chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: U
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: Left arm and hand paralyzed at first. Now not back to normal. I have had OT and some PT. It has been 8 months.
Age: 19.0
Sex: M
Vaccine: HEPAB, VARCEL
Symptoms: Ocular hyperaemia
Clinical narrative: Pt states his left eye became "blood shot red" and "lasted until the next morning around lunch".
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Angioedema, Chest pain, Cough, Dyspnoea
Clinical narrative: Addendum 12-October-2015: Upon second medical review the product code was changed to 390 (INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE). Initial unsolicited case received from literature on 17-Sep-2015 and additional information received on 20-Sep-2015. Abstract: The CDC's Advisory Committee on Immunization Practices voted for universal flu vaccination to expand protection against the flu. In addition to this administration expansion, six new influenza vaccines have been introduced into the market possibly introducing new allergenic potentials. We report two cases of delayed anaphylaxis to the flu vaccine. This case involves a 42-year-old female patient who was vaccinated with 0.1 mL intradermal dose of FLUZONE Intradermal Vaccine (batch number, dose and site of administration were not reported) on unspecified date. It was reported that patient had tolerated her first influenza vaccination 2 years prior without incident. The patient reports a rash with amoxicillin but denies allergies to egg or latex. The patient otherwise denies any past medical history and currently does not report taking any medications. On unspecified date, 3 hours post-vaccination patient experienced anaphylaxis, dry cough, chest pain, dyspnea, palpitations and bilateral periorbital angioedema. Lab tests included intradermal testing which showed a 6-7 mm wheal and 12 mm of erythema for the same at 1:100 concentrations. Prick testing was negative to egg yolk/white. Latex prick testing was negative. Patient did not receive any corrective treatments. It was reported that symptoms were resolved within 24 hours without treatment. Upon medical review, the case was considered as serious due to important medical event: Anaphylaxis. Documents held by Sender: none. Follow-up information received from a literature on 01 October 2015. The patient had received Amoxicillin (batch number, dose, expiry date were not reported) on an unknown date. On an unknown date, after receiving amoxicillin the patient had developed rash. The outcome of the event rash with amoxicillin was not reported. Sender's Comments: Follow up received on 01-October-2015 does not change the previous medical assessment. Anaphylaxis is listed with INFLUENZA SPLIT TRITON INTRADERMAL THIOMERSAL FREE VACCINE. This case meets Level 2 definition for anaphylaxis of the Brighton Collaboration. Complementary information regarding any drug or food intake during the period between vaccination and the event as well as allergic testings to identify the culprit antigen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Palpitations, Skin test negative, Skin test positive, Urticaria
Clinical narrative: Addendum 12-October-2015: Upon second medical review the product code was changed to 390 (INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE). Initial unsolicited case received from literature on 17-Sep-2015 and additional information received on 20-Sep-2015. Abstract: The CDC's Advisory Committee on Immunization Practices voted for universal flu vaccination to expand protection against the flu. In addition to this administration expansion, six new influenza vaccines have been introduced into the market possibly introducing new allergenic potentials. We report two cases of delayed anaphylaxis to the flu vaccine. This case involves a 42-year-old female patient who was vaccinated with 0.1 mL intradermal dose of FLUZONE Intradermal Vaccine (batch number, dose and site of administration were not reported) on unspecified date. It was reported that patient had tolerated her first influenza vaccination 2 years prior without incident. The patient reports a rash with amoxicillin but denies allergies to egg or latex. The patient otherwise denies any past medical history and currently does not report taking any medications. On unspecified date, 3 hours post-vaccination patient experienced anaphylaxis, dry cough, chest pain, dyspnea, palpitations and bilateral periorbital angioedema. Lab tests included intradermal testing which showed a 6-7 mm wheal and 12 mm of erythema for the same at 1:100 concentrations. Prick testing was negative to egg yolk/white. Latex prick testing was negative. Patient did not receive any corrective treatments. It was reported that symptoms were resolved within 24 hours without treatment. Upon medical review, the case was considered as serious due to important medical event: Anaphylaxis. Documents held by Sender: none. Follow-up information received from a literature on 01 October 2015. The patient had received Amoxicillin (batch number, dose, expiry date were not reported) on an unknown date. On an unknown date, after receiving amoxicillin the patient had developed rash. The outcome of the event rash with amoxicillin was not reported. Sender's Comments: Follow up received on 01-October-2015 does not change the previous medical assessment. Anaphylaxis is listed with INFLUENZA SPLIT TRITON INTRADERMAL THIOMERSAL FREE VACCINE. This case meets Level 2 definition for anaphylaxis of the Brighton Collaboration. Complementary information regarding any drug or food intake during the period between vaccination and the event as well as allergic testings to identify the culprit antigen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016293885) on 16-Jun-2016. This case involves a male patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus vaccine) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date following vaccination (Latency unknown), the patient experienced allergy to Tetanus Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood test, Cough, Fatigue, Lethargy, Loss of consciousness
Clinical narrative: 20 minutes after shots: Cough, child looked tired, slightly lethargic, child passed out for about 45 seconds to 1 minute. When he came to, he had no clue what happened and kept passing out. I rushed him to the ER where they treated him for syncope.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: 20 minutes after shots: Cough, child looked tired, slightly lethargic, child passed out for about 45 seconds to 1 minute. When he came to, he had no clue what happened and kept passing out. I rushed him to the ER where they treated him for syncope.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dysphagia, Oral discomfort, Urticaria
Clinical narrative: Hives, oral sensation, swallowing difficulty.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: Redness, itching and spreading of local reaction to immunization. Given prednisone and betamethasone.
Age: 0.33
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Diarrhoea, Laboratory test, Occult blood, Rotavirus test
Clinical narrative: Severe diarrhea and loose stools from rotavirus vaccine. It lasted until 7/25/2016. Saw at least 4 different doctors about symptoms and had tests done to see if something else was wrong. 2 doctors independently said that it was probably the vaccine since there was nothing else happening to her at that time. Her diarrhea episodes were about 8 times a day, when she previously only had one solid bowel movement a day.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's arm where immunization given became red and swollen that evening.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Eyelid ptosis, Fatigue, Feeling hot, Nausea
Clinical narrative: 7/22/16 4:30 pm felt hot but didn't take temperature, couldn't tolerate the heat beyond normal, very tired, achy back, neck and upper legs and drooping eyelids to where the patient wants to close her eyes - took some Tylenol. 7/23/16 - 7/26/16 same symptoms plus nausea.  Called PCP on 7/26/16 and left message asking to return call.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: 7/22/16 4:30 pm felt hot but didn't take temperature, couldn't tolerate the heat beyond normal, very tired, achy back, neck and upper legs and drooping eyelids to where the patient wants to close her eyes - took some Tylenol. 7/23/16 - 7/26/16 same symptoms plus nausea.  Called PCP on 7/26/16 and left message asking to return call.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Autoimmune thyroiditis, Hepatic cyst, Malaise, Nephrolithiasis, Palpitations
Clinical narrative: A spontaneous report was received on 14JUL2016 from a consumer. An approximately 38 year old female reported experiencing a swollen arm, heart racing and felt sick following immunization with BIOTHRAX when she was approximately 26 years old. In DEC2003 she received the first dose of BIOTHRAX (lot # reported as FAV068). Additional vaccines were received on same date or around same date in preparation for deployment. Following vaccination the consumer reports she experienced a swollen arm, heart racing and felt sick. She was seen at Emergency Room where treatment with Benadryl was given. The initial symptoms were reported to be resolved. The consumer also reported experiencing several health issues over the years since vaccination, including Hashimoto's thyroiditis (diagnosed approximately 2005); Lupus (diagnosed approximately 2008); vasculitis in both legs (diagnosed approximately 2012-2013); fluid around heart (diagnosed approximately 2006); cyst on liver (diagnosed approximately 2014); and kidney stones (diagnosed approximately 2004). Upon review of lot FAV068 it is noted that this lot of BIOTHRAX vaccine was never produced.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Pericardial effusion, Peripheral swelling, Systemic lupus erythematosus, Vasculitis
Clinical narrative: A spontaneous report was received on 14JUL2016 from a consumer. An approximately 38 year old female reported experiencing a swollen arm, heart racing and felt sick following immunization with BIOTHRAX when she was approximately 26 years old. In DEC2003 she received the first dose of BIOTHRAX (lot # reported as FAV068). Additional vaccines were received on same date or around same date in preparation for deployment. Following vaccination the consumer reports she experienced a swollen arm, heart racing and felt sick. She was seen at Emergency Room where treatment with Benadryl was given. The initial symptoms were reported to be resolved. The consumer also reported experiencing several health issues over the years since vaccination, including Hashimoto's thyroiditis (diagnosed approximately 2005); Lupus (diagnosed approximately 2008); vasculitis in both legs (diagnosed approximately 2012-2013); fluid around heart (diagnosed approximately 2006); cyst on liver (diagnosed approximately 2014); and kidney stones (diagnosed approximately 2004). Upon review of lot FAV068 it is noted that this lot of BIOTHRAX vaccine was never produced.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature decreased, Dizziness, Feeling hot, Nervousness, Pain
Clinical narrative: Sudden onset of feeling hot, with body aches, then felt shaky, dizzy and panicky. Lasted less than 1 hour. Temp check 1 hour after onset reported @ 96.6  Did not seek medical attention, felt completely well in the morning, no visible reaction at the site of injection, no other symptoms.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Panic reaction
Clinical narrative: Sudden onset of feeling hot, with body aches, then felt shaky, dizzy and panicky. Lasted less than 1 hour. Temp check 1 hour after onset reported @ 96.6  Did not seek medical attention, felt completely well in the morning, no visible reaction at the site of injection, no other symptoms.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dyspnoea, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt stated that her arm was hurting and swelling at the injection site on 7/24/2016.  The next day (7/25/2016) she had a fever and more swelling.  She also stated that she felt weak and was having some shortness of breath.  She did contact her md on 7/26/16 and they did not seem concerned and told her to notify the pharmacy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: On 7/23/16 child had hot feeling, redness, swelling and large lump on Left deltoid. No fever noted.  Mother took her to Urgent care and was prescribed an antibiotic twice daily for 10 days, on 7/26 Mother reports swelling, redness, and warm are gone, a small lump remains.
Age: 0.53
Sex: M
Vaccine: DTAP, HEP
Symptoms: Crying, Eye discharge, Eyelid margin crusting, Nasopharyngitis, Pyrexia
Clinical narrative: High fever started on Wednesday then turned to a cold on Friday by 3 am on Sunday I woke up to her crying because her eyes was closed shut due to excess mucus from her eye.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis, Pallor, Syncope, Tinnitus, Vomiting
Clinical narrative: After pt received his 1st HPV pt became diaphoretic, pale, vomited and fainted per father and nurse. Pt also complained of ringing in both ears. Vital Signs obtain and provider in to check patient. Pt instructed to lay down, pt left after about 20 minutes. Per nurse that gave vaccine pt was walking fine without difficulty. Father discharge with instructions.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Headache
Clinical narrative: Staff called from hospital and stated the patient came in complaining of headache since yesterday. She stated the patient said the only different was getting the PNEUMOVAX 23 immunization.
Age: 44.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Dyspnoea, Headache, Rash erythematous, Rash pruritic
Clinical narrative: Itchy raised red bumps; difficulty breathing; headache; diarrhea.
Age: 0.36
Sex: M
Vaccine: DTAPH, HEP, IPV, RVX, UNK
Symptoms: Cyanosis, Decreased appetite, Dyspnoea, Hypotonia, Lethargy
Clinical narrative: Patient went limp in my brother arm, was very lethargic. He had trouble breathing for about 30 seconds and his face turned blue. We had to try and keep him up by patting his back, flicking his toes, and gently bouncing him. He didn't eat for 5 hours straight after getting the vaccines.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Diarrhoea, Enema administration, Haematochezia, Intussusception
Clinical narrative: Patient had loose stools for a few days and was improving when seen 7/21/16 for 6 mo check up. He had diaper dermatitis and otherwise normal exam. Vaccines were given. 2 days later he had 1 loose, mucousy stool then had no BM x 24 hrs. Developed cramps intermittent pain, was given glycerin suppository and had bloody stool. Diagnosed w/ileocolic intussusception and underwent successful air contrast enema. Recovered w/no subsequent problems.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mucous stools, Ultrasound abdomen abnormal
Clinical narrative: Patient had loose stools for a few days and was improving when seen 7/21/16 for 6 mo check up. He had diaper dermatitis and otherwise normal exam. Vaccines were given. 2 days later he had 1 loose, mucousy stool then had no BM x 24 hrs. Developed cramps intermittent pain, was given glycerin suppository and had bloody stool. Diagnosed w/ileocolic intussusception and underwent successful air contrast enema. Recovered w/no subsequent problems.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative who referred to a 67 year old male patient. Patient's pertinent medical history, concomitant medication and drug reaction/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (strength, dose, lot # and expiration date were not provided). On an unknown date, after receiving the ZOSTAVAX, the patient was diagnosed with shingles then after a year from receiving the ZOSTAVAX the patient died. At the reporting time, the outcome of the event of shingles was unknown. The cause of the death was unknown. It was also unknown whether an autopsy was performed. The relatedness between the events and the ZOSTAVAX was not provided. Upon internal review, the patient's death was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative, concerning a patient of unknown age and gender. Patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On approximately 2015, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot # and expiration date were not provided). On an unknown date, within a year of the injection, the patient died. The cause of death was unknown. It was unknown whether an autopsy was performed or not. There was no product quality (PQC) involved. The causality was not stated. Upon internal review, the event of death was considered as medically significant. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Differential white blood cell count, Full blood count, Injection site urticaria, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Patient developed hives at the site of his previous allergen vaccines (described as posterior triceps area) that begin within 1-2 days of receiving his third anthrax vaccine received on 23 October 2015.
Age: 14.0
Sex: M
Vaccine: HPV9, MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 09-JUL-2016, the patient was vaccinated with expired dose of M-M-R II (lot # K005431, expiry date: 15-APR-2016) (route of administration: subcutaneous) (expired vaccine used). No adverse effects reported. The outcome of the events was unknown. Additional information had been requested.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Facial pain, Pain
Clinical narrative: On Saturday, 7/23/16, patient experienced dizziness and light headedness. No pain around injection site. Reports full-body pain particularly in the face. Patient believes it may be an infection from her know. Doctor was contacted and patient was told to call back in a few days if still experiencing symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report refers to a 69-year-old female patient who was reporting on herself. The patient did not have any concomitant medications nor pertinent medical history. The patient was allergic to penicillin. In approximately 2012 (reported as about 4 years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported. On 28-JUN-2016, the patient experienced a mild case of shingles on her abdomen and lower back. The patient received unspecified treatment. There was no lab diagnostics and studies performed. The patient's outcome was reported as not recovered/not resolved. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information is not expected since the healthcare professional's contact details were not provided.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting projectile
Clinical narrative: Information had been received on 29-JUN-2016 from a field representative who called for a licensed practical nurse. The nurse advised the primary reporter that after giving ROTATEQ (dose, lot number and date of use not reported) oral, the patient (age and gender unknown) almost immediately started projectile vomiting (date not reported). The outcome of event was unknown by reporter. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 60 year old female patient. Pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL (dose, lot # and Expiry date were unknown) subcutaneously. On an unknown date, the patient experienced redness, swelling and the skin area being heated at the injection site. The patient spoke to the pharmacist for medical attention. The patient received treatment for the events. On an unknown date, the outcome of the events were reported as recovered/resolved. The reporter did not assess the causality between the events and the suspect therapy. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient in her mid 60's (years old). Pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX VIA (dose, lot # and Expiry date were unknown) subcutaneously . On an unknown date, the patient experienced redness, swelling and the skin area being heated at the injection site. The  patient spoke to the pharmacist for medical attention. The patient received treatment for the events. On an unknown date, the outcome of the events were reported as recovered/resolved. The reporter did not assess the causality between the events and the suspect therapy. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L046887, expiration date 23-NOV-2017, route and dose were not reported). The vaccine had been stored under temperature of 6.9 Fahrenheit for 1 hour and 30 minutes. There was no previous temperature excursion. Data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (lot # M006104, expiration date 01-AUG-2017, route and dose were not reported). The vaccine had been stored under temperature of 6.9 Fahrenheit for 1 hour and 30 minutes. There was no previous temperature excursion. Data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 10-JUN-2016 the patient was vaccinated with improperly stored GARDASIL (lot # M014929, expiration date 27-MAY-2017, dose was not reported) intramuscularly. The lowest storage temperature of the vaccine was 29.3 Fahrenheit and the cumulative excursion time was 136 hours. Data logger had been involved. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with PROQUAD (lot number L041627 and expiration date 20-APR-2017, lot number L050907 and expiration date 14-JUL-2017, lot number M011664 and expiration date 08-SEP-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 24.1F and the time frame was 5 hours and 41 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with VARIVAX (lot number L025205 and expiration date 0-JUL-2017, lot number L042266 and expiration date 27-OCT-2017, lot number L048462 and expiration date 02-DEC-2017, lot number L048465 and expiration date 02-DEC-2017, lot number M009765 and expiration date 23-FEB-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 24.1F and the time frame was 5 hours and 41 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection, lot # L031272, expiration date 19-NOV-2016 (dose, route and site of administration were not reported). No adverse symptoms were reported. Product quality complaint was not involved. No further information was provided. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 31-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that has experienced temperature excursion. No adverse reaction was reporter. This is one of several reports received form the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Muscle spasms, Nausea
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient had no pertinent medical history, concurrent condition and concomitant medication. He had no previous drug reactions/allergies. Approximately on 20-JUL-2016, the patient was vaccinated with the third dose of GARDASIL 9 (Lot # 1045700 and expiration date 22-FEB-2018) intramuscularly (strength, dosing details and anatomical location were unknown). On the same day night (also reported as on 20-JUL-2016) the patient experienced leg cramping and nausea. On 21-JUL-2016, the patient went for golfing and "passed out". The patient did not sought medical attention and no treatment was given for the adverse event. No lab diagnostic tests were performed. The outcome of leg cramping, nausea and syncope was reported as recovering. Causality assessment was not provided. No product quality complaint was involved. Additional information is not expected as no reporter contact details were provided.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a register nurse and refers to a 18-year-old female patient. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with three doses of RECOMBIVAX HB (5 mcg/0.5ml, route of administration, lot number, and expiry dates were not reported). On 05-JUL-2016, following that administrations, an unknown type of blood test was performed to test for hepatitis B immunity. The primary reporter stated that, the results concluded that, the patient was seronegative for hepatitis B immunity. No additional adverse event was reported. The patients outcome was not reported. Relatedness between the adverse event and the vaccinations were not reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 18 year old patient of unknown gender. The patient's  medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received form the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # H021861, expiration date 09-OCT-2015; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L046900, expiration date: 23-FEB-2016, exact dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report concerning a 65 year old female patient with drug hypersensitivity to sulfas was received from the patient herself. The patient's medical history included a case of shingles (herpes zoster). In September of an unspecified year, the patient was vaccinated with ZOSTAVAX (strength, dose, route, frequency, lot and expiration date were not provided). Concomitant therapies included lidocaine (manufacturer unknown), valacyclovir hydrochloride and acetaminophen, VICODIN. On 11-JUL-2016, the patient experienced shingles (herpes zoster). The reporter stated that she sought medical attention and valacyclovir hydrochloride was given as treatment to the adverse events. No product quality complaint was involved. At the time of reporting the outcome of herpes zoster was reported as not recovered. The causality between ZOSTAVAX and herpes zoster was not assessed. Additional information is not expected as the reporter did not consent for follow-up attempts.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 18-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not reported) that had experienced temperature excursion. Reporter reported GARDASIL 9 with lot# K014191 (expiration date was not provided) which was not valid for GARDASIL 9. However, lot# K014191 was valid for GARDASIL. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: HIBV, PPV
Symptoms: Irritability, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a physician referring to a 9 month old male patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 14-JUL-2016, the patient was inadvertently administered a dose of PNEUMOVAX 23 (lot# L040178 with expiration date 18-AUG-2017; dose and route were not reported) (wrong vaccine administered). 4 hours after the injection, the patient spiked a fever of 102.2 Fahrenheit (F) and was fussy. The patient came to the physician's office seeking medical attention and treatment was given for the events. No lab diagnostic studies were performed. At the time of reporting, the patient was recovering from the events. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. No information on patient's pertinent medical history, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L040445, expiration date: 15-JAN-2017, dose and route of administration were not reported). The ZOSTAVAX was stored in temperature of -11C degrees for 2216 hours captured in Data Logger. There was no previous excursions. No adverse effects were reported. Additional information has been requested. This is a one of the several reports from the same reporter source.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II (lot # L027434, expiration date:22-JUL-2017, lot # L035674, expiration date: 17-AUG-2017, lot# L039613, expiration date: 08-OCT-2017) (strength, dose, route of administration and frequency were not reported). Administered doses of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour; 34 degrees Fahrenheit for 5 hours and 33 degrees Fahrenheit for 17 hours. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant therapies were reported. On 29-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (albumin status: rHA, lot # L024265, expiration date 01-JUL-2017, route of administration not provided). The vaccine was stored in an improper temperature of 50.8F for a cumulative period of 38 hours. The temperature excursion was captured by digital data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from nurse refer to 3 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that first patient was vaccinated on 06-JUL-2016, second patient was vaccinated on 08-JUL-2016 and third patient was vaccinated on 13-JUL-2016 with improperly stored doses of VARIVAX with lot # L048462, expiry date: 02-DEC-2017 (route, dose and frequency not reported). The vaccine was exposed to temperature of -3.3 Celsius for 2 hours. The vaccine had previous temperature excursion of 20.3 Celsius for 27 hours and 8 Celsius for 31 hours. No adverse effects were reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant therapies were reported. On 0n 01-JUL-2016, the patient was vaccinated with improperly stored MMR II (lot # L024265, expiration date 01-JUL-2017, route of administration not provided). The vaccine was stored in an improper temperature of 50.8F for a cumulative period of 38 hours. The temperature excursion was captured by digital data logger. No adverse effects were reported. Additional information has been requested. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Polymerase chain reaction positive, Rotavirus test positive
Clinical narrative: This literature marketed report as received from the authors in a published article refers to 18 patients of unknown gender under 70 months of age. The article described the result of follow-up epidemiological study which was conducted to determine the circulation genotypes during 2011 season and whether the increase in rotavirus (RV) diarrhea was caused by replacement genotypes. Similar proportions of RV genotypes were found among vaccinated and unvaccinated children. The local data suggested that 5 years after the introduction of RV vaccination there was no genotype replacement. This report refers to the 18 patients who on unknown dates were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) oral (dose and lot number not reported). The patients received at least one dose of RV vaccine at least 14 days prior to presentation, as determined from the hospital records or after querying the state registry. The patients presented to the emergency department during the RV season of 2011 and were diagnosed as having RV diarrhea. Stool samples analysis confirmed RV using polymerase chain reaction (PCR). The outcome of the event was unknown. The reporter considered the event to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (manufacturer unknown). Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M007728 (also reported as "M002778"), expiration date 21-MAR-2018, intramuscularly (exact dose and dose number were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 2 hours. Data logger was involved. There were no previous excursions reported.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot # L043214, expiration date: 30-AUG-2017 and lot # M005714, expiration date: 03-OCT-2017) (strength, dose, route of administration and frequency were not reported). The nurse reported also GARDASIL 9 with lot# L040459, expiration date: 06-APR-2017 which was not valid for GARDASIL 9. However, lot# L040459, is valid for GARDASIL. Administered doses of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour; 34 degrees Fahrenheit for 5 hours and 33 degrees Fahrenheit for 17 hours. No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician assistant (P.A.) concerning to a 63 year old female patient. The patient's concomitant conditions included hypertension, thyroid disease, acid reflux and environmental allergies as concurrent conditions. The patient's pertinent medical history was not reported. It was reported that sometime in March-2016 the patient was vaccinated with ZOSTAVAX (lot #, dose, route and expiration date were not provided). Concomitant therapies include unspecified blood pressure and thyroid meds. It was also reported that 3 weeks later, in 2016, the patient developed a rash on her upper chest, neck and face which persisted. The patient south treatment from dermatologist who was treating the rash. The patient was treated with "oral and topical steroids, antivirals", and the physician offered a VZV packet and she accepted. There were not laboratory tests performed. The outcome of rash on her upper chest, neck and face was not recovered/not resolved at the time of the report. There were not product quality complaint (PQC), overdose or cancer involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report concerning a patient of an unknown gender and age was received from a nurse practitioner. The patient's concurrent conditions and medical history were not provided. On 14-JUL-2016, the patient was vaccinated with VARIVAX lot #: M006731, expiration date 09-FEB-2018 (strength, dose, route and frequency were not provided). The reporter stated that the VARIVAX was improperly stored at a temperature of 27.7F for 1 hour and 12 minutes. There was no previous temperature excursion. There were no concomitant medications and symptoms reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a Registered Nurse (RN) concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. Concomitant therapies were not provided. On 19-JUL-2016 the patient was vaccinated with VARIVAX dose 1 and with PROQUAD (concentration and indication were not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients (reported as only a few) of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (lot # L016429 with expiration date 09-AUG-2017, dose and route were not reported). Since May 2016, the vaccine were improperly stored under 46.6. Fahrenheit (F) for cumulative time 838 hours. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 21-JUL-2016, the patient inadvertently received an expired dose of PNEUMOVAX 23 (lot# L00318, dose and route unknown) which had expired on 06-JUL-2016. This dose had also been improperly stored at 59F for 5 hours prior to the date of administration (date unspecified). No adverse effects were reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 2 year old patient. Information regarding pertinent medical history, drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (dose, anatomical location, lot#, expiration date and indication were not provided). Concomitant therapies were not provided. The medical assistant reported on an unknown date, that the patient was vaccinated with PNEUMOVAX 23 instead of PREVNAR 13, due to human error, also it was stated that no product quality complaint was involved. Additional information is not expected as the reporter did not provide the contact details.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's  medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received form the same reporter. Additional information has been requested.