chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Memory impairment, Nerve stimulation test, Nuclear magnetic resonance imaging, Transfusion
Clinical narrative: Initial unsolicited report received from a consumer on 20-Apr-2016. This case involves a 66-year-old female patient, who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration: not provided) in left deltoid on 25-Nov-2015. Patient's illness at the time of vaccination was reported as none. Patient denied pre-existing physician diagnosed allergies, birth defects, medical conditions and patient was reported to be in perfect health. Patient had not taken any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 25-Nov-2015, same day after vaccination, the patient felt funny, fell over her bed, had difficulty in breathing and felt like her heart stopped, she also had difficulty moving her mouth. Patient was advised to stay in bed and rest for few days by the pharmacist. Gradually the weakness worsened and the patient was sent to hospital on 23-Dec-2015 and at that point, 28 days after vaccination patient had developed itching and stinging from her toes to her face. Patient had no rash. She reported that she had continued difficulty in breathing. Patient was admitted on the same day and was suspected with Guillain-Barre. Patient was discharged on 24-Dec-2015 and was later readmitted to hospital that night and stayed for 7 days. Total duration of hospitalization was reported as 9 days. After about 6 weeks, on an unspecified date, patient had seizures. At the time of reporting patient still needed walker to walk. Laboratory nvestigations included spinal tap which confirmed Guillain-Barre. Patient also had performed other laboratory test (unspecified). Patient received corrective treatment with IVIG (intravenous immunoglobulin) and physical therapy. She also received Neurotin for seizures and it helped. The outcome of the event seizures was reported as recovering and the outcome of all other events was reported as not recovered. Documents held by sender: none. Sender's Comments: This is a consumer reported case on social media regarding Guillain Barre syndrome post vaccination of INFLUENZA USP TRIVAL A-B DOSE SUBVIRON VACCINE. Since there is no complete information available, the case cannot be completely analyzed and also role of vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dyskinesia, Dyspnoea, Fall, Feeling abnormal
Clinical narrative: Initial unsolicited report received from a consumer on 20-Apr-2016. This case involves a 66-year-old female patient, who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration: not provided) in left deltoid on 25-Nov-2015. Patient's illness at the time of vaccination was reported as none. Patient denied pre-existing physician diagnosed allergies, birth defects, medical conditions and patient was reported to be in perfect health. Patient had not taken any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 25-Nov-2015, same day after vaccination, the patient felt funny, fell over her bed, had difficulty in breathing and felt like her heart stopped, she also had difficulty moving her mouth. Patient was advised to stay in bed and rest for few days by the pharmacist. Gradually the weakness worsened and the patient was sent to hospital on 23-Dec-2015 and at that point, 28 days after vaccination patient had developed itching and stinging from her toes to her face. Patient had no rash. She reported that she had continued difficulty in breathing. Patient was admitted on the same day and was suspected with Guillain-Barre. Patient was discharged on 24-Dec-2015 and was later readmitted to hospital that night and stayed for 7 days. Total duration of hospitalization was reported as 9 days. After about 6 weeks, on an unspecified date, patient had seizures. At the time of reporting patient still needed walker to walk. Laboratory nvestigations included spinal tap which confirmed Guillain-Barre. Patient also had performed other laboratory test (unspecified). Patient received corrective treatment with IVIG (intravenous immunoglobulin) and physical therapy. She also received Neurotin for seizures and it helped. The outcome of the event seizures was reported as recovering and the outcome of all other events was reported as not recovered. Documents held by sender: none. Sender's Comments: This is a consumer reported case on social media regarding Guillain Barre syndrome post vaccination of INFLUENZA USP TRIVAL A-B DOSE SUBVIRON VACCINE. Since there is no complete information available, the case cannot be completely analyzed and also role of vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Heart rate abnormal, Immunoglobulin therapy, Laboratory test, Lumbar puncture abnormal
Clinical narrative: Initial unsolicited report received from a consumer on 20-Apr-2016. This case involves a 66-year-old female patient, who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration: not provided) in left deltoid on 25-Nov-2015. Patient's illness at the time of vaccination was reported as none. Patient denied pre-existing physician diagnosed allergies, birth defects, medical conditions and patient was reported to be in perfect health. Patient had not taken any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 25-Nov-2015, same day after vaccination, the patient felt funny, fell over her bed, had difficulty in breathing and felt like her heart stopped, she also had difficulty moving her mouth. Patient was advised to stay in bed and rest for few days by the pharmacist. Gradually the weakness worsened and the patient was sent to hospital on 23-Dec-2015 and at that point, 28 days after vaccination patient had developed itching and stinging from her toes to her face. Patient had no rash. She reported that she had continued difficulty in breathing. Patient was admitted on the same day and was suspected with Guillain-Barre. Patient was discharged on 24-Dec-2015 and was later readmitted to hospital that night and stayed for 7 days. Total duration of hospitalization was reported as 9 days. After about 6 weeks, on an unspecified date, patient had seizures. At the time of reporting patient still needed walker to walk. Laboratory nvestigations included spinal tap which confirmed Guillain-Barre. Patient also had performed other laboratory test (unspecified). Patient received corrective treatment with IVIG (intravenous immunoglobulin) and physical therapy. She also received Neurotin for seizures and it helped. The outcome of the event seizures was reported as recovering and the outcome of all other events was reported as not recovered. Documents held by sender: none. Sender's Comments: This is a consumer reported case on social media regarding Guillain Barre syndrome post vaccination of INFLUENZA USP TRIVAL A-B DOSE SUBVIRON VACCINE. Since there is no complete information available, the case cannot be completely analyzed and also role of vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pruritus, Seizure, Walking aid user
Clinical narrative: Initial unsolicited report received from a consumer on 20-Apr-2016. This case involves a 66-year-old female patient, who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration: not provided) in left deltoid on 25-Nov-2015. Patient's illness at the time of vaccination was reported as none. Patient denied pre-existing physician diagnosed allergies, birth defects, medical conditions and patient was reported to be in perfect health. Patient had not taken any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 25-Nov-2015, same day after vaccination, the patient felt funny, fell over her bed, had difficulty in breathing and felt like her heart stopped, she also had difficulty moving her mouth. Patient was advised to stay in bed and rest for few days by the pharmacist. Gradually the weakness worsened and the patient was sent to hospital on 23-Dec-2015 and at that point, 28 days after vaccination patient had developed itching and stinging from her toes to her face. Patient had no rash. She reported that she had continued difficulty in breathing. Patient was admitted on the same day and was suspected with Guillain-Barre. Patient was discharged on 24-Dec-2015 and was later readmitted to hospital that night and stayed for 7 days. Total duration of hospitalization was reported as 9 days. After about 6 weeks, on an unspecified date, patient had seizures. At the time of reporting patient still needed walker to walk. Laboratory nvestigations included spinal tap which confirmed Guillain-Barre. Patient also had performed other laboratory test (unspecified). Patient received corrective treatment with IVIG (intravenous immunoglobulin) and physical therapy. She also received Neurotin for seizures and it helped. The outcome of the event seizures was reported as recovering and the outcome of all other events was reported as not recovered. Documents held by sender: none. Sender's Comments: This is a consumer reported case on social media regarding Guillain Barre syndrome post vaccination of INFLUENZA USP TRIVAL A-B DOSE SUBVIRON VACCINE. Since there is no complete information available, the case cannot be completely analyzed and also role of vaccine cannot be assessed.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Localized hives, swelling, redness - we gave him a Benadryl and put some Benadryl cream on it.  The onset might have been earlier - that is when he told us about it.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Neurological examination normal, Psychogenic seizure
Clinical narrative: Pt has pseudoseizures and parents request report be submitted.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HPV4
Symptoms: Unevaluable event
Clinical narrative: No adverse event identified.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HPV4
Symptoms: Injection site pain
Clinical narrative: No adverse event identified.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: No adverse event identified.
Age: 1.01
Sex: F
Vaccine: HEP
Symptoms: Irritability, Vomiting projectile
Clinical narrative: Projectile vomiting and excessive fussiness.
Age: 1.02
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red pin size dots all over body.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Large hives on legs and on face.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: TC from mom 5/4/16. Received #3 HPV 5/3/16 pm. Developed a fever only 101.6->102.5. No other symptoms.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Psychogenic seizure
Clinical narrative: Pt has pseudoseizures and parents request report be submitted.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL, FLU4, HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 16 year old female patient. There were no concomitant medications, concurrent conditions and medical history reported. On 12-APR-2016, the patient was vaccinated with M-M-R II lot # L012481 exp. 10-APR-2017 (dose, route and site of administration were not reported) and at the same time, the patient was vaccinated with VARIVAX (Merck) L028275 exp. 28-JUL-2017 (dose, route and site of administration were not reported). After receiving the vaccines, on 14-APR-2016, the patient had a "urine pregnancy test" with result: positive. The patient also had a "blood obstetrics panel" performed on 12-APR-2016 (after the vaccines were given), however the results were unspecified. The patient sought medical attention and was treated with unspecified "prenatal vitamins". The patient became pregnant with last menstrual period (LMP) of 14-MAR-2016 and estimated date of delivery (EDD) of 19-DEC-2016. The pregnancy was outcome pending. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL, FLU4, HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 16 year old female patient. There were no concomitant medications, concurrent conditions and medical history reported. On 12-APR-2016, the patient was vaccinated with M-M-R II lot # L012481 exp. 10-APR-2017 (dose, route and site of administration were not reported) and at the same time, the patient was vaccinated with VARIVAX (Merck) L028275 exp. 28-JUL-2017 (dose, route and site of administration were not reported). After receiving the vaccines, on 14-APR-2016, the patient had a "urine pregnancy test" with result: positive. The patient also had a "blood obstetrics panel" performed on 12-APR-2016 (after the vaccines were given), however the results were unspecified. The patient sought medical attention and was treated with unspecified "prenatal vitamins". The patient became pregnant with last menstrual period (LMP) of 14-MAR-2016 and estimated date of delivery (EDD) of 19-DEC-2016. The pregnancy was outcome pending. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an unspecified number of patients' of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with inappropriately stored doses of PEDVAXHIB lot # I038502 (expiration date 16-AUG-2018) orally, (dose, dose number and frequency were not provided). Concomitant medications were not reported. The reporter stated that these unspecified number of doses of PEDVAXHIB were stored at 34 degrees Fahrenheit for 14 hours and the data logger was involved. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Allergy to vaccine, Skin ulcer
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Abnormal behaviour, Adrenal disorder, Allergy to vaccine, Anxiety, Biliary tract disorder
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood immunoglobulin G decreased, Chest discomfort, Cholecystitis, Drug hypersensitivity, Feeling abnormal
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Food allergy, Gallbladder disorder, Insomnia, Panic attack, Psychotic behaviour
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Skin ulcer, Urticaria, Weight increased
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood immunoglobulin G abnormal, Chest discomfort, Cholecystitis, Drug hypersensitivity, Feeling abnormal
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Food allergy, Immune system disorder, Insomnia, Panic attack, Psychotic behaviour
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Skin ulcer, Sphincter of Oddi dysfunction, Urticaria
Clinical narrative: This spontaneous report was received from a 61 year old female patient via Novartis (manufacturer control # PHEH2016US009713). No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, route of administration, administration site, lot # and expiry date were not specified). The patient reported, that she was extremely allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). She was at an healthcare provider's office and was stuck with the vaccine, despite not wanting it and was forced to sign a paper. On an unknown date, after vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient was covered top to bottom in sores. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of several reports concerning the same patient. 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 health care worker referring to an unspecified number of patients' of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients' were vaccinated with inappropriately stored doses of ROTATEQ lot # I009119 (expiration date 17-DEC-2016) orally, (dose, dose number and frequency were not provided). Concomitant medications were not reported. The reporter stated that these unspecified number of doses of ROTATEQ were stored at 34 degrees Fahrenheit for 14 hours and the data logger was involved. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same source. 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 registered medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in April 2016 (healthcare worker stated that vaccinations occurred between 01-APR-2016 and 07-APR-2016), the patients were vaccinated with ROTATEQ oral solution, lot # L029617, expiry date 19-MAY-2017 (dose was not specified). Administered doses of ROTATEQ underwent temperature excursion at 50.5 Fahrenheit degrees for 2 hours and 42 minutes. 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.
Sex: M
Vaccine: HPV4
Symptoms: Genital disorder male, Sexual dysfunction
Clinical narrative: Information has been received from a social media user via a market research referring to unspecified number of male patients of unknown age. On unknown dates the patients were vaccinated with GARDASIL (dose, strength and route were unknown). On unknown dates, the patient could not perform sexually and were hesitant to discuss their problem with parents. The patients might simply tell their parents that something was wrong down there. The patients' parents were advised to open their hearts about a formerly taboo subject and help their children times of the events. The outcome of the events was unknown. The reporter considered the events to be related to GARDASIL. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history or concurrent condition were not provided. On 29-APR-2016 the pharmacist administered a dose of ZOSTAVAX (subdermal, lot#, dose, dose number were unspecified) to the patient. On the same date, the patient experienced bleeding at the injection site. The event was treated by covering the site with a band aid. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history and concurrent condition was not reported. On 22-APR-2016, the patient was vaccinated with one improperly stored dose of VARIVAX (Merck) (lot # L049532, expiry 08-DEC-2017) (dose and route not reported). No adverse effects were reported. The data loggers were used. On unspecified date, the temperature was 6.5 Fahrenheit (F) for a time frame of 13 minutes and was back in range. A previous temperature excursion on unspecified date was reported to the same lot number, previously exposed to 6.7 F for 13 minutes. The total cumulative time out of range was 26 minutes. No additional information was provided. This case is one of the two reports received from same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016164803) on 28-MAR-2016. This case involves a female patient (age not reported), who was vaccinated with a dose of Flu Vaccine (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, at the time of vaccination, the patient was hurt and could feel the needle go in. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Listless, Pyrexia
Clinical narrative: Fever to 105 this morning, decreased to 100.4 after several hours, no treatment  given. Also listless.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Incorrect route of drug administration, Rash, Rash erythematous, Tenderness
Clinical narrative: Information has been received from a 61 year old female patient concerning herself with no drug allergies. The patient's pertinent medical history included high blood pressure. On 10-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, lot # and expiration date not reported) 1 shot, intramuscularly. Concomitant therapies included atorvastatin, losartan (manufacturer unknown), diazepam (manufacturer unknown), metformin and metitepine. In the evening of 10-DEC-2015, a rash under both her arms developed, that was black and "all of the hair went away". the rash was extremely painful to the touch. The rash then turned pink (date unspecified), then red (date unspecified). The patient had sought medical attention by having appointments with several doctors. Lab diagnostics studies were not performed. Her doctor had give her clotrimazole (manufacturer unknown) (MARRS#: 1605USA001588), betamethasone cream (manufacturer unknown) (MARRS#: 1605USA001592), triamcinolone, acetonide cream and BENADRYL as treatment for the events, but she had found all of them ineffective. The outcome of the events was reported as not recovered. The causal relationship between the events and ZOSTAVAX was unknown. This is one of several cases regarding the same patient. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Erectile dysfunction
Clinical narrative: Information has been received from a social media user via a market research referring to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and route were unknown). On an unknown date, the patient was inability to gain an erection within weeks of GARDASIL. The patient's parents were advised to open their hearts about a formerly taboo subject and help their child through times of the event. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This case is one of several cases received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Child developed hives after vaccine administration. Epinephrine and Benadryl administered, transported to ER, given prednisone in ER. No further symptoms.
Age: 32.0
Sex: M
Vaccine: ANTH, JEVX, ANTH, JEV1
Symptoms: Abdominal tenderness, Pain of skin, Tenderness
Clinical narrative: Pt complains of tenderness of scalp, right arm, around belt line etc.
Age: 32.0
Sex: M
Vaccine: ANTH, JEVX, ANTH, JEV1
Symptoms: Allodynia, Feeling hot, Injection site pain, Myalgia, Pain of skin
Clinical narrative: Pt complains of tenderness of scalp, right arm, around belt line etc.
Age: 32.0
Sex: M
Vaccine: ANTH, JEVX, ANTH, JEV1
Symptoms: Tenderness
Clinical narrative: Pt complains of tenderness of scalp, right arm, around belt line etc.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 8.5 cm x 6 cm redness w/some induration of area, tender and warm on day after vaccine. Developed myalgia, nausea, headache, stiffness on left entire arm and redness at site day of vaccination. Treated with cephalexin 10d.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: 8.5 cm x 6 cm redness w/some induration of area, tender and warm on day after vaccine. Developed myalgia, nausea, headache, stiffness on left entire arm and redness at site day of vaccination. Treated with cephalexin 10d.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in April 2016 (healthcare worker stated that vaccinations occurred between 01-APR-2016 and 07-APR-2016), the patients were vaccinated with RECOMBIVAX HB injection, lot # L033343, expiry date 13-SEP-2017 (dose, route of administration and administration site were not specified). Administered doses of RECOMBIVAX HB underwent temperature excursion at 50.5 Fahrenheit degrees for two hours and 42 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Fall, Tooth fracture
Clinical narrative: After receiving Hep A #2, HPV #9, client stood up to exit, fell forward brushing nurse shoulder then to floor. Small chip to (L) front tooth. Mom notified. Ice and TYLENOL provided. Grandma here to take home. Went to dentist.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 110 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (60 patients with doses of lot number L030870, expiration date 10-JUN-2018, 50 patients with doses of lot number L030872, expiration date 11-JUN-2018) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Back pain, Blood creatine phosphokinase increased, Blood thyroid stimulating hormone normal, Breast pain, Chest pain
Clinical narrative: Felt left upper arm pain after receiving HepA and Tdap vaccines in left upper arm. Pain persisted and she came to clinic for f/u on 4/18/16 complaining that left arm felt stiff and she couldn't hold things in her left hand due to pain, and felt like she couldn't move her arm normally.  Pain was now radiating into her entire left arm (to her fingers), left chest and breast area, and left shoulder and upper back. Severity of pain was not high, but she was disturbed by the symptoms.
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Differential white blood cell count normal, Full blood count normal, Grip strength decreased, Injected limb mobility decreased, Injection site pain
Clinical narrative: Felt left upper arm pain after receiving HepA and Tdap vaccines in left upper arm. Pain persisted and she came to clinic for f/u on 4/18/16 complaining that left arm felt stiff and she couldn't hold things in her left hand due to pain, and felt like she couldn't move her arm normally.  Pain was now radiating into her entire left arm (to her fingers), left chest and breast area, and left shoulder and upper back. Severity of pain was not high, but she was disturbed by the symptoms.
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Metabolic function test normal, Pain in extremity, Red blood cell sedimentation rate increased, Spinal X-ray normal, Urine analysis normal
Clinical narrative: Felt left upper arm pain after receiving HepA and Tdap vaccines in left upper arm. Pain persisted and she came to clinic for f/u on 4/18/16 complaining that left arm felt stiff and she couldn't hold things in her left hand due to pain, and felt like she couldn't move her arm normally.  Pain was now radiating into her entire left arm (to her fingers), left chest and breast area, and left shoulder and upper back. Severity of pain was not high, but she was disturbed by the symptoms.
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: X-ray limb normal
Clinical narrative: Felt left upper arm pain after receiving HepA and Tdap vaccines in left upper arm. Pain persisted and she came to clinic for f/u on 4/18/16 complaining that left arm felt stiff and she couldn't hold things in her left hand due to pain, and felt like she couldn't move her arm normally.  Pain was now radiating into her entire left arm (to her fingers), left chest and breast area, and left shoulder and upper back. Severity of pain was not high, but she was disturbed by the symptoms.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Crying, Insomnia, Irritability, Screaming
Clinical narrative: Started to become very fussy around 6 pm on 5/2/16, she would only sleep for about 30 minutes at a time and then wake up screaming. then the next morning (5/3/16) she started to become more fussy to the point of screaming and crying for 4 hours straight. Mom could not calm her down during that time. Once she was called down she started rubbing and pushing her forehead on the floor for over a half hour. She seems to be better today 5/4/16 but is still not acting like herself. Still a little fussy but seems to be eating well.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Apnoea, Blood glucose normal, Chest X-ray normal, Dyspnoea, Eye movement disorder
Clinical narrative: She was not breathing well when we checked on her, and was struggling so we woke her up. Her nostrils were so inflamed the Nasal Clear could not even fit to clear anything. As I was holding her she threw her head back with her eyes rolling backwards, and started shaking. White foam started to come out of her mouth and she was not breathing at all for about 20 seconds. There was no treatment, we immediately took her to the ER where they told us she was just going to be "that" baby that has seizures.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Foaming at mouth, Nasal inflammation, Posture abnormal, Seizure, Tremor
Clinical narrative: She was not breathing well when we checked on her, and was struggling so we woke her up. Her nostrils were so inflamed the Nasal Clear could not even fit to clear anything. As I was holding her she threw her head back with her eyes rolling backwards, and started shaking. White foam started to come out of her mouth and she was not breathing at all for about 20 seconds. There was no treatment, we immediately took her to the ER where they told us she was just going to be "that" baby that has seizures.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: NUMBNESS IN HAND SEVERE PAIN IN LEFT SHOULDER / ARM , GRADUALLY INCREASING TO NO RANGE OF MOTION AND  EXCRUCIATING PAIN.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported redness, discomfort and swelling at site of injection a week after the vaccine was administered.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-APR-2016, the patient was inadvertently administered an expired dose of RECOMBIVAX HB (lot # J014855, expiration date: 16-APR-2016, dose, route of administration and injection site were not provided). This was supported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: A 34-year-old patient with past medical history of nontraumatic compartment syndrome of lower extremity who reported to the Emergency Room with chief complaint of diffuse generalized pruritic rash and hives. Started 2 days ago 3 hours from getting the tetanus shot. He denied any shortness of breath, wheezing, difficulty swallowing, or other symptom. The patient was given SOLU-MEDROL 125 mg intravenously, BENADRYL 25 mg intravenously, ranitidine 50 mg intravenously, and 500 mL of normal saline. We will discharge him home on MEDROL Dosepak as directed. BENADRYL 125 mg every 6 hours if needed, and primary care provider for followup in 3 days if no improvement.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site scab, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient's son) on 17 March 2016. This case involves female patient (age not reported) who was vaccinated with a dose FLUZONE HD (batch number: U5016BA, expiry date: not reported), by intramuscular route in left deltoid on October 2014 and the patient also received a dose of Flu Vaccine (batch number, dose, expiry date, route and site of administration: not reported) on an unspecified date after receiving FLUZONE HD. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as allergies: none as per reporter. Medical history included history of diabetes, elevated blood pressure and illness at time of vaccination was reported as none. Patient was previously vaccinated with flu vaccines several times (batch number, manufacturer, expiry date route and site of administration: not reported) on unspecified dates. Concomitant medications were not reported. On unspecified date, following the vaccination, the patient had developed red area at injection site of left arm and itches at injection site, and repeated scab over, the patient also states that the scabs came off and also experienced shooting type pain in her left arm. At the time of reporting the patient still presented all the events. It was reported that the patient required doctor visit (unspecified date). Laboratory data was not reported. Patient had not received corrective treatment. The outcome of all the events was reported as not recovered. List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site scab, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient's son) on 17 March 2016. This case involves female patient (age not reported) who was vaccinated with a dose FLUZONE HD (batch number: U5016BA, expiry date: not reported), by intramuscular route in left deltoid on October 2014 and the patient also received a dose of Flu Vaccine (batch number, dose, expiry date, route and site of administration: not reported) on an unspecified date after receiving FLUZONE HD. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as allergies: none as per reporter. Medical history included history of diabetes, elevated blood pressure and illness at time of vaccination was reported as none. Patient was previously vaccinated with flu vaccines several times (batch number, manufacturer, expiry date route and site of administration: not reported) on unspecified dates. Concomitant medications were not reported. On unspecified date, following the vaccination, the patient had developed red area at injection site of left arm and itches at injection site, and repeated scab over, the patient also states that the scabs came off and also experienced shooting type pain in her left arm. At the time of reporting the patient still presented all the events. It was reported that the patient required doctor visit (unspecified date). Laboratory data was not reported. Patient had not received corrective treatment. The outcome of all the events was reported as not recovered. List of documents held by sender: none.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patient of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # K010215, expiry date: 05-MAY-2017). Lot # K010215 was confirmed as an invalid lot number for the product. Medical assistant reported that the vaccine underwent temperature excursion at 47 degree Fahrenheit for 16 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: Arm from shoulder to hand swollen 3x normal size. Vomiting night that immunization was given. Notified of symptoms on 5/4/16 by other dr. office.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site swelling, Injection site urticaria, Injection site warmth, Pain
Clinical narrative: Low grade fever, severe joint/body aches times 2 days. Single hive anterior to inj. site with progressing hot raised area 10x10 cm with increased joint pain. 04/11/2016 visited PCP and dosed with AUGMENTIN for 7 days. Symptoms resolved after antibiotic except continue to have mild skin discoloration size approx. 4x4 cm.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: Low grade fever, severe joint/body aches times 2 days. Single hive anterior to inj. site with progressing hot raised area 10x10 cm with increased joint pain. 04/11/2016 visited PCP and dosed with AUGMENTIN for 7 days. Symptoms resolved after antibiotic except continue to have mild skin discoloration size approx. 4x4 cm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD (lot # L034933, expiry date: 11-MAR-2017). Medical assistant reported that the vaccine underwent temperature excursion at 11 degree Fahrenheit for 13 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.