chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Swelling of eyelid
Clinical narrative: the patient's left upper and lower eye lids were red and swollen.; the patient's left upper and lower eye lids were red and swollen.; This spontaneous report was received from a nurse concerning a 9-week-old male patient. The patient's concurrent conditions included gastrooesophageal reflux disease (GERD), umbilical granuloma and poor weight gain. There were no known allergies. Concomitant therapies included diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (PEDIARIX) and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13).      On 23-JUL-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (mL) (strength was unknown; valid lot # S030968, expiration date reported as 16-APR-2022), intramuscularly in the right thigh; and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 mL (strength was unknown; valid lot # S025595, expiration date reported as 13-APR-2021) orally for prophylaxis.   About 4 hours after receiving the vaccines, the patient's left upper and lower eye lids were red and swollen. The mother of the patient watched the patient overnight, and the swelling and redness resolved on its own the next day 24-JUL-2020. No treatment was provided for the redness and swelling. The mother brought the child to the office the following day. The patient was seen by the physician on 24-JUL-2020. The relationship between the events and suspect vaccines was not provided.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: Product storage error
Clinical narrative: confirmed no reaction or other AE in patient; both were administered to a single patient after they undergone 4 total high temperature excursions; This spontaneous report was received from a Registered Nurse and was referring to a 11 week old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 28-SEP-2020, the patient was vaccinated with a dose of improperly stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R006746, expiration date 09-NOV-2020, (strength, dose, dose number, frequency, route or anatomical location were not reported) as prophylaxis. On the same date, the patient was also vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot number 1676327, expiration date 19-APR-2021, (strength, dose, dose number, or frequency were not reported), orally as prophylaxis. Both, hepatitis b vaccine (recombinant)(RECOMBIVAX HB) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) experienced the following temperature excursion: on an unknown date in August 2020, first excursion, 49,1 Fahrenheit degrees during 15 minutes; on 09-SEP-2020, second excursion, 46.6 Fahrenheit degrees during 1 minute; on 17-SEP-2020, third excursion, 46.9 Fahrenheit degrees during 8 minutes; on 20-SEP-2020, fourth excursion, 46.8 Fahrenheit degrees during 6 minutes. The digital data logger was involved. The reporter confirmed that the patient did not experience any reaction or adverse event. The reporter also stated that she did not have anything further to report for this case.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pain in extremity
Clinical narrative: patient experience pain in arm and described the pain as shooting pain down her arm to her fingers; patient experience pain in arm and described the pain as shooting pain down her arm to her fingers; redness at the injection site; Indication: "chronic lung disease"; This spontaneous report was received from a pharmacist referring to a 44 year old female patient with asthma and a drug reaction/allergy to sulfa. Patient's pertinent medical history was not provided. Concomitant therapies included estradiol, ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (BLISOVI FE), mometasone furoate (ASMANEX HFA) and prednisone.       On 30-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # S029542, expiration date on 10-JUN-2021, by intramuscular route, for chronic lung disease. On this same vaccination date, patient experienced pain in her arm (pain in extremity) which was described as a shooting pain (pain) down her arm to her fingers. Additionally, she also started to experience redness at the injection site (injection site erythema). No treatment was given for the adverse experiences and no medical attention was sought. It was unknown if any laboratory study was performed.  At reporting time, patient was recovering from the adverse experiences and causality assessment between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; 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 meet the criteria for Reportability
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 different adult patients who received VARIVAX and PROQUAD; The patients were supposed receive MMR-II and VARIVAX.; This spontaneous report was received from a medical assistant via company representative, referring to an adult patient in the 30s-40s. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.   On an unknown date, the patient was vaccinated once with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (for both of them the strength, dose, routes of administration, vaccination scheme frequency, anatomical sites of vaccination, lot numbers, and expiration dates were not reported), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age and wrong product administered).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA002048:
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient was administered expired PNEUMOVAX23 as confirmed by nurse; This spontaneous report was received from a nurse referring to a 18 year old female patient. Patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 05-OCT-2020, at 12:50, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) non-valid lot #S002528 (expiration date reported as August 2020) and non-valid lot # updated N-638557, for prophylaxis. No adverse experience (AE) was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 different adult patients who received VARIVAX and PROQUAD; The patients were supposed receive MMR-II and VARIVAX.; This spontaneous report was received from a medical assistant via company representative, referring to an adult patient in the 30s-40s. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.   On an unknown date, the patient was vaccinated once with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (for both of them the strength, dose, routes of administration, vaccination scheme frequency, anatomical sites of vaccination, lot numbers, and expiration dates were not reported), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age and wrong product administered).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001734:
Age: 1.58
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On 01-OCT-2020, the patient was vaccinated with  an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S025608, expiration date 18-AUG-2021, for prophylaxis  (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported) that was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was stored in a temperature of -14°C to-10°C (-12.50C) for 1 minute and -14°C to-10°C (-14C) for 1 minute (multiple excursions) as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; a dose of expired PNEUMOVAX 23 was inadvertently administered to the patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.    On 26-SEP-2020, the patient was inadvertently administered a dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S025133 with expiration date 15-SEP-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered). No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; 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 meet the criteria for Reportability
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: slight pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year 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 patient was vaccinated with 1st dose of Shingrix. After vaccination patient experinced slight pain. This case was linked with case US2020196160 as reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196160:same reporter
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Lymphadenopathy, Rash
Clinical narrative: Had shingles /was diagnosed / episode of shingles; Rash occured on the back of the head and around the ear; Swollen lymph nodes; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles, rash and enlargement of lymph nodes. On an unknown date, the outcome of the shingles, rash and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the shingles, rash and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for himself. The patient received vaccine 2 months ago from the reporting date and experienced rash in his head and swollen lymph nodes, one or two weeks later he was diagnosed and physician told him that that was an episode of shingles. On the day of reporting, 29th September 2020, the patient received 2nd dose. The reporter was agreed to follow up via email.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: on the right arm peeled; pain around the injection site; red circle around the injection site; bruise in the area where the injection was given; her right arm was swollen; difficulty sleeping; pain in her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, injection site erythema and swelling arm. In September 2020, the patient experienced difficulty sleeping, pain in arm and skin peeling. On an unknown date, the patient experienced injection site bruising. In September 2020, the outcome of the injection site pain, injection site erythema, injection site bruising, swelling arm, difficulty sleeping, pain in arm and skin peeling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site bruising, swelling arm, difficulty sleeping, pain in arm and skin peeling to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix and shortly after, her right arm was swollen, had pain around the injection site, and a red circle around the injection site that was about 4 inches long and 2.5 inches wide and these lasted for 2 weeks and then resolved. The patient reported that she had difficulty sleeping after receiving the second dose because of the pain in her right arm and this lasted 2 weeks and resolved. Patient reported that about 2 weeks after receiving the second dose of Shingrix developed a bruise in the area where the injection was given, and this lasted about 2 weeks and resolved and after that the skin around that same area on the right arm peeled and this had been resolved. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin exfoliation
Clinical narrative: on the right arm peeled; pain around the injection site; red circle around the injection site; bruise in the area where the injection was given; her right arm was swollen; difficulty sleeping; pain in her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, injection site erythema and swelling arm. In September 2020, the patient experienced difficulty sleeping, pain in arm and skin peeling. On an unknown date, the patient experienced injection site bruising. In September 2020, the outcome of the injection site pain, injection site erythema, injection site bruising, swelling arm, difficulty sleeping, pain in arm and skin peeling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site bruising, swelling arm, difficulty sleeping, pain in arm and skin peeling to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix and shortly after, her right arm was swollen, had pain around the injection site, and a red circle around the injection site that was about 4 inches long and 2.5 inches wide and these lasted for 2 weeks and then resolved. The patient reported that she had difficulty sleeping after receiving the second dose because of the pain in her right arm and this lasted 2 weeks and resolved. Patient reported that about 2 weeks after receiving the second dose of Shingrix developed a bruise in the area where the injection was given, and this lasted about 2 weeks and resolved and after that the skin around that same area on the right arm peeled and this had been resolved. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Malaise
Clinical narrative: Shivering; Feeling cold; Fever; Headache; Fatigue; Felt like I was coming down with something; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 3rd October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd October 2020, less than a day after receiving Shingrix, the patient experienced shivering, feeling cold, fever, headache, fatigue and feeling unwell. On 5th October 2020, the outcome of the shivering, feeling cold, fever, headache, fatigue and feeling unwell were recovered/resolved.   The reporter considered the shivering, feeling cold, fever, headache, fatigue and feeling unwell to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. On Saturday, the patient received 2nd dose of Shingrix on left arm. Later that evening he experienced shivering, feeling cold, fever, headache and fatigue. He stated that he felt like he was coming down with something. The patient experienced these symptoms through Sunday. On the date of reporting, the patient was feeling much better and symptoms were resolved. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shivering; Feeling cold; Fever; Headache; Fatigue; Felt like I was coming down with something; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 3rd October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd October 2020, less than a day after receiving Shingrix, the patient experienced shivering, feeling cold, fever, headache, fatigue and feeling unwell. On 5th October 2020, the outcome of the shivering, feeling cold, fever, headache, fatigue and feeling unwell were recovered/resolved.   The reporter considered the shivering, feeling cold, fever, headache, fatigue and feeling unwell to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. On Saturday, the patient received 2nd dose of Shingrix on left arm. Later that evening he experienced shivering, feeling cold, fever, headache and fatigue. He stated that he felt like he was coming down with something. The patient experienced these symptoms through Sunday. On the date of reporting, the patient was feeling much better and symptoms were resolved. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site pain, Oropharyngeal pain
Clinical narrative: pain at the injection site; sore throat; diarrhea; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st received on unknown date).   On 1st October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, sore throat, diarrhea and tiredness. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the sore throat, diarrhea and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sore throat, diarrhea and tiredness to be related to Shingrix.  Additional deatils were provided as follows: The patient was vaccinated with Shingrix. The reporter was patients daughter. The reporter stated that her mother complained of pain at the injection site but the daughter did not know which arm her mother had the injection. The patient also had tiredness, diarrhea and sore throat. The reporter wanted to know how long these would last, because the pain in her arm had subsided. The patient would talk to her doctor on reporting date. The reporter was also vaccinated with Shingrix. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Injection site erythema, Injection site pain, Lip pain
Clinical narrative: redness at injection site; sores on lips; pain and sores on lips; soreness at injection; This case was reported by a consumer via call center representative and described the occurrence of sores lip in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sores lip, lip pain, injection site pain and injection site erythema. On an unknown date, the outcome of the sores lip was recovered/resolved and the outcome of the lip pain, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the sores lip, lip pain, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. LOT and expiry details were unknown. After receiving Shingrix, the patient experienced pain and sores on lips and soreness and redness at the injection site. The reporter did not consent to follow up.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 31-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z5N5G, expiry date 30th June 2021) for prophylaxis.   On 5th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season .5 ml. On 5th October 2020, 8 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2020-2021 season in left arm. Approximately 8 hours after receiving the Fluarix Quadrivalent 2020-2021 season, the patient experienced hives.  The patient took children's Benadryl and the symptoms resolved. The reporter consented to follow up.
Sex: U
Vaccine: TTOX
Symptoms: Drug hypersensitivity
Clinical narrative: Multiple drug allergy; Initial information regarding an unsolicited case was received from Pfizer (MFR Control No: 2020364462) in the form of courtesy via physician assistant and transmitted to Sanofi on 24-Sep-2020  This case involves patient who experienced multiple drug allergy (Drug hypersensitivity), while treated with received vaccine tetanus toxoid and while treated with lithium (salt not specified), clemastine fumarate, phenylpropanolamine hydrochloride, triprolidine hydrochloride, varenicline tartrate [chantix], Benadryl, sulfa drugs  and pseudoephedrine.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking lithium (salt not specified) dosage unknown (with an unknown batch number), clemastine fumarate dosage unknown (with an unknown batch number), phenylpropanolamine hydrochloride dosage unknown (with an unknown batch number), triprolidine hydrochloride dosage unknown (with an unknown batch number), varenicline tartrate) 1 mg twice daily oral (with an unknown batch number) and pseudoephedrine dosage unknown (with an unknown batch number) for an unknown indication.  On an unknown date, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer lot number not reported.  On an unknown date (unknown latency) after the initiation of the suspect drugs the patient experienced multiple drug allergy (Drug hypersensitivity).  No relevant laboratory data was reported.  Action taken, corrective treatment and event outcome was unknown.  No further relevant information was reported.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: A pregnant female received a dose of Adacel vaccine, no AE; Initial information was received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA269365 (same reporter).  This case involves a female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5665AA, expiry date: 24-Sep-2021) via unknown route in unknown administration site for prophylactic vaccinations (between 07-Aug-2020 to 03-Sep-2020, exact date of vaccination was not reported).  It was case of vaccine exposure during pregnancy.   It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old female patient received  Flublok Quadrivalent/ NO AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 17-years-old female patient who received once 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number: QFAA2007, expiry date: 23-May-2021, strength: standard, route and site of administration not reported) (product administered to patient of inappropriate age) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication and pregnancy details were unknown.   It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day)  At the time of reporting, 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: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site haemorrhage
Clinical narrative: bled a lot after the injection/patient was concerned that the vaccine had not been well absorbed in her body because of bleeding; Initial information received on 29-Sep-2020 regarding an unsolicited valid serious case from a pharmacist.  This case involves a 71 years old female patient who bled a lot (Vaccination site haemorrhage), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient normally had a lot of pain, redness, and swelling after a flu shot.  Medical history, medical treatment(s) and family history were not provided.  The patient was on a blood thinner, but the reporter did not have the record of which blood thinner she takes. No other vaccine was given concomitantly.   On 28-Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ480AB and expiration date:30-Jun-2021) once via unknown route in unknown site (reported as likely the left arm as that is usually the site used by pharmacy) for prophylactic vaccination.  On an unknown date, the patient has serious bleeding after the injection (Vaccination site haemorrhage) (Unknown latency) and stated that lacked the injection site symptoms that differed from her normal experience . The patient was concerned that the vaccine had not been well absorbed in her body because of bleeding. Also, she did not have any pain from the injection and wanted to know if the vaccine was working.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event Vaccination site haemorrhage.; Sender's Comments: This case concerns a 71 years old female patient who had bleeding at vaccination site, after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Patient was on an unspecified blood thinner which is an important confounding factor in this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product storage error
Clinical narrative: A non-viable flu vaccine was administered to the patient due to delay in shipment, no AE; The patient was given two doses of Fluzone Quadrivalent High Dose, no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 65 year old female patient who was given two doses of a non-viable INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] due to delay in shipment (extra dose administered and product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medications   On 29-Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ510AB, expiry date: 30-Jun-2021) once via intramuscular route in the left deltoid for prophylactic vaccination   On 30-Sep-2020 the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ510AB, expiry date: 30-Jun-2021) once via intramuscular route in unknown administration site for prophylactic vaccination.  It was of actual medication error due to extra dose administered and incorrect product storage.  The vaccines were deemed not suitable for use due to the shipment that arrived late. The nurse reported that the patient was accidently given the vaccine on 29-Sep-2020 from the batch. The patient was called back to get revaccinated with a vaccine that was suitable for use. On 30-Sep-2020, she was accidently given a dose from the same batch as the day before. The vaccine was put away to avoid being used but was still used. The prescriber was not wanting to revaccinate the patient due to having two doses of the high dose in two days. There were  total  6-pateints that received the doses on 29-Sep-2020. The reporter had information on the above mentioned patient. There were no details about other 5 patients whether they got revaccinated with vaccines that were suitable for use.   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 regulatory authority. 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: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Immediate post-injection reaction, Injury, Pain
Clinical narrative: Moderate shoulder pain immediately, slowly developing to chronic severe shoulder pain persisting without any improvement for approximately 9 months.   Issue eventually mostly resolved after approximately 15 months.  Medical consultation indicated likely VIRSA tendonitis / bursitis due to poor needle location placement and depth.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site, Tendonitis
Clinical narrative: Moderate shoulder pain immediately, slowly developing to chronic severe shoulder pain persisting without any improvement for approximately 9 months.   Issue eventually mostly resolved after approximately 15 months.  Medical consultation indicated likely VIRSA tendonitis / bursitis due to poor needle location placement and depth.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK GIVEN TO PATIENT WHOS IS UNDER 18 YEARS OLD
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed Left leg herpes zoster rash at L3 -L4 distribution two days after receiving first Shingrix vaccine at pharmacy.  Has been placed on Valacyclovir for treatment.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache, severe chills, muscle aches and headache
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Myosclerosis, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Woke up at 5:24AM with a huge pain in the left calf and it woke me up and it took a few minutes to reduce the pain. I had to stand up and try to stretch my leg but it still hurt. Touching the area it feel like a hard muscle ball and I had to massage the area for a few minutes to be bearable. Almost 04 hours after the event it still sore and hurt when I move my leg or try to walk. The only other time I remember having such  muscle pain was tearing some muscles playing soccer years ago.
Sex: M
Vaccine: HEP
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Bruising, swelling, and pain at injection site. Swelling starts at thigh and continues down to the foot
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Injection site reaction, Pyrexia, Somnolence
Clinical narrative: Welt rose on left upper arm after receiving shot on Monday night. Felt tired on Tuesday and Wednesday.  Wednesday my temperature started creeping up through out the day. My temperature Wednesday morning was 96.6 at 1pm was 98.8 and at 8 pm was 101.7. Thursday was a lost day of fevers, sleep and chills. Sometime between Thursday night and Friday morning, my fever broke. My temp on Friday at 8 am was 98.8.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Welt rose on left upper arm after receiving shot on Monday night. Felt tired on Tuesday and Wednesday.  Wednesday my temperature started creeping up through out the day. My temperature Wednesday morning was 96.6 at 1pm was 98.8 and at 8 pm was 101.7. Thursday was a lost day of fevers, sleep and chills. Sometime between Thursday night and Friday morning, my fever broke. My temp on Friday at 8 am was 98.8.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Chills, dizziness, fatigue, headache, and rapid heart rate were present from Tuesday 10/7-Wednesday 10/8. No fever, rash, or shortness of breath.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills, dizziness, fatigue, headache, and rapid heart rate were present from Tuesday 10/7-Wednesday 10/8. No fever, rash, or shortness of breath.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: pt developed a very sore arm, headache and nausea 10/6/2020 which resolved on 10/7/2020
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; both vaccines administered in left arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone (Inactivated Influenza Vaccine)) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix and Fluzone (Inactivated Influenza Vaccine) at an unknown dose and frequency. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and off label use. The action taken with Fluzone (Inactivated Influenza Vaccine) was unknown. On an unknown date, the outcome of the pain in arm and off label use were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received both Fluzone and Shingrix during same visit. Both  vaccines were administered in left arm. which led to off label use. No report of adverse events were reported other than sore arm.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Flu shot put me in the hospital; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was recovered/resolved.   It was unknown if the reporter considered the hospitalization to be related to Flu vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient took the flu shot last time (unspecified time) and then patient was in the hospital for long time. The follow up was not required.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Flu shot killed my mom; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient died after vaccination with flu shot.; Reported Cause(s) of Death: Unknown cause of death
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal discomfort, Back pain, Chills, Headache, Pain
Clinical narrative: body aches mostly in her legs and back; mild upset stomach; headache; chills, shivering; body aches /  mostly in her legs and back; her temperature was 103; body aches mostly in her legs and back; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 30th September 2020, couple of hours after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced upset stomach, headache, chills, general body pain, fever and leg pain. On an unknown date, the patient experienced back pain. The patient was treated with ibuprofen (Motrin) and nyquil (nos) (Nyquil). On an unknown date, the outcome of the upset stomach, chills and general body pain were recovered/resolved and the outcome of the headache, fever, leg pain and back pain were unknown.   It was unknown if the reporter considered the upset stomach, headache, chills, general body pain, fever, leg pain and back pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. A couple hours later she experienced mild upset stomach which lasted all day. At about 6.38 pm she developed a headache, chills, shivering and body aches.  At 9 pm her temperature was 103, and between 1 to 2am her temperature went down to 102. This morning her temperature was down to 99, she still has a headache, body aches mostly in her legs and back which are all resolving.  She has taken Motrin for her symptoms and Nyquil last night. The patient also received a flu vaccine that same day also in her left arm. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020197214:Same Reporter
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: body aches mostly in her legs and back; mild upset stomach; headache; chills, shivering; body aches /  mostly in her legs and back; her temperature was 103; body aches mostly in her legs and back; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 30th September 2020, couple of hours after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced upset stomach, headache, chills, general body pain, fever and leg pain. On an unknown date, the patient experienced back pain. The patient was treated with ibuprofen (Motrin) and nyquil (nos) (Nyquil). On an unknown date, the outcome of the upset stomach, chills and general body pain were recovered/resolved and the outcome of the headache, fever, leg pain and back pain were unknown.   It was unknown if the reporter considered the upset stomach, headache, chills, general body pain, fever, leg pain and back pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. A couple hours later she experienced mild upset stomach which lasted all day. At about 6.38 pm she developed a headache, chills, shivering and body aches.  At 9 pm her temperature was 103, and between 1 to 2am her temperature went down to 102. This morning her temperature was down to 99, she still has a headache, body aches mostly in her legs and back which are all resolving.  She has taken Motrin for her symptoms and Nyquil last night. The patient also received a flu vaccine that same day also in her left arm. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020197214:Same Reporter
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Injection site erythema, Injection site swelling
Clinical narrative: vaccine poured out onto her skin; aCCIDENTAL EXPOSURE / vaccine poured out onto her skin; redness and swelling below the injection site; swelling below the injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 28th July 2020, please refer the case US2020AMR197929.).   On 29th September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season (intramuscular) and the 2nd dose of Shingrix .5 ml. In September 2020, 24 hrs after receiving Influenza vaccine Quadrivalent 2020-2021 season and Shingrix, the patient experienced erythema and swelling. On 29th September 2020, the patient experienced exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the erythema and swelling were not recovered/not resolved and the outcome of the exposure via skin contact and inadvertent exposure to vaccine were recovered/resolved.   It was unknown if the reporter considered the erythema and swelling to be related to Influenza vaccine Quadrivalent 2020-2021 season and Shingrix.  Additional details were provided as follows: The patient reported an accidental exposure from Shingrix.  The patient reported a pharmacist attempting to administer Shingrix, accidentally pulled the plunger out of the syringe, prior to administration and the vaccine poured out onto her skin, which led to exposure via skin contact nd inadvertent exposure to vaccine. The patient reports, the pharmacist proceeded to administer a flu shot to the same arm as well as a Shingrix vaccine. After 24 hours the patient reported redness and swelling below the injection site, which has not resolved.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197929:same reporter