chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Laboratory test normal
Clinical narrative: Initial unsolicited report received from a physician on 19-Sep-2016. This case involves a 71-year-old female patient who was vaccinated with a dose of Fluzone HD (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 15-Sep-2016. The patient's illness at time of vaccination was reported as none and the pre-existing physician diagnosed allergies included sulfa, PCN, Macrobid allergy and birth defects, medical conditions (specify) were reported as Vicryl sutures, breast cancer mult skin cancers, chronic sinus infections. Concomitant medications were not reported. The patient had not received any vaccinations within 4 weeks of vaccination with Fluzone HD vaccine. On 16-Sep-2016 in the am, one day after the vaccination, patient started having difficulty in breathing and hives. The patient was diagnosed with an anaphylactic reaction. The patient was taken to emergency room. Laboratory investigations were reported as none. Patient's corrective treatment included breathing treatments, steroids and Benadryl IV and was discharged with a Medrol Dose pack. The patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Anaphylactic reactions are listed post-vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of vaccine. patient have history of allergy to Penicillin, Sulfa drugs, Macrobid, Vicryl Sutures, also have history of Breast CA and chronic sinus infections. Complementary information regarding any drug or food intake during the period between vaccination and reaction as well as allergic testings to identify the culprit antigen, patient's history of reaction after previous vaccinations is needed for complete assessment of the case.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a non-health professional (Office staff) on 20-Sep-2016. This case involves a 5-year-old male patient, who was vaccinated with single dose of FLUZONE QUADRIVALENT (batch number: U5595DA, expiry date, route and site of administration were not reported) on 16-Sep-2016. Patient's ongoing illness, medical history, risk factors and concomitant medications were not reported. On an unspecified date in Sep 2016, post vaccination, the patient experienced swelling of arm. On 20 Sep 2016, parent brought child into office. Laboratory investigations and corrective treatments were not reported. The outcome of the event swelling of arm was not reported. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe itching on scalp began a few days after I received the vaccine. Approximately 1 week later, hives and severe itching began. I started taking Clairtin daily, with no resolve. Saw a Dermatologist and was prescribed Predisone for 3 weeks. Prednisone has not assisted with hives.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Fever to 102. Localized swelling, erythema and pruritus in the left deltoid area measuring 8.75 x 7.75cm.
Age: 0.17
Sex: M
Vaccine: DTAP, RVX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Moderate fever, swelling at the injection site, redness and warm at injection site. He was treated with Tylenol and sent home.
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient experienced swollen upper left arm and fever reaching 103.6 degrees. Both occurred right after shots. Patient went to hospital. Patient was admitted to hospital for 2 days and put on KEFLEX for one week. Patient now ok.
Sex: F
Vaccine: HPVX
Symptoms: Death
Clinical narrative: Information has been received from an online article via a company representative. The article stated that a doctor said that the incidence of cervical cancer was very low and it was impossible for Merck's Human papillomavirus (HPV) vaccine to lower the already low incidence of cervical cancer. It was reported that the promotion of this vaccine to prevent cervical cancer was entirely groundless, although it was promoted as this. The study confirmed that the indication of this vaccine had nothing to do with cervical cancer, however, the way of promotion still ignored this fact. In fact, there was no evidence to support that this vaccine could prevent any cancer. According to Merck's labeling, this vaccine (the 1st generation) targeted four types of all the 40 types of HPV, which could be self-healing in short time. The article also concerned about the potential risks of this vaccine, as it indicated all the clinical trials were conducted among the females aged 15-year old or above, however, Food and Drug Administration (FDA) and Merck had extended the target users to girls of 9-year old and above, even boys. It was reported that so far there had been 15,037 cases of adverse drug reaction for this vaccine, and the statistics only included cases that met the very stringent validation criteria. There had been 44 girls that were confirmed to die of this vaccine. All kinds of adverse drug reactions included Guillain-Barre syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral palsy) (captured in MARRS# 1609USA012858). This report refers to the 44 girls who were confirmed to die of this vaccine. Upon internal review, die of this vaccine was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Cerebral palsy, Encephalitis, Guillain-Barre syndrome, Paralysis, Systemic lupus erythematosus
Clinical narrative: Information has been received from an online article via a company representative. The article stated that a doctor said that the incidence of cervical cancer was very low and it was impossible for Merck's Human papillomavirus (HPV) vaccine to lower the already low incidence of cervical cancer. It was reported that the promotion of this vaccine to prevent cervical cancer was entirely groundless, although it was promoted as this. The study confirmed that the indication of this vaccine had nothing to do with cervical cancer, however, the way of promotion still ignored this fact. In fact, there was no evidence to support that this vaccine could prevent any cancer. According to Merck's labeling, this vaccine (the 1st generation) targeted four types of all the 40 types of HPV, which could be self-healing in short time. The article also concerned about the potential risks of this vaccine, as it indicated all the clinical trials were conducted among the females aged 15-year old or above, however, Food and Drug Administration (FDA) and Merck had extended the target users to girls of 9-year old and above, even boys. It was reported that so far there had been 15,037 cases of adverse drug reaction for this vaccine, and the statistics only included cases that met the very stringent validation criteria. There had been 44 girls that were confirmed to die of this vaccine (captured in MARRS#1609USA013709). All kinds of adverse drug reactions included Guillain-Barre syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral palsy). This report refers to unspecified number of patients who experienced Guillain-Barre syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral palsy). Upon internal review, the adverse events were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Thrombosis
Clinical narrative: Information has been received from an online article via a company representative. The article stated that a doctor said that the incidence of cervical cancer was very low and it was impossible for Merck's Human papillomavirus (HPV) vaccine to lower the already low incidence of cervical cancer. It was reported that the promotion of this vaccine to prevent cervical cancer was entirely groundless, although it was promoted as this. The study confirmed that the indication of this vaccine had nothing to do with cervical cancer, however, the way of promotion still ignored this fact. In fact, there was no evidence to support that this vaccine could prevent any cancer. According to Merck's labeling, this vaccine (the 1st generation) targeted four types of all the 40 types of HPV, which could be self-healing in short time. The article also concerned about the potential risks of this vaccine, as it indicated all the clinical trials were conducted among the females aged 15-year old or above, however, Food and Drug Administration (FDA) and Merck had extended the target users to girls of 9-year old and above, even boys. It was reported that so far there had been 15,037 cases of adverse drug reaction for this vaccine, and the statistics only included cases that met the very stringent validation criteria. There had been 44 girls that were confirmed to die of this vaccine (captured in MARRS#1609USA013709). All kinds of adverse drug reactions included Guillain-Barre syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral palsy). This report refers to unspecified number of patients who experienced Guillain-Barre syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral palsy). Upon internal review, the adverse events were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a female registered nurse of unknown age (was also the patient) referring to herself. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot #, expiration date and route not reported). On an unknown date, the patient experienced pneumonia after receiving PNEUMOVAX 23. The outcome of the event was unknown. The causality between the event and PNEUMOVAX 23 was not provided. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (Lot # K008931, expiry04-MAR-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On 07-JUL-2016 the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot# M007728, L010598, expiry 06-AUG-2016; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a adult male who received ENGERIX B adult (batch number AHBVB584AA, expiry date 6th November 2010). Co-suspect products included ENGERIX B adult (batch number AHBVB584AA, expiry date 6th November 2010) and ENGERIX B Adult (batch number AHBVB670AA, expiry date 11th April 2011). On 22nd July 2008, the patient received the 1st dose of ENGERIX B adult. On 18th August 2008, the patient received the 2nd dose of ENGERIX B adult. On 10th November 2008, the patient received the 3rd dose of ENGERIX B adult. On 10th November 2008, not applicable after receiving ENGERIX B adult and ENGERIX B adult, not applicable after receiving ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. On 9th December 2008, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too short were unknown. It was unknown if the reporter considered the therapy non-responder to be related  to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: The patient's initials or date of birth was not provided. The age at vaccination was not reported. On 10th November 2016, the patient received 3rd dose of ENGERIX B adult, which led to shortening of the vaccination schedule. On 9th December 2008, 29 days after receiving 3rd dose of ENGERIX B adult, the anti-HBs (hepatitis B surface antibody) titer was found to be less than 8mlU/ml. Thus, leading the patient to be a therapy non-responder.
Sex: U
Vaccine: HPV4
Symptoms: Cerebral palsy, Encephalitis, Guillain-Barre syndrome, Systemic lupus erythematosus, Thrombosis
Clinical narrative: Information was received from a chief researcher through an online article via a company representative referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date, dose and route were unknown). On unknown dates, the patients experienced adverse events included Guillain-Barre syndrome (paralysis), lupus erythematosus, thrombus and encephalitis (cerebral palsy). The outcome of the events was unknown. The causality assessment between the events and GARDASIL was not reported. Upon internal review, all the events were determined to be medically significant events. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information was received from a chief researcher through an online article via a company representative referring to 44 female patients of unknown age. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date, dose and route were unknown). On unknown dates, the patients died of this vaccine. The cause of death was unknown. It was unknown if autopsy was performed. The reporter considered death to be related to GARDASIL. Upon internal review, death was determined to be a medically significant event. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPVX, TD
Symptoms: Hypoaesthesia, Paraesthesia, Raynaud's phenomenon, Skin discolouration
Clinical narrative: Purple and white discoloration, tingling and numbness to bilateral hands. Also know as Raynauds.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient claimed to have a sore arm, redness at injection site, swelling at injection site, and muscle was hard at injection site, and fever at injection site.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: RED, WARM, SWOLLEN, INFLAMED ARM (LEFT DELTOID).
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: RED, WARM, SWOLLEN, INFLAMED ARM (LEFT DELTOID).
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site warmth, Pain, Pain in extremity, Rash
Clinical narrative: RED, WARM, SWOLLEN, INFLAMED ARM (LEFT DELTOID).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored hepatitis b vaccine (recombinant) (manufacturer unknown) (lot#, strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Injection site induration
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site induration in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site induration. On an unknown date, the outcome of the injection site induration was unchanged. The reporter considered the injection site induration to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. In 2016, 3 weeks before the reporting date, the patient received BEXSERO. The patient experienced a full knot, like a hard ball at the injection site. The field representative was unable to provide any further details and did not have the last name of the initial reporter. The field representative advised to contact another nurse to obtain further details and the contact details were provided from the same. The nurse usually did not come in to the office until 3:00 pm.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored PEDVAXHIB (Lot# L014428, expiry 12-MAR-2018; L042835, expiry 19-AUG-2018; strength, dosage, frequency and route unspecified). The vaccines were exposed -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot# M007728, expiry 21-MAR-2018; M011840, expiry 01-FEB-2018; L043214, expiry 30-AUG-2017; L027282, expiry 21-SEP-2017; L013429, expiry 21-JUL-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding multiple unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On multiple unspecified dates from 18-JAN-2016 to 28-JUN-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details, lot# and expiry date not known). The administered vaccines experienced a temperature excursion of 51.1 degree Fahrenheit for 18 hours 30 minutes. There was no previous excursion. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product preparation error, Syringe issue, Underdose
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a partial dose of PNEUMOVAX 23 (dose unknown, lot# M022947, expiration date: 12-NOV-2017) intramuscularly, due to dose leaking between the syringe and the needle hub. The nurse reported that she aspirated the PNEUMOVAX 23 from a vial into an administration syringe and failed to properly attach the needle to the administration syringe. The patient had not experienced any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Lot# L027287, expiry 21-JUL-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding multiple unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On multiple unspecified dates from 18-JAN-2016 to 28-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ (dosing details, lot# and expiry date not known). The administered vaccines experienced a temperature excursion of 51.1 degree Fahrenheit for 18 hours 30 minutes. There was no previous excursions. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 53 years old female patient with anemia, low iron level and unspecified thyroid issue. The patient was in an unspecified hospital two weeks ago (on approximately 05-SEP-2016) for low iron level and she received an iron infusion. Concomitant therapies included unspecified thyroid medication, hydrochlorothiazide (manufacturer unknown), PLAVIX, and NORVASC. The patient had no drug reaction or allergies. On 16-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, lot # L038926, expiration date: 06-JAN-2017) subcutaneously. On an unspecified date in September 2016, after receiving the vaccine, the patient noted redness and itching at the injection site where she received the ZOSTAVAX. The patient called the reporter's pharmacy and reported the events. She came into the pharmacy to seek medical attention on 18-SEP-2016, and the pharmacist noted redness and swelling at the injection site as well as "the area surrounding the ZOSTAVAX injection site was warm to the touch". Unspecified treatment had been given for the events. No lab test was performed. The patient did not recover from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction, Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received pneumococcal PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse reaction related to syncope on an unspecified date with outcome of unknown.
Sex: M
Vaccine: MENB
Symptoms: Adverse reaction, Musculoskeletal stiffness, Somnolence
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, by a contactable consumer reported for himself. This male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced neck stiff and drowsy on an unspecified date with outcome of unknown. "He did spray some "raid" (not clear over the call) and probably he had reaction and illness from that.
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age, race and ethnicity received PREVNAR 13, (lot M79319, expiry date Aug2017, NDC 0005197102) via an unspecified route of administration on an unspecified date in Sep2016 at 0.5 ml single for immunization.  The patient medical history and concomitant medications were not reported. The patient had not reported any allergies.  On an unspecified date in Sep2016 the patient experienced swelling in arm, itchiness that came and went and arm warm to touch. The patient was not recovered from swelling in arm, the outcome of the other events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable pharmacist, reporting for his daughter, via a Pfizer sales representative. This female patient of an unspecified age, race and ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunization. The patient medical history was not reported, there were no concomitant medications. On an unspecified date the patient experienced nausea, vomiting, headache and pain at injection site. Events outcome was unknown.
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative who reported the same events for 3 different patients. This is the 3rd of 3 reports. A 14-year-old patient of an unspecified ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, fever, headache, malaise, all on an unspecified date with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016449736 Same reporter/drug/events, different patient; US-PFIZER INC-2016449750 Same reporter/drug/events, different patient.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Tendonitis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified day in Jun2015 for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified day in Jun2015 the patient experienced extreme pain and tendinitis. Outcome was unknown.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Chest X-ray, Chest pain, Injection site pain
Clinical narrative: Severe pain in shoulder, chest on left side, after 1 day it spread to left shoulder and chest as well, movement is impede severely as well, now pain is spreading to knee.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder, chest on left side, after 1 day it spread to left shoulder and chest as well, movement is impede severely as well, now pain is spreading to knee.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse events, but RN gave a pediatric dose of Hepatitis A to and adult.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Pain, Pyrexia, Rash pustular, Skin warm
Clinical narrative: Pain, swelling, redness, fever, pox area area, hot to touch. Went to urgent care 9/28/16. Started antibiotics. Mother stated doctor thinks it might be an abscess or MRSA. Pt is going back to doctor on 9/30/16 for follow up.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Swelling
Clinical narrative: Pain, swelling, redness, fever, pox area area, hot to touch. Went to urgent care 9/28/16. Started antibiotics. Mother stated doctor thinks it might be an abscess or MRSA. Pt is going back to doctor on 9/30/16 for follow up.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and erythema right upper arm. No treatment, just continue to monitor.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Discomfort, Injection site pain
Clinical narrative: Customer had an uneventful vaccine administration. There was no bleeding and there was no initial pain reported by customer. Customer states her arm started to feel painful at injection site approximately 2 hours after receiving vaccination. She also reported bruising at this time. She used ice throughout the night for the discomfort. She called her PCP this morning and they suggested they call the PH department where she received her flu shot. She is at work (school dept) where the school nurse recommended ice throughout the day today then heat tomorrow. It was also recommended that she take Tylenol as needed for discomfort.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Genital rash, Rash erythematous, Skin warm
Clinical narrative: Mother stated child had red, warm rash on genitals that she just noticed today. Rash is not painful and doesn't itch. Advised mother to take child to the doctor for examination and treatment if needed and she agreed.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 26-SEP-2016, the patient was vaccinated with VAQTA, strength 25/0.5 (unit unknown), (dose 0.5 ml, once, lot # M015290 and expiry date 20-SEP-2017) via intramuscular route. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (lot# L033696, expiry 28-FEB-2017 and L033698, expiry 28-FEB-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 26-SEP-2016, the patient was vaccinated with an expired dose of VARIVAX (lot # K015992 and expiry date 23-SEP-2016) (strength, dosing details, anatomical location unknown). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. No concomitant medications were reported. On 23-AUG-2016, the patient was vaccinated with GARDASIL 9 (dose, route and lot numbers were not reported) and again received the next dose one month later on 23-SEP-2016. It was reported that no apparent adverse effects were observed. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates between 01-JUL-2016 and 06-SEP-2016, the patients were vaccinated with improperly stored doses of M-M-R II, lot # L011528, expiration date: 03-APR-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 15.8 degrees Fahrenheit (reported as low temperature) for 148 hours and 50.7 degrees Fahrenheit (reported as high temperature) for 1 hour and 30 minutes. The temperature excursion was captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter (linked with MARRS# 1609USA013203, 1609USA013449, 1609USA013451). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates between 01-JUL-2016 and 06-SEP-2016, the patients were vaccinated with improperly stored doses of VAQTA, lot # L048456, expiration date: 25-MAY-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 15.8 degrees Fahrenheit (reported as low temperature) for 148 hours and 50.7 degrees Fahrenheit (reported as high temperature) for 1 hour and 30 minutes. The temperature excursion was captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter (linked with MARRS# 1609USA013203, 1609USA013449, 1609USA013450). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist referring to 2 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. On approximately 15-SEP-2016 (reported as about a week ago), the patients were administered ZOSTAVAX 19400PFU (lot # L046896, expiration date 23-FEB-2017; dose and route were unknown at physician's office. On approximately 17-SEP-2016 (reported as approximately 2 to 3 days after administration), the patients had pretty severe reactions including redness and swelling down to their elbows. No rash was reported. Both patients made a phone call to the physician to report the reactions, but it was unknown if any treatment was recommended. The outcome of the events was unknown. The causality assessment between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin disorder
Clinical narrative: Information has been received from a 78 years old female referring to herself, who had had a cancer (details unspecified). The patient's concurrent condition and concomitant therapy were unknown. On 24-JAN-2012, the patient was vaccinated with ZOSTAVAX (lot# , expiration date, dose and route were unknown). On 08-AUG-2016 (while on ZOSTAVAX), the patient developed shingles. The patient had sought for medical attention by visiting her doctor. At the time of the report. the patient did not recovered from the event, still had marks on her skin from the shingles. The causality assessment between the events and ZOSTAVAX was not reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#, expiration date, dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was unknown. It was unknown if the reporter considered the injection site warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The injection site became hot to the touch immediately after vaccination. The field representative was unable to provide any further details. The field representative requested to contact another nurse to obtain further details and the contact details were provided for the same. The nurse usually did not come in to the office until 3:00 pm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: PATIENT COMPLAINED OF ITCHING LOCALIZED ON THE SITE OF ADMINISTRATION. NO SWELLING OR REDNESS VISIBLE. PATIENT WAS CLOSELY MONITORED. AT 12:05PM BP WAS CHECKED AND REGISTERED AT 120/76. AT 12:20 PATIENT INFORMED ADMINISTERING PHARMACIST THAT THE ITCHINESS WAS PRACTICALLY GONE. AT 12:26PM BP WAS CHECKED AGAIN AND REGISTERED AT 122/76. PATIENT WAS RELEASED AT 12:30PM. AND WAS ADVICED TO TAKE BENADRYL AT HOME.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Erythema, Nodule
Clinical narrative: Phone call from mom. Red raised very sore knots bigger than the size of a quarter. Slept with ice packs on. Doctor told her to take Benadryl.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Immediate pain at site. Felt like needle "hit something". MD appt 2 wks later after continued pain, limited range of motion. Needle went into tendon instead of muscle. Cortisone injections, physical therapy, ultrasound treatments. MRI 12/2015 showed spot where vaccine entered tendon. Over next months, Increased pain and increased limited range of motion. MRI 8/2016 showed rotator cuff tear where vaccine injection broke down tendon. Had Rotator Cuff Repair of left shoulder on 09/06/2016.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff repair, Rotator cuff syndrome, Ultrasound therapy
Clinical narrative: Immediate pain at site. Felt like needle "hit something". MD appt 2 wks later after continued pain, limited range of motion. Needle went into tendon instead of muscle. Cortisone injections, physical therapy, ultrasound treatments. MRI 12/2015 showed spot where vaccine entered tendon. Over next months, Increased pain and increased limited range of motion. MRI 8/2016 showed rotator cuff tear where vaccine injection broke down tendon. Had Rotator Cuff Repair of left shoulder on 09/06/2016.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red sore raised area. Used an ice pack. Spot got worse on 9/28 went to the doctor. Took Benadryl and Zyrtec. Came in today spot is still there, red and sore but a lot better.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Developed redness, hot, swollen area below the injection site.  Pt did not complain of fever.  Redness and soreness of the arm was getting worse.  Given Medrol Dose pack, Benadryl, and Keflex.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site inflammation, Injection site scar, Injection site warmth
Clinical narrative: Warm, erythematous, inflammed skin covering 6cm x 5cm around injection site and BCG scar (left deltoid) seen 9/29/16 in office. Father reported that symptoms began 9/28/16.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Tonic convulsion
Clinical narrative: Seizure, tonic. fell and hit head on floor.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain that just kept getting worse as time went on. Took Advil, but didn't help much. Next day, could even lift arm up without extreme pain. 2 Days later, pain has even worsened.
Age: 41.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Fatigue, Insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: Ached all over, nausea, insomnia, fatigue, and extremely sore arm.  My arm is still very sore and it has been two weeks since the vaccination.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Neurological examination, Nystagmus, Vertigo, Vomiting
Clinical narrative: Continuous vertigo, right lateral nystagmus, nausea/vomiting.
Age: 0.33
Sex: U
Vaccine: PNC13
Symptoms: Vocal cord paralysis
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. An infant patient of unspecified age ethnicity and gender received at the age of 4 months the 2nd dose of PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  The patient previously took at the age of 2 months the 1st dose of Prevnar 13 for immunisation. The patient experienced vocal cord paralysis on an unspecified date with outcome of unknown.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A 72-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose in 2014 for pneumonia, immunisation. The patient medical history and concomitant medications were not reported. The past drug history included pneumonia shot received in 2008 and another in 2013 for immunisation. The patient experienced pneumonia twice afterwards on an unspecified date with outcome of unknown. She was recommended to get another shot of PREVNAR 13. Consumer wanted to know what is the recommendation in this case. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 56 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, lot# and expiration date unknown) subcutaneously. On an unknown date, the patient had bruising and a rash at the injection site after receiving ZOSTAVAX. The patient saw a physician and no treatment was given for the events. The patient had recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's relevant medical history, drug history and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 lot # reported as 36301, expiration date December 2017 (dose and route of administration not reported) that underwent a temperature excursion and had been exposed to a temperature of 32.1 degrees Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any relevant tests were done. This is one of several reports received from the same source. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Itching, Swelling, Hot to the touch, redness, soreness.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Oedema peripheral
Clinical narrative: Diffuse subaxillary swelling on side of injection.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Flushing, Nausea, Pharyngeal oedema, Vomiting
Clinical narrative: The pt became flushed with shortness of breath, felt as though she could not breath, nausea and vomiting. Felt throat swelling.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: PAIN THE 1ST AND SECOND DAY, RED BAND AROUND LEFT ARM WITH SOME SWELLING THIS MORNING 09/29/2016.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Swelling, redness and tender to touch at injection site 12 hour post. Myalgia since injection. Patient was given steroids and antibiotics.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Severe headache upon waking. Not able to be relieved by any pain medications. Headache has continued through mid day 9/28 with no relief by pain medications.