chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Vaccination complication
Clinical narrative: chills; Reaction to the Flu shot; High heart rate; Initial information was received on 21-Oct-2020 regarding an unsolicited valid serious case from a consumer or non-healthcare professional via pharmacy.  This case involves a 75 years old male patient (89.3 kg) who experienced chills, reaction to the flu shot (vaccination complication) and high heart rate (heart rate increased) while he received INFLUENZA VACCINE and was treated with TREPROSTINIL SODIUM [TYVASO].  At the time of the event, the patient had ongoing medical history of pulmonary arterial hypertension.  Concomitant medications included SILDENAFIL CITRATE.  Past medical treatments, vaccinations and family history were not provided.  On 21-Jan-2020, the patient started taking TREPROSTINIL SODIUM dosage inhalation use (batch number- 2101833, expiration date: 30-Jun-2021) concentration of 0.6 mg/ml delivered by Tyvaso Inhalation Device (TD-300/A) (device only for Pulmonary arterial hypertension. The current dose was prescribed was 60-120 µg (10-20 breaths), four times a day (QID)  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 27-Sep-2020, the patient developed a serious chills, reaction to the flu shot (vaccination complication), high heart rate (heart rate increased), eight months six days following the first dose intake TREPROSTINIL SODIUM and unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized for three days after this event occurred.   The patient was discharged on 30-Sep-2020.  Relevant laboratory test results included: Heart rate - On 27-Sep-2020:  [high].  No action was taken for TREPROSTINIL SODIUM as it was continued.  It was not reported if the patient received any corrective treatment or not.  The reporter did not provide causality for the events of vaccination complication, chills and heart rate increased.  The outcome of the events chills, reaction to the flu shot and high heart rate was unknown.  Senders comment: The company has assessed the serious adverse event of vaccination complication, chills and heart rate increased as not related to IH (inhalation) treprostinil and TD-300/A device. Vaccination complication was likely a reaction to the flu vaccine and chills and heart rate increased were likely clinical cascade from vaccination complication.  There will be no information on the batch number for this case.; Sender's Comments: This case concerns a 75 years old male patient who experienced chills, reaction to the flu shot, high heart rate after vaccination with INFLUENZA VACCINE (unknown manufacturer) and while treated with TREPROSTINIL SODIUM. The history of patient includes pulmonary arterial hypertension. There is, however, no information regarding lab tests to rule out alternate etiologies. Based upon the reported information, the role of both the suspect products cannot be individually assessed.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: patient passed away; Initial information received on 28-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer (non-healthcare professional).  This case was linked to cases 2020SA304724 and 2020SA282884.  This case involves a female patient of an unknown age who passed away (death), while she received INFLUENZA VACCINE (H1N1 vaccination).  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient passed away (death), three days following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. The medical examiner said from complications of the H1N1 vaccination, he/she would rather have the flu.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment before she died.  It was unknown if an autopsy was done and cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a female patient of unknown age who died 3 days after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient passed away
Age: 8.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 8 year old male patient received a dose of FLUBLOK QIV, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse and transmitted to Sanofi on 09-Oct-2020.  This case involves a 8 year old male patient who received a INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   No other concomitant vaccines administered to the patient.  On 02-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ446AA and expiry date: 18-Mar-2021) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (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: 5.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to 5-year-old patient with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a health professional via agency (reference number: 00318069) and transmitted to Sanofi on 15-Oct-2020.   This case involved a 5-year-old female received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Unknown batch number and expiration date) via unknown route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 11-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. No other concomitant vaccine was administered.  It was a case of actual medication error 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: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling, Vaccination site mass
Clinical narrative: patient had red, swollen, hard, golf ball sized reaction at injection site; patient had red, swollen, hard, golf ball sized reaction at injection site; patient had red, swollen, hard, golf ball sized reaction at injection site; patient had red, swollen, hard, golf ball sized reaction at injection site; Initial information regarding this unsolicited valid non-serious case was received from other health professional on 16-Oct-2020.  This case involved a 31 year old female patient who had red, swollen (Vaccination site inflammation associated with Vaccination site erythema and Vaccination site swelling), hard, golf ball sized reaction at injection site (Vaccination site mass), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 01-Oct-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6706AA, expiry date: 03-Jul-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed red, swollen (Vaccination site inflammation associated with Vaccination site erythema and Vaccination site swelling), hard, golf ball sized reaction at injection site (Vaccination site mass), unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that it was two weeks later, and the size had gone down, it was no longer golf ball sized but it continued to be hard and somewhat swollen. She had no fever.  Final diagnosis was patient had red, swollen, hard, golf ball sized reaction at injection site.   The patient was recommended with alternate ice and heat and ibuprofen, warm compresses as a corrective treatment.  At the time of reporting, the patient was recovering from the event, vaccination site mass and the event outcome was unknown for the other reported events.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Wrong technique in product usage process
Clinical narrative: arm was sore after the vaccine; while administering vaccine to the patient plunger was pushed hard as it did not push down; Initial information regarding an unsolicited valid serious case was received from a pharmacist. This case involves female patient (unknown demographics) who experienced arm was sore (pain in extremity) ) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm was sore (pain in extremity) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It is also medication error case due to while administering vaccine to the patient plunger was pushed hard as it did not push down (wrong technique in product usage process) (latency: one day).  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  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 be no information available on the batch number for this case.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Pain in extremity, Vaccination site movement impairment
Clinical narrative: patient complained of arm pain; experiencing left, shoulder pain (not injection site); has lost some range of motion in that arm; Initial information regarding this unsolicited valid non-serious case was received from a consumer and transmitted to Sanofi on 16-Oct-2020.  This case involved a 30 years old female patient who complained of arm pain (Pain in extremity) and experiencing left, shoulder pain (not injection site) and has lost some range of motion in that arm (Arthralgia associated with Vaccination site movement impairment), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 05-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2009, expiry date: 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination. No other vaccines or medications were received at that visit.  On 05-Oct-2020, the patient complained of arm pain (Pain in extremity) and experiencing left, shoulder pain (not injection site) and has lost some range of motion in that arm (Arthralgia associated with Vaccination site movement impairment), the same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Final diagnosis was that the patient complained of arm pain and experiencing left, shoulder pain (not 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 events.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Anaphylactic reaction, Milk allergy
Clinical narrative: anaphylactic reaction; milk allergy; Initial information was received on 21-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-professional.  This case involves child female patient (age unknown) who experienced anaphylactic reaction and milk allergy, while she received IPV (VERO) [IPOL] and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  Medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported for both the suspects) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic reaction (unknown latency) following the administration of IPV (VERO) and DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed non-serious milk allergy (unknown latency) following the administration of IPV (VERO) and DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The reporter mentioned that anaphylactic reaction was traced to a milk allergy, and that now people with milk allergies were warned not to get DTaP, but that was not known at the time. No other information provided.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for both the events at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient (age unknown) who experienced anaphylactic reaction and milk allergy after vaccination with IPOL and DTAP vaccine. The time to onset is unknown. However, medical condition at the time of vaccination, laboratory data and other investigations ruling out alternate etiologies were not reported. Based upon the reported information the role of the individual vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Injection site pain, Myalgia, Neck pain, Pain
Clinical narrative: Facial dropping on right side; Pain in muscles of arms which is radiated up into muscles in edge of neck; Pain in muscles of arms; injection site pain; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (Reference number- 00327750) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 65 years old female patient who experienced facial dropping on right side (facial paralysis), pain in muscles of arms which is radiated up into muscles in edge of neck (myalgia and pain) and injection site pain (vaccination site pain), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   On 22-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Prefilled syringe, lot uj453ab, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 22-Oct-2020, the patient developed a serious facial dropping on right side (facial paralysis), one month following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On 22-Oct-2020, the patient developed a non-serious pain in muscles of arms which is radiated up into muscles in edge of neck (myalgia and pain) and injection site pain as well (vaccination site pain), one month following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of events was reported as unknown, at the time of reporting.; Sender's Comments: This case concerns a 65 years old female patient who experienced facial dropping on right side, pain in muscles of arms which is radiated up into muscles in edge of neck and experienced injection site pain as well, one month after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Facial dropping on right side; Pain in muscles of arms which is radiated up into muscles in edge of neck; Pain in muscles of arms; injection site pain; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (Reference number- 00327750) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 65 years old female patient who experienced facial dropping on right side (facial paralysis), pain in muscles of arms which is radiated up into muscles in edge of neck (myalgia and pain) and injection site pain (vaccination site pain), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   On 22-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Prefilled syringe, lot uj453ab, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 22-Oct-2020, the patient developed a serious facial dropping on right side (facial paralysis), one month following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On 22-Oct-2020, the patient developed a non-serious pain in muscles of arms which is radiated up into muscles in edge of neck (myalgia and pain) and injection site pain as well (vaccination site pain), one month following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of events was reported as unknown, at the time of reporting.; Sender's Comments: This case concerns a 65 years old female patient who experienced facial dropping on right side, pain in muscles of arms which is radiated up into muscles in edge of neck and experienced injection site pain as well, one month after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Loss of consciousness, Nausea, Urticaria, Vomiting
Clinical narrative: At 7:30 pm, I passed out and was very nauseous.  I was given ZOFRAN through an IV. At about 8:00pm I broke out in hives mostly on my body,  I was given benedryl,  methylPREDNISolone and PEPCID.  This calmed down the hives. I became light headed again (time unknown) and puked. I was discharged around 11:00pm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Cold sweat, Headache, Muscle spasms
Clinical narrative: Chills/shivering; fever; body aches; cold sweats; headache; cramps/spasms in shoulders, stomach, sides, back, feet; stiff neck
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Chills/shivering; fever; body aches; cold sweats; headache; cramps/spasms in shoulders, stomach, sides, back, feet; stiff neck
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given Flublok rather than Fluzone Quad. No adverse reaction from patient noted. Prescriber and family notified.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection
Sex: M
Vaccine: FLUX
Symptoms: Deafness unilateral
Clinical narrative: it caused him to go deaf in one ear.; This case was reported by a consumer via interactive digital media and described the occurrence of deafness unilateral in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included theraflu unknown unknown (batch number UNK, expiry date unknown) for flu.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and theraflu unknown at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season and theraflu unknown, the patient experienced deafness unilateral (serious criteria GSK medically significant). The action taken with theraflu unknown was unknown. On an unknown date, the outcome of the deafness unilateral was unknown.   It was unknown if the reporter considered the deafness unilateral to be related to Influenza vaccine Quadrivalent unspecified season and theraflu unknown.  Additional information was provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient received his shot a year before reporting because he works in the medical field, it caused him to go deaf in one ear. The case had been linked with US2020AMR215313, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215313:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; muscle aches; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix. On 28th October 2020, 1 days after receiving Shingrix, the patient experienced chills, muscle pain and headache. On an unknown date, the outcome of the chills, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient enquired that how long did the Shingrix side effects lasted. The patient got the first injection of Shingrix a day before reporting and on the day of reporting was experiencing muscle aches, chills and headache. The patient was just wondering how long this would last, 2 -3 days. The patient enquired if they could take Advil or Tylenol to address these symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked how long will fever last after second dose of Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Nodule, Pain in extremity, Swelling
Clinical narrative: Sore arm with a knot; Arm with a knot/Swelling; Redness; Felt like I had the flu; This case was reported by a pharmacist 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.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, local swelling, erythema and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, local swelling, erythema and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm, local swelling, erythema and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sore arm with a knot, redness, swelling, and felt like the patient had the flu for a couple days.  The patient experienced complete recovery. It was a couple of months ago when he had the injection.  This was his second dose and couldn't remember the specific date.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; slight headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 2nd dose of Shingrix. On 28th October 2020, 1 days after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix. On the day of reporting,  the patient experienced fever and slight headache. The patient asked anything to do.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Oropharyngeal pain
Clinical narrative: HAD A SORE THROAT; TROUBLE BRETAHING; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced sore throat and difficulty breathing. On an unknown date, the outcome of the sore throat and difficulty breathing were unknown.   It was unknown if the reporter considered the sore throat and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced symptoms sore throat and trouble breathing 4 hours after having the 2nd dose of Shingrix.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Lip swelling, Pruritus, Rash, Throat tightness
Clinical narrative: Rash running down both arms; Itching; Difficulty breathing; Feeling of throat tightening; Lip swelling; This case was reported by a nurse via call center representative and described the occurrence of rash in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA384A, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis.   On 9th October 2020, the patient received the 2nd dose of Menveo (intramuscular) and Bexsero (intramuscular). In October 2020, 1 hr after receiving Menveo and Bexsero, the patient experienced rash, pruritus, difficulty breathing, throat tightness and lip swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash, pruritus, difficulty breathing, throat tightness and lip swelling were recovered/resolved.   It was unknown if the reporter considered the rash, pruritus, difficulty breathing, throat tightness and lip swelling to be related to Menveo and Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Approximately one hour after receiving the Menveo and Bexsero the patient developed a rash running down both arms, itching, difficulty breathing and feeling of throat tightening.  The patient self treated with Benadryl and the symptoms improved, approximately 4 hours later the symptoms began to return and the patient developed lip swelling.  Another dose of Benadryl was administered and the symptoms completely resolved without medical intervention.  The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Ageusia, Facial paralysis, Hypoaesthesia
Clinical narrative: Bells Palsy; numbness on the left half of the face / numbess from left eye to left jaw / numbess from left half of the nose to the left ear; cannot taste food; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 62-year-old male 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 22nd October 2020, the patient received the 1st dose of Shingrix and the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season. On 22nd October 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced bell's palsy (serious criteria GSK medically significant), numbness facial and taste loss. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the bell's palsy, numbness facial and taste loss were unknown.   It was unknown if the reporter considered the bell's palsy, numbness facial and taste loss to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional case details were reported as follows: The patient reported case for himself. The patient received Shingrix vaccine in the right arm and the flu shot in the left arm. The patient received the first dose of the Shingrix and a flu shot on a Thursday, few days before day of reporting, and experienced numbness on the left half of the face, numbness from left eye to left jaw and numbness from left half of the nose to the left ear. The patient could not taste food. He was seen at the urgent care on 22nd October 2020 and was started on steroid. The patient got a pneumonia vaccine on the following Tuesday and that was the day, he came to know that he had numbness on the left half of his face. The patient did not know the name of the other vaccines and also he was not sure of the dates of the vaccines and also did not know the lot and expiration date of the vaccines. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included drug allergy (history of anaphylactic shock to various medications & anesthesia). Previously administered products included Quadruple (Quadruple bypass surgery) and Vaginal dryness. Concurrent medical conditions included heart disorder, sjogren's syndrome and allergy.   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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. Approximately 14 years ago the patient received a flu vaccine (unknown manufacturer) and she was sick for 1 week after receiving the vaccine. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, No AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse practitioner.  This case is linked to case 2020SA268092, 2020SA268091, 2020SA268094, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 77 years old female patient who was vaccinated with 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the right deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant was given to the patient on the same day.  It was an actual medication error case due to incorrect product storage.   It was reported that the boxes were cold, but the ice packs were not hard frozen, they gave 6 doses before they got call not to use product because it was too long in transit and asked if they should revaccinate patient.  No adverse event reported at the time of reporting.  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: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse Practitioner.  This case is linked to case 2020SA268090, 2020SA268092, 2020SA268094, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 83 years old female patient who was vaccinated with 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes,lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error). It was reported that the boxes were cold but the ice packs were not hard frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. As the vaccines that were not suitable for use were administered to the patients.  No adverse event reported at the time of reporting.  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: 88.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse Practitioner.  This case is linked to case 2020SA268090, 2020SA268091, 2020SA268094, 2020SA268089 and 2020SA268092 (same reporter).  This case involves a 88 years old male patient who was vaccinated with 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date: 30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error). It was reported that the boxes were cold, but the ice packs were not hard frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. As the vaccines that were not suitable for use were administered to the patients.   No adverse event reported at the time of reporting.  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: 65.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case is linked to case 2020SA268090, 2020SA268091, 2020SA268092, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 65 years old female patient who was vaccinated with 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error). It was reported that the boxes were cold, but the ice packs were not hard frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.   It was an actual medication error case due to incorrect product storage. As the vaccines that were not suitable for use were administered to the patients.  No adverse event reported at the time of reporting.  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.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got deathly ill after first flu shot n wound up in the hospital; Initial information was received on 24-Oct-2020 regarding an unsolicited valid serious social media case from a consumer (patient).  This case is linked to case 2020SA300788 (same reporter).  This case involves patient of an unknown demographics who got deathly ill after first flu shot n wound up in the hospital (malaise), while he/she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got deathly ill (malaise) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event on an unknown date. Consumer also stated that he/she would never get another dose and doctor also agreed not to get one again.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was not reported.; Sender's Comments: This poorly documented social media case concerns a patient of an unknown demographics who got deathly ill after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Renal failure
Clinical narrative: flu; kidney failure; Initial information was received on 24-Oct-2020 regarding an unsolicited valid serious social media case from the consumer (patient).   This case involves a patient of an unknown demographics (current age reported as 67-year-old patient) who developed flu (influenza) and kidney failure (renal failure), while the patient received INFLUENZA VACCINE.  The patient got vaccinated with flu vaccine every year for prophylactic vaccination.  The patient's medical history, medical treatment(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date (reported as several years ago), the patient developed serious flu (influenza) and kidney failure (renal failure), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for flu on an unknown date for a week and had kidney failure. The event of kidney failure was also assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was not reported.  Information on batch number requested.; Sender's Comments: This case concerns a patient of an unknown demographics who had influenza and renal failure, after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Also, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.  This case was linked to case 2020SA302174 (same reporter).
Age: 8.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 8 years female old patient received FLUBLOK QUADRIVALENT vaccine/ NO AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 8-years-old female patient who received 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2023, expiry date: 30-Jun-2021) via an unknown route and administration site on 26-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  This caller was evasive about answering questions regarding the patient. She wanted to know the effects on a patient less than 18 years of age.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: A patient was given Fluzone High Dose vaccine and less than a quarter of the vaccine was left in the prefilled syringe/No AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown demographic who was given a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] vaccine and less than a quarter of the vaccine was left in the prefilled syringe (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (Underdose).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was the case of vaccine underdose (latency at the time of vaccination).   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.