chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from the patient's mother via a company representative concerning a 18 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for prevention of HPV. On an unknown date, after receiving the vaccination with GARDASIL 9, the patient experienced premature ovarian failure. A product quality complaint was not involved. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and GARDASIL 9 was not reported.  Additional information is not expected as there are no contact details of the reporter.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Oropharyngeal pain, Viral upper respiratory tract infection
Clinical narrative: Information has been received on 21-FEB-2017 from a consumer regarding herself as a 76 year old female patient with allergy to some chemicals and allergy to nickel. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 07-FEB-2017 the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration not reported), 0.5 ml injection for prophylaxis. On 15-FEB-2017, the patient experienced a bad cold. The patient also reported she had a sore throat, headache and a temperature of 100 degrees when she went to her doctor's office. On 16-FEB-2017, the patient went to her doctor's office for her cold and had a temperature of 100 degrees. The patient reported she received unspecified treatment. The patient reported that her cold is almost gone. The patient's present status was reported as recovering. Additional information is not expected as the reporter details were not provided.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received on 21-FEB-2017 from a registered pharmacist regarding a 39 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient, who is 39 years old was vaccinated with either GARDASIL 9 (lot number, expiration, dose and route not reported) or GARDASIL 9 (lot number, expiration, dose and route not reported) for prophylaxis.  No adverse effects were reported. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not provided). It was reported that the patient was vaccinated with ZOSTAVAX 3 years ago and was now experiencing shingles on an unspecified date. The outcome of shingles was unknown. Causality was not assessed by the physician. Additional information has been requested.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous report was received from a 67 year old female patient via a company representative concerning herself. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 10-FEB-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported), and with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown), both for prophylaxis (reported as vaccination). On 10-FEB-2017, the patient experienced "a lot of pain in her upper arm" between the elbow and shoulder (in the tricep area) (pain in extremity) with a pain scale 3 out of 10, and fatigue. The patient consulted a physician who prescribed her ADVIL and warm compresses to alleviate the pain. On 14-FEB-2017, the patient was recovered from the events. A product quality complaint was not involved. The causal relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. There was no information on concomitant medications, medical history and concurrent conditions. On unknown dates, unknown number of patients were vaccinated with improperly stored ROTATEQ (Lot# M018957 with expiry:22-NOV-2017, Lot#M019691 with expiry:02-NOV-2017, dosing details not provided) for prophylaxis. The vaccine was stored at a temperature below 36F (2C) but above 32F (0C) (33F) for 46hours 30 min. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001864.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Peripheral swelling, Rash erythematous
Clinical narrative: Information has been received from a 61 year old female patient concerning herself. Concurrent condition included hypothyroid, high blood pressure and restless legs syndrome. Concomitant therapies included SYNTHROID, HYZAAR, PRILOSEC, TOPROL, hydrochlorothiazide, CRESTOR and SINEMET (strength: 10/100 mg and 25/100 mg). The patient had no drug reactions/allergies. On 21-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (1 dose, strength, route, lot # and expiration date unknown, in the right arm) for prophylaxis. On 21-FEB-2017 (reported as "that night"), the patient experienced a red rash, swelling and hardness at the injection site. On 24-FEB-2017 (reported as "today" as of the reporting time), the patient's whole arm was swollen but the majority of the swelling was at the injection site. The patient did not seek medical attention and no lab diagnostic study was performed. The outcome of the events was not recovered (reported as "not improved"). No product quality complaint (PQC) involved. The causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse regarding a 75 years old female patient. The patient's pertinent medical history, concurrent conditions or drug allergies and concomitant medications were not reported. On 16-FEB-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M043424, expiry date: 06-JUN-2018 (strength, dose, frequency were not reported) for prophylaxis. The nurse reported that the PNEUMOVAX 23 "was administered closer to the bicep region rather than the recommended deltoid region." Nurse also stated that "the patient said she felt discomfort in her arm right away after the injection" and that the patient experienced "redness, swelling, warmth, and discomfort around the injection site" at an unspecified time after the injection. The patient returned to office to have an unspecified physician assistant "look at her arm" on 17-FEB-2017, no information provided on treatment or follow up (incorrect route of drug administration, injection site swelling, injection site erythema, injection site discomfort and injection site warmth). The outcome of the events was unknown. The reporter did not provide the causality assessment for the events. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Limb discomfort
Clinical narrative: This spontaneous report was received from a nurse regarding a 75 years old female patient. The patient's pertinent medical history, concurrent conditions or drug allergies and concomitant medications were not reported. On 16-FEB-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M043424, expiry date: 06-JUN-2018 (strength, dose, frequency were not reported) for prophylaxis. The nurse reported that the PNEUMOVAX 23 "was administered closer to the bicep region rather than the recommended deltoid region." Nurse also stated that "the patient said she felt discomfort in her arm right away after the injection" and that the patient experienced "redness, swelling, warmth, and discomfort around the injection site" at an unspecified time after the injection. The patient returned to office to have an unspecified physician assistant "look at her arm" on 17-FEB-2017, no information provided on treatment or follow up (incorrect route of drug administration, injection site swelling, injection site erythema, injection site discomfort and injection site warmth). The outcome of the events was unknown. The reporter did not provide the causality assessment for the events. No product quality complaint was involved. 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 medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients might be vaccinated with improperly stored doses of VARIVAX injection (lot # M037642; expiration date: 01-SEP-2018; dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccine experienced the temperature excursion of above -15 degrees Celsius, but below -10 degrees Celsius for 7 hours and 14 minutes and above -10 degrees Celsius, but below -8 degrees Celsius for 2 hours and 38 minutes. There was no previous temperature excursions. Digital data logger was involved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 75 year old female patient with allergy to penicillin. The patient did not have medical history or concomitant medication. On 26-FEB-2017, the patient was vaccinated with PNEUMOVAX 23 (lot number M037669, expiration date 09-MAY-2018, dose, route and anatomical injection site were not reported) for pneumonia prevention. On 26-FEB-2017 at night, the patient experienced "pain and redness" in the left arm. On 27-FEB-2017, the patient's doctor diagnosed her with cellulitis and prescribed KEFLEX. A product quality complaint was not involved. At the time of the report, the outcome of cellulitis was not recovered. The causal relationship between the event and PNEUMOVAX 23 was not reported. Upon internal review cellulitis was considered to be as medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. There was no information on concomitant medications, medical history and concurrent conditions.  On unknown dates, unknown number of patients were vaccinated with improperly stored GARDASIL 9 via intramuscular route, lot# M031557, expiry: 07-APR-2017 for prophylaxis. The vaccine was stored at a temperature below 36F (2C) but above 32F (0C) (33F) for 46hours 30 min. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011404:
Sex: U
Vaccine: TTOX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) on 22-FEB-2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date (about ten years ago). Patient's medical history and concomitant medications were not reported.  On an unspecified date, following the vaccination, the patient had severe reaction described as injection site really swelled up and experienced a lot of pain at injection site. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited case received from a physician via other company Pfizer under the manufacturer control number: 2016555849 on 22 Feb 2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient had Allergy to tetanus. The patient lab tests and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 22-FEB-2017. This case involves a 75 year old male patient who was vaccinated with an intramuscular dose of FLUZONE HD (batch number and expiry date were not reported) in right deltoid on an unspecified date in SEP-2016. The patient had a medical history of arthritis. Concomitant medication was not reported. On an unspecified date in SEP-2016, following the vaccination, the patient developed right arm soreness with difficulty lifting arm over head. It was reported that the patient has not seen physician. Patient's lab data and corrective treatment were not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Formication, Pain in extremity
Clinical narrative: Initial unsolicited report received from a patient on 22-FEB-2017. This case involves an 81-year-old female patient who was intramuscularly vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose and dose in series were not reported) in the left deltoid on 05-OCT-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as seasonal allergies, and allergic to some BP medicines (she did not name the medications) and Illness at the time of vaccination was reported as no. Any other vaccinations within four weeks of vaccinations and concomitant medications were also not reported. On an unknown date, sometime after receiving vaccine, the patient had developed pain in the left arm and the sensation that something was crawling under her skin. The patient's emergency room (ER) or doctor visit was not reported. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of event was not recovered reported as symptoms have eased, but have not gone away completely. List of documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain in collarbone, used warm compressions to treat.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Local reaction, Pruritus, Skin warm
Clinical narrative: Approximately 30 hrs post-injection, pt. developed local Rxns including swelling, hot to the touch, hard, 2 inch diameter of redness, itching and pain described similar to a bee sting. She experienced on-and-off headaches. Her symptoms persisted and RPh was contacted after approximately 48 hrs. Pt. was counseled to apply ice, use an analgesic and to follow up w/her PCP (no fever). Pharmacy also notified PCP.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Approximately 30 hrs post-injection, pt. developed local Rxns including swelling, hot to the touch, hard, 2 inch diameter of redness, itching and pain described similar to a bee sting. She experienced on-and-off headaches. Her symptoms persisted and RPh was contacted after approximately 48 hrs. Pt. was counseled to apply ice, use an analgesic and to follow up w/her PCP (no fever). Pharmacy also notified PCP.
Age: 7.0
Sex: F
Vaccine: IPV, TD
Symptoms: Lip dry, Pallor, Syncope
Clinical narrative: Lips dry, patient pale and faint, not alert, syncopal episode, eyes open 2-3 seconds.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Injection site mass, Injection site pain, Malaise
Clinical narrative: Small quarter-sized painful lump at injection sight; occasional varying degrees of muscle pain (mild to severe); occasional extreme and enduring joint pain; searing pain; chills; limited movement, range, use of left arm; general malaise.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal disorder, Myalgia
Clinical narrative: Small quarter-sized painful lump at injection sight; occasional varying degrees of muscle pain (mild to severe); occasional extreme and enduring joint pain; searing pain; chills; limited movement, range, use of left arm; general malaise.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Dehydration, Headache, Lethargy
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 16 year old male patient. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapy were unknown. On 01-FEB-2017, the patient was vaccinated with a dose (it was unknown which dose was administered) of GARDASIL, 0.5 ml, intramuscularly (Lot # and expiration date not provided) for prophylaxis. At the next day, on 02-FEB-2017, the patient experienced rash on forearm, belly, chest and back (rash), Joint pain (arthralgia), was lethargic (lethargy) and he felt dehydrated after pushing fluids (dehydration). Subsequently, on 06-FEB-2017, the patient and his mother sought medical attention because the patient was experiencing " shooting pain from the head into the neck, shoulder, hands, arms and back ". There was no product quality complaint involved. At the reporting time, the patient had not recovered from the event. The causal relationship between vaccination with GARDASIL and the events was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Rash
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 16 year old male patient. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapy were unknown. On 01-FEB-2017, the patient was vaccinated with a dose (it was unknown which dose was administered) of GARDASIL, 0.5 ml, intramuscularly (Lot # and expiration date not provided) for prophylaxis. At the next day, on 02-FEB-2017, the patient experienced rash on forearm, belly, chest and back (rash), Joint pain (arthralgia), was lethargic (lethargy) and he felt dehydrated after pushing fluids (dehydration). Subsequently, on 06-FEB-2017, the patient and his mother sought medical attention because the patient was experiencing " shooting pain from the head into the neck, shoulder, hands, arms and back ". There was no product quality complaint involved. At the reporting time, the patient had not recovered from the event. The causal relationship between vaccination with GARDASIL and the events was not provided. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 6 month-old infant of unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates; at 3, 6 and 8 months of age, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative referring to a 70 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, reported as 1 year after the patient was administered ZOSTAVAX vaccine, the patient experienced the shingles virus. It was unknown whether the patient sought medical attention, a treatment was given for the adverse event or lab diagnostics studies were performed; it was unknown if the patient was hospitalized or experienced significant disability, incapacity, life threatening, cancer or an overdose. The patient did not die. At the time of the report, the patient was recovered from herpes zoster. The causal relationship between herpes zoster and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 67 year old female patient. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 17-FEB-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # L017265, expiration date: 10-JAN-2017) for prophylaxis (Expired product administered). No adverse effects were reported. No further information reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tic
Clinical narrative: Information has been received on 17-FEB-2017 from a female physician via a company representative referring to a 12-year-old male patient. The patient's medical history included "Behavioral issues". Concomitant medication and drug reactions/allergies were reported as "unknown" by the reporter. The physician reported that the patient who had been administered a single shot of GARDASIL 9 (strength and site not reported; lot number M031557 and expiration date 17-APR-2019) intramuscularly for prophylaxis, had developed a "tick" that "started to occur occasionally but now occurs all the time." It was also noted that the patient had been administered MENACTRA and BOOSTRIX on the same day the GARDASIL 9 was administered on 20-JAN-2017.  The patient had received the shot of GARDASIL 9 on 20-JAN-2017 but the specific date of adverse event (AE) onset was unknown by reporter.  At the time of report, 17-FEB-2017, medical attention was not sought, no laboratory studies performed, no treatment given for the adverse event. At the time of the call the patient did not recover but is expected to meet with his physicians (as reported) on 20-FEB-2017. All quoted information is included as stated and no other information was given at the time of the call. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 20-FEB-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (intramuscular, lot # M031557, expiration date: 07-APR-2019, dose was unknown) for prophylaxis. No adverse effects were reported. The temperature for the vaccine stored was 32 Fahrenheit degree to 36 Fahrenheit degree with 3 hours 10 minutes time frame. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Compartment syndrome, Fasciotomy, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt states she went to ER at 9pm after receiving vaccine at 1000 earlier in the day. Pt had increasing swelling, redness and pain in LUE. Per pt, she developed compartment syndrome and had a LUE fasciotomy.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Reaction to vaccine area is warm, itchy and hard. Pt. advised to apply ice to area.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site joint movement impairment, Injection site pain, Injection site swelling, Sensory loss
Clinical narrative: Pt. endorses pain, swelling, decreased ROM of left shoulder; diminished sensation of inferolateral left forearm, left palm, left 4th/5th digit.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Gait disturbance, Hypotonia, Irritability, Pain in extremity, Pyrexia
Clinical narrative: Got Hep B vaccine on 2/24/17. That night was fussy. Had pain in leg next night and wouldn't walk. Fever to 103 and hives. Seen in ER. Strep (-). Next day fever, limp and walk resolved.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Got Hep B vaccine on 2/24/17. That night was fussy. Had pain in leg next night and wouldn't walk. Fever to 103 and hives. Seen in ER. Strep (-). Next day fever, limp and walk resolved.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Was given varicella vaccine on 3/3/17. The next day, it was reddened, swollen and sore. It continued to spread and on 3/6/17 it is approx 7cmx10cm, red, painful and warm to the touch.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site soreness, red, hot to touch, itchy. Dr. advised BENADRYL and cool compress. Could be normal reaction.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Joint swelling, Pain
Clinical narrative: (R) knee swelling, pain occurred after first and second injection in arm.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: I received my second dose of BEXSERO Meningococcal B Vaccine on the morning of March 3, 2017. Of course, as with the first dose, I felt extreme muscle pain following the vaccination. I also felt very fatigued and tired in the evening so I went to bed early that night (as with the first dose). However, I do not remember having such a bad injection site reaction. Three days later (today, March 4) I have a lot of redness at the site, it is very tender to the touch, and also a little bit itchy. I am hoping it will go away on its own so I don't have to go back into the doctor.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Decreased activity, Grip strength decreased, Injected limb mobility decreased, Injection site pain
Clinical narrative: Left arm from shoulder to elbow. Throbbing pain. Increases at night while laying down.  Restricted movement in multiple directions.  Restricted activity.  Hand strength at less than half strength of before vaccine.  Arthritis type pain in elbow.  One month after pain developed, visited doctor who said to reduce activity and take Advil at 600mg. Reduction in activity does not result in one week later.  600 mg of Advil every 12 hours does help with pain but does NOT relieve all pain or restricted movement.  I have been referred to an orthopedic physician and have an appointment next week.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling and pain. Offered oral prednisone to her to help counteract reaction given that it is still swollen but since she feels ROM is improving, prefers to cont with heat and gentle stretches. Stay on ZYRTEC until swelling resolves.
Age: 10.0
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea and fever for three days. Redness at the site of the arm. Red streaks down the arm. Golf-ball size swelling at site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, 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 medical history, concurrent conditions and concomitant therapies were not reported. On 26-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M004328, expiration date 26-JAN-2018 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered doses of VARIVAX were exposed to a temperature excursion of total time >-10°C but <8°C (>14°F but <46°F) for 10 hours. Data logger was involved.  There were previous excursions reported as follows: total time >-10°C but <8°C (>14°F but <46°F) for 22 hours and total time >-15°C but <-10°C (>5°F but <14°F) for 1 hour. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007980: US-009507513-1703USA002299: US-009507513-1703USA002300.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, 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 medical history, concurrent conditions and concomitant therapies were not reported. On 08-FEB-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M016234, expiration date 31-MAR-2018 (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. Administered dose of M-M-R II was exposed to a temperature excursion of >8°C but <25°C (>46°F but <77°F) for 10 hours. Data logger was involved. There were previous excursions reported as follows: >8°C but <25°C (>46°F but <77°F) for 10 hours. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA007980: US-009507513-1703USA002298: US-009507513-1703USA002299.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Feeling abnormal, Injected limb mobility decreased, Laboratory test, Malaise, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 73-year-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration at single dose in the left arm on Jan2017 for immunisation. Medical history included heart condition (had for 20 years). Concomitant medication included influenza vaccine (FLU) in the right arm on Jan2017 for immunisation. In Jan2017, the patient got very sick with outcome of unknown. On an unspecified date in 2017, limited movement of her left arm with outcome of not recovered, pain in left arm with outcome of not recovered. The events were described as follows: She got very sick the next day after the shot and was in bed for a whole week. She felt like she had pneumonia. Pain in left arm started about a week after she got the shot. A few weeks after getting the shot she had the limited movement in her left arm. The patient underwent lab tests and procedures which included on unknown date X-ray: showed bone and it was negative for a fracture. Therapeutic measures were taken as a result of the events included Cortisone shot, but it did not do anything.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 73-year-old female patient received the first dose of PREVNAR 13, via an unspecified route of administration at single dose in the left arm on Jan2017 for immunisation. Medical history included heart condition (had for 20 years). Concomitant medication included influenza vaccine (FLU) in the right arm on Jan2017 for immunisation. In Jan2017, the patient got very sick with outcome of unknown. On an unspecified date in 2017, limited movement of her left arm with outcome of not recovered, pain in left arm with outcome of not recovered. The events were described as follows: She got very sick the next day after the shot and was in bed for a whole week. She felt like she had pneumonia. Pain in left arm started about a week after she got the shot. A few weeks after getting the shot she had the limited movement in her left arm. The patient underwent lab tests and procedures which included on unknown date X-ray: showed bone and it was negative for a fracture. Therapeutic measures were taken as a result of the events included Cortisone shot, but it did not do anything.
Age: 90.0
Sex: F
Vaccine: PNC13, FLUX, PNC13
Symptoms: Dyspnoea, Fall, Femur fracture, Immune system disorder, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 90-year-old female patient received a single dose of PREVNAR 13 via an unspecified route of administration in the arm in Aug2016 for immunization. She also had influenza vaccine for immunization in Aug2016 (she was unsure if it was before or after pneumococcal 13-val conj vac). The patient medical history and concomitant medications were not reported. On an unspecified day in Aug2016 the patient all of a sudden for a couple seconds could not move legs, she had hives, very heavy breathing, felt like in a race, maybe she was allergic to vaccine, her immune system was down. She also  fell and broke her left femur on 23Aug2016 due to which she was hospitalized from Aug2016 for 2-3 months and she was having a lot of physical therapy and in rehabilitation. It was reported that when the patient first got home after vaccination with PREVNAR 13 on an unspecified day in Aug2016, all of a sudden for a couple seconds she could not move her legs and then it went away. She then stated that her dog ran away and she ran after it and got very heavy breathing, she felt like in a race. She could not recall if the breathing was the same day as the shot or not. The heavy breathing lasted about 3 months and then went away. She told her heart doctor about it and he thought she maybe was allergic to the vaccine. She also stated she got hives around the same times but no specific time frame was known and that did not last too long and went away. The patient recovered from could not move legs in Aug2016, very heavy breathing and hives on an unspecified date in 2016, outcome of fall, femur fracture, immune system was down and allergy to vaccine was unknown.
Age: 90.0
Sex: F
Vaccine: PNC13, FLUX, PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 90-year-old female patient received a single dose of PREVNAR 13 via an unspecified route of administration in the arm in Aug2016 for immunization. She also had influenza vaccine for immunization in Aug2016 (she was unsure if it was before or after pneumococcal 13-val conj vac). The patient medical history and concomitant medications were not reported. On an unspecified day in Aug2016 the patient all of a sudden for a couple seconds could not move legs, she had hives, very heavy breathing, felt like in a race, maybe she was allergic to vaccine, her immune system was down. She also  fell and broke her left femur on 23Aug2016 due to which she was hospitalized from Aug2016 for 2-3 months and she was having a lot of physical therapy and in rehabilitation. It was reported that when the patient first got home after vaccination with PREVNAR 13 on an unspecified day in Aug2016, all of a sudden for a couple seconds she could not move her legs and then it went away. She then stated that her dog ran away and she ran after it and got very heavy breathing, she felt like in a race. She could not recall if the breathing was the same day as the shot or not. The heavy breathing lasted about 3 months and then went away. She told her heart doctor about it and he thought she maybe was allergic to the vaccine. She also stated she got hives around the same times but no specific time frame was known and that did not last too long and went away. The patient recovered from could not move legs in Aug2016, very heavy breathing and hives on an unspecified date in 2016, outcome of fall, femur fracture, immune system was down and allergy to vaccine was unknown.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 72-year-old female patient received the first dose of PREVNAR 13 (lot M88543, exp. date Jul2017, NDC number 00005197105) at single dose for immunization on 17Feb2017 16:30 via intramuscular route in the left arm. Medical history included allergy. The patient had received an influenza vaccine 6 months before the vaccination with PREVNAR 13. On unspecified date in Feb2017 the patient experienced rash and cellulitis. The patient was not hospitalized for the event but she was in urgent care for the cellulitis. The outcome of the events was unknown. The patient received some antibiotics for the events. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Chills, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (wife). A male patient of unknown age and race/ethnicity received on 28Feb2017 a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. On 01Mar2017, the patient had arm swollen, bad chills and stomach upset. Outcome was unknown.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Tremor
Clinical narrative: Patient stated she had tremors and dizziness lasting 4-5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Eye swelling, Pruritus, Rash
Clinical narrative: Swelling, rash and blister around both eyes. Burning and itching. Still affected today March 6, 2017.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Pt. became infected with Influenza A despite having received the vaccine 2 months prior.
Age: 1.17
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None stated.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Crying, Eczema, Eye pruritus, Food allergy, Haematochezia
Clinical narrative: Allergic reaction, hours and hours of non-stop crying, severe eczema covered all body, itchy, eyes, neck and behind ears, food allergies (nobody ever had any kind of allergy in our family), pieces of blood in the bowel.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Allergic reaction, hours and hours of non-stop crying, severe eczema covered all body, itchy, eyes, neck and behind ears, food allergies (nobody ever had any kind of allergy in our family), pieces of blood in the bowel.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, X-ray
Clinical narrative: Pain in injection area of pneumococcal vaccine. Medicine collected in injection area in muscle and was not absorbed properly. Continued pain and severe soreness at place of injection. See answer #12.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Blood test, Diabetic ketoacidosis, Lethargy, Pollakiuria, Urine output increased
Clinical narrative: Vomiting, frequent heavy urination, lethargic. Diagnosed with diabetic ketoacidosis.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Vomiting
Clinical narrative: Vomiting, frequent heavy urination, lethargic. Diagnosed with diabetic ketoacidosis.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Abdominal X-ray, Anxiety, Biopsy stomach normal, Blood creatine phosphokinase MB increased, Blood magnesium normal
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blood thyroid stimulating hormone normal, Brain natriuretic peptide normal, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Dyspnoea, Echocardiogram normal, Ejection fraction normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Haematemesis, Helicobacter test negative, Hyperhidrosis, Impaired work ability, Insomnia
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Laboratory test normal, Lymphadenopathy, Metabolic function test normal, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Oesophagogastroduodenoscopy normal, Pain, Painful respiration, Pneumomediastinum, Pulmonary function test normal
Clinical narrative: Onset of left, substernal throbbing chest pain and dyspnea. Pain worse on 6 Jun after 4-mile run. 3 Jun 16 (post-vaccine date (PVD) 9), onset of chest pain (CP) and shortness of breath. CP increased with deep breaths, also reported nausea, and diaphoresis. 6 Jun 16 (PVD 12), sought evaluation for continued CP (10/10) following 4-mile run. Treated with ZOFRAN, morphine, DILAUDID and TORADOL. ECG with NSR, sinus arrhythmia, rightward axis - borderline ECG. Elevated Troponin, CXR showed pneumomediastinum. Admitted to Hospital for pain management and observation. Discharged on OXYCONTIN for chest pain. Placed on limited duty. 13 Jun 2016 (PVD 19), ER evaluation - c/o SOB, CP and vomited blood x 3; anxious --> ATIVAN. CXR normal. Discharged: anxiety, hematemesis, CP, insomnia r/t medical problems. REC: PFTs, GI eval, albuterol inhaler, repeat ECG, referral to behavioral health. As of FEB 2017, patient continues to have ongoing chest wall pain. Additional cardiology evaluations do not support pain is cardiac in origin.