chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Disorientation, Dizziness, Hypoaesthesia, Overdose, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of feet in a 38-year-old female patient who received RABAVERT. Co-suspect products included HYPERRAB. Previously administered products included antibiotics (she had weird reaction to antibiotics). Concurrent medical conditions included rabies. On 1st December 2015, the patient received RABAVERT and HYPERRAB. On 1st December 2015, an unknown time after receiving RABAVERT, the patient experienced overdose. In December 2015, the patient experienced swelling of feet and dizziness. On an unknown date, the outcome of the swelling of feet, dizziness and overdose were unknown. It was unknown if the reporter considered the swelling of feet and dizziness to be related to RABAVERT. Additional details were received as follows: The reporter herself was the patient. The reporter had weird reaction to antibiotics. The reporter called to ask about rabies vaccine because she had rabies vaccines in emergency room due to being exposed to rabies. On 1st December 2015 (day before yesterday from reporting date), the patient received RABAVERT and HYPERRAB in the emergency room. The patient received 4 shots in total of rabies vaccine, which led to overdose. It was not clear how many doses of RABAVERT and how many doses of HYPERRAB were administered to patient. The reporter inquired about what could be the adverse events of both RABAVERT and HYPERRAB, and was informed that RABAVERT was divested to GlaxoSmithKline. She was told to contact the manufacturer of HYPERRAB for information about the same. In December 2015, less than a week after receiving RABAVERT and HYPERRAB the patient experienced feet swelled up twice the size, dizziness, could not feel her hand and did not know where she was. The patient did not know which medication caused her symptoms and is concerned about receiving more injections of these medications. Number was provided for GlaxoSmithKline, and attempted to connect the patient with a GlaxoSmithKline representative for assistance. The transfer could not take place as the message said that the GSK response center is temporarily closed and to call at a later time. The reporter was informed of this and told to call GlaxoSmithKline later. The reporter stated that she would like to find out if it was dangerous to continue with these rabies medications. The reporter was informed to contact her physician as her physician could advise her on her condition and treatments.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of urticaria in a 14-year-old male patient who received FLUARIX QUADRIVALENT (batch number 37CC4, expiry date 30th June 2016). On 9the December 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 10th December 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced urticaria and injection site urticaria. On an unknown date, the outcome of the urticaria and injection site urticaria were not recovered/not resolved. The reporter considered the urticaria and injection site urticaria to be possible related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reported injection site of FLUARIX QUADRIVALENT vaccine was left arm. The patient experienced severe urticaria on his trunk, back, torso and arm (injection site urticaria). The reported adverse events were worsened and unresolved throughout the day. The patient visited the reporting healthcare professional twice but no hospitalization was required.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L023230 with expiration date 28-JUL-2017 or lot #L007560 with expiration date 15-JUN-2017 or lot #L013429 with expiration date 21-JUL-2017). There was no adverse effect reported. This is one of several reports received from the same source. 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 licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 29-SEP-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 45 year old patient of unknown age. No pertinent or historical conditions were reported. On an unknown date, the patient was inadvertently administered a dose of ZOSTAVAX (strength, dose and route unknown) instead of (Merck) VARIVAX. No adverse effects were reported. Additional information is not expected since the reporter refused to be contacted.
Age: 16.0
Sex: U
Vaccine: HEPA, MEN
Symptoms: Injection site pain, Ocular hyperaemia
Clinical narrative: Information has been received from a medical assistant referring to a 16 year old patient of unknown gender. There was no pertinent medical history. The patient was allergic to penicillin (unspecified) and egg. On 18-NOV-2015, the patient was vaccinated with first dose of VAQTA (lot number L015460, expiration date 20-JUL-2017, dose and route unknown) in unspecified arm. Concomitantly, the patient received an unspecified meningococcal vaccine (lot number, dose and route unknown) in the same arm. On the same day, the patient experienced a sore arm at injection site and red eyes later in the day of vaccination. The patient sought medical attention via contacting physician's office by the parent. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and VAQTA was unspecified. This is one of two reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: FLUX, HEPA
Symptoms: Headache, Injection site pain, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a medical assistant referring to a 13 year old patient of unknown gender. There was no pertinent medical history. The patient was allergic to penicillin (unspecified). On 18-NOV-2015, the patient was vaccinated with first dose of VAQTA (lot number L015460, expiration date 20-JUL-2017, dose and route unknown) in unspecified arm. Concomitantly, the patient received an unspecified flu vaccine (lot number, dose and route unknown). On the same day, the patient experienced a sore arm at injection site and red eyes later in the day of vaccination. The patient also had additional symptoms including a fever of 102F, sore throat and headache. The patient sought medical attention via contacting physician's office by the parent. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and VAQTA was unspecified. This is one of two reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 02-DEC-2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number L028281 and expiration date 28-OCT-2016). There was no concomitant therapy. On an unknown date in December 2015 (reported as following the ZOSTAVAX injection), the patient experienced a rash at the injection site. It was also stated that the patient was to receive cortisone shots for back pain, which started on an unknown date. There were no lab diagnostics studies performed. The rash at the injection site resolved after a few days, on an unknown date in December 2015. The outcome of the event of back pain was not reported. The patient sought medical attention (she called the pharmacist). The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 02-DEC-2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number L028281 and expiration date 28-OCT-2016). There was no concomitant therapy. On an unknown date in December 2015 (reported as following the ZOSTAVAX injection), the patient experienced a rash at the injection site. It was also stated that the patient was to receive cortisone shots for back pain, which started on an unknown date. There were no lab diagnostics studies performed. The rash at the injection site resolved after a few days, on an unknown date in December 2015. The outcome of the event of back pain was not reported. The patient sought medical attention (she called the pharmacist). The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Comments: LEFT Deltoid, s/p anthrax injection, 10 cm by 10 cm warm, erythematous rash, with well demarcated borders, no active discharge, with TTP noted in a triangle pattern beginning at injection site with Tenderness approx 3 cm both medial and lateral of injection extending distally 4 cm with tapered tenderness. No systemic symptoms.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Nerve conduction studies
Clinical narrative: Guillain Barre Syndrome requiring IVIG and plasmapheresis treatment.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Plasmapheresis
Clinical narrative: Guillain Barre Syndrome requiring IVIG and plasmapheresis treatment.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Pain
Clinical narrative: Tired, achy, went to bed early.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: SORE AND PAIN AT SITE INJECTION.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Severe Shoulder pain at the time of injection.  Pain improved but recently worsening.  Sometimes radiating to elbow and shooting pain center of shoulder when lifting arms over head to remove clothing. Also a general all over muscle pain that comes and goes started over past few days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, redness at injection site approximately 6 inches long.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient came by pharmacy 12/19/15 and said arms still hurts from shot and inquired what needs to do.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Arthritis, Asthenia, Cold sweat, Dizziness
Clinical narrative: I felt very weak, painful joints, hypotensive, dizzy, cold and clammy and an overwhelming sense of not feeling well, like my immune system was being attacked. I called the employee clinic and reported it to RN and she said to see my primary. I took Motrin, Vit. C and drank lots of fluids and felt better in a few days except my Rt Knee remained inflamed. Reported to my Dr on Dec. 4 when my rt Knee symptoms persisted and a MRI shows an inflammatory process of my rt knee, unable to walk properly, constant rt knee pain and unable to work I took home.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Gait disturbance, Hypotension, Impaired work ability, Malaise, Nuclear magnetic resonance imaging abnormal
Clinical narrative: I felt very weak, painful joints, hypotensive, dizzy, cold and clammy and an overwhelming sense of not feeling well, like my immune system was being attacked. I called the employee clinic and reported it to RN and she said to see my primary. I took Motrin, Vit. C and drank lots of fluids and felt better in a few days except my Rt Knee remained inflamed. Reported to my Dr on Dec. 4 when my rt Knee symptoms persisted and a MRI shows an inflammatory process of my rt knee, unable to walk properly, constant rt knee pain and unable to work I took home.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: X-ray limb
Clinical narrative: I felt very weak, painful joints, hypotensive, dizzy, cold and clammy and an overwhelming sense of not feeling well, like my immune system was being attacked. I called the employee clinic and reported it to RN and she said to see my primary. I took Motrin, Vit. C and drank lots of fluids and felt better in a few days except my Rt Knee remained inflamed. Reported to my Dr on Dec. 4 when my rt Knee symptoms persisted and a MRI shows an inflammatory process of my rt knee, unable to walk properly, constant rt knee pain and unable to work I took home.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Pyrexia, Tremor
Clinical narrative: Chills, fever, shakiness, weakness x 6 hr.
Age: 58.0
Sex: M
Vaccine: FLUC3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Pain
Clinical narrative: Upon injection, patient immediately complained of pain and asked if that was normal. I told him it was possible to have some pain/discomfort at injection site, and sometimes the arm may be sore afterwards for a day or so. He said he'd gotten shots before but never had any pain. There was a small drop of blood which I had covered with a bandaid. I uncovered the area and sat with him for a few minutes to see if there were any visible changes. There was no evidence of redness, irritation or swelling. I asked the patient if he wanted to put some ice on it and he refused. I got another bandaid for the patient - although there was no more bleeding- and placed the new bandaid over the area. I asked patient to please contact the pharmacy if he continued to have problems or it worsened, and he left the pharmacy. We never heard from him again.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Activities of daily living impaired, Pain, Pain in extremity
Clinical narrative: Shooting pain in left arm that is inconsistent with any medical condition other than the vaccine.  Lasting from onset to present.  Limits activities. Flares up upon exertion of deltoid muscle.  Very unusual because I do not usually have pain or complain of pain.
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: Angioedema
Clinical narrative: Angioedema of bilateral breasts, labia, bilateral lower extremities, face, right upper extremity.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Patient denies constantly aching at the vaccinated site. Denies any swelling or bruising. Patient has tried to massage it but the pain has not improved. Patient called in to pharmacy 12/19/2015 5:30pm to report to me that he had experienced pain ever since he received the vaccination. I advised the patient take Ibuprofen/Tylenol to help with the pain and for him to follow-up with his PCP. I also advised him to call me back if condition worsen or if he has any other questions.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Flatulence
Clinical narrative: Flatulence / Diarrhea / Loose Stools.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Large, red, swollen approx 6" wide x 4" long (oval) around the injection site. Very sore to the touch.  Very hard knot around injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: At the site w/injection, patient noticed mild itchiness, some soreness, redness and swelling. It started 7 days after vaccine administration.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelled, reddish arm, elbow-shoulder. BENADRYL-not sure if effective yet.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Lymphadenopathy
Clinical narrative: Patient followed up with pharmacy a week after receiving immunizations to state she had swollen lymph nodes in arm that received flu shot and that she couldn't raise that arm initially. And she was in bed for several days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Left arm discomfort occurred the morning after vaccine administration. Discomfort subsided but the discomfort has returned. Arm has been sore for off and on since vaccine was administered in July.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein, Full blood count, Metabolic function test, Nausea, Pain in extremity
Clinical narrative: Pain in injected arm 1 hour after administration with worsening pain over 24 hours, nausea, fever.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Pain in injected arm 1 hour after administration with worsening pain over 24 hours, nausea, fever.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Tremor
Clinical narrative: Possible seizure or syncope, patient wasn't able to stand for a second, then when mom picked her up she felt a little shake from patient. Spoke to mom about a hour later and next day, she said patient is fine, patient acted normal and also slept fine.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Acne, Pain, Pruritus, Scab
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 65 year old female patient. The patient's concurrent conditions included allergy to codeine. On 03-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L029482, expiration date: 06-NOV-2016), dose and route were not reported. Other suspect therapies included FLUZONE and PREVNAR 13; both administered on 03-DEC-2015 at an unknown dose and unknown route. On 12-DEC-2015, the patient began to experience "painful, itchy spots" on her torso and on the following morning (reported as 14-DEC-2015), the spots like "pimples", remaining mostly on the torso. She sought medical attention by calling the pharmacy. The pharmacist reported that as of 15-DEC-2015, the patient stated that the spots have mostly crusted over. The pharmacist stated, that the patient has not visited her primary care physician yet, and probably would not. No treatment was given for the events. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX, FLUZONE and PREVNAR 13 was not provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a 5 year old male patient. No information regarding the patient's medical history and concomitant medications was reported. On 02-NOV-2015 at 02:42 pm, the patient was vaccinated with an improperly stored dose (it was patient's first dose) of PROQUAD (Merck) lot # K009891, expiration date 11-JAN-2016, subcutaneous in the right arm (strength and dose were not provided). Concomitant vaccinations included the first dose of KINRIX lot # reported As S4L2R, intramuscular in the left arm and the first dose of influenza virus vaccine (unspecified) lot # reported as DF92Z, intramuscular in the left arm (both given on the same time as the suspect vaccine). There was no illness at the time of vaccination. No adverse effects were reported. The patient was vaccinated at public health clinic/hospital and the vaccine was purchased with public funds. This is one of the several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patients of unknown age and gender. Since 01-OCT-2015, the patients were vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported; lot#K007262 expiration date:25-NOV-2015, L012215 expiration date: 13-JAN-2017), which were exposed to temperatures outside of the recommended range. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 02-OCT-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist who was reporting on behalf of the patient's husband refers to an approximately 74 year old female patient with no pertinent medical history. On 12-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # I011533, expiration date: 20-JUL-2016, 0.65 ml, subcutaneously. The patient had no concomitant therapies. On an unknown date in 2015, the patient had a recent case of shingles. The patient sought medical attention, she called pharmacist and nurse practitioner. On 08-DEC-2015, nurse practitioner prescribed to the patient VALTREX 1 gram, three times a day for 7 days. No lab diagnostics studies were performed. Varicella zoster virus (VZV) packet was declined by pharmacist. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 18 year old male patient. No patient's concurrent conditions, medical history or concomitant medications were reported. On 08-JUL-2015, the patient was vaccinated with a first dose of GARDASIL 9 lot # K026247, expiry date 29-JAN-2017, 0.5 ml, intramuscularly in the right arm. On 28-NOV-2015, the second dose administered was GARDASIL lot # K010215, expiry date 05-MAY-2017. in the right arm (dose and route were not reported). No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The causality assessment between adverse event of interchange of vaccine products and suspect therapies was not provided. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. The reporter stated that, on 16-DEC-2015, the patient was vaccinated with the second dose of PNEUMOVAX 23, 0.5 ml intramuscularly, with lot number L019836 and expiry date 24-MAR-2017, instead of PREVNAR 13. The patient had received the first dose of PNEUMOVAX 23 on an unspecified date in June 2014. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Approximately in 2014, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot# were not reported). The reporter stated that the patient had recently outbreak of herpes zoster, approximately in 2015. The patient sought medical attention contacting doctor's office. The outcome of herpes zoster was reported as not recovered. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 16-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J004311 and expiration date on 12-JUN-2014, (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 72 year old female patient refers to herself. The patient stated that she has had shingles twice, in 1996 and in 2002 (unspecified dates). On an unknown date in August 2012, the patient was vaccinated with ZOSTAVAX (first dose, subcutaneous). On 08-DEC-2015 (also reported as three years later), after developing a painful rash around her eyes she was diagnosed with shingles again (herpes zoster and drug ineffective). No treatment was given for the event. The outcome was reported as not recovered/not resolved. The patient sought medical attention by visiting the physician's office. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 10-DEC-2015, the patients were inadvertently vaccinated with expired doses of MMRII (lot # J014872, expiry date 21-NOV-2015; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, IPV, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a 5 year old female patient. No information regarding the patient's medical history and concomitant medications was reported. On 17-SEP-2015 at 02:46 pm, the patient was vaccinated with an improperly stored dose (it was the patient's first dose) of PROQUAD (Merck) lot # K008185, expiration date 05-DEC-2015, subcutaneous in the right thigh (strength and dose were not provided). Concomitant vaccinations included the fifth dose (reported as number of previous doses: #4 else) of IPV (unspecified) lot # reported as L4694, intramuscular in the left thigh and the first dose of HAVRIX pediatric dose, lot # reported as NK747, intramuscular in the right thigh (both given on the same time as the suspect vaccine). There was no illness at the time of vaccination. No adverse effects were reported. The patient was vaccinated at public health clinic/hospital and the vaccine was purchased with public funds. This is one of the several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 16 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 02-NOV-2015 at 02:59 PM., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) injection, lot# K026385, subcutaneously (dose and expiration date were not reported) that was improperly stored. The patient's concomitant vaccines given on the same day and time included HAVRIX, (manufacturer reported as GlaxoSmithKline, first dose, intramuscularly) and FLUARIX (first dose, intramuscularly). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration and indication were not reported, lot # L013063, expiration date: 14-APR-2017, L001330 expiration date: 13-JAN-2017; L010146 expiration date: 24-MAR-2017; L020000 expiration date: 02-JUN-2017). No adverse events reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unspecified dates, the patients were inadvertently vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). Concomitant therapy was not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, frequency, route of administration and indication were not reported, lot # K022445 expiration date: 17-OCT-2016, L013545 expiration date: 17-OCT-2016, L030585 expiration date: 10-FEB-2017). No adverse events reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 07-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two 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 medical assistant refers to an unknown number of patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route of administration, lot number, expiration date and therapy type were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two reports received from the same reporter. 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 nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot number# reported as L014415 expiration date: 25-JUL-2017, L013429 expiration date: 21-JUN-2017). No adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 10-DEC-2015, the patient was inadvertently vaccinated with ZOSTAVAX (lot number K011002 and expiration date 07-NOV-2015, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
Sex: F
Vaccine: HPV4
Symptoms: Cardiac disorder, Lung disorder, Tachycardia
Clinical narrative: This spontaneous report was received from a consumer via company representative referring to a her daughter: female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, frequency, route of administration and indication were not reported). On an unknown date, the patient developed tachycardia and experienced cardio-pulmonary issues. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 12 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 24-AUG-2015 at 01:43 PM, the patient was vaccinated with the second dose (reported as #1 given elsewhere) of (Oka/Merck) VARIVAX injection, lot # L010145, subcutaneously in the left arm (dose and expiration date were not reported) that was improperly stored. The patient's concomitant vaccines given on the same day and time included GARDASIL injection, lot # K011562, intramuscularly in the right arm (dose and expiration date were not provided). No adverse effects were reported.  This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-DEC-2015, the patient was vaccinated with improperly stored doses of ROTATEQ (orally, lot # L025598, expiration date 13-JAN-2017; dose was not reported) and PEDVAXHIB (lot # L030865, expiration date 07-JUN-2018; dose and route of administration were not reported). NO adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 years and 2 months old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 25-NOV-2015, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ML (route of administration, lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 7 year old female patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 17-SEP-2015 at 02:28 PM, the patient was vaccinated with the first dose of VARIVAX, injection, lot # L010145, subcutaneously in the right arm (dose and expiration date were not provided) that was improperly stored. The patient's concomitant vaccines given on the same date and time included HAVRIX (ped-adol, first dose, intramuscularly in the right arm) and poliovirus vaccine inactivated (unspecified) (manufacturer reported as Sanofi, fifth dose (4 doses given elsewhere), intramuscularly in the left arm). No adverse effects were reported.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: This spontaneous report was received from a 82 year old female patient with depression and drug reactions or allergies to OTC cold medicines that contain epinephrine and some unspecified antibiotics reporting on herself. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included PARNATE. On an unknown date the patient experienced difficulty sleeping. The outcome of the event was not reported. Relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there is no consent to contact the reporter.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 13 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 24-AUG-2105 at 08:49 AM, the patient was vaccinated with the second dose (reported as #1 elsewhere) of (Oka/Merck) VARIVAX injection, lot # L010145, subcutaneously in the right arm (dose and expiration date were not reported) that was improperly stored. The patient's concomitant vaccines given on the same date and time included HAVRIX (ped-adol, intramuscularly in the left arm) and poliovirus vaccine inactivated (unspecified) (manufacturer reported as Sanofi, 4 doses given elsewhere, intramuscularly in the left arm). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-DEC-2015, the patient was vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L025598, expiration date 13-JAN-2017; dose was not reported) and PEDVAXHIB (lot # L030865, expiration date 07-JUN-2018; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 16 year old female patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 01-SEP-2015 at 08:40 AM., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) injection, lot # L010145, subcutaneously in the right arm (dose and expiration date were not provided) that was improperly stored. The patient's concomitant medications given on the same date and time included IPOL (manufacturer reported as Sanofi, intramuscularly in the right arm, fifth dose (4 doses given elsewhere)) and HAVRIX (intramuscularly in the right arm). No adverse effects reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
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 patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored GARDASIL lot # K006117, expiration date 14-JAN-2017 and lot # K006124 expiration date 02-FEB-2017 (dose, route and site of administration were not reported). There were no adverse symptoms reported. No product quality issue was involved. 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 registered nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored VAQTA lot # K018181, expiration date 04-JUN-2017 (dose, route and site of administration were not reported). There were no adverse symptoms reported. No product quality issue 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 medical assistant refers to unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of improperly stored ROTATEQ (dose was not reported) lot # L008054, expiration date 30-NOV-2016 orally. No adverse effects have been reported. This is one of several 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 medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored RECOMBIVAX HB (dose and route were not reported) lot # L016427, expiration date 13-APR-2017, lot # L004754, expiration date 10-NOV-2016 and lot # J012515, expiration date 14-APR-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 15-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.