chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
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 (reported as approximately 50) of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 24-OCT-2016 (it was also the date of the temperature excursion), the patients were subcutaneously vaccinated with the improperly stored doses of PROQUAD (albumin status rHA, for prophylaxis, lot # M033209 with expiration date 09-JAN-2018, lot # M009746 with expiration date 23-AUG-2017, lot # M011660 with expiration date 08-SEP-2017, lot # M033215 with expiration date 09-JAN-2018, lot # M014302 with expiration date 22-SEP-2017; dose was not reported). No adverse effects were noted. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014846.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a 54 year old male consumer refers himself. The patient's medical history included lumbar fusion and knee replacement. His current condition included allergy to sulphur. On 27-DEC-2016, the patient was vaccinated with ZOSTAVAX (dose, lot number and expiry date were not reported), intravenous for prophylaxis. There were no concomitant medications. On 27-DEC-2016, the patient experienced slight lightheadedness (dizziness). On an unknown date, the patient got his yearly physical (blood work) done. The outcome of dizziness was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to multiple unknown patients of unknown age and gender. Patients' current condition, concomitant medication and medical history were not provided. On 8,9,10 and 11-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored GARDASIL 9 (lot # M004116, expired date 12-OCT-2017, dose and route were unknown) after 78, 102, 126 and 150 hours of exposure to 53 Fahrenheit, respectively. On 15-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored GARDASIL 9 (lot #L026602, expired date 12-OCT-2017, dose and route were unknown) after 96 hours of exposure to 53 Fahrenheit. The data logger was involved, and there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014841.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored VAQTA(lot # M009377, expiration 17-JUN-2017; lot # M016191, expiration 26-MAY-2017; lot # M018644, expiration 20-SEP-2017; lot # L048460, expiration 14-JAN-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014500: US-009507513-1612USA014501: US-009507513-1612USA014502: US-009507513-1612USA014503: US-009507513-1612USA014504: US-009507513-1610USA013229:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored VARIVAX (lot # L000456, expiration 06-JAN-2017; lot # L008269, expiration 11-MAR-2017; lot # L015045, expiration 29-APR-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA013229: US-009507513-1612USA014504: US-009507513-1612USA014502: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1612USA014501:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored ZOSTAVAX (lot # L046899, expiration 23-FEB-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014500: US-009507513-1612USA014504: US-009507513-1612USA014502: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1610USA013229:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse effects reported; improperly stored vaccines have been administered to unspecified patients; Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored PROQUAD (lot # L021599, expiration 10-DEC-2016, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014500: US-009507513-1612USA014504: US-009507513-1610USA013229: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1612USA014501.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored RECOMBIVAX HB (lot # M007763, expiration 15-SEP-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014500: US-009507513-1612USA014504: US-009507513-1612USA014502: US-009507513-1610USA013229: US-009507513-1612USA014499: US-009507513-1612USA014501:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored ROTATEQ (lot # M019706, expiration 24-OCT-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014500: US-009507513-1610USA013229: US-009507513-1612USA014502: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1612USA014501.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to multiple unknown patients of unknown age and gender. Patients' current condition, concomitant medication and medical history were not provided. On 8 and 15-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored ROTATEQ (lot # L037924, expired date 22-JUN-2017, oral, dose was unknown) after 78 and 246 hours of exposure to 53 Fahrenheit, respectively. On 10, 11 12 and 15-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored ROTATEQ  (lot # L037574, expired date 1-JUL-2017, oral, dose was unknown) after 48,72,96 and 168 hours of exposure to 53 Fahrenheit, respectively. The data logger was involved, and there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.   Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014271:
Sex: U
Vaccine: VARCEL
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 (reported as approximately 50) of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 24-OCT-2016 (it was also the date of the temperature excursion), the patients were subcutaneously vaccinated with the improperly stored doses of VARIVAX (for prophylaxis; lot # M030138 with expiration date 15-JUN-2018, lot # L049532 with expiration date 08-DEC-2017 and lot # M014916 with expiration date 25-MAR-2018; dose was not reported). No adverse effects were noted. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014016.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016564536) on 19 Dec 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (manufacturer: unknown, batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date, after the vaccination the patient had "flue" (it was reported that patient had terrible side effects to the medication). The patient lab tests and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016561061)on 19-Dec-2016. This case involves a 77-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration: not reported) on 16-Nov-16. Patient's medical history and concomitant medications were not reported. On an unspecified date of Nov-2016, after the vaccination patient had flu like symptoms, upper respiratory congestion, fever, chills, muscle ached all over, coughing. It was also reported that patient thought of some flu like symptoms diagnosis upon visit in Stat Care facility. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. Patient got recovered from the event coughing on 01-Dec-2016 and also got improved from all other events. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Upper respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016561061)on 19-Dec-2016. This case involves a 77-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration: not reported) on 16-Nov-16. Patient's medical history and concomitant medications were not reported. On an unspecified date of Nov-2016, after the vaccination patient had flu like symptoms, upper respiratory congestion, fever, chills, muscle ached all over, coughing. It was also reported that patient thought of some flu like symptoms diagnosis upon visit in Stat Care facility. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. Patient got recovered from the event coughing on 01-Dec-2016 and also got improved from all other events. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event, Malaise
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2014319637) on 22-Dec-2016. This case involves a female patient (age- unspecified), who was vaccinated with a dose of FLU SHOT (batch number, expiry date, route and site of administration: not reported) and REVATIO (batch number, expiry date- 31 Aug 2017, route and site of administration: not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unspecified date and unspecified time frame, after the vaccination patient experienced unspecified adverse event (NOS) and felt sick. Laboratory investigations and corrective treatment were not reported. The outcome of events were not reported. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site urticaria
Clinical narrative: Urticaria of proximal half of left lateral upper arm- extends out from vaccine site.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Patient stated soreness for days, aching, chills, fatigue, and nausea.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of GARDASIL (lot, expiration date and dose were unknown) for prophylaxis for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Follow up information has been received on 07-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. No additional information is available. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA008984: US-009507513-1610USA008979: US-009507513-1610USA008977: US-009507513-1610USA008851: US-009507513-1610USA008982: US-009507513-1610USA008988: US-009507513-1610USA009024:, MERCK 1610USA008986:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown). The reporter stated that on unknown dates in 2016, the patients received improperly stored doses of GARDASIL 9 (lot # L040054, expiration date: 26-DEC-2017). No adverse effects were reported. Temperature excursion occurred on 01-SEP-2016: Temperature: 45F Time frame: 18 hours. Digital data logger was involved. This is one of several reports received from the same source. Follow-up information was received on 28-DEC-2016: all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1612USA015140: US-009507513-1612USA015141: US-009507513-1612USA015142: MERCK 1610USA011550:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was inadvertently vaccinated with two doses of VARIVAX simultaneously (route and site of administration, dose, lot# and expiry date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 19-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L029485, expiry date 06-NOV-2016 (dose, route and site of administration were not reported).  No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown). The reporter stated that on unknown dates in 2016, the patients received improperly stored doses of RECOMBIVAX HB (lot# M010671, expiration date: 02-JUN-2018, dose and route of administration were not reported). No adverse effects were reported. Temperature excursion occurred on 01-SEP-2016: Temperature: 45F Time frame: 18 hours Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1610USA011550.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown).   The reporter stated that on unknown dates in 2016, the patients received improperly stored doses of ROTATEQ orally (lot # M017514, expiration date: 07-NOV-2017, dose not provided). No adverse effects were reported. Temperature excursion occurred on 01-SEP-2016: Temperature: 45F Time frame: 18 hours Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA011550:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator and refers to an unspecified amount of patients (age and gender unknown). The reporter stated that on unknown dates in 2016, the patients received improperly stored doses of VAQTA (lot# M027879, expiration date: 24-JAN-2018, dose and route of administration were not reported). No adverse effects were reported. Temperature excursion occurred on 01-SEP-2016: Temperature: 45F Time frame: 18 hours Digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1610USA011550.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. called and left arm still hurts where she got the flu shot and its been three weeks, has been using ibuprofen and using her arm, feel she needs physical therapy, her arm is not red but it continues to hurt, please advise. Got flu shot 9/27/16 and continues to have soreness at site and trouble lifting arm.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Same night as Men A/Flu Shot administered, patient had an itchy left face all night. When he woke up following morning Left facial cheek, red, mildly swollen, itchy. No anaphylaxis (no breathing difficulty/no tongue swelling). No fever, no neck pain. Otherwise fine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: Patient states she received flu vaccine at Employee Health on Tuesday, 12/20/16 afternoon and then about 6 hours later began to get itchy welts on her trunk and extremities and felt slight tingling on her tongue. Patient took OTC BENADRYL x 1 dose and tingling and itching of welts subsided. Left TCM 12/21/16 for Employee Health after clinic hours yesterday eve and spoke am 12/22/16 and complete form -12/22/16 asymptomatic, no welts, no SOB, no throat closing ever, tingling on tongue resolved 12/22/2016.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: BUE with redness, warmth at injection sits. Pt reports tenderness to palpation almost a 2 inch diameter. AUGMENTIN 875 mg one PO BID x 10 days on 12/28/16.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Bradycardia, Oxygen saturation decreased, Respiration abnormal
Clinical narrative: Multiple bradycardia, desaturation events with periodic breathing requiring increase in respiratory support.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm swelling and redness around injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising, Injection site swelling, Peripheral swelling
Clinical narrative: Arm is bruised and swollen at site of injection and down the entire arm.
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: The varicella vaccine was administered on 12/01/2016 with redness at injection sight immediately.  On 12/15/2016 at the injection sight on the left thigh there  was a 1" diameter inflamed and raised spot. This spot reamaind for approximately four days.  The spot was red, hit to the touch, and raised.  It resembled a chicken pox sore.
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: The varicella vaccine was administered on 12/01/2016 with redness at injection sight immediately.  On 12/15/2016 at the injection sight on the left thigh there  was a 1" diameter inflamed and raised spot. This spot reamaind for approximately four days.  The spot was red, hit to the touch, and raised.  It resembled a chicken pox sore.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Red rash around injection site, later spread down toward elbow and up across left shoulder, strong itching. Persisted for approx 3 wks, lessening now. Did not seek treatment, self-treated with topical ointment.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm redness and swelling around injection site.
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified adult patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis instead of M-M-R II (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. Product quality complaint (PQC) was not involved. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. In January 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (route of administration, lot # and expiration date were not reported), in June 2016 with the second dose of RECOMBIVAX HB injection (route of administration, lot # and expiration date were not reported) and in August 2016 with the third dose of RECOMBIVAX HB injection (route of administration, lot # and expiration date were not reported). The physician assistant stated the patient had "titers drawn" on an unspecified date in 2016 (after the 3rd dose of RECOMBIVAX HB) and the patient was not showing immunity for Hepatitis B. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report concerning a 60 year old female patient was received from her husband. The patient had no  pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 20-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX Injection (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 26-DEC-2016, the patient experienced shingles. No product quality complaint (PQC) was involved. At the time of the report, the patient had not recovered from the shingles. The causality assessment between the event and the ZOSTAVAX was not reported. Additional information is not expected as the reporter did not provide consent for follow up.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Painful limited range of motion.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Balance disorder, Burning sensation, Computerised tomogram normal, Dyspnoea
Clinical narrative: Symptoms started on 10/13: Numbness in legs, feet, arms, hands, back and face. Waves of tingling, burning, twitches, spasms all over body. Never pain, head pains. Very weak legs and arms. hard to walk, hard to write. Loss of balance, blurry vision. Breathing difficulty. Two trips to the ER. Several PCP and Neurologist visits. Neurologist confirms flu shot was culprit. The symptoms were daily for at least 2 months. Now they come and go, but I am still weak and it is life disrupting.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram normal, Gait disturbance, Headache, Hypoaesthesia, Laboratory test normal
Clinical narrative: Symptoms started on 10/13: Numbness in legs, feet, arms, hands, back and face. Waves of tingling, burning, twitches, spasms all over body. Never pain, head pains. Very weak legs and arms. hard to walk, hard to write. Loss of balance, blurry vision. Breathing difficulty. Two trips to the ER. Several PCP and Neurologist visits. Neurologist confirms flu shot was culprit. The symptoms were daily for at least 2 months. Now they come and go, but I am still weak and it is life disrupting.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Muscle twitching, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Symptoms started on 10/13: Numbness in legs, feet, arms, hands, back and face. Waves of tingling, burning, twitches, spasms all over body. Never pain, head pains. Very weak legs and arms. hard to walk, hard to write. Loss of balance, blurry vision. Breathing difficulty. Two trips to the ER. Several PCP and Neurologist visits. Neurologist confirms flu shot was culprit. The symptoms were daily for at least 2 months. Now they come and go, but I am still weak and it is life disrupting.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication, Vision blurred
Clinical narrative: Symptoms started on 10/13: Numbness in legs, feet, arms, hands, back and face. Waves of tingling, burning, twitches, spasms all over body. Never pain, head pains. Very weak legs and arms. hard to walk, hard to write. Loss of balance, blurry vision. Breathing difficulty. Two trips to the ER. Several PCP and Neurologist visits. Neurologist confirms flu shot was culprit. The symptoms were daily for at least 2 months. Now they come and go, but I am still weak and it is life disrupting.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Rheumatoid arthritis
Clinical narrative: Patient experienced joint pain and swelling. Patient continues experiencing these symptoms and was diagnosed with RA.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Patient complains of redness and swelling at injection site AND spreading to the chest.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: The next day of vaccination, patient arm started to swell around her elbow. It is warm to the touch and red. Patient reported this to the RPH and was advised to see her doctor should her symptoms not subside.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Injection site injury, Joint range of motion decreased, Musculoskeletal pain, Nausea
Clinical narrative: Right after vaccine - Started having horrible shoulder pain, limited range of motion of all arm. Taking pain killers prescribed by doctor so strong that I feel dizzy and nauseated. It's been over 6 weeks and overwhelming pain won't go away.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: Right after vaccine - Started having horrible shoulder pain, limited range of motion of all arm. Taking pain killers prescribed by doctor so strong that I feel dizzy and nauseated. It's been over 6 weeks and overwhelming pain won't go away.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fatigue
Clinical narrative: The significant correction has been performed on 30 December 2016 to add narrative. Initial unsolicited report received from a pharmacist via other company (Pfizer) (Manufacturer Report Number: 2016558876) on 19 December 2016. This case involves three male patients under the age of 65 years they were vaccinated  with a dose of INFLUENZA VACCINE (FLU VACCINE) other company product and PNEUMOVAX 23 other company product (Merk) (batch number and expiratory date was reported as unknown for both vaccines) (dose, dose in series, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were unknown. On an unspecified date, following the vaccination, the patients experienced fatigue. Relevant laboratory data was not reported. Corrective treatment was unknown. The outcome of event was reported as unknown.  The reporter assessed the causal relationship with POLYSACCHARIDE and PNEUMOVAX 23 as related. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Injection site reaction, Swelling
Clinical narrative: Acute reaction at admin site, (R) deltoid region.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: About 3 hrs after vaccination on 9/26/16, I was unable to move left shoulder, and arm. Throughout that night I experienced pain in arm and shoulder(moderate). I had to us (R) hand to undress. On 9/27/16 I call Dr office. Gradually improved thru week. Still experience occasional tenderness in upper (L) arm. Still have occasional tenderness in upper (L) arm 12/07/16.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness/swelling/warm by touch hurt. Pt has experienced symptoms for a week.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Sore right arm, knot under skin near shoulder bone. Has persisted since vaccine on 10/23/16.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Blood pressure increased, Feeling hot, Tinnitus
Clinical narrative: Pt experienced ringing in the ears and felt hot after 1 hour of administration. Then her blood pressure was over 200 (systolic) and 180 average after multiple readings per caregiver. These episodes have occurred before without vaccination due to low metoprolol daily dose.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Syncope
Clinical narrative: Pt felt dizzy and fainted approximately 10 minutes after vaccine administration.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm pain a month after vaccine.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt called stating that her arm was sore (1 month) post receiving the flu shot. Pt stated that the vaccine maybe was given too high up her arm.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Shoulder to elbow, golf ball sized swelling. Diagnosed with cellulitis. Received IV BENADRYL/antibiotics.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Pt deceased of suspected SIDS on the day following administration of routine 6 month vaccines as well as flu shot.
Age: 57.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Pruritus generalised
Clinical narrative: Red and swollen at site-called pharmacy. Instructed to take benadryl and ice. Symptoms continued and itching all over including scalp. Patient went to dr and was precribed medrol dose pack and zyrtec for symptom relief.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Birth control.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistance referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/ allergies, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB  lot # reported as M023895 expiration date 15-SEP-2017 (dose  and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 46.6 degrees Fahrenheit  for 45 minutes. Data logger was involved. There were no previous excursions reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy test positive, Anaphylactic reaction, Angioedema, Blood immunoglobulin E increased, Conjunctival hyperaemia
Clinical narrative: In was reported in a letter to the Editor that an approximately 68 years old patient in authors clinic, with a documented history of red meat allergy since November 2008 required emergency department treatment and epinephrine administration upon receipt of live attenuated herpes zoster vaccine (manufacturer unknown) containing the Oka VZV strain in September 2014. Within minutes of vaccine administration in a local pharmacy she had a sensation of mental clouding progressing to lightheadedness, wheezing, and throat tightness and she self-administered 50 mg diphenhydramine five minutes after symptom onset. She sought emergency care 30 minutes after vaccine receipt at which point she was documented to be dyspneic, flushed, with facial, oral and uvular angioedema and bilateral conjunctival injections with stable vital signs and blood pressure of 149/83, without documented wheezing on pulmonary examination. She was placed on oxygen and administered an additional 25 mg of diphenhydramine, 8mg of intramuscular dexamethasone, 20 mg of famotidine, nebulized albuterol and 0.3 mg of intramuscular epinephrine for her respiratory distress, angioedema, and cutaneous signs. Her symptoms resolved within 20-30 minutes and she was discharged uneventfully after 3 hours observation. One month after her episode of anaphylaxis following vaccination in 2014, she was tested for alpha-gal allergy, with galactose-alpha-1,3-galactose slgE = 32.5 kU/L, beef slgE =23.1 kU/L, lamb/mutton slgE = 12.2 kU/L, and pork slgE = 17.1 kU/L. To authors knowledge, this was the first report of vaccine induced anaphylaxis associated with alpha-gal allergy. Authors somewhat limited the claim of complete causality by the presence of low level IgE antibodies to porcine gelatin in authors patient. Nevertheless, the presence of antigen binding directly to alpha-gal IgE found in patient sera and depletion of alpha-gal slgE in overnight incubation with ZOSTAVAX would suggest that the increased gelatin content or some other shared element in the manufacturing process of the vaccine increases the likelihood of alpha-gal contamination. Upon internal review, anaphylaxis was considered serious as medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Dizziness, Dyspnoea, Flushing, Respiratory distress
Clinical narrative: In was reported in a letter to the Editor that an approximately 68 years old patient in authors clinic, with a documented history of red meat allergy since November 2008 required emergency department treatment and epinephrine administration upon receipt of live attenuated herpes zoster vaccine (manufacturer unknown) containing the Oka VZV strain in September 2014. Within minutes of vaccine administration in a local pharmacy she had a sensation of mental clouding progressing to lightheadedness, wheezing, and throat tightness and she self-administered 50 mg diphenhydramine five minutes after symptom onset. She sought emergency care 30 minutes after vaccine receipt at which point she was documented to be dyspneic, flushed, with facial, oral and uvular angioedema and bilateral conjunctival injections with stable vital signs and blood pressure of 149/83, without documented wheezing on pulmonary examination. She was placed on oxygen and administered an additional 25 mg of diphenhydramine, 8mg of intramuscular dexamethasone, 20 mg of famotidine, nebulized albuterol and 0.3 mg of intramuscular epinephrine for her respiratory distress, angioedema, and cutaneous signs. Her symptoms resolved within 20-30 minutes and she was discharged uneventfully after 3 hours observation. One month after her episode of anaphylaxis following vaccination in 2014, she was tested for alpha-gal allergy, with galactose-alpha-1,3-galactose slgE = 32.5 kU/L, beef slgE =23.1 kU/L, lamb/mutton slgE = 12.2 kU/L, and pork slgE = 17.1 kU/L. To authors knowledge, this was the first report of vaccine induced anaphylaxis associated with alpha-gal allergy. Authors somewhat limited the claim of complete causality by the presence of low level IgE antibodies to porcine gelatin in authors patient. Nevertheless, the presence of antigen binding directly to alpha-gal IgE found in patient sera and depletion of alpha-gal slgE in overnight incubation with ZOSTAVAX would suggest that the increased gelatin content or some other shared element in the manufacturing process of the vaccine increases the likelihood of alpha-gal contamination. Upon internal review, anaphylaxis was considered serious as medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Throat tightness, Wheezing
Clinical narrative: In was reported in a letter to the Editor that an approximately 68 years old patient in authors clinic, with a documented history of red meat allergy since November 2008 required emergency department treatment and epinephrine administration upon receipt of live attenuated herpes zoster vaccine (manufacturer unknown) containing the Oka VZV strain in September 2014. Within minutes of vaccine administration in a local pharmacy she had a sensation of mental clouding progressing to lightheadedness, wheezing, and throat tightness and she self-administered 50 mg diphenhydramine five minutes after symptom onset. She sought emergency care 30 minutes after vaccine receipt at which point she was documented to be dyspneic, flushed, with facial, oral and uvular angioedema and bilateral conjunctival injections with stable vital signs and blood pressure of 149/83, without documented wheezing on pulmonary examination. She was placed on oxygen and administered an additional 25 mg of diphenhydramine, 8mg of intramuscular dexamethasone, 20 mg of famotidine, nebulized albuterol and 0.3 mg of intramuscular epinephrine for her respiratory distress, angioedema, and cutaneous signs. Her symptoms resolved within 20-30 minutes and she was discharged uneventfully after 3 hours observation. One month after her episode of anaphylaxis following vaccination in 2014, she was tested for alpha-gal allergy, with galactose-alpha-1,3-galactose slgE = 32.5 kU/L, beef slgE =23.1 kU/L, lamb/mutton slgE = 12.2 kU/L, and pork slgE = 17.1 kU/L. To authors knowledge, this was the first report of vaccine induced anaphylaxis associated with alpha-gal allergy. Authors somewhat limited the claim of complete causality by the presence of low level IgE antibodies to porcine gelatin in authors patient. Nevertheless, the presence of antigen binding directly to alpha-gal IgE found in patient sera and depletion of alpha-gal slgE in overnight incubation with ZOSTAVAX would suggest that the increased gelatin content or some other shared element in the manufacturing process of the vaccine increases the likelihood of alpha-gal contamination. Upon internal review, anaphylaxis was considered serious as medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Redness and swelling the day following vaccine. Pt. went to doctor and was instructed to go to the hospital. Diagnosed with cellulitis and given IV antibiotics.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Chills, Vomiting
Clinical narrative: Pt rec'd the Men B vaccine by Trumenba. Shortly after pt began to vomit, complain of stomach pain, and chills. Pt was monitored in the office and given water to drink.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Computerised tomogram normal, Electroencephalogram, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: Seizure that was about 5 minutes.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: Headache, muscle & joint pain, nausea, red swelling at injection site followed by prickly rash and reddness purple edge 4x4 expanding in oval pattern, severe fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Rash
Clinical narrative: Headache, muscle & joint pain, nausea, red swelling at injection site followed by prickly rash and reddness purple edge 4x4 expanding in oval pattern, severe fatigue.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, CSF test normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal
Clinical narrative: Initially presented as a blurry patch in my right eye visual field but has progressed into bilateral optic neuritis and low vision impairment in both eyes.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Optic neuritis, Vision blurred, Visual acuity reduced
Clinical narrative: Initially presented as a blurry patch in my right eye visual field but has progressed into bilateral optic neuritis and low vision impairment in both eyes.
Age: 0.33
Sex: M
Vaccine: DTPHIB, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Generalised erythema, Urticaria
Clinical narrative: Redness all over skin including huge patches of redness and raised hives from her neck down to her toes.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizure that was approximately 10 minutes.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Blood pressure decreased, Deafness, Disorientation, Dizziness
Clinical narrative: Became dizzy, shaking, pale white, drop in pulse and BP, stomach pain, shortness of breath, disorientation, hearing loss, red vision, panic attack. Was monitored after code blue was called. Given water and rested while monitored. Fine for the rest of the day.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Dyschromatopsia, Dyspnoea, Heart rate decreased, Pallor, Panic attack
Clinical narrative: Became dizzy, shaking, pale white, drop in pulse and BP, stomach pain, shortness of breath, disorientation, hearing loss, red vision, panic attack. Was monitored after code blue was called. Given water and rested while monitored. Fine for the rest of the day.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Tremor
Clinical narrative: Became dizzy, shaking, pale white, drop in pulse and BP, stomach pain, shortness of breath, disorientation, hearing loss, red vision, panic attack. Was monitored after code blue was called. Given water and rested while monitored. Fine for the rest of the day.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Local reaction, Periorbital disorder, Swelling
Clinical narrative: Local reaction to injection site. Periorbital and perioral reaction on right side within 10 minutes of injection. Give 50mg BENADRYL and swelling went down.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient believes she had another bout of shingles. She did not go to the doctor as it looked just like her other cases of shingles. It was a much smaller area and cleared up in approximately 3 weeks with NEOSPORIN. She was told to report it.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Body temperature increased, Chest X-ray normal, Febrile convulsion, Influenza A virus test negative
Clinical narrative: Febrile seizure lasting 45 seconds. EMS activated and when arrived temp 103.1. CXR negative, Flu A/B negative, glucose 139.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Influenza B virus test, Influenza virus test negative
Clinical narrative: Febrile seizure lasting 45 seconds. EMS activated and when arrived temp 103.1. CXR negative, Flu A/B negative, glucose 139.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Diarrhoea, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Symptoms started about 5pm day of vaccines with redness, swelling at site. Hives started on arm in am 12/30/16 pain in arm, neck, and head that continues. It continues to be hot to touch. No respiratory distress but felt like her throat was thickening all night. She did not rest well. She had abdominal pain with diarrhea all the next day, but better now.