chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Echocardiogram normal, Electrocardiogram normal, Headache, Loss of consciousness, Malaise
Clinical narrative: Passed out with no notice, ER visit for Syncope, headache, shoulder pain, ongoing feeling of illness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Syncope, X-ray normal
Clinical narrative: Passed out with no notice, ER visit for Syncope, headache, shoulder pain, ongoing feeling of illness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Influenza like illness, Pain
Clinical narrative: PT HAD REDNESS, SWELLING, SORENESS FOR 3 DAYS AFTER VACCINE WAS GIVEN AND HAD FLU-LIKE SYMPTOMS FOR 48 HOURS AFTER THAT (FEVER, CHILLS, FATIGUE).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: PT HAD REDNESS, SWELLING, SORENESS FOR 3 DAYS AFTER VACCINE WAS GIVEN AND HAD FLU-LIKE SYMPTOMS FOR 48 HOURS AFTER THAT (FEVER, CHILLS, FATIGUE).
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Pain in extremity, Vaccination site pain
Clinical narrative: Patient states that she had a little soreness after the vaccination for a few days, but then it went away. However, 7 days after vaccination (07/09) the patient states that at night her arm was very painful that she cried and took some ibuprofen. Patient states that it still hurts today (07/10). Patient is going to take some ibuprofen for a couple days and then if not relieved will go to an urgent care. Patient states no redness or swelling.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Asthenia, Confusional state, Dizziness, Fatigue
Clinical narrative: Severe body aches, with the pain especially concentrated in the joints (knees, neck, back, and shoulders). Very tired and fatigued, slept for almost 24 hours straight. Fever for about 8 hours with sweating. Weak and dizzy. Vaccine was administered in the right deltoid. Glands swollen under the right shoulder in the armpit; it hurt to lift the right arm or move the right arm. I treated this by sleeping, drinking fluids, staying in bed for 48 hours, applying ice to sore and stiff joints and eventually taking 650mg of Tylenol. I considered going to the emergency room or an urgent care center but was too exhausted and confused to make a trip to the emergency room or urgent care center, and I was concerned about the financial burden of going to see a doctor at the ER or urgent care. I have to have the final dose of the Rabavert vaccine on 7/15/2016 and I am afraid of having the same reaction.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Hyperhidrosis, Hypersomnia, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Severe body aches, with the pain especially concentrated in the joints (knees, neck, back, and shoulders). Very tired and fatigued, slept for almost 24 hours straight. Fever for about 8 hours with sweating. Weak and dizzy. Vaccine was administered in the right deltoid. Glands swollen under the right shoulder in the armpit; it hurt to lift the right arm or move the right arm. I treated this by sleeping, drinking fluids, staying in bed for 48 hours, applying ice to sore and stiff joints and eventually taking 650mg of Tylenol. I considered going to the emergency room or an urgent care center but was too exhausted and confused to make a trip to the emergency room or urgent care center, and I was concerned about the financial burden of going to see a doctor at the ER or urgent care. I have to have the final dose of the Rabavert vaccine on 7/15/2016 and I am afraid of having the same reaction.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Severe body aches, with the pain especially concentrated in the joints (knees, neck, back, and shoulders). Very tired and fatigued, slept for almost 24 hours straight. Fever for about 8 hours with sweating. Weak and dizzy. Vaccine was administered in the right deltoid. Glands swollen under the right shoulder in the armpit; it hurt to lift the right arm or move the right arm. I treated this by sleeping, drinking fluids, staying in bed for 48 hours, applying ice to sore and stiff joints and eventually taking 650mg of Tylenol. I considered going to the emergency room or an urgent care center but was too exhausted and confused to make a trip to the emergency room or urgent care center, and I was concerned about the financial burden of going to see a doctor at the ER or urgent care. I have to have the final dose of the Rabavert vaccine on 7/15/2016 and I am afraid of having the same reaction.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: PT C/O OF ABDOMINAL RASH APPROX 2 DAYS FOLLOWING ADMINISTRATION OF VACCINE. PT STATES RASH COVERS ABDOMEN BUT IS UNSURE IF RELATED TO VACCINE OR IF IT IS JUST A FLARE OF HASHIMOTO'S SX. PT INSTRUCTED TO CHECK IN WITH MD OFFICE ON MONDAY OR TO SEEK URGENT CARE IF CONDITION WORSENS (SHORTNESS OF BREATH, WORSENING RASH WITH HIVES, ELEVATED FEVER).
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Muscle twitching, Vaccination site reaction
Clinical narrative: Continuous muscle twitching.  Twitching was first noticed at site of the tetanus booster vaccination (right shoulder).  The following day, the muscle twitching moved to the upper right deltoid area, where it twitched consistently for approximately 36 hours.  The twitch is now concentrated in the left deltoid area.  Other non-consistent muscle twitches are occurring randomly throughout the body.  After a revisit to the doctor, I was unable to get a reason as to why the twitching was occurring, and was advised to report as an adverse event.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Of left arm--swelling, redness, hot to touch, painful.
Age: 67.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: TONGUE SWELLING, DIFFICULTY SWALLOWING.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: PAIN AT SITE OF INJECTION.  REDNESS SURROUNDING SITE EVOLVED NEXT DAY, ALONG WITH FLU LIKE SYMPTOMS. THE FOLLOWING DAY AND DAYS SINCE REDNESS SLOWLY TRAVELING DOWN ARM.
Age: 21.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED IMMUNIZATION ADMINISTERED-NO ADVERSE SIGNS/SYMPTOMS REPORTED WHEN PATIENT CALLED BACK ON 07/07/2016.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: 7 vesicles arose at site of injection on L qaud. Still there today.. now more red.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M005714, expiration date on 03-OCT-2017 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. No adverse events reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Information has been received from a physician referring to a female patient in her 70's. The patient's concurrent or historical condition was unknown. On an unknown date in 2016 (reported as "over 30 days ago"), the patient was administered ZOSTAVAX (lot#, expiration date, dose and route unknown) on an unspecified pharmacy. Concomitant therapy was not provided. The patient experienced a hard-red-lump injection site reaction on an unspecified date after administration of ZOSTAVAX. The patient saw the physician on 29-JUN-2016 because of the lump. The patient also complained of a "metallic taste in her month". The physician indicated that the redness was not a rash. The outcome of adverse events was reported as not recovered. The causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. There was no medical history of concurrent condition reported. Many years ago, on an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were unknown). No concomitant therapy was reported. An unspecified time after receiving the dose of ZOSTAVAX, the patient had a "mild case" of shingles. The outcome of the event was unknown. Causality was not provided. Varicella zoster virus (VZV) packet was not sent to pharmacist as the patient's event occurred "many years ago". Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: Information has been received via a field employee from a more than 70 year old male physician with neuralgia from Guillain-Barre syndrome referring to himself. In summer of 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were unknown). Around 20-MAR-2016, the patient developed a burning sensation on his forehead. The patient visited his dermatologist, who diagnosed the burning sensation as the beginning of shingles. VALTREX and prednisone (manufacturer unspecified) were given as the treatment. The burning sensation lasted for another week after starting therapy with VALTREX and prednisone (manufacturer unspecified) before it resolved in 2016. The patient said that he felt this would have been a lot worse if he had not received ZOSTAVAX. The causality was not reported. Follow up information was received from the physician who is currently 78 years old, reporting on himself. The patient's medical history included varicella zoster virus infection in age 8 (70 years ago). In June 2015, the patient was vaccinated in his left arm with a first dose of ZOSTAVAX. The patient was vaccinated with private funds. It was reported that the dermatome involved was facial region/trigeminal nerve V1 with three lesions, which lasted 7 days. A pain scale was reported as 5. The patient did not have recent exposure to herpes nor chickenpox. No other laboratory diagnostic tests were performed. At the time of the report, the patient recovered in April 2016. Additional information is not expected, as all correspondence was received. Patient, product, event details and narrative were updated.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received via a field employee from a more than 70 year old male physician with neuralgia from Guillain-Barre syndrome referring to himself. In summer of 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were unknown). Around 20-MAR-2016, the patient developed a burning sensation on his forehead. The patient visited his dermatologist, who diagnosed the burning sensation as the beginning of shingles. VALTREX and prednisone (manufacturer unspecified) were given as the treatment. The burning sensation lasted for another week after starting therapy with VALTREX and prednisone (manufacturer unspecified) before it resolved in 2016. The patient said that he felt this would have been a lot worse if he had not received ZOSTAVAX. The causality was not reported. Follow up information was received from the physician who is currently 78 years old, reporting on himself. The patient's medical history included varicella zoster virus infection in age 8 (70 years ago). In June 2015, the patient was vaccinated in his left arm with a first dose of ZOSTAVAX. The patient was vaccinated with private funds. It was reported that the dermatome involved was facial region/trigeminal nerve V1 with three lesions, which lasted 7 days. A pain scale was reported as 5. The patient did not have recent exposure to herpes nor chickenpox. No other laboratory diagnostic tests were performed. At the time of the report, the patient recovered in April 2016. Additional information is not expected, as all correspondence was received. Patient, product, event details and narrative were updated.
Sex: U
Vaccine: MMR, MMR
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 concurrent conditions and medical history were not reported. On 25-JUN-2016, the patient was vaccinated with an expired dose of M-M-R II, the lot number was K012472, 0.5 ml, subcutaneously (the strength and frequency were unknown) after an expiration date of 11-JUN-2016 (also reported as 11-JUN-2017). There were no concomitant therapies reported. No adverse reactions was reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site pain
Clinical narrative: Fatigue, pain around injection site.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Activated partial thromboplastin time shortened, Blood creatinine normal, Blood electrolytes normal, Blood urea normal, Blood urine absent
Clinical narrative: "Deep rash" different from the maculopapular rash that had been persistent since the time of vaccination.  Persistent cough, rhinorrhea, nasal congestion. Normal vitals and otherwise normal exam. Diagnosed with nonthrombocytopenic purpura following normal CBC, electrolytes/renal function, urinalysis, and PT/PTT.  Discharged from the ED with outpatient follow-up.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Cough, Haematocrit normal, Haemoglobin normal, International normalised ratio normal, Nasal congestion
Clinical narrative: "Deep rash" different from the maculopapular rash that had been persistent since the time of vaccination.  Persistent cough, rhinorrhea, nasal congestion. Normal vitals and otherwise normal exam. Diagnosed with nonthrombocytopenic purpura following normal CBC, electrolytes/renal function, urinalysis, and PT/PTT.  Discharged from the ED with outpatient follow-up.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Platelet count normal, Protein urine absent, Prothrombin time normal, Purpura, Rash
Clinical narrative: "Deep rash" different from the maculopapular rash that had been persistent since the time of vaccination.  Persistent cough, rhinorrhea, nasal congestion. Normal vitals and otherwise normal exam. Diagnosed with nonthrombocytopenic purpura following normal CBC, electrolytes/renal function, urinalysis, and PT/PTT.  Discharged from the ED with outpatient follow-up.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash maculo-papular, Rhinorrhoea, Urine analysis normal, White blood cell count normal
Clinical narrative: "Deep rash" different from the maculopapular rash that had been persistent since the time of vaccination.  Persistent cough, rhinorrhea, nasal congestion. Normal vitals and otherwise normal exam. Diagnosed with nonthrombocytopenic purpura following normal CBC, electrolytes/renal function, urinalysis, and PT/PTT.  Discharged from the ED with outpatient follow-up.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lethargy, Mobility decreased
Clinical narrative: Increased lethargy and stayed in bed for 3 days after vaccine.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Muscle twitching, Nausea, Syncope
Clinical narrative: Syncope with leg twitching 5 minutes after injection.  Also c/o nausea and headache remainder of day.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored PNEUMOVAX 23 (lot # M000592, expiration date 12-OCT-2017). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 72 year old female patient with asthma. The patient had no drug reactions/allergies. On 21-JUN-2016, the patient was vaccinated with ZOSTAVAX (lot # L035285 with expiry date 30-DEC-2016, 19 400 PFU/single dose), subcutaneously. Concomitant therapies included montelukast 10 mg and unspecified blood pressure medicine. On 23-JUN-2016, the patient experienced chills, itching, a low grade fever, bruising and also about a 1 1/2 inch redness and 1/2 inch swelling at the injection site. BENADRYL was prescribed as the treatment. No lab diagnostics were performed. The patient's present status was reported as recovering. The causality of the events was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 72 year old female patient with asthma. The patient had no drug reactions/allergies. On 21-JUN-2016, the patient was vaccinated with ZOSTAVAX (lot # L035285 with expiry date 30-DEC-2016, 19 400 PFU/single dose), subcutaneously. Concomitant therapies included montelukast 10 mg and unspecified blood pressure medicine. On 23-JUN-2016, the patient experienced chills, itching, a low grade fever, bruising and also about a 1 1/2 inch redness and 1/2 inch swelling at the injection site. BENADRYL was prescribed as the treatment. No lab diagnostics were performed. The patient's present status was reported as recovering. The causality of the events was not reported. 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 an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX (lot# K011081 with expiration date 08-AUG-2016; lot# L020002 with expiration date 02-JUN-2017; lot# L028276 with expiration date 28-JUL-2017; lot# L002216 with expiration date 21-JAN-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F, 30 minutes at 6.1 F on the seventh of April (year unspecified) 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Exposure via direct contact, Nodule, Underdose
Clinical narrative: This spontaneous report was received from a nurse (also reporter as medical assistant) refers to a 4 year old male patient. The patient has no pertinent medical history and concomitant medications. On 13-JUN-2016, a vaccination attempt was made to administer M-M-R II, subcutaneous in the arm. During the administration of a dose the patient moved his arm, the needle came out of the patient's arm, and a portion of the dose squirted on the patient's skin in an unspecified location. The reporter stated that the patient's mother mentioned that the patient developed a knot on his arm at an unspecified time following the vaccination attempt. The outcome of "knot on his arm" was reported as recovered. The reporter did not provide the relatedness of the event with M-M-R II. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient called 7/11/16 and stated her arm was painful with radiation to her shoulder, felt like a bruise however no visible bruising, no nodule, no fever.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. The patient's historical medications included vaccination with (CRM197) (PREVNAR 13) "over a year ago". On 06-JUL-2016, the patient received an expired dose of PNEUMOVAX23 expiration date 14-APR-2016 (dose, route of administration and lot # were not reported). On an unknown date in July 2016 (reported as "an unspecified time after the patient received PNEUMOVAX23)"), the patient developed redness and warmth at the injection site. The outcome of the event was not reported. The relatedness between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL (lot# K005881 with expiration date 14-JAN-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of 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 was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 01-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # I002422, expiration date 23-APR-2016 (strength, dose and route of administration and anatomical location were not provided). No adverse effects were reported. Additional information had been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthropod bite, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 12 month 3 week old female patient. Information on the concurrent condition, pertinent medical history and drug allergies of the patient were not reported. On 16-MAY-2016, the patient was vaccinated with VARIVAX lot #M000760 (expiry date, dose number, route and anatomical location were not reported). Concomitant medication were not reported. On an unknown date, there were bug bites on the baby but some looked like chicken pox and there was a possibility that the marks were chicken pox (unknown by the reporter if it was chicken pox). On 25-JUN-2016, the patient had sought medical attention and treatment was given for the event. There was no Product Quality Concerns (PQC) involved. The outcome of varicella was unknown at the time of reporting. No further information was provided. Relatedness of the event were not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Alanine aminotransferase increased, Antibody test negative, Aspartate aminotransferase increased, Bacterial test negative, Bartonella test negative
Clinical narrative: Pt with acute febrile illness consistent with tick borne infection - fever, malaise, myalgia with abn labs began afternoon after vaccination (shortly thereafter), req hosp 7/12 to 7/14/2015. Peds I.D. (Dept Head) and ward (Gen Peds) attendings in agreement that sx are consistent with tick related disease and not vaccine reaction after tx with doxycycline. (Resolved after tx antibx.)
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Borrelia test negative, Ehrlichia test, Malaise, Myalgia, Platelet count decreased
Clinical narrative: Pt with acute febrile illness consistent with tick borne infection - fever, malaise, myalgia with abn labs began afternoon after vaccination (shortly thereafter), req hosp 7/12 to 7/14/2015. Peds I.D. (Dept Head) and ward (Gen Peds) attendings in agreement that sx are consistent with tick related disease and not vaccine reaction after tx with doxycycline. (Resolved after tx antibx.)
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Pyrexia, Tick-borne fever, Typhus rickettsia test, White blood cell count decreased
Clinical narrative: Pt with acute febrile illness consistent with tick borne infection - fever, malaise, myalgia with abn labs began afternoon after vaccination (shortly thereafter), req hosp 7/12 to 7/14/2015. Peds I.D. (Dept Head) and ward (Gen Peds) attendings in agreement that sx are consistent with tick related disease and not vaccine reaction after tx with doxycycline. (Resolved after tx antibx.)
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The spontaneous report was received from a physician and refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 14-JUN-2016, the patient was vaccinated with one improperly stored dose of RECOMBIVAX HB lot # L033343, expiration date 13-SEP-2017 (strength, dose, route of administration and anatomical location were not provided). No adverse effects were reported. The vaccine was exposed for 35 Fahrenheit degrees for 1 hour on 29-APR-2016, for 33 Fahrenheit degrees for 1 hour and 30 minutes on 18-MAY-2016 and for 21.9 Fahrenheit degrees for 1 hour on 14-JUN-2016 (3 hours and 30 minutes in total). The vaccine was back in range. This was data logger issue. There were no previous excursions. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-JUN-2016, the patient was vaccinated with one improperly stored dose of GARDASIL lot # L035105, expiration date 14-MAY-2017 (strength, dose, route of administration and anatomical location were not provided). No adverse effects were reported. The vaccine was exposed for 35 Fahrenheit degrees for 1 hour on 29-APR-2016, for 33 Fahrenheit degrees for 1 hour and 30 minutes on 18-MAY-2016 and for 21.9 Fahrenheit degrees for 1 hour on 14-JUN-2016 (3 hours and 30 minutes in total). The vaccine was back in range. This was data logger issue. There were no previous excursions. This is one of two cases received from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring a 64 years old male patient. Medical history and concurrent conditions were not provided. On approximately 11-MAY-2016 (reported as "about 6 weeks ago"), the patient was vaccinated with ZOSTAVAX injection (dose, route, lot number and expiration date were not reported). On approximately 18-MAY-2016 (reported as "1-2 weeks" after receiving ZOSTAVAX), the patient developed a rash on his neck, lasting for an unspecified duration of time, which was treated with ABREVA. No laboratory diagnostics were performed. No Product Quality Complaint (PQC) was involved. The outcome of the event was unknown at the reporting time. The causal relationship between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 17-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II injection (strength, dose and route of administration were not provided) (lot # L015280, expiration date: 30-APR-2017). The temperature excursion was of 48F and the time frame was 120 hours. There was no previous temperature excursion. The temperature excursion was not detected by a digital data logger. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027076 and expiration date 25-MAY-2017, lot # L039141 and expiration date 16-AUG-2017, orally; exact doses were not reported). It was reported that the vaccine were exposed to a temperature excursion described as minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cold sweat, Influenza like illness, Injection site cellulitis, Injection site rash
Clinical narrative: This spontaneous report as received from a physician via field representative, refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (via the intramuscular or subcutaneous route). On an unknown date, the patient experienced a "reaction to PNEUMOVAX23 -she developed cold sweats, flu like symptoms, rash from elbow to shoulder on injection site arm and cellulitis. Patient sought medical attention-she visited the physician's office. Patient was treated with unspecified antibiotics. The outcome of the events was unknown. Causality assessment was not provided. Addition information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Cold sweat, Influenza like illness, Injection site cellulitis, Injection site erythema
Clinical narrative: This spontaneous report as received from a physician via field representative, refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (via the intramuscular or subcutaneous route). On an unknown date, the patient experienced a "reaction to PNEUMOVAX23 -she developed cold sweats, flu like symptoms, rash from elbow to shoulder on injection site arm and cellulitis. Patient sought medical attention-she visited the physician's office. Patient was treated with unspecified antibiotics. The outcome of the events was unknown. Causality assessment was not provided. Addition information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Vaccination complication
Clinical narrative: This spontaneous report as received from a physician via field representative, refers to a female patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (via the intramuscular or subcutaneous route). On an unknown date, the patient experienced a "reaction to PNEUMOVAX23 -she developed cold sweats, flu like symptoms, rash from elbow to shoulder on injection site arm and cellulitis. Patient sought medical attention-she visited the physician's office. Patient was treated with unspecified antibiotics. The outcome of the events was unknown. Causality assessment was not provided. Addition information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 4 months old, male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-APR-2016 at 12:39, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient states she has had multiple shingles outbreaks since receiving vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Fatigue, Feeding disorder, Headache, Hypersensitivity
Clinical narrative: She woke at 4:30 am not able to move with major severe muscle aches and fatigue, headache, nausea, fever, she couldn't even put on her own shoes. Gave Benadryl at onset and used ibuprofen for fever, Gatorade because could not eat.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Myalgia, Nausea, Pyrexia
Clinical narrative: She woke at 4:30 am not able to move with major severe muscle aches and fatigue, headache, nausea, fever, she couldn't even put on her own shoes. Gave Benadryl at onset and used ibuprofen for fever, Gatorade because could not eat.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of M-M-R II (lot# K009956 with expiration date 14-JUL-2016; lot# K011188 with expiration date 12-AUG-2016; lot# K011317 with expiration date 13-AUG-2016; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events 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 as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent medical conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of PROQUAD recombinant human albumin status (lot# L050909 with expiration date 14-JUN-2017; lot # L033697 with expiration date 28-FEB-207; lot# L051099 with expiration date 17-JUN-2017; lot# L030585 with expiration date 10-FEB-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30  minutes at 47.5 Fahrenheit (F)  on the fifth of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 month old female patient. The patient had no concomitant medications and no drug reactions or allergies. On 21-JUN-2016, the patient was vaccinated with oral ROTATEQ oral solution, lot # reported as L046319, expiry date 28-SEP-2017 (dose was not specified). Other suspect therapies included DTaP, Hib, poliovirus vaccine and PREVNAR, administered on the same day. On 21-JUN-2016, the patient instantaneously vomited after receiving oral ROTATEQ. The patient sought medical attention in the office, at the time of the event. No treatment was given. No lab diagnostics were performed. The outcome of the event and the causality assessment were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 month old male patient. The patient had no concomitant medications and no drug reactions or allergies. On 29-JUN-2016, the patient was vaccinated with ROTATEQ oral solution, lot # reported as M005733, expiry date 20-JAN-2017 (dose was not specified). Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, hib conj vaccine (unspecified carrier), poliovirus vaccine and PREVNAR, administered on the same day. On 29-JUN-2016, the patient instantaneously vomited after receiving ROTATEQ, The patient sought medical attention in the office at the time of the event. No treatment was given. No lab diagnostics were performed. The outcome of the event and the causality assessment were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age. On 23-JUN-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency, route of administration and indication were not reported, lot# L021215 with expiration date 10-JUN-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age. On 23-JUN-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency, route of administration and indication were not reported lot# L041206 with expiration date 20-OCT-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter and refers to a 2 patients of unknown age and gender. On 23-JUN-2016, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration and indication were not reported lot# L048462 with expiration date 02-DEC-2017). 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: M
Vaccine: ADEN_4_7, ANTH, CHOL, HEP, HEPA, IPV, JEVX, MMR
Symptoms: Blood uric acid increased, Gouty arthritis
Clinical narrative: Developed gouty arthritis in the months following anthrax vaccination. Has been suffering gouty arthritis acute flares multiple times per year since the vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Generalised erythema, Injection site erythema, Injection site reaction, Rash pruritic
Clinical narrative: Itchy rash with redness of skin that started on the site of the injection, and spread to involve almost the entire body. Took Benadryl tablet, without relief. Came in to the office for evaluation on 7/11/16 with the same symptoms. Treated with 3 day course of oral prednisone, Cetirizine and Benadryl.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Chills, Headache, Malaise, Nausea, Photosensitivity reaction
Clinical narrative: Patient developed severe bilateral temporal pain as well as severe chills, photosensitivity, and nausea. Mom administered Ibuprofen and symptoms subsided within 2-3 hours.  Patient then went to bed and slept for 11 hours.  The following day, patient was complaining of malaise but had no pain or other symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Erythema, swelling, pain at injection site, headache, diarrhea still persisting 6 days post injection (not resolved). Also fatigue, upset stomach, malaise.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise
Clinical narrative: Erythema, swelling, pain at injection site, headache, diarrhea still persisting 6 days post injection (not resolved). Also fatigue, upset stomach, malaise.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Chills, Nausea
Clinical narrative: After vaccination, client went home an approximately 1.5 hours later dad called that client was very nauseated, chills, and had severe abdominal pain.  The next day the family was contacted and the client was doing fine.  Had a quick onset.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 22-JUN-2016, the patients were vaccinated with improperly stored ZOSTAVAX, lot no. M001747/expiration date 07-APR-2017. No adverse event was reported. Temperature was 17.6 F and time frame was 4 hours, 15 minutes. There was no previous temperature excursion and call was not because of data logger. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored GARDASIL 9 (reported lot # K006124, with expiration date 02-FEB-2017 and L038135 with expiration 27-MAY-2017, both were not valid). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Extremely tired, Headache and high fever.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Borrelia test negative, Fatigue, Lethargy, Pyrexia
Clinical narrative: Extremely tired, Headache and high fever.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Nausea, Tremor, Vaccination complication, Vomiting
Clinical narrative: 7:45 am received vaccinations.  At 11:30 received a phone call from Mother that client had been taken to the ER.  He had severe shaking, nausea/vomiting/and a temp of 104.3.  IV was started and a full liter administered and then was released.  Was told it was a reaction to the vaccines.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Ultrasound scan normal
Clinical narrative: Left upper arm red, swollen, and painful.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Painful lump at injection site with swelling and redness.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Redness and swelling, warmth, pain at injection site, followed by red splotchy areas on distal arm over next 24-36 hours.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Parotid gland enlargement, Parotitis
Clinical narrative: She began to experience ipsilateral facial/parotid swelling following her 2nd dose of Bexsero. Came to the office on 7/9/2016 with parotitis.
Age: 0.53
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer referring to his 27 weeks old son. The patient's concurrent or historical condition was not provided. On 30-MAY-2016, the patient was vaccinated with first dose of ROTATEQ (oral, dose and lot number unknown) (drug used for unapproved schedule). Concomitant therapy was not provided. According to the doctor's instruction the date of 2nd dose was 30-JUN-2016. But the reporter came to known from Merck website that, the 3rd dose should be given before 32 weeks of age. His son's age was 32 week plus 3 days on 01-JUL-2016. His 2nd dose was still pending. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 6 months old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-APR-2016 at 18:26, the patient was vaccinated with improperly stored dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On 06-JUL-2016, the patient was inadvertently vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # L042258, expiration date 18-AUG-2018, dose and route of administration were not provided). No adverse were effects reported. Additional information is not expected as the reporter did not wish to be contacted.