chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain and tingling. BEXSERO was discontinued. On an unknown date, the outcome of the pain and tingling were recovered/resolved. It was unknown if the reporter considered the pain and tingling to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient was in her early 20's at the time of reporting. The age at vaccination was not reported. The patient experienced severe pain and tingling for several days. The patient would not get the second dose of BEXSERO because of the side effects she experienced. The reporter thought it had something to do with receiving this BEXSERO vaccine and MENACTRA previously. The reporter agreed to be followed up. It was unknown if the reporter considered the severe pain and tingling to be related to MENACTRA as well. This case has been linked to the US2018GSK135774, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Heart rate increased, Pain, Pain in extremity
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case was also linked with 2018SA033791 and 2018SA036621 (same reporter). This case involves a 61 years old female patient who experienced pain in her wrist/sharp pain in her finger, pain all over her body in one degree or another, painful flares and heart rate sometimes goes to the 140-180, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE QUADRIVALENT with she took the flu vaccine for 17 years prior without complication. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis in Jul-2017 whose diagnosis was made after her primary care doctor referred her to a rheumatologist. On an unspecified date in Oct 2017, the patient received a single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unspecified date in Oct 2017, 24 hours post vaccination, she experienced a sharp pain in her finger. Since this initial sharp pain, she has experienced pain all over her body in one degree or another. On an unspecified date, the patient developed a pain in her wrist. It was reported that she had relief of the pain when she takes her methotrexate and prednisone as prescribed. Because the methotrexate and prednisone have undesirable side effects, she often times does not take either. This will inevitably lead to painful flares. It was also reported that her heart rate sometimes goes to the 140-180, which she believes is not because of the known side effect of prednisone, but rather caused by the flu vaccine. Final diagnosis was painful flares, pain all over her body in one degree or another, pain in her wrist/sharp pain in her finger and heart rate sometimes goes to the 140-180. The patient was treated with METHOTREXATE and PREDNISONE. The outcome of the events was not reported. The patient believes the events were related to the vaccination. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Disability, Gait inability, Guillain-Barre syndrome, Walking aid user
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid serious case received from a nurse. This case involves (65-70 year) male patient who experienced Guillain Barré syndrome and could not walk, while he 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 FLUZONE HIGH DOSE lot number not reported via unknown route. The patient developed a serious Guillain-Barre syndrome following the administration of FLUZONE HIGH DOSE. This event was leading to disability. The patient developed a serious could not walk (walking disability) following the administration of FLUZONE HIGH DOSE. This event was leading to disability. It was reported that patient used cane to walk. The patient had to have extensive rehab and used cane. Other relevant tests included No lab data. Final diagnosis was could not walk and Guillain Barre syndrome. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for Guillain Barré syndrome and as Unknown for could not walk. Sender's Comments: This case involves an elderly patient who presented with Guillain Barré syndrome (GBS) and could not walk post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Guillain-Barré Syndrome is a listed event for FLUZONE HIGH DOSE. However, further information including patient's medical history, medical condition at the time of vaccination, clinical description of GBS, CSF, EGM, viral and bacterial serology result would be relevant for accurate assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer (office staff). This case involves a 12 months old male patient who was administered an expired dose of ACT-HIB lot UI799AA, expiry date: 08-Jul-2018, via intramuscular route in the left thigh on 30-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; MMR for Immunisation; and VARICELLA VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from pharmacist on 30-Jul-2018. This case involves a 55-year-old female patient who was vaccinated with fourth dose (expired) of IMOVAX RABIES (expiration date: 24 Jul 2018, batch number, dose and site of administration was not reported) via intramuscular route on 30-Jul-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired drug administered. It was unknown if patient had any adverse event. 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. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA209352, 2018SA209359 and 2018SA209360 (same reporter). This case involves a five years old male patient who received a 0.5 mL fourth dose of vaccine IPOL (lot N1G41, expiry date: 28-Jul-2019) via intramuscular route in left deltoid on 30-Jul-2018, which was supposed to be discarded related to an excursion and incorrectly stored. 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 incorrect product storage with an excursion of Opened Polio 48.6 degrees F. x 2 hours and 40 minutes and deteriorated drug administered. It was reported that patient had a Polio vaccine from the same vial that was supposed to be discarded related to an excursion. It was not reported if the patient experienced any adverse event or not. 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. Documents held by sender: none.
Age: 0.83
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 months old male patient who received third 0.5 ml dose of vaccine IPOL lot N1G41 via unknown route in the right thigh on 30-Jul-2018 after excursion of opened polio 48.6 degrees F. x 2 hours and 40 minutes. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to incorrect product storage. It was not reported whether patient had experienced any adverse event or not. 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: 0.08
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a one months old (also reported as 2 months) female patient who was received a 0.5 mL dose of QUADRACEL (lot number: C5222AA, expiry date: 20-Jun-2019) via intramuscular route in the left thigh instead of PENTACEL (batch number and expiry date were not reported) on 30-Jul-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. 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. Documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Adverse event, Product preparation error
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 4 months old male patient who received Dtap and polio portion of the vaccine PENTACEL (Frequency once), 0.5 ml, lot C5456AA via intramuscular route in the left thigh on 30 Jul 2018. Concomitant medications included PREVNAR; and ROTAVIRUS VACCINE "also reported as Rodo virisu". It was a case of actual adverse event due to Inappropriate reconstitution technique as patient received only the Dtap and the polio portion and did not give the HIB portion of vaccine PENTACEL. It was unknown if any adverse event occurred. 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: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of an unknown demographics who received an expired PENTACEL 15 days after the expiration date, while he/she received vaccine PENTACEL. 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 expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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. Documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old patient (gender unknown) who received 0.5ml dose of suspect MENACTRA (lot U5984AB), expiry date not provided via intramuscular route in the right arm on 26-Jul-2018 at 13:31 that was out at room temperature. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that dose of MENACTRA that was administered to a patient that was out at room temperature. MENACTRA broke cold chain management after delivery service failed to get package to destination within 48 hours. 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.
Age: 6.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial unsolicited report received from an other health professional on 31-Jul-2018. This case involves a six-years-old female patient who was vaccinated with a 0.5 ml dose of ADACEL lot U5792AA via intramuscular route in left thigh on 08-Jun-2018 instead of DTaP. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that the patient tolerated vaccine well, without notice of adverse reaction. 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.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccination site inflammation
Clinical narrative: Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient of an unknown demographics who experienced pain, swelling and redness at the injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (also reported as one week ago), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient developed a non-serious pain, swelling and redness at the injection site, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was pain, swelling and redness at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: IPV, TYP
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from an other health professional on 31-Jul-2018. This case involves a 56-years-old male patient who was vaccinated with a dose of 0.5 ml IPOL lot number not reported via unknown route in the left deltoid instead of 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE lot PIA171M. The patient's past vaccination(s) included TYPHOID. The patient's past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered. It was reported that the patient with no allergic reaction was observed. 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.
Sex: U
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from other health professional on 31-Jul-2018. This case involves 4 months old patient (gender not reported) who was vaccinated with expired 0.5 ml second dose of Pentacel (Batch number: C54008A, expiration date: 24-Jun-2018) via intramuscular route via right leg on 30-July-2018. The patients medical history was not reported. Concomitant medications included PNEUMOCOCCAL CONJUGATE VACCINE for immunisation and ROTAVIRUS VACCINE for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. 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.
Age: 0.58
Sex: U
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven months old patient (gender not reported) who received third dose of PENTACEL lot C5462AA, expiry date: 26-Jul-2019, via intramuscular route in the right thigh and a dose of ACT-HIB lot UI894AAA, expiry date: 28-Sep-2019, in the left thigh on 20-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation. It was a case of actual medication error due to extra dose of HiB component administered. It was reported that the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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. Documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old female patient who was inadvertently injected with Adacel rather than DTaP, while she received vaccines DAPTACEL and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD for Immunisation. On 08-Jun-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5792AA via intramuscular route in the left thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to wrong vaccine administered. (Other relevant tests included No lab data.) Final diagnosis was patient was inadvertently injected with Adacel rather than DTaP. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for patient was inadvertently injected with Adacel rather than DTaP. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (Office Staff) on 01-Aug-2018. This case involves a five-year-old male patient who was inadvertently vaccinated with a dose of 0.5 ml ADACEL (frequency once, lot number: C5467BA, via unknown route in the left thigh) instead of DAPTACEL on 01-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE; MMR; and VARICELLA VACCINE. It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered as patient was administered Adacel inadvertently during his 5th dose of the series of tetanus-diphtheria-pertussis 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. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Cellulitis, Chills, Headache, Pain
Clinical narrative: Stared with a temp 102.5 the day after vaccine, headache, chills and body aches. Was seen at urgent care 8/5/18, dx cellulitis of arm  given Keflex 500mg 1 po tid x10.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Patient came in next day and said she felt nauseated and the local injection site was very red and hot. We explained this is a reaction that could happen and to monitor the red area. She came in 2 days later and the "red area" had increased in size and traveled down to her arm. When I called her 4 days after her vaccine administration she explained the redness had descended to the inner elbow portion of her arm however it was no longer red but now yellow/green/blue as if it looked like a bruising had occurred. She did state she no longer had the nausea and was feeling fine aside from the arm looking bruised.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Ear pain, Eye swelling, Headache
Clinical narrative: PT RECIEVED BEXSERO VACCINE AND BACTRIM AT APPT 8/2/18 ARROUND 1420. PT TOOK FIRST DOSE OF BACTRIM AT APPROX 1500 AND THEN AROUND 1700 PT DEVELOPED NASAL CONGESTION, BILAT EAR PAIN, JAW PAIN AND BILAT HIP PAIN. APPROX 15 MIN LATER PT DEVELOPED CHILLS AND LOW GRADE TEMP OF 99.9, PT TOOK IBUPROFEN AT THAT TIME. APPROX 8PM FEVER UP 101.4, DEVELOPED FRONTAL HA WITH LIGHT SENSITIVITY AND NAUSEA, MOM GAVE TYLENOL AND BENADRYL AT THAT TIME. PT WAS FEBRILE ALL NIGHT, WITH TEMP STAYING AROUND 100.0, WOKE THIS AM APPROX 0800 WITH MILD LIP SWELLING WHICH HAS IMPROVED BUT NOW PUFFY AROUND EYES. MOM JUST NOTICED MILD RED RASH ON LOWER EXTREMITIES, NON PRUITIC. PT STILL C/O BODY ACHES, HA, THROAT FEELS A LITTLE SWOLLEN BUT NOT SORE.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Lip swelling, Nasal congestion, Nausea, Pain, Pain in jaw
Clinical narrative: PT RECIEVED BEXSERO VACCINE AND BACTRIM AT APPT 8/2/18 ARROUND 1420. PT TOOK FIRST DOSE OF BACTRIM AT APPROX 1500 AND THEN AROUND 1700 PT DEVELOPED NASAL CONGESTION, BILAT EAR PAIN, JAW PAIN AND BILAT HIP PAIN. APPROX 15 MIN LATER PT DEVELOPED CHILLS AND LOW GRADE TEMP OF 99.9, PT TOOK IBUPROFEN AT THAT TIME. APPROX 8PM FEVER UP 101.4, DEVELOPED FRONTAL HA WITH LIGHT SENSITIVITY AND NAUSEA, MOM GAVE TYLENOL AND BENADRYL AT THAT TIME. PT WAS FEBRILE ALL NIGHT, WITH TEMP STAYING AROUND 100.0, WOKE THIS AM APPROX 0800 WITH MILD LIP SWELLING WHICH HAS IMPROVED BUT NOW PUFFY AROUND EYES. MOM JUST NOTICED MILD RED RASH ON LOWER EXTREMITIES, NON PRUITIC. PT STILL C/O BODY ACHES, HA, THROAT FEELS A LITTLE SWOLLEN BUT NOT SORE.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pharyngeal oedema, Photophobia, Pyrexia, Rash, Rash erythematous
Clinical narrative: PT RECIEVED BEXSERO VACCINE AND BACTRIM AT APPT 8/2/18 ARROUND 1420. PT TOOK FIRST DOSE OF BACTRIM AT APPROX 1500 AND THEN AROUND 1700 PT DEVELOPED NASAL CONGESTION, BILAT EAR PAIN, JAW PAIN AND BILAT HIP PAIN. APPROX 15 MIN LATER PT DEVELOPED CHILLS AND LOW GRADE TEMP OF 99.9, PT TOOK IBUPROFEN AT THAT TIME. APPROX 8PM FEVER UP 101.4, DEVELOPED FRONTAL HA WITH LIGHT SENSITIVITY AND NAUSEA, MOM GAVE TYLENOL AND BENADRYL AT THAT TIME. PT WAS FEBRILE ALL NIGHT, WITH TEMP STAYING AROUND 100.0, WOKE THIS AM APPROX 0800 WITH MILD LIP SWELLING WHICH HAS IMPROVED BUT NOW PUFFY AROUND EYES. MOM JUST NOTICED MILD RED RASH ON LOWER EXTREMITIES, NON PRUITIC. PT STILL C/O BODY ACHES, HA, THROAT FEELS A LITTLE SWOLLEN BUT NOT SORE.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient noted that first attempt at injection resulted in pharmacist being unable to inject drug. 2nd attempt was above deltoid muscle on R upper arm. Has since developed severe pain R shoulder, limited range of motion, radiating pain to right arm. Advised ice/heat, gentle stretching. If no improvement will consider imaging of shoulder +/- physical therapy.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse referring to a currently 18 year old female patient with amoxicillin allergy. No other information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-JUN-2018 the patient was vaccinated with her second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 25-JUN-2018, the patient was seen in the physician office and it was confirmed she was pregnant. The LMP and EDD were not known. The pregnancy outcome was pending. On an unspecified date, a "routine prenatal lab work" was performed (results not provided). No adverse effects were reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 25th July 2018, the patient experienced injection site warmth, injection site swelling, injection site erythema and general body pain. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site swelling, injection site erythema and general body pain were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, injection site erythema and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient experienced injection site pain the day they received SHINGRIX. A patient's injection site became swollen, red, and hot one day after receiving SHINGRIX. The patient also developed whole body pain. The symptoms were "moderate to severe."
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cyst, Depressed mood, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (8 to 10 years ago.). On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced shivering. In May 2018, the patient experienced fever, feeling down and cyst. On an unknown date, the patient experienced sickness. On an unknown date, the outcome of the fever and shivering were recovered/resolved and the outcome of the sickness, feeling down and cyst were unknown. It was unknown if the reporter considered the fever, sickness, feeling down, shivering and cyst to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, in the same night of his shot he was shivering, it resolved after he got in bed and under the covers. Within the next day, the patient had fever of 99.4 degree F and that resolved within 1 to 2 days. The patient also had a cyst on his back the day of the vaccination that he wonders if that could have caused the fever. The patient stated that the pharmacy was requiring the physician's prescription for him to get the 2nd shot due to the fever from the 1st vaccination. The patient stated that he felt sick and didn't feel like doing much.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd July 2018, 4 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX left arm. The patient experienced a rash at the injection site about 1-2 inch in diameter. After 8 days post vaccination the rash was now 4 inches in diameter. The reporter gave permission to contact his health care provider. No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 53-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (the patient had shingles two to ten times every year for the past 19 years). On 17th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th May 2018, 11 days after receiving SHINGRIX, the patient experienced shingles, swelling of eyelid and rash. On an unknown date, the outcome of the shingles was resolved with sequelae and the outcome of the swelling of eyelid was recovered/resolved and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the shingles, swelling of eyelid and rash to be related to SHINGRIX. Additional details were provided as follows: The patient said that everyone where she lives got the shingles multiple times. The patient received SHINGRIX in the left arm. The patient had an outbreak of shingles on her left eyelid on 28th May 2018 which caused her eyelid to swell. The patient had several outbreaks of Shingles, on eyeballs, eyelids and cheeks usually left side. It resolved within a few days. The patient had another outbreak of shingles on 5th July 2018 on her left cheek. It lasted until 23rd July 2018 and still appeared where the bumps were located. The patient did not have a physician at this time. The patient had denied permission to contact their physician.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received SHINGRIX. On 26th July 2018, less than an hour after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient stated that within an hour or so after receiving SHINGRIX, she started to experience severe pain in her arm. The pain was not just at the injection site but down her entire arm. The pain was so intense that she was unable to do anything with her right arm. If the patient needed to use the right arm for something, she had to use her left arm to move the other. The patient was still experiencing pain on the day of reporting but not as intense.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 24th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, fever and injection site warmth. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovering/resolving and the outcome of the injection site swelling was unchanged and the outcome of the fever was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX via subcutaneous route, which led to inappropriate route of vaccination. The physician visit was required for swelling which had not improved.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Depression, Influenza like illness, Lethargy, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 30th July 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In July 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, lethargy, depression and influenza-like symptoms. On an unknown date, the outcome of the muscle pain, lethargy, depression and influenza-like symptoms were unchanged. It was unknown if the reporter considered the muscle pain, lethargy, depression and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. In morning of the reporting day, the patient experienced muscle aches all over the body, flu like symptoms, lethargy and depression. The patient had an appointment with his cardiologist in two to three weeks from the reporting date. The patient gave permission to contact his physician. No further details were provided by the patient. The patient was referred to his health care provider.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 18-year-old female patient who received ENERGIX B for prophylaxis. Co-suspect products included ENERGIX B for prophylaxis and ENERGIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENERGIX B, the 2nd dose of ENERGIX B and the 3rd dose of ENERGIX B. On an unknown date, unknown after receiving ENERGIX B, ENERGIX B and ENERGIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENERGIX B, ENERGIX B, ENERGIX B. Additional information was received as follows: The age at vaccination was not reported. The patient received a 4th dose of ENERGIX B (0.5 ml, batch number LR2T7, expiry date 24th January 2021) in accordance with Centers for Disease Control and Prevention (CDC) guidance for previously vaccinated healthcare personnel with anti-HBs titers less than 10 mIU/mL. Lab Comments: Lab test was done on an unknown date.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In March 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site warmth. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site warmth were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The patient received the 2nd dose of SHINGRIX, 2 months after receiving the 1st dose. After vaccination, later within 12 hours, the patient experienced similar symptoms as experienced with the 1st dose but were less severe. The events lasted for a period of approximately 1 week. The patient was vaccinated with the 2nd dose under normal circumstances the same way as the pharmacy always administered. This case was linked with case US2018120276 (1st dose), reported by the same reporter for the same patient.
Sex: F
Vaccine: PNC13
Symptoms: Antibody test negative, Blood immunoglobulin A decreased, Neutrophil count increased, White blood cell count increased
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient's mother). A 5-year-old female patient received PREVNAR 13, (batch/lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient had been getting multiple infections about once per month. The patient's immunologist did a blood test and found that her "Pneumo AB" level was low and her neutrophils and WBCs were high. The patient had an IgA level that was slightly low. The physician recommended a booster of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) for this child. The mother had concerns about giving her a booster. The mother wanted to know if this was commonly done and why the patient might need one. The patient must have had the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) series as an infant as she was up to date on all of her immunizations. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (HCP). A female patient of an unspecified age received PREVNAR 13 (lot/batch number not provided), via an unspecified route of administration in Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified day in Jul2018, patient has developed a large red area that is warm to touch at the PCV13 injection site. She was vaccinated less than a week ago in Jul2018. Physician was treating with oral antibiotics for possible infection. The outcome of the events was unknown. Information regarding batch/lot number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Headache, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative.   A 16 years old patient of unspecified gender received TRUMENBA on an unspecified date, at 0.5 ml single dose, intramuscular, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced severe swelling, headache and fever. These events required the patient's hospitalization. Events outcome was unknown.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Throat tightness
Clinical narrative: Patient felt throat closing after administration of vaccines.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Hyperhidrosis, Malaise, Posture abnormal
Clinical narrative: Gave SHINGRIX VX, pt stated that she "did not feel well," propped her feet up in a chair, started passing out (slumping in chair, sweating profusely), Tech called EMS and alerted store manager with Code White; EMS arrived, pt was more alert, sipping on water; pt stated that she "did not want to go to the ER." Waiver was signed with EMS. Pt called pharmacy to state she was home and doing well.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: patient arm turned red and was painful, lasted about 3 days and is going away slowly
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Severe shakes and chills in middle of the night, body aches, headache, fever, malaise. Last approximately 48 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Severe shakes and chills in middle of the night, body aches, headache, fever, malaise. Last approximately 48 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain, Swelling, Tenderness
Clinical narrative: PT DEVELOPED PAIN, REDNESS, TENDERNESS, SWELLING AND BRUISING.
Age: 16.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient was given wrong vaccine.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site became red, hot, and tender with redness spreading down arm and to arm pit by day 4. Started ABX on 25th and finally got better on 7/28. Pain did not improve until 7/27/2018. No fever. Redness slowly fading each day a little more completely gone on 7/30/2018.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: RIGHT DELTOID RED, WARM, TENDER.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Appx 12 hours after vaccination with SHINGRIX, patient developed fever (highest was 102 degrees), severe headache, nausea, and chills. These symptoms all resolved about 12 hours after they began.