chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Rotator cuff syndrome
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient (older than 65 years old) who experienced rash around the injection site and a "hard lump"., rash around the injection site and a "hard lump"., my shoulder "hurt badly, when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., cuff injury and upper arm for the pain, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT lot number, expiry date not reported. On an unknown date, post vaccination patient developed a non-serious rash around the injection site and a "hard lump", rash around the injection site and a "hard lump". (vaccination site induration), my shoulder "hurt badly (musculoskeletal discomfort), when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been. (vaccination site erythema), cuff injury (rotator cuff syndrome), upper arm for the pain. Lab data not reported. Final diagnosis was upper arm for the pain, cuff injury, when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., my shoulder "hurt badly, rash around the injection site and a "hard lump". and rash around the injection site and a "hard lump". It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for rash around the injection site and a "hard lump"., as Unknown for rash around the injection site and a "hard lump"., as Unknown for my shoulder "hurt badly, as Unknown for when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., as Unknown for cuff injury and as Unknown for upper arm for the pain.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a nine-weeks old female patient who received a dose of 0.25 ml of FLUZONE QUADRIVALENT (lot number: UJ005AF and expiration date: 30-Jun-2019) via intramuscular route in the right thigh on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) for Immunisation; ROTATEQ for Immunisation; and HEPATITIS B VACCINE on an unknown date. It was a case of actual medication error due to inappropriate age at vaccine administration because a 9 week baby was administered the vaccine. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 43 years old female patient (pregnancy status: no) who was accidentally vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE lot 03047AA; expiry date: 31-May-2019 via intramuscular route in the deltoid NOS. on 26-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and accidental overdose. The patient didn't experience any adverse symptoms following the vaccination. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Injection site swelling, Palpitations, Urticaria
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult female patient who experienced hives, palpitations, allergic reactions, injection site swelling and shortness of breath, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported via unknown route in unknown administration site). On 25-Oct-2018, the patient developed a non-serious full body hives, palpitations, allergic reactions, swollen injection site and shortness of breath (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was shortness of breath, injection site swelling, allergic reactions, palpitations and hives. It was not reported if the patient received a corrective treatment. On an unknown date the event outcome was unknown for all the events. List of documents held by sender: none.
Sex: U
Vaccine: FLU4, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 16 years old patient of unknown gender who received a dose of vaccine MENACTRA inadvertently on 26-Oct-2018 and had their second dose of unspecified date of June-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunization. On 26-Oct-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot 46153AA expiry date: 21-Mar-2020 via intramuscular route in the right arm. 1 other doses were administered on unknown date of June-2018 for suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was case of actual medication error due to Extra dose administered. No adverse event was experienced. 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. List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old male patient who was vaccinated with the vaccine QUADRACEL (Batch number: C5497AA) (expiry date, dose, dose in series, route and site of administration were not reported) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was administered to a seven year old patient. It was unknown if any adverse event occurred or not following the administration of vaccination. 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. Documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old patient (gender unknown) who received vaccines FLUBLOK QIV instead of FLUZONE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 24-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1826, expiry date not provided via unknown route in the left arm instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that due to nearly identical packaging, a dose of FLUBLOK was inadvertently given to a 7-year-old child instead of FLUZONE. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Sex: F
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 46 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ030AA, expiration date: May-2019, route and site of administration was not reported) on 26-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to overdose and inappropriate age at vaccine administration (FLUZONE HIGH-DOSE accidentally administered to a 46 year old female/No AE). The patient did not experience any side effects so no medical treatment was needed. 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298678, 2018SA298675, 2018SA298672, 2018SA300038, 2018SA300042 and 2018SA300042, same reporter. This case involves an unknown gender patient (age ranging from 32-50) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 25-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA, expiry date 15-May-2019 via intramuscular route on unknown site of administration. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that patient with age ranging from 32-50, was inadvertently administered FLUZONE HIGH DOSE. The patient did not experience any adverse reaction after the injection. 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. List of documents held by sender- none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298677, 2018SA298678, 2018SA298675, 2018SA300042, 2018SA300037 and 2018SA298672 (same reporter). This case involves a patient of an unknown age (ages ranging from 32-50) who received vaccine FLUZONE HIGH DOSE lot UJ039AA, expiry date: 15-May-2019 via unknown route on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Overdose and Inappropriate age at vaccine administration. It was reported that inadvertently administered FLUZONE HIGH DOSE who was less than 65 years of age. None of the persons report any reaction at this time. 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. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298678, 2018SA298675, 2018SA298672, 2018SA300037, 2018SA300038 (same reporter). This case involves a patient (demographics unknown, ages ranging from 32-50 years) who received vaccine FLUZONE HIGH DOSE inadvertently. The patient's past medical history was not provided. No other vaccines were administered on that day. On 25-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA via unknown route in the unknown site. It was a case of actual medication error due to inappropriate age at vaccine administration, Overdose accidental, and wrong vaccine administered because of Flu vaccine. It was reported that they had two different kinds of flu vaccine which caused the confusion. The patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: The next day, Oct. 27, patient woke up with a red, raised, uniform, rash. The rash was not itchy and there was a raised bump at injection site. Patient states on 10/31 the rash had decreased to about halfway.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint instability, Musculoskeletal stiffness
Clinical narrative: Injection was placed well high of the normal location into the members shoulder joint. Aprox 1.5 hours after vaccination, member developed pain and stiffness in Left shoulder and felt as though he had instability in his shoulder. Upon return to his command, he presented to medical department and had his shoulder evaluated. There was marked decreased Range of motion as well as pain upon movement. Member described it as a dull aching pain. This has continued for 5 days with minimal relief of symptoms.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Injection was placed well high of the normal location into the members shoulder joint. Aprox 1.5 hours after vaccination, member developed pain and stiffness in Left shoulder and felt as though he had instability in his shoulder. Upon return to his command, he presented to medical department and had his shoulder evaluated. There was marked decreased Range of motion as well as pain upon movement. Member described it as a dull aching pain. This has continued for 5 days with minimal relief of symptoms.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per patient's mother, the patient began experiencing redness, pain and swelling in the left bicep within a few hours after receiving the flu shot in the same arm. The patient was taken to an urgent that evening and was given antibiotics by the physician to treat for possible cellulitis. The patient's mother states that symptoms are clearing up with the antibiotics when contacted the following week.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient complaining of excruciating pain to Right arm/shoulder 10/10. Denies numbness or tingling. Unable to perform full active or passive ROM or flexion or extension 2/2 pain. Patient needs to be evaluated by specialty physician for further testing.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Muscular weakness, Syncope
Clinical narrative: Pt rec'd PNEUMOVAX 23 IM; c/o SOB, syncope, muscle weakness; O2 applied and 25mg Diphenhydramine IM administered.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Patient called and expressed concern that her arm still hurt 2 and 1/2 weeks after receiving her flu shot and wanted to know what she should do. I ask specific questions about where it hurt and she said upper arm and included the shoulder area. She did not feel it was in the joint but it was just achy all the time and makes it difficult to sleep.
Age: 91.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Left shoulder pain/inflammation.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site warmth, Wrong technique in product usage process
Clinical narrative: Employee was given the flu shot with a 5/8th in needle. Essentially into subcutaneous tissue. She experienced redness, tenderness and warmth at site. She used icepacks and pain medication (unknown) to ease tenderness.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Patient received a flu shot in her left arm and PREVNAR 13 in her right arm. Patient's husband reported to the pharmacy today to show a picture of red bruising on the patient's right arm and stated that the bruising began originally on 10/30/2018 and is "warm to the touch" as of last night. The patient's husband has also stated that the patient's temperature is normally 97.6 but is now 98.6 degrees as of today. The patient has not reported any adverse effects to her left arm and has not reported any difficulty with breathing.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: CLIENT BROUGHT THE FLU CONSENT FORM TO RN TO RECEIVE HER FLU VACCINE AT CLINIC. CLIENT STATES SHE WANTS THE FLU VACCINE HOWEVER, SHE IS ALLERGIC TO WHOLE EGGS. CLIENT STATES SHE IS ABLE TO CONSUME FOOD WITH EGG AND EGG PRODUCTS SUCH AS CAKE, CUPCAKES, AND CASSEROLES WITHOUT ANY PROBLEMS. NOTIFIED CLIENT THAT AN EGG ALLERGY IS NOT A CONTRAINDICATION FOR THE FLU VACCINE. THE LAST TIME SHE RECEIVED A FLU VACCINE WAS 29 YEARS AGO. CLIENT STATES THAT SHE HAD A LOCALIZED REACTION AND THE SITE OF THE INJECTION WAS SWOLLEN AND RED. ASKED THE CLIENT IF SHE WANTED TO GO AHEAD AND RECEIVE THE FLU VACCINE TODAY. CLIENT GAVE CONSENT TO RECEIVE HER FLU VACCINE.  NOTIFIED CLIENT THAT SHE WILL NEED TO HANG OUT FOR ABOUT 20 MINUTES AFTER HER FLU VACCINE FOR HER SAFETY AND TO WATCH FOR ANAPHYLACTIC REACTIONS. CLIENT VERBALIZED UNDERSTANDING. FLU VACCINE WAS ADMINISTERED BY RN AT 0835. CLIENT STATES SHE FEELS SOME SHORTNESS OF BREATH AT 0847. ASSESSED THE CLIENT. CLIENT IS TALKING, CONSCIOUS, AND APPEARS TO HAVE NO CHANGES IN COLOR. RN TOOK CLIENT'S BLOOD PRESSURE ON RIGHT ARM:156/98. RN TOOK PULSE: 60 AND RESPIRATIONS: 16. ANOTHER EMPLOYEE CALLED 911 AT 0850. I SPOKE TO DISPATCH AND NOTIFIED DISPATCH OF SITUATION AND ANSWERED THEIR QUESTIONS.  EMT/PARAMEDICS CAME TO THE SCENE AT 0854. GAVE REPORT ON THE CLIENT TO THE EMT.  PARAMEDICS TOOK CLIENT'S VITALS AND ASSESSED THE CLIENT. CLIENT STATES SHE IS FEELING BETTER AND HER SHORTNESS OF BREATH IS SUBSIDING. CLIENT STATES SHE DOES NOT WANT TO GO TO THE HOSPITAL. AFTER ABOUT 10 MINUTES OF PARAMEDICS ASSESSING AND TALKING TO THE CLIENT, THE PARAMEDIC NOTIFIES CLIENT THAT SHE CAN SIGN A REFUSAL FORM. CLIENT SIGNS THE REFUSAL FORM. PARAMEDIC LETS HER KNOW THAT IF SHE HAS ANY OTHER ALLERGIC REACTION SYMPTOMS SUCH AS CHEST PAIN, HIVES, ITCHINESS, SHE DOES NEED TO GO TO THE ER IMMEDIATELY. CLIENT AND CLIENT'S HUSBAND VERBALIZED UNDERSTANDING. EMT/PARAMEDICS LEAVE THE SCENE AROUND 0911. I TOOK CLIENT'S BLOOD PRESSURE AT 0913 AND IT WAS 160/86 LEFT ARM. CLIENT STATES SHE IS DOING BETTER AND SHE IS ABLE TO GO HOME WITH HER HUSBAND. LET CLIENT KNOW THAT I WILL BE CONTACTING HER TOMORROW TO SEE HOW SHE IS DOING. CLIENT VERBALIZED UNDERSTANDING.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Extreme fatigue for 5 days starting about 8 hours, swelling in lymph nodes under the arm pits for 6 weeks. Pain in those lymph nodes for 3 weeks. sore at the injection site for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about November 2013, the physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 04-SEP-2014, the patient was treated by a nurse practitioner for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Gait disturbance, Nervous system disorder, Nuclear magnetic resonance imaging
Clinical narrative: This initial spontaneous report was received from a female patient of unknown age referring to herself. She had no pertinent medical history or drugs reactions/allergies and was taking no concomitant medication. On 17-JAN-2007, the patient received her first dose of GARDASIL (lot # 0955F) because her mom recommended she take it at 17 years old (she did not specify whether she was 17 when she received it). The second dose was given on 12-MAR-2007 (lot # 0012U) and the third dose was given on 18-JUN-2007 (lot # 0525U). The expiration date for all three doses was unknown. In July 2007, the patient started to experience symptoms. She was unable to walk down the stairs and was diagnosed with psoriatic arthritis on 17-AUG-2007. She also experienced a "nerve reaction." She visited an orthopedic physician who informed her to see a rheumatologist. The patient was hospitalized for the nerve reaction for up to two days (dates not provided). The patient was treated with HUMIRA, CELEBREX, ENBREL, ORENCIA, REMICADE, methotrexate, and NEURONTIN. She mentioned that HUMIRA stopped working and that she experienced a "nerve reaction" after taking ENBREL. The following tests were performed (date and results not specified): magnetic resonance image (MRI), computed tomography (CT) scan, and unspecified blood work every other month. The events were not resolved at the time of reporting. Causality assessment was not provided. The patient wished to speak to the legal department regarding the adverse event she experienced after receiving GARDASIL. The patient mentioned that she used to work at a hospital and has seen multiple cases of people diagnosed with psoriatic and rheumatoid arthritis after receiving GARDASIL (case # 1811USA000122). Upon internal review, psoriatic arthritis was considered to be a medically significant event. The is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1811USA000122.
Sex: F
Vaccine: HPV4
Symptoms: Psoriatic arthropathy
Clinical narrative: This initial spontaneous report was received from a female patient of unknown age referring to herself. She had no pertinent medical history or drugs reactions/allergies and was taking no concomitant medication. On 17-JAN-2007, the patient received her first dose of GARDASIL (lot # 0955F) because her mom recommended she take it at 17 years old (she did not specify whether she was 17 when she received it). The second dose was given on 12-MAR-2007 (lot # 0012U) and the third dose was given on 18-JUN-2007 (lot # 0525U). The expiration date for all three doses was unknown. In July 2007, the patient started to experience symptoms. She was unable to walk down the stairs and was diagnosed with psoriatic arthritis on 17-AUG-2007. She also experienced a "nerve reaction." She visited an orthopedic physician who informed her to see a rheumatologist. The patient was hospitalized for the nerve reaction for up to two days (dates not provided). The patient was treated with HUMIRA, CELEBREX, ENBREL, ORENCIA, REMICADE, methotrexate, and NEURONTIN. She mentioned that HUMIRA stopped working and that she experienced a "nerve reaction" after taking ENBREL. The following tests were performed (date and results not specified): magnetic resonance image (MRI), computed tomography (CT) scan, and unspecified blood work every other month. The events were not resolved at the time of reporting. Causality assessment was not provided. The patient wished to speak to the legal department regarding the adverse event she experienced after receiving GARDASIL. The patient mentioned that she used to work at a hospital and has seen multiple cases of people diagnosed with psoriatic and rheumatoid arthritis after receiving GARDASIL (case # 1811USA000122). Upon internal review, psoriatic arthritis was considered to be a medically significant event. The is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1811USA000122.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Gingival blister, Injection site pain, Oral mucosal blistering, Oral mucosal eruption
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of mouth broke out in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced mouth broke out, blistering of mouth, gingival blister, feeling abnormal, injection site pain and fever. On an unknown date, the outcome of the mouth broke out, blistering of mouth, feeling abnormal, injection site pain and fever were recovered/resolved and the outcome of the gingival blister was unknown. It was unknown if the reporter considered the mouth broke out, blistering of mouth, gingival blister, feeling abnormal, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The caller reported that the inside of her mouth and gums broke out in blisters like oral herpes after receiving SHINGRIX. She also felt feverish and felt like crap for about 2 weeks. The injection site was also very sore.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of mouth broke out in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced mouth broke out, blistering of mouth, gingival blister, feeling abnormal, injection site pain and fever. On an unknown date, the outcome of the mouth broke out, blistering of mouth, feeling abnormal, injection site pain and fever were recovered/resolved and the outcome of the gingival blister was unknown. It was unknown if the reporter considered the mouth broke out, blistering of mouth, gingival blister, feeling abnormal, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The caller reported that the inside of her mouth and gums broke out in blisters like oral herpes after receiving SHINGRIX. She also felt feverish and felt like crap for about 2 weeks. The injection site was also very sore.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of arthralgia in a adult male patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovered/resolved. It was unknown if the reporter considered the arthralgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient developed arthralgia that lasted for 30 hours after receiving the SHINGRIX vaccine. No other information was given.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dry skin, Pruritus, Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included automobile accident (about 2 weeks prior to getting SHINGRIX). On 10th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced pruritus, burning sensation, skin rough and skin irritation. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the pruritus, burning sensation and skin rough were recovering/resolving and the outcome of the skin irritation was unknown. It was unknown if the reporter considered the pruritus, burning sensation, skin rough and skin irritation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX and about 1 to 2 weeks later she noticed an irritating itch on her bottom. She developed an area on her skin on her right buttock that was rough, itchy and irritated, about 2x2 inches. It was really bad for 2 to 3 weeks and was improved at the reporting time, but every time she thought it was going away it started itching again. She had used an ointment on it and steroid cream. Only the steroid cream seemed to help. She saw her doctor, who thought it was not shingles, but was unable to tell her what it was.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 12th October 2018, the patient received the 1st dose of SHINGRIX. On 14th October 2018, 2 days after receiving SHINGRIX, the patient experienced erythema, pain and swelling. The patient was treated with BENADRYL. On an unknown date, the outcome of the erythema, pain and swelling were recovering/resolving. It was unknown if the reporter considered the erythema, pain and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient did not intend to get 2nd dose of SHINGRIX vaccine. The patient took BENADRYL to help with the pain and redness.  The patient had denied permission to contact their physician.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hot flush, Influenza like illness, Injection site paraesthesia, Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included Tetanus vaccine with an associated reaction of lymphadenopathy (approximately 30 years ago, he got a Tetanus shot (unknown manufacturer)) and SHINGRIX with an associated reaction of influenza like illness (For the tolerability of 1st dose, refer case US2018188644 reported for same patient). On 11th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, hot flashes, chills, enlargement of lymph nodes and tingling sensation. On an unknown date, the patient experienced pain. The patient was treated with paracetamol (Tylenol). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms, hot flashes, chills and pain were recovered/resolved and the outcome of the enlargement of lymph nodes and tingling sensation were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, hot flashes, chills, pain, enlargement of lymph nodes and tingling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm and experienced flu-like symptoms, hot flashes, chills, and aches. The patient stated that he took Tylenol for these symptoms. The patient stated that 2 days after receiving the 2nd dose, he noticed that the lymph nodes under his right armpit were swollen.  The patient also noticed a tingling sensation from his right elbow to his right shoulder.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included Tetanus vaccine with an associated reaction of lymphadenopathy (approximately 30 years ago, he got a Tetanus shot (unknown manufacturer)) and SHINGRIX with an associated reaction of influenza like illness (For the tolerability of 1st dose, refer case US2018188644 reported for same patient). On 11th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, hot flashes, chills, enlargement of lymph nodes and tingling sensation. On an unknown date, the patient experienced pain. The patient was treated with paracetamol (Tylenol). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms, hot flashes, chills and pain were recovered/resolved and the outcome of the enlargement of lymph nodes and tingling sensation were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, hot flashes, chills, pain, enlargement of lymph nodes and tingling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm and experienced flu-like symptoms, hot flashes, chills, and aches. The patient stated that he took Tylenol for these symptoms. The patient stated that 2 days after receiving the 2nd dose, he noticed that the lymph nodes under his right armpit were swollen.  The patient also noticed a tingling sensation from his right elbow to his right shoulder.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 65-year-old female patient received PREVNAR 13 twice. First dose of PREVNAR 13 was given on 14Jan2016 and the second one was given on 24Sep2018, both at single dose, for immunization. The patient's arm got sore on an unknown date in 2018. Outcome of the event was unknown. Physician considered that patient's arm got sore because the way the immunization was given to her, not the immunization. The information on the lot number has been requested. Follow-up (22Oct2018): New information received from a contactable physician includes:events updated (arm got sore added). No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient) via Pfizer sales representative. A 65-years old female patient received, on an unspecified date, pneumococcal 13-val conj vac (Dipht CRM197 Protein) at single dose, in the arm, for immunization. On the same day, the patient received also a flu vaccine. Relevant medical history was unknown. She mentioned the arm she received the pneumonia shot in swelled. She believed she received an antibiotic in the ER for swelling. Clinical outcome of the adverse event was unknown at time of this report. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Cellulitis, Erythema, Inadequate aseptic technique in use of product, Nausea
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a female patient (unknown demographics) who experienced cellulitis, nausea, and left arm was very sore and red and there were all over joint pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 05-Oct-2018 at 12:45, the patient received a dose of suspect FLUZONE QUADRIVALENT lot UJ011AG, exp date: 30 June 2019 via unknown route in the upper left arm. On 06-Oct-2018, the patient developed a serious cellulitis, left arm was very sore and red and there were all over joint pain one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE . It was reported that reporter believes that the Vaccine was contaminated with bacteria. This was assessed as serious due to medically significant event. On 06-Oct-2018, the patient developed a non-serious nausea one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was an actual medication error case due to Inadequate aseptic technique in use of product. It was reported that the nurse opened the refrigerated package, and put it on a dirty and unsterilized sink prior to administering. (Other relevant tests included no lab data.) Final diagnosis was cellulitis, nausea. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. List of documents held by sender: none; Sender's Comments: This case involves a female patient (unknown demographics) who presented with nausea, redness, sore arm with joint pain and was diagnosed with cellulitis one day post vaccination with FLUZONE QUADRIVALENT. Time to onset is compatible. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, and lab tests ruling out alternate etiologies. Moreover, it was reported as adequate aseptic measures were not taken during vaccination (opened the refrigerated package, and put it on a dirty and unsterilized sink prior to administering). Hence there is a possibility that the cellulitis is due to introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.