chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: body and muscle ache; body and muscle ache; Fever; This case was reported by a other health professional via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) (batch number 7323T, expiry date 6th May 2022) and (batch number 7JK53, expiry date unknown) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 29th August 2020, 2 days after receiving Shingrix, the patient experienced fever, general body pain and muscle pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the general body pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine, the patent had fever.  On 31st August 2020, during morning, the patient was feeling OK. The fever was gone. However, later during the day, the patient contacted them and mentioned she was still having body and muscle ache.  The patient didn't have a good weekend.  No other information was provided. The reporter consent to follow up. The reported batch number 7323T was corrected to 7JK53 as per sales data sheet.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Shingles over her left eye; This case was reported by a other health professional via call center representative and described the occurrence of ophthalmic herpes zoster in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number AL34K, expiry date 11th February 2022) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. On 8th August 2020, 2 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was recovering/resolving.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving 1st dose of Shingrix, the patient started to had shingles over her left eye. At the time of reporting, the patient was doing good.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Hypoaesthesia, Injection site swelling, Insomnia, Pain
Clinical narrative: Injection site swelling traveling down her arm; Fingers numbness; Arm pain / throbbing hurts so much that she can't sleep; can't sleep; throbbing pain; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date 14th May 2022) for prophylaxis.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain. The patient was treated with paracetamol (Tylenol) and ibuprofen (Motrin). On an unknown date, the outcome of the extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient developed right arm injection site swelling traveling down her arm and right two fingers numbness.  The patient also reported that right arm pain and throbbing hurts so much that she can't sleep. She has taken Tylenol and Motrin with no relief. The reporter did not consent to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Injection site swelling traveling down her arm; Fingers numbness; Arm pain / throbbing hurts so much that she can't sleep; can't sleep; throbbing pain; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date 14th May 2022) for prophylaxis.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain. The patient was treated with paracetamol (Tylenol) and ibuprofen (Motrin). On an unknown date, the outcome of the extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient developed right arm injection site swelling traveling down her arm and right two fingers numbness.  The patient also reported that right arm pain and throbbing hurts so much that she can't sleep. She has taken Tylenol and Motrin with no relief. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Movement disorder, Pain in extremity, Peripheral swelling
Clinical narrative: experienced swelling; arm feeling hot; arm is still sore; having difficulty moving; arm redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On 28th August 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, extremities hot feeling of, pain in arm, movement disorder and erythema of extremities. On an unknown date, the outcome of the swelling arm, extremities hot feeling of and erythema of extremities were recovered/resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the movement disorder was not recovered/not resolved.   The reporter considered the swelling arm, extremities hot feeling of, pain in arm, movement disorder and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose of Shingrix that night experienced swelling and the other effects as noted in this report.  The effects lasted for 2 days. Her arm was still sore, but it was not red.  The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Inappropriate schedule of product administration, Neoplasm malignant
Clinical narrative: receiving first dose of Shingrix 12 months ago / second dose was interrupted due to being diagnosed with canc; This case was reported by a consumer via call center representative and described the occurrence of cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix 12 months ago and that the second dose was interrupted due to being diagnosed with cancer.  The consumer underwent chemotherapy and had been cleared to receive Shingrix vaccine. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: headache; body aches; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced headache, general body pain and fever. On an unknown date, the outcome of the headache, general body pain and fever were unknown.   It was unknown if the reporter considered the headache, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and reported fever, body aches and headache. The reporter did not consent to follow up. The reporter did not want to provide any additional personal details about herself or the adverse events reported. The reporter did not get consent to follow up with HCP.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash over arm and chest; itching; red crackle spot; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 13th September 2022) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash, itchy rash and red rash. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the itchy rash was not recovered/not resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the rash, itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced itching, red crackle spot, rash all over the arm and chest after the 1st dose of Shingrix. The reporter asked can receive the second dose.  No further information provided. The reporter consent to follow up. This case has been linked with case US2020176170, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176170:same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: tingling feet, described as pins and needles.; leg stiffness in both legs and tingling feet, described as pins and needles.; chills; headache; sore arm; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On 18th June 2020, less than a day after receiving Shingrix, the patient experienced chills, headache and pain in arm. On 20th June 2020, the patient experienced tingling of extremity and limbs stiffness. On an unknown date, the outcome of the tingling of extremity and limbs stiffness were not recovered/not resolved and the outcome of the chills, headache and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tingling of extremity, limbs stiffness, chills, headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experiencing sore arm, headache, and chills on the same day as the injection. These events resolved over a day or 2 days .  The patient also reported that she was experiencing leg stiffness in both legs and tingling feet, described as pins and needles. These had not resolved.  The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Eye pain
Clinical narrative: chest tightness; prickling in her eyes; cough; Initial information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional  This case involves a female patient (age unspecified) who had tightness in her chest (chest discomfort), prickling in her eyes (eye pain) and cough, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious tightness in her chest (chest discomfort), prickling in her eyes (eye pain) and cough (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was recovering.  There will be no information available on lot number
Sex: U
Vaccine: FLUR4
Symptoms: Vaccination complication
Clinical narrative: Reaction to H1N1 vaccine; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care  professional.  This case involves patient (age and gender unknown) who had reaction to H1N1 vaccine (vaccination complication) , while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past vaccinations included H1N1 vaccine (three vaccine since 1975). The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided. At the time of the event, the patient had ongoing reaction to  sulfa drugs.   On an unknown date, the patient received a dose  of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious reaction to H1N1 vaccine (vaccination complication) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data reported.   It was not reported if the patient received a corrective treatment.  The patient outcome was unknown for the vaccine complication.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Eye pain
Clinical narrative: tightness in her chest; prickling in her eyes; cough; Initial information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) who had tightness in her chest (chest discomfort), prickling in her eyes (eye pain) and cough, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious tightness in her chest (chest discomfort), prickling in her eyes (eye pain) and cough (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was recovering.  There will be no information available on lot number
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyskinesia, Myalgia, Oxygen saturation decreased, Pyrexia
Clinical narrative: shaking about two hours after the injection; Could not control body movements rapid and random fingers would not move in the directions as patient wanted them to; rapid decline of blood or oxygen level to 70; muscle aches; Violent chills; first day temperature rose to 100 second day day fever was 99 and third day temperature was 98; Initial information received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a 69-years-old female patient who experienced shaking about two hours after the injection (tremor), could not control body movements rapid and random fingers would not move in the directions as patient wanted them to which is much like a patient with Parkinson's (dyskinesia), rapid decline of blood or oxygen level to 70 (oxygen saturation decreased), muscle aches (myalgia), violent chills (chills), first day temperature rose to 100 second day day fever was 99 and third day temperature was 98 (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date patient developed a non-serious shaking about two hours after the injection (tremor), could not control body movements rapid and random fingers would not move in the directions as patient wanted them to which is much like a patient with Parkinson's (dyskinesia), rapid decline of blood or oxygen level to 70 (oxygen saturation decreased), muscle aches (myalgia), violent chills (chills), first day temperature rose to 100 second day day fever was 99 and third day temperature was 98 (pyrexia) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: On an unknown date: Body temperature [Temperature rose to 100 next day fever was 99 and then 98] On an unknown date: Oxygen saturation decreased [rapid decline of blood or oxygen level to 70]  The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (ASPIRIN [ACETYLSALICYLIC ACID]) for Pyrexia.  On an unknown date, the patient recovered from all events.   There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: shaking about two hours after the injection; Could not control body movements rapid and random fingers would not move in the directions as patient wanted them to; rapid decline of blood or oxygen level to 70; muscle aches; Violent chills; first day temperature rose to 100 second day day fever was 99 and third day temperature was 98; Initial information received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a 69-years-old female patient who experienced shaking about two hours after the injection (tremor), could not control body movements rapid and random fingers would not move in the directions as patient wanted them to which is much like a patient with Parkinson's (dyskinesia), rapid decline of blood or oxygen level to 70 (oxygen saturation decreased), muscle aches (myalgia), violent chills (chills), first day temperature rose to 100 second day day fever was 99 and third day temperature was 98 (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date patient developed a non-serious shaking about two hours after the injection (tremor), could not control body movements rapid and random fingers would not move in the directions as patient wanted them to which is much like a patient with Parkinson's (dyskinesia), rapid decline of blood or oxygen level to 70 (oxygen saturation decreased), muscle aches (myalgia), violent chills (chills), first day temperature rose to 100 second day day fever was 99 and third day temperature was 98 (pyrexia) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: On an unknown date: Body temperature [Temperature rose to 100 next day fever was 99 and then 98] On an unknown date: Oxygen saturation decreased [rapid decline of blood or oxygen level to 70]  The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (ASPIRIN [ACETYLSALICYLIC ACID]) for Pyrexia.  On an unknown date, the patient recovered from all events.   There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Fluzone Quadrivalent instead of Fluzone HD/ No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown gender (over the age of 65) who received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination instead of vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and  concomitant medications were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHib was mixed with sterile water instead of the saline/No Ae; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 months old female patient  who received 0.5 mL first dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date not reported) via intramuscular route in one of legs for prophylactic vaccination which was mixed with sterile water instead of the saline on 25-Aug-2020 (product preparation error).   The patient's past vaccination(s) included Pentacel (child has received Pentacel series previously). The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation. It was an actual medication error due to wrong solution used in drug reconstitution.  Case details: Reporter stated that another nurse reconstituted ActHIB for patient to administer and it was later discovered that it was erroneously reconstituted. Reporting nurse administered dose after preparation by another HCP.   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.  There will be no information available on the batch number for this case.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: red, round, slightly raised, tender to touch area at the injection site; red, round, slightly raised area at the injection site; round, slightly raised, tender to touch area at the injection site; Adacel was vaccinated to 73 years old patient; red, round, slightly raised area at the injection site; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer (patient) or non-health care professional.  This case involves a 73-years-old female patient who experienced red, round, slightly raised, tender to touch area at the injection site (vaccination site inflammation, vaccination site erythema, vaccination site swelling and vaccination site pain), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 04-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious red, round, slightly raised, tender to touch area at the injection site (vaccination site inflammation, vaccination site erythema, vaccination site swelling and vaccination site pain) unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was a case of an actual medication error case due to inappropriate age at vaccine administration.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site urticaria
Clinical narrative: injection site became welt up and it was a little larger than a half dollar and probably the size of a plum; low grade temperature; injection site hard lump; injection site felt bruised inside; injection site became red, tender to touch and painful; injection site was tender to touch and painful; injection site became red; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient).  This case is linked to cases 2020SA229160, 2020SA219448 and 2020SA218631 (same reporter).  This case involves a 40-years-old female patient who experienced injection site felt bruised inside (vaccination site bruising), injection the site became red, tender to touch and painful (vaccination site inflammation, vaccination site erythema, vaccination site pain), injection site became welt up and it was a little larger than a half dollar and probably the size of a plum(vaccination site urticaria), injection site hard lump (vaccination site mass) and low grade temperature (pyrexia), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 22-Jul-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6638AA, expiry date: 04-Dec-2022) via an unknown route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious  injection site felt bruised inside (vaccination site bruising), injection the site became red, tender to touch and painful (vaccination site inflammation, vaccination site erythema, vaccination site pain), injection site became welt up and it was a little larger than a half dollar and probably the size of a plum(vaccination site urticaria), injection site hard lump (vaccination site mass) and low grade temperature (pyrexia), within a two week period following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE..  Laboratory details included body temperature results not reported.   An unknown corrective treatment was received.  The outcome of events was unknown.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: injection site became welt up and it was a little larger than a half dollar and probably the size of a plum; low grade temperature; injection site hard lump; injection site felt bruised inside; injection site became red, tender to touch and painful; injection site was tender to touch and painful; injection site became red; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient).  This case is linked to cases 2020SA229160, 2020SA219448 and 2020SA218631 (same reporter).  This case involves a 40-years-old female patient who experienced injection site felt bruised inside (vaccination site bruising), injection the site became red, tender to touch and painful (vaccination site inflammation, vaccination site erythema, vaccination site pain), injection site became welt up and it was a little larger than a half dollar and probably the size of a plum(vaccination site urticaria), injection site hard lump (vaccination site mass) and low grade temperature (pyrexia), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 22-Jul-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6638AA, expiry date: 04-Dec-2022) via an unknown route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious  injection site felt bruised inside (vaccination site bruising), injection the site became red, tender to touch and painful (vaccination site inflammation, vaccination site erythema, vaccination site pain), injection site became welt up and it was a little larger than a half dollar and probably the size of a plum(vaccination site urticaria), injection site hard lump (vaccination site mass) and low grade temperature (pyrexia), within a two week period following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE..  Laboratory details included body temperature results not reported.   An unknown corrective treatment was received.  The outcome of events was unknown.
Age: 9.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 9-year-old patient was inadvertently administered Adacel/no AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 9 years old patient who was inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (wrong product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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 batch number for this case.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered with a fluzone quadrivalent when she requested for Fluzone high dose/ No Ae; Initial information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75 years old female patient who was administered with the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination when she requested for INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] vaccine (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received an extra dose of Menactra; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11 years old female patient who received an extra dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6690AA  and expiration date: 31-Aug-2021) via intramuscular route in the right deltoid as prophylactic vaccination on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for prophylactic vaccination on an unknown date.  It was an actual medication error case due to extra dose administered.  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: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Mishandled and cold chain break for vaccines happened during shipment/No Ae; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves five patients of unknown demographics who received the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination which were  mishandled and cold chain break happened during shipment (product storage error)   The patients medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to incorrect product storage.  Case details: Reporter stated that inventory personnel at head office said they received Fluzone QIV which were picked up on 24-Aug-2020 at the supplier's and delivered on 28 -Aug-2020 and mishandled and cold chain break happened during shipment. Last Friday, they receive an email that the vaccines were not viable, but they were already administered to five patients.  At the time of this 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 and Module VI of the 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: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old received Flublok/no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age). It was reported that the error occurred possibly due to a knowledge gap and just grabbing a flu-vaccine.   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Mild rash on wrist and forearm of arm where vaccine was administered. Fading but still present 5 days later.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Contusion
Clinical narrative: Patient came to pharmacy 14 days after receiving vaccine and had a very large bruise on her arm, from her deltoid almost down to her elbow.
Sex: U
Vaccine: FLUX
Symptoms: Anxiety, Illness
Clinical narrative: thought I was going to die; sick / thought I was going to die.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and impending doom. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the impending doom was unknown.   It was unknown if the reporter considered the sickness and impending doom to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient was so sick for 2 weeks thought he/she was going to die.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; Initial information was received on 25-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via phone.  This case is linked to cases 2020SA218631, 2020SA219448 and 2020SA219456 (same reporter).  This case involves a 33-year-old female patient who experienced pain at the injection site (vaccination site pain), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant vaccine.   On 05-Aug-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (prefilled syringe, lot U6638AA and expiration date 12-Apr-2022) via an intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed non-serious pain at the injection site (vaccination site pain), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, few weeks later the patient had recovered from the event.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel that was administered to patients after it underwent a temperature excursion of 30 degrees F/NO AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional .  This case involves a 54 year old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5667AA, expiry date-26-Sep-21) after it underwent a temperature excursion of 30 degrees Fahrenheit on 24-Aug-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  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 . 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: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: pt  says she developed hives and itchyness at the site of injection/ arm of injection.  She was taking benadryl to alleviate symptoms
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Hypoaesthesia, Joint range of motion decreased, Joint stiffness
Clinical narrative: Joint pain, swelling, joint stiffness, muscle pain, left arm to wrist pain, neck pain, headache, numbness in fingers on day one of injectionnumbness in left ring and baby finger on day 2 post injection, limited range of motion from day one to day 4 this includes limited flexion, extension, internal and external rotation,
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain in extremity, Swelling
Clinical narrative: Joint pain, swelling, joint stiffness, muscle pain, left arm to wrist pain, neck pain, headache, numbness in fingers on day one of injectionnumbness in left ring and baby finger on day 2 post injection, limited range of motion from day one to day 4 this includes limited flexion, extension, internal and external rotation,
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Patient to office with c/o rash that started yeseterday. Appears red and flat rash with  Dark red areas in the center. Started on RLE and has spread up to front and back of trunk over night.  No fever.  No body aches or pains.  Took Bendryl 50 mg this am . No relief from topical treatment.  Denies working outside or hiking but does live in a wooded area.  -------------------  1)  Problem # 1:  MACULOPAPULAR RASH (ICD-709.8) (ICD10-R21) 2)  Assessment: New 3)  Started yesterday, Rash on bilat legs and trunk, red and flat rash that started yesterday. Dark red areas in the center. Started on RLE and has spread up to front and back of trunk.  4)  No fever.  5)  No body aches or pains.  6)  Took Bendryl 50 mg this am and used hydrocortisone on it with no relief.  7)  No working out in the garden.  8)  Poss pityriasis rosea vs. lyme test . Wil send to derm for punch biopsy of lesions. Will start with one week of doxy until  lyme test is back. .   9)  Follow up as needed.   10)  Make an appointment for consultation with Dermatologist
Age: 18.0
Sex: M
Vaccine: HEPA, MENB, MNQ, VARCEL
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: CLIENT BECAME THIRSTY AND FELT LIGHT HEADED. DRANK A FEW SIPS OF WATER AND FELL OFF LEFT SIDE OF CHAIR ONTO LEFT SIDE OF FOREHEAD. AREA RED BUT NO BUMP. LOST COLOR, CONSCIOUS AND BODY STIFFENED FOR 5-10 SEC. WOKE UP ALERT TO TIME AND PLACE. SLOWLY SAT BACK UP AND RETURNED TO CHAIR. GIVEN SIPS OF WATER, CANDY, ICE BAG FOR FOREHEAD, COOL COMPRESSES. STATED HADN'T EATEN THIS AM. BP 110/60, P 60. STATED FELT OK AFTER 5 MINUTES AND WANTED TO LEAVE WITH MOM. COLOR WAS IMPROVED. ENCOURAGED TO GET SOMETHING TO EAT WITH PROTEIN/CARBS, TAKE IT EASY TODAY AND CONTACT DOCTOR IF FURTHER PROBLEMS. STATES THIS HAPPENED 2 TIMES BEFORE WHEN YOUNGER AFTER BEE STING AND WHEN DEHYDRATED.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB, MNQ, VARCEL
Symptoms: Pallor, Skin reaction, Thirst
Clinical narrative: CLIENT BECAME THIRSTY AND FELT LIGHT HEADED. DRANK A FEW SIPS OF WATER AND FELL OFF LEFT SIDE OF CHAIR ONTO LEFT SIDE OF FOREHEAD. AREA RED BUT NO BUMP. LOST COLOR, CONSCIOUS AND BODY STIFFENED FOR 5-10 SEC. WOKE UP ALERT TO TIME AND PLACE. SLOWLY SAT BACK UP AND RETURNED TO CHAIR. GIVEN SIPS OF WATER, CANDY, ICE BAG FOR FOREHEAD, COOL COMPRESSES. STATED HADN'T EATEN THIS AM. BP 110/60, P 60. STATED FELT OK AFTER 5 MINUTES AND WANTED TO LEAVE WITH MOM. COLOR WAS IMPROVED. ENCOURAGED TO GET SOMETHING TO EAT WITH PROTEIN/CARBS, TAKE IT EASY TODAY AND CONTACT DOCTOR IF FURTHER PROBLEMS. STATES THIS HAPPENED 2 TIMES BEFORE WHEN YOUNGER AFTER BEE STING AND WHEN DEHYDRATED.