chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: Case number PHHY2015US155837, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 599685) on 24 Nov 2015. This report refers to a 30 years old pregnant female patient. Past historical condition was reported as hypothyroid and anxiety. The concomitant medication included as levothyroxine (manufacturer unknown) and ZOLOFT. The patient vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number and expiry date: not reported) in the intramuscularly left arm on 05 Oct 2015. On 06 Oct 2015, female patient had vaginal bleeding in pregnancy and the patient was taken to emergency room. The outcome of the events was unknown. The seriousness of the events was reported as non serious and causality not reported. The seriousness assessment of vaginal haemorrhage was upgraded based on information available in source document. Follow up information received on 12 Jan 2016: Reporter was anonymous, so no further follow up could be pursued. This case was considered as lost to follow up.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Case number PHHY2016US005759, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 602821) on 18 Jan 2016. This report refers to a 23 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN, (batch number: 158005) intramuscularly into left arm on 15 Oct 2015. On the same day, within the same minute of vaccination, the patient experienced loss of consciousness and seizures. The patient went to emergency room due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "seizures" was upgraded based on information in the source document.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Dyspnoea
Clinical narrative: Case number PHHY2016US005775, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 602916) on 18 Jan 2016. This report refers to a 44 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157903) into left arm on 13 Oct 2015. On 14 Oct 2015 the patient presented with skin blister and shortness of breath. The patient went to emergency room due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "shortness of breath" was upgraded based on information in the source document.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased, Chest discomfort, Heart rate increased
Clinical narrative: Case number PHHY2015US173946, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 603868) website on 29 Dec 2015. This report refers to a 68 years old male patient. Past medical history included as hypertension, high cholesterol and current condition included diabetes. Concomitant medications included as losartan (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), simvastatin (manufacturer unknown), metformin (manufacturer unknown) and Levothyroxine. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into left arm, intramuscularly on 19 Oct 2015. On the same day after vaccination, the patient experienced felt a fullness in chest. The patient took blood pressure several times with digital blood pressure machine. Blood pressure showed that, 131/93, 142/94, 135/93, 155/87, 139/84, 120/76 (unit unspecified) and pulse rate was 165, 162, 150, 102, 98, 78 (unit unspecified) on an unknown date. The outcome of felt a fullness in chest was reported as complete recovery and events, blood pressure and pulse rate increased was not reported. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of felt a fullness in chest, pulse rate increased and blood pressure increased was upgraded to medically significant based on the information available in the source document.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram normal, Blood glucose increased, Blood lactic acid, Blood pH increased, Blood sodium decreased
Clinical narrative: This patient received a flu shot (Intramuscular) on 12/18/2015. At approximately 0300 hrs on 12/19/15 she experienced pain on the bottom of her feet and that they felt cold and numb. She had a temperature of 102.6. She went into the local Emergency room at approximately 05:50 hrs on 12/19/15 and was evaluated. It was noted that she had a cough, no dyspnea, mild headache with no neck stiffness but c/o diffuse myalgias. No rash, trouble with speech or swallowing or focal weakness was noted. She was again seen in the local ER on 12/21/2015 after developing a left facial droop and facial numbness.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood thyroid stimulating hormone decreased, Body temperature increased, Borrelia test negative, Chest X-ray normal, Full blood count normal
Clinical narrative: This patient received a flu shot (Intramuscular) on 12/18/2015. At approximately 0300 hrs on 12/19/15 she experienced pain on the bottom of her feet and that they felt cold and numb. She had a temperature of 102.6. She went into the local Emergency room at approximately 05:50 hrs on 12/19/15 and was evaluated. It was noted that she had a cough, no dyspnea, mild headache with no neck stiffness but c/o diffuse myalgias. No rash, trouble with speech or swallowing or focal weakness was noted. She was again seen in the local ER on 12/21/2015 after developing a left facial droop and facial numbness.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Metabolic function test abnormal, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: This patient received a flu shot (Intramuscular) on 12/18/2015. At approximately 0300 hrs on 12/19/15 she experienced pain on the bottom of her feet and that they felt cold and numb. She had a temperature of 102.6. She went into the local Emergency room at approximately 05:50 hrs on 12/19/15 and was evaluated. It was noted that she had a cough, no dyspnea, mild headache with no neck stiffness but c/o diffuse myalgias. No rash, trouble with speech or swallowing or focal weakness was noted. She was again seen in the local ER on 12/21/2015 after developing a left facial droop and facial numbness.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Protein total, Troponin, Urine analysis normal, VIIth nerve paralysis
Clinical narrative: This patient received a flu shot (Intramuscular) on 12/18/2015. At approximately 0300 hrs on 12/19/15 she experienced pain on the bottom of her feet and that they felt cold and numb. She had a temperature of 102.6. She went into the local Emergency room at approximately 05:50 hrs on 12/19/15 and was evaluated. It was noted that she had a cough, no dyspnea, mild headache with no neck stiffness but c/o diffuse myalgias. No rash, trouble with speech or swallowing or focal weakness was noted. She was again seen in the local ER on 12/21/2015 after developing a left facial droop and facial numbness.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture, Blood lactic acid, Cellulitis, Erythema, Full blood count
Clinical narrative: Information has been received from a 65 year old female consumer concerning herself. The patient's concurrent condition included cancer. Concomitant medication was not reported. On 07-JAN-2016, the patient was administered PNEUMOVAX 23 (dose and frequency not provided) by an unknown medical professional at Clinic. On that day the patient experienced itching, redness and swelling 2 inches away from the injection site. The patient went to the walk in clinic on an unspecified date to see about getting treatment. On the same day, an unknown physician suggested the patient to go the emergency room (ER) and she went to the ER. Blood work was done (result not provided). The patient was given antibiotic and anti-itch cream on 09-JAN-2016. It was determined that the reaction was from a bacterial skin infection from the initial clinic not being sanitary enough to administer vaccines. The outcome of the events and causality was not reported. Additional information is not expected because the reporter refused additional contact.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Induration, Metabolic function test, Peripheral swelling, Skin bacterial infection
Clinical narrative: Information has been received from a 65 year old female consumer concerning herself. The patient's concurrent condition included cancer. Concomitant medication was not reported. On 07-JAN-2016, the patient was administered PNEUMOVAX 23 (dose and frequency not provided) by an unknown medical professional at Clinic. On that day the patient experienced itching, redness and swelling 2 inches away from the injection site. The patient went to the walk in clinic on an unspecified date to see about getting treatment. On the same day, an unknown physician suggested the patient to go the emergency room (ER) and she went to the ER. Blood work was done (result not provided). The patient was given antibiotic and anti-itch cream on 09-JAN-2016. It was determined that the reaction was from a bacterial skin infection from the initial clinic not being sanitary enough to administer vaccines. The outcome of the events and causality was not reported. Additional information is not expected because the reporter refused additional contact.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Inadequate aseptic technique in use of product, Pruritus, Swelling
Clinical narrative: Information has been received from a 65 year old female consumer concerning herself. The patient's concurrent condition included cancer. Concomitant medication was not reported. On 07-JAN-2016, the patient was administered PNEUMOVAX 23 (dose and frequency not provided) by an unknown medical professional at Clinic. On that day the patient experienced itching, redness and swelling 2 inches away from the injection site. The patient went to the walk in clinic on an unspecified date to see about getting treatment. On the same day, an unknown physician suggested the patient to go the emergency room (ER) and she went to the ER. Blood work was done (result not provided). The patient was given antibiotic and anti-itch cream on 09-JAN-2016. It was determined that the reaction was from a bacterial skin infection from the initial clinic not being sanitary enough to administer vaccines. The outcome of the events and causality was not reported. Additional information is not expected because the reporter refused additional contact.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Dizziness postural
Clinical narrative: I got the flu shot FLUVIRIN SYR INJ at pharmacy on 12/19/2015. On 12/26 I started feeling dizzy. I woke up 12/27 with severe vertigo, ceiling spinning, and vomited into the garbage next to my bed. My stomach hurt and I didn't eat until 4 pm, along with diarrhea. The vomiting and vertigo continued the next day 12/28, didn't eat until 2 pm, stomach ache. The next day 12/28 my nose was bleeding, my ear was bleeding, and I started a fever, plus headache, which continued for a week. My head felt numb, with water in my ear, and nasal congestion. As of today, Jan 11, I still have vertigo, can't drive, crashed into table when I stood up, spilled drink over myself last night. The diarrhea and stomach upset continues. The vertigo is still bad, I dread lying down (ceiling rotates and feel nauseated). I'm too dizzy to drive, so I haven't seen the doctor.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ear haemorrhage, Epistaxis, Headache, Hypoaesthesia, Impaired driving ability
Clinical narrative: I got the flu shot FLUVIRIN SYR INJ at pharmacy on 12/19/2015. On 12/26 I started feeling dizzy. I woke up 12/27 with severe vertigo, ceiling spinning, and vomited into the garbage next to my bed. My stomach hurt and I didn't eat until 4 pm, along with diarrhea. The vomiting and vertigo continued the next day 12/28, didn't eat until 2 pm, stomach ache. The next day 12/28 my nose was bleeding, my ear was bleeding, and I started a fever, plus headache, which continued for a week. My head felt numb, with water in my ear, and nasal congestion. As of today, Jan 11, I still have vertigo, can't drive, crashed into table when I stood up, spilled drink over myself last night. The diarrhea and stomach upset continues. The vertigo is still bad, I dread lying down (ceiling rotates and feel nauseated). I'm too dizzy to drive, so I haven't seen the doctor.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Thirst, Vertigo
Clinical narrative: I got the flu shot FLUVIRIN SYR INJ at pharmacy on 12/19/2015. On 12/26 I started feeling dizzy. I woke up 12/27 with severe vertigo, ceiling spinning, and vomited into the garbage next to my bed. My stomach hurt and I didn't eat until 4 pm, along with diarrhea. The vomiting and vertigo continued the next day 12/28, didn't eat until 2 pm, stomach ache. The next day 12/28 my nose was bleeding, my ear was bleeding, and I started a fever, plus headache, which continued for a week. My head felt numb, with water in my ear, and nasal congestion. As of today, Jan 11, I still have vertigo, can't drive, crashed into table when I stood up, spilled drink over myself last night. The diarrhea and stomach upset continues. The vertigo is still bad, I dread lying down (ceiling rotates and feel nauseated). I'm too dizzy to drive, so I haven't seen the doctor.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: I got the flu shot FLUVIRIN SYR INJ at pharmacy on 12/19/2015. On 12/26 I started feeling dizzy. I woke up 12/27 with severe vertigo, ceiling spinning, and vomited into the garbage next to my bed. My stomach hurt and I didn't eat until 4 pm, along with diarrhea. The vomiting and vertigo continued the next day 12/28, didn't eat until 2 pm, stomach ache. The next day 12/28 my nose was bleeding, my ear was bleeding, and I started a fever, plus headache, which continued for a week. My head felt numb, with water in my ear, and nasal congestion. As of today, Jan 11, I still have vertigo, can't drive, crashed into table when I stood up, spilled drink over myself last night. The diarrhea and stomach upset continues. The vertigo is still bad, I dread lying down (ceiling rotates and feel nauseated). I'm too dizzy to drive, so I haven't seen the doctor.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Ear congestion
Clinical narrative: I got the flu shot FLUVIRIN SYR INJ at pharmacy on 12/19/2015. On 12/26 I started feeling dizzy. I woke up 12/27 with severe vertigo, ceiling spinning, and vomited into the garbage next to my bed. My stomach hurt and I didn't eat until 4 pm, along with diarrhea. The vomiting and vertigo continued the next day 12/28, didn't eat until 2 pm, stomach ache. The next day 12/28 my nose was bleeding, my ear was bleeding, and I started a fever, plus headache, which continued for a week. My head felt numb, with water in my ear, and nasal congestion. As of today, Jan 11, I still have vertigo, can't drive, crashed into table when I stood up, spilled drink over myself last night. The diarrhea and stomach upset continues. The vertigo is still bad, I dread lying down (ceiling rotates and feel nauseated). I'm too dizzy to drive, so I haven't seen the doctor.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nasal congestion, Nausea, Pyrexia, Vertigo, Vomiting
Clinical narrative: I got the flu shot FLUVIRIN SYR INJ at pharmacy on 12/19/2015. On 12/26 I started feeling dizzy. I woke up 12/27 with severe vertigo, ceiling spinning, and vomited into the garbage next to my bed. My stomach hurt and I didn't eat until 4 pm, along with diarrhea. The vomiting and vertigo continued the next day 12/28, didn't eat until 2 pm, stomach ache. The next day 12/28 my nose was bleeding, my ear was bleeding, and I started a fever, plus headache, which continued for a week. My head felt numb, with water in my ear, and nasal congestion. As of today, Jan 11, I still have vertigo, can't drive, crashed into table when I stood up, spilled drink over myself last night. The diarrhea and stomach upset continues. The vertigo is still bad, I dread lying down (ceiling rotates and feel nauseated). I'm too dizzy to drive, so I haven't seen the doctor.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 14-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K005402, expiration date 07-NOV-2015, exact dose and route of administration were not reported). It was reported that the patient was not exhibiting any adverse effects. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-JAN-2016 the patient was vaccinated with a dose of an improperly stored oral, ROTATEQ (lot # L013203, expiration date 28-JAN-2017, dose and route unknown). No adverse effects was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age who reports on herself. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with the dose of PNEUMOVAX 23 (reported as unspecified pneumonia vaccine) injection (dose, lot# and expiration date were not reported). On an unknown date (reported as after receiving an unspecified pneumonia vaccine), the patient developed pain in her bones and around the injection site. The outcome of the adverse events and the causality between the adverse events and PNEUMOVAX 23 were not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On 12-JAN-2016 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L038018/L027733, expiration date 13-SEP-2017 (dose, dose #, route and application site were not reported). The reporter was not aware of any adverse effects. This is one of several reports received from the same source. 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 certified medical assistant referring to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, an unspecified number of patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB (Lot # K026532, expiration date 07-AUG-2017) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Fussy after 2 mo imms. No fever. Seems uncomfortable. Not inconsolable.
Age: 56.0
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a patient's mother refers to a currently 56 years old male patient. The patient was immunocompromised due to a stroke (reported as stoke) he had 9 years ago. On an unspecified date, the patient was vaccinated with the dose of LIQUID PEDVAXHIB (reported as unspecified flu shot) injection (dose, lot# and expiration date were not reported) which resulted in high fevers. The outcome of high fevers and the causality between high fevers and LIQUID PEDVAXHIB were not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 4.5
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a 4.5 year old patient of unknown gender. On 04-JAN-2016 the patient was inadvertently vaccinated with the third doses of (Oka/Merck) VARIVAX and MMR II (dose and route unknown, lot# and expiration date not available, the physician did not have patient's chart). No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling redness of whole left thigh, starting about an hour after vaccination and lasting about 24 hours.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Noticed tender raised lump at area of injection. First recognized 3 weeks after vaccine given. No redness, no abscess.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since an unknown date, an unspecified number of improperly stored doses of GARDASIL 9 (lot # L020015, expiration date 16-AUG-2017) were administered to an unspecified number of patients. No adverse effects have been reported. The reporter stated that there was not product quality complaints involved. This is one of several cases from the same reporter. Additional information is not expected, because the reporter refused additional contact.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a nineteen and half years old patient of unknown gender. No medical history was reported. On 28-DC-2015 the patient was vaccinated with adult dose of RECOMBIVAX HB 10 mcg/ml (strength) (route, dose and frequency: unknown) (overdose, incorrect dose administered). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L010595, expiration date 12-NOV-2016) were administered to an unspecified number of patients. No adverse effects have been reported. The reporter stated that there was no product quality complaints involved. This is one of several cases from the same reporter. Additional information is not expected, because the reporter refused additional contact.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient had a sudden onset of Dizziness, followed by nausea and vomiting. Advise patient to force fluids and promethazine 25 mg was given for nausea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Urticaria on 1/16/16, after MMR-V, flu, DTaP-IPV on 1/11/16. C/O paresthesias in lower extremities in 1/18-19 without weakness. Had urticaria after MMR 12/23/12 (vaccine in 12/19). Did not have DTaP, IPV, flu, VARIVAX at that visit.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a female patient of unknown age. Patient's current conditions, pertinent medical history and drug reaction/allergies were not provided. On an unknown date the patient was vaccinated with VARIVAX (Merck) injection (dose, route, frequency, lot# and expiration date not provided). Concomitant medications were not provided. On an unknown date, the patient had titers completed and the results showed a sub-therapeutic level for varicella. The patient had no other adverse effects. The outcome of the event 'sub-therapeutic level of response for varicella' was not known. The reporter did not provide the relatedness of VARIVAX (Merck) to the adverse event. There was no product quality complaint. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Migraine, Vomiting
Clinical narrative: Information has been received from a consumer referring to her daughter, an 18 year old female patient with none drug reactions/allergies. The patient was vaccinated with doses of GARDASIL (route, strength, dose and lot # were unknown) on 04-AUG-2015, 15-SEP-2015 and 02-DEC-2015, respectively. Concomitant medication included birth control pills. On an unknown date the patient experienced migraine, some dizziness, and vomit. The patient didn't seek medical attention. No treatment was given for the events. The outcome of the events was unknown. The causality was not reported. Additional information is not expected as the reporter didn't like to be contacted and there was no reporter's contact information.
Sex: U
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Pain
Clinical narrative: Information has been received from a registered nurse referring to a 2 unspecified office staff of unknown age. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, frequency, lot number, route and indication not provided). In December 2011, the patients experienced fatigue, severe redness at injection site erythema and body aches an unspecified time after receiving the vaccination. The outcome of events was unknown. There was no product quality issue (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On 12-JAN-2016 the patients were vaccinated with improperly-stored doses of VAQTA lot # L023936, expiration date 15-MAR-2017; lot # L015460, expiration date 20-JUL-2017, (dose, dose #, route and application site were not reported). The reported was not aware of any adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patient was vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency and route of administration were not reported, lot # reported as L019297 with expiration date: 18-AUG-2017, L020015 with expiration date: 16-AUG-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: JC virus test positive, Multiple sclerosis
Clinical narrative: Information received on 08JAN2016 from a pharmaceutical company and consumer. A 38 year old male experienced Multiple Sclerosis following the administration of BioThrax (anthrax vaccine adsorbed) and other vaccines. On 05JAN2016, the consumer contacted a pharmaceutical company to report that he was John Cunningham virus (JCV) positive. At that time, he was on therapy with Aubagio (teriflunomide) and Tysabri (natalizumab) for multiple sclerosis. The natalizumab was stopped for the JCV. During contact with the consumer, he revealed to the pharmaceutical company that he felt that there was a link between the multiple sclerosis and anthrax immunization that he received. The pharmaceutical company forwarded the report to the vaccine manufacturer. On 08JAN2016, contact was made with the consumer by the vaccine manufacturer. The consumer reported that he had received the vaccine in two intervals for a total of 5 doses. He recalled that in 1999 his dosage of anthrax vaccine was halted due to the agency "putting the vaccine on hold for side effects". Immunization was resumed in approximately 2000-2001. The consumer also recalled that he was immunized for smallpox, Japanese encephalitis, and other vaccines on or around that time.  In 2010, he was diagnosed with multiple sclerosis. The consumer stated that he felt the multiple sclerosis was related to anthrax vaccine because he had no prior hereditary issues or autoimmune disorders, and he was told that his multiple sclerosis could be due to "environmental triggers" which he attributed to the anthrax vaccine. The consumer denied concurrent medication and medical history at the time of event. Reporter's Comments: Report forwarded from Sanofi, which contains information regarding an Anthrax vaccine. Sender's Comments: This is a consumer report from an individual who received multiple vaccines including BioThrax, smallpox and Japanese encephalitis vaccine and reports his subsequent diagnosis of multiple sclerosis. While the consumer believes the diagnosis of multiple sclerosis is related to BioThrax vaccination, multiple vaccines were administered on or about the same time.  In the absence of adequate medical assessment of the reported events a causality association is deemed not assessable.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patient was vaccinated with improperly stored doses of VAQTA (dose, frequency and route of administration were not reported, lot # L036300 with expiration date: 04-NOV-2016, lot # L039659 with expiration date: 14-MAR-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site injury, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Severe pain at injection site in RIGHT shoulder. Pain still continues to this reporting date. My shoulder was injured because the flu shot was given too high. I have received a cortisone shot and physical therapy to treat this injury.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever with febrile seizures. Medication was unable to keep the fever under control.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route of administration were not reported, lot # L029631 with exp. date 14-AUG-2017 and L025738 with exp. date: 14-AUG-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patients were orally vaccinated with improperly stored doses of oral, ROTATEQ (dose, frequency were not reported), lot # reported as L027070 with expiration date: 30-APR-2017, lot # reported as L029615 with expiration date: 15-MAY-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified patient of unknown age and gender. On 15-JAN-2016 the patient was inadvertently vaccinated with ZOSTAVAX (lot # J014851, expiration date 24-OCT-2014, strength, dose and route were unknown) which was expired on 24-OCT-2014 (Expired product administered). No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 2 month old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JAN-2016, the patient was vaccinated with an adult dose of RECOMBIVAX HB strength 10/1.0 mcrg/ml, as her first dose (lot #, dose and route were not provided). No adverse symptoms were reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Incorrect route of drug administration, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 48 year old female patient. Concurrent condition included dialysis since on an unknown date (some time). The patient drug reactions or allergies included sulfa allergy. On 15-JAN-2016 (reported as today), the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot #: L029306, expiry date: 26-MAR-2017) (dose# not specified) 0.5 ml, once, intravenously (incorrect route of drug administration) during an outpatient dialysis treatment for unspecified reason. On an unknown date in January 2016 (reported as unspecified time after receiving PNEUMOVAX 23), the patient experienced unspecified allergic reaction and was administered an unspecified dose of BENADRYL (manufacturer unspecified). On 15-JAN-2016 (reported as the same day ("about an hour" after receiving the dose of PNEUMOVAX 23)) she also got nauseous and was administered an unspecified dose of ZOFRAN (manufacturer unspecified). Patient had sought medical attention by taking treatment with unspecified doses of BENADRYL and ZOFRAN for the adverse event. The pharmacist reported that the patient was "fine" after receiving the unspecified doses of BENADRYL and ZOFRAN. There was no Product Quality Complaint (PQC) filed. The reporter did not provide the causality between the events allergic reaction and nauseous and suspect therapy PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 injection (lot # L019297 with expiration date 18-AUG-2017; dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of M-M-R II (lot # L002873, rHA status, expiration date 27-JAN-2017) were administered to an unspecified number of patients. No adverse effects have been reported. The reporter stated that there was not product quality complaints involved. This is one of several cases from the same reporter. Additional information is not expected, because the reporter refused additional contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of VAQTA (lot # K018181, expiration date 04-JUN-2017) were administered to an unspecified number of patients. No adverse effects have been reported. The reporter stated that there was not product quality complaints involved. This is one of several cases from the same reporter. Additional information is not expected, because the reporter refused additional contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L024256, expiry date 01-JUL-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was reported. No insertion and removal event was reported. The action taken with the suspect therapy and outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On multiple unspecified dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K010213, expiry date 17-JAN-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was reported. No insertion and removal related event was reported. The action taken with the suspect therapy and outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Balance disorder, Pyrexia, Somnolence
Clinical narrative: Rec'd. 12 mo vaccinations at @CE on 01/12/16. Mom reports pt. with fever beginning 01/14/16. 102 F Max. Also states 'losing balance' easily, clingy, increased sleeping. Seen in office 01/16/16 for s/s. Per dr, likely vaccine reaction. Gait normal in office and temp 8.1. To tx with TYLENOL/MOTRIN and monitor.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Local reaction, Swelling
Clinical narrative: Large local reaction - 10-12 cm swelling and induration.
Sex: U
Vaccine: MMRV
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. No information on patient's medical history, concurrent conditions or concomitant mediations was provided. On 12-JAN-2016, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) injection, lot # L024123, expiration date 30-DEC-2016 (dose and route were not reported). No adverse effects were reported. The vaccine was kept at 17.2 Fahrenheit (F) for 2 hours. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients. The patients medical histories and concurrent conditions were not reported. On unspecified dates starting on or after 06-JAN-2016, the patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) Temperature of 6.5 F in a time frame of 30 minutes (Lot # L010144; expiration date 24-MAR-2017) (dose and route of administration were not reported). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient complained of a swollen and red arm (unspecified arm). The patient was referred to her primary care physician and was diagnosed with severe cellulitis. The patient was given an unspecified treatment. The outcome of the event was unknown. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site streaking
Clinical narrative: Striations at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 24 hours after the injection my arm at the injection site swelled up to about the size of a large orange, site was red and burning and there is still a round discolored area about the size of a half dollar at the site - not improving and vaccine was on 12/23/15.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm, Swelling
Clinical narrative: Patient scheduled to be seen at medical center, presenting with c/o rash from recent vaccine administered at local store on 9/11, 3 days prior to presentation. Patient states that the rash started the day that the flu vaccine was administered. The rash is on the patient's upper right arm and is described per treatment room note as being red, swollen, warm to touch and itchy. Rash is described as being 4 cm x 7 cm. Pt denies pain and denies fever. Symptoms: 1. Skin Rash, 2. Rash, 3. Urticaria Pruritus. Treatment Drugs Used: 1-Acetaminophen Dose: 650 Units: MG Freq: TID Route: PO, 2- Hydroxyzine Dose: 10 Units: MG Freq: BID Route: PO
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: Patient scheduled to be seen at medical center, presenting with c/o rash from recent vaccine administered at local store on 9/11, 3 days prior to presentation. Patient states that the rash started the day that the flu vaccine was administered. The rash is on the patient's upper right arm and is described per treatment room note as being red, swollen, warm to touch and itchy. Rash is described as being 4 cm x 7 cm. Pt denies pain and denies fever. Symptoms: 1. Skin Rash, 2. Rash, 3. Urticaria Pruritus. Treatment Drugs Used: 1-Acetaminophen Dose: 650 Units: MG Freq: TID Route: PO, 2- Hydroxyzine Dose: 10 Units: MG Freq: BID Route: PO
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a 30mm diameter red, slightly raised mark around the injection site for 2 weeks after immunization.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV9
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Hives, itching, throat itching.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Seizure, seen in ER.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Pain at inj site, tenderness, itching, & redness on first night. Then swelling into a big blister at the area Saturday. Got worse on Sun-Mon but better Tuesday AM. Still painful but blister is smaller.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug/reactions allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K008334 with expiration date 09-JUN-2016 and lot # K002327 with expiration date 07-FEB-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. Second excursion for RECOMBIVAX HB: Temperature/time: 34.7F for 15 minutes. Previous excursion: 34.4F for 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K010215 with expiration date 05-MAY-2017 and lot # L023905 with expiration date 27-MAY-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. Third excursion for GARDASIL: Temperature/time: 34.7F for 15 minutes. Previous excursions: 34.4F for 30 minutes plus 48F for 8 hours. This is one of several reports received 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 Certified Medical Assistant referring to 10 unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On an unknown dates, the patient were vaccinated with improperly stored doses (Temperature 75F, between a time frame of 5 days) of oral, ROTATEQ, (Lot# L013206; expiration date 29-JAN-2017). Concomitant medications was not reported. No adverse effects reported. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Diarrhoea, Flushing, Irritability, Nausea, Pyrexia
Clinical narrative: Flushed cheeks, nausea, vomiting, low-grade fever, diarrhea, irritability for two days following event onset.  Given oral fluids for hydration and Tylenol to reduce fever.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Vomiting
Clinical narrative: Flushed cheeks, nausea, vomiting, low-grade fever, diarrhea, irritability for two days following event onset.  Given oral fluids for hydration and Tylenol to reduce fever.