chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Asthenia, Contusion, Fall, Head injury, Malaise
Clinical narrative: This spontaneous report was received from a Nurse, via Pfizer, referring to a 18 year old female patient. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with GARDASIL (dose, route, anatomical location and lot # were not reported. Other suspect therapies included TRUMENBA (0.5 ml, intramuscular injection, apparently in deltoid, lot # M68769). It was also reported that immediately after vaccination, the patient fainted while was sitting on the exam table and she fell off the table and hit her head on the floor, she has a contusion. On 23-JUN-2016, the patient was followed up by her physician and on 27-JUN-2016, she was seen by her doctor for observation and "she was doing well" at that time. No treatment was reported. It was not a product quality complaint involved. The outcome of "the patient fainted while was sitting on the exam table and she fell of the table and hit her head on the floor", contusion and weakness was reported as improved but still ongoing, while the patient recovered from the event of "feeling well". The causality assessment between the events and the suspect therapies was not provided. Additional information is not expected due there is not consent to follow-up.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a Nurse, via Pfizer, referring to a 18 year old female patient. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with GARDASIL (dose, route, anatomical location and lot # were not reported. Other suspect therapies included TRUMENBA (0.5 ml, intramuscular injection, apparently in deltoid, lot # M68769). It was also reported that immediately after vaccination, the patient fainted while was sitting on the exam table and she fell off the table and hit her head on the floor, she has a contusion. On 23-JUN-2016, the patient was followed up by her physician and on 27-JUN-2016, she was seen by her doctor for observation and "she was doing well" at that time. No treatment was reported. It was not a product quality complaint involved. The outcome of "the patient fainted while was sitting on the exam table and she fell of the table and hit her head on the floor", contusion and weakness was reported as improved but still ongoing, while the patient recovered from the event of "feeling well". The causality assessment between the events and the suspect therapies was not provided. Additional information is not expected due there is not consent to follow-up.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Asthenia, Contusion, Fall, Head injury, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a Nurse, via Pfizer, referring to a 18 year old female patient. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with GARDASIL (dose, route, anatomical location and lot # were not reported. Other suspect therapies included TRUMENBA (0.5 ml, intramuscular injection, apparently in deltoid, lot # M68769). It was also reported that immediately after vaccination, the patient fainted while was sitting on the exam table and she fell off the table and hit her head on the floor, she has a contusion. On 23-JUN-2016, the patient was followed up by her physician and on 27-JUN-2016, she was seen by her doctor for observation and "she was doing well" at that time. No treatment was reported. It was not a product quality complaint involved. The outcome of "the patient fainted while was sitting on the exam table and she fell of the table and hit her head on the floor", contusion and weakness was reported as improved but still ongoing, while the patient recovered from the event of "feeling well". The causality assessment between the events and the suspect therapies was not provided. Additional information is not expected due there is not consent to follow-up.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Widespread mild hives on limbs, chest, groin.  Some mild itching on arms and legs.  Went to bed (no difficulty falling asleep); upon awakening at 5:30 AM the following morning, the hives had resolved.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cystitis, Fatigue, Influenza like illness, Kidney infection
Clinical narrative: Based on additional information received on 11-Aug-2016, new company suspect drug influenza vaccine was added. Initial information regarding this clinical sponsored solicited case was received on 03-Dec-2015 from a consumer (patient's daughter) via the Patient Support Program. This case concerns a female patient of an unknown age who developed kidney infection, bladder infection, staph infection, flu-like symptoms, UTI, felt weak, washed out unspecified time duration after receiving Praluent and influenza vaccine. No past drugs, medical history or concurrent conditions were reported. On 27-Oct-2015, the patient received subcutaneous alirocumab at a dose of 75 mg every two weeks via alirocumab prefilled pen (concomitant device) (strength: 75 mg/ml; form, lot/batch number and expiry date: unknown) for hyperlipidemia nec/noc and cholesterol. On the same day the patient received influenza vaccine (Lot/ batch number, expiry date and other therapy details: unknown). The patient's daughter reported that patient received a sample medication from the medical doctor's office and patient experienced flu-like symptoms (onset and latency: unknown) and had kidney, bladder and staph infection (onset and latency: unknown for all events) while on the medication. On follow up it was reported that on an unknown date an unknown duration after receiving therapies, the patient felt weak and washed out, had UTI Action taken: no action was taken in response to the event (Therapy with alirocumab remained ongoing as planned). Corrective treatment: Not reported. Outcome: recovered for UTI, felt weak, washed out and unknown for rest all events. Reporter causality: Unknown for all events w.r.t alirocumab and not reported for influenza vaccine. Company causality: Not associated. Seriousness criteria: important medical event (kidney infection, bladder infection, staph infection and UTI). Additional information was received on 11-Aug-2016 from patient via patient support program: New company suspect drug influenza vaccine was added, height and weight were added, therapy details updated, new events of urinary tract infection, feelings of weakness and washed-out were added and text amended accordingly; Sender's Comments: Sanofi company comment dated 11-08-2016: This case concerns an 84-years old female patient who experienced kidney infection, bladder infection, urinary tract infection and staphylococcal infection after taking Alircoumab. The causal role of the drug with the event cannot be assessed due to lack of adequate information about patient's past medical history, concurrent conditions and concomitant medications. However, patient's advancing and female gender are the confounders for the same.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Staphylococcal infection, Urinary tract infection
Clinical narrative: Based on additional information received on 11-Aug-2016, new company suspect drug influenza vaccine was added. Initial information regarding this clinical sponsored solicited case was received on 03-Dec-2015 from a consumer (patient's daughter) via the Patient Support Program. This case concerns a female patient of an unknown age who developed kidney infection, bladder infection, staph infection, flu-like symptoms, UTI, felt weak, washed out unspecified time duration after receiving Praluent and influenza vaccine. No past drugs, medical history or concurrent conditions were reported. On 27-Oct-2015, the patient received subcutaneous alirocumab at a dose of 75 mg every two weeks via alirocumab prefilled pen (concomitant device) (strength: 75 mg/ml; form, lot/batch number and expiry date: unknown) for hyperlipidemia nec/noc and cholesterol. On the same day the patient received influenza vaccine (Lot/ batch number, expiry date and other therapy details: unknown). The patient's daughter reported that patient received a sample medication from the medical doctor's office and patient experienced flu-like symptoms (onset and latency: unknown) and had kidney, bladder and staph infection (onset and latency: unknown for all events) while on the medication. On follow up it was reported that on an unknown date an unknown duration after receiving therapies, the patient felt weak and washed out, had UTI Action taken: no action was taken in response to the event (Therapy with alirocumab remained ongoing as planned). Corrective treatment: Not reported. Outcome: recovered for UTI, felt weak, washed out and unknown for rest all events. Reporter causality: Unknown for all events w.r.t alirocumab and not reported for influenza vaccine. Company causality: Not associated. Seriousness criteria: important medical event (kidney infection, bladder infection, staph infection and UTI). Additional information was received on 11-Aug-2016 from patient via patient support program: New company suspect drug influenza vaccine was added, height and weight were added, therapy details updated, new events of urinary tract infection, feelings of weakness and washed-out were added and text amended accordingly; Sender's Comments: Sanofi company comment dated 11-08-2016: This case concerns an 84-years old female patient who experienced kidney infection, bladder infection, urinary tract infection and staphylococcal infection after taking Alircoumab. The causal role of the drug with the event cannot be assessed due to lack of adequate information about patient's past medical history, concurrent conditions and concomitant medications. However, patient's advancing and female gender are the confounders for the same.
Sex: F
Vaccine: VARZOS
Symptoms: Implantable cardiac monitor insertion, Local swelling, Pain of skin, Rash vesicular, Ultrasound scan normal
Clinical narrative: This spontaneous report has been received from a 71 year old female consumer reporting on herself. The patient's medical history included heart attack, breast cancer and atrial fibrillation, apart from this drug allergies included sulfa drugs, latex and PERCOCET. Approximately in 2012 (reported as 3-4 years ago), the patient was vaccinated with ZOSTAVAX, injection, subcutaneously, one dose (anatomical location, lot#, and expiration date were not provided). The patient was taking "loads" of concomitant medications. It was stated by the reporter, that on an unknown date in 2016, she received an LINQ (implantable cardiac monitor insertion) implant in her chest. Then, in approximately July 2016 (reported as "almost a month ago"), the patient experienced shingles like symptoms, from her belly button to her left abdomen, there was pain an pinching and also the area was "puffed out" (swelling). The patient reported that she received the vaccine at a supermarket, she did not know information about the physician, and she did not received any treatment. On an unknown date the patient performed a ultrasound but did not find anything and also she sought medical attention. No product quality complaint was involved. The outcome of implantable cardiac monitor insertion was unknown. The outcome of herpes zoster, swelling and pain of skin was reported as not recovered. Upon internal review implantable cardiac monitor insertion was determined to be medically significant. The relatedness between the events and ZOSTAVAX, was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pallor, Skin lesion
Clinical narrative: Patient had several immunizations in both his right and left thigh on 8/10/16. On the morning of 8/18/16, the patient's mother noticed redness on the right leg. It appeared to be itchy. On 8/19/16, he was evaluated in the office by NP and patient had right upper thigh with erythematous raised lesion. + blanchable. No fluctuance and nontender.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from Pfizer, Inc. [2016385284] on 17-AUG-2016 via a consumer. A patient's mother reported her daughter was vaccinated with GARDASIL and experienced alopecia (MARRS # 0901USA02690). The patient's mother reported that according to the internet 2000 girls had the same problem (alopecia) (MARRS # 1608USA010994), 200 died (MARRS # 1608USA011010) and 65 had neurological problems and they were in wheelchairs. No further information was reported. Neurological problems and they were in wheelchairs was considered to be disabling. Additional information is not expected. Information was received via a business partner.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Computerised tomogram, Coordination abnormal, Demyelination, Lumbar puncture
Clinical narrative: Incapacitation for demyelinating disease onset. Loss of mobility, coordination, balance. Pain. Hospitalization for IV steroid treatment.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Pain, Somatosensory evoked potentials
Clinical narrative: Incapacitation for demyelinating disease onset. Loss of mobility, coordination, balance. Pain. Hospitalization for IV steroid treatment.
Sex: M
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial information regarding this clinically sponsored solicited case was received on 28-Mar-2016 from patient's wife via the Patient Support Program. This case concerns a male patient of unknown age who had multitude of health issues, COPD and he came down with influenza B an unknown duration after commencing treatment with influenza vaccine and PRALUENT. No information on any past drug, concomitant drug, medical history or concurrent condition was reported. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiration date: unknown). On an unknown date, the patient received alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date unspecified) for other and unspecified hyperlipidemia delivered via prefilled pen. Patient's wife reported that the patient took the flu shot and came down with influenza B on an unknown date (latency: unspecified), because the patient had COPD (date and latency: unknown) so he was placed in the hospital. The patient was taking TAMIFLU as corrective treatment and was getting better. The reporter informed that the patient expired in April and that he had a multitude of health issues (onset and latency: unspecified). It was unknown whether an autopsy was done or not. It was reported that the patient had two injections up to that point. Action taken: Unknown for both the drugs. Outcome: fatal for multitude of health issues, Recovering for other events. Seriousness criteria: Hospitalization, patient died from multitude of health issues. Reporter causality: Unknown with respect to alirocumab and not reported with respect to influenza vaccine for multitude of health issues and unknown for both the drugs for other events. Company causality: Not associated with respect to both the drugs. Additional information was received on 23-May-2016 from patient's wife: new event "multitude of health issues" added, action taken updated, form of alirocumab added and text updated accordingly. Reported Cause(s) of Death: multitude of health issues.
Sex: U
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from Pfizer, Inc. [2016385284] on 17-AUG-2016 via a consumer. A patient's mother reported her daughter was vaccinated with GARDASIL and experienced alopecia (MARRS # 0901USA02690.) The patient's mother reported that according to the internet 2000 girls had the same problem (alopecia) (MARRS # 1608USA010994), 200 died and 65 had neurological problems and they were in wheelchairs (MARRS # 1608USA011013). No further information was reported. Additional information is not expected. Information was received via a business partner.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Acne varioliformis, Blood aluminium, Epistaxis, Fatigue, Malaise
Clinical narrative: Epistaxis, nausea, fatigue, malaise, acne varioliformis.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Metal poisoning, Nausea
Clinical narrative: Epistaxis, nausea, fatigue, malaise, acne varioliformis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling right thigh concerning for possible cellulitis. Seen in Urgent Care and started on Clindamycin. Follow-up with PCP on 8/22 showed significant improvement ? strong site reaction to KINRIX vs. cellulitis.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain, Periarthritis, X-ray
Clinical narrative: Limited range of motion of left arm, pain, frozen shoulder thus far treatment is physical therapy, but surgery is recommended.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Feeling cold, Headache, Myalgia, Pyrexia
Clinical narrative: Reaction was immediate. Intense chills, severe backache extending up to neck. Dull headache, muscle aches. The rest of day: occasional chills, continued backache, low grade fever, muscle aches (101.1). Overnight: headache and backache intense enough to interfere with sleep, even with acetaminophen. Ongoing backache after 24 hours (time of this reporting).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse / office manager 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 in February 2016, the patient was administered the first dose of GARDASIL 9 intramuscularly (lot # and expiration date were not reported). On an unknown date in May 2016, the patient received the second dose of GARDASIL 9 intramuscularly (lot # and expiration date were not reported) and on 17-AUG-2016, the third dose of GARDASIL 9 intramuscularly (lot # and expiration date were not reported) (coded as inappropriate schedule of vaccine administered). There was no adverse event reported. Additional information is not expected because there was no consent to contact nurse.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L031602, expiry date 20-OCT-2017)(strength, dose and route of administration were not reported). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a multiple unspecified patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L044530 and expiry date 09-FEB-2017. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Muscle spasms
Clinical narrative: This spontaneous report as received from a patient's wife refers to a 63 year old male patient. The patient's concurrent conditions included high blood pressure and leg spasms. He did no have any drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ZESTRIL. On an unknown date, the patient had unspecified blood work done due to leg spasm and the results came back positive for antinuclear antibody (ANA) titer. There was no treatment given for the event. The outcome of the event was unknown. The patient received medical attention via office visit. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
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 and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 18-AUG-2016, the patient was vaccinated with expired dose of GARDASIL, dose 0.5 ml, subcutaneously (expiration date 22-JUN-2016) (strength, anatomical location, lot# were unknown). No adverse effect was reported. No product quality complaint was involved. 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 registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored ROTATEQ lot # M012495 with expiration date: 09-OCT-2017, orally (dose was not reported). Administered doses of ROTATEQ underwent temperature excursion at 66 Fahrenheit degrees, for 945 minutes. Previous temperature excursion was at 50 Fahrenheit degrees, for 750 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Unevaluable event
Clinical narrative: No adverse effects caused by this event.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. ON 16-AUG-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L042266, expiration date 27-OCT-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursions was reported. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information was received from a nurse regarding multiple unspecified patients (demographics not provided). The nurse reported that multiple unspecified patients received ZOSTAVAX (19400 PFU) and (crm197) PREVNAR concomitantly on unspecified dates (lot numbers, dosages, and routes of administration not provided). The nurse also reported that multiple different unspecified patients received ZOSTAVAX and PNEUMOVAX 23 concomitantly on unspecified dates (lot number, dosages, and routes of administration not provided). The nurse also reported that multiple different unspecified patients on unspecified immunosuppressants have received ZOSTAVAX on unspecified dates (lot numbers, dosages, and routes of administration not provided). No adverse effects were reported for any of these unspecified patients. The nurse mentioned that multiple different unspecified patients developed a "shingles rash" on their trunks an unspecified time after receiving ZOSTAVAX (lot numbers, dosages, and routes of administration not provided). The nurse also mentioned that multiple different unspecified patients developed redness around the injection site an unspecified time after receiving ZOSTAVAX (lot number, dosages, and routes of administration not provided). No further information was provided. The outcome of the "shingles rash" and redness around the injection site were not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incoherent, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reaction and concomitant medications were reported. On an unknown date, multiple unspecified patients were inadvertently vaccinated with VARIVAX (dosing details, lot # and expiry date were not reported). It was reported that the vaccines were exposed (excursion 1) to the temperature of -4.2C during a time frame of 1 hour 6 minutes. It was reported that the  vaccines were exposed (excursion 2) to the temperature of -2C during a time frame of 2 hours 20 minutes. No previous temperature excursion was reported. No adverse effect were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 1st dose of GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided). The patient's concomitant medications were not reported. It was stated that on an unknown date (reported as "one year later"), the patient was vaccinated with the 2nd dose of GARDASIL 9. Furthermore, no adverse event was reported and no product quality issue was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Dyspnoea, Rash pruritic, Urticaria, Vomiting
Clinical narrative: Patient received vaccines and exited the room to sit in the waiting room. Pt began wheezing, coughing and on exam he had difficulty breathing w/wheezes one exam. He was treated w/albuterol/0.5mg and 1 unit dose ATROVENT and given PRELONE by mouth. He vomited the PRELONE via nebulizer. He then developed an urticarial rash on face, chest, and back w/associated pruritis. Child given BENADRYL. His breathing improved and the urticaria was in the process of resolving
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Wheezing
Clinical narrative: Patient received vaccines and exited the room to sit in the waiting room. Pt began wheezing, coughing and on exam he had difficulty breathing w/wheezes one exam. He was treated w/albuterol/0.5mg and 1 unit dose ATROVENT and given PRELONE by mouth. He vomited the PRELONE via nebulizer. He then developed an urticarial rash on face, chest, and back w/associated pruritis. Child given BENADRYL. His breathing improved and the urticaria was in the process of resolving
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 month old patient of unspecified gender. The medical assistant reported that the  patient, who date of birth was 27-APR_2010, received the 1st dose of VARIVAX (confirmed Lot # 1105Z and exp., 25-AUG-2012) on 13-APR_2011 (dose unspecified), this was outside the recommendations per the VARIVAS prescribing information (inappropriate age of vaccine administration; product use in unapproved population). No adverse effects reported. No further information was provided. No product quality completed was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse 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 an unknown date in 2013, the patient received the first dose of GARDASIL injection, intramuscularly (dose, lot #, expiry date and anatomical location were not specified). In September 2013, the patient was vaccinated was vaccinated with the second dose of GARDASIL injection, intramuscularly (dose, lot #, expiry date and anatomical location were not reported). In December 2013, the patient was administered with the third dose of GARDASIL injection, intramuscularly (dose, lot #, expiry date and anatomical location were not provided). The reporter stated that the patient's parents were concerned that GARDASIL obtained from the pharmacy and transported to the physician's office might had been improperly stored. The parents  were concerned about the second and the third dose, as the vaccines were stored in their car. No adverse events were reported. Product quality complaint (PQC) was no involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Eye inflammation, Iritis
Clinical narrative: This spontaneous report as received from a 61 year old pre-diabetic patient refers to herself. The patient had an allergy to preservatives in local anesthesia. On 15-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported). Concomitant therapies included vitamin B (unspecified) drops and vitamin D (unspecified) drops. On approximately 12-NOV-2015 (reported as 4 weeks after vaccination), the patient experienced iritis / inflammation of eye. This condition recurred 4 times. In July 2016, the patient noticed her right eye had a twitch that was coming and going intermittently. No laboratory diagnostic studies were performed. An unspecified treatment was given for the adverse events. The outcome of events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a registered nurse who is also the patient's mother refers to her son a 16 month old male patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 29-MAR-2008, the patient was vaccinated with the first dose of inactivated VAQTA (strength, dose, route of administration, lot number and expiration date were not provided). Then on 06-AUG-2008, the patient was vaccinated with the second dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported), which was considered as a product use issue, because the doses were administered within a shorter interval than it was recommended in the prescribing information. Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Seemed to develop a bruise around the injection site initially. But then turned bright red and slightly warm to the touch. Redness is about 3 inches across in diameter, somewhat swollen but not particularly painful.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Nausea, Vomiting, Abdominal Pain.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Laceration
Clinical narrative: Patient fell forward to floor resulting in a cut to his chin.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions and concomitant medications was reported. In October 2015, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (dose, lot #, expiry date and anatomical location were not specified). On 05-AUG-2016, the patient was vaccinated with a second dose of ZOSTAVAX injection, subcutaneously, lot # M018593, expiry date 28-JUN-2017 (dose and anatomical location were not specified). No adverse effects were reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD therapy type (albumin status): rHA, lot # L031602, expiry date 18-FEB-2017, lot # M004892, expiry date 25-JUL-2017 (strength, dose and route of administration were not reported). No adverse event was 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: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L042266, expiration date 27-OCT-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of the 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 a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored does of VARIVAX (lot # L042266 expiration date 27-OCT-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored dose of PROQUAD (lot # L050907, expiration date 14-JUL-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report was received from an approximately 76 year old male retired pharmacist reporting on himself. The patient had no pertinent medical history and no known drug reactions or allergies. In approximately 2007, reported as "nine years ago", the pharmacist was vaccinated with a dose of ZOSTAVAX, 19400 PFU, 0.65 ml, subcutaneous (lot number and expiration date were not provided). There was no concomitant medication. Also in approximately 2007, reported as "nine years ago", the pharmacist experienced herpes zoster following the administration of ZOSTAVAX. The pharmacist also experienced itching on his right shoulder that went halfway up his back. The physician prescribed prednisone (manufacturer unknown) as treatment. There were no laboratory diagnostics studies performed. On an unknown date, the pharmacist recovered. The pharmacist did not assess the relationship of the event To ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives that started don left arm near injection site. Then more hives on Right arm, legs, face. Mildly itchy.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II of lots L034737 with expiry date 09-SEP-2017, L040960 with expiry date 05-MAR-2021, L036851 with expiry date 23-SEP-2017, L049455 with expiry date 03-DEC-2017 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTP
Symptoms: Abdominal discomfort, Crying
Clinical narrative: Persistent crying, gastric upset.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Rash
Clinical narrative: LOCALIZED RASH.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Edema, redness, and warmth from elbow bend to shoulder. Patient's caregiver gave "antihistamine and NSAID".
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site swelling, Oedema, Pruritus, Pyrexia
Clinical narrative: The patient received PREVNAR 13 0.5ml IM today in Left Deltoid. aaox3, nad, Left ar on proximal humeral have edema, pink fading erythema, warm area that cover the circumference of the arm 3 inches wide. No suppuration, no pustula, no fluctuation under skin. Local reaction to PREVNAR 13, will be treated with ice for 20 minutes tid, for 2 days, TYLENOL 500 mg tid for 3 days and Tramadol q8hrs prn for pain. Symptoms: Fever and redness, itching, swelling at injection site. Treatment: Acetaminophen 500 mg tid, Tramadol 50 mg prn.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: The patient received PREVNAR 13 0.5ml IM today in Left Deltoid. aaox3, nad, Left ar on proximal humeral have edema, pink fading erythema, warm area that cover the circumference of the arm 3 inches wide. No suppuration, no pustula, no fluctuation under skin. Local reaction to PREVNAR 13, will be treated with ice for 20 minutes tid, for 2 days, TYLENOL 500 mg tid for 3 days and Tramadol q8hrs prn for pain. Symptoms: Fever and redness, itching, swelling at injection site. Treatment: Acetaminophen 500 mg tid, Tramadol 50 mg prn.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to two unspecified patients of unknown age and gender, who on an unknown dates were vaccinated with an improperly stored doses VAQTA (lot# L045713, expiry date 14-JAN-2017) (dose and route were not reported). No adverse effects were reported. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unspecified number of patient of unknown age and gender, who on an unknown date were vaccinated with improperly stored dose PEDVAXHIB (lot # L038502, expiry date 16-AUG-2018) (dose and route were not reported). No adverse effects were reported. No further information was 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 as received from a registered nurse, refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# reported as L005559, expiry date 15-APR-2017)(dose and route were not reported). No adverse effects were reported. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot number as lot validation has been received M014310, expiration date: 26-MAY-2017 (strength, dose, route of administration were not reported). The administered dose of ZOSTAVAX experienced temperature excursion of 35 degree Fahrenheit for unknown time, reported as "worse case cumulative 35 hours', on unknown date. There was no data logger involved. No adverse events were reported. Additional information is not expected because there was no consent to contact.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also provided as an administrator) refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M012985, expiration date: 12-SEP-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also provided as an administrator) refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M017337, expiration date: 05-OCT-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The medical assistant reported that a patient was inadvertently administered a dose of VARIVAX (lot # M003441 with expiration date: 19-JAN-2018) instead of an intended dose of ZOSTAVAX on 27-JUL-2016. The medical assistant reported that the nurse who administered the VARIVAX mistakenly thought VARIVAX was for prevention of shingles. No adverse effect reported. No product quality complaint was involved. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also provided as an administrator) refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # L050956, expiration date: 17-DEC-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a male patient (pharmacist) of unknown age via field employee, regarding himself. Information regarding patient's medical history, current conditions, drug reactions/allergies and concomitant medications information were unknown. About a year and a half ago in 2015, the patient was vaccinated with ZOSTAVAX (dosing details not provided). Patient reported that on 16-AUG-2016, he experienced tingling. It was unknown if any treatment was provided for the adverse event. Patient stated that he was recovering and was scheduled to see his doctor on 18-AUG-2016. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was administered improperly stored RECOMBIVAX HB (lot# M010671, expired date 02-JUN-2018, dose unknown) intramuscularly. The vaccine was exposed to multiple excursions totaling 10 hours and 55 minutes to a low temperature of 32 Fahrenheit degree (F). No adverse effect was reported. 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 certified medical assistant, and refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043214, expiration date 30-AUG-2017 (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. The temperature excursion was 30.6F during 25 hours, and was detected by a data logger. The reporter stated that there were no previous temperature excursions. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 07-JUL-2016 from a medical assistant who reported that on unspecified dates, an unspecified number of patients received an improperly stored dose of RECOMBIVAX HB 2.5/0.5 (lot# L038018, expiration date 13-SEP-2017), ROTATEQ (lot# L033543, expiration date 30-MAY-2017) or VAQTA (lot# M009377, expiration date 17-JUN-2017). Temperature for all products was reported as 0.9C and time frame was seven hours. Call was because of a data logger. No adverse effect reported. Additional information has been requested.