chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 52 year old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with a dose of PREVNAR one year ago, in approximately 2015. Concomitant medications were reported as 'there was nothing new in her current medication therapy'. On 21-AUG-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot# reported as L022262; expiry date: 05-NOV-2016) subcutaneously. Other suspect vaccine included AFLURIA. Following vaccination, on an unknown date, in approximately 2016, patient experienced a red swollen arm. Patient was seen by a nurse practitioner at a physician's office. The nurse practitioner thought that it 'might be a Staphylococcus cellulitis infection but was some kind of a bacterial infection' that the patient received unspecified antibiotic shots for. Patient had recovered from the event in approximately 2016. Causality assessment was not provided. No Product Quality Complaint (PQC) was involved. Upon internal review, Staphylococcus cellulitis infection was considered to be medically significant. This is one of the two reports from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abdominal discomfort, Complement factor C3, Complement factor C4 decreased, Complement factor normal, Oropharyngeal pain
Clinical narrative: MCV4 vaccine administered in office on 8/23, hives and itching developed when he got home, went to UC. They started him on MEDROL pack, no effect, went to PCP, IM BENADRYL and prednisone given, oral prednisone ordered, no effect, went to ED, admitted for IV steroids.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: MCV4 vaccine administered in office on 8/23, hives and itching developed when he got home, went to UC. They started him on MEDROL pack, no effect, went to PCP, IM BENADRYL and prednisone given, oral prednisone ordered, no effect, went to ED, admitted for IV steroids.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a consumer referring to a 66 years old female patient. The patient's medical history and concurrent conditions were unknown by the reporter. On 02-SEP-2016, the patient was vaccinated with ZOSTAVAX injection, expiration date in April 2016 (strength, dose, lot number, route of administration were not provided). The patient's relevant concomitant medication, and relevant past drug history were unknown by the reporter. The primary reporter stated that after ZOSTAVAX was administered, they discovered that the product had expired in April 2016. Relevant laboratory data was unknown. The reporter stated that was unknown if the patient was continuing with ZOSTAVAX. Additional information is expected.
Sex: M
Vaccine: PPV, PPV
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Information has been received from a nurse via a company representative referring to a 74 year old male patient. The patient's current conditions and medical history were not reported. Concomitant therapies included LIPITOR. On 01-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were unknown) (reported as "primary vaccine for the patient"). On 31-AUG-2016, the patient presented weakness and possible Guillain Barre. The area where the patient feeling weakness was not specified. The patient was hospitalized for an unspecified amount of time due to the adverse event. The patient had been discharged and was currently in physical therapy. The events of weakness and possible Guillain Barre were recovering until the day of report. The causal relationship between the events and PNEUMOVAX 23 was unknown. Upon internal review, the event of possible Guillain Barre was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia
Clinical narrative: Information has been received from a nurse via a company representative referring to a 74 year old male patient. The patient's current conditions and medical history were not reported. Concomitant therapies included LIPITOR. On 01-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were unknown) (reported as "primary vaccine for the patient"). On 31-AUG-2016, the patient presented weakness and possible Guillain Barre. The area where the patient feeling weakness was not specified. The patient was hospitalized for an unspecified amount of time due to the adverse event. The patient had been discharged and was currently in physical therapy. The events of weakness and possible Guillain Barre were recovering until the day of report. The causal relationship between the events and PNEUMOVAX 23 was unknown. Upon internal review, the event of possible Guillain Barre was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Asthma, Back pain, Fatigue, Fibromyalgia, Headache
Clinical narrative: Asthma, rashes, fibromyalgia, lower back pain, headache, chronic fatigue, sleep apnea.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Sleep apnoea syndrome
Clinical narrative: Asthma, rashes, fibromyalgia, lower back pain, headache, chronic fatigue, sleep apnea.
Age: 0.33
Sex: M
Vaccine: 6VAX-F, OPV, PPV, RVX
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Leg with severe swelling, hot, red spots about the size of quarters and non stop crying for more than 3 hours.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Activities of daily living impaired, Altered state of consciousness, Arthralgia, Asthenia, Axillary pain
Clinical narrative: While at work on 3 occasions between 4:00pm and 9:00pm I got really warm and felt like I was going to pass out. That same night I went to bed and woke up in a complete sweat, had a headache and low grade fever. The next morning I woke up and my muscles and joints hurt, nausea, low grade fever, dizzy and felt disoriented and not to mention, the left arm was so painful and my armpit was extremely sore!!! I called the clinic and spoke with my Drs nurse and she excused me from work because I was incapable of going! I rested all day Wednesday. I took a lot of Ibuprofen which didn't help the fever or pain for very long. I had absolutely no appetite and did my best at keeping hydrated!Wednesday night I woke up a few times drenched in sweat that I had to wash my pillow and bedding. I couldn't afford to miss another day, so Thursday I went to work. It was completely rough as I work in healthcare. I was in a sweat my entire 8 hours and was dizzy, weak and nauseous as well as leg achiness and feeling of being shocked. I forgot to mention I did call facility back and talked to my Drs nurse and she said I had an allergic reaction to the pneumonia vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Decreased appetite, Disorientation, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: While at work on 3 occasions between 4:00pm and 9:00pm I got really warm and felt like I was going to pass out. That same night I went to bed and woke up in a complete sweat, had a headache and low grade fever. The next morning I woke up and my muscles and joints hurt, nausea, low grade fever, dizzy and felt disoriented and not to mention, the left arm was so painful and my armpit was extremely sore!!! I called the clinic and spoke with my Drs nurse and she excused me from work because I was incapable of going! I rested all day Wednesday. I took a lot of Ibuprofen which didn't help the fever or pain for very long. I had absolutely no appetite and did my best at keeping hydrated!Wednesday night I woke up a few times drenched in sweat that I had to wash my pillow and bedding. I couldn't afford to miss another day, so Thursday I went to work. It was completely rough as I work in healthcare. I was in a sweat my entire 8 hours and was dizzy, weak and nauseous as well as leg achiness and feeling of being shocked. I forgot to mention I did call facility back and talked to my Drs nurse and she said I had an allergic reaction to the pneumonia vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Myalgia, Nausea, Night sweats, Pain in extremity
Clinical narrative: While at work on 3 occasions between 4:00pm and 9:00pm I got really warm and felt like I was going to pass out. That same night I went to bed and woke up in a complete sweat, had a headache and low grade fever. The next morning I woke up and my muscles and joints hurt, nausea, low grade fever, dizzy and felt disoriented and not to mention, the left arm was so painful and my armpit was extremely sore!!! I called the clinic and spoke with my Drs nurse and she excused me from work because I was incapable of going! I rested all day Wednesday. I took a lot of Ibuprofen which didn't help the fever or pain for very long. I had absolutely no appetite and did my best at keeping hydrated!Wednesday night I woke up a few times drenched in sweat that I had to wash my pillow and bedding. I couldn't afford to miss another day, so Thursday I went to work. It was completely rough as I work in healthcare. I was in a sweat my entire 8 hours and was dizzy, weak and nauseous as well as leg achiness and feeling of being shocked. I forgot to mention I did call facility back and talked to my Drs nurse and she said I had an allergic reaction to the pneumonia vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: While at work on 3 occasions between 4:00pm and 9:00pm I got really warm and felt like I was going to pass out. That same night I went to bed and woke up in a complete sweat, had a headache and low grade fever. The next morning I woke up and my muscles and joints hurt, nausea, low grade fever, dizzy and felt disoriented and not to mention, the left arm was so painful and my armpit was extremely sore!!! I called the clinic and spoke with my Drs nurse and she excused me from work because I was incapable of going! I rested all day Wednesday. I took a lot of Ibuprofen which didn't help the fever or pain for very long. I had absolutely no appetite and did my best at keeping hydrated!Wednesday night I woke up a few times drenched in sweat that I had to wash my pillow and bedding. I couldn't afford to miss another day, so Thursday I went to work. It was completely rough as I work in healthcare. I was in a sweat my entire 8 hours and was dizzy, weak and nauseous as well as leg achiness and feeling of being shocked. I forgot to mention I did call facility back and talked to my Drs nurse and she said I had an allergic reaction to the pneumonia vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Developed large red and swollen welt on my left arm. Within 24 hours the welt grew to 6 inches long and was raised about 1/4 inch high. It took over a week and a half to heal.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Myalgia, Pyrexia, Rash, Urticaria
Clinical narrative: Fever, uncontrollable shivering/teeth chattering, muscle aches, and rash/hives all over torso.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Injection site bruising, Injection site pain, Injection site swelling, Throat irritation
Clinical narrative: Swollen quarter sized bump on site of injection area, tenderness, pain and soreness at injection spot, arm bruised at injection spot, tired, scratchy throat.
Age: 30.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness, hard and hot at injection site.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site reaction, Iontophoresis, Myositis
Clinical narrative: Patient developed localized myositis of the deltoid at the site of injection which became so severe that she has been unable to abduct her left arm above 90 degrees for the last 5 months. We are doing massage, physical therapy and iontophoresis and she is slowly improving, but may be permanently disabled.
Age: 69.0
Sex: F
Vaccine: RAB
Symptoms: Depression, Lethargy, Palpitations
Clinical narrative: Initial unsolicited report received from a consumer on 31 August 2016. This case involves a 69-year-old female patient, who was vaccinated with a dose of IMOVAX and IMOGAM (batch number, expiry date, dose, dose in series, route and site of administration was unknown for both vaccinations) on 19 August 2016. The patient had a medical history of Hashimoto's disease. Concomitant medications was unknown. On 19 August 2016, same day following the vaccination, the patient experienced increased palpitations, lethargy and depression. Laboratory data and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: MEN
Symptoms: Encephalitis meningococcal, Optic nerve injury
Clinical narrative: Initial unsolicited report received from a Consumer on 01 September 2016. This case involves a 23-year-old male patient who was vaccinated with a booster dose of Meningococcal Vaccine (batch number, expiry date, site and route of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, reported as past June for 15 days the patient had experienced encephalitis meningitis, patient also experience optic nerve damage to the left eye. It was reported that night mare meningitis comes in many forms not just bacterial. Laboratory investigations and corrective treatment were not reported. The patient was recovered from event (duration 15 days). Upon internal review the case was considered as serious because of important medical event Encephalitis and optic nerve damage. List of documents held by sender: none. Sender's Comments: This case corresponds to a poorly documented social media case, where manufacturer of the MENINGOCOCCAL VACCINE was not provided. Encephalitis meningitis was reported after administration of MENINGOCOCCAL VACCINE. Time to onset of event is unknown. Details regarding relevant medical history, CSF, MRI or other diagnostic reports, any history of infection after vaccination are needed to further assess the case. Based on available information role of the vaccine can not be assess.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Radiculopathy
Clinical narrative: Left arm numbness, tingling.
Sex: U
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer) on 02 September 2016. Manufacturer Report Number: 2016407947. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLU VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had seizure. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: seizure. List of documents held by sender: none. Sender's Comments: Patient had seizure following flu vaccine manufacturer unknown. Time to onset is unknown, detail medical history during or before vaccination, past vaccination history and its tolerance, any CNS disorder, traumatic history etc. are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient experiencing minor muscle pain and soreness at the injection site for 3 weeks. No swelling or redness in the area.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest pain, Cough, Hyperhidrosis, Nausea
Clinical narrative: Pt woke up the next day with chest pains, sweating, nausea, weakness and cough. PCP referred pt to ER, ER treated for nausea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Received vaccines on 9/7/16, leg started to swell immediately. They elevated, iced. Swelling did go down with elevation. Swelling and redness on left middle thigh, swelling going down to knee, red, some pain, hot to touch, red and streaky.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Received vaccines on 9/7/16, leg started to swell immediately. They elevated, iced. Swelling did go down with elevation. Swelling and redness on left middle thigh, swelling going down to knee, red, some pain, hot to touch, red and streaky.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Heart rate increased, Influenza virus test negative, Lumbar puncture normal, Nausea
Clinical narrative: Fast Heart rate 140's, dizzy, tingling all over body, nausea, fever 102 took Aspirin. Went to ER.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Fast Heart rate 140's, dizzy, tingling all over body, nausea, fever 102 took Aspirin. Went to ER.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Pallor, Syncope
Clinical narrative: Felt faint, had syncope, pale.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test abnormal, Myalgia, Pain, Pyrexia, Rash
Clinical narrative: Patient received vaccination 8/23/16. On 8/26/16 she had muscle aches, pain, fever 102. Still experiencing some muscle ache (taking TYLENOL). Rash 9/6/16, seen Dermatologist and primary (no meds)  9/8/16 - blood work showed UTI (CIPRO).
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection
Clinical narrative: Patient received vaccination 8/23/16. On 8/26/16 she had muscle aches, pain, fever 102. Still experiencing some muscle ache (taking TYLENOL). Rash 9/6/16, seen Dermatologist and primary (no meds)  9/8/16 - blood work showed UTI (CIPRO).
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Pain, Productive cough, Pyrexia
Clinical narrative: Patient received vaccination 8/20/16. On 9/1/16 had productive cough, aches, pain, fever. Went to walk in clinic and received KEFLEX for 10 day tx. On 9/7/16 say primary care and MD was given AZITHROMYCIN (stop warfarin). Patient is recovering.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Received flu vaccine on 9-3-16. Came in on 9-8-16 to report muscle soreness, stiffness, and numbness in arm and finger. Said she could not lift her arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Next day- Upper arm swollen, red an rash in armpit area.
Age: 0.11
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 5 weeks old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-SEP-2016, when the patient was 5 weeks and 4 days old, he/she was vaccinated with PEDVAXHIB, 0.5 ml, route: unknown, (inappropriate schedule of vaccine administration). No adverse effects and no product quality complaint (PQC) reported. No further information provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash morbilliform, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 1 year old male patient. At the time of vaccination, the patient had runny nose. On 19-AUG-2016, the patient was vaccinated with M-M-R II subcutaneously (dose, lot # and expiration date were not reported). In approximately August 2016, reported as within 5 days after vaccination, the patient was covered from head all the way down with a like measles rash. The patient was also running a fever of "102" and a runny nose. The reporter believed that it was not measles it was just the way the patient responded to vaccine. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient sought medical attention (unspecified). The outcome of the events was reported as recovering. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429, expiration date: 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 30.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant concerning a 30-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date:19-OCT-2017 (also reported as 14-APR-2016), dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5  total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On approximately 31-JAN-2016 reported as 8 months ago, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 31-AUG-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported. No adverse effect was 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 registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 05-AUG-2016 or 12-AUG-2016, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M005714, expiration date 03-OCT-2017; strength, dose, frequency and route were unknown). The vaccines were exposed to temperature excursion of 11.5 degree Centigrade for 1 hour and 45 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was 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: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 05-AUG-2016 or 12-AUG-2016, the patients were vaccinated with doses of improperly stored M-M-R II (therapy type rHA (recombinant human albumin), lot # L020189, expiration date 03-JUN-2017; strength, dose, frequency and route were unknown). The vaccines were exposed to temperature excursion of 11.5 degree Centigrade for 1 hour and 45 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2016, the patient was vaccinated with the improperly stored dose ROTATEQ (orally,  it was unspecified which lot # from the following: lot # K0022993 with expiration date 20-JUL-2016, lot # L035511 with expiration date 21-MAY-2017 or lot # L029618 with expiration date 20-MAY-2017; dose was not provided). No adverse event was reported. The vaccine was stored in the maximum temperature of 22.7 degrees of Celsius for 3 hours and 48 minutes and in the minimum temperature of 0.2 degree of Celsius for 31 hours and 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with the improperly stored doses of VARIVAX (it was unspecified which lot # from the following: lot # L039092 with expiration date 06-OCT-2017, lot # L043622 with expiration date 03-NOV-2017 or lot # M004326 with expiration date 25-JAN-2018; dose and route were not provided), VAQTA (it was unspecified which lot # from the following: lot # M011116 with expiration date 17-JUN-2017 or lot # K008333 with expiration date 10-MAR-2017; dose and route were not provided) and M-M-R II (albumin status rHA, it was unspecified which lot # from the following: lot # L003855 with expiration date 05-FEB-2017 or lot # L026553 with expiration date 16-JUL-2017; dose and route were not provided). No adverse event was reported. VARIVAX was stored in the maximum temperature of -5.2 degrees of Celsius for 50 hours and 17 minutes. VAQTA and M-M-R II were stored in the maximum temperature of 22.7 degrees of Celsius for 3 hours and 48 minutes in the minimum temperature of 0.2 degree of Celsius for 31 hours and 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Patient called the pharmacy stating that she was not feeling very well, had body aches, fever, and possible chest pain.  Told patient that this sometimes happens with vaccinations and that she could use some Tylenol to help with the fever and chills.  Also instructed her to call her doctor and let them know what was going on, just to be safe.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeding disorder, Gait disturbance, Hyperacusis, Hypersomnia
Clinical narrative: Extreme nausea, followed by a migraine like headache, sensitivity to light and sound. Intense All Over Muscle ache. 18 hours blurred vision and unsteady gait, patient slept in vehicle, unsafe to drive.  Injection arm unable to lift. Symptoms worsened over 48 hours. Unable to eat, unusual thirst, extreme fatigue. 16 hours after injection patient left work, unable to continue.  Once home patient took 800mg ibuprofen, 10 mg phenegren, 10mg norco and slept for 18.5 hours before pain, nausea and standing stability returned and patient felt confident to function.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Impaired work ability, Injected limb mobility decreased, Migraine, Myalgia
Clinical narrative: Extreme nausea, followed by a migraine like headache, sensitivity to light and sound. Intense All Over Muscle ache. 18 hours blurred vision and unsteady gait, patient slept in vehicle, unsafe to drive.  Injection arm unable to lift. Symptoms worsened over 48 hours. Unable to eat, unusual thirst, extreme fatigue. 16 hours after injection patient left work, unable to continue.  Once home patient took 800mg ibuprofen, 10 mg phenegren, 10mg norco and slept for 18.5 hours before pain, nausea and standing stability returned and patient felt confident to function.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Photophobia, Thirst, Vision blurred
Clinical narrative: Extreme nausea, followed by a migraine like headache, sensitivity to light and sound. Intense All Over Muscle ache. 18 hours blurred vision and unsteady gait, patient slept in vehicle, unsafe to drive.  Injection arm unable to lift. Symptoms worsened over 48 hours. Unable to eat, unusual thirst, extreme fatigue. 16 hours after injection patient left work, unable to continue.  Once home patient took 800mg ibuprofen, 10 mg phenegren, 10mg norco and slept for 18.5 hours before pain, nausea and standing stability returned and patient felt confident to function.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Patient had a breakout of shingles at injection site accompanied by redness and swelling.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Muscle spasms
Clinical narrative: Painful arm where injection was received; worsened by next day and persisted until present time; mother notes pain has subsided but spasms still continue.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Injection site pruritus, Pain in extremity, Swelling
Clinical narrative: SEVERE PAIN IN ARM; SWELLING; ITCHING AT INJECTION POINT; FATIGUE; LOST OF APPETITE.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L037561, expiration date: 29-SEP-2017 (dose and route of administration were not reported). No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of 6.1 degrees Fahrenheit 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several 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 registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 05-AUG-2016 or 12-AUG-2016, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L011084, expiration date 01-APR-2017; strength, dose, frequency and route were unknown). The vaccines were exposed to temperature excursion of -14.7 degree centigrade for 15 minutes; -13.0 degree centigrade for 15 minutes; -11.6 degree centigrade for 15 minutes; -10.2 degree centigrade for 15 minutes; -8.9 degrees centigrade for 15 minutes; -7.9 degree centigrade for 15 minutes; -6.7 degree centigrade for 15 minutes; -5.8 degree centigrade for 30 minutes; -9.8 degree centigrade for 15 minutes and -13.5 degree centigrade for 15 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, site, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route and site and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route, site and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2016, the patient was vaccinated with the improperly stored dose of VAQTA (it was unspecified which lot # from the following: lot # M011116 with expiration date 17-JUN-2017 or lot # K008333 with expiration date 10-MAR-2017; dose and route were not provided). No adverse event was reported. The vaccine was stored in the maximum temperature of 22.7 degrees of Celsius for 3 hours and 48 minutes and in the minimum temperature of 0.2 degree of Celsius for 31 hours and 1 minute. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-JUN-2016, the patient was vaccinated with an incorrectly stored does of VARIVAX lot # L045953 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-JUN-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX lot # L045953 (dose and route of administration were not 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
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L050909, expiration date: 14-JUN-2017 (dose and route of administration were not reported). No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of 6.1 degrees Fahrenheit 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-JUN-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX lot # L045993 (dose and route of administration were not reported).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # reported as M012498, expiry date 09-OCT-2017 (dose was not specified). The administered dose of ROTATEQ was stored at 33.4 Fahrenheit degrees for 52 minutes. There was no previous temperature excursion. 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: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse referring to a 73 years old male patient. The patient had high cholesterol and was allergic to sulfa. Concomitant medication included atorvastatin, omega-3 marine triglycerides and aspirin (manufacturer unknown). On 24-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M005287 with expiration date 08-OCT-2017, 0.5 ml, intramuscular). On 26-AUG-2016, the patient called the physician's office to report redness and swelling in the right upper arm that the vaccine was administered in. The reporter stated that the patient was seen in the office on 26-AUG-2016 and was diagnosed with cellulitis of the right upper arm. Treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event and the causality were not reported. Upon internal review, the event cellulitis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 05-AUG-2016 or 12-AUG-2016, the patients were vaccinated with doses of improperly stored PROQUAD (therapy type rHA, lot # M017335, expiration date 05-OCT-2017; strength, dose, frequency and route were unknown). The vaccines were exposed to temperature excursion of -14.7 degree centigrade for 15 minutes; -13.0 degree centigrade for 15 minutes; -11.6 degree centigrade for 15 minutes; -10.2 degree centigrade for 15 minutes; -8.9 degree centigrade for 15 minutes; -7.9 degree for 15 minutes; -6.7 degree centigrade for 15 minutes; -5.8 degree centigrade for 30 minutes; -9.8 degree centigrade for 15 minutes and -13.5 degree centigrade for 15 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On 30-AUG-2016, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (lot # M010486, expiry date: 25-MAY-2017) via subcutaneous route. Medical assistant reported that the patient received their first dose of ZOSTAVAX (lot # L011529, expiry date: 30-JUL-2016) on 30-JUN-2015. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 20-MAY-2016, the patient was vaccinated with improperly stored M-M-R II (lot # L003855 and expiration date 05-FEB-2017; lot # L026553 and expiration date 16-JUL-2017, albumin status therapy type, dose and route of administration were not reported) and VAQTA (lot # M011116 and expiration date 17-JUN-2017; lot # K008333 and expiration date 10-MAR-2017, dose and route of administration were not reported). The maximum temperature of excursion was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes. The minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. 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 a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that 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 on 20.3 Celsius for 27 hours and 8 Celsius for 30 hours. No adverse effects were reported. No further information provided. A phone was placed to the licensed practical nurse on 07-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. 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 a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that second patient was vaccinated on 08-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. A phone was placed to the licensed practical nurse on 07-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored VAQTA (lot # M011116 and expiration date 17-JUN-2017; lot # K008333 and expiration date 10-MAR-2017, dose and route of administration were not reported). The maximum temperature of excursion was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes. The minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. There were no known adverse effects. No product quality complaint (PQC) was involved. 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 physician referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot# M014929 and expiry date: 27-MAY-2017 (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # M008551 and expiry date: 02-JUN-2018 (dosing and route not provided). No adverse effects and no product quality complaint (PQC) was reported. No further information reported. This is one of the three reports received from the same reporter. Additional information has been requested.