chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site pain, Limb discomfort
Clinical narrative: pain at the injection site; chills; muscle aches everywhere; headache; nausea; extreme pain / painful to move the right arm; arm is feeling too heavy to lift / feels like deadweight with extreme pain when I go to move it; arm is feeling too heavy to lift / limited mobility around the injection site (from the upper arm to the shoulder) / painful to move the right arm / feels like deadweight with extreme pain when I go to move it; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 3 days after receiving Shingrix, the patient experienced injection site pain, chills, muscle pain, headache, nausea, pain, heaviness in arm and mobility decreased. In October 2020, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain and pain were not recovered/not resolved and the outcome of the chills, muscle pain, headache, nausea, heaviness in arm and mobility decreased were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the injection site pain, chills, muscle pain, headache, nausea, pain, heaviness in arm, mobility decreased and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the upper right arm and not feeling well. The patient experiencing chills, muscle aches everywhere, headache, and nausea.  These lasted from the evening of getting the shot up to 48 hours after and stated everything had resolved, except the pain at the injection site.  The patient was still had extreme pain; arm was feeling too heavy to lift.  There was limited mobility around the injection site from the upper arm to the shoulder, feels like deadweight with extreme pain when go to move it and states it was painful to move the right arm. The reporter did not consent to follow up. Not all information was available.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Nausea, Pain
Clinical narrative: pain at the injection site; chills; muscle aches everywhere; headache; nausea; extreme pain / painful to move the right arm; arm is feeling too heavy to lift / feels like deadweight with extreme pain when I go to move it; arm is feeling too heavy to lift / limited mobility around the injection site (from the upper arm to the shoulder) / painful to move the right arm / feels like deadweight with extreme pain when I go to move it; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 3 days after receiving Shingrix, the patient experienced injection site pain, chills, muscle pain, headache, nausea, pain, heaviness in arm and mobility decreased. In October 2020, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain and pain were not recovered/not resolved and the outcome of the chills, muscle pain, headache, nausea, heaviness in arm and mobility decreased were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the injection site pain, chills, muscle pain, headache, nausea, pain, heaviness in arm, mobility decreased and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the upper right arm and not feeling well. The patient experiencing chills, muscle aches everywhere, headache, and nausea.  These lasted from the evening of getting the shot up to 48 hours after and stated everything had resolved, except the pain at the injection site.  The patient was still had extreme pain; arm was feeling too heavy to lift.  There was limited mobility around the injection site from the upper arm to the shoulder, feels like deadweight with extreme pain when go to move it and states it was painful to move the right arm. The reporter did not consent to follow up. Not all information was available.
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral
Clinical narrative: slight neuropathy; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a adult female patient who received Flu Seasonal TIV Quebec (FluLaval 2012-13 season) (batch number AFLLA733AA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval 2012-13 season. On an unknown date, unknown after receiving FluLaval 2012-13 season, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown.   It was unknown if the reporter considered the neuropathy to be related to FluLaval 2012-13 season.  Additional details were provided as follows: Age at vaccination was not reported but it could be 53 years or 54 years. The patient experienced slight neuropathy after receiving the Flulaval in 2012. The batch number of FluLaval  was reported as ASLLA733AA was corrected to AFLLA733AA as per sales data sheet. The reporter did not consent to follow-up.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pharmacist administered 13 year old patient with Flublok, no adverse event; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA278793 (17 years old, same reporter).  This case involved a 13 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number-QFAA2047, expiration date- 30-Jun-2021) via an unknown route in left upper arm for prophylactic vaccination on 06-Oct-2020 (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, patient had not experienced any adverse events.  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: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was administered to a patient with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other health professional on 07-Oct-2020.  This case involves a 17 month old male who received a dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (FLU), HEPATITIS A VACCINE (HEPATITIS A) and HIB VACCINE (HIB) all used for prophylactic vaccination.  On 07-Oct-2020, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Lot number-C5523BA, expiration date- 30-Sep-2020, once dose) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication due to expired vaccine used. (latency: at the same time of vaccination)  At the time of reporting, the patient had no adverse event.  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: 83.0
Sex: F
Vaccine: FLUR4
Symptoms: Malaise, Nausea, Pain
Clinical narrative: she has felt achy all over; nauseated; she is having malaise; she is feeling "pretty sick"; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 83 years old female patient who felt achy all over (pain); nauseated (nausea); she was having malaise; she was feeling pretty sick (malaise), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Polymyalgia rheumatica.  No concomitant medication were reported.  On 05-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in the left arm for prophylactic vaccination.  On 08-Oct-2020, the patient felt achy all over (pain); nauseated (nausea); she was having malaise; she was feeling pretty sick (malaise) 3 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Final diagnosis was pain, nausea, malaise.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for all events.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered to a 4 years old with no AE; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a four years old patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date not reported) via an unknown route on unknown site on 14-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration (latency on same day).  At the time of reporting, patient had no adverse events.  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.  There will no information on the lot number for this case.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pediatric patients that were administered Flublok with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist The Agency (Reference number-00326369) and transmitted to Sanofi on 21-Oct-2020.  This case was linked to case 2020SA299919 (12 year old patient).  This case involved a 13 year old patient who received 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number Uj497aa and expiry date: not reported) via an intramuscular route in the right deltoid for prophylactic vaccination on 21-Oct-2020, (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination details and family history were not provided.  Concomitant medication included sodium (NA).   No other vaccines administered to the patient.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  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 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: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: the child has some muscle pain a the injection site; Pharmacist advised FLUBLOK was given to an 14 year old in error yesterday; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist The Agency (Reference number- 00327983) transmitted to Sanofi on 21-Oct-2020.  This case involved a 14 year old female patient who received pharmacist advised INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age) and for whom reported that the child has some muscle pain a the injection site (Vaccination site pain).  Medical history, medical treatment, vaccination details and family history were not provided.  Concomitant medication included sodium (NA).  On 20-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ509AA, expiry date: 10-May-2021) via intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age as the patient was 14 year old).  On 22-Oct-2020, the patient developed a non-serious some muscle pain at the injection site (Vaccination site pain), 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  Final diagnosis was Not Applicable pharmacist advised flublok was given to an 14 year old in error yesterday and the child has some muscle pain a the injection site.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event, vaccination site pain.  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: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: Moderate pain and significant swelling of upper left arm. Unable to raise arm to shoulder level or higher without pain. Took 2 ibuprofen, and 2 more ibuprofen 6 hours later.  Swelling had resolved by following morning, and pain was decreased but still mild to moderate. Pain resolved completely by 3rd day.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Blood iron increased, Blood lead increased, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client was given Adult dosage of Hep A vaccine on 10/14/2020. Mother reports no adverse side effects on 11/3/2020. Mother does report the clients iron and lead levels were increased at his last PCP appointment. RN contacted clients PCP with no return call at this time. Medication error was found during monthly inventory of vaccines on 11/2/2020.
Age: 45.0
Sex: M
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Ran prescription correctly for Flucelevax but got Fluad out of refrigerator
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Ear pruritus, Headache, Heart rate increased, Injection site erythema
Clinical narrative: After receiving Influenza vaccine employee developed swelling and redness at injection site.  Then developed hives, headache, inner ear itching, elevated BP and heart rate. She went to the Emergency Department that night.  Her symptoms were resolved the next day when contacted except for some grogginess.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Somnolence, Urticaria
Clinical narrative: After receiving Influenza vaccine employee developed swelling and redness at injection site.  Then developed hives, headache, inner ear itching, elevated BP and heart rate. She went to the Emergency Department that night.  Her symptoms were resolved the next day when contacted except for some grogginess.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Dysgeusia, Hypoaesthesia oral, Swelling face
Clinical narrative: Around 30 minutes after injection,  I developed numbness around the mouth area to include a metallic taste. Around 600 p.m. is when I started feeling tightness in my chest and urges to cough. 645 is when I developed facial swelling and hives . My husband administered 50 mg Benedryl . I woke the next morning  11/4/20 still having  pockets of swelling in my face and chest tightness.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Around 30 minutes after injection,  I developed numbness around the mouth area to include a metallic taste. Around 600 p.m. is when I started feeling tightness in my chest and urges to cough. 645 is when I developed facial swelling and hives . My husband administered 50 mg Benedryl . I woke the next morning  11/4/20 still having  pockets of swelling in my face and chest tightness.
Age: 10.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was coming in for a Tdap, a flu shot was administered instead.  We did then administer the correct vaccine. No signs or symptoms.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: & Numbness in left wrist and left side of lip
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling
Clinical narrative: Itching, bumps, swelling at various points on the body
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Swelling face
Clinical narrative: flu vax given, then 3 days later, started having numbness in lips and teeth began hurting, then numbness progress to side of face. Spoke to family known physicians. advised to take benadryl and used ice packs to calm the swelling in face (right side by eye and lip). Still having swelling and numbness (slight swelling) off and on, on upper lip. At time of vax, arm turned bright red in area.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Toothache
Clinical narrative: flu vax given, then 3 days later, started having numbness in lips and teeth began hurting, then numbness progress to side of face. Spoke to family known physicians. advised to take benadryl and used ice packs to calm the swelling in face (right side by eye and lip). Still having swelling and numbness (slight swelling) off and on, on upper lip. At time of vax, arm turned bright red in area.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in arm
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Cough, Dysphonia, Eye swelling
Clinical narrative: Before and after receiving the vaccination,  I was feeling fine.  Approximately four hours after the injection, I started feeling a tightness in my chest and a slight dry cough.  I could also feel myself starting to wheeze with each breath.  As I began talking, my voice became quite hoarse until I could barely speak.  I was overcome by extreme chills and terrible headache.  I bundled myself up with layers of clothes and blankets and climbed into bed with a cup of regular tea.  Bedroom temperature was at 71 degrees and I couldn?t warm up.  Used a hand warmer for more heat. By 7 PM,, my eyes were terrible swollen, along with upper lip.  I then consumed a Benedryl capsule, which did not help tightness of Che?s.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lip swelling, Wheezing
Clinical narrative: Before and after receiving the vaccination,  I was feeling fine.  Approximately four hours after the injection, I started feeling a tightness in my chest and a slight dry cough.  I could also feel myself starting to wheeze with each breath.  As I began talking, my voice became quite hoarse until I could barely speak.  I was overcome by extreme chills and terrible headache.  I bundled myself up with layers of clothes and blankets and climbed into bed with a cup of regular tea.  Bedroom temperature was at 71 degrees and I couldn?t warm up.  Used a hand warmer for more heat. By 7 PM,, my eyes were terrible swollen, along with upper lip.  I then consumed a Benedryl capsule, which did not help tightness of Che?s.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Anxiety, Faecaloma, Heart rate increased, Throat tightness
Clinical narrative: The very next day after getting a flu shot:  Complaints of nervous stomach and tightness in throat.   No history of anxiety issues.  Has been having anxiety attacks daily ever since, sometimes multiple times a day.  Varies from mild to severe where he has nervous stomach, fast heart rate, tightness in throat, and physically shaking.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor, X-ray gastrointestinal tract abnormal
Clinical narrative: The very next day after getting a flu shot:  Complaints of nervous stomach and tightness in throat.   No history of anxiety issues.  Has been having anxiety attacks daily ever since, sometimes multiple times a day.  Varies from mild to severe where he has nervous stomach, fast heart rate, tightness in throat, and physically shaking.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Injection site pain, Injection site scar, Neck pain, Pain
Clinical narrative: Pain at injection site after 2 months. Stinging when injection was given. Visible scarring at injection site. Pain that radiates from arm to neck and shoulder blade. Patient reported to multiple pharmacists at this location, but pharmacy manager assessed arm and vaccination site today.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain at injection site after 2 months. Stinging when injection was given. Visible scarring at injection site. Pain that radiates from arm to neck and shoulder blade. Patient reported to multiple pharmacists at this location, but pharmacy manager assessed arm and vaccination site today.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site induration, Injection site pain, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Pain at injection site after 2 months. Stinging when injection was given. Visible scarring at injection site. Pain that radiates from arm to neck and shoulder blade. Patient reported to multiple pharmacists at this location, but pharmacy manager assessed arm and vaccination site today.
Age: 86.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: vax on 10.27.20, two days later 10.29.20, on left arm became red and skin raised at site. Redness began going around upper arm. Redness wasn't hot to the touch, went away some. On 10.30.20 face and neck began looking sun burnt. Took steroids (prednisone) and it started to subside. no fever.  Not sure exactly which flu shot was given.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Patient had flu mist in her nostril and before it was administered she freaked out and wouldn't let me do it. Since I already opened it and it touched patient I had to waste it.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no other adverse event; patient received a dose of Gardasil 9 after it was stored outside of the recommended storage range; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 30-OCT-2020, the patient was vaccinated with an improperly stored one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S031287, expiration dare 08-APR-2022 for prophylaxis (exact dose, dose #, route of administration and anatomical location were not provided).  The temperature excursion was 8.6 Celsius degree for 9 hours and 10 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse event were reported. 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: S031287; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Some mild pain; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine and had some mild pain which got resolved within a week. The reporter consented to follow-up. For tolerance to the 2nd dose of Shingrix, refer case US2020215518.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020215518:Same suspect, same reporter, same patient, different dose (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: aches and pains for several days; This case was reported by a consumer via call center representative and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient enquired that how long do the side effects, aches and pains last, for several days. No other information was available.
Sex: U
Vaccine: FLUR4
Symptoms: Erythema, Eye pruritus, Lip pruritus, Pruritus, Urticaria
Clinical narrative: itchy around entire the body, especially around the eyes and lips; a large red itchy welt on arm where patient received vaccination also 3 -4 inches down from the injection site; entire arm was red; entire arm was red; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves patient with unknown demographics who experienced itchy around entire the body (pruritus), especially around the eyes and lips, a large red itchy welt on arm where patient received vaccination also 3 -4 inches down from the injection site (urticaria) and entire arm was red (erythema and vaccination site reaction), while patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination concomitant medication and family history were not provided.  On 02-Oct-2020 at 10:45 am, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 02-Oct-2020 at 02:00 pm, the patient developed a non-serious itchy around entire the body (pruritus), especially around the eyes and lips, a large red itchy welt on arm where patient received vaccination also 3-4 inches down from the injection site (urticaria) and entire arm was red (erythema and vaccination site reaction) 3 hours 15 minutes following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   Details of laboratory data not reported.   On same day, the patient was treated with LORATADINE (CLARITINE) also It was reported that, patient could not take Benadryl due to other health conditions.  Event outcome was unknown as it was not reported at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUR4
Symptoms: Vaccination site erythema
Clinical narrative: itchy around entire the body, especially around the eyes and lips; a large red itchy welt on arm where patient received vaccination also 3 -4 inches down from the injection site; entire arm was red; entire arm was red; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves patient with unknown demographics who experienced itchy around entire the body (pruritus), especially around the eyes and lips, a large red itchy welt on arm where patient received vaccination also 3 -4 inches down from the injection site (urticaria) and entire arm was red (erythema and vaccination site reaction), while patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination concomitant medication and family history were not provided.  On 02-Oct-2020 at 10:45 am, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 02-Oct-2020 at 02:00 pm, the patient developed a non-serious itchy around entire the body (pruritus), especially around the eyes and lips, a large red itchy welt on arm where patient received vaccination also 3-4 inches down from the injection site (urticaria) and entire arm was red (erythema and vaccination site reaction) 3 hours 15 minutes following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   Details of laboratory data not reported.   On same day, the patient was treated with LORATADINE (CLARITINE) also It was reported that, patient could not take Benadryl due to other health conditions.  Event outcome was unknown as it was not reported at the time of reporting.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist stated FLUBLOK was given to an 11 year old child in error over the weekend with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00327558) and transmitted to Sanofi on 22-Oct-2020.  This case involved a 11 year old patient of unknown demographics who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration.  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 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: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Malaise, Pneumonia, Pyrexia
Clinical narrative: after 4 days, the patient went to the hospital complaining of fever and not feeling well. He found out he got pneumonia and the patient stays at the hospital for about 23 days. He started getting better on 10/10 and left the hospital on 10/20
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Nausea, Presyncope, Pyrexia, Vomiting
Clinical narrative: Pt had near syncopal episode approx. 20 mins after the vaccines. Was treated with snack and returned to baseline. Approx 5 hours after the vaccinations developed fever, nausea and vomiting that mother reported continued throughout the night. He was back to baseline in the morning, no fever and no nausea/vomiting.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: patient described intense pain at the site of the pneumonia vaccine. States that the pain was so intense the next day, she had limited range of motion.
Age: 22.0
Sex: M
Vaccine: FLUC4, MNQ, TDAP
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness and fever of 100.4 (self-reported)
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Induration, Pain, Pain in extremity
Clinical narrative: Large, 3 cm area of induration on the left leg, and smaller area of induration on the right leg.  Area painful to touch.  No erythema.  Approximately 7 hours after the administration.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: employee had redness at injection site was warm and  tender to touch, spread more to all of her deltoid muscle area, recommended physician follow up treatment
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Magnetic resonance imaging brain normal, Tinnitus
Clinical narrative: I received the Flu shot on Monday 10/5/20 between 1pm -3pm. ( hospital does not have time). 1 Week later on the dot 10/12/20 @ 1pm, My ears started to ring. My right ear stopped and my left ear continued to ring and has since.  Also my left ear lost hearing. I only have about 4% hearing compared to my right at 96%. I was not sick and had nothing else different in my life other than the Flu shot 1 week prior.   On 10/12/20- I had a phone appointment with a doctor , and they said I should be seen.   On 10/14/20- I was told to go see the nurse to get my ears cleaned out, 3 nurses looked at my ears and they were clear. Dr. looked at my ears, said that it may be my Eustachian tube to take Flonase and sudafed for 10 days even though I wasn't sick. I took the regimie for a couple days and contacted my main doctor and was adamant that I needed to be seen by a specialist as  I didnt feel like it was my Eustachian tube.   On 10/22/20 I went to the Audiologist and saw the ENT. They tested my hearing and confirmed I have no blockage in my Eustachian tube.  AUDIOLOGICAL RESULTS: Pure Tone Air and Bone Testing:  Right ear: hearing within normal limits, Left ear: moderately severe and sensorineural hearing loss. Speech Reception Threshold:  10 dB at the right ear and 80 dB at the left ear. Speech Discrimination Score (Word Recognition Score):  96% for the right ear and 4% for the left ear. Acoustic Impedance Testing:  Right ear: type A tympanogram consistent with normal middle ear function, Left ear: type A tympanogram consistent with normal middle ear function. Ipsilateral Stapedial Reflexes:  Right ear: present at expected levels, Left ear: absent. I was prescribed steroids to see if it will help. So far as of today no change.   10/24/20- I had a MRI and it was negative of abnormalities.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Tympanometry abnormal
Clinical narrative: I received the Flu shot on Monday 10/5/20 between 1pm -3pm. ( hospital does not have time). 1 Week later on the dot 10/12/20 @ 1pm, My ears started to ring. My right ear stopped and my left ear continued to ring and has since.  Also my left ear lost hearing. I only have about 4% hearing compared to my right at 96%. I was not sick and had nothing else different in my life other than the Flu shot 1 week prior.   On 10/12/20- I had a phone appointment with a doctor , and they said I should be seen.   On 10/14/20- I was told to go see the nurse to get my ears cleaned out, 3 nurses looked at my ears and they were clear. Dr. looked at my ears, said that it may be my Eustachian tube to take Flonase and sudafed for 10 days even though I wasn't sick. I took the regimie for a couple days and contacted my main doctor and was adamant that I needed to be seen by a specialist as  I didnt feel like it was my Eustachian tube.   On 10/22/20 I went to the Audiologist and saw the ENT. They tested my hearing and confirmed I have no blockage in my Eustachian tube.  AUDIOLOGICAL RESULTS: Pure Tone Air and Bone Testing:  Right ear: hearing within normal limits, Left ear: moderately severe and sensorineural hearing loss. Speech Reception Threshold:  10 dB at the right ear and 80 dB at the left ear. Speech Discrimination Score (Word Recognition Score):  96% for the right ear and 4% for the left ear. Acoustic Impedance Testing:  Right ear: type A tympanogram consistent with normal middle ear function, Left ear: type A tympanogram consistent with normal middle ear function. Ipsilateral Stapedial Reflexes:  Right ear: present at expected levels, Left ear: absent. I was prescribed steroids to see if it will help. So far as of today no change.   10/24/20- I had a MRI and it was negative of abnormalities.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Grimacing, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: HPI: Received above flu vaccine 10/6 at 2:13 pm in L arm. Felt immediate spasm and pain and states "injection felt low." Reports swelling in L arm, redness, heat, and pain at injection site; denies adverse reaction to flu vaccine or injections in past. Seen in urgent care 72 hrs after injection on 10/9. Provider in UC states she could see puncture from injection over anterior biceps. Treated for phlebitis with ice and Motrin and limited shifts to 8 hrs, which EE states helped. States no change and continued to have pain in L arm. Seen by PCP this Mon. 11/2 and prescribed Bactrim DS BID via since possible cellulitis or abscess. PCP instructed to completed abx course, apply heat and massage area. Today, 11/4 , reports throbbing 7/10 pain from just distal to shoulder and proximal to elbow over anterior bicep; denies joint pain. Painful with ROM and with work or by end-of-day, states L arm feels fatigued; denies weakness. + sleep disturbances and reports "jolting, shocking pain" waking her from sound sleep. Unable to lie on L side d/t pain. Also reports difficulty with ADLs like dressing or anything with arms overhead. Continues to use q4-6hrs ibuprofen and tylenol for pain, but "doesn't like taking pills without any relief." Denies paresthesias, radiating pain, fever, chills. PMH includes RC repair in R arm.  EXAM: L ARM: 3" x 1" vertical flat patch of erythema over anterior biceps. Hot to touch. +TTP over area with skin changes. Decreased sensation to light touch around periphery of erythema and absent sensation in center. FROM of shoulder and elbow with discomfort at movement endpoints. Limited IR compared to R caused stated discomfort and grimacing.  5/5 BUE with L biceps testing causing stated discomfort and grimacing.  A/P: Referral to ortho. Ordered MRI. Complete bactrim as directed by PCP. Limited work shift to 8 hrs.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Muscle fatigue, Muscle spasms, Pain
Clinical narrative: HPI: Received above flu vaccine 10/6 at 2:13 pm in L arm. Felt immediate spasm and pain and states "injection felt low." Reports swelling in L arm, redness, heat, and pain at injection site; denies adverse reaction to flu vaccine or injections in past. Seen in urgent care 72 hrs after injection on 10/9. Provider in UC states she could see puncture from injection over anterior biceps. Treated for phlebitis with ice and Motrin and limited shifts to 8 hrs, which EE states helped. States no change and continued to have pain in L arm. Seen by PCP this Mon. 11/2 and prescribed Bactrim DS BID via since possible cellulitis or abscess. PCP instructed to completed abx course, apply heat and massage area. Today, 11/4 , reports throbbing 7/10 pain from just distal to shoulder and proximal to elbow over anterior bicep; denies joint pain. Painful with ROM and with work or by end-of-day, states L arm feels fatigued; denies weakness. + sleep disturbances and reports "jolting, shocking pain" waking her from sound sleep. Unable to lie on L side d/t pain. Also reports difficulty with ADLs like dressing or anything with arms overhead. Continues to use q4-6hrs ibuprofen and tylenol for pain, but "doesn't like taking pills without any relief." Denies paresthesias, radiating pain, fever, chills. PMH includes RC repair in R arm.  EXAM: L ARM: 3" x 1" vertical flat patch of erythema over anterior biceps. Hot to touch. +TTP over area with skin changes. Decreased sensation to light touch around periphery of erythema and absent sensation in center. FROM of shoulder and elbow with discomfort at movement endpoints. Limited IR compared to R caused stated discomfort and grimacing.  5/5 BUE with L biceps testing causing stated discomfort and grimacing.  A/P: Referral to ortho. Ordered MRI. Complete bactrim as directed by PCP. Limited work shift to 8 hrs.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Paraesthesia, Phlebitis, Sensory loss, Sleep disorder
Clinical narrative: HPI: Received above flu vaccine 10/6 at 2:13 pm in L arm. Felt immediate spasm and pain and states "injection felt low." Reports swelling in L arm, redness, heat, and pain at injection site; denies adverse reaction to flu vaccine or injections in past. Seen in urgent care 72 hrs after injection on 10/9. Provider in UC states she could see puncture from injection over anterior biceps. Treated for phlebitis with ice and Motrin and limited shifts to 8 hrs, which EE states helped. States no change and continued to have pain in L arm. Seen by PCP this Mon. 11/2 and prescribed Bactrim DS BID via since possible cellulitis or abscess. PCP instructed to completed abx course, apply heat and massage area. Today, 11/4 , reports throbbing 7/10 pain from just distal to shoulder and proximal to elbow over anterior bicep; denies joint pain. Painful with ROM and with work or by end-of-day, states L arm feels fatigued; denies weakness. + sleep disturbances and reports "jolting, shocking pain" waking her from sound sleep. Unable to lie on L side d/t pain. Also reports difficulty with ADLs like dressing or anything with arms overhead. Continues to use q4-6hrs ibuprofen and tylenol for pain, but "doesn't like taking pills without any relief." Denies paresthesias, radiating pain, fever, chills. PMH includes RC repair in R arm.  EXAM: L ARM: 3" x 1" vertical flat patch of erythema over anterior biceps. Hot to touch. +TTP over area with skin changes. Decreased sensation to light touch around periphery of erythema and absent sensation in center. FROM of shoulder and elbow with discomfort at movement endpoints. Limited IR compared to R caused stated discomfort and grimacing.  5/5 BUE with L biceps testing causing stated discomfort and grimacing.  A/P: Referral to ortho. Ordered MRI. Complete bactrim as directed by PCP. Limited work shift to 8 hrs.
Age: 68.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Nodule, Pain, Pain in extremity
Clinical narrative: PATIENT RECIEVED VACCINE IN SEPTEMBER AND HER ARM IS STILL PAINFUL. SHE STILL HAS A "KNOT" ON HER ARM AND STILL CANNOT FULLY EXTEND HER ARM UPWARDS. SHE STATES THE PAIN IS WORSE AT NIGHT AND THAT IT SEEMS TO RADIATE TO DIFFERENT AREAS.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: pt received immunization around noon, and by 6pm then 9pm very bad pain in all of her muscles (back, shoulders, neck, legs) and very intense headache
Age: 16.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MENB, MMR, TDAP
Symptoms: Bradycardia, Dizziness, Pallor, Syncope, Tachypnoea
Clinical narrative: patient stated getting dizzy/faint while seated on exam table - change in color of face (pale), bradycardia, tachypnea, laid patient down on exam table, monitored vitals, deep breathing, inhaled ammonia salt stick, drank cool water, reassess after 5 mins patient stable, vitals stable,  allowed to rest additional 5 min on exam table with knees bent
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event
Clinical narrative: none
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Fibrin D dimer, Haematocrit normal, Haemoglobin normal, Headache
Clinical narrative: Marked sore arm which developed parasthesias 18 days after injection Patient here complaining of numbness and weakness to left arm after receiving flu vaccine 2 weeks ago. Patient states that the numbness radiating into left hand and pain radiating into left shoulder and up into her neck. Patient states that arm feels heavy and weak. Pain to injection site when pressure is applied. Had injection in her left deltoid on Wednesday Oct 21 at Pharmacy. Felt sore the next day, "like I would expect" but pain never resolved. On Thursday October 29 she developed diarrhea and has this, along with a headache on Thursday, Friday, Sat and Sunday. Yesterday, stools were formed but pain in the arm markedly escalated with throbbing pain and radiation moving into the neck and hand on the left side. The patient is a 39 year old female who presents with a complaint of Arm pain. The onset of the arm pain had been sudden and has been occurring in a persistent pattern for 18 days (but markedly worse the last 48 hours). The course has been increasing. The arm pain is described as moderate.