, Feeling abnormal, Gastrointestinal motility disorder, Hyperhidrosis
Clinical narrative: gastrointestinal motility; nausea; abdominal cramps; sweating; presyncopy; tired; feeling moderate to severe myalgia and and it woke him up; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 69 years old male patient who experienced feeling moderate to severe myalgia (myalgia), presyncopy (presyncope), abdominal cramps (abdominal pain), sweating (hyperhidrosis), nausea and tired (fatigue) and gastrointestinal motility (gastrointestinal motility disorder) while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Past vaccination included Fluzone High Dose (every year for the last 10 years).  Medical history, medical treatment and family history were not provided.  Concomitant medication was not reported  On 31-Aug-2020 18:00, the patient received a 0.7 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On 01-Sep-2020 01:00, the patient developed a non-serious feeling moderate to severe myalgia (myalgia) 7 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 01-Sep-2020 01:00, the patient developed a non-serious sweating (hyperhidrosis), abdominal cramps (abdominal pain), gastrointestinal motility (gastrointestinal motility disorder), nausea, tired (fatigue) and presyncopy (presyncope) 10 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also reported that he didn't feel like himself but his breathing was ok. States he laid down on the floor and tried to ride it out but if he needed to he could call his wife who was in another room. States he tried to stay awake and felt it wasn't Corona Virus Disease (COVID), has a pulse oximeter but didn't use it and it took him 10-15 minutes to get over it.  Details of laboratory data not reported.    The patient was treated with DICLOFENAC SODIUM (THERMACARE SCHMERZGEL [DICLOFENAC SODIUM]), took 2 PARACETAMOL (TYLENOL) (1000 mg) and IBUPROFEN (ADVIL [IBUPROFEN]) (1000 mg).  On an unknown date, the patient was recovered from the nausea, gastrointestinal motility disorder and abdominal pain. The patient was recovering from the all other events (reported was this morning he feels 60-70 % like himself).  There will be no information available on the batch number for this case.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Presyncope
Clinical narrative: gastrointestinal motility; nausea; abdominal cramps; sweating; presyncopy; tired; feeling moderate to severe myalgia and and it woke him up; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 69 years old male patient who experienced feeling moderate to severe myalgia (myalgia), presyncopy (presyncope), abdominal cramps (abdominal pain), sweating (hyperhidrosis), nausea and tired (fatigue) and gastrointestinal motility (gastrointestinal motility disorder) while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Past vaccination included Fluzone High Dose (every year for the last 10 years).  Medical history, medical treatment and family history were not provided.  Concomitant medication was not reported  On 31-Aug-2020 18:00, the patient received a 0.7 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On 01-Sep-2020 01:00, the patient developed a non-serious feeling moderate to severe myalgia (myalgia) 7 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 01-Sep-2020 01:00, the patient developed a non-serious sweating (hyperhidrosis), abdominal cramps (abdominal pain), gastrointestinal motility (gastrointestinal motility disorder), nausea, tired (fatigue) and presyncopy (presyncope) 10 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also reported that he didn't feel like himself but his breathing was ok. States he laid down on the floor and tried to ride it out but if he needed to he could call his wife who was in another room. States he tried to stay awake and felt it wasn't Corona Virus Disease (COVID), has a pulse oximeter but didn't use it and it took him 10-15 minutes to get over it.  Details of laboratory data not reported.    The patient was treated with DICLOFENAC SODIUM (THERMACARE SCHMERZGEL [DICLOFENAC SODIUM]), took 2 PARACETAMOL (TYLENOL) (1000 mg) and IBUPROFEN (ADVIL [IBUPROFEN]) (1000 mg).  On an unknown date, the patient was recovered from the nausea, gastrointestinal motility disorder and abdominal pain. The patient was recovering from the all other events (reported was this morning he feels 60-70 % like himself).  There will be no information available on the batch number for this case.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event, Wrong patient received product
Clinical narrative: Patient accidentally received a fifth injection of Ipol after already completing the four dose series before/No AE; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old male patient who on 03-Sep-2020 accidentally received a fifth injection of IPV (VERO) [IPOL] after already completing the four dose series before (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL HP) and MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  On an unknown date the patient received first, second, third and fourth dose of suspect IPV (VERO) (lot number and expiry date not reported) via unknown route at an unknown administration site and on 03-Sep-2020, the patient received a 0.5 mL fifth  dose of same vaccine (injection, lot R1B251M and expiry date 13-Mar-2021) via subcutaneous route in the right arm for prophylactic vaccination.  It was an actual medication error case due to extra dose administered.  Case details: It was reported by the nurse that a fill in data entry clerk accidentally pulled up the wrong brother's name (they had very similar names) and the vaccines that were scheduled were given to the wrong brother. Because of this, Ipol was inadvertently given to a 12 year old patient who already had completed the four Ipol injection series and this was an unnecessary dose. The patient did not experience any adverse events due to this.  At the time of reporting, patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number (first, second, third and fourth doses) for this case.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ActHIB was administrated to a patient/ No Ae; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional  This case involves a 15 months old male patient who on 01-Sep-2020 was vaccinated with the dose of expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] vaccine (lot UJ125AG and expiry date 12-Aug-2020) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).   The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was an actual medication error case due to expired vaccine used.   At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Epistaxis, Fall, Lip injury, Nasal injury, Unresponsive to stimuli
Clinical narrative: About 2 minutes after vaccine administration, patient was sitting, mother witnessed her slump forward then suddenly fell forward off exam table, she hit her nose and lip on sink then slumped to the ground face down. Mother called for help, I found patient lying face forward on ground, unresponsive but breathing for about 10 seconds then became alert and able to answer questions. She had small amount of bleeding from the nares, no other signs of injury. She rested on the floor for several minutes then placed on exam table. Monitored for about 20 minutes, able to ambulate, given water and Tylenol PO.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: severe muscular ache, severe headace, shivering overnight.
Age: 11.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Arthralgia, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: The evening of Sept. 8 my sone started to get tow welts on the arm the injections were done, arm was sore and warm to the touch. We have allergy medication and when he woke the morning of Sept 10 almost his entire upper arm was one large welt, red, warm to the touch and he was also running a low grade fever of 100.8. He was complains of pain in his arm and later in the arm it had gone to his shoulder area.
Age: 11.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Urticaria
Clinical narrative: The evening of Sept. 8 my sone started to get tow welts on the arm the injections were done, arm was sore and warm to the touch. We have allergy medication and when he woke the morning of Sept 10 almost his entire upper arm was one large welt, red, warm to the touch and he was also running a low grade fever of 100.8. He was complains of pain in his arm and later in the arm it had gone to his shoulder area.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Pain
Clinical narrative: Experienced low grade fever, headache, joint pain, chills, which progressed into rash all over face, front torso, back, and upper and lower extremities this then progressed into body aches and diarrhea.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Experienced low grade fever, headache, joint pain, chills, which progressed into rash all over face, front torso, back, and upper and lower extremities this then progressed into body aches and diarrhea.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Redness, irritated, rash, itchy, surrounding arm and below injection site, extending to chest area. Patient was advised to take Benadryl and watch for additional issues, none reported. Recovered, but site showed some bruising, that has faded.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus, Rash, Skin irritation
Clinical narrative: Redness, irritated, rash, itchy, surrounding arm and below injection site, extending to chest area. Patient was advised to take Benadryl and watch for additional issues, none reported. Recovered, but site showed some bruising, that has faded.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Unevaluable event
Clinical narrative: Uknown, patient refused to share details with pharmacy staff
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Pain, Product administered at inappropriate site
Clinical narrative: Patient complained of severe pain & swelling at the injection site on the day following vaccination. In-office assessment 2 days after vaccination  revealed   "L anterior and superior shoulder significant swelling and tenderness. No redness or warmth of the joint. no redness @ injection site, injection site- injection was given too high. Severely decreased ROM due to severe pain." Patient was prescribed a methylprednisolone dose pack, opioid pain medication and referred to orthopedics. Was seen by ortho 4 days later.  Symptoms were still present at that time but improved.  No further treatment provided.  Patient scheduled for follow u pin 6 weeks.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Skin warm
Clinical narrative: Headache at base of skull, area of redness greater than 100mm with warmth
Age: 63.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Eye laser surgery, Retinal tear, Visual impairment
Clinical narrative: Patient started having visual changes approximately an hour after receiving vaccinations and was seen an ophthalmologist a few days later (because of the weekend - she received vaccines on Friday 12/20/2019) and had a L side torn retina and received laser eye surgery at that time in ophthalmologist's office and then a 2nd laser surgery about a week after that.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyskinesia, Eyelid disorder, Tic
Clinical narrative: Facial Tics- opening eyes wide, and jerking of the neck to the side.  All day, every day.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: fever, chills, nausea, diarrhea
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information about concomitant medication, current condition or historical condition was provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, batch/lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions by a health care provider (HCP) in a medical group. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a HCP in the same medical group for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: fatigued; muscle aches.; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 2nd dose of Shingrix. On 31st August 2020, less than a day after receiving Shingrix, the patient experienced fever. On 1st September 2020, the patient experienced fatigue and muscle pain. On an unknown date, the outcome of the fever, fatigue and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, fatigue and muscle pain to be related to Shingrix.  Additional information was provided as follows: The patient stated that he/she received shingle shot yesterday morning. The patient developed fever and this morning at the time of reporting, 1 day after receiving vaccine the patient was fatigue and muscle aches. The patient wanted to know how long did these side effects last. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: muscle aches; fatigued; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 2nd dose of Shingrix. On 1st September 2020, 1 days after receiving Shingrix, the patient experienced muscle pain and fatigue. In September 2020, the patient experienced fever. On an unknown date, the outcome of the fever, muscle pain and fatigue were unknown.   It was unknown if the reporter considered the fever, muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and developed fever,fatigued and muscle aches. The reporter asked long did these side effects last.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: numbness in my right hand; This case was reported by a consumer via call center representative and described the occurrence of numbness in hand in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced numbness in hand. On an unknown date, the outcome of the numbness in hand was unknown.   It was unknown if the reporter considered the numbness in hand to be related to Shingrix.  Additional details were reported as follows: The patient got the Shingrix shot in his left deltoid and experienced numbness in his right hand. The patient wanted to know whether numbness in hand could be caused by the vaccine and also whether there were other side effects of the Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue post injection; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient asked duration of fatigue post Shingrix injection.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Myalgia, Peripheral swelling
Clinical narrative: have been very dizzy; had significant muscle pain; swelling in the arm in which it was given; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix. On 3rd September 2020, 1 days after receiving Shingrix, the patient experienced dizziness. In September 2020, the patient experienced muscle pain and swelling arm. On an unknown date, the outcome of the dizziness, muscle pain and swelling arm were unknown.   It was unknown if the reporter considered the dizziness, muscle pain and swelling arm to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in unknown arm. The patient experienced dizziness, significant muscle pain and swelling in the arm in which vaccine was given after vaccination. The reporter asked whether these were possible side effects of vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: hospital with flu never again no shots for me/ Suepctd VF; hospital with flu never again no shots for me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of malaise (received flu vaccine and got sick, refer case US2020AMR180806).   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and influenza (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu shot in 2016 and patient was hospitalized 2 days in hospital with flu. The patient stated that the patient never had shot again. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratoty confirmation was not known.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR180806:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Near death experience
Clinical narrative: Guillane Barre Syndrome; It nearly killed him; struggles with numb hands and feet; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a 50-year-old male 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 guillain barre syndrome (serious criteria hospitalization and GSK medically significant), near death experience (serious criteria hospitalization and GSK medically significant) and numbness of extremities. On an unknown date, the outcome of the guillain barre syndrome and near death experience were recovered/resolved and the outcome of the numbness of extremities was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, near death experience and numbness of extremities to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Guillane Barre Syndrome from the flu shot. It nearly killed the patient. The patient was in ICU for weeks and the recovery process was months.  The patient was still struggles with numb hands and feet 5 years later.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Injection site pain, Joint swelling, Muscle spasms
Clinical narrative: pain at the injection site / injection site started to hurt again; on his right leg only "painful cramps; swollen - leg / Heel and foot are still - swollen /; painful leg, foot and heel / inner thigh is starting to hurt again; Painful ankle; knee area was so swollen; patient could not walk; patient had fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date on right arm and experienced fever. For the tolerance of 1st dose, refer linked case US2020AMR176846).   On 26th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain, leg cramps, swelling of legs, pain in extremity, pain ankle, swelling of knees, gait inability and fever. The patient was treated with analgesic, nos (Pain Killer). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, swelling of legs, pain in extremity and pain ankle were not recovered/not resolved and the outcome of the leg cramps, swelling of knees, gait inability and fever were unknown.   It was unknown if the reporter considered the injection site pain, leg cramps, swelling of legs, pain in extremity, pain ankle, swelling of knees, gait inability and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient. The patient received Shingrix in the left arm.  After receiving Shingrix, the patient had pain at the injection site that last a couple of weeks.  Few days after the 2nd dose of Shingrix, the patient had on his right leg only painful cramps in the inside of his thigh, midway in between hip and knee.  The patient had swollen and painful leg, foot, ankle and heel.  The knee area was so swollen his kneecap wiggled around.  The patient could not walk.  Till the time of reporting, heel and foot were painful and swollen 6 months after vaccine. The patient took medications for pain. The patient's inner thigh was starting to hurt again and still had swelling in his leg at the time of reporting.  The patient's injection site started to hurt again when the patient recently started exercising the shoulder area. The patient had fever. The reporter consented to follow up. This case was linked with case US2020AMR176846, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR176846:same patient
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: pain at the injection site / injection site started to hurt again; on his right leg only "painful cramps; swollen - leg / Heel and foot are still - swollen /; painful leg, foot and heel / inner thigh is starting to hurt again; Painful ankle; knee area was so swollen; patient could not walk; patient had fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date on right arm and experienced fever. For the tolerance of 1st dose, refer linked case US2020AMR176846).   On 26th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain, leg cramps, swelling of legs, pain in extremity, pain ankle, swelling of knees, gait inability and fever. The patient was treated with analgesic, nos (Pain Killer). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, swelling of legs, pain in extremity and pain ankle were not recovered/not resolved and the outcome of the leg cramps, swelling of knees, gait inability and fever were unknown.   It was unknown if the reporter considered the injection site pain, leg cramps, swelling of legs, pain in extremity, pain ankle, swelling of knees, gait inability and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient. The patient received Shingrix in the left arm.  After receiving Shingrix, the patient had pain at the injection site that last a couple of weeks.  Few days after the 2nd dose of Shingrix, the patient had on his right leg only painful cramps in the inside of his thigh, midway in between hip and knee.  The patient had swollen and painful leg, foot, ankle and heel.  The knee area was so swollen his kneecap wiggled around.  The patient could not walk.  Till the time of reporting, heel and foot were painful and swollen 6 months after vaccine. The patient took medications for pain. The patient's inner thigh was starting to hurt again and still had swelling in his leg at the time of reporting.  The patient's injection site started to hurt again when the patient recently started exercising the shoulder area. The patient had fever. The reporter consented to follow up. This case was linked with case US2020AMR176846, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR176846:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lethargy, Pain in extremity, Rash, Rash macular
Clinical narrative: Arm Soreness; Lethargy; Rash; Small blotchy area towards her left back; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, 48 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the patient experienced pain in arm, lethargy and rash. On an unknown date, the outcome of the pain in arm, lethargy and rash were recovered/resolved and the outcome of the erythema was recovering/resolving.   It was unknown if the reporter considered the pain in arm, lethargy, rash and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient had left arm soreness, lethargy, and a rash on her left side.   The patient also noticed a small blotchy area towards her left back but that it was disappearing.   The patient wanted to know if getting the 2nd dose of Shingrix would be contraindicated because of the rashes.  The reporter did not consent to follow-up. No information was given.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Reaction to it because it contained latex; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis.   Concurrent medical conditions included latex allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2016-2017 season (intramuscular). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent 2016-2017 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that 3 or 4 years ago in 2016 or 2017 got a flu shot and was not sure it was Fluarix but thinks that was the name of it and had a reaction to it because it contained latex. The patient said that she received the shot intramuscularly in the left deltoid via pre-filled syringe. The caller was the patient and did not want to share her email or date of birth.  The patient did not had a personal fax number. The patient was calling to make sure that Fluarix Quadravalent 2020-2021 prefilled syringes have no latex in them.  The patient doctor had called the manufacturer possibly GSK of the flu shot prior to giving the shot to confirm it was latex free and he was told the vaccine was latex free but they were referring to the vials not the pre-filled syringes.   The reporter wanted this information shared with GSK safety department because she believes that her doctor received incorrect and misleading information.  After that the doctor began ordering using the vials instead of the pre-filled syringes. The reporter did not want to share her MD contact name. and said that she was living in another state when she had the reaction.   No further questions were asked.  The reporter was calling from her allergist's waiting room. The reporter did not consent to follow up. The Reporter provided limited information and did not want to share her MD contact name.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site mass, Injection site rash, Injection site swelling
Clinical narrative: lump the size of a quarter / a non-tender lump; redness; some swelling; This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA197A, expiry date unknown) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Menveo (intramuscular). On 20th July 2020, 19 days after receiving Menveo, the patient experienced injection site lump, injection site erythema and injection site swelling. On 1st September 2020, the outcome of the injection site lump, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: The patient received Menveo and had lump the size of a quarter, that was a non-tender lump, with redness and some swelling.  The patient had not contacted again HCP, so HCP thinks patient had recovered from the lump.  The exact dates of onset could not provide but an estimate was given by reporter. The reporter consented to follow up. The HCP mentioned Menveo was given subcutaneously but then said that it was intramuscular administration. This case linked with US2020176182, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176182:same reporter
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: lump the size of a quarter / non-tender lump; redness; swelling; This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA197A, expiry date unknown) for prophylaxis.   On 14th July 2020, the patient received the 1st dose of Menveo (intramuscular). On 28th July 2020, 14 days after receiving Menveo, the patient experienced injection site lump, injection site erythema and injection site swelling. On 1st September 2020, the outcome of the injection site lump, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: The patient received Menveo and had lump the size of a quarter, that was a non-tender lump, with redness and some swelling.  The patient had not contacted again HCP, so HCP thinks patient had recovered from the lump.  The exact dates of onset could not provide but an estimate was given by reporter. The reporter consented to follow up. The HCP mentioned Menveo was given subcutaneously but then said that it was intramuscular administration. This case linked with US2020176181, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176181:same reporter
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Engerix-B on 18-Mar-2020 and the second dose on 05-Aug-2020 as could not get them on time due to pandemic situation.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 68-year-old male patient who received HBV (Engerix B) (batch number H2T35, expiry date 29th May 2020) and (batch number B79CS, expiry date 20th May 2022) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in 18th March 2020 (batch number: B79CS, expiry date 20th May 2022)).   On 5th August 2020, the patient received the 2nd dose of Engerix B. On 18th March 2020, the dose was an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination is not applicable. The patient received the first dose of Engerix-B on 18th March 2020 and the second dose on 5th August 2020 as could not get them on time due to pandemic situation. The reporter consented to follow up.